The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from February 8 - February 14. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.

NON-CORONAVIRUS LEGISLATIVE UPDATE

House   

  • None of note. 

Senate      

  • On February 8, Sen. Richard Shelby (R-AL) announced that he would not seek re-election in 2022 after serving more than forty years in the Senate.

  • On February 9, the impeachment trial against former President Trump began. The Senate voted (56-44) that it is constitutional to try a former president. Six Republicans, including Sens. Bill Cassidy (R-LA), Susan Collins (R-ME), Lisa Murkowski (R-AK), Mitt Romney (R-UT), Ben Sasse (R-NE), and Pat Toomey (R-PA) , joined all Democrats in voting that the trial was constitutional. In a surprise vote on February 13, the Senate voted to allow witnesses to be called in the impeachment trial, potentially delaying the timetable for reaching a verdict. However, later in the day they agreed to admit a witness statement into the trial record instead of calling witnesses, setting up a vote on impeachment. Later that day, the Senate voted 57-43 to convict Trump, falling 10 votes short of the 67 needed for conviction. Sen. Richard Burr (R-NC) joined the aforementioned Republicans in voting to convict Trump.

  • On February 12, the Appropriations Committee announced the majority and minority Chairs, Ranking Members, and Subcommittee rosters. The Labor, Health & Human Services (HHS), and Education, and Related Agencies Subcommittee continued to be led by Chair Patty Murray (D-WA) and Ranking Member Roy Blunt (R-MO), and includes the following members: Dick Durbin (D-IL), Jack Reed (D-RI), Jeanne Shaheen (D-NH), Jeff Merkley (D-OR), Brian Schatz (D-HI), Tammy Baldwin (D-WI), Chris Murphy (D-CT), Joe Manchin (D-WV), Shelby, Lindsey Graham (R-SC), Jerry Moran (R-KS), Shelley Moore Capito (R-WV), John Kennedy (R-LA), Cindy Hyde-Smith (R-MS), Mike Braun (R-IN), and Marco Rubio (R-FL).

NON-CORONAVIRUS REGULATORY UPDATE

  • On February 10, the Department of Justice (DOJ) submitted a letter to the Supreme Court indicating it has changed its position in the pending case that challenges the constitutionality of the Affordable Care Act (ACA). DOJ now argues that the ACA's individual mandate remains valid, and, even if the court determines it is not, the rest of the law can remain intact. A ruling in the case is expected shortly. 

  • On February 10, the Food & Drug Administration (FDA) published a report entitled Office of Generic Drugs (OGD) 2020 Annual Report. The report noted that through COVID-19, OGD prioritized the assessment of generic drug submissions for products that could help address COVID-19. The report also noted that OGD approved or tentatively approved 948 Abbreviated New Drug Applications, including 72 first generics.

  • On February 12, the Centers for Medicare & Medicaid Services (CMS) announced that the Special Enrollment Period for the federal Health Marketplace will occur from February 15 through May 15, pursuant to President Biden’s Executive Order (EO) on Strengthening Medicaid and the ACA. At least 13 states plus D.C. that operate their own Marketplace platforms will also reopen their state exchanges. A fact sheet on the announcement is available here.

  • On February 12, CMS sent letters to states rescinding the letter that former CMS Administrator Seema Verma issued weeks before her exit that would provide additional protections for Section 1115 demonstrations. Additionally, CMS sent letters to certain states maintaining that the Agency does not believe that their Medicaid programs “promote the objectives of the Medicaid program” and giving them 30 days to provide CMS with a rebuttal. States receiving these letters include: Arizona, Arkansas, Georgia, Indiana, Nebraska, Ohio, South Carolina, Utah, and Wisconsin,.

  NON-CORONAVIRUS WHITE HOUSE UPDATE  

  • Nothing of note.

CORONAVIRUS UPDATE  

Legislative

  • On February 8, the House Subcommittee on the Coronavirus Crisis urged White House Chief of Staff Ron Klain and HHS Acting Secretary Norris Cochran to release documents and information from the Trump Administration regarding potential political interference in COVID-19 efforts, including suppressing scientific information and reports, suppressing testing, and interfering in COVID-19 vaccines and treatments.

  • On February 8, Sens. Chuck Grassley (R-IA) and Joni Ernst (R-IA) urged the Centers for Disease Control and Prevention (CDC) to publicly release its weekly formula for allocating COVID-19 vaccines to states, territories, tribes, other public health jurisdictions, and federal entities after reports of Iowa not receiving its fair share of vaccines.

  • On February 8, the House Committee on Ways & Means announced that the Committee will consider nine legislative recommendations under S. Con. Res. 5, this year’s budget resolution, summing to half of the $1.9 trillion Democratic COVID-19 relief package. The Committee held markups February 10 through February 12.

The Committee’s Recommendations Relating to Continuation of Job-Based Coverage, included: 

    • Creating an 85% federal subsidy for COBRA premiums;

    • Creating a COBRA election extension period;

    • Providing a refundable payroll tax credit to reimburse employers and plans who paid the subsidized portion of the premium to assistance eligible individuals;

    • Increasing ACA premium tax credits for 2021 and 2022 for taxpayers with income below 400% of the federal poverty level (FPL); and

    • Providing advanced premium tax credits if the taxpayer’s income was no higher than 133% of the FPL for individuals receiving unemployment compensation.

    • A summary of these recommendations is available here.

Recommendations Relating to Support to Skilled Nursing Facilities in Response to COVID-19, included: 

    • Providing for infection control support to skilled nursing facilities through contracts with quality improvement organizations; and

    • Funding for strike teams for resident and employee safety in skilled nursing facilities.

    • A summary of these recommendations is available here.

  • On February 10 and 11, the Financial Services Committee held a markup to consider legislative recommendations under S. Con. Res. 5, including providing:

    • $30 billion for emergency housing and rental assistance;

    • $10 billion to the Defense Production Act to increase medical supplies necessary to addressing COVID-19; and

    • $10 billion supporting small businesses, and $15 billion supporting airlines.

    • A memorandum from the committee is available here.

  • On February 11, the Energy & Commerce Committee held a markup to consider legislative recommendations under S. Con. Res. 5, relating to Public Health, Medicaid, CHIP, and other provisions. The recommendations include:

    • Public Health:

      • $46 billion to HHS for COVID-19 testing;

      • $8.5 billion to CDC to promote public health measures and vaccinate against COVID-19;

      • $7.6 billion to HHS to establishing, expanding, and sustaining a public health workforce;

      • $7.6 billion for Community Health Centers (CHCs) to conduct COVID-19 related efforts;

      • $5.2 billion to HHS to address the vaccine and therapeutic supply chain;

      • $1.8 billion to HHS for Personal Protective Equipment, testing supplies, and vaccines; and

      • $1.75 billion to CDC to expand genomic sequencing.

    • Medicaid

      • Requiring Medicaid coverage of COVID-19 vaccines and treatment without beneficiary cost sharing matched at 100 percent federal medical assistance percentage (FMAP);

      • Granting states the flexibility to extend Medicaid eligibility to women for 12 months postpartum for five years;

      • Incentivizing states to expand Medicaid by temporarily increasing the state’s base FMAP to 95% two years the expansion population;

      • Eliminating the cap on Medicaid drug rebates (AMP), starting in calendar year 2023; and

      • Temporarily increasing FMAP by 7.35% for states to make improvements to Medicaid home- and community-based services for one year.

    • CHIP

      • Requiring CHIP coverage of COVID-19 vaccines and treatment without cost sharing to the beneficiary with vaccines matched at 100 percent FMAP; and

      • Granting states the flexibility to extend Medicaid eligibility to women for 12 months postpartum for five years.

    • The memorandum from the committee is available here. A summary of the legislation is available here.

  • On February 12, the Oversight and Reform Committee held a markup to consider legislative recommendations under S. Con. Res. 5, including the Coronavirus State and Local Fiscal Recovery Funds. The recommendations include:

    • Creating new State and Local Coronavirus Relief Funds to help mitigate the effects of COVID-19 and its negative economic impacts;

    • Providing emergency paid leave for civilian federal employees and postal workers; and

    • Providing additional funds to the Government Accountability Office (GAO) and the Pandemic Response Accountability Committee to promote transparency and support oversight of coronavirus relief funds.

    • A summary of the legislation is available here. Direct funding estimates for states, localities, Tribes, and territories are available here.

  • On February 12, Rep. Pramila Jayapal (D-WA) and Rep. Suzan DelBene (D-WA) urged Acting HHS Secretary Cochran to include a ban on preferential access to COVID-19 vaccines in the CDC provider agreements and requirements, and a report on how HHS intends to establish greater accountability for these types of grievances and others. They indicate their concern emanates from reports that individuals with influence have been granted special access to vaccines by hospitals around the country.

  • The House Budget Committee is expected to consider committee recommendations for the $1.9 trillion “American Rescue Plan” during the week of February 15. The full House is expected to consider this package the week of February 22. Senate Democrats may bypass committees and bring a bill straight to the floor.

Regulatory   

  • On February 9, the Federal Emergency Management Agency announced it is seeking bids on two $3 billion contracts to staff federally supported and community vaccine centers around the country.

  • On February 9, the FDA issued an emergency use authorization (EUA) for Lilly’s antibody treatment of bamlanivimab and etesevimab for the treatment of mild to moderate COVID-19 that are at high risk of progressing to severe COVID-19 for those 12 years old or older.

  • On February 10, the CDC released a report finding that fitting a cloth mask over a medical procedure mask or wearing tightly fitted medical masks can reduce exposure to COVID-19 to more effectively slow the spread of COVID-19. 

  • On February 10, the FDA issued an EUA for Visby’s rapid point-of-care PCR COVID-19 test.

  • On February 11, HHS and Department of Defense (DoD) finalized the purchase for an additional 100 million doses of COVID-19 vaccines from both Pfizer and Moderna to help meet demand for COVID-19 vaccines.

  • The FDA will allow Moderna to increase the number of COVID-19 vaccine doses from 10 to 14 per vial, to increase the supply of available vaccines.

  • The CDC will host a virtual forum to promote confidence in COVID-19 vaccines and the equitable distribution of the shots on February 22-24.

  • The FDA Vaccines and Related Biological Products Advisory Committee will hold a meeting on February 26 to discuss the emergency use authorization of the Johnson & Johnson COVID-19 vaccine. 

  • The FDA is expected to release draft guidance and standards regarding COVID-19 variants, vaccine booster shots, diagnostic tests, and treatments in the coming weeks. 

  • The CDC has identified the U.K. COVID-19 variant, B.1.1.7, in 12 states. The variant from South Africa was detected in California, Maryland, South Carolina, and Virginia, and the variant from Brazil was detected in Minnesota. 

  • As of February 14, nearly than 38.3 million people have received the first dose of COVID-19 vaccines (over 14 million have received both doses) and more than 70 million doses have been distributed, according to the CDC COVID Data Tracker.

  • COVID-19 information released by CMS is posted here; specific waivers are available here.

White House

  • On February 9, President Biden announced the Administration will allocate 1 million COVID-19 vaccine doses to CHCs to improve vaccine equity and better target high risk populations . Roughly 250 sites will receive the vaccine in the initial phase of the program, which will eventually include any of the nation’s 1,400 CHCs that want to participate.

  • On February 9, President Biden announced the Administration will increase the overall, weekly vaccine supply to states, Tribes, and territories to 11 million doses nationwide beginning this week. The Administration is committing to maintaining this as the minimum supply level for the next three weeks and will continue to work with manufacturers in their efforts to ramp up supply.

  • On February 10, the White House announced the members of the COVID-19 Health Equity Task Force, including Mayra Alvarez, James Hildreth, Andrew Imparato, Victor Joseph, Joneigh Khaldun, Octavio Martinez, Tim Putnam, Vincent Toranzo, Mary Turner, Homer Venters, Bobby Watts, and Haeyoung Yoon. The Task Force will hold its first meeting on February 26.

 Other

  • On February 8, Veru released positive efficacy and safety results from the company’s Phase II clinical trial of VERU-111 for the treatment of high-risk hospitalized COVID-19 patients.

  • On February 8, the Joint Commission released a report entitled Supporting safe, equitable care during the COVID-19 pandemic that recommended actions organizations can take to identify and address racial and ethnic disparities while removing barriers to providing safe, equitable and quality health care during and after COVID-19. 

  • On February 11, preliminary results from the U.K. RECOVERY trial found positive efficacy results from the use of tocilizumab for hospitalized patients with severe COVID-19. The trial found that tocilizumab lowered the risk of COVID-19 related death, reduced the need for a mechanical ventilator, and shortened the time until patients were successfully discharged. 

  • As of February 14, the U.S. had 27,616,922 confirmed COVID-19 cases resulting in 484,997 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.  

RULES AT THE WHITE HOUSE OMB

Pending Review

  • None of note.

 REPORTS     

HHS Office of Inspector General (OIG)

  • On February 11, OIG released a report entitled Illinois Made Capitation Payments to Managed Care Organizations for Medicaid Beneficiaries With Concurrent Eligibility in Another State. The report found that Illinois made an estimated $3.8 million in capitation payments on behalf of Medicaid beneficiaries who were concurrently eligible and residing in another State in August 2018. OIG recommended that Illinois develop or enhance current procedures to identify beneficiaries with concurrent eligibility in another State and ensure that procedures are in place for caseworkers to timely review and terminate eligibility for beneficiaries who were identified as concurrently eligible in another State. Illinois accepted our recommendations. A summary of the report is available here.

Congressional Budget Office (CBO)

  • On February 8, CBO released a report entitled Monthly Budget Review: January 2021. The report found that the federal budget deficit was $738 billion in fiscal year (FY) 2021 so far, $348 billion more than the deficit during the same period of FY 2020. CBO found that outlays were 23% higher and revenues were 1% higher than during the same period in FY 2020. A summary of the report is available here.

  • On February 11, CBO released a report entitled The Budget and Economic Outlook: 2021 to 2031. The report projects a federal budget deficit of $2.3 trillion in 2021, nearly $900 billion less than the deficit in 2020. CBO estimates that the annual deficits will average $1.2 trillion a year from 2022 to 2031 and exceed their 50-year average of 3.3% of GDP. The Federal debt is projected to reach 102% of GDP at the end of 2021, and by 2031, debt would equal 107% of GDP. As COVID-19 vaccinations increase, the GDP is expected to grow 3.7% in 2021. A summary of the report is available here. 

Government Accountability Office (GAO)

  • On February 11, the GAO released a report entitled Operation Warp Speed (OWS): Accelerated COVID-19 Vaccine Development Status and Efforts to Address Manufacturing Challenges. The report found that OWS and vaccine companies adopted several strategies to accelerate vaccine development and mitigate risk. GAO's analysis of the OWS vaccine candidates' technology readiness levels showed that COVID-19 vaccine development under OWS generally followed traditional practices, with the FDA issuing specific guidance that identified ways that vaccine development may be accelerated during the pandemic. GAO identified manufacturing challenges, including: limited manufacturing capacity, disruptions to manufacturing supply chains, and gaps in the available workforce, that the DoD and HHS are attempting to mitigate. A summary of the report is available here.

  • On February 11, the GAO released a report entitled Electronic Health Records (EHR): VA Has Made Progress in Preparing for New System, but Subsequent Test Findings Will Need to Be Addressed. The report found that if the VA does not close or appropriately address all critical and high severity test findings prior to deploying at future locations, the system may not perform as intended. GAO recommended that the VA should postpone deployment of its new EHR system at planned locations until any resulting critical and high severity test findings are appropriately addressed. A summary of the report is available here.

Congressional Research Service (CRS)

  • On February 8, CRS released a report entitled The Federal Reserve’s Response to COVID-19: Policy Issues. The report provided an overview of the Federal Reserve’s response to COVID-19 including emergency lending and oversight of the actions.

UPCOMING HEARINGS

Senate

  • None of note.

House

  • Energy & Commerce Oversight and Investigations Subcommittee

Hearing with COVID-19 Vaccine Manufacturers 

February 23, TBD. 

OTHER HEALTH POLICY NEWS

  • On February 8, Deloitte released a report entitled Implications of the COVID-19 crisis for the health care ecosystem: Gearing up for the next normal. The report predicts that health spending may decrease over the next two decades due to the shift from reactive to preventive health care caused by COVID-19. 

  • On February 8, eight health care organizations called for Congressional leaders to increase the FMAP provided to states for Medicaid and enact a glidepath for the future reduction in funding.

  • On February 9, a working paper released in the National Bureau of Economic Research found that a modest $10 increase in out-of-pocket costs will cause 23% of Medicare patients to stop taking drugs they need, which led to a 33% increase in monthly mortality.

  • On February 10, the One Percent Steps for Health Care Reform published an article in Health Affairs highlighting a variety of issues that individually would decrease health care spending by one percent, including: decreasing cost barriers for living kidney donations, addressing orphan drugs, reforming how Medicare reimburses biosimilars, reducing fraud in home health, addressing surprise medical bills, and others. The group identifies 16 areas that if addressed would decrease health care spending by 1%.

  • On February 11, the Maryland House of Delegates voted 95 to 38 to override Maryland Governor Larry Hogan’s (R) veto of a Prescription Drug Affordability Board that would set drug prices paid by government workers in the state.