Dr. Collins Departs NIH

Dr. Francis Collins spent his last day at the helm of the National Institutes of Health (NIH) on December 19. Collins, a physician-geneticist, was nominated to lead the NIH by President Obama in 2009 and was confirmed unanimously by the Senate. He is the longest-serving NIH director and the first presidentially appointed NIH director to serve in more than one administration, with a career spanning three decades at the agency. Collins previously directed the National Human Genome Research Institute and led the Human Genome Project. Dr. Collins’s tenure will also be remembered for his frequent serenading of NIH staff and his membership in the band the Affordable Rock ‘n’ Roll Act.

CMS to Consider DIR Fees

The Biden administration announced last week that it plans to issue new regulations to tackle direct and indirect remuneration (DIR) levied by pharmaceutical benefit managers (PBMs) on pharmacies. In a letter sent by Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure to lawmakers last week, Brooks- LaSure characterizes the recent spike in DIR fees as “troubling,” and that CMS will use its administrative authority to issue proposed rulemaking to address price concessions and DIR. CMS estimates that the fees increased 91,500% between 2010 and 2019. The announcement was met with bipartisan support from lawmakers in Congress.

CMS Releases Final GME Regulation

The Centers for Medicare and Medicaid Services (CMS) has released the fiscal year (FY) 2022 Hospital Inpatient Prospective Payment System (IPPS)/Long Term Care Hospital (LTCH) Prospective Payment System final rule. The regulation includes finalized graduate medical education (GME) policies, including policies to distribute 1,000 new Medicare-funded physician residency slots to qualifying hospitals, phasing in 200 slots per year over five years. In allocating these new residency slots, CMS will prioritize hospitals with training programs in areas demonstrating the greatest need for providers, as determined by Health Professional Shortage Areas (HPSAs). The first round of 200 residency slots will be announced by January 31, 2023, and will become effective July 1, 2023. The rule also solicits comment on certain other GME issues to inform potential future rulemaking. Comments are due 60 days after the regulation’s publication in the Federal Register.

HHS Announces $9 Billion in PRF Phase 4 Payments

The U.S. Department of Health and Human Services (HHS) has announced the release of an additional $9 billion in Provider Relief Fund (PRF) Phase 4 payments to support health care providers impacted by the COVID-19 pandemic. The average payment for small providers was $58,000, for medium providers was $289,000, and for large providers was $1.7 million. More than 69,000 providers in all 50 states, Washington, D.C., and eight territories will receive the Phase 4 payments, which started to be made last week. The payments are part of the $25.5 billion the Administration is releasing to health care providers to recruit and retain staff, purchase masks and other supplies, modernize facilities, or other activities needed to respond to COVID-19. The Health Resources and Services Administration (HRSA) is currently reviewing the remaining Phase 4 applications and will make the remainder of Phase 4 payments in 2022. HRSA is prioritizing smaller providers by reimbursing a higher percentage of their losses and expenses and is distributing 25% of Phase 4 funding as bonus payments based on the amount and type of services provided to Medicare, Medicaid, or CHIP patients. HHS has also updated the Terms and Conditions for Phase 4 and American Rescue Plan (ARP) Rural payments. Recipients whose payment(s) exceed $10,000 are required to notify HHS of a merger with or acquisition of any other health care provider. These providers who report a merger or acquisition may be more likely to be audited to ensure compliant use of funds.

Health Care Spending Increases by Almost 10%

U.S. health care spending increased to $4.1 trillion last year as the country worked to respond to the coronavirus pandemic. The latest data, released by the Centers for Medicare and Medicaid Services (CMS) last week, shows a 9.7% increase in national health spending in 2020, more than double the usual growth rate. The federal government’s share of health spending increased by 36%. CMS attributes this growth to federal subsidies to prevent the closure of hospitals and medical practices; funding to develop and deploy COVID tests, vaccines, treatments, and countermeasures; and assistance to state Medicaid programs. The report also indicates that the number of uninsured people remained around 30 million, though there was a shift in coverage toward Medicaid and the Affordable Care Act (ACA) marketplaces. Out-of-pocket health care spending declined by 3.7%, largely due to postponed care in light of the pandemic.

OSHA Enforcement of Vaccine Mandate Delayed

While the courts have put a preliminary injunction in place for half of the states with respect to the CMS rule related to certain providers and COVID vaccination and all of the states for the government contractor rule related to COVID vaccination, once the courts lifted the injunction for the OSHA emergency temporary standard (ETS) related to the employer COVID vaccination on Friday, OSHA updated its website on Saturday to state the following: “To account for any uncertainty created by the stay, OSHA is exercising enforcement discretion with respect to the compliance dates of the ETS. To provide employers with sufficient time to come into compliance, OSHA will not issue citations for noncompliance with any requirements of the ETS before January 10 and will not issue citations for noncompliance with the standard’s testing requirements before February 9, so long as an employer is exercising reasonable, good faith efforts to come into compliance with the standard. OSHA will work closely with the regulated community to provide compliance assistance.” Hart Health Strategies Inc. has prepared a new resource in its series of documents related to the COVID-19 pandemic to assist you in tracking the status of various COVID-19 vaccine mandates. The document is attached as an appendix to this newsletter and will be updated on a regular basis.

Recently Introduced Health Legislation

S.Res.477 — A resolution expressing support for the designation of September 2021 as “Sickle Cell Disease Awareness Month” in order to educate communities across the United States about sickle cell disease and the need for research, early detection methods, effective treatments, and preventative care programs with respect to complications from sickle cell disease and conditions related to sickle cell disease; Sponsor: Sen. Scott, Tim [R-SC]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

H.Res.846 — Recognizing the maternal health crisis among indigenous women in the United States, which includes American Indian, Alaska Native, and Native Hawaiian women, recognizing the importance of reducing mortality and morbidity among indigenous women, and calling for urgent Federal funding changes to ensure comprehensive, high- quality, and culturally competent maternal health and family planning services are available; Sponsor: Rep. Craig, Angie [D-MN-2]; Committees: House - Natural Resources; Energy and Commerce

S.Res.479 — A resolution supporting the goals and ideals of American Diabetes Month; Sponsor: Sen. Shaheen, Jeanne [D- NH]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.3386 — A bill to prevent, treat, and cure tuberculosis globally; Sponsor: Sen. Menendez, Robert [D-NJ]; Committees: Senate - Foreign Relations

S.3389 — A bill to amend title XIX of the Social Security Act to establish a demonstration project to improve outpatient clinical care for individuals with sickle cell disease; Sponsor: Sen. Booker, Cory A. [D-NJ]; Committees: Senate – Finance

S.3390 — A bill to increase research, education, and treatment for cerebral cavernous malformations; Sponsor: Sen. Lujan, Ben Ray [D-NM]; Committees: Senate - Health, Education, Labor, and Pensions

S.3393 — A bill to amend the Internal Revenue Code of 1986 to permanently extend the Health Coverage Tax Credit; Sponsor: Sen. Brown, Sherrod [D-OH]; Committees: Senate – Finance

S.3394 — A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to emergency use authorization transparency; Sponsor: Sen. Hassan, Margaret Wood [D-NH]; Committees: Senate - Health, Education, Labor, and Pensions

S.3395 — A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to records and other information inspections; Sponsor: Sen. Baldwin, Tammy [D-WI]; Committees: Senate - Health, Education, Labor, and Pensions

H.Res.856 — Expressing support for the designation of “National Amplified Musculoskeletal Pain Syndrome Awareness Day”; Sponsor: Rep. Wild, Susan [D-PA-7]; Committees: House - Energy and Commerce

H.R.6257 — To prohibit the Federal Government from imposing a vaccine mandate on individuals traveling on public or private transportation for hire within the United States, and for other purposes; Sponsor: Rep. Webster, Daniel [R-FL-11]; Committees: House - Transportation and Infrastructure

H.R.6271 — To amend the Internal Revenue Code of 1986 to improve access to health care through expanded health savings accounts, and for other purposes; Sponsor: Rep. LaTurner, Jake [R-KS-2]; Committees: House - Ways and Means; Energy and Commerce; Judiciary

H.R.6273 — To direct the Secretary of Veterans Affairs to establish the Zero Suicide Initiative pilot program of the Department of Veterans Affairs; Sponsor: Rep. Lee, Susie [D-NV-3]; Committees: House - Veterans’ Affairs

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