Health Care Watch: February 1, 2021
The following Health Care Watch provides a summary of legislative and regulatory health care activities from January 25 - January 31. 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 January 25, House Appropriations Chair Rosa DeLauro (D-CT) announced the Democratic roster and respective chairs for the Appropriations Committee’s 12 subcommittees. Rep. Brenda Lawrence (D-MI) was selected to serve as Vice Chair of the full committee. Chair DeLauro will continue to Chair the Labor, Health & Human Services, Education, and Related Agencies Subcommittee that also includes: Lucille Roybal-Allard (D-CA), Barbara Lee (D-CA), Mark Pocan (D-WI), Katherine Clark (D-MA), Lois Frankel (D-FL), Cheri Bustos (D-IL), Bonnie Watson Coleman (D-NJ), Brenda Lawrence (D-MI), and Josh Harder (D-CA).
On January 28, House Appropriations Ranking Member Kay Granger (R-TX) announced the Republican roster and respective ranking members for the Appropriations Committee’s 12 subcommittees. Rep. Tom Cole (R-OK) will continue to be Ranking Member of the Labor, Health & Human Services, Education, and Related Agencies Subcommittee that also includes: Rep. Andy Harris (R-MD), Rep. Chuck Fleischmann (R-TN), Rep. Jaime Herrera Beutler (R-WA), Rep. John Moolenaar (R-MI), and Rep. Ben Cline (R-VA).
On January 25, the House transmitted the article of impeachment against former President Trump to the Senate. On January 26, 45 Republican senators unsuccessfully moved to dismiss the trial which is set to begin on February 9.
Senate
On January 25, the Senate confirmed Janet Yellen as Treasury Secretary. On January 26, the Senate confirmed Antony Blinken as Secretary of State.
Majority Leader Chuck Schumer (D-NY) and Minority Leader Mitch McConnell (R-KY) continue to negotiate a Senate organizational resolution. Schumer did not commit to maintaining the legislative filibuster, but Sens. Joe Manchin (D-WV) and Kyrsten Sinema (D-AZ) signaled to McConnell their commitment to keeping the filibuster. McConnell expressed his support for a power-sharing agreement modeled on the 2001 Senate agreement.
NON-CORONAVIRUS REGULATORY UPDATE
On January 26, Health Resources and Services Administration (HRSA) delayed the final rule entitled Implementation of Executive Order (EO) on Access to Affordable Life-Saving Medications until March 22, 2021, in accordance with the Biden Administration’s “regulatory freeze” memo. The rule would require health centers participating in the 340B program to make insulin and injectable epinephrine available to low-income patients or below the same price the health center paid through the 340B program.
On January 26, the Centers for Medicare & Medicaid Services (CMS) withdrew a series of proposed rules in accordance with the Biden Administration’s “regulatory freeze” memo including: Conditions for Coverage for End-Stage Renal Disease Facilities--Third Party Payments (CMS-3337), Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367), and Revisions to Medicare Part A Enrollments (CMS-4194)
On January 27, the Food and Drug Administration (FDA) hosted a series of meetings related to biosimilar review entitled Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act.
On January 29, the HHS OIG delayed the final “rebate rule” entitled Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees until March 22, 2021. The OIG indicated that the rule was delayed in accordance with the “regulatory freeze” memo and given the pending litigation related to the rule.
On January 29, the Labor Department Occupational Safety and Health Administration released workplace COVID-19 safety, in response to President Biden’s executive actions last week. The guidance recommends for workplaces to adopt COVID-19 prevention measures including separating and sending home infected or potentially infected people, implementing physical distancing, installing barriers where physical distancing cannot be maintained, and using face coverings. It also includes guidance on use of personal protective equipment, improving ventilation, providing supplies for good hygiene, and routine cleaning and disinfection.
The 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
On January 28, President Biden issued two Executive Orders (EOs) to re-open enrollment to the Health Insurance Marketplace, strengthen Medicaid and the Affordable Care Act (ACA), and protect women’s health.
EO on Strengthening Medicaid and the Affordable Care Act, which establishes a Special Enrollment Period for HealthCare.gov from February 15, 2021 – May 15, 2021. A fact sheet from CMS is available here. Under the EO, states must make the decision to open their respective state marketplaces, with Colorado, California, and Washington already announcing that they will reopen. The EO also tasks agency heads with reviewing then suspending, revising, or rescinding existing agency actions and other policies that limit Americans’ access to health care; and tasks agencies with considering actions to protect and strengthen access to health care.
Memorandum on Protecting Women’s Health at Home and Abroad, which directs Health & Human Services (HHS) to review and potentially rescind restrictive regulations under the Title X family planning program; revokes the Mexico City Policy; withdraws the U.S. from the Geneva Consensus Declaration; and resumes funding for the U.N. Population Fund and other global women’s health programs.
Press reports indicate that the Biden administration may be considering reversing guidance released at the end of the Trump administration entitled Announcement of Practice Guidelines for the Administration of Buprenorphine for Treatment Opioid Use Disorder due to concerns that HHS lacked the authority to issue guidelines that allowed physicians to avoid requirements mandated by Congress. The guidance eliminates the requirement that physicians registered to prescribe controlled substances obtain a “X” waiver” before being allowed to prescribe buprenorphine, to increase access to the opioid treatment.
The Biden Administration announced a series of appointments this week, including:
Nikki Budzinski for Office of Management & Budget (OMB) Chief of Staff;
Kacey Wulff for HHS Office of the Assistant Secretary for Preparedness and Response Chief of Staff; and
K. Sabeel Rahman for OMB Office of Information and Regulatory Affairs Senior Counselor.
CORONAVIRUS UPDATE
Legislative
On January 29, Reps. Annie Kuster (D-NH) and Larry Bucshon (R-IN) introduced the Immunization Infrastructure Modernization Act which would expand vaccination data-sharing between states, federal agencies, and health care providers.
On January 31, 10 Senate Republicans proposed a smaller COVID relief package to President Biden that includes:
$160 billion for vaccines, testing, treatment and personal protective equipment;
$4 billion for behavioral health and substance abuse services;
Targeted, direct relief checks;
Extended enhanced federal unemployment benefits;
Small business relief through the Paycheck Protection Program and the Economic Injury Disaster Loan Program; and
Support for school reopening plans.
The letter notes that not all funding from the previous economic relief package has been spend and calls for a smaller, targeted third COVID relief package.
Next week, the House and Senate are expected to consider budget resolutions that will allow for COVID relief legislation to move through the budget reconciliation process and only require 50 votes in the Senate to pass. This move, which eliminates the need to move a bipartisan bill, will likely afford an expedited timeline to consider President Biden’s relief plan.
Regulatory
On January 26, the National Institutes of Health launched the COVID-19 Neuro Databank/Biobank, a database to collect information on COVID-19-related neurological symptoms, complications, and outcomes, as well as COVID-19 effects on pre-existing neurological conditions.
On January 26, acting FDA Commissioner Janet Woodcock advocated for creating a new clinical trials network built into community practices to better prepare for future pandemics.
On January 26, HHS purchased an additional 200 million COVID-19 vaccine doses, 100 million doses from Moderna and Pfizer, respectively. President Biden also announced that states and other jurisdictions will receive 10 million doses per week for at least the next three weeks, an increase from 8.6 million per week. HHS will give states a three-week estimate of incoming vaccine supply, instead of a one-week outlook.
On January 28, HHS amended the Public Readiness and Emergency Preparedness Act, to allow recently retired or inactive doctors and nurses to administer COVID-19 vaccines and permit any licensed provider to administer shots in any state.
On January 27, the Office of Special Council reported to President Biden that the Office of the Assistant Secretary for Preparedness and Response misappropriated at least $25 to $26 million from the Biomedical Advanced Research and Development Authority for the use of vaccine and drug research, and public health emergencies, as recently as fiscal year 2019. The report also found that the Assistant Secretary for Preparedness and Response failed to account for $517.8 million in administrative expenses from 2007 to 2016.
On January 28, the Department of Defense announced that it is evaluating a Federal Emergency Management Agency request to help administer COVID-19 vaccines.
The Centers for Disease Control and Prevention (CDC) has identified the U.K. COVID-19 variant, B.1.1.7, in 12 states. The variant from South Africa was detected in South Carolina and the variant from Brazil was detected in Minnesota. There have been other COVID-19 variants detected in the U.K., South Africa, and Brazil.
As of January 29, more than 27 million people have received the first dose of COVID-19 vaccines (over 22 million have received both doses) and more than 49 million doses have been distributed, according to the CDC COVID Data Tracker. Alabama, Arizona, California, Hawaii, Idaho, Illinois, Kansas, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Nebraska, Ohio, Pennsylvania, and Wisconsin have all administered less than 50% of the vaccine doses they’ve received.
White House
On January 25, President Biden signaled his interest in speeding up vaccine distribution from 1 million vaccinations per day in his first 100 days to 1.5 million vaccinations per day. President Biden also indicated that he anticipates COVID-19 vaccines will be broadly available by spring.
On January 27, White House’s COVID-19 response team Senior Advisor Andy Slavitt indicated that under the Defense Production Act, President Biden may require drug manufacturers not currently making vaccines to produce Pfizer’s or Moderna’s vaccines.
On January 27, the White House COVID-19 Task Force released previously unreleased state COVID-19 profile statistics. The reports include numbers of COVID-19 cases, percentages of hospitals with staffing and supply shortages, and the most at-risk counties and localities.
Other
On January 28, Novavax announced that its COVID-19 vaccine is 89.3% effective in preventing COVID-19 in U.K. trials and 49.4% effective against the variant first identified in South Africa.
On January 29, Johnson & Johnson (J&J) announced that its one dose COVID-19 vaccine was 72% effective in the U.S. trial and 52% effective against the variant first identified in South Africa. The U.S. has pre-purchased 100 million doses of the vaccine, with an option to buy an additional 200 million doses.
On January 25, Merck announced that the company will stop developing their two COVID-19 vaccines after inadequate immune responses in Phase I trials. Merck will focus on research and production of the company’s two therapeutic candidates, MK-4482 and MK-7110.
On January 25 and 26, Moderna and Pfizer announced that their COVID-19 vaccines are effective against the COVID-19 variants from U.K. and in South Africa. Both companies found that their vaccines provide shorter term protection against the South Africa variant, so both companies indicated interest in developing booster shots for this strain.
On January 25, the World Health Organization released new guidance about Moderna’s COVID-19 vaccine, recommending against pregnant women from receiving the COVID-19 vaccine, except those at high risk of exposure or having a severe case. Moderna nor Pfizer’s COVID-19 vaccines have been recommended for pregnant women.
On January 25, the International Chamber of Commerce published a study suggesting that the monopolization of the COVID-19 vaccine supply may greatly impact wealthy countries’ economies, with losses totaling up to $9.2 trillion.
On January 26, the Bipartisan Commission on Biodefense published a report recommending creating the Apollo Program for Biodefense to detect and trace any new pathogens; distribute rapid point-of-person tests within days of detection; develop effective treatments; and support fast vaccine development and rollout.
On January 26, a study published in the Journal of Science found that a blood cancer drug, plitidepsin, is over 27 times more potent than remdesivir against COVID-19 in Phase II trials, promoting plitidepsin as a promising COVID-19 therapeutic.
On January 26, Regeneron announced positive initial results from the Phase III trial evaluating REGEN-COV, casirivimab and imdevimab antibody cocktail, for the prevention of COVID-19 for high risk individuals. The results found that REGEN-COV resulted in 100% prevention of symptomatic infection and approximately 50% lower overall rates of infection.
On January 26, Lilly released Phase III data finding that its COVID-19 antibody cocktail, bamlanivimab and etesevimab, significantly reduced COVID-19-related hospitalizations and deaths by reducing viral load and accelerating symptom resolution in high-risk COVID-19 patients.
On January 26, Pfizer announced it will deliver 200 million COVID-19 vaccine doses to the U.S. by the end of May, two months sooner than initially predicted.
On January 27, Lilly and GlaxoSmithKline announced intentions to evaluate combining the company’s respective COVID-19 therapies for low-risk patients with mild to moderate COVID-19. Lilly expanded clinical trials to include bamlanivimab in combination with VIR-7831 for the treatment of COVID-19.
On January 27, Sanofi agreed to produce the Pfizer COVID-19 vaccine to increase manufacturing capacity and capabilities and meet demand. On January 29, Novartis also agreed to produce the Pfizer COVID-19 vaccine.
On January 28, New York Attorney General Tish James released a report finding that the state’s count of COVID-19 deaths in nursing homes may have been underreported by as much as 50%.
On January 28, the Diabetes Leadership Council urged the National Governors Association to include type 1 diabetes patients in “high-risk groups” for state’s COVID-19 vaccine prioritization. The Council also submitted comments to the CDC’s Advisory Committee on Immunization Practices to include type 1 diabetes patients in vaccine guidance.
States are considering reallocating COVID-19 vaccines from nursing homes and other long-term care facilities through a federal program, because health officials are reporting that vaccines are going unused.
As of January 30, the U.S. had 26,032,572 confirmed COVID-19 cases resulting in 438,708 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
Pending Review
HHS-CDC
Requirement for Persons to Wear Masks While on Conveyances and at Stations, Ports, or Similar Transportation Hubs; Notice; Received 1/26/21
Temporary Halt in Residential Eviction to Prevent the Further Spread of COVID-19; Notice; Received 1/26/21
REPORTS
HHS Office of Inspector General (OIG)
On January 28, OIG released a report entitled Massachusetts Made at Least $14 Million in Improper Medicaid Payments for the Nonemergency Medical Transportation (NEMT) Program. The report found that Massachusetts claimed Federal Medicaid reimbursement for some lines of service submitted by transportation providers that did not comply with certain Federal and State requirements and lines of service often did not have proper driver qualifications and vehicle inspection, registration, and maintenance policies or schedule documentation, resulting in $14,142,730 in improper payments. OIG recommended that Massachusetts Executive Office of Health and Human Services should refund improper payments, perform data matches to ensure only NEMT claims are paid when there is a corresponding qualifying medical service, work with brokers to ensure proper documentation, evaluate opportunities to better monitor transportation services, and work brokers to implement controls to better trace driver qualifications and vehicle records. A summary is available here.
On January 28, OIG released a report entitled California Claimed at Least $2 Million in Unallowable Medicaid Reimbursement for a Selected Provider's Opioid Treatment Program Services. The report found that California did not claim Medicaid reimbursement for the selected provider's opioid treatment program (OTP) services in accordance with Federal and State requirements, resulting in at least $2.4 million in improper payments, and there was a lack of oversight. OIG recommended that California refund the unallowable OTP payments, ensure that providers comply with Federal and State requirements for providing and claiming reimbursement for OTP services, verify corrective action plans, perform post-payment reviews to identify disallowances for OTP services that did not comply with State requirements, and work with providers to improve the quality of care provided to beneficiaries by correcting deficiencies. A summary of the report is available here.
On January 29, OIG released a report entitled Louisiana Did Not Correctly Determine Medicaid Eligibility for Some Newly Enrolled Beneficiaries. The report found that Louisiana made improper Medicaid payments on behalf of some beneficiaries who met eligibility requirements for the new adult group, resulting in $20.1 million in improper payments. OIG recommended that Louisiana provide notice and cancel ineligible beneficiaries, educate State analysts on established policies and procedures regarding requirements regarding eligibility, income, and provide retroactive eligibility, and redetermine Medicaid eligibility for beneficiaries who do not meet Federal and State requirements. A summary of the report is available here.
Government Accountability Office (GAO)
On January 28, GAO released a report entitled COVID-19: Critical Vaccine Distribution, Supply Chain, Program Integrity, and Other Challenges Require Focused Federal Attention. The reported noted that GAO’s 31 previous recommendations remained unimplemented and proposed additional recommendations, including:
Develop and make public a comprehensive national COVID-19 testing strategy;
Establish a time frame for documenting and sharing a national plan for distributing and administering COVID-19 vaccines;
Outline an approach for how efforts would be coordinated across federal agencies and nonfederal entities;
Establish a process for regularly engaging with Congress and nonfederal stakeholders as the supply chain strategy for pandemic preparedness changes;
Ensure drug manufacturing data are complete and accessible;
Establish an expert committee comprised of knowledgeable health care professionals from the public and private sectors, academia, and nonprofits to systematically review and inform the alignment of ongoing data collection and reporting standards for key health indicators;
Ensure that inspection plans for future fiscal years identify, analyze, and respond to the issues presented by the backlog of inspections that could jeopardize its goal of risk-driven inspections, and assess alternative inspection tools; and
Accurately report data in the federal procurement database system and provide information that would allow the public to distinguish between spending on other transaction agreements and procurement contracts.
A summary of the report is available here.
UPCOMING HEARINGS
Senate
None of note.
House
None of note.
OTHER HEALTH POLICY NEWS
On January 25, the Federal Trade Commission filed a lawsuit against Endo International and Impax Laboratories claiming that the companies violated antitrust laws through an agreement that eliminated competition for the pain medicine oxymorphone ER.
On January 25, the Colorado Department of Health Care Policy and Financing issued an “Invitation to Negotiate” to solicit contractors to help develop Colorado's Canadian Drug Importation Program. The bid deadline is April 26.
On January 25, 116 health groups urged HHS Secretary nominee Xavier Becerra to rescind Medicaid work and community engagement requirements in states with pending waivers.
On January 27, the Urban Institute released a report entitled Medicaid Expansion Would Have a Larger Impact Than Ever during the COVID-19 Pandemic. The report found that if the remaining 14 states that have not yet expanded Medicaid had expanded eligibility in 2020, 4.4 million fewer people would have been uninsured that year. Even without the COVID-19 pandemic, the difference would have been 3.8 million.
On January 27, 29 substance abuse advocates called for HHS Secretary nominee Becerra and Acting HHS Secretary Norris Cochran to oppose Dr. Janet Woodcock as FDA Commissioner due to her participation in the “agency failures” during the opioid crisis.
On January 27, the RAND Corporation released a report finding U.S. prices for prescription drugs are more than 256% higher than 32 other countries. The report identified that most brand-name drug prices were higher than those in comparison countries. Unbranded generic drugs prices were on average 84% of those in other countries.
On January 27, 31 professional and advocacy organizations released a set of principles to encourage state and local governments to use opioid settlement funds to support evidence-based efforts to help people with substance use disorders and not to fill holes in their budgets.
On January 27, Protect Our Care released a report with recommendations of policies to include in the next COVID-19 relief bill to increase coverage, lower costs, strengthen protections, and address inequities. The report advocated for passing the Patient Protection and Affordable Care Enhancement Act, giving Medicare the ability to negotiate for lower drug prices, passing Biden’s American Rescue Plan, and reversing measures implemented during the Trump Administration that reduced health care access and coverage.
On January 27, Missouri Governor Mike Parson released the state’s budget funds, which estimates that Medicaid expansion will add $1.9 billion to the state budget, without cuts to other needs. In 2020, Missouri voted to expand Medicaid.
On January 27, the Oklahoma Health Care Authority Board voted in support of plans to spend up to $2.2 billion to privatize the state’s Medicaid program.