United States: Washington Healthcare Update | April 19, 2021

This week in Washington:  President sends budget request to Congress.

House

House Passes Bill to Extend Medicare Sequester Moratorium

On April 13, the House of Representatives voted 384-38 to pass a bill that would eliminate the 2 percent cut to all Medicare payments, known as sequestration, until the end of 2021. In addition, the legislation would make several changes to the rural health clinic provisions included in the Consolidated Appropriations Act of 2021. The bill would increase FY 2030 sequester cuts to pay for the change. The bill was passed by the Senate last month, and President Biden is expected to sign it into law.

House Passes Eight Health Care Bills

This week, the House of Representatives passed the following eight bills:

• H.R. 172, the "United States Anti-Doping Agency Reauthorization Act of 2021," was introduced by Reps. Mike Thompson (D-CA), Bill Johnson (R-OH) and Diana DeGette (D-CO). The bill would extend and increase the authorization level for the U.S. Anti-Doping Agency (USADA) through fiscal year 2030, empower the agency to encourage a positive sporting environment for young athletes by providing educational materials on sportsmanship, character building and healthy performance, and would improve anti-doping efforts in the United States by encouraging federal agencies to coordinate and share information with USADA to prevent the use of performance-enhancing drugs and methods. The bill passed on the House floor by a vote of 381-37.
• S. 578, the "Food Allergy Safety, Treatment, Education, and Research Act of 2021" or the "FASTER Act of 2021," was introduced by Sen. Tim Scott (R-SC). The bill would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to include sesame as a major allergen. The bill would also require the Department of Health and Human Services (HHS) to report specific recommendations and strategies to reduce risks related to food allergies, including recommendations for the development of a regulatory process to add additional foods or ingredients to the list of major food allergens. The bill passed on the House floor by a vote of 415-11.
• H.R. 189, the "John Lewis NIMHD Research Endowment Revitalization Act," was introduced by Reps. Nanette Diaz Barragan (D-CA), Earl "Buddy" Carter (R-GA) and Van Taylor (R-TX). The bill authorizes the National Institute on Minority Health and Health Disparities to facilitate research on minority health disparities through research endowments at current or former centers of excellence. The bill passed on the House floor by voice vote.
• H.R. 941, the "Timely ReAuthorization of Necessary Stem-cell Programs Lends Access to Needed Therapies Act of 2021" or the "TRANSPLANT Act of 2021," was introduced by Reps. Doris Matsui (D-CA), Gus Bilirakis (R-FL) and Chellie Pingree (D-ME). The bill would reauthorize the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory to facilitate lifesaving bone marrow and umbilical cord blood donations to help patients suffering from blood cancers, disorders and diseases. The bill would also require HHS to review the state of science related to adult stem cells and birthing tissues for the purpose of potentially including in the program, and would require the National Institutes of Health, in consultation with other agencies, to further the field of regenerative medicine and commission a report by the Comptroller General on the state of the regenerative medicine workforce. The bill passed on the House floor by a vote of 415-2.
• S. 164, the "Advancing Education on Biosimilars Act of 2021," was introduced by Sens. Margaret Wood Hassan (D-NH) and Bill Cassidy (R-LA). The legislation would help provide patients and health care providers with greater information about biologics and biosimilars by requiring the Food and Drug Administration (FDA) to establish a public website with educational materials, including what products are interchangeable, as well as how to report any adverse events. The bill would also support the development of continuing education programs for health care providers about biologics. The bill passed on the House floor by a vote of 412-8.
• S. 415, the "Ensuring Innovation Act," was introduced by Sens. Bill Cassidy (R-LA), Tina Smith (D-MN) and Roger Marshall (R-KS). The legislation clarifies that five-year new chemical entity eligibility is only available for drugs containing no active component that has previously been approved in the United States. This would help reduce drug costs and improve access to more affordable generic drugs by ensuring that market exclusivity, which can delay generic drugs from entering the market, is only made available to truly innovative products. The bill passed on the House floor by voice vote.
• H.R. 1002, the "Debarment Enforcement of Bad Actor Registrants Act of 2021" or the "DEBAR Act of 2021," was introduced by Rep. Bob Latta (R-OH). The bill would amend the Controlled Substances Act to allow the attorney general to prohibit any registrant from manufacturing, distributing or dispensing a controlled substance or a List I chemical if that registrant meets or has met any of the conditions for suspension or revocation of registration, or has a history of prior suspension or revocations. The bill passed on the House floor by a vote of 411-5.
• H.R. 1899, the "Ensuring Compliance Against Drug Diversion Act," was introduced by Rep. Morgan Griffith (R-VA). The bill terminates the controlled substance registration of any registrant if the registrant dies, ceases legal existence, discontinues business or professional practice, or surrenders registration. A registrant who ceases legal existence or discontinues business is required to notify the Drug Enforcement Administration (DEA). Registrants must receive written consent from DEA in order to assign or transfer a registration, and they are also required to return certain documentation if a registrant's work is discontinued. The bill passed on the House floor by a vote of 412-5.

Two of the bills, the Advancing Education on Biosimilars Act and the Ensuring Innovation Act, previously passed the Senate and are on their way to President Biden's desk.

House Members Divided on Fentanyl Analogue Scheduling

In an April 14 Energy and Commerce Committee Subcommittee on Health hearing, several House Republicans expressed support for legislation that would extend or make permanent the Schedule 1 classification for fentanyl-related substances. On the other hand, some Democrats expressed support for a bill that would use harm-reduction strategies to address the fentanyl crisis.

In 2018, the Trump administration temporarily scheduled fentanyl-related substances as Schedule 1, which means that these substances are classified as illicit drugs with high potential for abuse and no potential medical use. Congress extended this classification in 2020 but it is set to expire on May 6. If the deadline is not extended past May 6, the Drug Enforcement Agency (DEA) will schedule individual fentanyl analogues once they are discovered, as was done prior to the Schedule 1 designation. Stakeholders express concern that allowing the Schedule 1 designation to end would make it more complicated to prosecute individuals for fentanyl distribution.

For more information on the hearing, click here.

Rep. Kevin Brady to Retire

On April 13, Rep. Kevin Brady (R-TX), ranking member and former chair of the House Ways and Means Committee, stated that he would not be running for reelection in 2022. He is currently serving his 13th term.

Senate

Senate Finance Hearing to Consider Nominees for CMS Administrator and HHS Deputy Secretary

On April 15, the Senate Finance Committee held a hearing to consider the nominations of Andrea Joan Palm to be deputy secretary of Health and Human Services (HHS) and Chiquita Brooks-LaSure to be administrator of the Centers for Medicare and Medicaid Services (CMS). Member questions centered on waivers, telehealth, equity, border policy, behavioral health and drug pricing.

Bipartisan Bill Would Require Cost-Free Breast Cancer Diagnostic Tests

On April 13, the Access to Breast Cancer Diagnosis Act of 2021 was reintroduced by Sens. Jeanne Shaheen (D-NH) and Roy Blunt (R-MO). The bill would require group health plans and individual insurers to cover diagnostic breast cancer tests that may be needed following an additional screening. The legislation was previously introduced in the last Congress. Under current law, plans are required to provide breast cancer screenings at no cost. Approximately 10 percent of breast cancer screenings require follow-up testing, which can include mammograms, ultrasounds and MRIs and can cost patients hundreds or thousands of dollars and result in delayed treatment.

Senators Ask HHS Secretary Becerra to Enforce Hospital Price Transparency Rule

On April 13, Senate Energy and Commerce Committee members, including Chair Frank Pallone (D-NJ), ranking member Cathy McMorris Rodgers (R-WA), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) and Health Subcommittee ranking member Brett Guthrie (R-KY) wrote a letter to Health and Human Services (HHS) asking Secretary Xavier Becerra to ensure that hospitals are complying with the Hospital Price Transparency Rule.

The Hospital Price Transparency Rule, which went into effect Jan. 1, 2021, requires hospitals to make public the list of standard charges for items and services in a consumer-friendly format. The charges that need to be made public include gross charges, discount cash price, payer-specific negotiated charges and de-identified minimum and maximum negotiated charges for all items and services. HHS can issue warnings, request an action plan and issue penalties for hospitals found to be noncompliant with the rule.

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