The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from February 1 - February 7. 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
On February 3, House Republicans voted 145-61 to keep Rep. Liz Cheney (R-WY) as Chair of the GOP conference, following backlash from Rep. Cheney’s vote to impeach President Trump.
Senate
On February 2, Senate Majority Leader Chuck Schumer (D-NY) announced Democratic committee assignments for the 117th Congress. Of note, Sen. Elizabeth Warren (D-MA) will join the Finance Committee and Sens. Ben Ray Lujan (D-NM) and John Hickenlooper (D-CO) will join the HELP Committee. Sen. Warren will no longer serve on the HELP Committee in the 117th Congress.
On February 2, the Senate confirmed Alejandro Mayorkas as Department of Homeland Security Secretary (56-43) and Pete Buttigieg Department of Transportation Secretary (86-13).
On February 3, Senate Republican Leader Mitch McConnell (R-KY) announced the Republican committee assignments for the 117th Congress. Of note, Sen. John Barasso (R-WY) will serve on the Finance Committee and Sens. Roger Marshall (R-KS), Tommy Tuberville (R-AL), and Jerry Moran (R-KS) will serve on the HELP Committee.
On February 3, Majority Leader Schumer and Republican Leader McConnell reached an agreement for the Senate organizational resolution. The power-sharing agreement is almost identical to the 2001 agreement, with Democrats leading committees and the filibuster intact.
On February 4, Sens. Mark Warner (D-VA) and Raphael Warnock (D-GA) proposed a bill entitled, States Achieve Medicaid Expansion Act of 2021, which would give additional federal funding to states that expanded Medicaid and those who choose to expand in the future to cover the full cost of expansion for three years. The federal match would decrease to 90% by the sixth year of expansion.
The impeachment trial against former President Trump is set to begin on February 9.
Shawn Bishop will return to the Finance Committee as the chief health policy aide for Committee Democrats, replacing Elizabeth Jurinka who moved to the White House Office of Legislative Affairs.
NON-CORONAVIRUS REGULATORY UPDATE
The Food and Drug Administration (FDA) will host meetings entitled Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards on April 7.
NON-CORONAVIRUS WHITE HOUSE UPDATE
The Biden Administration announced a series of appointments this week, including former Nevada State Senator Yvanna Cancela for Health & Human Services (HHS) Deputy Director of Intergovernmental Affairs.
On February 3, the White House Office of National Drug Control Policy announced its priorities under the Biden Administration and staffing changes.
On February 3, the White House Office of Management & Budget (OMB) concluded its review of a notice from CDC entitled Temporary Halt in Residential Eviction to Prevent the Further Spread of COVID-19.
On February 3, OMB concluded its review of a notice from CDC entitled Requirement for Persons to Wear Masks While on Conveyances and at Stations, Ports, or Similar Transportation Hubs.
CORONAVIRUS UPDATE
Legislative
On February 2, the Senate voted 50-49 to begin the budget reconciliation process. This move allows Democrats to pass a COVID relief bill without GOP support. On February 5, the Senate passed a budget resolution following a "vote-a-rama" of 41 different amendment votes. The Senate voted to reject raising the federal minimum wage to $15 an hour during a public health emergency and in favor of more targeted eligibility for the proposed direct stimulus checks.
On February 2, the Budget Committee Chair John Yarmuth released highlights of President Biden’s American Rescue Plan and a section-by-section analysis of the 2021 Budget Resolution.
On February 2, the Energy & Commerce Oversight and Investigations Subcommittee held a hearing entitled No Time To Lose: Solutions To Increase Covid-19 Vaccinations In The States. The hearing examined the distribution and administration of COVID-19 vaccines in the U.S., and identified areas where states require federal assistance, including increasing the vaccine supply to states and increasing allocation transparency. Witnesses included: Ngozi Ezike, M.D., Director, Illinois Department of Public Health; Joneigh Khaldun, M.D., Chief Medical Executive and Chief Deputy Director, Michigan HHS, Clay Marsh, M.D. COVID-19/Coronavirus Czar; West Virginia; Courtney Phillips, Secretary, Louisiana Department of Health; and Jill Hunsaker Ryan, Executive Director, Colorado Department of Public Health and Environment. The Memorandum from Energy & Commerce Committee Chair Frank Pallone (D-NJ) is available here.
On February 3, the Energy & Commerce Health Subcommittee held a hearing entitled Road to Recovery: Ramping Up COVID-19 Vaccines, Testing, and Medical Supply Chain.There was broad consensus that the U.S. needs to be more independent and develop a more stable domestic supply chain for medical supplies. Many Congress members voiced their concerns around vaccine administration equity and the need to better target vulnerable communities. The witnesses reiterated the importance of developing a robust public health data system and investing in public health to combat future public health issues. Witnesses included: Luciana Borio, M.D. Vice President, In-Q-Tel, Former Acting Chief Scientist, FDA, Former Director for Medical and Biodefense Preparedness, National Security Council; Greg Burel President and Principal Consultant, Hamilton Grace, Former Director, U.S. Strategic National Stockpile; Michael Leavitt, Founder and Chair, Leavitt Partners, Former HHS Secretary, Former Governor of Utah; and Julie Morita, M.D., Executive Vice President, Robert Wood Johnson Foundation. The Memorandum from Chair Pallone is available here.
On February 4, the House Financial Services Committee held a hearing entitled More than a Shot in the Arm: The Need for Additional COVID-19 Stimulus. The Committee discussed the previous COVID relief packages passed by Congress, President Biden’s American Rescue Plan, and the growing need for additional relief to address a variety of needs, including housing insecurity, state and local funding, small business relief, and supporting domestic production of medical supplies. Witnesses included: Clarence Anthony, CEO, Executive Director, National League of Cities; Derrick Johnson, President, CEO, National Association for the Advancement of Colored People; Janet Murguía, President, CEO, UnidosUS; William Spriggs, Chief Economist, The American Federation of Labor and Congress of Industrial Organizations; Dr. Michael Strain, Economist, American Enterprise Institute. The Committee Memorandum is available here.
On February 4, Sen. Tammy Baldwin (D-WI) and Rep. Ami Bera (D-CA) introduced a bill entitled, Tracking COVID–19 Variants Act, which would allocate $2 billion to identify and track new variants of COVID-19.
On February 5, the House approved H.Con.Res. 11, Establishing the congressional budget for the United States Government for fiscal year (FY) 2021 and setting forth the appropriate budgetary levels for FY 2022 through 2030, in a 218-212 vote. This budget measure directs committees to begin drafting COVID relief legislation.
House Committees are expected to markup their portions of the COVID relief package the week of February 8.
Regulatory
On February 1, the Department of Defense (DoD) and HHS awarded Ellume $231.8 million for 8.5 million rapid, over-the-counter, at-home COVID-19 tests.
On February 1, the Centers for Disease Control and Prevention (CDC) releasedpreliminary data finding racial disparities in vaccinations. The data shows that 60.4% of those who received their first COVID-19 vaccine dose were White while those who are the highest risk for infection and severe adverse health outcomes are disproportionately Black, American Indian, and Hispanic. The CDC also reported that over half of states failed to provide racial and ethnic demographic data related to vaccine distribution.
On February 4, the FDA revised the Emergency Use Authorization (EUA) for the use of convalescent plasma for the treatment of COVID-19 for hospitalized patients early in the course of an infection or those with impaired immune systems. The guidance authorizes that plasma with high levels of COVID-19 antibodies may be used going forward and plasma with low levels of antibodies cannot be used due to the lack of studies proving that it is effective in hospitalized patients.
On February 5, the CDC released a report finding that statewide mask mandates have decreased COVID-19 hospitalizations and cases.
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 (J&J) 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 Maryland, South Carolina and Virginia, and the variant from Brazil was detected in Minnesota.
As of February 7, more than 30.2 million people have received the first dose of COVID-19 vaccines (over 8.3 million have received both doses) and more than 59.3 million doses have been distributed, according to the CDC COVID Data Tracker.
White House
White House advisers aim to pass President Biden’s $1.9 trillion COVID-19 relief package during the first week of March, before enhanced unemployment insurance benefits expire on March 15.
On February 1, White House's COVID response team Senior Adviser Andy Slavitt advised providers against holding back COVID-19 vaccine doses that have been reserved for second doses.
On February 1, President Biden met with 10 moderate Senate Republicans that proposed a $618 billion COVID relief package. President Biden called the package too small, but voiced his willingness to compromise, as long as a package is passed quickly. The U.S. Chamber of Commerce urged President Biden to pursue a more targeted approach to COVID relief and to work with Republicans to pass a bipartisan package.
On February 2, White House Coronavirus Response Coordinator Jeff Zients announced that the federal government will begin to distribute COVID-19 vaccine doses directly to retail pharmacies. CVS will begin distributing vaccines on February 11 and Walgreens will begin distributing vaccines on February 12.
On February 5, Secretary of Defense Lloyd Austin deployed 1,100 active-duty troops to five Federal Emergency Management Agency (FEMA) COVID-19 vaccination centers to assist in COVID-19 vaccination efforts, in addition to National Guard assistance.
On February 5, the White House invoked the use of the Defense Production Act to increase the production of COVID-19 tests and personal protective equipment. Six companies will make at least 61 million at-home or point-of-care COVID-19 tests.
Other
On February 1, a study prepublished in The Lancet suggests that the AstraZeneca COVID-19 vaccine may significantly reduce transmission of COVID-19, in addition to protecting against the virus. On February 4, another study prepublished in The Lancetfound that the AstraZeneca COVID-19 vaccine may be less effective against the U.K. COVID-19 variant.
On February 1, BioNTech announced it will manufacture 2 billion doses of the Pfizer-BioNTech COVID-19 vaccine in 2021, an increase from previous projections of 1.3 billion doses.
On February 2, the Phase III clinical trial data of the Russian COVID-19 vaccine Sputnik V was published in The Lancet; the vaccine is 91.6% effective against COVID-19. The Russian Direct Investment Fund indicated that it will not prioritize U.S. or U.K. authorization for the vaccine.
On February 2, Pfizer announced plans to study whether a third dose of its COVID-19 vaccine administered between six and 12 months after the initial two-dose inoculation increases protection against emerging COVID-19 variants.
On February 3, Bristol Myers Squibb reached an agreement with the Rockefeller University, granting Bristol Myers Squibb a global exclusive license to develop, manufacture, and commercialize Rockefeller’s monoclonal antibody COVID-19 treatment.
On February 3, COVAX published its first interim distribution forecast of the Pfizer and Moderna COVID-19 vaccines.
On February 3, GlaxoSmithKline partnered with CureVac to manufacture CureVac’s COVID-19 vaccine and jointly develop another COVID-19 vaccine to target new variants.
On February 4, Gilead Sciences announced it has reached $2.8 billion in revenue in 2020 from remdesivir, the COVID-19 treatment.
On February 4, the U.K. announced it will begin studying whether mixing COVID-19 vaccine doses impacts the effectiveness of the vaccines.
On February 4, J&J filed for EUA of its COVID-19 vaccine with the FDA. Phase III trial showed the vaccine prevented moderate to severe COVID-19 in 66% of patients in clinical trials around the world and was 72% effective in U.S. trials.
On February 4, Novavax announced the company will begin the review process for the authorization of its COVID-19 vaccine while Phase III trials continue in the U.S. and U.K.
As of February 5, the U.S. had 26,928,129 confirmed COVID-19 cases resulting in 462,272 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 4, OIG released a report entitled Opioid Use in Medicare Part D During the Onset of the COVID-19 Pandemic. The report found that during the first eight months of 2020, about 5,000 Medicare beneficiaries per month suffered an opioid overdose. The number of beneficiaries receiving short-term opioid prescriptions also decreased during COVID-19, with a sharp decline in April. OIG identified that about 220,000 beneficiaries received high amounts of opioids in the first eight months of 2020 while the number of beneficiaries receiving drugs for medication-assisted treatment of opioid use disorder increased slightly. A summary of the report is available here.
Congressional Budget Office (CBO)
On February 1, the CBO released a report entitled An Overview of the Economic Outlook: 2021 to 2031. CBO projected that the economic expansion that began in mid-2020 will continue. The real GDP is projected to return to its prepandemic level in mid-2021 and to surpass its maximum sustainable level in early 2025. The number of people employed is projected to return to its prepandemic level in 2024. A summary of the report is available here.
On February 4, the CBO released a report entitled CBO’s Model of Drug Price Negotiations Under the Elijah E. Cummings Lower Drug Costs Now Act: Working Paper 2021-01. The report estimates the budgetary effects of legislation from the 116thCongress, H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act. The analysis found that under the legislation, the resulting average drug price would be close 120% of the index of international drug prices and prices would be reduced by 57% - 75%, relative to current prices. A summary of the report is available here.
Government Accountability Office (GAO)
On February 1, the GAO released a report entitled Veterans Community Care Program: Immediate Actions Needed to Ensure Health Providers Associated with Poor Quality Care Are Excluded. The report found that the Department of Veterans Affairs’ (VA) Optum and TriWest eligibility restrictions may not consistently exclude all ineligible providers from participating in the Veterans Community Care Program (VCCP). The VA's contracts with these contractors do not require the verification of providers' history of license sanctions, including a revoked license, in all states during credentialing. The GAO found that only one of the two contractors has a process that includes verifying providers' licensure history in all states and neither has a sufficient process for continuously monitoring provider licenses. The GAO recommended that the VA require its contractors to have credentialing and monitoring policies that ensure compliance with VA MISSION Act license restrictions and that it assess the risk to veterans when former VA providers with quality concerns continue to provide VCCP care. A summary of the report is available here.
On February 5, the GAO released a report entitled DoD Health Care: DoD Should Monitor Implementation of Its Clinical Practice Guidelines. The report found that the military branches are not systematically monitoring military treatment facilities’ (MTFs') implementation of the 22 clinical practice guidelines (CPGs) that were jointly developed by the DoD and VA in October 2020 to address specific health conditions. GAO recommended that DoD Defense Health Agency work with the military services to develop and implement a systematic process to monitor MTFs' implementation of VA-DOD CPGs. DOD concurred with this recommendation. A summary of the report is available here.
On February 5, the GAO released a report entitled Medicaid: CMS Needs to Implement Risk-Based Oversight of Puerto Rico's Procurement Process. GAO found that seven of the eight selected Puerto Rico Medicaid program procurements did not include important steps to promote competition and mitigate the risk for fraud, waste, and abuse, underscoring the need for federal oversight. GAO recommended that CMS implement risk-based oversight of the Medicaid procurement process in Puerto Rico. HHS concurred with this recommendation. A summary of the report is available here.
On February 5, the GAO released a report entitled VA Health Care: Community Living Centers Were Commonly Cited for Infection Control Deficiencies Prior to the COVID-19 Pandemic. The report found that infection prevention and control deficiencies were the most common type of deficiency cited in inspected community living centers (CLC), with 95% having an infection prevention and control deficiency cited in 1 or more years from FY 2015 - FY 2019. GAO also found 62% of inspected CLCs had infection prevention and control deficiencies cited in consecutive fiscal years. A summary of the report is available here.
UPCOMING HEARINGS
Senate
Homeland Security and Governmental Affairs Committee
Nomination of Neera Tanden for Office of Management and Budget Director
February 9, 9:15 a.m. Senate Dirksen Building
Budget Committee
Nomination of Neera Tanden for Office of Management and Budget Director
February 10, 10:00 a.m. Senate Dirksen Building
House
Education & Labor Committee
Markup of reconciliation recommendations to House Budget Committee
February 9, 3:00 p.m. via Webex
Note: The Energy & Commerce and Ways & Means Committees are also expected to markup their recommendations this week
OTHER HEALTH POLICY NEWS
On February 1, the Supreme Court scheduled oral arguments on March 29 to review Medicaid work requirements.
On February 1, a study published in Health Affairs found that while telemedicine use increased drastically during the pandemic, with more than 30% of all visits being telehealth visits, its use varied widely across patient demographics, medical needs, and clinical specialties during COVID-19. Use was significantly lower in low-income areas and varied widely across specialties.
On February 3, the Urban Institute published a report in Health Affairs entitled Medicaid Physician Fees Remained Substantially Below Fees Paid By Medicare In 2019. The report found that Medicaid physician fees remained well below Medicare and private insurance fees in 2019, despite growth in Medicaid enrollment.
On February 3, 75 health advocacy groups called for Congress to prioritize H.R. 369, the Health Care Affordability Act of 2021 when considering additional COVID relief.
On February 4, the Medicaid and CHIP Payment and Access Commission (MACPAC) sent a letter to the chairs and ranking members of the Senate Finance and House Energy & Commerce Committees, noting concerns requiring congressional consideration and forthcoming Commission recommendations. In advance of its formal report, MACPAC argued in favor of enhanced federal matches for other services, beyond vaccine administration; proposed ways to address systemic racism and to make improvements to maternal mortality; and recommended that Congress enact an automatic countercyclical Medicaid financing adjustment to ensure that federal funds flow to Medicaid during economic downturns.
On February 4, McKinsey & Co. reached a $573 million agreement with 53 Attorney Generals to settle opioid related investigations of the company driving sales of Purdue Pharma’s OxyContin.
On February 4, the Partnership for America’s Health Care Future released a report entitled Economic Shocks and Probable Expansions to a Public Option. The report found that a public option is likely to evolve from a deficit-neutral program into an expensive entitlement program that will increase the federal debt or require higher taxes and concludes that it will likely not be politically feasible to pursue a budget-neutral public option.