Weekly Health Care Policy Update – September 10, 2021

September 17, 2021

In this update: 

  • COVID-19 Response
    • President Biden Announces Additional Vaccine Requirements in Covid-19 Action Plan
    • HHS Expands PREP Act Declaration for Monoclonal Antibody Administration
  • Administration
    • Biden Administration Releases Pandemic Preparedness Plan
  • Legislative
    • House Committees Begin Considering Build Back Better Reconciliation Legislation
  • Regulatory
    • HHS Releases Plan to Lower Prescription Drug Prices
    • CMS Announces $452 Million for States with State-Based Reinsurance 1332 Waivers
    • CMS Releases Report on Vermont All-Payer Model
    • HRSA Issues Additional FY 2022 FQHC Service Area Competition
  • Other
    • Study Finds Pfizer Covid Vaccine Works in Pregnancy
    • Justice Department Files Suit Over Texas Abortion Law 
  • Congressional Hearings
  • New York State
    • Governor Hochul Announces New Administration Appointments
    • NYS Designates Covid-19 as Airborne Infectious Disease, Triggering HERO Act Employee Safety Requirements
    • New York State Postpones Carve-In of BH into Medicaid Advantage Plus

COVID-19 Response

President Biden Announces Additional Vaccine Requirements in Covid-19 Action Plan
On September 9th, President Biden announced a new Covid-19 “action plan” in response to persisting vaccine hesitancy and the rise of the Delta variant. The Administration’s plan has six components, one of which is significantly expanded vaccination requirements: 

  • Vaccine-or-Testing Mandate for Large Employers: The Department of Labor’s Occupational Safety and Health Administration (OSHA) will shortly issue an Emergency Temporary Standard (ETS) to require all employers with more than 100 employees to institute a mandate for all employees to receive a Covid-19 vaccination or submit a test at least weekly. Employers would also be required to offer paid time off for employees to receive vaccinations. This is expected to affect about 80 million workers.
  • Vaccine Mandate in Medicare and Medicaid COPs: The Centers for Medicare and Medicaid Services (CMS) announced that it will require Covid-19 vaccination for all staff in Medicare and Medicaid-certified facilities as a Condition of Participation (COP) in the programs. Such facilities include hospitals, dialysis facilities, ambulatory surgery settings, and home health agencies, among others. This mandate builds on and supersedes the August 18th requirement covering nursing homes only. CMS plans to issue an implementing Interim Final Rule with Comment Period (IFC) in October, but expects unvaccinated providers “to begin the process immediately.” This is expected to cover roughly 17 million health care workers,
  • Vaccine Mandate for Federal Employees and Contractors: Biden has issued an Executive Order to require all federal agencies to require Covid-19 vaccination for their employees, with exceptions “only as required by law”. A separate Executive Order requires federal contractors to ensure adequate Covid-19 safety protocols, which would extend this requirement to their employees. Covered individuals may expect to have about 75 days to become fully vaccinated. The Administration estimates that this will cover roughly four million workers.

The other components of the Administration’s plan include: 

  • Preparing to provide booster shots for all eligible individuals, starting as early as the week of September 20th, pending approval by the Food and Drug Administration (FDA) and a recommendation from the Advisory Committee on Immunization Practices (ACIP);
  • Taking additional measures to encourage reopening of schools, including promoting testing, masking, and vaccination;
  • Increasing the availability of testing, including at-home tests, and continuing current mask requirements;
  • Expanding support for small businesses through additional support for the Economic Injury Disaster Loan (EIDL) and streamlining of the Paycheck Protection Program (PPP) loan forgiveness process; and
  • Improving care for people with Covid-19, through Surge Response Teams and increased provision of monoclonal antibody treatments.

Details on the plan have been posted on the White House website here. The President’s remarks can be found here.
 
HHS Expands PREP Act Declaration for Monoclonal Antibody Administration
On September 9th, the Department of Health and Human Services (HHS) announced that it has executed a new amendment to its Covid-19 PREP Act Emergency Declaration expanding the range of personnel covered to administer Covid-19 monoclonal antibody (mAb) therapeutics. Under the amended declaration, licensed pharmacists, pharmacy technicians, and pharmacy interns are covered when administering Covid-19 mAb treatments orally, through intramuscular injection, or through subcutaneous injection.
 
HHS is holding a stakeholder call on September 13th to provide further details. The call may be accessed here.

Administration Updates

Biden Administration Releases Pandemic Preparedness Plan
On September 3rd, the Biden Administration released a proposed Pandemic Preparedness Plan, which outlines $65 billion of investments over the next 7-10 years that the Administration believes are necessary to protect the United States from future pandemics. It outlines five major areas for legislative priorities, including: 

  • Bolstering vaccines, therapeutics, and diagnostics;
  • Promoting situational awareness about infectious disease threats;
  • Strengthening the public health system;
  • Improving strategic national stockpiles; and
  • Improving biosecurity and biosafety.

The plan is part of the response to Biden’s initial January 20th Executive Order requiring a whole-of-government review of national biopreparedness policies. The Administration plans to issue a full strategy document later this year.

Legislative Updates

House Committees Begin Considering Build Back Better Reconciliation Legislation
On September 7th, the House Ways and Means Committee released draft legislation for the proposed $3.5 trillion reconciliation “Build Back Better Act” bill. The Committee began markup of the legislation on September 9th and is expected to continue for several days. The first five subtitles of the bill address: 1) universal paid family and medical leave; 2) retirement security; 3) child care access and equity; 4) trade adjustment assistance; and 5) Medicare and elder justice. This final section would expand Medicare benefits to include vision (in 2022), hearing (in 2023), and dental (in 2028) coverage.
 
A section-by-section summary of the draft legislation is available here. The Committee is expected to mark up the tax portion of the reconciliation bill, which would include any changes to advance premium tax credits (APTCs), next Tuesday and Wednesday. That draft legislation has not yet been released.
 
On September 9th, the House Energy and Commerce (E&C) Committee announced that it will begin markup of the Build Back Better Act starting September 13th. The E&C Committee’s consideration will include 16 Committee Prints, including sections on drug pricing, the Affordable Care Act, Medicare, CHIP, Medicaid, and public health, which cover these elements of President Biden’s Build Back Better agenda. It includes a proposal for $190 billion to expand access to home and community-based service (HCBS) in Medicaid.
 
The E&C announcement is available here.

Regulatory Updates

HHS Releases Plan to Lower Prescription Drug Prices
On September 9th, the HHS  Office of the Assistant Secretary for Planning and Evaluation (ASPE) announced the release of its “Comprehensive Plan for Addressing High Drug Prices.” HHS was directed to submit this plan by President Biden’s July Executive Order on Promoting Competition. The plan outlines the three following goals for action on drug prices:

  • Make prices more affordable (e.g., negotiating prices and preventing unreasonable price increases);
  • Improve and promote competition (e.g., strengthening the supply chain, promoting biosimilars and generics, and increasing transparency); and
  • Foster scientific innovation (e.g., supporting private research and improving market incentives).

The plan outlines possible legislative approaches to address drug prices, such as: 

  • Legislation that would allow HHS to directly negotiate Medicare Part B and Part D drug prices;
  • A cap on catastrophic spending in Medicare Part D;
  • Legislation to speed the entry of biosimilar and generic drugs, including shortening the period of exclusivity; 
  • Prohibition on “pay-for-delay” agreements; and
  • Investments to foster innovation, such as in ARPA-H.

It also proposes that HHS consider administrative or regulatory options, such as: 

  • Testing models involving value-based payments for drugs in Part B;
  • Testing additional cost-sharing models to incentivize the use of biosimilars and generics in Part D;
  • The use of Medicare total cost of care models; and
  • Data collection from pharmacy benefit managers and insurers to improve transparency.

The full report is available here.
 
CMS Announces $452 Million for States with State-Based Reinsurance 1332 Waivers 
On September 7th, CMS announced the distribution of $452 million in “pass-through funding” for states with state-based reinsurance programs created through approved section 1332 waivers. These funds reimburse issuers for a portion of health care provider claims that would otherwise be paid by some consumers and by the federal government through higher premiums. States with reinsurance waivers have seen reductions in the individual market statewide average premium, ranging from 3.75% to 41.17%, compared to states without such programs.
 
These distributions are the result of the American Rescue Plan’s (ARP) increased premium subsidies, which will increase enrollment and therefore the appropriate pass-through funding. State distributions range from $2.5 million to $139 million, based on the size of the state’s reinsurance program. This announcement covers 13 of the 14 states with 1332 reinsurance programs; the allocation for the last state, New Jersey, will be announced later.
 
CMS Releases Report on Vermont All-Payer Model 
On September 3rd, CMS released an evaluation and summary of findings of the first two performance years of Vermont’s All-Payer Accountable Care Organization (ACO) Model. The model was launched on January 1, 2017, with an anticipated end date of December 31, 2022. IT aims to assess whether scaling an ACO program across all payers in the state can reduce program expenditures while preserving or improving care quality, by generating sufficient incentives and alignment across payers for broad delivery system transformation.
 
The report found that in its first two years, the All-Payer ACO model achieved statistically significant growth spending reductions in total Medicare Parts A and B spending, significant decreases in acute care stays and days in 2019, significant decreases in specialty evaluation and management visits in 2019, and significantly lower numbers of beneficiaries with unplanned 30-day readmissions. Stakeholders also agreed that the initiative provided an important, unifying forum for providers, payers, and the State to engage in meaningful discussions about health care reform and goal setting.
 
HRSA Issues Additional FY 2022 FQHC Service Area Competition
On September 2nd, the Health Resources and Services Administration (HRSA) posted a new Service Area Competition (SAC) opportunity for fiscal year (FY) 2022. Through the SAC, organizations may apply to participate in the Federally Qualified Health Center (FQHC) program by taking over a grant in an existing service area. FQHCs are typically approved for a three-year period and, if they seek to renew, must reapply to the SAC. For this opportunity, there are additional SACs open in Brooklyn and Schenectady.
 
Applications are due November 1st. More information is available here. 

Other Updates

Study Finds Pfizer Covid Vaccine Works in Pregnancy
On September 7th, Naturepublished a new analysis that found that the estimated effectiveness of the Pfizer/BioNTech Covid-19 vaccine in pregnant women aged 16 years and older with no history of SARS-CoV-2 was 96% for roughly two months after the second dose. The cohort included 10,861 pregnant women vaccinated between December 2020 and June 2021 and 10,861 unvaccinated pregnant women. Due to the timing of the study, the results mainly reflect efficacy against the original reference strain and the B.1.1.7 (Alpha) variant. The authors conclude that vaccine effectiveness for pregnant women is not lower than for the general population.
 
Justice Department Files Suit Over Texas Abortion Law 
On September 9th, the Department of Justice announced that it has filed a lawsuit against the State of Texas challenging Texas Senate Bill 8, which placed new restrictions on abortion. The law bans abortions after about six weeks, allows private citizens to sue anyone perceived to be helping patients obtain abortions, and has no exceptions for rape or incest. The suit claims that Texas acted “in open defiance of the Constitution” and is seeking a permanent injunction from a federal court in the Western District of Texas. The suit follows a 5-4 decision by the Supreme Court on September 1st  to decline to provide injunctive relief, in which Chief Justice John Roberts joined Justices Breyer, Kagan, and Sotomayor in the dissent. The Justice Department’s challenge is likely to eventually rise to the Supreme Court for a final decision. 

Congressional Hearings

No health care-related hearings, other than legislation markup, are scheduled next week. 

New York State Updates

Governor Hochul Announces New Administration Appointments
On September 8th, Governor Hochul announced the following appointments to her administration:

  • Jeff Lewis has been appointed Chief of Staff to the Governor. Lewis previously served in Hochul’s Lieutenant Governor’s office, first as Director of External Affairs and then as Chief of Staff. He also worked as a legislative correspondent for Hochul during her time in the U.S. House of Representatives.
  • Linda Sun has been appointed Deputy Chief of Staff. Sun most recently served as Deputy Superintendent for Intergovernmental Affairs and Chief Diversity Officer at the New York State Department of Financial Services (DFS).
  • Melissa Bochenski has been appointed Deputy Chief of Staff. Bochenski was previously Deputy Chief of Staff for Hochul’s Lieutenant Governor’s office and also served as an executive assistant and office manager for Hochul during her time in the U.S. House of Representatives.
  • Julissa Gutierrez will continue to serve as Chief Diversity Officer for the State of New York, a position to which she was appointed in early 2020. Gutierrez previously served as Deputy Director of Constituency Affairs in the Governor’s office and as Special Assistant to the Commissioner at the New York City Department of Youth and Community Development.
  • Shirley Paul has been appointed Senior Advisor to the Governor. Paul was an Assistant Director for Legislative Affairs at SUNY Systems Administration and previously served then-Lieutenant Governor Hochul as Senior Advisor and Counsel.
  • Sinéad Doherty has been appointed Deputy Secretary for Executive Operations. Doherty was most recently the Director of Operations of Good Tidings Foundation, a California-based children’s nonprofit, and previously served as Director of Operations in Hochul’s Lieutenant Governor’s office.
  • Padma Seemangal has been appointed Deputy Secretary for Policy Operations. Seemangal previously served as Director of Communications and Public Affairs at Global Strategy Group and as a Senior Advisor to then-Lieutenant Governor Hochul.
  • Hazel Crampton-Hays has been appointed Press Secretary. Crampton-Hays was most recently the Press Secretary for New York City Comptroller Scott Stringer.
  • Jelanie DeShong has been appointed Assistant Secretary for Intergovernmental Affairs. DeShong most recently served as the Director of Government Relations for SUNY Downstate Health Sciences University and was previously the Director of Community Engagement for then-Lieutenant Governor Hochul.
  • Devan Cayea has been appointed the Director of Strategic Planning and Scheduling. Cayea was previously the Director of Operations in Senator Amy Klobuchar’s Capitol Hill office and served on the Biden for America presidential campaign.
  • Fohat Aird-Bombo has been appointed Director of Advance. Aird-Bombo previously served as Director of Advance and Special Events for then-Lieutenant Governor Hochul.

The Governor’s press release is available here.
 
NYS Designates Covid-19 as Airborne Infectious Disease, Triggering HERO Act Employee Safety Requirements
On September 6th, Governor Hochul announced that the Commissioner of Health has designated Covid-19 as a “highly infectious communicable disease that presents a serious risk of harm to the public health in New York State.” Under the recently passed New York State HERO Act, this designation requires all employers to implement workforce safety plans to protect employees against exposure and disease during an airborne infectious disease outbreak.
 
The Commissioner’s designation is available here and additional details on the HERO Act, including the prevention standard and model exposure prevention plan, are available here. The designation will remain in effect until September 30th, at which point the Commissioner will review the level of Covid-19 transmission in the state and determine whether to continue the designation.
 
New York State Postpones Carve-In of BH into Medicaid Advantage Plus
The New York State Department of Health (DOH) has announced that the planned carve-in of behavioral health (BH) services into the Medicaid Advantage Plus (MAP) benefit package has been postponed to January 1, 2023. The transition was previously scheduled to take place on January 1, 2022. These services will continue to be available for MAP beneficiaries on a fee-for-service basis until the carve-in occurs in accordance with the updated timeline.