Health Care Checkup
June 11, 2021
THE BIG PICTURE
The Department of Health and Human Services Secretary (HHS), Xavier Becerra, testified before the House Ways and Means (W&M) Committee to defend the Administration’s HHS budget request for fiscal year (FY) 2022. Becerra also testified before the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies. The proposed budget is a 23% increase from the previous year and includes extra funding for the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). At the W&M hearing, Becerra was questioned on topics ranging from maternal mortality to the crisis at the southern border. Becerra discussed the agency’s commitment to continue the fight against COVID-19 and to prepare for future public health emergencies. MCRT’s summary of the W&M hearing can be found here.
 
On Friday, HHS released revised reporting requirements for recipients of Provider Relief Fund (PRF) payments. The revised requirements can be viewed here.
 
The U.S. Food and Drug Administration (FDA) approved an Alzheimer’s drug,  Aduhelm (aducanumab), which is the first new treatment for Alzheimer’s the agency has approved in nearly two decades. Aduhelm does not cure the disease, but rather may help to slow cognitive decline from it. The FDA’s decision to approve the drug has been controversial because many say the clinical benefit of the drug has been murky and it is costly. Members of Congress, along with members of a Food and Drug Administration expert panel have been critical of acting FDA Commissioner Janet Woodcock’s decision to approve the drug. So far, three members of the panel have resigned over the decision, with one writing that the approval of Aduhelm “was probably the worst drug approval decision in recent U.S. history.”
 
The FDA’s vaccine advisory panel met to discuss whether COVID-19 vaccines are safe for children. While children seem to have less serious side-effects from the virus than adults, some children develop a rare, but serious inflammatory syndrome called MIS-C. Paul Offit, a pediatrician at the Children’s Hospital of Philadelphia, said “We’re going to have to have a highly vaccinated or highly immune population for years, if not decades, and it just seems silly to think we’re not going to have to include children as part of that.
 
The Office of Management and Budget (OMB) began its review of a surprise billing  rule which was the result of legislation that was enacted late last year. OMB is reviewing an interim file rule that is expected to incorporate provisions from the No Surprises Act, which was signed into law in December 2020, as part of the Consolidated Appropriations Act of 2021. Under the No Surprises Act, providers can no longer charge patients more than in-network rates for services rendered out-of-network. This also applies to services rendered by out-of-network doctors in in-network settings.
 
The Centers for Medicare and Medicaid Services (CMS) announced that health providers will receive an additional $35 for each COVID-19 vaccine administered to Medicare beneficiaries in their homes. This change will increase the total payment to physicians for at-home COVID-19 vaccinations from approximately $40 per vaccine dose to approximately $75 per vaccine dose.
 
Jonathan Blum, a veteran of the Obama Administration, has rejoined CMS as the Principal Deputy Administrator, which is the same position he held in the Obama Administration. At CMS, he worked on Medicare physician payment data and helped to develop value-based payment policies. Blum also worked on Medicare policy for OMB.
 
It has also been reported that the Biden Administration has tapped Erin Richardson as CMS Administrator Chiquita Brooks-LaSure’s Chief of Staff. Currently, Richardson is the Senior Vice President of Government Affairs at the Federation of American Hospitals. Prior to her current role, she was a Domestic Policy Council adviser during the Obama Administration and a House Ways and Means Committee staffer.
What to Expect Next Week: Next Tuesday, the House Energy and Commerce Subcommittee on Health will hold a hearing on booster shots and enhancing public health through vaccine legislation. Also on Tuesday, the Senate Finance Committee will hold a hearing titled, "Mental Health Care in America: Addressing Root Causes and Identifying Policy Solutions." On Wednesday, the Senate HELP Committee will mark up the nominations of Dawn O’Connell to be the Assistant Secretary for Preparedness and Response at HHS and Miriam Delphin-Rittmon to be the Assistant Secretary of Health for Mental Health and Substance Use at HHS. 
DEEP DIVE
House Ways and Means Committee Holds Hearing on HHS Budget Request for FY 2022
 
On Tuesday, the Department of Health and Human Services Secretary (HHS), Xavier Becerra, testified before the House Ways and Means Committee to defend the Administration’s HHS budget request for fiscal year (FY) 2022. The proposed budget is a 23% increase from the previous year and includes extra funding for the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). At the hearing, Becerra was questioned on topics ranging from maternal mortality to the crisis at the southern border. Becerra discussed the agency’s commitment to continue the fight against COVID-19 and to prepare for future public health emergencies. When asked about domestic manufacturing for personal protective equipment (PPE), Becerra said the Administration is looking to invest in infrastructure to help bolster manufacturing in the U.S. The Secretary also discussed the Administration’s dedication to expanding the Affordable Care Act (ACA) to help more Americans gain access to health coverage. Several Representatives questioned Becerra on the issue of Medicare insolvency and asked whether HHS has a plan to ensure Medicare does not run out of funding. Becerra did not give a concrete answer to the questions, but he said he looks forward to working with Congress to find a solution. MCRT’s summary of the hearing can be found here.
 
Acting FDA Commissioner Faces Criticism for Approving Controversial Alzheimer’s Drug
 
This week, the U.S. Food and Drug Administration (FDA) approved an Alzheimer’s drug called Aduhelm, which is the first new treatment for Alzheimer’s the agency has approved in nearly two decades. Aduhelm does not cure the disease, but rather helps to slow cognitive decline from it. The FDA’s decision to approve the vaccine has been controversial because the clinical benefit of the drug has been murky. Members of Congress, along with members of a Food and Drug Administration expert panel have been critical of acting FDA Commissioner Janet Woodcock’s decision to approve the drug. So far, three members of the panel have resigned over the decision, with one writing that the approval of Aduhelm “was probably the worst drug approval decision in recent U.S. history.” Additionally, several Senators have said that the decision has made them reluctant to vote for Woodcock to stay in the role permanently. Senator Catherine Cortez Masto (D-NV) said that she does not trust Woodcock’s judgment and would not back her to run the FDA permanently. Senator Ed Markey (D-MA) said he had “deep reservations” about her.
 
FDA Begins to Review Safety of COVID-19 Vaccinations in Children
 
This week, the FDA’s vaccine advisory panel met to discuss whether COVID-19 vaccines are safe for children. While children seem to have less serious side-effects from the virus than adults, some children develop a rare, but serious inflammatory syndrome called MIS-C. Paul Offit, a pediatrician at the Children’s Hospital of Philadelphia, said “We’re going to have to have a highly vaccinated or highly immune population for years, if not decades, and it just seems silly to think we’re not going to have to include children as part of that.” Since many children receive vaccinations during childhood, the FDA asked the advisory panel for its opinion on whether children should receive COVID-19 vaccines alongside other routine childhood immunizations. The experts expressed that they still need to determine whether the COVID vaccine would interfere or interact with the other routine vaccinations.
 
Senate Finance Committee Begins Updating Drug Pricing Bill from Last Congress
 
It has been reported that Senate Finance Chair Ron Wyden (D-OR) plans to update a drug pricing bill from the 116th Congress that he co-wrote with Senator Chuck Grassley (R-IA). Wyden plans to add Medicare price negotiation into the bill. Senator Grassley would likely oppose the changes, as he has said that a Medicare price negotiation bill would not get enough votes to pass in the Senate.
 
HHS Issues Revised Reporting Requirements for Recipients of Provider Relief Fund Payments
 
On Friday, HHS released revised reporting requirements for recipients of Provider Relief Fund (PRF) payments. The agency listed the following as the key updates:
  • “The period of availability of funds is based on the date the payment is received (rather than requiring all payments be used by June 30, 2021, regardless of when they were received).”
  • “Recipients are required to report for each Payment Received Period in which they received one or more payments exceeding, in the aggregate, $10,000 (rather than $10,000 cumulatively across all PRF payments).”
  • “Recipients will have a 90-day period to complete reporting (rather than a 30-day reporting period).”
  • “The reporting requirements are now applicable to recipients of the Skilled Nursing Facility and Nursing Home Infection Control Distribution in addition to General and other Targeted Distributions.”
  • “The PRF Reporting Portal will open for providers to start submitting information on July 1, 2021.”
 
The revised requirements can be viewed here.
 
OMB Begins Review of Surprise Billing Rule

Early this week, the Office of Management and Budget (OMB) began its review of a surprise billing rule which was the result of legislation that was enacted late last year. OMB has issued an interim file rule that is expected to incorporate provisions from the No Surprises Act, which was signed into law in December 2020, as part of the Consolidated Appropriations Act of 2021. Under the No Surprises Act, providers can no longer charge patients more than in-network rates for services rendered out-of-network. This also applies to services rendered by out-of-network doctors in in-network settings. The Act also sets up a dispute resolution process for any claims that providers and payers cannot agree on within 30 days. Under this dispute resolution process, arbitrators choose between the amount sought by the provider or the amount offered by the payer. The law is slated to go into effect on January 1, 2022, so it is expected that CMS may still change certain components based on the feedback it receives during the notice-and-comment period.
 
Biden Administration Looks to Increase Vaccinations for Home-Bound Medicare Beneficiaries by Bolstering Payments for At-Home COVID-19 Vaccinations
 
On Wednesday, the Centers for Medicare and Medicaid Services (CMS) announced that health providers will receive an additional $35 for each COVID-19 vaccine administered to Medicare beneficiaries in their homes. This change will increase the total payment to physicians for at-home COVID-19 vaccinations from approximately $40 per vaccine dose to approximately $75 per vaccine dose. The Administration hopes this move will incentivize providers to administer COVID-19 vaccine doses in patients’ homes. CMS said, “some beneficiaries have great difficulty leaving their homes or face a taxing effort getting around their communities easily to access vaccination [at retail pharmacies, physicians’ offices, or mass vaccination sites].” CMS Administrator Chiquita Brooks-LaSure said, “CMS is committed to meeting the unique needs of Medicare consumers and their communities, particularly those who are homebound or who have trouble getting to a vaccination site. That’s why we’re acting today to expand the availability of the COVID-19 vaccine to people with Medicare at home.”
 
Health Spending Set to Increase in 2022
 
In a report released Wednesday, PwC found that medical costs in the U.S. are expected to increase by 6.5% in 2022. The increase is slightly lower than 2021’s increase, but it is higher than other years. According to the report, medical costs will increase in part due to care that was deferred during the COVID-19 pandemic. The report claims that employers will feel the brunt of this cost increase, as 15% of U.S. consumers with employer-sponsored insurance said that they deferred at least some care during 2020. These same consumers reported that they delayed approximately 62% of their care during March and September 2020. The report also said that industry efforts to improve the health-care supply chain, increase wages for staff, and prepare for future pandemics will drive health care costs up. Additionally, it is unclear how long the federal government will continue to pay for COVID-19 vaccines and testing, so these sources may drive up costs as well, depending on how much manufacturers will continue charging for those resources.
 
FDA Announces New Plans to Strengthen America’s Pharmaceutical Supply
 
The U.S. Food and Drug Administration (FDA) announced new plans to ensure the U.S. has access to the pharmaceuticals necessary for economic security, health security, and national defense. The plan includes increasing domestic manufacturing and promoting research into innovations that would make supply chains more resilient. The agency also aims to create “robust quality management maturity to ensure consistent and reliable drug manufacturing and quality performance.” These new actions are in accordance with President Joe Biden’s Executive Order 14017 to secure America’s critical supply chains, which the President signed on February 24, 2021.
 
New Posts Filled at CMS
 
Jonathan Blum, a veteran of the Obama Administration, has rejoined CMS as the Principal Deputy Administrator, which is the same position he held in the Obama Administration. At CMS, he worked on Medicare physician payment data and helped to develop value-based payment policies. Blum also worked on Medicare policy for OMB. After leaving the Obama Administration, Blum was an Executive Vice President at CareFirst BlueCross BlueShield and a Managing Principal for Medicare at the consulting firm Health Management Associates. In a statement on Blum’s return to CMS, Administrator Chiquita Brooks-LaSure said, “A tireless public servant and health policy expert, he brings invaluable experience to CMS as we navigate the COVID-19 pandemic, serve the individuals that rely on CMS for health coverage, and work to advance health equity.”
 
It has also been reported that CMS has tapped Erin Richardson as Chiquita Brooks-LaSure’s Chief of Staff. Currently, Richardson is the Senior Vice President of Government Affairs at the Federation of American Hospitals. Prior to her current role, she was a Domestic Policy Council adviser during the Obama Administration and a House Ways and Means Committee staffer.
SENATE HEARINGS AND EXECUTIVE SESSIONS
Senate Finance Committee – Hearing
Full Committee Hearing: "Mental Health Care in America: Addressing Root Causes and Identifying Policy Solutions."
Tuesday, June 15 at 10:00 AM ET

Senate Appropriations Committee - Hearing
Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies: Fiscal Year 2022 Budget Request for the U.S. Department of Agriculture
Tuesday, June 15 at 10:00 AM ET

Senate Appropriations Committee - Hearing
Subcommittee on Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies: Hearing on the President’s Fiscal Year 2022 Budget Request for the United States Department of Education
Wednesday, June 16 at 10:00 AM ET

Senate Judiciary Committee - Hearing
The Constitution Subcommittee Hearing: "Protecting Roe: Why We Need the Women’s Health Protection Act."
Wednesday, June 16 at 2:30 PM ET

Senate Health, Education, Labor and Pensions Committee - Hearing
Full Committee Hearing: "COVID-19 Response and Recovery: Supporting the Needs of Students in Higher Education & Lessons on Safely Returning to Campus on Safely Returning to Campus."
Thursday, June 17 at 10:00 AM ET
HOUSE HEARINGS AND EXECUTIVE SESSIONS
House Committee on Energy and Commerce - Hearing
Subcommittee on Health Hearing: "Booster Shot: Enhancing Public Health through Vaccine Legislation"
Tuesday, June 15 at 10:30 AM ET

House Committee on Education and Labor - Hearing
House Committee on Education and Labor Hearing: Examining the Policies and Priorities of the U.S. Department of Health and Human Services
Wednesday, June 16 at 9:00 AM ET

House Committee on Veterans' Affairs - Hearing
Subcommittee on Economic Opportunity Hearing: Veteran Homelessness in the Wake of COVID-19
Wednesday, June 16 at 10:00 AM ET
ADMINISTRATION ANNOUNCEMENTS
Centers for Medicare & Medicaid Services
 
Food and Drug Administration
 
Guidance Documents from the Centers for Disease Control and Prevention

National Institutes of Health
QUICK LINKS
1341 G Street NW
Washington, DC 20005
202-585-0258