POLICY BRIEFINGS

FDA Issues Draft Guidance on Clinical Trial Diversity


The Food and Drug Administration (FDA) released new draft guidance for the industry last week recommending that drug and medical device companies create formal plans for ensuring clinical trial diversity. The agency suggests that manufacturers send their plans, outlining specific goals for attracting and enrolling underrepresented groups and racial and ethnic minorities, to the FDA early in the clinical development process. According to the draft guidance, companies should also consider strategies for retaining diverse trial participants.


CMS Requests Feedback on Nursing Home Staffing Levels


The Centers for Medicare and Medicaid Services (CMS) is asking for public comments on requiring minimum staffing levels in nursing homes. The agency, which is also considering tying some payments to level of staff turnover, plans to issue rulemaking on the issue within a year. The move is a part of President Joe Biden’s agenda to strengthen oversight of the nation’s nursing home industry.


Recently Introduced Health Legislation


H.R.7487 — To amend the Internal Revenue Code of 1986 to clarify that individuals who have access to certain healthcare services through a worksite health clinic are eligible to make pre-tax contributions to a health savings account. Sponsor: Rep. Sewell, Terri A. [D-AL-7]; Committees: House - Ways and Means

H.R.7483 — To direct the Secretary of Health and Human Services to conduct a study on the direct and indirect costs of serious mental illness for nongovernmental entities, the Federal Government, and State, local, and Tribal governments, and for other purposes. Sponsor: Rep. Reschenthaler, Guy [R-PA-14]; Committees: House - Energy and Commerce

H.R.7482 — To authorize the Secretary of Health and Human Services to award grants to eligible entities for creating or enhancing capacity to treat patients with Long COVID through a multidisciplinary approach. Sponsor: Rep. Pressley, Ayanna [D-MA-7]; Committees: House - Energy and Commerce

H.R.7475 — To amend title XIX of the Social Security Act to provide coverage under the Medicaid program for services provided by doulas and midwives, and for other purposes. Sponsor: Rep. Moore, Gwen [D-WI-4]; Committees: House - Energy and Commerce

H.R.7474 — To amend the Public Health Service Act to increase the transparency of pharmaceutical research costs, and for other purposes. Sponsor: Rep. Maloney, Carolyn B. [D-NY-12]; Committees: House - Energy and Commerce; Financial Services

H.R.7473 — To prohibit pharmaceutical manufacturers from interfering with therapeutically equivalent or interchangeable substitution decisions by health care providers to limit competition from a generic drug or biosimilar biological product, and for other purposes. Sponsor: Rep. Maloney, Carolyn B. [D-NY-12]; Committees: House - Judiciary

H.R.7472 — To amend the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to eligible products at a discounted price for qualified research, and for other purposes. Sponsor: Rep. Maloney, Carolyn B. [D-NY-12]; Committees: House - Energy and Commerce

H.R.7458 — To establish a procedure for terminating the suspension of entries and imports from designated places related to the COVID–19 pandemic. Sponsor: Rep. Golden, Jared F. [D-ME-2]; Committees: House - Energy and Commerce

H.R.7436 — To amend title 38, United States Code, to improve the quality assurance program of the Veterans Benefits Administration of the Department of Veterans Affairs. Sponsor: Rep. Cloud, Michael [R-TX-27]; Committees: House - Veterans’ Affairs

H.R.7435 — To amend the Internal Revenue Code of 1986 to provide that coverage under Medicare is permissible for purposes of contributions to health savings accounts. Sponsor: Rep. Bera, Ami [D-CA-7]; Committees: House - Ways and Means

H.Res.1045 —Supporting the goals and ideals of “National Youth HIV/AIDS Awareness Day”. Sponsor: Rep. Lee, Barbara [D-CA-13]; Committees: House - Energy and Commerce

H.Res.1051 — Expressing support for the designation of the week of April 11 through April 17, 2022, as the fifth annual “Black Maternal Health Week” to bring national attention to the maternal health crisis in the United States and the importance of reducing maternal mortality and morbidity among Black women and birthing persons; Sponsor: Rep. Adams, Alma S. [D-NC-12]; Committees: House - Energy and Commerce; Financial Services; Transportation and Infrastructure; Education and Labor; Judiciary; Natural Resources; Agriculture; Veterans’ Affairs

H.R.7497 — To provide for lower prices for drugs through drug price negotiation, and for other purposes; Sponsor: Rep. Slotkin, Elissa [D-MI-8]; Committees: House - Energy and Commerce; Ways and Means; Education and Labor

H.R.7500 — Fiscal Year 2022 Veterans Affairs Major Medical Facility Authorization Act; Sponsor: Rep. Allred, Colin Z. [D- TX-32]; Committees: House - Veterans’ Affairs

H.R.7504 — To amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research; Sponsor: Rep. Buchanan, Vern [R-FL-16]; Committees: House - Ways and Means

H.R.7505 — To amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities; Sponsor: Rep. Buchanan, Vern [R-FL-16]; Committees: House - Ways and Means

H.R.7506 — To amend the Public Health Service Act with respect to preventing end-stage kidney disease, and for other purposes; Sponsor: Rep. Butterfield, G. K. [D-NC-1]; Committees: House - Energy and Commerce; Ways and Means

H.R.7508 — Improving Specialty Care for Women Veterans Act; Sponsor: Rep. Crist, Charlie [D-FL-13]; Committees: House - Veterans’ Affairs

H.R.7512 — To amend title XXVII of the Public Health Service Act, title I of the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to limit enrollment in coverage for excepted benefits to individuals enrolled in a health plan providing minimum essential coverage; Sponsor: Rep. Hayes, Jahana [D-CT-5]; Committees: House - Energy and Commerce; Education and Labor; Ways and Means

H.R.7513 — To establish a Commission on the Federal Regulation of Cannabis to study a prompt and plausible pathway to the Federal regulation of cannabis, and for other purposes; Sponsor: Rep. Joyce, David P. [R-OH-14]; Committees: House - Energy and Commerce; Judiciary; Ways and Means; Agriculture; Financial Services

H.R.7515 — To amend the Internal Revenue Code of 1986 to provide an exception from the passive loss rules for investments in specified medical research small business pass-thru entities; Sponsor: Rep. Kelly, Mike [R-PA-16]; Committees: House - Ways and Means

H.R.7524 — To direct the Secretary of Veterans Affairs to seek to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine to study the incidence and mortality of cancer among individuals who served in the Navy, Air Force, or Marine Corps as aircrew; Sponsor: Rep. Pfluger, August [R-TX-11]; Committees: House - Veterans’ Affairs

H.R.7529 — To require direct-to-consumer advertisements for prescription drugs and biological products to include truthful and not misleading pricing information; Sponsor: Rep. Williams, Nikema [D-GA-5]; Committees: House - Energy and Commerce; Ways and Means



April 18, 2022: | Page 1 Page 2

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BRIEFING ARCHIVE

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