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Medicare covers over 60 million seniors and nonelderly adults with significant long-term disabilities. Under current law, people with a sufficient work history are entitled to enroll in Medicare at age 65, and enrollment for non-elderly adults is limited to people who receive SSDI, generally after best place to buy propecia online a 24 month waiting period. This issue brief highlights key differences between Medicare and Medicaid and raises questions about how a policy to lower the age of Medicare eligibility could affect individuals who are currently enrolled in Medicaid.How could lowering the Medicare age affect people eligible for full Medicaid benefits?. What is best place to buy propecia online current policy?.

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Unlike the ACA expansion pathway, individuals who qualify under these pathways may be dually eligible for Medicare. For those dually eligible for Medicare and Medicaid, Medicare is the primary payer, and Medicaid provides wrap-around benefits, filling in gaps in Medicare coverage, and also helps with Medicare’s out-of-pocket costs (discussed below).What are the key policy choices and implications? best place to buy propecia online. Lowering the age for Medicare would require policy choices about whether to allow individuals in the new age range to continue to receive full Medicaid benefits, if eligible under the ACA expansion or other poverty- or disability-related pathways, or whether these individuals would move from Medicaid to Medicare as their sole or primary source of coverage. How these eligibility issues are resolved has important implications for enrollee benefits and cost-sharing as well as state and federal costs (discussed below).

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The appeals process also differs between the two programs, with Medicaid allowing services to continue while an appeal is pending.What are the best place to buy propecia online key policy choices and implications?. Policy choices about whether individuals in the new age range could retain Medicaid if eligible or instead would move from Medicaid to Medicare are important because individuals currently eligible for Medicaid could lose access to benefits not covered by Medicare if they are required to move to Medicare as their sole source of coverage. Additionally, those appealing benefit reductions or terminations would not have continued access to services while appeals are resolved in Medicare as is the case in Medicaid.How could lowering the Medicare age affect provider networks for current Medicaid enrollees?. What is current best place to buy propecia online policy?.

People may have access to different provider networks in Medicare vs. Medicaid, due to different managed care and network best place to buy propecia online adequacy rules. Once eligible for coverage, Medicare allows enrollees to choose whether to receive benefits under the traditional Medicare program, or enroll in a Medicare Advantage managed care plan. Traditional Medicare offers access to a broad provider network, while Medicare Advantage plans have restricted provider networks.

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The Medicare Savings Program (MSP) is a Medicaid pathway that helps to cover Medicare’s premiums and/or cost-sharing requirements for current Medicare enrollees with low income and limited assets. This is an important consideration because Medicare’s premiums and cost-sharing are higher than those under Medicaid, which limits best place to buy propecia online the populations who can be subject to premiums and has nominal cost-sharing. Box 1 summarizes current Medicare out-of-pocket costs and the assistance available through MSP.Box 1. Medicare Out-of-Pocket Costs and the best place to buy propecia online Medicare Savings ProgramMedicare Part A, which covers inpatient hospital services, has an annual deductible of $1,484 in 2021.

Medicare Part A also requires co-insurance for hospital stays over 60 days. Most Medicare beneficiaries qualify for Part A without a premium, based on their work history. Medicare Part B, which covers outpatient services, requires a monthly best place to buy propecia online premium of $148.50 for most beneficiaries in 2021. Part B also requires an annual deductible of $203 in 2021 and co-insurance of 20% of the Medicare-approved cost of services after the deductible is met.To help low-income enrollees afford Medicare’s out-of-pocket costs, state Medicaid programs must offer three MSP pathways:Qualified Medicare Beneficiaries (QMBs) generally have incomes up to 100% FPL ($1,073 per month for an individual and $1,452 for a couple in 2021).

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The asset limits described above also apply to the SLMB group.Qualified Individuals (QIs) are eligible for Medicaid assistance with Medicare Part B premiums through an expansion of the SLMB program. The QI program covers Medicare beneficiaries with incomes up to 135% FPL ($1,449 per best place to buy propecia online month for an individual and $1,960 for a couple in 2021). The asset limits described above also apply to the QI group. Unlike other Medicaid pathways, because Congress only appropriates a limited amount of funds to each state to pay for the QI program, once a state’s QI appropriation is spent, additional individuals who meet the eligibility criteria cannot receive help.What are the key policy choices and implications?.

Proposals to lower the Medicare age best place to buy propecia online likely will have to account for what type of assistance would be available to make the new coverage affordable for lower income enrollees, such as individuals who may lose Medicaid and transfer to Medicare. Without addressing this issue, some people could face higher out-of-pocket costs in Medicare compared to Medicaid. For example, people best place to buy propecia online ages 60-64 who currently receive Medicaid in the ACA expansion group are eligible for that coverage based on their low incomes and without an asset test. When these individuals become eligible for Medicare under current law, they must meet both income and asset limits (Box 1) to qualify for MSP help with Medicare out-of-pocket costs.

Though a few states have expanded or eliminated MSP asset limits, this generally means that individuals with savings above $7,970 would be ineligible for MSP, even though they might have been eligible for full Medicaid benefits in expansion states.How might lowering the Medicare age affect state and federal costs and provider payments?. What is current best place to buy propecia online policy?. Medicare is a federal program primarily financed by a combination of payroll taxes, general revenue, and premiums. In traditional Medicare, the best place to buy propecia online federal government establishes the methodology for making payments to hospitals, physicians and other health care providers under the traditional Medicare program and uses a formula to establish capitated payments to Medicare Advantage plans.

In contrast, Medicaid is financed jointly by states and the federal government, and states determine provider payment rates within broad federal standards.What are the key policy choices and implications?. The precise impact of lowering the Medicare age on federal and state costs depends on how the policy is structured. Transitioning current Medicaid enrollees to Medicare would be likely to increase federal spending and reduce best place to buy propecia online state costs as states would no longer share in the costs of covering these individuals. If individuals 60-64 are permitted to retain their current Medicaid eligibility, states would continue to fund a share of these individuals’ Medicaid costs, though Medicare would be the primary payer for the benefits it covers.

If enrollees move to Medicare and do not retain full Medicaid eligibility, the federal government would no longer pay for a share of benefits that are only best place to buy propecia online available through Medicaid (like long-term care).Whether and how lowering the Medicare age would affect provider payment rates is likely to vary depending on the type of provider. Medicaid payment rates for hospitals vary across states, but after accounting for supplemental payments, overall rates for hospitals are comparable to or higher than Medicare. Lowering the Medicare age might lead to lower revenues for physicians, as Medicaid payment rates for physicians tend to be lower than Medicare. Gross margins for Medicare Advantage plans are higher than for Medicaid managed best place to buy propecia online care plans, though Medicare Advantage plans now cover an older population with higher health spending.

While rates in Medicaid plans must be actuarily sound, they tend to be lower than other markets.Looking AheadLowering the Medicare enrollment age could have considerable impacts on the scope of covered benefits, out-of-pocket costs, and provider access for low-income people as well as implications for state and federal health care costs. Depending on individual best place to buy propecia online circumstances and key policy decisions, people who move from Medicaid to Medicare might experience higher out-of-pocket costs and/or fewer covered benefits. On the other hand, they might have access to a broader provider network in traditional Medicare, compared to their state’s Medicaid program. On the whole, current Medicaid enrollees are likely to face different issues than those who move from private insurance or uninsured status to Medicare.The question of what would happen when a new, expensive prescription drug comes to market for a disease like Alzheimer’s that afflicts millions of people has loomed large in discussions over drug prices in the U.S.—and now we’re about to find out.

After a nearly 20-year dry spell in new treatments for Alzheimer’s disease, the best place to buy propecia online Food and Drug Administration (FDA) just approved a new Alzheimer’s medication, Aduhelm (aducanumab), developed by Biogen, with an expected annual price tag of $56,000. While the scientific community debates the evidence of the effectiveness of this new drug, the FDA’s decision raises hope for Alzheimer’s patients and their families, along with serious cost concerns for patients and payers, particularly Medicare.Alzheimer’s disease is estimated to affect about 6 million Americans, the vast majority of whom are age 65 and older and therefore eligible for Medicare. As an intravenous infused best place to buy propecia online medication administered by physicians, Aduhelm will be covered under Medicare Part B, which generally covers FDA-approved physician-administered medications that are reasonable and necessary for the individual patient. (In contrast, Medicare Part D covers retail prescription drugs.) With FDA approval in hand, attention now turns to decision-makers at the Centers for Medicare &.

Medicaid Services (CMS) who may opt to undertake a National Coverage Determination process that could set some limits on the conditions of Medicare coverage for Aduhelm based on the drug’s clinical effectiveness.Medicare’s long-standing practice is to make coverage determinations without taking cost into consideration. While Medicare sets best place to buy propecia online rates for hospitals and other providers, it does not set its own rates for drugs covered under Part B. Instead, Medicare reimburses providers 106% of the Average Sales Price (ASP), which is the average price to all non-federal purchasers in the U.S, inclusive of rebates. For drugs best place to buy propecia online where no ASP is available, such as a new drug like Aduhelm, Medicare pays 103% of the wholesale acquisition cost (WAC) until ASP data are available.

The WAC is equivalent to a list price and typically higher than ASP. Biogen has set the list price for Aduhelm at $56,000 for a year of treatment.It is hard to know exactly how many Medicare beneficiaries will take Aduhelm, but even a conservative estimate would lead to a substantial increase in Medicare spending. In 2017, nearly 2 best place to buy propecia online million Medicare beneficiaries used one or more of the currently-available Alzheimer’s treatments covered under Part D, based on our analysis of Medicare Part D claims data. If just one-quarter of these beneficiaries are prescribed Aduhelm, or 500,000 beneficiaries, and Medicare pays 103% of $56,000 in the near term, total spending for Aduhelm in one year alone would be nearly $29 billion, paid by Medicare and the patients who use this drug – an amount that far exceeds spending on any other drug covered under Medicare Part B or Part D, based on 2019 spending.

To put best place to buy propecia online this $29 billion amount in context, total Medicare spending for all Part B drugs was $37 billion in 2019.If 1 million Medicare beneficiaries receive Aduhelm, which may even be on the low end of Biogen’s expectations, spending on Aduhelm alone would exceed $57 billion dollars in a single year – far surpassing spending on all other Part B-covered drugs combined. In fact, this amount is roughly the same that Medicare paid for all hospital outpatient services in 2019.Alzheimer’s patients covered under Medicare Part B could also face high out-of-pocket costs for treatment with Aduhelm, both for the drug itself and for the cost of related medical services. For most Part B covered drugs and services, Medicare pays 80% of the cost and beneficiaries are responsible for the remaining 20%. This means beneficiaries would face about $11,500 in coinsurance for one year of Aduhelm treatment, which best place to buy propecia online represents nearly 40% of the $29,650 in median annual income per Medicare beneficiary in 2019.

Because Aduhelm is not a cure for Alzheimer’s disease, patients could incur these annual out-of-pocket costs over multiple years.The majority of beneficiaries in traditional Medicare have supplemental insurance, such as Medigap, employer-sponsored retiree coverage, or Medicaid, that would cover some or all of the coinsurance. However, beneficiaries with best place to buy propecia online Medigap or retiree health could see their premiums rise to account for higher plan liability associated with costs for Aduhelm. And close to 6 million Medicare beneficiaries, or 10% of all beneficiaries, are in traditional Medicare with no supplemental coverage, which means they are fully exposed to Medicare’s cost-sharing requirements and lack the financial protection of an out-of-pocket cap, unlike enrollees in Medicare Advantage plans.The 24 million beneficiaries enrolled in Medicare Advantage plans are also responsible for cost sharing for Part B drugs, like Abuhelm, though they typically do not have supplemental insurance to help with these expenses. According to our estimates, in 2021, nearly 90% of Medicare Advantage enrollees are in plans that charge 20% coinsurance for Part B drugs provided in-network, the same as under traditional Medicare, though some plans impose coinsurance as high as 45% or 50% for Part B drugs administered by out-of-network providers.

Medicare Advantage enrollees who use Aduhelm would be responsible for their share of costs until they reach the annual out-of-pocket maximum ($7,550 for in-network care and $11,300 for combined in-network and out-of-network care in 2021).The billions of dollars in best place to buy propecia online new Medicare Part B spending will likely lead to higher Part B premiums for all 56 million Part B enrollees in traditional Medicare and Medicare Advantage. Since Part B premiums are set to equal 25% of projected annual Part B expenditures, an increase in spending would lead to an increase in premiums. State and federal Medicaid spending will also rise, since Medicaid pays the Part B premium for about 12 million low-income Medicare beneficiaries with Medicaid, and covers coinsurance for 9 million of these beneficiaries who have both Medicare and full Medicaid coverage.The introduction of a new high-priced drug could energize efforts best place to buy propecia online in Congress to enact drug price legislation. Under H.R.

3, which passed the House of Representatives in the last Congress and was recently reintroduced, the HHS Secretary would have authority to negotiate prices for up to 250 drugs, drawing from the 125 drugs with the highest net spending in Medicare Part D and the 125 drugs with the highest net spending in the U.S. Overall, which best place to buy propecia online could include drugs covered under Part B, such as Aduhelm. Negotiated prices would be made available to enrollees in Part D plans and private insurance coverage, and to providers that administer physician-administered drugs. Other proposals under active consideration would limit annual price increases for Part B and Part D drugs and limit the financial incentives under Medicare’s existing Part B best place to buy propecia online reimbursement system for physicians to administer higher-priced drugs.

The Center for Medicare and Medicaid Innovation could also test models to modify Medicare payments for high-priced drugs.At a time when federal and state policymakers are weighing several policy options to lower prescription drug prices, the approval of Aduhelm provides the latest high-profile example of the potential budgetary consequences of Medicare’s role as a price-taker in the pharmaceutical marketplace. Concerns about the impact on Medicare spending associated with Aduhelm are reminiscent of discussions that took place after the introduction of high-cost treatments for hepatitis C, though in that case, the new drugs cured the disease and were approved for a much smaller patient population. Aduhelm may represent hope for Alzheimer’s patients and their families who have waited years for new treatments to come along, but that hope is likely to come at a high best place to buy propecia online cost to Medicare, beneficiaries, and taxpayers.This work was supported in part by Arnold Ventures. We value our funders.

KFF maintains full editorial control over all of its policy analysis, polling, and journalism activities..

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We each have the moral obligation to call out racism in all its forms and to come together to continue the work to eliminate the systemic racism experienced by First Nations, Inuit and Métis in Canada’s healthcare systems. As such, the Government of Canada convened a virtual gathering today to listen to Indigenous Peoples and healthcare professionals share the lived experience of the systemic racism in federal, provincial and territorial healthcare systems. Today, all present acknowledged the critical need to take real action to address the unacceptable racism and best place to buy propecia online discrimination in all of our institutions. The experiences shared by the participants will inform urgent, concrete short-term measures that governments, health authorities, educational institutions, health professional associations, regulatory colleges and accreditation organizations can implement to prevent and document systemic and overt racism and ensure consequences and accountability. Today’s dialogue also emphasized the actions we need to take to strengthen the representation of Indigenous Peoples in the delivery of health services, support improved safety of Indigenous Peoples in the healthcare system and improve culturally safe approaches to care and services.

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October 16, 2020Time. 3:30 PM (EDT) Location. Sir John A. Macdonald Building - Room 200144 Wellington StreetOttawa, Ontario The media availability will also be held by teleconference:Toll-free (Canada/US) dial-in number. 1-866-206-0153Local dial-in number.

Effects of propecia on pregnancy

Start Preamble Department of Veterans effects of propecia on pregnancy Affairs. Interim final rule. The Department of Veterans Affairs (VA) is issuing this interim final rule to effects of propecia on pregnancy confirm that its health care professionals may practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other requirements that unduly interfere with their practice. Specifically, this rulemaking confirms VA's current practice of allowing VA health care professionals to deliver health care services in a State other than the health care professional's State of licensure, registration, certification, or other State requirement, thereby enhancing beneficiaries' access to critical VA health care services. This rulemaking effects of propecia on pregnancy also confirms VA's authority to establish national standards of practice for health care professionals which will standardize a health care professional's practice in all VA medical facilities.

Effective Date. This rule is effective on November 12, 2020. Comments effects of propecia on pregnancy. Comments must be received on or before January 11, 2021. Comments may be submitted through www.Regulations.gov or mailed to, Beth Taylor, 10A1, 810 Vermont Avenue effects of propecia on pregnancy NW, Washington, DC 20420.

Comments should indicate that they are submitted in response to [“RIN 2900-AQ94—Authority of VA Professionals to Practice Health Care.”] Comments received will be available at regulations.gov for public viewing, inspection, or copies. Start Further Info Beth Taylor, effects of propecia on pregnancy Chief Nursing Officer, Veterans Health Administration. 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-7250. (This is not a toll-free number.) End Further Info End Preamble Start Supplemental Information On January 30, 2020, the World Health Organization (WHO) declared the hair loss treatment outbreak to be a Public Health Emergency of International Concern. On January effects of propecia on pregnancy 31, 2020, the Secretary of the Department of Health and Human Services declared a Public Health Emergency pursuant to 42 United States Code (U.S.C.) 247d, for the entire United States to aid in the nation's health care community response to the hair loss treatment outbreak.

On March 11, 2020, in light of new data and the rapid spread in Europe, WHO declared hair loss treatment to be a propecia. On March 13, 2020, the President declared a National Emergency due to hair loss treatment effects of propecia on pregnancy under sections 201 and 301 of the National Emergencies Act (50 U.S.C. 1601 et seq.) and consistent with section 1135 of the Social Security Act (SSA), as amended (42 U.S.C. 1320b-5). As a result of responding to the needs of our veteran population and other non-veteran beneficiaries during the hair loss treatment National Emergency, where VA has had to shift health care Start Printed Page 71839professionals to other locations or duties to assist in the care of those affected by this propecia, VA has become acutely aware of the need to promulgate this rule to clarify the policies governing VA's provision of health care.

This rule is intended to confirm that VA health care professionals may practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other requirements that unduly interfere with their practice. In particular, it will confirm (1) VA's continuing practice of authorizing VA health care professionals to deliver health care services in a State other than the health care professional's State of licensure, registration, certification, or other requirement. And (2) VA's authority to establish national standards of practice for health care professions via policy, which will govern their employment, subject only to State laws where the health care professional is licensed, credentialed, registered, or subject to some other State requirements that do not unduly interfere with those duties. We note that the term State as it applies to this rule means each of the several States, Territories, and possessions of the United States, the District of Columbia, and the Commonwealth of Puerto Rico, or a political subdivision of such State. This definition is consistent with the term State as it is defined in 38 U.S.C.

101(20). A conflicting State law is one that would unduly interfere with the fulfillment of a VA health care professional's Federal duties. We note that the policies and practices confirmed in this rule only apply to VA health care professionals appointed under 38 U.S.C. 7306, 7401, 7405, 7406, or 7408 or title 5 of the U.S. Code, which does not include contractors working in VA medical facilities or those working in the community.

VA has long understood its governing statutory authorities to permit VA to engage in these practices. Section 7301(b) of title 38 the U.S. Code establishes that the primary function of the Veterans Health Administration (VHA) within VA is to provide a complete medical and hospital service for the medical care and treatment of veterans. To allow VHA to carry out its medical care mission, Congress established a comprehensive personnel system for certain VA health care professionals, independent of the civil service rules. See Chapters 73-74 of title 38 of the U.S.

Code. Congress granted the Secretary express statutory authority to establish the qualifications for VA's health care professionals, determine the hours and conditions of employment, take disciplinary action against employees, and otherwise regulate the professional activities of those individuals. 38 U.S.C. 7401-7464. Section 7402 of 38 U.S.C.

Establishes the qualifications of appointees. To be eligible for appointment as a VA employee in a health care profession covered by section 7402(b) (other than a medical facility Director appointed under section 7402(b)(4)), most individuals, after appointment, must, among other requirements, be licensed, registered, or certified to practice their profession in a State, or satisfy some other State requirement. However, the standards prescribed in section 7402(b) establish only the basic qualifications for VA health care professionals and do not limit the Secretary from establishing other qualifications or rules for health care professionals. In addition, the Secretary is responsible for the control, direction, and management of the Department, including agency personnel and management matters. See 38 U.S.C.

303. Such authorities permit the Secretary to further regulate the health care professions to make certain that VA's health care system provides safe and effective health care by qualified health care professionals to ensure the well-being of those veterans who have borne the battle. In this rulemaking, VA is detailing its authority to manage its health care professionals by stating that they may practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other State requirements that unduly interfere with their practice. VA believes that this is necessary in order to provide additional protection for VA health care professionals against adverse State actions proposed or taken against them when they are practicing within the scope of their VA employment, particularly when they are practicing across State lines or when they are performing duties consistent with a VA national standard of practice for their health care profession. Practice Across State Lines Historically, VA has operated as a national health care system that authorizes VA health care professionals to practice in any State as long as they have a valid license, registration, certification, or fulfill other State requirements in at least one State.

In doing so, VA health care professionals have been practicing within the scope of their VA employment regardless of any unduly burdensome State requirements that would restrict practice across State lines. We note, however, that VA may only hire health care professionals who are licensed, registered, certified, or satisfy some other requirement in a State, unless the statute requires or provides otherwise (e.g., 38 U.S.C. 7402(b)(14)). The hair loss treatment propecia has highlighted VA's acute need to exercise its statutory authority of allowing VA health care professionals to practice across State lines. In response to the propecia, VA needed to and continues to need to move health care professionals quickly across the country to care for veterans and other beneficiaries and not have State licensure, registration, certification, or other State requirements hinder such actions.

Put simply, it is crucial for VA to be able to determine the location and practice of its VA health care professionals to carry out its mission without any unduly burdensome restrictions imposed by State licensure, registration, certification, or other requirements. This rulemaking will support VA's authority to do so and will provide an increased level of protection against any adverse State action being proposed or taken against VA health care professionals who practice within the scope of their VA employment. Since the start of the propecia, in furtherance of VA's Fourth Mission, VA has rapidly utilized its resources to assist parts of the country that are undergoing serious and critical shortages of health care resources. VA's Fourth Mission is to improve the Nation's preparedness for response to war, terrorism, national emergencies, and natural disasters by developing plans and taking actions to ensure continued service to veterans, as well as to support national, State, and local emergency management, public health, safety and homeland security efforts. VA has deployed personnel to support other VA medical facilities that have been impacted by hair loss treatment as well as provided support to State and community nursing homes.

As of July 2020, VA has deployed personnel to more than 45 States. VA utilized the Disaster Emergency Medical Personnel System (DEMPS), VA's main deployment program, for VA health care professionals to travel to locations deemed as national emergency or disaster areas, to help provide health care services in places such as New Orleans, Louisiana, and New York City, New York. As of June 2020, a total of 1,893 staff have been mobilized to meet the needs of our facilities and Fourth Start Printed Page 71840Mission requests during the propecia. VA deployed 877 staff to meet Federal Emergency Management Agency (FEMA) Mission requests, 420 health care professionals were deployed as DEMPS response, 414 employees were mobilized to cross level staffing needs within their Veterans Integrated Service Networks (VISN), 69 employees were mobilized to support needs in another VISN, and 113 Travel Nurse Corps staff responded specifically for hair loss treatment staffing support. In light of the rapidly changing landscape of the propecia, it is crucial for VA to be able to move its health care professionals quickly across the country to assist when a new hot spot emerges without fear of any adverse action from a State be proposed or taken against a VA health care professional.

We note that, in addition to providing in person health care across State lines during the propecia, VA also provides telehealth across State lines. VA's video to home services have been heavily leveraged during the propecia to deliver safe, quality VA health care while adhering to Centers for Disease Control and Prevention (CDC) physical distancing guidelines. Video visits to veterans' homes or other offsite location have increased from 41,425 in February 2020 to 657,423 in July of 2020. This represents a 1,478 percent utilization increase. VA has specific statutory authority under 38 U.S.C.

1730C to allow health care professionals to practice telehealth in any State regardless of where they are licensed, registered, certified, or satisfy some other State requirement. This rulemaking is consistent with Congressional intent under Public Law 115-185, sec. 151, June 6, 2018, codified at 38 U.S.C. 1730C for all VA health care professionals to practice across State lines regardless of the location of where they provide health care. This rulemaking will ensure that VA professionals are protected regardless of how they provide health care, whether it be via telehealth or in-person.

Beyond the current need to mobilize health care resources quickly to different parts of the country, this practice of allowing VA health care professionals to practice across State lines optimizes the VA health care workforce to meet the needs of all VA beneficiaries year-round. It is common practice within the VA health care system to have primary and specialty health care professionals routinely travel to smaller VA medical facilities or rural locations in nearby States to provide care that may be difficult to obtain or unavailable in that community. As of January 14, 2020, out of 182,100 licensed health care professionals who are employed by VA, 25,313 or 14 percent do not hold a State license, registration, or certification in the same State as their main VA medical facility. This number does not include the VA health care professionals who practice at a main VA medical facility in one State where they are licensed, registered, certified, or hold some other State requirement, but also practice at a nearby Community Based Outpatient Clinic (CBOC) in a neighboring State where they do not hold such credentials. Indeed, 49 out of the 140 VA medical facilities nationwide have one or more sites of care in a different State than the main VA medical facility.

Also, VA has rural mobile health units that provide health care services to veterans who have difficulty accessing VA health care facilities. These mobile units are a vital source of health care to veterans who live in rural and medically underserved communities. Some of the services provided by the mobile units include, but are not limited to, health care screening, mental health outreach, influenza and pneumonia vaccinations, and routine primary care. The rural mobile health units are an integral part of VA's goal of encouraging healthier communities and support VA's preventative health programs. Health care professionals who provide health care in these mobile units may provide services in various States where they may not hold a license, registration, or certification, or satisfy some other State requirement.

It is critical that these health care professionals are protected from any adverse State action proposed or taken when performing these crucial services. In addition, the practice of health care professionals of providing health care across State lines also gives VA the flexibility to hire qualified health care professionals from any State to meet the staffing needs of a VA health care facility where recruitment or retention is difficult. As of December 31, 2019, VA had approximately 13,000 vacancies for health care professions across the country. As a national health care system, it is imperative for VA to be able to recruit and retain health care professionals, where recruitment and retention is difficult, to ensure there is access to health care regardless of where the VA beneficiary resides. Permitting VA health care professionals to practice across State lines is an important incentive when trying to recruit for these vacancies, particularly during a propecia, where private health care facilities have greater flexibility to offer more competitive pay and benefits.

This is also especially beneficial in recruiting spouses of active service members who frequently move across the country. National Standard of Practice This rulemaking also confirms VA's authority to establish national standards of practice for health care professions. We note that this rulemaking does not create any such national standards. All national standards of practice will be created via policy. For the purposes of this rulemaking, a national standard of practice describes the tasks and duties that a VA health care professional practicing in the health care profession may perform and may be permitted to undertake.

Having a national standard of practice means that individuals from the same VA health care profession may provide the same type of tasks and duties regardless of the VA medical facility where they are located or the State license, registration, certification, or other State requirement they hold. We emphasize that VA will determine, on an individual basis, that a health care professional has the necessary education, training, and skills to perform the tasks and duties detailed in the national standard of practice. The need for national standards of practice have been highlighted by VA's large-scale initiative regarding the new electronic health record (EHR). VA's health care system is currently undergoing a transformational initiative to modernize the system by replacing its current EHR with a joint EHR with Department of Defense (DoD) to promote interoperability of medical data between VA and DoD. VA's new EHR system will provide VA and DoD health care professionals with quick and efficient access to the complete picture of a veteran's health information, improving VA's delivery of health care to our nation's veterans.

For this endeavor, DoD and VA established a joint governance over the EHR system. In order to be successful, VA must standardize clinical processes with DoD. This means that all health care professionals in DoD and VA who practice in a certain health care profession must be able to carry out the same duties and tasks irrespective of State requirements. The reason why this is important is because each health care profession is designated a role in the EHR system that sets forth specific privileges within the EHR that dictate allowed tasks for such profession. These tasks include, but are not limited to, dispensing and administrating medications.

Prescriptive practices. Ordering of procedures and diagnostic imaging. And required level of oversight. VA has the ability to modify these privileges within EHR, however, VA Start Printed Page 71841cannot do so on an individual user level, but rather at the role level for each health care profession. In other words, VA cannot modify the privileges for all health care professionals in one State to be consistent with that State's requirements.

Instead, the privileges can only be modified for every health care professional in that role across all States. Therefore, the privileges established within EHR cannot be made facility or State specific. In order to achieve standardized clinical processes, VA and DoD must create the uniform standards of practice for each health care specialty. Currently, DoD has specific authority from Congress to create national standards of practice for their health care professionals under 10 U.S.C. 1094.

While VA lacks a similarly specific statute, VA has the general statutory authority, as explained above, to regulate its health care professionals and authorize health care practices that preempt conflicting State law. This regulation will confirm VA's authority to do so. Absent such standardized practices, it will be incredibly difficult for VA to achieve its goal of being an active participant in EHR modernization because either some VA health care professionals would fear potential adverse State actions or DoD and VA would need to agree upon roles that are consistent with the most restrictive States' requirements to ensure that all health care professionals are acting within the scope of their State requirements. VA believes that agreement upon roles that are consistent with the most restrictive State is not an acceptable option because it will lead to delayed care and consequently decreased access and level of health care for VA beneficiaries. One example that impacts multiple health care professions throughout the VA system is the ability to administer medication without a provider (physician or advanced practice nurse practitioner) co-signature.

As it pertains to nursing, almost all States permit nurses to follow a protocol. However, some States, such as New York, North Carolina, and South Carolina, do not permit nurses to follow a protocol without a provider co-signature. A protocol is a standing order that has been approved by medical and clinical leadership if a certain sequence of health care events occur. For instance, if a patient is exhibiting certain signs of a heart attack, there is a protocol in place to administer potentially life-saving medication. If the nurse is the first person to see the signs, the nurse will follow the approved protocol and immediately administer the medication.

However, if the nurse cannot follow the protocol and requires a provider co-signature, administration of the medication will be delayed until a provider is able to co-sign the order, which may lead to the deterioration of the patient's condition. This also increases the provider's workload and decreases the amount of time the provider can spend with patients. Historically, VA physical therapists (PTs), occupational therapists, and speech therapists were routinely able to determine the need to administer topical medications during therapy sessions and were able to administer the topical without a provider co-signature. However, in order to accommodate the new EHR system and variance in State requirements, these therapists would need to place an order for all medications, including topicals, which would leave these therapists waiting for a provider co-signature in the middle of a therapy session, thus delaying care. Furthermore, these therapists also routinely ordered imaging to better assess the clinical needs of the patient, but would also have to wait for a provider co-signature, which will further delay care and increase provider workload.

In addition to requiring provider co-signatures, there will also be a significant decrease in access to care due to other variances in State requirements. For instance, direct access to PTs will be limited in order to ensure that the role is consistent with all State requirements. Direct access means that a beneficiary may request PT services without a provider's referral. However, while almost half of the States allow unrestricted direct access to PTs, over half of the States have some limitations on requesting PT services. For instance, in Alabama, a licensed PT may perform an initial evaluation and may only provide other services as delineated in specific subdivisions of the Alabama Physical Therapy Practice Act.

Furthermore, in New York, PT treatment may be rendered by a licensed PT for 10 visits or 30 days, whichever shall occur first, without a referral from a physician, dentist, podiatrist, nurse practitioner, or licensed midwife. This is problematic as VA will not be able to allow for direct access due to these variances and direct access has been shown to be beneficial for patient care. Currently, VISN 23 is completing a two-year strategic initiative to implement direct access and have PTs embedded into patient aligned care teams (PACT). Outcomes thus far include decreased wait times, improved veteran satisfaction, improved provider satisfaction, and improved functional outcomes. Therefore, VA will confirm its authority to ensure that health care professionals are protected against State action when they adhere to VA's national standards of practice.

We reiterate that this rulemaking does not establish national standards of practice for each health care profession, but merely confirms VA's authority to do so, thereby preempting any State restrictions that unduly interfere with those practices. The actual national standards of practice will be developed in subregulatory policy for each health care profession. As such, VA will make a concerted effort to engage appropriate stakeholders when developing the national standards of practice. Preemption As previously explained, in this rulemaking, VA is confirming its authority to manage its health care professionals. Specifically, this rulemaking will confirm VA's long-standing practice of allowing its health care professionals to practice in a State where they do not hold a license, registration, certification, or satisfy some other State requirement.

The rule will also confirm that VA health care professionals must adhere to VA's national standards of practice, as determined by VA policy, irrespective of conflicting State licensing, registration, certification, or other State requirements that unduly burden that practice. We do note that VA health care professionals will only be required to perform tasks and duties to the extent of their education, skill, and training. For instance, VA would not require a registered nurse to perform a task that the individual nurse was not trained to perform. Currently, practice in accordance with VA employment, including practice across State lines or adhering to a VA standard of practice, may jeopardize VA health care professionals' credentials or result in fines and imprisonment for unauthorized health care practice. This is because most States have restrictions that limit health care professionals' practice or have rules that prohibit health care professionals from furnishing health care services within that State without a license, registration, certification, or other requirement from that State.

We note that, some States, for example Rhode Island, Utah, and Michigan, have enacted legislation or regulations that specifically allow certain VA health care professionals to practice in those States when they do not hold a State license. Several VA health care professionals have already had actions proposed or taken against them by various States Start Printed Page 71842while practicing health care within the scope of their VA employment, while they either practiced in a State where they do not hold a license, registration, certification, or other State requirement that unduly interfered with their VA employment. In one instance, a VA psychologist was licensed in California but was employed and providing supervision of a trainee at the VA Medical Center (VAMC) in Nashville, Tennessee. California psychology licensing laws require supervisors to hold a license from the State where they are practicing and do not allow for California licensed psychologists to provide supervision to trainees or unlicensed psychologists outside the State of California. The California State Psychology Licensing Board proposed sanctions and fines of $1,000 for violating section 1387.4(a) of the CA Code of Regulations (CCR).

The VA system did not qualify for the exemption of out of State supervision requirements listed in CCR section 1387.4. In addition, a VA physician who was licensed in Oregon, but was practicing at a VAMC in Biloxi, Mississippi had the status of their license changed from active to inactive because the Oregon Medical Board determined the professional did not reside in Oregon, in violation of Oregon's requirement that a physician physically reside in the State in order to maintain an active license. This rulemaking serves to preempt State requirements, such as the ones discussed above, that were or can be used to take an action against VA health care professionals for practicing within the scope of their VA employment. State licensure, registration, certification, and other State requirements are preempted to the extent such State laws unduly interfere with the ability of VA health care professionals to practice health care while acting within the scope of their VA employment. As explained above, Congress provided general statutory provisions that permit the VA Secretary to authorize health care practices by health care professionals at VA, which serve to preempt conflicting State laws that unduly interfere with the exercise of health care by VA health care professionals pursuant to that authorization.

Although some VA health care professionals are required by Federal statute to have a State license, see, e.g., 38 U.S.C. 7402(b)(1)(C) (providing that, to be eligible to be appointed to a physician position at the VA, a physician must be licensed to practice medicine, surgery, or osteopathy in a State), a State may not attach a condition to the license that is unduly burdensome to or unduly interferes with the practice of health care within the scope of VA employment. Under well-established interpretations of the Supremacy Clause, Federal laws and policies authorizing VA health care professionals to practice according to VA standards preempt conflicting State law. That is, a State law that prevents or unreasonably interferes with the performance of VA duties. See, e.g., Hancock v.

Train, 426 U.S. 167, 178-81 (1976). Sperry v. Florida, 373 U.S. 379, 385 (1963).

Miller v. Arkansas, 352 U.S. 187 (1956). Ohio v. Thomas, 173 U.S.

276, 282-84 (1899). State Bar Disciplinary Rules as Applied to Federal Government Attorneys, 9 Op. O.L.C. 71, 72-73 (1985). When a State law does not conflict with the performance of Federal duties in these ways, VA health care professionals are required to abide by the State law.

Therefore, VA's policies and regulations will preempt State licensure, registration, and certification laws, rules, or other requirements only to the extent they conflict with the ability of VA health care professionals to practice health care while acting within the scope of their VA employment. We emphasize that, in instances where there is no conflict with State requirements, VA health care professionals should abide by the State requirement. For example, if a State license requires a health care professional to have a certain number of hours of continuing professional education per year to maintain their license, the health care professional must adhere to this State requirement if it does not prevent or unduly interfere with the exercise of VA employment. To determine whether a State requirement is conflicting, VA would assess whether the State law unduly interferes on a case-by-case basis. For instance, if Oregon requires all licensed physicians to reside in Oregon, VA would likely find that it unduly interferes with already licensed VA physicians who reside and work for VA in the State of Mississippi.

We emphasize that the intent of the regulation is to only preempt State requirements that are unduly burdensome and interfere with a VA health care professionals' practice for the VA. For instance, it would not require a State to issue a license to an individual who does not meet the education requirements to receive a license in that State. We note that this rulemaking also does not affect VA's existing requirement that all VA health care professionals adhere to restrictions imposed by the Controlled Substances Act, 21 U.S.C. 801 et seq. And implementing regulations at 21 CFR 1300, et seq., to prescribe or administer controlled substances.

Any preemption of conflicting State requirements will be the minimum necessary for VA to effectively furnish health care services. It would be costly and time-consuming for VA to lobby each State board for each health care profession specialty to remove restrictions that impair VA's ability to furnish health care services to beneficiaries and then wait for the State to implement appropriate changes. Doing so would not guarantee a successful result. Regulation For these reasons, VA is establishing a new regulation titled Health care professionals' practice in VA, which will be located at 38 CFR 17.419. This rule will confirm the ability of VA health care professionals to practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other requirements that unduly interfere with their practice.

Subsection (a) of § 17.419 contains the definitions that will apply to the new section. Subsection (a)(1) contains the definition for beneficiary. We are defining the term beneficiary to mean a veteran or any other individual receiving health care under title 38 of the U.S. Code. We are using this definition because VA provides health care to veterans, certain family members of veterans, servicemembers, and others.

This is VA's standard use of this term. Subsection (a)(2) contains the definition for health care professional. We are defining the term health care professional to be an individual who meets specific criteria that is listed below. Subsection (a)(2)(i) will require that a health care professional be appointed to an occupation in VHA that is listed or authorized under 38 U.S.C. 7306, 7401, 7405, 7406, or 7408 or title 5 of the U.S.

Code. Subsection (a)(2)(ii) requires that the individual is not a VA-contracted health care professional. A health care professional does not include a contractor or a community health care professional because they are not considered VA employees nor appointed under 38 U.S.C. 7306, 7401, 7405, 7406, or 7408 or title 5 of the U.S. Code.

Subsection (a)(2)(iii) lists the required qualifications for a health care professional. We note that these qualifications do not include all general Start Printed Page 71843qualifications for appointment, such as to hold a degree of doctor of medicine. These qualifications are related to licensure, registration, certification, or other State requirements. Subsection (a)(2)(iii)(A) states that the health care professional must have an active, current, full, and unrestricted license, registration, certification, or satisfies another State requirement in a State to practice the health care specialty identified under 38 U.S.C. 7402(b).

This standard ensures that VA health care professionals are qualified to practice their individual health care specialty if the specialty requires such credential. Subsection (a)(2)(iii)(B) states that the individual has other qualifications as prescribed by the Secretary for one of the health care professions listed under 38 U.S.C. 7402(b). Some health care professionals appointed under 38 U.S.C. 7401(3) whose qualifications are listed in 38 U.S.C.

7402(b) are not required to meet State license, registration, certification, or other requirements and rely on the qualifications prescribed by the Secretary. Therefore, these individuals would be included in this subsection and required to have the qualifications prescribed by the Secretary for their health care profession. Subsection (a)(2)(iii)(C) states that the individual is otherwise authorized by the Secretary to provide health care services. This would include those individuals who practice a health care profession that does not require a State license, registration, certification, or other requirement and is also not listed in 38 U.S.C. 7402(b), but is authorized by the Secretary to provide health care services.

Subsection (a)(2)(iii)(D) includes individuals who are trainees or may have a time limited appointment to finish clinicals or other requirements prior to being fully licensed. Therefore, the regulation will state that the individual is under the clinical supervision of a health care professional that meets the requirements listed in subsection (a)(2)(iii)(A)-(C) and the individual must meet the requirements in subsection (a)(2)(iii)(D)(i) or (a)(2)(iii)(D)(ii). Subsection (a)(2)(iii)(D)(i) states that the individual is a health professions trainee appointed under 38 U.S.C. 7405 or 7406 participating in clinical or research training under supervision to satisfy program or degree requirements. Subsection (a)(2)(iii)(D)(ii) states that the individual is a health care employee, appointed under title 5 of the U.S.

Code, 38 U.S.C. 7401(1) or (3), or 38 U.S.C. 7405 for any category of personnel described in 38 U.S.C. 7401(1) or (3) who must obtain an active, current, full and unrestricted licensure, registration, or certification or meet the qualification standards as defined by the Secretary within the specified time frame. These individuals have a time-limited appointment to obtain credentials.

For example, marriage and family therapists require a certain number of supervised clinical post-graduate hours prior to receiving their license. Lastly, as we previously discussed in this rulemaking, we are defining the term State in subsection (a)(3) as the term is defined in 38 U.S.C. 101(20), and also including political subdivisions of such States. This is consistent with the definition of State in 38 U.S.C. 1730C(f) which is VA's statutory authority to preempt State law when the covered health care professional is using telehealth to provide treatment to an individual under this title.

We believe that it is important to define the term in the same way as it is defined for health care professionals practicing via telehealth so that way it is consistent regardless of whether the health care professional is practicing in-person or via telehealth. Moreover, as subdivisions of a State are granted legal authority from the State itself, it makes sense to subject entities created by a State, or authorized by a State to create themselves, to be subject to the same limitations and restrictions as the State itself. Section 17.419(b) details that VA health care professionals must practice within the scope of their Federal employment irrespective of conflicting State requirements that would prevent or unduly interfere with the exercise of Federal duties. This provision confirms that VA health care professionals may furnish health care consistent with their VA employment obligations without fear of adverse action proposed or taken by any State. In order to clarify and make transparent how VA utilizes or intends to utilize our current statutory authority, we are providing a non-exhaustive list of examples.

The first example is listed in subsection (b)(1)(i). It states that a health care professional may practice their VA health care profession in any State irrespective of the State where they hold a valid license, registration, certification, or other qualification. The second example is listed in subsection (b)(1)(ii). It states that a health care professional may practice their VA health care profession consistent with the VA national standard of practice as determined by VA. As previously explained, VA intends to establish national standards of practice via VA policy.

A health care professional's practice within VA will continue to be subject to the limitations imposed by the Controlled Substances Act, 21 U.S.C. 801, et seq. And implementing regulations at 21 CFR 1300, et seq., on the authority to prescribe or administer controlled substances, as well as any other limitations on the provision of VA care set forth in applicable Federal law and policy. This will ensure that professionals are still in compliance with critical laws concerning the prescribing and administering of controlled substances. This requirement is stated in subsection (b)(2).

Subsection (c) expressly states the intended preemptive effect of § 17.419, to ensure that conflicting State and local laws, rules, regulations, and requirements related to health care professionals' practice will have no force or effect when such professionals are practicing health care while working within the scope of their VA employment. In circumstances where there is a conflict between Federal and State law, Federal law would prevail in accordance with Article VI, clause 2, of the U.S. Constitution. Executive Order 13132 establishes principles for preemption of State law when it is implicated in rulemaking or proposed legislation. Where a Federal statute does not expressly preempt State law, agencies shall construe any authorization in the statute for the issuance of regulations as authorizing preemption of State law by rulemaking only when the exercise of State authority directly conflicts with the exercise of Federal authority or there is clear evidence to conclude that the Congress intended the agency to have the authority to preempt State law.

In this situation, the Federal statutes do not expressly preempt State laws. However, VA construes the authorization established in 38 U.S.C. 303, 501, and 7401-7464 as authorizing preemption because the exercise of State authority directly conflicts with the exercise of Federal authority under these statutes. Congress granted the Secretary express statutory authority to establish the qualifications for VA's health care professionals, determine the hours and conditions of employment, take disciplinary action against employees, and otherwise regulate the professional activities of those individuals. 38 U.S.C.

7401-7464. Specifically, section 7402(b) states that most health care professionals, after appointment by VA, must, among other Start Printed Page 71844requirements, be licensed, registered, or certified to practice their profession in a State. To that end, VA's regulations and policies will preempt any State law or action that conflicts with the exercise of Federal duties in providing health care at VA. In addition, any regulatory preemption of State law must be restricted to the minimum level necessary to achieve the objectives of the statute pursuant to the regulations that are promulgated. In this rulemaking, State licensure, registration, and certification laws, rules, regulations, or other requirements are preempted only to the extent such State laws unduly interfere with the ability of VA health care professionals to practice health care while acting within the scope of their VA employment.

Therefore, VA believes that the rulemaking is restricted to the minimum level necessary to achieve the objectives of the Federal statutes. The Executive Order also requires an agency that is publishing a regulation that preempts State law to follow certain procedures. These procedures include. The agency consult with, to the extent practicable, the appropriate State and local officials in an effort to avoid conflicts between State law and Federally protected interests. And the agency provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.

For the reasons below, VA believes that it is not practicable to consult with the appropriate State and local officials prior to the publication of this rulemaking. The National Emergency caused by hair loss treatment has highlighted VA's acute need to quickly shift health care professionals across the country. As both private and VA medical facilities in different parts of the country reach or exceed capacity, VA must be able to mobilize its health care professionals across State lines to provide critical care for those in need. As explained in the Supplementary Information above, as of June 2020, a total of 1,893 staff have been mobilized to meet the needs of our facilities and Fourth Mission requests during the propecia. VA deployed 877 staff to meet Federal Emergency Management Agency (FEMA) Mission requests, 420 health care professionals were deployed as DEMPS response, 414 employees were mobilized to cross level staffing needs within their Veterans Integrated Service Networks (VISN), 69 employees were mobilized to support needs in another VISN, and 113 Travel Nurse Corps staff responded specifically for hair loss treatment staffing support.

Given the speed in which it is required for our health care professionals to go to these facilities and provide health care, it is also essential that the health care professionals can follow the same standards of practice irrespective of the location of the facility or the requirements of their individual State license. This is important because if multiple health care professionals, such as multiple registered nurses, licensed in different States are all sent to one VA medical facility to assist when there is a shortage of professionals, it would be difficult and cumbersome if they could not all perform the same duties and each supervising provider had to be briefed on the tasks each registered nurse could perform. In addition, not having a uniform national scope of practice could limit the tasks that the registered nurses could provide. This rulemaking will provide health care professionals an increased level of protection against adverse State actions while VA strives to increase access to high quality health care across the VA health care system during this National Emergency. It would be time consuming and contrary to the public health and safety to delay implementing this rulemaking until we consulted with State and local officials.

For these reasons, it would be impractical to consult with State and local officials prior to the publication of this rulemaking. We note that this rulemaking does not establish any national standards of practice. Instead, VA will establish the national standards of practice via subregulatory guidance. VA will, to the extent practicable, make all efforts to engage with State and local officials when establishing the national standards of practice via subregulatory guidance. Also, this interim final rule will have a 60-day comment period that will allow State and local officials the opportunity to provide their input on the rule.

Administrative Procedures Act An Agency may forgo notice and comment required under the Administrative Procedures Act (APA), 5 U.S.C. 553, if the agency for good cause finds that compliance would be impracticable, unnecessary, or contrary to the public interest. An agency may also bypass the APA's 30-day publication requirement if good cause exists. The Secretary of Veterans Affairs finds that there is good cause under the provisions of 5 U.S.C. 553(b)(B) to publish this rule without prior opportunity for public comment because it would be impracticable and contrary to the public interest and finds that there is good cause under 5 U.S.C.

553(d)(3) to bypass its 30-day publication requirement for the same reasons as outlined above in the Federalism section, above. In short, this rulemaking will provide health care professionals protection against adverse State actions while VA strives to increase access to high quality health care across the VA health care system during this National Emergency. In addition to the needs discussed above regarding the National Emergency, it is also imperative that VA move its health care professionals across State lines in order to facilitate the implementation of the new EHR system immediately. VA implemented EHR at the first VA facility in October 2020 and additional sites are scheduled to have EHR implemented over the course of the next eight years. The next site is scheduled for implementation in Quarter 2 of Fiscal Year 2021 (i.e., between January to March 2021).

Due to the implementation of the new EHR system, VA expects decreased productivity and reduced clinical staffing during training and other events surrounding EHR enactment. VA expects a productivity decrease of up to 30 percent for the 60 days before implementation and the 120 days after at each site. Any decrease in productivity could result in decreased access to health care for our Nation's veterans. In order to support this anticipated productivity decrease, VA is engaging in a “national supplement,” where health care professionals from other VA medical facilities will be deployed to those VA medical facilities and VISNs that are undergoing EHR implementation. The national supplement would mitigate reduced access during EHR deployment activities, such as staff training, cutover, and other EHR implementation activities.

Over the eight-year deployment timeline, the national supplement is estimated to have full time employee equivalents of approximately 60 nurses, 3 pharmacy technicians, 5 mental health and primary care providers, and other VA health care professionals. We note that the actual number of VA health care professionals deployed to each site will vary based on need. The national supplement will require VA health care professionals on a national level to practice health care in States where they do not hold a State license, registration, certification, or other requirement. In addition, VISNs will be providing local cross-leveling and intra-VISN staff deployments to support EHRM implementation activities. Put simply, in order to mitigate the decreased Start Printed Page 71845productivity as a result of EHR implementation, VA must transfer VA health care professionals across the country to States where they do not hold a license, registration, certification, or other requirement to assist in training on the new system as well as to support patient care.

Therefore, it would be impracticable and contrary to the public health and safety to delay implementing this rulemaking until a full public notice-and-comment process is completed. This rulemaking will be effective upon publication in the Federal Register. As noted above, this interim final rule will have a 60-day comment period that will allow State and local officials the opportunity to provide their input on the rule, and VA will take those comments into consideration when deciding whether any modifications to this rule are warranted. Paperwork Reduction Act This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

Regulatory Flexibility Act The Regulatory Flexibility Act, 5 U.S.C. 601-612, is not applicable to this rulemaking because a notice of proposed rulemaking is not required under 5 U.S.C. 553. 5 U.S.C. 601(2), 603(a), 604(a).

Executive Orders 12866, 13563, and 13771 Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages. Distributive impacts. And equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this rule is a significant regulatory action under Executive Order 12866.

VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's website at http://www.va.gov/​orpm/​, by following the link for “VA Regulations Published From FY 2004 Through Fiscal Year to Date.” This interim final rule is not subject to the requirements of E.O. 13771 because this rule results in no more than de minimis costs. Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year.

This interim final rule will have no such effect on State, local, and tribal governments, or on the private sector. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C. 804(2). Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are.

64.007, Blind Rehabilitation Centers. 64.008, Veterans Domiciliary Care. 64.009, Veterans Medical Care Benefits. 64.010, Veterans Nursing Home Care. 64.011, Veterans Dental Care.

64.012, Veterans Prescription Service. 64.013, Veterans Prosthetic Appliances. 64.018, Sharing Specialized Medical Resources. 64.019, Veterans Rehabilitation Alcohol and Drug Dependence. 64.022, Veterans Home Based Primary Care.

64.039 CHAMPVA. 64.040 VHA Inpatient Medicine. 64.041 VHA Outpatient Specialty Care. 64.042 VHA Inpatient Surgery. 64.043 VHA Mental Health Residential.

64.044 VHA Home Care. 64.045 VHA Outpatient Ancillary Services. 64.046 VHA Inpatient Psychiatry. 64.047 VHA Primary Care. 64.048 VHA Mental Health Clinics.

64.049 VHA Community Living Center. And 64.050 VHA Diagnostic Care. Start List of Subjects Administrative practice and procedureAlcohol abuseAlcoholismClaimsDay careDental healthDrug abuseForeign relationsGovernment contractsGrant programs-healthGrant programs-veteransHealth careHealth facilitiesHealth professionsHealth recordsHomelessMedical and dental schoolsMedical devicesMedical researchMental health programsNursing homesReporting and recordkeeping requirementsScholarships and fellowshipsTravel and transportation expensesVeterans End List of Subjects Signing Authority The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Brooks D. Tucker, Assistant Secretary for Congressional and Legislative Affairs, Performing the Delegable Duties of the Chief of Staff, Department of Veterans Affairs, approved this document on October 19, 2020, for publication.

Start Signature Consuela Benjamin, Regulations Development Coordinator, Office of Regulation Policy &. Management, Office of the Secretary, Department of Veterans Affairs. End Signature For the reasons stated in the preamble, the Department of Veterans Affairs is amending 38 CFR part 17 as set forth below. Start Part End Part Start Amendment Part1. The authority citation for part 17 is amended by adding an entry for § 17.419 in numerical order to read in part as follows.

End Amendment Part Start Authority 38 U.S.C. 501, and as noted in specific sections. End Authority * * * * * Section 17.419 also issued under 38 U.S.C. 1701 (note), 7301, 7306, 7330A, 7401-7403, 7405, 7406, 7408). * * * * * Start Amendment Part2.

Add § 17.419 to read as follows. End Amendment Part Health care professionals' practice in VA. (a) Definitions. The following definitions apply to this section. (1) Beneficiary.

The term beneficiary means a veteran or any other individual receiving health care under title 38 of the United States Code. (2) Health care professional. The term health care professional is an individual who. (i) Is appointed to an occupation in the Veterans Health Administration that is listed in or authorized under 38 U.S.C. 7306, 7401, 7405, 7406, or 7408 or title 5 of the U.S.

Code. (ii) Is not a VA-contracted health care professional. And (iii) Is qualified to provide health care as follows. (A) Has an active, current, full, and unrestricted license, registration, certification, or satisfies another State requirement in a State. (B) Has other qualifications as prescribed by the Secretary for one of Start Printed Page 71846the health care professions listed under 38 U.S.C.

7402(b). (C) Is an employee otherwise authorized by the Secretary to provide health care services. Or (D) Is under the clinical supervision of a health care professional that meets the requirements of subsection (a)(2)(iii)(A)-(C) of this section and is either. (i) A health professions trainee appointed under 38 U.S.C. 7405 or 7406 participating in clinical or research training under supervision to satisfy program or degree requirements.

Or (ii) A health care employee, appointed under title 5 of the U.S. Code, 38 U.S.C. 7401(1) or (3), or 38 U.S.C. 7405 for any category of personnel described in 38 U.S.C. 7401(1) or (3) who must obtain an active, current, full and unrestricted licensure, registration, certification, or meet the qualification standards as defined by the Secretary within the specified time frame.

(3) State. The term State means a State as defined in 38 U.S.C. 101(20), or a political subdivision of such a State. (b) Health care professional's practice. (1) When a State law or license, registration, certification, or other requirement prevents or unduly interferes with a health care professional's practice within the scope of their VA employment, the health care professional is required to abide by their Federal duties, which includes, but is not limited to, the following situations.

(i) A health care professional may practice their VA health care profession in any State irrespective of the State where they hold a valid license, registration, certification, or other State qualification. Or (ii) A health care professional may practice their VA health care profession within the scope of the VA national standard of practice as determined by VA. (2) VA health care professional's practice is subject to the limitations imposed by the Controlled Substances Act, 21 U.S.C. 801 et seq. And implementing regulations at 21 CFR 1300 et seq., on the authority to prescribe or administer controlled substances, as well as any other limitations on the provision of VA care set forth in applicable Federal law and policy.

(c) Preemption of State law. Pursuant to the Supremacy Clause, U.S. Const. Art. IV, cl.

2, and in order to achieve important Federal interests, including, but not limited to, the ability to provide the same complete health care and hospital service to beneficiaries in all States as required by 38 U.S.C. 7301, conflicting State laws, rules, regulations or requirements pursuant to such laws are without any force or effect, and State governments have no legal authority to enforce them in relation to actions by health care professionals within the scope of their VA employment. End Supplemental Information [FR Doc. 2020-24817 Filed 11-10-20. 8:45 am]BILLING CODE 8320-01-P.

Start Preamble best place to buy propecia online Department click now of Veterans Affairs. Interim final rule. The Department of Veterans Affairs (VA) best place to buy propecia online is issuing this interim final rule to confirm that its health care professionals may practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other requirements that unduly interfere with their practice.

Specifically, this rulemaking confirms VA's current practice of allowing VA health care professionals to deliver health care services in a State other than the health care professional's State of licensure, registration, certification, or other State requirement, thereby enhancing beneficiaries' access to critical VA health care services. This rulemaking also confirms VA's authority to establish national standards of practice for health care professionals which will standardize a health care professional's practice in best place to buy propecia online all VA medical facilities. Effective Date.

This rule is effective on November 12, 2020. Comments best place to buy propecia online. Comments must be received on or before January 11, 2021.

Comments may be submitted through www.Regulations.gov or mailed to, Beth Taylor, 10A1, 810 best place to buy propecia online Vermont Avenue NW, Washington, DC 20420. Comments should indicate that they are submitted in response to [“RIN 2900-AQ94—Authority of VA Professionals to Practice Health Care.”] Comments received will be available at regulations.gov for public viewing, inspection, or copies. Start Further Info Beth Taylor, Chief Nursing Officer, Veterans best place to buy propecia online Health Administration.

810 Vermont Avenue NW, Washington, DC 20420, (202) 461-7250. (This is not a toll-free number.) End Further Info End Preamble Start Supplemental Information On January 30, 2020, the World Health Organization (WHO) declared the hair loss treatment outbreak to be a Public Health Emergency of International Concern. On January 31, 2020, the Secretary of best place to buy propecia online the Department of Health and Human Services declared a Public Health Emergency pursuant to 42 United States Code (U.S.C.) 247d, for the entire United States to aid in the nation's health care community response to the hair loss treatment outbreak.

On March 11, 2020, in light of new data and the rapid spread in Europe, WHO declared hair loss treatment to be a propecia. On March 13, 2020, the President declared a National Emergency due to hair loss treatment under sections best place to buy propecia online 201 and 301 of the National Emergencies Act (50 U.S.C. 1601 et seq.) and consistent with section 1135 of the Social Security Act (SSA), as amended (42 U.S.C.

1320b-5). As a result of responding to the needs of our veteran population and other non-veteran beneficiaries during the hair loss treatment National Emergency, where VA has had to shift health care Start Printed Page 71839professionals to other locations or duties to assist in the care of those affected by this propecia, VA has become acutely aware of the need to promulgate this rule to clarify the policies governing VA's provision of health care. This rule is intended to confirm that VA health care professionals may practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other requirements that unduly interfere with their practice.

In particular, it will confirm (1) VA's continuing practice of authorizing VA health care professionals to deliver health care services in a State other than the health care professional's State of licensure, registration, certification, or other requirement. And (2) VA's authority to establish national standards of practice for health care professions via policy, which will govern their employment, subject only to State laws where the health care professional is licensed, credentialed, registered, or subject to some other State requirements that do not unduly interfere with those duties. We note that the term State as it applies to this rule means each of the several States, Territories, and possessions of the United States, the District of Columbia, and the Commonwealth of Puerto Rico, or a political subdivision of such State.

This definition is consistent with the term State as it is defined in 38 U.S.C. 101(20). A conflicting State law is one that would unduly interfere with the fulfillment of a VA health care professional's Federal duties.

We note that the policies and practices confirmed in this rule only apply to VA health care professionals appointed under 38 U.S.C. 7306, 7401, 7405, 7406, or 7408 or title 5 of the U.S. Code, which does not include contractors working in VA medical facilities or those working in the community.

VA has long understood its governing statutory authorities to permit VA to engage in these practices. Section 7301(b) of title 38 the U.S. Code establishes that the primary function of the Veterans Health Administration (VHA) within VA is to provide a complete medical and hospital service for the medical care and treatment of veterans.

To allow VHA to carry out its medical care mission, Congress established a comprehensive personnel system for certain VA health care professionals, independent of the civil service rules. See Chapters 73-74 of title 38 of the U.S. Code.

Congress granted the Secretary express statutory authority to establish the qualifications for VA's health care professionals, determine the hours and conditions of employment, take disciplinary action against employees, and otherwise regulate the professional activities of those individuals. 38 U.S.C. 7401-7464.

Section 7402 of 38 U.S.C. Establishes the qualifications of appointees. To be eligible for appointment as a VA employee in a health care profession covered by section 7402(b) (other than a medical facility Director appointed under section 7402(b)(4)), most individuals, after appointment, must, among other requirements, be licensed, registered, or certified to practice their profession in a State, or satisfy some other State requirement.

However, the standards prescribed in section 7402(b) establish only the basic qualifications for VA health care professionals and do not limit the Secretary from establishing other qualifications or rules for health care professionals. In addition, the Secretary is responsible for the control, direction, and management of the Department, including agency personnel and management matters. See 38 U.S.C.

303. Such authorities permit the Secretary to further regulate the health care professions to make certain that VA's health care system provides safe and effective health care by qualified health care professionals to ensure the well-being of those veterans who have borne the battle. In this rulemaking, VA is detailing its authority to manage its health care professionals by stating that they may practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other State requirements that unduly interfere with their practice.

VA believes that this is necessary in order to provide additional protection for VA health care professionals against adverse State actions proposed or taken against them when they are practicing within the scope of their VA employment, particularly when they are practicing across State lines or when they are performing duties consistent with a VA national standard of practice for their health care profession. Practice Across State Lines Historically, VA has operated as a national health care system that authorizes VA health care professionals to practice in any State as long as they have a valid license, registration, certification, or fulfill other State requirements in at least one State. In doing so, VA health care professionals have been practicing within the scope of their VA employment regardless of any unduly burdensome State requirements that would restrict practice across State lines.

We note, however, that VA may only hire health care professionals who are licensed, registered, certified, or satisfy some other requirement in a State, unless the statute requires or provides otherwise (e.g., 38 U.S.C. 7402(b)(14)). The hair loss treatment propecia has highlighted VA's acute need to exercise its statutory authority of allowing VA health care professionals to practice across State lines.

In response to the propecia, VA needed to and continues to need to move health care professionals quickly across the country to care for veterans and other beneficiaries and not have State licensure, registration, certification, or other State requirements hinder such actions. Put simply, it is crucial for VA to be able to determine the location and practice of its VA health care professionals to carry out its mission without any unduly burdensome restrictions imposed by State licensure, registration, certification, or other requirements. This rulemaking will support VA's authority to do so and will provide an increased level of protection against any adverse State action being proposed or taken against VA health care professionals who practice within the scope of their VA employment.

Since the start of the propecia, in furtherance of VA's Fourth Mission, VA has rapidly utilized its resources to assist parts of the country that are undergoing serious and critical shortages of health care resources. VA's Fourth Mission is to improve the Nation's preparedness for response to war, terrorism, national emergencies, and natural disasters by developing plans and taking actions to ensure continued service to veterans, as well as to support national, State, and local emergency management, public health, safety and homeland security efforts. VA has deployed personnel to support other VA medical facilities that have been impacted by hair loss treatment as well as provided support to State and community nursing homes.

As of July 2020, VA has deployed personnel to more than 45 States. VA utilized the Disaster Emergency Medical Personnel System (DEMPS), VA's main deployment program, for VA health care professionals to travel to locations deemed as national emergency or disaster areas, to help provide health care services in places such as New Orleans, Louisiana, and New York City, New York. As of June 2020, a total of 1,893 staff have been mobilized to meet the needs of our facilities and Fourth Start Printed Page 71840Mission requests during the propecia.

VA deployed 877 staff to meet Federal Emergency Management Agency (FEMA) Mission requests, 420 health care professionals were deployed as DEMPS response, 414 employees were mobilized to cross level staffing needs within their Veterans Integrated Service Networks (VISN), 69 employees were mobilized to support needs in another VISN, and 113 Travel Nurse Corps staff responded specifically for hair loss treatment staffing support. In light of the rapidly changing landscape of the propecia, it is crucial for VA to be able to move its health care professionals quickly across the country to assist when a new hot spot emerges without fear of any adverse action from a State be proposed or taken against a VA health care professional. We note that, in addition to providing in person health care across State lines during the propecia, VA also provides telehealth across State lines.

VA's video to home services have been heavily leveraged during the propecia to deliver safe, quality VA health care while adhering to Centers for Disease Control and Prevention (CDC) physical distancing guidelines. Video visits to veterans' homes or other offsite location have increased from 41,425 in February 2020 to 657,423 in July of 2020. This represents a 1,478 percent utilization increase.

VA has specific statutory authority under 38 U.S.C. 1730C to allow health care professionals to practice telehealth in any State regardless of where they are licensed, registered, certified, or satisfy some other State requirement. This rulemaking is consistent with Congressional intent under Public Law 115-185, sec.

151, June 6, 2018, codified at 38 U.S.C. 1730C for all VA health care professionals to practice across State lines regardless of the location of where they provide health care. This rulemaking will ensure that VA professionals are protected regardless of how they provide health care, whether it be via telehealth or in-person.

Beyond the current need to mobilize health care resources quickly to different parts of the country, this practice of allowing VA health care professionals to practice across State lines optimizes the VA health care workforce to meet the needs of all VA beneficiaries year-round. It is common practice within the VA health care system to have primary and specialty health care professionals routinely travel to smaller VA medical facilities or rural locations in nearby States to provide care that may be difficult to obtain or unavailable in that community. As of January 14, 2020, out of 182,100 licensed health care professionals who are employed by VA, 25,313 or 14 percent do not hold a State license, registration, or certification in the same State as their main VA medical facility.

This number does not include the VA health care professionals who practice at a main VA medical facility in one State where they are licensed, registered, certified, or hold some other State requirement, but also practice at a nearby Community Based Outpatient Clinic (CBOC) in a neighboring State where they do not hold such credentials. Indeed, 49 out of the 140 VA medical facilities nationwide have one or more sites of care in a different State than the main VA medical facility. Also, VA has rural mobile health units that provide health care services to veterans who have difficulty accessing VA health care facilities.

These mobile units are a vital source of health care to veterans who live in rural and medically underserved communities. Some of the services provided by the mobile units include, but are not limited to, health care screening, mental health outreach, influenza and pneumonia vaccinations, and routine primary care. The rural mobile health units are an integral part of VA's goal of encouraging healthier communities and support VA's preventative health programs.

Health care professionals who provide health care in these mobile units may provide services in various States where they may not hold a license, registration, or certification, or satisfy some other State requirement. It is critical that these health care professionals are protected from any adverse State action proposed or taken when performing these crucial services. In addition, the practice of health care professionals of providing health care across State lines also gives VA the flexibility to hire qualified health care professionals from any State to meet the staffing needs of a VA health care facility where recruitment or retention is difficult.

As of December 31, 2019, VA had approximately 13,000 vacancies for health care professions across the country. As a national health care system, it is imperative for VA to be able to recruit and retain health care professionals, where recruitment and retention is difficult, to ensure there is access to health care regardless of where the VA beneficiary resides. Permitting VA health care professionals to practice across State lines is an important incentive when trying to recruit for these vacancies, particularly during a propecia, where private health care facilities have greater flexibility to offer more competitive pay and benefits.

This is also especially beneficial in recruiting spouses of active service members who frequently move across the country. National Standard of Practice This rulemaking also confirms VA's authority to establish national standards of practice for health care professions. We note that this rulemaking does not create any such national standards.

All national standards of practice will be created via policy. For the purposes of this rulemaking, a national standard of practice describes the tasks and duties that a VA health care professional practicing in the health care profession may perform and may be permitted to undertake. Having a national standard of practice means that individuals from the same VA health care profession may provide the same type of tasks and duties regardless of the VA medical facility where they are located or the State license, registration, certification, or other State requirement they hold.

We emphasize that VA will determine, on an individual basis, that a health care professional has the necessary education, training, and skills to perform the tasks and duties detailed in the national standard of practice. The need for national standards of practice have been highlighted by VA's large-scale initiative regarding the new electronic health record (EHR). VA's health care system is currently undergoing a transformational initiative to modernize the system by replacing its current EHR with a joint EHR with Department of Defense (DoD) to promote interoperability of medical data between VA and DoD.

VA's new EHR system will provide VA and DoD health care professionals with quick and efficient access to the complete picture of a veteran's health information, improving VA's delivery of health care to our nation's veterans. For this endeavor, DoD and VA established a joint governance over the EHR system. In order to be successful, VA must standardize clinical processes with DoD.

This means that all health care professionals in DoD and VA who practice in a certain health care profession must be able to carry out the same duties and tasks irrespective of State requirements. The reason why this is important is because each health care profession is designated a role in the EHR system that sets forth specific privileges within the EHR that dictate allowed tasks for such profession. These tasks include, but are not limited to, dispensing and administrating medications.

Prescriptive practices. Ordering of procedures and diagnostic imaging. And required level of oversight.

VA has the ability to modify these privileges within EHR, however, VA Start Printed Page 71841cannot do so on an individual user level, but rather at the role level for each health care profession. In other words, VA cannot modify the privileges for all health care professionals in one State to be consistent with that State's requirements. Instead, the privileges can only be modified for every health care professional in that role across all States.

Therefore, the privileges established within EHR cannot be made facility or State specific. In order to achieve standardized clinical processes, VA and DoD must create the uniform standards of practice for each health care specialty. Currently, DoD has specific authority from Congress to create national standards of practice for their health care professionals under 10 U.S.C.

1094. While VA lacks a similarly specific statute, VA has the general statutory authority, as explained above, to regulate its health care professionals and authorize health care practices that preempt conflicting State law. This regulation will confirm VA's authority to do so.

Absent such standardized practices, it will be incredibly difficult for VA to achieve its goal of being an active participant in EHR modernization because either some VA health care professionals would fear potential adverse State actions or DoD and VA would need to agree upon roles that are consistent with the most restrictive States' requirements to ensure that all health care professionals are acting within the scope of their State requirements. VA believes that agreement upon roles that are consistent with the most restrictive State is not an acceptable option because it will lead to delayed care and consequently decreased access and level of health care for VA beneficiaries. One example that impacts multiple health care professions throughout the VA system is the ability to administer medication without a provider (physician or advanced practice nurse practitioner) co-signature.

As it pertains to nursing, almost all States permit nurses to follow a protocol. However, some States, such as New York, North Carolina, and South Carolina, do not permit nurses to follow a protocol without a provider co-signature. A protocol is a standing order that has been approved by medical and clinical leadership if a certain sequence of health care events occur.

For instance, if a patient is exhibiting certain signs of a heart attack, there is a protocol in place to administer potentially life-saving medication. If the nurse is the first person to see the signs, the nurse will follow the approved protocol and immediately administer the medication. However, if the nurse cannot follow the protocol and requires a provider co-signature, administration of the medication will be delayed until a provider is able to co-sign the order, which may lead to the deterioration of the patient's condition.

This also increases the provider's workload and decreases the amount of time the provider can spend with patients. Historically, VA physical therapists (PTs), occupational therapists, and speech therapists were routinely able to determine the need to administer topical medications during therapy sessions and were able to administer the topical without a provider co-signature. However, in order to accommodate the new EHR system and variance in State requirements, these therapists would need to place an order for all medications, including topicals, which would leave these therapists waiting for a provider co-signature in the middle of a therapy session, thus delaying care.

Furthermore, these therapists also routinely ordered imaging to better assess the clinical needs of the patient, but would also have to wait for a provider co-signature, which will further delay care and increase provider workload. In addition to requiring provider co-signatures, there will also be a significant decrease in access to care due to other variances in State requirements. For instance, direct access to PTs will be limited in order to ensure that the role is consistent with all State requirements.

Direct access means that a beneficiary may request PT services without a provider's referral. However, while almost half of the States allow unrestricted direct access to PTs, over half of the States have some limitations on requesting PT services. For instance, in Alabama, a licensed PT may perform an initial evaluation and may only provide other services as delineated in specific subdivisions of the Alabama Physical Therapy Practice Act.

Furthermore, in New York, PT treatment may be rendered by a licensed PT for 10 visits or 30 days, whichever shall occur first, without a referral from a physician, dentist, podiatrist, nurse practitioner, or licensed midwife. This is problematic as VA will not be able to allow for direct access due to these variances and direct access has been shown to be beneficial for patient care. Currently, VISN 23 is completing a two-year strategic initiative to implement direct access and have PTs embedded into patient aligned care teams (PACT).

Outcomes thus far include decreased wait times, improved veteran satisfaction, improved provider satisfaction, and improved functional outcomes. Therefore, VA will confirm its authority to ensure that health care professionals are protected against State action when they adhere to VA's national standards of practice. We reiterate that this rulemaking does not establish national standards of practice for each health care profession, but merely confirms VA's authority to do so, thereby preempting any State restrictions that unduly interfere with those practices.

The actual national standards of practice will be developed in subregulatory policy for each health care profession. As such, VA will make a concerted effort to engage appropriate stakeholders when developing the national standards of practice. Preemption As previously explained, in this rulemaking, VA is confirming its authority to manage its health care professionals.

Specifically, this rulemaking will confirm VA's long-standing practice of allowing its health care professionals to practice in a State where they do not hold a license, registration, certification, or satisfy some other State requirement. The rule will also confirm that VA health care professionals must adhere to VA's national standards of practice, as determined by VA policy, irrespective of conflicting State licensing, registration, certification, or other State requirements that unduly burden that practice. We do note that VA health care professionals will only be required to perform tasks and duties to the extent of their education, skill, and training.

For instance, VA would not require a registered nurse to perform a task that the individual nurse was not trained to perform. Currently, practice in accordance with VA employment, including practice across State lines or adhering to a VA standard of practice, may jeopardize VA health care professionals' credentials or result in fines and imprisonment for unauthorized health care practice. This is because most States have restrictions that limit health care professionals' practice or have rules that prohibit health care professionals from furnishing health care services within that State without a license, registration, certification, or other requirement from that State.

We note that, some States, for example Rhode Island, Utah, and Michigan, have enacted legislation or regulations that specifically allow certain VA health care professionals to practice in those States when they do not hold a State license. Several VA health care professionals have already had actions proposed or taken against them by various States Start Printed Page 71842while practicing health care within the scope of their VA employment, while they either practiced in a State where they do not hold a license, registration, certification, or other State requirement that unduly interfered with their VA employment. In one instance, a VA psychologist was licensed in California but was employed and providing supervision of a trainee at the VA Medical Center (VAMC) in Nashville, Tennessee.

California psychology licensing laws require supervisors to hold a license from the State where they are practicing and do not allow for California licensed psychologists to provide supervision to trainees or unlicensed psychologists outside the State of California. The California State Psychology Licensing Board proposed sanctions and fines of $1,000 for violating section 1387.4(a) of the CA Code of Regulations (CCR). The VA system did not qualify for the exemption of out of State supervision requirements listed in CCR section 1387.4.

In addition, a VA physician who was licensed in Oregon, but was practicing at a VAMC in Biloxi, Mississippi had the status of their license changed from active to inactive because the Oregon Medical Board determined the professional did not reside in Oregon, in violation of Oregon's requirement that a physician physically reside in the State in order to maintain an active license. This rulemaking serves to preempt State requirements, such as the ones discussed above, that were or can be used to take an action against VA health care professionals for practicing within the scope of their VA employment. State licensure, registration, certification, and other State requirements are preempted to the extent such State laws unduly interfere with the ability of VA health care professionals to practice health care while acting within the scope of their VA employment.

As explained above, Congress provided general statutory provisions that permit the VA Secretary to authorize health care practices by health care professionals at VA, which serve to preempt conflicting State laws that unduly interfere with the exercise of health care by VA health care professionals pursuant to that authorization. Although some VA health care professionals are required by Federal statute to have a State license, see, e.g., 38 U.S.C. 7402(b)(1)(C) (providing that, to be eligible to be appointed to a physician position at the VA, a physician must be licensed to practice medicine, surgery, or osteopathy in a State), a State may not attach a condition to the license that is unduly burdensome to or unduly interferes with the practice of health care within the scope of VA employment.

Under well-established interpretations of the Supremacy Clause, Federal laws and policies authorizing VA health care professionals to practice according to VA standards preempt conflicting State law. That is, a State law that prevents or unreasonably interferes with the performance of VA duties. See, e.g., Hancock v.

Train, 426 U.S. 167, 178-81 (1976). Sperry v.

Florida, 373 U.S. 379, 385 (1963). Miller v.

Thomas, 173 U.S. 276, 282-84 (1899). State Bar Disciplinary Rules as Applied to Federal Government Attorneys, 9 Op.

O.L.C. 71, 72-73 (1985). When a State law does not conflict with the performance of Federal duties in these ways, VA health care professionals are required to abide by the State law.

Therefore, VA's policies and regulations will preempt State licensure, registration, and certification laws, rules, or other requirements only to the extent they conflict with the ability of VA health care professionals to practice health care while acting within the scope of their VA employment. We emphasize that, in instances where there is no conflict with State requirements, VA health care professionals should abide by the State requirement. For example, if a State license requires a health care professional to have a certain number of hours of continuing professional education per year to maintain their license, the health care professional must adhere to this State requirement if it does not prevent or unduly interfere with the exercise of VA employment.

To determine whether a State requirement is conflicting, VA would assess whether the State law unduly interferes on a case-by-case basis. For instance, if Oregon requires all licensed physicians to reside in Oregon, VA would likely find that it unduly interferes with already licensed VA physicians who reside and work for VA in the State of Mississippi. We emphasize that the intent of the regulation is to only preempt State requirements that are unduly burdensome and interfere with a VA health care professionals' practice for the VA.

For instance, it would not require a State to issue a license to an individual who does not meet the education requirements to receive a license in that State. We note that this rulemaking also does not affect VA's existing requirement that all VA health care professionals adhere to restrictions imposed by the Controlled Substances Act, 21 U.S.C. 801 et seq.

And implementing regulations at 21 CFR 1300, et seq., to prescribe or administer controlled substances. Any preemption of conflicting State requirements will be the minimum necessary for VA to effectively furnish health care services. It would be costly and time-consuming for VA to lobby each State board for each health care profession specialty to remove restrictions that impair VA's ability to furnish health care services to beneficiaries and then wait for the State to implement appropriate changes.

Doing so would not guarantee a successful result. Regulation For these reasons, VA is establishing a new regulation titled Health care professionals' practice in VA, which will be located at 38 CFR 17.419. This rule will confirm the ability of VA health care professionals to practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other requirements that unduly interfere with their practice.

Subsection (a) of § 17.419 contains the definitions that will apply to the new section. Subsection (a)(1) contains the definition for beneficiary. We are defining the term beneficiary to mean a veteran or any other individual receiving health care under title 38 of the U.S.

Code. We are using this definition because VA provides health care to veterans, certain family members of veterans, servicemembers, and others. This is VA's standard use of this term.

Subsection (a)(2) contains the definition for health care professional. We are defining the term health care professional to be an individual who meets specific criteria that is listed below. Subsection (a)(2)(i) will require that a health care professional be appointed to an occupation in VHA that is listed or authorized under 38 U.S.C.

7306, 7401, 7405, 7406, or 7408 or title 5 of the U.S. Code. Subsection (a)(2)(ii) requires that the individual is not a VA-contracted health care professional.

A health care professional does not include a contractor or a community health care professional because they are not considered VA employees buy propecia online nor appointed under 38 U.S.C. 7306, 7401, 7405, 7406, or 7408 or title 5 of the U.S. Code.

Subsection (a)(2)(iii) lists the required qualifications for a health care professional. We note that these qualifications do not include all general Start Printed Page 71843qualifications for appointment, such as to hold a degree of doctor of medicine. These qualifications are related to licensure, registration, certification, or other State requirements.

Subsection (a)(2)(iii)(A) states that the health care professional must have an active, current, full, and unrestricted license, registration, certification, or satisfies another State requirement in a State to practice the health care specialty identified under 38 U.S.C. 7402(b). This standard ensures that VA health care professionals are qualified to practice their individual health care specialty if the specialty requires such credential.

Subsection (a)(2)(iii)(B) states that the individual has other qualifications as prescribed by the Secretary for one of the health care professions listed under 38 U.S.C. 7402(b). Some health care professionals appointed under 38 U.S.C.

7401(3) whose qualifications are listed in 38 U.S.C. 7402(b) are not required to meet State license, registration, certification, or other requirements and rely on the qualifications prescribed by the Secretary. Therefore, these individuals would be included in this subsection and required to have the qualifications prescribed by the Secretary for their health care profession.

Subsection (a)(2)(iii)(C) states that the individual is otherwise authorized by the Secretary to provide health care services. This would include those individuals who practice a health care profession that does not require a State license, registration, certification, or other requirement and is also not listed in 38 U.S.C. 7402(b), but is authorized by the Secretary to provide health care services.

Subsection (a)(2)(iii)(D) includes individuals who are trainees or may have a time limited appointment to finish clinicals or other requirements prior to being fully licensed. Therefore, the regulation will state that the individual is under the clinical supervision of a health care professional that meets the requirements listed in subsection (a)(2)(iii)(A)-(C) and the individual must meet the requirements in subsection (a)(2)(iii)(D)(i) or (a)(2)(iii)(D)(ii). Subsection (a)(2)(iii)(D)(i) states that the individual is a health professions trainee appointed under 38 U.S.C.

7405 or 7406 participating in clinical or research training under supervision to satisfy program or degree requirements. Subsection (a)(2)(iii)(D)(ii) states that the individual is a health care employee, appointed under title 5 of the U.S. Code, 38 U.S.C.

7401(1) or (3), or 38 U.S.C. 7405 for any category of personnel described in 38 U.S.C. 7401(1) or (3) who must obtain an active, current, full and unrestricted licensure, registration, or certification or meet the qualification standards as defined by the Secretary within the specified time frame.

These individuals have a time-limited appointment to obtain credentials. For example, marriage and family therapists require a certain number of supervised clinical post-graduate hours prior to receiving their license. Lastly, as we previously discussed in this rulemaking, we are defining the term State in subsection (a)(3) as the term is defined in 38 U.S.C.

101(20), and also including political subdivisions of such States. This is consistent with the definition of State in 38 U.S.C. 1730C(f) which is VA's statutory authority to preempt State law when the covered health care professional is using telehealth to provide treatment to an individual under this title.

We believe that it is important to define the term in the same way as it is defined for health care professionals practicing via telehealth so that way it is consistent regardless of whether the health care professional is practicing in-person or via telehealth. Moreover, as subdivisions of a State are granted legal authority from the State itself, it makes sense to subject entities created by a State, or authorized by a State to create themselves, to be subject to the same limitations and restrictions as the State itself. Section 17.419(b) details that VA health care professionals must practice within the scope of their Federal employment irrespective of conflicting State requirements that would prevent or unduly interfere with the exercise of Federal duties.

This provision confirms that VA health care professionals may furnish health care consistent with their VA employment obligations without fear of adverse action proposed or taken by any State. In order to clarify and make transparent how VA utilizes or intends to utilize our current statutory authority, we are providing a non-exhaustive list of examples. The first example is listed in subsection (b)(1)(i).

It states that a health care professional may practice their VA health care profession in any State irrespective of the State where they hold a valid license, registration, certification, or other qualification. The second example is listed in subsection (b)(1)(ii). It states that a health care professional may practice their VA health care profession consistent with the VA national standard of practice as determined by VA.

As previously explained, VA intends to establish national standards of practice via VA policy. A health care professional's practice within VA will continue to be subject to the limitations imposed by the Controlled Substances Act, 21 U.S.C. 801, et seq.

And implementing regulations at 21 CFR 1300, et seq., on the authority to prescribe or administer controlled substances, as well as any other limitations on the provision of VA care set forth in applicable Federal law and policy. This will ensure that professionals are still in compliance with critical laws concerning the prescribing and administering of controlled substances. This requirement is stated in subsection (b)(2).

Subsection (c) expressly states the intended preemptive effect of § 17.419, to ensure that conflicting State and local laws, rules, regulations, and requirements related to health care professionals' practice will have no force or effect when such professionals are practicing health care while working within the scope of their VA employment. In circumstances where there is a conflict between Federal and State law, Federal law would prevail in accordance with Article VI, clause 2, of the U.S. Constitution.

Executive Order 13132 establishes principles for preemption of State law when it is implicated in rulemaking or proposed legislation. Where a Federal statute does not expressly preempt State law, agencies shall construe any authorization in the statute for the issuance of regulations as authorizing preemption of State law by rulemaking only when the exercise of State authority directly conflicts with the exercise of Federal authority or there is clear evidence to conclude that the Congress intended the agency to have the authority to preempt State law. In this situation, the Federal statutes do not expressly preempt State laws.

However, VA construes the authorization established in 38 U.S.C. 303, 501, and 7401-7464 as authorizing preemption because the exercise of State authority directly conflicts with the exercise of Federal authority under these statutes. Congress granted the Secretary express statutory authority to establish the qualifications for VA's health care professionals, determine the hours and conditions of employment, take disciplinary action against employees, and otherwise regulate the professional activities of those individuals.

38 U.S.C. 7401-7464. Specifically, section 7402(b) states that most health care professionals, after appointment by VA, must, among other Start Printed Page 71844requirements, be licensed, registered, or certified to practice their profession in a State.

To that end, VA's regulations and policies will preempt any State law or action that conflicts with the exercise of Federal duties in providing health care at VA. In addition, any regulatory preemption of State law must be restricted to the minimum level necessary to achieve the objectives of the statute pursuant to the regulations that are promulgated. In this rulemaking, State licensure, registration, and certification laws, rules, regulations, or other requirements are preempted only to the extent such State laws unduly interfere with the ability of VA health care professionals to practice health care while acting within the scope of their VA employment.

Therefore, VA believes that the rulemaking is restricted to the minimum level necessary to achieve the objectives of the Federal statutes. The Executive Order also requires an agency that is publishing a regulation that preempts State law to follow certain procedures. These procedures include.

The agency consult with, to the extent practicable, the appropriate State and local officials in an effort to avoid conflicts between State law and Federally protected interests. And the agency provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings. For the reasons below, VA believes that it is not practicable to consult with the appropriate State and local officials prior to the publication of this rulemaking.

The National Emergency caused by hair loss treatment has highlighted VA's acute need to quickly shift health care professionals across the country. As both private and VA medical facilities in different parts of the country reach or exceed capacity, VA must be able to mobilize its health care professionals across State lines to provide critical care for those in need. As explained in the Supplementary Information above, as of June 2020, a total of 1,893 staff have been mobilized to meet the needs of our facilities and Fourth Mission requests during the propecia.

VA deployed 877 staff to meet Federal Emergency Management Agency (FEMA) Mission requests, 420 health care professionals were deployed as DEMPS response, 414 employees were mobilized to cross level staffing needs within their Veterans Integrated Service Networks (VISN), 69 employees were mobilized to support needs in another VISN, and 113 Travel Nurse Corps staff responded specifically for hair loss treatment staffing support. Given the speed in which it is required for our health care professionals to go to these facilities and provide health care, it is also essential that the health care professionals can follow the same standards of practice irrespective of the location of the facility or the requirements of their individual State license. This is important because if multiple health care professionals, such as multiple registered nurses, licensed in different States are all sent to one VA medical facility to assist when there is a shortage of professionals, it would be difficult and cumbersome if they could not all perform the same duties and each supervising provider had to be briefed on the tasks each registered nurse could perform.

In addition, not having a uniform national scope of practice could limit the tasks that the registered nurses could provide. This rulemaking will provide health care professionals an increased level of protection against adverse State actions while VA strives to increase access to high quality health care across the VA health care system during this National Emergency. It would be time consuming and contrary to the public health and safety to delay implementing this rulemaking until we consulted with State and local officials.

For these reasons, it would be impractical to consult with State and local officials prior to the publication of this rulemaking. We note that this rulemaking does not establish any national standards of practice. Instead, VA will establish the national standards of practice via subregulatory guidance.

VA will, to the extent practicable, make all efforts to engage with State and local officials when establishing the national standards of practice via subregulatory guidance. Also, this interim final rule will have a 60-day comment period that will allow State and local officials the opportunity to provide their input on the rule. Administrative Procedures Act An Agency may forgo notice and comment required under the Administrative Procedures Act (APA), 5 U.S.C.

553, if the agency for good cause finds that compliance would be impracticable, unnecessary, or contrary to the public interest. An agency may also bypass the APA's 30-day publication requirement if good cause exists. The Secretary of Veterans Affairs finds that there is good cause under the provisions of 5 U.S.C.

553(b)(B) to publish this rule without prior opportunity for public comment because it would be impracticable and contrary to the public interest and finds that there is good cause under 5 U.S.C. 553(d)(3) to bypass its 30-day publication requirement for the same reasons as outlined above in the Federalism section, above. In short, this rulemaking will provide health care professionals protection against adverse State actions while VA strives to increase access to high quality health care across the VA health care system during this National Emergency.

In addition to the needs discussed above regarding the National Emergency, it is also imperative that VA move its health care professionals across State lines in order to facilitate the implementation of the new EHR system immediately. VA implemented EHR at the first VA facility in October 2020 and additional sites are scheduled to have EHR implemented over the course of the next eight years. The next site is scheduled for implementation in Quarter 2 of Fiscal Year 2021 (i.e., between January to March 2021).

Due to the implementation of the new EHR system, VA expects decreased productivity and reduced clinical staffing during training and other events surrounding EHR enactment. VA expects a productivity decrease of up to 30 percent for the 60 days before implementation and the 120 days after at each site. Any decrease in productivity could result in decreased access to health care for our Nation's veterans.

In order to support this anticipated productivity decrease, VA is engaging in a “national supplement,” where health care professionals from other VA medical facilities will be deployed to those VA medical facilities and VISNs that are undergoing EHR implementation. The national supplement would mitigate reduced access during EHR deployment activities, such as staff training, cutover, and other EHR implementation activities. Over the eight-year deployment timeline, the national supplement is estimated to have full time employee equivalents of approximately 60 nurses, 3 pharmacy technicians, 5 mental health and primary care providers, and other VA health care professionals.

We note that the actual number of VA health care professionals deployed to each site will vary based on need. The national supplement will require VA health care professionals on a national level to practice health care in States where they do not hold a State license, registration, certification, or other requirement. In addition, VISNs will be providing local cross-leveling and intra-VISN staff deployments to support EHRM implementation activities.

Put simply, in order to mitigate the decreased Start Printed Page 71845productivity as a result of EHR implementation, VA must transfer VA health care professionals across the country to States where they do not hold a license, registration, certification, or other requirement to assist in training on the new system as well as to support patient care. Therefore, it would be impracticable and contrary to the public health and safety to delay implementing this rulemaking until a full public notice-and-comment process is completed. This rulemaking will be effective upon publication in the Federal Register.

As noted above, this interim final rule will have a 60-day comment period that will allow State and local officials the opportunity to provide their input on the rule, and VA will take those comments into consideration when deciding whether any modifications to this rule are warranted. Paperwork Reduction Act This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

Regulatory Flexibility Act The Regulatory Flexibility Act, 5 U.S.C. 601-612, is not applicable to this rulemaking because a notice of proposed rulemaking is not required under 5 U.S.C. 553.

5 U.S.C. 601(2), 603(a), 604(a). Executive Orders 12866, 13563, and 13771 Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages.

Distributive impacts. And equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility.

The Office of Information and Regulatory Affairs has determined that this rule is a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's website at http://www.va.gov/​orpm/​, by following the link for “VA Regulations Published From FY 2004 Through Fiscal Year to Date.” This interim final rule is not subject to the requirements of E.O.

13771 because this rule results in no more than de minimis costs. Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year.

This interim final rule will have no such effect on State, local, and tribal governments, or on the private sector. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C.

804(2). Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are. 64.007, Blind Rehabilitation Centers.

64.008, Veterans Domiciliary Care. 64.009, Veterans Medical Care Benefits. 64.010, Veterans Nursing Home Care.

64.011, Veterans Dental Care. 64.012, Veterans Prescription Service. 64.013, Veterans Prosthetic Appliances.

64.018, Sharing Specialized Medical Resources. 64.019, Veterans Rehabilitation Alcohol and Drug Dependence. 64.022, Veterans Home Based Primary Care.

64.039 CHAMPVA. 64.040 VHA Inpatient Medicine. 64.041 VHA Outpatient Specialty Care.

64.042 VHA Inpatient Surgery. 64.043 VHA Mental Health Residential. 64.044 VHA Home Care.

64.045 VHA Outpatient Ancillary Services. 64.046 VHA Inpatient Psychiatry. 64.047 VHA Primary Care.

64.048 VHA Mental Health Clinics. 64.049 VHA Community Living Center. And 64.050 VHA Diagnostic Care.

Start List of Subjects Administrative practice and procedureAlcohol abuseAlcoholismClaimsDay careDental healthDrug abuseForeign relationsGovernment contractsGrant programs-healthGrant programs-veteransHealth careHealth facilitiesHealth professionsHealth recordsHomelessMedical and dental schoolsMedical devicesMedical researchMental health programsNursing homesReporting and recordkeeping requirementsScholarships and fellowshipsTravel and transportation expensesVeterans End List of Subjects Signing Authority The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Brooks D. Tucker, Assistant Secretary for Congressional and Legislative Affairs, Performing the Delegable Duties of the Chief of Staff, Department of Veterans Affairs, approved this document on October 19, 2020, for publication.

Start Signature Consuela Benjamin, Regulations Development Coordinator, Office of Regulation Policy &. Management, Office of the Secretary, Department of Veterans Affairs. End Signature For the reasons stated in the preamble, the Department of Veterans Affairs is amending 38 CFR part 17 as set forth below.

Start Part End Part Start Amendment Part1. The authority citation for part 17 is amended by adding an entry for § 17.419 in numerical order to read in part as follows. End Amendment Part Start Authority 38 U.S.C.

501, and as noted in specific sections. End Authority * * * * * Section 17.419 also issued under 38 U.S.C. 1701 (note), 7301, 7306, 7330A, 7401-7403, 7405, 7406, 7408).

* * * * * Start Amendment Part2. Add § 17.419 to read as follows. End Amendment Part Health care professionals' practice in VA.

(a) Definitions. The following definitions apply to this section. (1) Beneficiary.

The term beneficiary means a veteran or any other individual receiving health care under title 38 of the United States Code. (2) Health care professional. The term health care professional is an individual who.

(i) Is appointed to an occupation in the Veterans Health Administration that is listed in or authorized under 38 U.S.C. 7306, 7401, 7405, 7406, or 7408 or title 5 of the U.S. Code.

(ii) Is not a VA-contracted health care professional. And (iii) Is qualified to provide health care as follows. (A) Has an active, current, full, and unrestricted license, registration, certification, or satisfies another State requirement in a State.

(B) Has other qualifications as prescribed by the Secretary for one of Start Printed Page 71846the health care professions listed under 38 U.S.C. 7402(b). (C) Is an employee otherwise authorized by the Secretary to provide health care services.

Or (D) Is under the clinical supervision of a health care professional that meets the requirements of subsection (a)(2)(iii)(A)-(C) of this section and is either. (i) A health professions trainee appointed under 38 U.S.C. 7405 or 7406 participating in clinical or research training under supervision to satisfy program or degree requirements.

Or (ii) A health care employee, appointed under title 5 of the U.S. Code, 38 U.S.C. 7401(1) or (3), or 38 U.S.C.

7405 for any category of personnel described in 38 U.S.C. 7401(1) or (3) who must obtain an active, current, full and unrestricted licensure, registration, certification, or meet the qualification standards as defined by the Secretary within the specified time frame. (3) State.

The term State means a State as defined in 38 U.S.C. 101(20), or a political subdivision of such a State. (b) Health care professional's practice.

(1) When a State law or license, registration, certification, or other requirement prevents or unduly interferes with a health care professional's practice within the scope of their VA employment, the health care professional is required to abide by their Federal duties, which includes, but is not limited to, the following situations. (i) A health care professional may practice their VA health care profession in any State irrespective of the State where they hold a valid license, registration, certification, or other State qualification. Or (ii) A health care professional may practice their VA health care profession within the scope of the VA national standard of practice as determined by VA.

(2) VA health care professional's practice is subject to the limitations imposed by the Controlled Substances Act, 21 U.S.C. 801 et seq. And implementing regulations at 21 CFR 1300 et seq., on the authority to prescribe or administer controlled substances, as well as any other limitations on the provision of VA care set forth in applicable Federal law and policy.

(c) Preemption of State law. Pursuant to the Supremacy Clause, U.S. Const.

Art. IV, cl. 2, and in order to achieve important Federal interests, including, but not limited to, the ability to provide the same complete health care and hospital service to beneficiaries in all States as required by 38 U.S.C.

7301, conflicting State laws, rules, regulations or requirements pursuant to such laws are without any force or effect, and State governments have no legal authority to enforce them in relation to actions by health care professionals within the scope of their VA employment. End Supplemental Information [FR Doc. 2020-24817 Filed 11-10-20.

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Abemaciclib 215268 Verzenio Eli is generic propecia just as good Lilly Canada http://www.col-twinger-strasbourg.ac-strasbourg.fr/etablissement/services/restauration/ Inc. N/A 2019-04-08 2025-04-08 N/A 2027-04-08 acalabrutinib 214504 Calquence AstraZeneca Canada Inc. N/A 2019-08-23 2025-08-23 N/A 2027-08-23 aclidinium bromide 157598 Tudorza Genuair AstraZeneca is generic propecia just as good Canada Inc. Duaklir Genuair 2013-07-29 2019-07-29 N/A 2021-07-29 afatinib dimaleate 158730 Giotrif Boehringer Ingelheim (Canada) Ltd. N/A 2013-11-01 2019-11-01 N/A 2021-11-01 aflibercept 149321 Eylea Bayer Inc.

N/A 2013-11-08 is generic propecia just as good 2019-11-08 N/A 2021-11-08 albiglutide 165145 Eperzan GlaxoSmithKline Inc. N/A 2015-07-15 2021-07-15 N/A 2023-07-15 alectinib hydrochloride 189442 Alecensaro Hoffmann-La Roche Limited N/A 2016-09-29 2022-09-29 N/A 2024-09-29 alirocumab 183116 Praluent Sanofi-aventis Canada Inc. N/A 2016-04-11 2022-04-11 N/A 2024-04-11 alogliptin benzoate 158335 Nesina Takeda Canada Inc. KazanoOseni 2013-11-27 2019-11-27 N/A 2021-11-27 alpelisib 226941 Piqray is generic propecia just as good Novartis Pharmaceuticals Canada Inc. N/A 2020-03-11 2026-03-11 N/A 2028-03-11 amifampridine (supplied as amifampridine phosphate) 232685 Firdapse Kye Pharmaceuticals Inc.

N/A 2020-07-31 2026-07-31 N/A 2028-07-31 anthrax is generic propecia just as good immune globulin (human) 200446 Anthrasil Emergent BioSolutions Canada Inc. N/A 2017-11-06 2023-11-06 Yes 2026-05-06 antihemophilic factor (recombinant BDD), Fc fusion protein 163447 Eloctate Sanofi-Aventis Canada Inc. N/A 2014-08-22 2020-08-22 Yes 2023-02-22 antihemophilic factor (recombinant), pegylated 189709 Adynovate Takeda Canada Inc. N/A 2016-11-17 2022-11-17 Yes 2025-05-17 antihemophilic factor (recombinant, B-domain deleted, pegylated) (also known as damoctocog alfa pegol) 210935 is generic propecia just as good Jivi Bayer Inc. N/A 2018-10-18 2024-10-18 Yes 2027-04-18 antihemophilic factor (recombinant, B-domain deleted) (also known as simoctocog alfa) 169551 Nuwiq Octapharma Pharmazeutika Produktionsges.m.b.H N/A 2014-10-23 2020-10-23 Yes 2023-04-23 antihemophilic factor VIII (recombinant), singlechain (also known as lonoctocog alfa) 190891 Afstyla CSL Behring Canada Inc.

N/A 2016-12-12 2022-12-12 Yes 2025-06-12 anthrax antigen fiate 212387 Biothrax Emergent Biodefense Operations Lansing LLC N/A 2018-12-13 2024-12-13 N/A 2026-12-13 antihemophilic factor VIII (recombinant, B-domain truncated), PEGylated (turoctocog alfa pegol) 218531 Esperoct Novo Nordisk Canada Inc. N/A 2019-07-04 2025-07-04 Yes 2028-01-04 apalutamide 211942 Erleada Janssen is generic propecia just as good Inc. N/A 2018-07-03 2024-07-03 N/A 2026-07-03 apremilast 169862 Otezla Amgen Canada Inc. N/A 2014-11-12 2020-11-12 N/A 2022-11-12 asfotase alfa 179340 Strensiq Alexion Pharma International Sàrl N/A 2015-08-14 2021-08-14 Yes 2024-02-14 asunaprevir 172617 Sunvepra Bristol-Myers Squibb Canada N/A 2016-03-09 2022-03-09 N/A 2024-03-09 atezolizumab 196843 Tecentriq Hoffmann-La Roche Limited N/A 2017-04-12 2023-04-12 N/A 2025-04-12 avelumab 204052 Bavencio EMD Serono, a Division of EMD Inc., Canada N/A 2017-12-18 2023-12-18 N/A 2025-12-18 axicabtagene ciloleucel 218389 Yescarta Gilead Sciences Canada Inc N/A 2019-02-13 2025-02-13 N/A 2027-02-13 azelastine hydrochloride 169604 Dymista Meda Pharmaceuticals Ltd. N/A 2014-10-23 is generic propecia just as good 2020-10-23 Yes 2023-04-23 baloxavir marboxil 227361 Xofluza Hoffmann-La Roche Limited N/A 2020-02-19 2026-02-19 Yes 2028-08-19 baricitinib 193687 Olumiant Eli Lilly Canada Inc.

N/A 2018-08-17 2024-08-17 N/A 2026-08-17 bazedoxifene acetate 160681 Duavive Pfizer Canada Inc. N/A 2014-10-23 2020-10-23 N/A 2022-10-23 is generic propecia just as good benralizumab 204008 Fasenra AstraZeneca Canada Inc. N/A 2018-02-22 2024-02-22 Yes 2026-08-22 bepotastine besilate 179294 Bepreve Bausch and Lomb Incorporated N/A 2016-07-27 2022-07-27 Yes 2025-01-27 bictegravir 203718 Biktarvy Gilead Sciences Canada, Inc. N/A 2018-07-10 2024-07-10 Yes 2027-01-10 bilastine 184231 Blexten Aralez Pharmaceutials Canada Inc. N/A 2016-04-21 2022-04-21 Yes 2024-10-21 binimetinib 237410 Mektovi Pfizer Canada ULC N/A 2021-03-02 2027-03-02 N/A 2029-03-02 blinatumomab 181723 Blincyto Amgen Canada Incorporated is generic propecia just as good N/A 2015-12-22 2021-12-22 Yes 2024-06-22 bosutinib 152211 Bosulif Pfizer Canada Inc.

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N/A 2016-01-15 2022-01-15 N/A 2024-01-15 carglumic acid 171358 Carbaglu Recordati Rare Diseases N/A 2015-04-10 2021-04-10 Yes 2023-10-10 cedazuridine 234610 Inqovi Otsuka Pharmaceutical Co., Ltd. N/A 2020-07-07 2026-07-07 N/A 2028-07-07 ceftolozane 178006 Zerbaxa Merck Canada Inc. N/A 2015-09-30 2021-09-30 N/A 2023-09-30 cemiplimab 218718 Libtayo Sanofi-Aventis Canada Inc. N/A 2019-04-10 2025-04-10 N/A 2027-04-10 cenegermin 218145 Oxervate Dompé farmaceutici S.p.A. N/A 2019-02-08 2025-02-08 N/A 2027-02-08 ceritinib 175702 Zykadia Novartis Pharmaceuticals Canada Inc.

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XigduoQtern 2014-12-12 2020-12-12 N/A 2022-12-12 daratumumab 187648 Darzalex Janssen Inc. Darzalex SC 2016-06-29 2022-06-29 N/A 2024-06-29 darolutamide 226146 Nubeqa Bayer Inc. N/A 2020-02-20 2026-02-20 N/A 2028-02-20 deferiprone 162924 Ferriprox Chiesi Canada Corp. N/A 2015-02-13 2021-02-13 Yes 2023-08-13 defibrotide sodium 200808 Defitelio Jazz Pharmaceuticals Ireland Limited N/A 2017-07-10 2023-07-10 Yes 2026-01-10 difluprednate 154517 Durezol Novartis Pharmaceuticals Canada Inc. N/A 2013-11-04 2019-11-04 Yes 2022-05-04 dimethyl fumarate 154776 Tecfidera Biogen Idec Canada Inc.

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Lomb Incorporated N/A 2018-12-27 2024-12-27 N/A 2026-12-27 ledipasvir 173180 Harvoni Gilead Sciences Canada Inc. N/A 2014-10-15 2020-10-15 Yes 2023-04-15 lefamulin acetate 233292 Xenleta Sunovion Pharmaceuticals Canada Inc. N/A 2020-07-10 2026-07-10 N/A 2028-07-10 lemborexant 231286 Dayvigo Eisai Limited N/A 2020-11-04 2026-11-04 N/A 2028-11-04 lenvatinib mesylate 180877 Lenvima Eisai Limited N/A 2015-12-22 2021-12-22 N/A 2023-12-22 letermovir 204165 Prevymis Merck Canada Inc. N/A 2017-11-01 2023-11-01 N/A 2025-11-01 levomilnacipran hydrochloride 167319 Fetzima Allergan Inc. N/A 2015-05-08 2021-05-08 N/A 2023-05-08 lifitegrast 199810 Xiidra Novartis Pharmaceuticals Canada Inc.

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May 31, 2021Our file number. 21-109448-84 Health Canada is issuing this Notice to clinical trial sponsors to clarify the approach to various types of clinical research with cannabis. Health Canada recognizes that conducting clinical research (i.e., research carried out on humans) with cannabis is critical to generating high-quality evidence that can be used to better understand the health risks and benefits of cannabis use, inform health policies and protect the health and safety of Canadians. Clinical research also supports the development of cannabis-based drug products that are safe, effective and of high quality. Sponsors interested in conducting research with cannabis must meet certain requirements under the Cannabis Act and its regulations.

Authorization to conduct research with cannabis must be obtained by applying for a federal cannabis research licence from the Controlled Substances and Cannabis Branch of Health Canada. The Application requirements for cannabis research licences webpage provides more information on how to obtain a research licence from Health Canada under the Cannabis Act and its regulations. Table of contents General requirements for research with cannabis - Food and Drugs Act (FDA) and Cannabis Act Any research with cannabis that meets the definition of a clinical trial in the Food and Drug Regulations (FDR) is subject to Part C, Division 5 of those regulations. Under Part C, Division 5 of the FDR, a clinical trial means. "An investigation in respect of a drug for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug." This definition only applies to clinical trials that are interventional and not observational (see section below on observational studies).

The application of this definition does not depend on how data generated from a clinical trial will be used. This means that research that is not intended to support the development of an authorized drug product could still meet the definition of a clinical trial, if any of the criteria set out in the definition above are met. Division 5 is a set of internationally aligned regulations under the FDR that govern the sale and importation of drugs for use in clinical trials. These regulations are designed to support research and innovation in an ethical manner to ensure the protection of clinical trial participants, as well as the integrity of the data generated. They also ensure that the same level of scrutiny is applied to all clinical trials, regardless of the drug substance being tested.

Under Division 5, sponsors must file a clinical trial application (CTA) to conduct a clinical trial. A CTA does not need to be submitted to Health Canada if a clinical trial is investigating an authorized drug product (i.e., one that has received a Notice of Compliance (NOC) or a Drug Identification Number (DIN)) and is used within the parameters authorized under the NOC or DIN (e.g., indication, dosage, formulation, route of administration, etc.). A CTA to investigate cannabis, or any other drug substance, must contain standard information and documentation to ensure that the trial is properly designed and that participants (and other implicated persons) are not exposed to undue risk. This includes, but is not limited to, a study protocol, informed consent forms, an Investigator's Brochure (IB), chemistry and manufacturing information, along with other pertinent information. Sponsors who are considering undertaking a clinical trial to investigate cannabis are encouraged to request a pre-application meeting with the Office of Clinical Trials to discuss their specific circumstances and requirements.

Approval from a Research Ethics Board (REB) must also be obtained before starting a clinical trial. More information on CTA requirements for drug products can be found in the Guidance Document For Clinical Trial Sponsors. Clinical Trial Applications. Quality (chemistry and manufacturing) requirements for CTAs involving cannabis are the same as for any pharmaceutical product used in a clinical trial. The scope and detail of information submitted in support of the quality portion of a CTA should be sufficient to enable Health Canada to make an adequate assessment of the characteristics of the drug.

Sponsors are expected to submit progressively more detailed quality information through subsequent clinical trial phases. More information on quality requirements can be found in the Guidance Document - Quality (Chemistry and Manufacturing) Guidance. Clinical Trial Applications (CTAs) for Pharmaceuticals. In addition to CTA requirements, clinical trials in Canada are conducted in accordance with internationally accepted principles of Good Clinical Practices (GCP). As part of GCP, drugs used in clinical trials must meet Good Manufacturing Practices (GMP), which is a requirement under Part C, Division 5 of the FDR.

Health Canada is aware that it may be challenging for some sponsors to obtain GMP-grade cannabis for research, but this requirement is necessary to ensure the consistency of the investigational product throughout the clinical trial(s). Sponsors must also report to Health Canada any serious and unexpected adverse drug reactions (ADRs) that occur during a clinical trial. For more information on ADR reporting, please visit the following webpage. Clinical Trials - Adverse Drug Reaction (ADR) Reporting. Clinical trials with cannabis for therapeutic purposes, or with intent to market as a drug under the Food and Drug Regulations Clinical research is essential to understanding the effects of cannabis in a therapeutic context, as well as for the development of drug products that are safe and effective.

An increased availability of authorized drugs containing cannabis provides Canadians with a greater selection of therapeutic options to meet their health needs. High-quality research also helps guide practitioners in making evidence-based decisions when prescribing and managing patients using these drugs. When a clinical trial with cannabis is conducted for therapeutic purposes, standard clinical trial requirements apply (as described above). In addition, sponsors are reminded that, should they plan to seek market authorization under the FDR, studies that do not meet the requirements of Division 5 may not be accepted. In particular, the IB (which is a regulatory requirement described in C.05.005(e) of the FDR) should be prepared in accordance with the Health Canada / ICH Guidance Document E6.

Good Clinical Practice. Consolidated Guideline. This means that the data contained in the IB should be specific to the product being investigated, include the results of any pre-clinical studies, and any relevant clinical studies, and be updated annually. Researchers have informed Health Canada that a product-specific IB is not always feasible for cannabis, and acts as an impediment to cannabis research in Canada. In early phase trials, Health Canada may consider that the absence of the full set of product-specific pre-clinical studies in the IB is acceptable if the clinical trial involves a cannabis product that is produced under GMP conditions, and for which there is sufficient evidence of safe human use.

Health Canada expects that the sponsor will be developing a product-specific IB, aligned with the requirements of ICH M3(R2), for trials designed to confirm the efficacy and safety of the cannabis product for use in the treatment of a specific disease/condition, and that the IB will be updated as new information accumulates. Some flexibility may be acceptable for cannabis products where a similar product has received market authorization either in Canada or another member state of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). In this situation, Health Canada may consider the absence of a full set of product-specific pre-clinical studies acceptable in early phase trials if the sponsor can provide information that establishes the similarity of the chemical and physical properties of the investigational product to the marketed product. Synthetic products that are not duplicates of naturally occurring phytocannabinoids, or where a similar product has not received market authorization either in Canada or in an ICH member state, require product-specific pre-clinical studies, even for early phase trials. The sponsor also needs to provide an attestation that the investigational product is manufactured in a facility that is compliant with GMP.

Sponsors who are considering undertaking a clinical trial to investigate cannabis are encouraged to request a pre-application meeting with the Office of Clinical Trials to discuss their specific circumstances and requirements. Clinical trials with cannabis for non-therapeutic purposes Clinical research is also needed to better understand the psychological and physiological effects of cannabis for non-therapeutic purposes. For example, this can include investigating the time to onset or duration of effects of a cannabis product, the impact of cannabis use on driving performance, or various types of public health research. For the purposes of this document only, non-therapeutic cannabis research can be considered to be an interventional investigation aimed at. Increasing the knowledge on cannabis and its effects in a healthy user population.

Generating knowledge on cannabis to inform public health and public safety measures, public education, and policy. And/or Furthering research and development of cannabis products aimed for sale under the cannabis legal framework. It would exclude studies that have the following objectives. Assessing potential therapeutic effects/outcomes/indications. And/ or Assessing the efficacy in treating a disease state, symptoms or conditions.

Clinical trials with cannabis for non-therapeutic purposes are currently subject to Part C, Division 5 of the FDR and require the submission of a CTA to Health Canada. However, the Department recognizes that Division 5 may not be ideally suited to regulate research for non-therapeutic purposes using commercially available products containing cannabis sold under the cannabis legal framework. In order to facilitate non-therapeutic cannabis research, it is Health Canada's intention to exempt cannabis used in these studies from the application of the FDA/FDR, and to create a framework under the Cannabis Regulations for non-therapeutic cannabis research. More information regarding this regulatory initiative can be found in this Notice of Intent and this Forward Regulatory Plan.In the interim, for clinical trials with cannabis for non-therapeutic purposes, the Department may consider the absence of product specific pre-clinical and clinical information acceptable for these studies, provided there is sufficient information on the product's main active ingredient(s) - for example, cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC). However, the IB must continue to include all the types of information listed under C.05.005(e) on these active ingredients, and must contain sufficient information to support the specific study.

The information must be relevant to the product under investigation in terms of route of administration, dosage regimen (dose and frequency) and product form or class (e.g., cannabis extract, edible cannabis, cannabis topicals, dried cannabis or fresh cannabis). The information must also be updated annually, and include recent and relevant clinical trial results. If sponsors wish to be eligible for this approach, their clinical trials must be conducted on healthy adults who are currently using cannabis, using the same product form/class that participants have normally used and the same route of administration. The dosage regimen of cannabis administered in the trial is not to exceed what the participant would normally have consumed within a similar period of time. Additionally, although the investigational product does not have to be available for retail sale on the legal market (i.e.

It may be under development), it must meet the requirements of the Cannabis Regulations for legal retail sale and meet GMP quality requirements. If dried cannabis is administered through smoking or vaping, adequate measures to prevent exposure of other individuals (e.g., research staff or other participants) to second-hand smoke or vapour is to be included in the protocol. All other aspects of Division 5, including (but not limited to) the requirement for REB approval, a qualified investigator at each site, submission of chemistry and manufacturing information, adherence to GCP and adverse reaction reporting requirements, continue to apply. Sponsors who are considering undertaking a clinical trial to investigate cannabis are encouraged to request a pre-application meeting with the Office of Clinical Trials to discuss their specific circumstances and requirements. When submitting a CTA, sponsors are to indicate in their cover letter whether the clinical trial is for therapeutic purposes or for non-therapeutic purposes.

Please see below for a tabular summary of these scenarios. Type of cannabis product Type of clinical trial Eligibility for a non-product-specific IB Yes No Cannabis products of botanical origin† and synthetics that are duplicates of naturally occurring cannabinoids Non-therapeutic purpose trial √†† Therapeutic purpose early phase trial √†† Therapeutic purpose confirmatory trial √ Synthetics that are not duplicates of naturally occurring cannabinoids Non-therapeutic purpose trial √ Therapeutic purpose early phase trial √ Therapeutic purpose confirmatory trial √ Cannabis products††† where a similar product has received market authorization either in Canada or in an ICH member state Non-therapeutic purpose trial √†††† Therapeutic purpose early phase trial √†††† Therapeutic purpose confirmatory trial √ † Dried cannabis, fresh cannabis, edible cannabis, cannabis topicals, cannabis extracts (including cannabis oil) †† Information on the main active ingredients and on human use may be considered acceptable ††† Cannabis products of botanical origin or synthetics that are duplicates of naturally occurring cannabinoids †††† Information that establishes similarity of the chemical and physical properties of the investigational product to the marketed product may be considered acceptable Other types of cannabis-based research that are not considered clinical trials Sponsors should consult the definition of a clinical trial in Part C, Division 5 of the FDR to determine whether their study protocol meets the criteria for a clinical trial. When in doubt, sponsors should consult the Office of Clinical Trials. Observational studies Sponsors who intend to conduct an observational study using cannabis do not need to submit a CTA to Health Canada. A study is considered observational if it meets all of the following criteria.

The protocol does not assign to the participants a specific intervention. The prescription of a drug containing cannabis or authorization of cannabis for medical purposes is clearly separated from the decision to include the patient in the study. The investigator has no control over the prescribing, authorization or administration of the cannabis product. The cannabis product being used must be sourced from the legal regulated Canadian market. The number of inclusion criteria must be very limited (e.g., adults using cannabis and the ability to provide consent).

And The collection of data should involve no to minimal health risks. For observational studies, the sponsors are reminded to consult with their Research Ethics Boards regarding applicable ethics requirements.Serious adverse reactions observed during the course of an observational study should be reported to Canada Vigilance. Information on cannabis adverse reaction reporting can be found in the Cannabis adverse reaction reporting guide. Organoleptic testing, and testing of detection devices Although the Department cannot, in advance, provide a complete list of study protocols that would not meet the definition of a clinical trial, two examples include. Organoleptic testing (e.g., assessment of consumer preference with respect to taste or smell) of products containing cannabis, provided that the cannabis is in its final form and meets the requirements in the Cannabis Regulations for retail sale.

Research on the verification, validation or standardization of a device detecting cannabis for judicial or forensic use (e.g., roadside testing devices), provided that the study focuses on the device and not on the properties or effects of cannabis. Clinical research involving parts of the cannabis plant permitted in natural health products The requirements of the Natural Health Products Regulations apply to clinical trials for natural health products, including those containing permitted parts of the cannabis plant (see section 3.4 of Health Canada's Health products containing cannabis or for use with cannabis. Guidance for the Cannabis Act, the Food and Drugs Act, and related regulations document for more details on permitted parts). More information about these requirements can be found in the Clinical Trials for Natural Health Products guidance document. Veterinary research In order to conduct veterinary drug research or studies using drugs containing cannabis, the investigator or the sponsor is required to submit either an Experimental Studies Certificate (ESC) or a veterinary Investigational New Drug (IND) application to Health Canada's Veterinary Drugs Directorate (VDD).

For all research or studies to be conducted using a veterinary drug, the objective is to ensure that there is appropriate oversight to cover the overall health and safety of study animals. If the study includes food-producing animals, Health Canada also considers relevant information to address food safety. Sponsors are strongly urged to request a pre-submission meeting with VDD before submitting an ESC or IND application for research involving cannabis. More information can be found on the veterinary drugs forms and applications page. Compliance and enforcement As part of its regulatory responsibilities, Health Canada promotes, monitors and enforces compliance.

As such, Health Canada Inspectors may conduct inspections of clinical trials under the authority of Section 23 of the FDA. The purpose of these inspections is to verify compliance with Part C, Division 5 of the FDR, which include the requirement to comply with GCP. For more information on compliance and enforcement, please refer to the Compliance and Enforcement Policy for Health Products (POL-0001) and to the various guidance documents available on the Health Canada Good Clinical Practices webpage. Contact Information. Office of Clinical Trials - Therapeutic Products DirectorateHealth Products and Food BranchE-mail.

Hc.oct.enquiries-requetes.bec.sc@canada.ca Natural and Non-prescription Health Products DirectorateHealth Products and Food BranchE-mail. Nhpd-cta.dec-dpsn@hc-sc.gc.ca Veterinary Drugs DirectorateHealth Products and Food BranchE-mail:hc.vdd.skmd.so-dgps.dmv.cp.sc@canada.ca Licensing and Medical Access DirectorateControlled Substances and Cannabis BranchE-mail:hc.sp-licensing-cannabis-licences-sp.sc@canada.ca Clinical Trial Compliance ProgramRegulatory Operations and Enforcement BranchE-mail. Gcp_bpc@hc-sc.gc.ca.

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Soliqua 2017-05-25 2023-05-25 N/A 2025-05-25 lomitapide mesylate 160385 Juxtapid Aegerion Pharmaceuticals Canada Ltd. N/A 2014-02-04 2020-02-04 N/A 2022-02-04 lorlatinib 215733 Lorbrena Pfizer Canada ULC N/A 2019-02-22 2025-02-22 N/A 2027-02-22 lubiprostone 179333 Amitiza Sucampo Pharma Americas LLC N/A 2015-10-14 2021-10-14 N/A 2023-10-14 lumacaftor 181715 Orkambi Vertex Pharmaceuticals (Canada) Incorporated N/A 2016-01-26 2022-01-26 Yes 2024-07-26 luspatercept 236441 Reblozyl Celgene Inc. N/A 2020-09-25 2026-09-25 N/A 2028-09-25 lutetium177 Lu oxodotreotide 217184 Lutathera Advanced Accelerator Applications USA, Inc. N/A 2019-01-09 2025-01-09 N/A 2027-01-09 macitentan 161372 Opsumit Janssen Inc.

N/A 2013-11-06 2019-11-06 Yes 2022-05-06 mecasermin 235023 Increlex Ipsen Biopharmaceuticals Canada Inc. N/A 2020-12-17 2026-12-17 Yes 2029-06-17 mepolizumab 179850 Nucala GlaxoSmithKline Inc. N/A 2015-12-03 2021-12-03 Yes 2024-06-03 midostaurin 201101 Rydapt Novartis Pharmaceuticals Canada Inc. N/A 2017-07-21 2023-07-21 Yes 2026-01-21 mifepristone 160063 Mifegymiso Linepharma International Limited N/A 2015-07-29 2021-07-29 Yes 2024-01-29 migalastat hydrochloride 196956 Galafold Amicus Therapeutics UK LTD N/A 2017-09-05 2023-09-05 N/A 2025-09-05 modified vaccinia propecia (ankara-bavarian nordic) 144762 Imvamune Bavarian Nordic A/S N/A 2013-11-21 2019-11-21 N/A 2021-11-21 naloxegol oxalate 167790 Movantik Knight Therapeutics Inc.

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N/A 2019-07-16 2025-07-16 N/A 2027-07-16 netupitant 196495 Akynzeo Elvium Life Sciences N/A 2017-09-28 2023-09-28 N/A 2025-09-28 nintedanib (supplied as nintedanib esilate) 176043 Ofev Boehringer Ingelheim (Canada) Ltd N/A 2015-06-25 2021-06-25 N/A 2023-06-25 niraparib 216792 Zejula GlaxoSmithKline Inc. N/A 2019-06-27 2025-06-27 N/A 2027-06-27 nivolumab 180828 Opdivo Bristol-Myers-Squibb Canada N/A 2015-09-25 2021-09-25 Yes 2024-03-25 nusinersen 200070 Spinraza Biogen Canada Inc. N/A 2017-06-29 2023-06-29 Yes 2025-12-29 obeticholic acid 198418 Ocaliva Intercept Pharmaceuticals Inc. N/A 2017-05-24 2023-05-24 N/A 2025-05-24 obiltoxaximab 230825 Anthim Elusys Therapeutics, Inc.

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N/A 2017-08-16 2023-08-16 N/A 2025-08-16 zanubrutinib 242748 Brukinsa BeiGene Switzerland GmbH N/A 2021-03-01 2027-03-01 N/A 2029-03-01Important. This updated Notice replaces the previous version that was published on September 18, 2020. May 31, 2021Our file number. 21-109448-84 Health Canada is issuing this Notice to clinical trial sponsors to clarify the approach to various types of clinical research with cannabis.

Health Canada recognizes that conducting clinical research (i.e., research carried out on humans) with cannabis is critical to generating high-quality evidence that can be used to better understand the health risks and benefits of cannabis use, inform health policies and protect the health and safety of Canadians. Clinical research also supports the development of cannabis-based drug products that are safe, effective and of high quality. Sponsors interested in conducting research with cannabis must meet certain requirements under the Cannabis Act and its regulations. Authorization to conduct research with cannabis must be obtained by applying for a federal cannabis research licence from the Controlled Substances and Cannabis Branch of Health Canada.

The Application requirements for cannabis research licences webpage provides more information on how to obtain a research licence from Health Canada under the Cannabis Act and its regulations. Table of contents General requirements for research with cannabis - Food and Drugs Act (FDA) and Cannabis Act Any research with cannabis that meets the definition of a clinical trial in the Food and Drug Regulations (FDR) is subject to Part C, Division 5 of those regulations. Under Part C, Division 5 of the FDR, a clinical trial means. "An investigation in respect of a drug for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug." This definition only applies to clinical trials that are interventional and not observational (see section below on observational studies).

The application of this definition does not depend on how data generated from a clinical trial will be used. This means that research that is not intended to support the development of an authorized drug product could still meet the definition of a clinical trial, if any of the criteria set out in the definition above are met. Division 5 is a set of internationally aligned regulations under the FDR that govern the sale and importation of drugs for use in clinical trials. These regulations are designed to support research and innovation in an ethical manner to ensure the protection of clinical trial participants, as well as the integrity of the data generated.

They also ensure that the same level of scrutiny is applied to all clinical trials, regardless of the drug substance being tested. Under Division 5, sponsors must file a clinical trial application (CTA) to conduct a clinical trial. A CTA does not need to be submitted to Health Canada if a clinical trial is investigating an authorized drug product (i.e., one that has received a Notice of Compliance (NOC) or a Drug Identification Number (DIN)) and is used within the parameters authorized under the NOC or DIN (e.g., indication, dosage, formulation, route of administration, etc.). A CTA to investigate cannabis, or any other drug substance, must contain standard information and documentation to ensure that the trial is properly designed and that participants (and other implicated persons) are not exposed to undue risk.

This includes, but is not limited to, a study protocol, informed consent forms, an Investigator's Brochure (IB), chemistry and manufacturing information, along with other pertinent information. Sponsors who are considering undertaking a clinical trial to investigate cannabis are encouraged to request a pre-application meeting with the Office of Clinical Trials to discuss their specific circumstances and requirements. Approval from a Research Ethics Board (REB) must also be obtained before starting a clinical trial. More information on CTA requirements for drug products can be found in the Guidance Document For Clinical Trial Sponsors.

Clinical Trial Applications. Quality (chemistry and manufacturing) requirements for CTAs involving cannabis are the same as for any pharmaceutical product used in a clinical trial. The scope and detail of information submitted in support of the quality portion of a CTA should be sufficient to enable Health Canada to make an adequate assessment of the characteristics of the drug. Sponsors are expected to submit progressively more detailed quality information through subsequent clinical trial phases.

More information on quality requirements can be found in the Guidance Document - Quality (Chemistry and Manufacturing) Guidance. Clinical Trial Applications (CTAs) for Pharmaceuticals. In addition to CTA requirements, clinical trials in Canada are conducted in accordance with internationally accepted principles of Good Clinical Practices (GCP). As part of GCP, drugs used in clinical trials must meet Good Manufacturing Practices (GMP), which is a requirement under Part C, Division 5 of the FDR.

Health Canada is aware that it may be challenging for some sponsors to obtain GMP-grade cannabis for research, but this requirement is necessary to ensure the consistency of the investigational product throughout the clinical trial(s). Sponsors must also report to Health Canada any serious and unexpected adverse drug reactions (ADRs) that occur during a clinical trial. For more information on ADR reporting, please visit the following webpage. Clinical Trials - Adverse Drug Reaction (ADR) Reporting.

Clinical trials with cannabis for therapeutic purposes, or with intent to market as a drug under the Food and Drug Regulations Clinical research is essential to understanding the effects of cannabis in a therapeutic context, as well as for the development of drug products that are safe and effective. An increased availability of authorized drugs containing cannabis provides Canadians with a greater selection of therapeutic options to meet their health needs. High-quality research also helps guide practitioners in making evidence-based decisions when prescribing and managing patients using these drugs. When a clinical trial with cannabis is conducted for therapeutic purposes, standard clinical trial requirements apply (as described above).

In addition, sponsors are reminded that, should they plan to seek market authorization under the FDR, studies that do not meet the requirements of Division 5 may not be accepted. In particular, the IB (which is a regulatory requirement described in C.05.005(e) of the FDR) should be prepared in accordance with the Health Canada / ICH Guidance Document E6. Good Clinical Practice. Consolidated Guideline.

This means that the data contained in the IB should be specific to the product being investigated, include the results of any pre-clinical studies, and any relevant clinical studies, and be updated annually. Researchers have informed Health Canada that a product-specific IB is not always feasible for cannabis, and acts as an impediment to cannabis research in Canada. In early phase trials, Health Canada may consider that the absence of the full set of product-specific pre-clinical studies in the IB is acceptable if the clinical trial involves a cannabis product that is produced under GMP conditions, and for which there is sufficient evidence of safe human use. Health Canada expects that the sponsor will be developing a product-specific IB, aligned with the requirements of ICH M3(R2), for trials designed to confirm the efficacy and safety of the cannabis product for use in the treatment of a specific disease/condition, and that the IB will be updated as new information accumulates.

Some flexibility may be acceptable for cannabis products where a similar product has received market authorization either in Canada or another member state of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). In this situation, Health Canada may consider the absence of a full set of product-specific pre-clinical studies acceptable in early phase trials if the sponsor can provide information that establishes the similarity of the chemical and physical properties of the investigational product to the marketed product. Synthetic products that are not duplicates of naturally occurring phytocannabinoids, or where a similar product has not received market authorization either in Canada or in an ICH member state, require product-specific pre-clinical studies, even for early phase trials. The sponsor also needs to provide an attestation that the investigational product is manufactured in a facility that is compliant with GMP.

Sponsors who are considering undertaking a clinical trial to investigate cannabis are encouraged to request a pre-application meeting with the Office of Clinical Trials to discuss their specific circumstances and requirements. Clinical trials with cannabis for non-therapeutic purposes Clinical research is also needed to better understand the psychological and physiological effects of cannabis for non-therapeutic purposes. For example, this can include investigating the time to onset or duration of effects of a cannabis product, the impact of cannabis use on driving performance, or various types of public health research. For the purposes of this document only, non-therapeutic cannabis research can be considered to be an interventional investigation aimed at.

Increasing the knowledge on cannabis and its effects in a healthy user population. Generating knowledge on cannabis to inform public health and public safety measures, public education, and policy. And/or Furthering research and development of cannabis products aimed for sale under the cannabis legal framework. It would exclude studies that have the following objectives.

Assessing potential therapeutic effects/outcomes/indications. And/ or Assessing the efficacy in treating a disease state, symptoms or conditions. Clinical trials with cannabis for non-therapeutic purposes are currently subject to Part C, Division 5 of the FDR and require the submission of a CTA to Health Canada. However, the Department recognizes that Division 5 may not be ideally suited to regulate research for non-therapeutic purposes using commercially available products containing cannabis sold under the cannabis legal framework.

In order to facilitate non-therapeutic cannabis research, it is Health Canada's intention to exempt cannabis used in these studies from the application of the FDA/FDR, and to create a framework under the Cannabis Regulations for non-therapeutic cannabis research. More information regarding this regulatory initiative can be found in this Notice of Intent and this Forward Regulatory Plan.In the interim, for clinical trials with cannabis for non-therapeutic purposes, the Department may consider the absence of product specific pre-clinical and clinical information acceptable for these studies, provided there is sufficient information on the product's main active ingredient(s) - for example, cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC). However, the IB must continue to include all the types of information listed under C.05.005(e) on these active ingredients, and must contain sufficient information to support the specific study. The information must be relevant to the product under investigation in terms of route of administration, dosage regimen (dose and frequency) and product form or class (e.g., cannabis extract, edible cannabis, cannabis topicals, dried cannabis or fresh cannabis).

The information must also be updated annually, and include recent and relevant clinical trial results. If sponsors wish to be eligible for this approach, their clinical trials must be conducted on healthy adults who are currently using cannabis, using the same product form/class that participants have normally used and the same route of administration. The dosage regimen of cannabis administered in the trial is not to exceed what the participant would normally have consumed within a similar period of time. Additionally, although the investigational product does not have to be available for retail sale on the legal market (i.e.

It may be under development), it must meet the requirements of the Cannabis Regulations for legal retail sale and meet GMP quality requirements. If dried cannabis is administered through smoking or vaping, adequate measures to prevent exposure of other individuals (e.g., research staff or other participants) to second-hand smoke or vapour is to be included in the protocol. All other aspects of Division 5, including (but not limited to) the requirement for REB approval, a qualified investigator at each site, submission of chemistry and manufacturing information, adherence to GCP and adverse reaction reporting requirements, continue to apply. Sponsors who are considering undertaking a clinical trial to investigate cannabis are encouraged to request a pre-application meeting with the Office of Clinical Trials to discuss their specific circumstances and requirements.

When submitting a CTA, sponsors are to indicate in their cover letter whether the clinical trial is for therapeutic purposes or for non-therapeutic purposes. Please see below for a tabular summary of these scenarios. Type of cannabis product Type of clinical trial Eligibility for a non-product-specific IB Yes No Cannabis products of botanical origin† and synthetics that are duplicates of naturally occurring cannabinoids Non-therapeutic purpose trial √†† Therapeutic purpose early phase trial √†† Therapeutic purpose confirmatory trial √ Synthetics that are not duplicates of naturally occurring cannabinoids Non-therapeutic purpose trial √ Therapeutic purpose early phase trial √ Therapeutic purpose confirmatory trial √ Cannabis products††† where a similar product has received market authorization either in Canada or in an ICH member state Non-therapeutic purpose trial √†††† Therapeutic purpose early phase trial √†††† Therapeutic purpose confirmatory trial √ † Dried cannabis, fresh cannabis, edible cannabis, cannabis topicals, cannabis extracts (including cannabis oil) †† Information on the main active ingredients and on human use may be considered acceptable ††† Cannabis products of botanical origin or synthetics that are duplicates of naturally occurring cannabinoids †††† Information that establishes similarity of the chemical and physical properties of the investigational product to the marketed product may be considered acceptable Other types of cannabis-based research that are not considered clinical trials Sponsors should consult the definition of a clinical trial in Part C, Division 5 of the FDR to determine whether their study protocol meets the criteria for a clinical trial. When in doubt, sponsors should consult the Office of Clinical Trials.

Observational studies Sponsors who intend to conduct an observational study using cannabis do not need to submit a CTA to Health Canada. A study is considered observational if it meets all of the following criteria. The protocol does not assign to the participants a specific intervention. The prescription of a drug containing cannabis or authorization of cannabis for medical purposes is clearly separated from the decision to include the patient in the study.

The investigator has no control over the prescribing, authorization or administration of the cannabis product. The cannabis product being used must be sourced from the legal regulated Canadian market. The number of inclusion criteria must be very limited (e.g., adults using cannabis and the ability to provide consent). And The collection of data should involve no to minimal health risks.

For observational studies, the sponsors are reminded to consult with their Research Ethics Boards regarding applicable ethics requirements.Serious adverse reactions observed during the course of an observational study should be reported to Canada Vigilance. Information on cannabis adverse reaction reporting can be found in the Cannabis adverse reaction reporting guide. Organoleptic testing, and testing of detection devices Although the Department cannot, in advance, provide a complete list of study protocols that would not meet the definition of a clinical trial, two examples include. Organoleptic testing (e.g., assessment of consumer preference with respect to taste or smell) of products containing cannabis, provided that the cannabis is in its final form and meets the requirements in the Cannabis Regulations for retail sale.

Research on the verification, validation or standardization of a device detecting cannabis for judicial or forensic use (e.g., roadside testing devices), provided that the study focuses on the device and not on the properties or effects of cannabis. Clinical research involving parts of the cannabis plant permitted in natural health products The requirements of the Natural Health Products Regulations apply to clinical trials for natural health products, including those containing permitted parts of the cannabis plant (see section 3.4 of Health Canada's Health products containing cannabis or for use with cannabis. Guidance for the Cannabis Act, the Food and Drugs Act, and related regulations document for more details on permitted parts). More information about these requirements can be found in the Clinical Trials for Natural Health Products guidance document.

Veterinary research In order to conduct veterinary drug research or studies using drugs containing cannabis, the investigator or the sponsor is required to submit either an Experimental Studies Certificate (ESC) or a veterinary Investigational New Drug (IND) application to Health Canada's Veterinary Drugs Directorate (VDD). For all research or studies to be conducted using a veterinary drug, the objective is to ensure that there is appropriate oversight to cover the overall health and safety of study animals. If the study includes food-producing animals, Health Canada also considers relevant information to address food safety. Sponsors are strongly urged to request a pre-submission meeting with VDD before submitting an ESC or IND application for research involving cannabis.

More information can be found on the veterinary drugs forms and applications page. Compliance and enforcement As part of its regulatory responsibilities, Health Canada promotes, monitors and enforces compliance. As such, Health Canada Inspectors may conduct inspections of clinical trials under the authority of Section 23 of the FDA. The purpose of these inspections is to verify compliance with Part C, Division 5 of the FDR, which include the requirement to comply with GCP.

For more information on compliance and enforcement, please refer to the Compliance and Enforcement Policy for Health Products (POL-0001) and to the various guidance documents available on the Health Canada Good Clinical Practices webpage. Contact Information. Office of Clinical Trials - Therapeutic Products DirectorateHealth Products and Food BranchE-mail. Hc.oct.enquiries-requetes.bec.sc@canada.ca Natural and Non-prescription Health Products DirectorateHealth Products and Food BranchE-mail.

Nhpd-cta.dec-dpsn@hc-sc.gc.ca Veterinary Drugs DirectorateHealth Products and Food BranchE-mail:hc.vdd.skmd.so-dgps.dmv.cp.sc@canada.ca Licensing and Medical Access DirectorateControlled Substances and Cannabis BranchE-mail:hc.sp-licensing-cannabis-licences-sp.sc@canada.ca Clinical Trial Compliance ProgramRegulatory Operations and Enforcement BranchE-mail. Gcp_bpc@hc-sc.gc.ca.

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October 9, does propecia decrease testosterone best online propecia 2020U.S. Department of Labor’s OSHA Announces $913,133In hair loss Violations WASHINGTON, DC – Since the start of the hair loss propecia through Oct. 1, 2020, the does propecia decrease testosterone U.S.

Department of Labor’s Occupational Safety and Health Administration (OSHA) has cited 62 establishments for violations, resulting in proposed penalties totaling $913,133. OSHA does propecia decrease testosterone inspections have resulted in the agency citing employers for violations, including failures to. OSHA has already announced citations relating to 37 establishments, which can be found at dol.gov/newsroom.

In addition to those establishments, the does propecia decrease testosterone 25 establishments below have received hair loss-related citations totaling $429,064 from OSHA relating to one or more of the above violations from Sept. 25 to Oct. 1, 2020 does propecia decrease testosterone.

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1474628 Brockton Massachusetts $12,145 Hackensack Meridian Health does propecia decrease testosterone Hospitals Corp. 1472186 Hackensack New Jersey $15,422 Essex Residential Care LLC 1472725 West Caldwell New Jersey $13,494 Barnert Subacute Rehabilitation Center LLC 1474902 Paterson New Jersey $13,494 84 Cold Hill Road Operations LLC 1473525 Mendham New Jersey $13,494 Hackensack Meridian Health System 1477909 North Bergen New Jersey $13,494 292 Applegarth Road Operations LLC 1487345 Monroe Township New Jersey $23,133 1515 Lamberts Mill Road Operations LLC 1472780 Westfield New Jersey $26,988 Hackensack Meridian Health Hospitals Corp. 1474520 Hackensack New Jersey $9,639 The Matheny School and Hospital 1476359 Peapack does propecia decrease testosterone New Jersey $13,494 IJKG Opco LLC 1477379 Bayonne New Jersey $25,061 MPV New Jersey MD Medical Services P.C.

1482167 Nutley New Jersey $23,133 Prime Healthcare Services - St. Michael’s LLC does propecia decrease testosterone 1472330 Newark New Jersey $25,061 Robert Wood Johnson Barnabas Health 1475320 Toms River New Jersey $13,494 St. Barnabas Hospital 1472869 Bronx New York $23,133 St.

Barnabas Hospital 1473218 Bronx New York $23,133 Northwell Health Orzac Center for Rehabilitation 1476726 Valley Stream New York $23,133 Hudson Pointe Acquisition LLC 1486893 Bronx New York $22,555 VA NY Harbor Healthcare System, St Albans Community Living Center 1474970 Jamaica New York $0 Masonic Village of the Grand Lodge of PA 1475223 Lafayette Hill Pennsylvania $15,422 A full list of what standards does propecia decrease testosterone were cited for each establishment – and the inspection number – are available here. An OSHA standards database can be found here. Resources are available on the agency’s does propecia decrease testosterone hair loss treatment webpage to help employers comply with these standards.

Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees. OSHA’s role is to does propecia decrease testosterone help ensure these conditions for America’s working men and women by setting and enforcing standards and providing training, education and assistance. For more information, visit www.osha.gov.

The mission of the Department of Labor is to foster, promote, and develop the welfare of the wage earners, job seekers, and retirees of the United States. Improve working does propecia decrease testosterone conditions. Advance opportunities for profitable employment.

And assure work-related benefits and does propecia decrease testosterone rights. # # # Media Contact. Megan Sweeney, 202-693-4661, sweeney.megan.p@dol.gov Release does propecia decrease testosterone Number.

20-1947-NAT U.S. Department of Labor news materials are does propecia decrease testosterone accessible at http://www.dol.gov. The Department’s Reasonable Accommodation Resource Center converts departmental information and documents into alternative formats, which include Braille and large print.

For alternative format requests, please contact the Department at (202) 693-7828 (voice) or (800) 877-8339 (federal relay).About does propecia decrease testosterone Insight Insight provides an in-depth look at health care issues in and affecting California.Have a story suggestion?. Let us know. PETALUMA, Calif does propecia decrease testosterone.

€” Late on the night of Sept. 27, a bumper-to-bumper caravan of fleeing cars, horse trailers, RVs and overstuffed pickup trucks snaked east on Highway 12, the flames of the Glass Fire glowing orange in their rearview mirrors.With her cat, Bodhi, in his carrier in the back seat, 80-year-old Diana Dimas, who doesn’t see well at night, kept her eyes glued to the rear lights of her neighbor’s Toyota. She and Magdalena Mulay had met a few does propecia decrease testosterone years before at a bingo night in their sprawling retirement community on the outskirts of Santa Rosa.

Both Libras, each with two marriages behind her, the two women soon became the sort of friends who finish each other’s sentences.Now, for the second time in three years, they heard the alarms and fled together as fire consumed the golden hills of Northern California’s wine country.“I thought, where on earth are we going to go?. € recalled Dimas does propecia decrease testosterone. She remembered that when the catastrophic Tubbs Fire hit in 2017, people had sought refuge outside well-lit supermarkets, which had water and bathrooms.

Which is how Dimas and Mulay and dozens of other seniors ended up spending the night of the most recent evacuation in the parking lot of does propecia decrease testosterone the Sonoma Safeway. Email Sign-Up Subscribe to California Healthline’s free Daily Edition. At midnight, Mulay was trying to get comfortable enough to catch a few winks in her driver’s seat when her phone began does propecia decrease testosterone to chirp.

A friend was calling to wish her a happy 74th birthday.The stories of that Sunday night — as a 20-acre fire started that morning merged with two other fires to become an 11,000-acre conflagration forcing tens of thousands from their homes in two counties — spotlight the challenges of evacuating elderly and infirm residents from the deadly wildfires that have become an annual occurrence in California. This year, the hair loss, which is especially dangerous to the elderly, has further complicated the problem.While the 2020 fire season will go down does propecia decrease testosterone as the state’s biggest on record, rescuers have so far managed to avoid horrors on the scale of three years ago, when the firestorm that raced through California’s wine country killed 45 people. Almost all were over 65 — found in wheelchairs, trapped in their garages, isolated and hard of hearing, or simply too stubborn to leave.

The same grim pattern emerged from the Camp Fire, which leveled the Northern California town of Paradise in 2018.Assisted care homes in particular does propecia decrease testosterone came under scrutiny after the 2017 fire, when ill-equipped and untrained workers at two Santa Rosa facilities abandoned two dozen frail, elderly residents as the flames closed in, according to state investigators. They concluded the seniors would have died in the flames had emergency workers and relatives not arrived at the last minute to rescue them.“The problem is we don’t value elders as a society,” said Debbie Toth, CEO of Choice in Aging, an advocacy group. €œIf children needed to be evacuated, we’d have a freaking Romper Room stood up overnight to entertain them so they wouldn’t be damaged by the experience.”The destructive effects of climate change in California have dovetailed with a rapidly graying population — which in a decade is projected to include 8.6 million senior citizens.

That has fueled a growing does propecia decrease testosterone demand for senior housing, from assisted care homes to swanky “active adult” facilities complete with golf courses and pools.Proximity to nature is a major selling point of Oakmont Village, Dimas and Mulay’s upscale community of nearly 5,000 over-55s, which has everything from bridge games to cannabis clubs. But the woodlands and vineyards surrounding this suburban sprawl have put thousands of elderly citizens in hazardous wildfire zones.“With seniors, there’s mobility issues, hearing issues — even the sense of smell is often gone in the later years,” said Marrianne McBride, who heads Sonoma County’s Council on Aging. Getting out fast in an emergency does propecia decrease testosterone is especially challenging for those who no longer drive.

In Sunday’s evacuation, some residents who followed official advice to call ride services had to wait hours, until 3 or 4 a.m., for the overtaxed vans.Dimas and Mulay managed to scramble into their cars and get on the road shortly after 10 p.m., when a mandatory evacuation order went out for the thousands of seniors in Oakmont Village. But it was after midnight when residents of two Santa does propecia decrease testosterone Rosa assisted care homes in the evacuation zone were shuffled onto city buses in their bathrobes, some with the aid of walkers. Off-duty drivers braved thick smoke and falling embers to ferry some of them to safety, only to spend hours being sent from one shelter to another as evacuation sites filled up fast because of social distancing rules designed to prevent the spread of hair loss treatment.Other precautions, including masks and temperature checks, were followed.

But health officials nonetheless voiced concerns that vulnerable people in their 80s and 90s — especially residents of skilled nursing homes, the source of most of Sonoma County’s hair loss deaths so far — had been moved among multiple does propecia decrease testosterone locations, upping their chance for exposure.In the following days, shelters were fielding frantic calls from out-of-town relatives searching for their loved ones. €œWe were getting phone calls from Michigan, other places across the country, saying, ‘I’m trying to find my mother!. €™â€ said Allison Keaney, CEO of the Sonoma-Marin Fairgrounds, which sheltered several hundred horses, chickens, goats and llamas as well as displaced people.Bart Pettijohn rests on his does propecia decrease testosterone cot with his dog, Clumsy, in an evacuation center at the Petaluma Veterans Memorial Building on Sept.

30. Volunteer health care workers and a veterinarian were among those who checked up on dozens of seniors and pets forced out of their homes during the biggest wildfire season in California history.(Rachel Scheier for California Healthline)By Wednesday afternoon, a few dozen evacuees remained at the shelters, does propecia decrease testosterone mostly seniors without relatives or friends nearby to take them in, like Dimas and Mulay. The two women had left the Safeway lot and were sleeping on folding cots in a gym at the Veterans Memorial Building in Petaluma, an old poultry industry town dotted with upscale subdivisions.This was their first time out and around other people since March, when the two friends had been planning a big night out to see Il Volo, an Italian pop group.

Seven months later, the new outfits they bought for the concert still hang unworn in their closets.“All we do since the shutdown is stay home and talk on the phone,” said Mulay, who spoke to a reporter while sitting next to her friend on a folding chair outside the shelter. €œNow, with does propecia decrease testosterone all these crowds — it’s terrifying.”Dimas likened the propecia followed by the fires to “a ball rolling downhill, getting bigger and bigger. And then there we were, with the flashing lights all around us and the cops shouting, ‘Go this way!.

€™ ‘Keep moving!. €™â€Listos California — an outreach program, for seniors and other vulnerable people, run out of the Governor’s Office of Emergency Services — allotted $50 million to engage dozens of nonprofits and community groups around the state to help warn and locate people during disasters. (“Listos” means “ready” in Spanish.)In Sonoma and Napa counties, where the Glass Fire had destroyed at least 630 structures by late last week, the bolstered threat of wildfires in recent years has promoted new alert systems — including a weather radio that has strobe lights for the deaf or can shake the bed to awaken you.But while counties are legally responsible for alerting people and providing shelter for them once they’re out, no public agency is responsible for overseeing the evacuation.

Practices differ widely by county, said Listos co-director Karen Baker.If Sonoma County has learned anything from the disasters of the past few years, it’s not to depend too much on any system in an emergency. €œYou’ve got to have a neighborhood network,” McBride said. €œAs community members, we have to rely on each other when these things happen.”Early last week, word filtered through the shelters that the fire had consumed a triplex and two single-family homes in the Oakmont neighborhood, but firefighters had battled the blaze through the night with hoses, shovels and chainsaws and miraculously managed to save the rest of the community.A week later, to their relief, Oakmont’s senior residents were allowed to return home.

By then, Mulay had developed severe back pain. Dimas missed her TV.Back in her apartment with Bodhi, Dimas noted with horror that the blaze had come close enough to her building to incinerate several juniper bushes and scorch a redwood just 2 feet away.“The whole thing feels surreal, like, ‘Oh, my God, did that really happen, or did I dream it?. €™â€ she said.

Rachel Scheier. @rachelscheier Related Topics Aging Insight Public Health hair loss treatment Natural Disasters.

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OSHA best place to buy propecia online inspections have resulted in the agency citing employers for violations, including failures to. OSHA has already announced citations relating to 37 establishments, which can be found at dol.gov/newsroom. In addition to those establishments, the 25 establishments below have received hair loss-related citations totaling $429,064 from OSHA relating to one or more of the above violations from best place to buy propecia online Sept. 25 to Oct.

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1472186 Hackensack New Jersey $15,422 Essex Residential Care LLC 1472725 West Caldwell New Jersey $13,494 Barnert Subacute Rehabilitation Center LLC 1474902 Paterson New Jersey $13,494 84 Cold Hill Road Operations LLC 1473525 Mendham New Jersey $13,494 Hackensack Meridian Health System 1477909 North Bergen New Jersey $13,494 292 Applegarth Road Operations LLC 1487345 Monroe Township New Jersey $23,133 1515 Lamberts Mill Road Operations LLC 1472780 Westfield New Jersey $26,988 Hackensack Meridian Health Hospitals Corp. 1474520 Hackensack New Jersey $9,639 The best place to buy propecia online Matheny School and Hospital 1476359 Peapack New Jersey $13,494 IJKG Opco LLC 1477379 Bayonne New Jersey $25,061 MPV New Jersey MD Medical Services P.C. 1482167 Nutley New Jersey $23,133 Prime Healthcare Services - St. Michael’s LLC best place to buy propecia online 1472330 Newark New Jersey $25,061 Robert Wood Johnson Barnabas Health 1475320 Toms River New Jersey $13,494 St.

Barnabas Hospital 1472869 Bronx New York $23,133 St. Barnabas Hospital 1473218 Bronx New York $23,133 Northwell Health Orzac Center for Rehabilitation 1476726 Valley Stream New York $23,133 Hudson Pointe Acquisition LLC 1486893 Bronx New York $22,555 VA NY Harbor best place to buy propecia online Healthcare System, St Albans Community Living Center 1474970 Jamaica New York $0 Masonic Village of the Grand Lodge of PA 1475223 Lafayette Hill Pennsylvania $15,422 A full list of what standards were cited for each establishment – and the inspection number – are available here. An OSHA standards database can be found here. Resources are best place to buy propecia online available on the agency’s hair loss treatment webpage to help employers comply with these standards.

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Improve working best place to buy propecia online conditions. Advance opportunities for profitable employment. And assure work-related benefits and rights best place to buy propecia online. # # # Media Contact.

Megan Sweeney, 202-693-4661, best place to buy propecia online sweeney.megan.p@dol.gov Release Number. 20-1947-NAT U.S. Department of Labor news materials are accessible best place to buy propecia online at http://www.dol.gov. The Department’s Reasonable Accommodation Resource Center converts departmental information and documents into alternative formats, which include Braille and large print.

For alternative format requests, please contact the Department at (202) 693-7828 (voice) or (800) 877-8339 (federal relay).About Insight Insight best place to buy propecia online provides an in-depth look at health care issues in and affecting California.Have a story suggestion?. Let us know. PETALUMA, best place to buy propecia online Calif. €” Late on the night of Sept.

27, a bumper-to-bumper caravan of fleeing cars, horse trailers, RVs and overstuffed pickup trucks snaked east on Highway 12, the flames of the Glass Fire glowing orange in their rearview mirrors.With her cat, Bodhi, in his carrier in the can you buy over the counter propecia back seat, 80-year-old Diana Dimas, who doesn’t see well at night, kept her eyes glued to the rear lights of her neighbor’s Toyota. She and Magdalena Mulay had met a few years before at a bingo night in their sprawling retirement best place to buy propecia online community on the outskirts of Santa Rosa. Both Libras, each with two marriages behind her, the two women soon became the sort of friends who finish each other’s sentences.Now, for the second time in three years, they heard the alarms and fled together as fire consumed the golden hills of Northern California’s wine country.“I thought, where on earth are we going to go?. € recalled best place to buy propecia online Dimas.

She remembered that when the catastrophic Tubbs Fire hit in 2017, people had sought refuge outside well-lit supermarkets, which had water and bathrooms. Which is how Dimas and Mulay and dozens of other seniors best place to buy propecia online ended up spending the night of the most recent evacuation in the parking lot of the Sonoma Safeway. Email Sign-Up Subscribe to California Healthline’s free Daily Edition. At midnight, Mulay was trying to get comfortable enough to catch a few winks in her driver’s seat when her phone began to chirp best place to buy propecia online.

A friend was calling to wish her a happy 74th birthday.The stories of that Sunday night — as a 20-acre fire started that morning merged with two other fires to become an 11,000-acre conflagration forcing tens of thousands from their homes in two counties — spotlight the challenges of evacuating elderly and infirm residents from the deadly wildfires that have become an annual occurrence in California. This year, the hair loss, which is especially dangerous to the elderly, has further complicated the problem.While the 2020 fire season will go down as the state’s biggest on record, rescuers have so far managed to avoid horrors on the scale of three years ago, best place to buy propecia online when the firestorm that raced through California’s wine country killed 45 people. Almost all were over 65 — found in wheelchairs, trapped in their garages, isolated and hard of hearing, or simply too stubborn to leave. The same grim pattern emerged from the Camp Fire, which leveled the Northern California town of Paradise in 2018.Assisted care homes in particular came under scrutiny after the 2017 fire, when ill-equipped and untrained workers best place to buy propecia online at two Santa Rosa facilities abandoned two dozen frail, elderly residents as the flames closed in, according to state investigators.

They concluded the seniors would have died in the flames had emergency workers and relatives not arrived at the last minute to rescue them.“The problem is we don’t value elders as a society,” said Debbie Toth, CEO of Choice in Aging, an advocacy group. €œIf children needed to be evacuated, we’d have a freaking Romper Room stood up overnight to entertain them so they wouldn’t be damaged by the experience.”The destructive effects of climate change in California have dovetailed with a rapidly graying population — which in a decade is projected to include 8.6 million senior citizens. That has fueled a growing demand for senior housing, from assisted care homes to swanky “active adult” facilities complete with golf courses and pools.Proximity to nature is a major selling point of Oakmont Village, Dimas and Mulay’s upscale community of nearly 5,000 over-55s, which best place to buy propecia online has everything from bridge games to cannabis clubs. But the woodlands and vineyards surrounding this suburban sprawl have put thousands of elderly citizens in hazardous wildfire zones.“With seniors, there’s mobility issues, hearing issues — even the sense of smell is often gone in the later years,” said Marrianne McBride, who heads Sonoma County’s Council on Aging.

Getting out fast in an emergency is especially challenging for those who best place to buy propecia online no longer drive. In Sunday’s evacuation, some residents who followed official advice to call ride services had to wait hours, until 3 or 4 a.m., for the overtaxed vans.Dimas and Mulay managed to scramble into their cars and get on the road shortly after 10 p.m., when a mandatory evacuation order went out for the thousands of seniors in Oakmont Village. But it was after midnight when residents of two Santa Rosa assisted care best place to buy propecia online homes in the evacuation zone were shuffled onto city buses in their bathrobes, some with the aid of walkers. Off-duty drivers braved thick smoke and falling embers to ferry some of them to safety, only to spend hours being sent from one shelter to another as evacuation sites filled up fast because of social distancing rules designed to prevent the spread of hair loss treatment.Other precautions, including masks and temperature checks, were followed.

But health officials nonetheless voiced concerns that vulnerable people in their 80s and 90s — especially residents best place to buy propecia online of skilled nursing homes, the source of most of Sonoma County’s hair loss deaths so far — had been moved among multiple locations, upping their chance for exposure.In the following days, shelters were fielding frantic calls from out-of-town relatives searching for their loved ones. €œWe were getting phone calls from Michigan, other places across the country, saying, ‘I’m trying to find my mother!. €™â€ said Allison Keaney, CEO of the Sonoma-Marin Fairgrounds, which sheltered several hundred horses, chickens, goats and llamas as well as displaced people.Bart Pettijohn rests on his cot with his dog, Clumsy, in an evacuation center at the Petaluma Veterans Memorial Building on Sept. 30.

Volunteer health care workers and a veterinarian were among those who checked up on dozens of seniors and pets forced out of their homes during the biggest wildfire season in California history.(Rachel Scheier for California Healthline)By Wednesday afternoon, a few dozen evacuees remained at the shelters, mostly seniors without relatives or friends nearby to take them in, like Dimas and Mulay. The two women had left the Safeway lot and were sleeping on folding cots in a gym at the Veterans Memorial Building in Petaluma, an old poultry industry town dotted with upscale subdivisions.This was their first time out and around other people since March, when the two friends had been planning a big night out to see Il Volo, an Italian pop group. Seven months later, the new outfits they bought for the concert still hang unworn in their closets.“All we do since the shutdown is stay home and talk on the phone,” said Mulay, who spoke to a reporter while sitting next to her friend on a folding chair outside the shelter. €œNow, with all these crowds — it’s terrifying.”Dimas likened the propecia followed by the fires to “a ball rolling downhill, getting bigger and bigger.

And then there we were, with the flashing lights all around us and the cops shouting, ‘Go this way!. €™ ‘Keep moving!. €™â€Listos California — an outreach program, for seniors and other vulnerable people, run out of the Governor’s Office of Emergency Services — allotted $50 million to engage dozens of nonprofits and community groups around the state to help warn and locate people during disasters. (“Listos” means “ready” in Spanish.)In Sonoma and Napa counties, where the Glass Fire had destroyed at least 630 structures by late last week, the bolstered threat of wildfires in recent years has promoted new alert systems — including a weather radio that has strobe lights for the deaf or can shake the bed to awaken you.But while counties are legally responsible for alerting people and providing shelter for them once they’re out, no public agency is responsible for overseeing the evacuation.

Practices differ widely by county, said Listos co-director Karen Baker.If Sonoma County has learned anything from the disasters of the past few years, it’s not to depend too much on any system in an emergency. €œYou’ve got to have a neighborhood network,” McBride said. €œAs community members, we have to rely on each other when these things happen.”Early last week, word filtered through the shelters that the fire had consumed a triplex and two single-family homes in the Oakmont neighborhood, but firefighters had battled the blaze through the night with hoses, shovels and chainsaws and miraculously managed to save the rest of the community.A week later, to their relief, Oakmont’s senior residents were allowed to return home. By then, Mulay had developed severe back pain.

Dimas missed her TV.Back in her apartment with Bodhi, Dimas noted with horror that the blaze had come close enough to her building to incinerate several juniper bushes and scorch a redwood just 2 feet away.“The whole thing feels surreal, like, ‘Oh, my God, did that really happen, or did I dream it?. €™â€ she said. Rachel Scheier. @rachelscheier Related Topics Aging Insight Public Health hair loss treatment Natural Disasters.