Health Care Watch: December 21, 2020
The following Health Care Watch provides a summary of legislative and regulatory health care activities from December 14 - December 20. 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.
BIDEN TRANSITION
On December 14, the Electoral College formalized the 2020 Presidential election results, confirming Joe Biden as the 46th president of the U.S. in a 306-232 vote.
Biden announced a series of appointments and nominations this week, including:
Alejandro Mayorkas for Homeland Security Secretary;
Pete Buttigieg for Transportation Secretary;
Former Governor Jennifer Granholm (D-MI) for Energy Secretary;
Former EPA Director Gina McCarthy for White House Office of Domestic Climate Policy Chief;
Michael Regan for Environmental Protection Agency Administrator; and
Rep. Deb Haaland (D-NM) for Interior Secretary.
Biden and incoming First Lady Jill Biden will receive the Pfizer COVID-19 vaccine in public on December 21.
NON-CORONAVIRUS LEGISLATIVE UPDATE
Senate
On December 14, Finance Ranking Member Ron Wyden (D-OR) urged Chairman Chuck Grassley (R-IA) to begin reviewing the incoming administration’s nominations, specifically Janet Yellen for Treasury Secretary and Xavier Becerra for Health & Human Services (HHS) Secretary, so that the department heads are in place to immediately begin work after inauguration.
House
On December 20, the House approved a one-day continuing resolution (CR) that gives Congress time to avoid a government shutdown and put the finishing touches on a $900 billion coronavirus relief agreement that is expected to pass with the $1.4 trillion annual government funding measure. Both chambers are expected to vote on the package on December 21. Earlier on December 11 and December 18, Congress passed two short-term CRs to avert shutdowns as they worked on a COVID-19 relief bill. The package includes (but is not limited to) the following priorities:
$286 billion in direct economic relief for workers and families (including up to $600 in direct payments per adult and child);
$325 billion for small business;
$12 billion for support for community development financial institutions and minority depository institutions;
$45 billion for transportation;
$69 billion for vaccines, testing and tracing, community health and provider support;
$82 billion for schools;
$25 billion for rental assistance;
$26 billion for nutrition and agriculture;
$10 billion for child care; and
$7 billion for broadband.
The package also includes an agreement to protect patients from receiving “surprise” medical bills. Earlier in the week on December 14, 27 bipartisan senators urged Majority Leader Mitch McConnell (R-KY) and Democratic Leader Chuck Schumer (D-NY) to include surprise billing legislation in the year-end spending bill. A summary of the bipartisan, bicameral surprise billing legislation is available here.
On December 17, the Oversight & Reform Committee held a hearing entitled Purdue Pharma's Role in the Opioid Epidemic. The Sackler family refused to acknowledge personal wrongdoing or responsibility in contributing to the opioid crisis. Witnesses included: Mortimer Sackler, Richard Sackler, David Sackler, and Kathe Sackler; as well as Craig Landau, President, CEO, Purdue Pharma.
NON-CORONAVIRUS REGULATORY UPDATE
On December 14, Centers for Medicare & Medicaid Services (CMS) issued a notice seeking public comment on a new Review Choice Demonstration for Inpatient Rehabilitation Facility (IRF) services. The demonstration aims to develop improved methods for the identification, investigation, and prosecution of potential Medicare fraud, and ensure the right payments are made at the right time for IRF services through either pre-claim or post-payment review. The demonstration would incorporate flexibility and choice for IRFs, as well as risk-based options to reward IRFs who demonstrate compliance with Medicare IRF policies. CMS plans to implement the demonstration in Alabama, and then expand to California, Pennsylvania, and Texas. The demonstration would begin in 2021. A summary of the report is available here. Comments are due on February 16, 2021.
On December 14, a myriad of federal departments issued a joint final rule entitled Equal Participation of Faith-Based Organizations in the Federal Agencies’ Programs and Activities. The rule implements the 2018 Executive Order (EO) 13831, the Establishment of a White House Faith and Opportunity Initiative, ensuring that faith-based and secular organizations are treated equally in HHS-supported programs and clarifies that faith-based organizations do not lose their legal protections and rights when they participate in federal programs and activities. A summary of the rule is available here.
On December 14, the Special Interest Group for Inventory Information Approval System Standards (SIGIS) approved the Trump Administration’s plan to provide $200 in drug discount cards to Medicare beneficiaries. The panel’s approval is essential for mass-producing millions of cards that work at retail locations. SIGIS had previously indicated that the Administration’s plan did not meet the requisite standards. Reports indicate that the Administration is still grappling with operational concerns related to issuance of the cards.
On December 14, 29 state Attorney Generals (AG), including California AG and Biden’s HHS Secretary nominee Xavier Becerra, urged HHS to address some drug manufacturers’ refusal or threat of refusal to provide 340B Drug Pricing Program discounts to contract pharmacies. The letter calls for HHS to determine that drug manufacturers are in violation of 340B requirements. This letter follows a lawsuit filed on December 11 by a series of hospital associations against HHS for not properly enforcing 340B drug discount requirements.
On December 14, the White House Office of Management & Budget (OMB) received a final rule from CMS entitled Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" (CMS-3372).
On December 16, the Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics released preliminary data finding that annual drug overdose deaths reached 81,230 between June 2019 and May 2020, the highest number of drug overdose deaths over a 12 month period ever recorded.
On December 15, HealthCare.gov open enrollment closed except for 10 states and the District of Columbia whose marketplaces remain open. Most of the state-based marketplaces do not close until early to mid-January. Over 8.2 million people selected plans through HealthCare.gov during the open enrollment period.
On December 16, the CMS Office of the Actuary published a study in Health Affairs entitled National Health Care Spending In 2019: Steady Growth For The Fourth Consecutive Year. The report found that total national healthcare spending grew 4.6%, reaching $3.8 trillion in 2019 and the share of the economy devoted to health spending held stable. The study also found that personal health care spending accounted for 84% of total health care spending in 2019 and increased 5.2%, a faster rate than the 4.1% it increased in 2018, though the net cost of health insurance declined 3.8%. Comparing types of health insurance, while private health insurance spending increased at a slower rate than 2018, Medicare spending grew at a faster rate than 2018, and Medicaid spending increased 2.9% in 2019, to $613.5 billion.
On December 17, HHS announced it will cut $200 million in federal Medicaid funding each quarter from California over the state’s policy mandating all California health care plans cover abortion without exclusion or limitation. The penalty begins Q1 of 2020.
On December 17, the HHS Office for Civil Rights released the 2016-2017 Health Insurance Portability and Accountability Act of 1996 (HIPAA) Audits Industry Report, reviewing selected health care entities and business associates for compliance with certain provisions of the HIPAA Privacy, Security, and Breach Notification Rules.
On December 17, CMS published the Long-Term Care Hospital CARE December 2020 Data Set and Inpatient Rehabilitation Facility Patient Assessment Instrument Quarterly Q&As.
On December 17, OMB concluded its review of a final rule from HRSA entitled Implementation of EO 13937, EO on Access to Affordable Life-saving Medications.
On December 17, the CMS Center for Medicare & Medicaid Innovation announced a new Direct Contracting Model entitled Professional and Global Options Medicaid Managed Care Organization (MCO)-based Direct Contracting Entity for dual eligible beneficiaries. This model coordinates Medicare and Medicaid services through Medicaid MCOs to improve health outcomes for dually eligible beneficiaries. A fact sheet on the model is available here.
On December 17, the Department of Justice reached a $22 million settlement with Biogen to resolve claims that it illegally used charity donations as kickbacks to cover out-of-pockets costs of Medicare patients taking Biogen’s multiple sclerosis drugs, Avonex and Tysabri.
On December 18, the HHS Office for Civil Rights issued guidance on how HIPAA permits covered entities to use health information exchanges to disclose protected health information for the public health activities of a public health authority.
The Food & Drug Administration (FDA) will host a meeting entitled Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act on January 27, 2021.
NON-CORONAVIRUS WHITE HOUSE UPDATE
None of note.
CORONAVIRUS UPDATE
Legislative
On December 14, 18 Senate Democrats asked Operation Warp Speed (OWS) about reports that the government declined to purchase additional doses of the Pfizer COVID-19 vaccine earlier this year. The senators asked for more transparency around OWS vaccine preparations and how much funding is available, and is needed, to purchase, distribute, and administer COVID-19 vaccine.
On December 19, Sen. McConnell received Pfizer’s COVID-19 vaccine.
As discussed above, on December 21, both chambers are expected to vote on a $900 billion COVID-19 relief agreement that is expected to pass with the $1.4 trillion annual government funding measure.
Regulatory
On December 18, the FDA authorized Moderna’s COVID-19 vaccine for emergency use. Earlier in the week, on December 15, the FDA Vaccines and Related Biological Products Advisory Committee released early meeting documents and on December 17, the Committee voted 20-0 with one member abstaining, to endorse the widespread use of the vaccine for adults 18 and over. HHS Secretary Alex Azar said 5.9 million Moderna vaccine doses are ready to ship nationwide.
On December 14, states began receiving Pfizer’s COVID-19 vaccine and distributing the vaccine to health care providers. Federal health officials expected 145 sites across all states to have received the COVID-19 vaccine shipments by December 14, 425 sites by December 15, and the remaining 66 by December 16. CVS and Walgreens began administering COVID-19 vaccines in nursing homes on December 18. On December 16, two Alaskan health workers experienced serious allergic reactions to the Pfizer vaccine, the first adverse effect from the vaccine reported in the U.S.
On December 14, OWS Chief Advisor Moncef Slaoui predicted that the U.S. could see Johnson & Johnson's (J&J) and AstraZeneca’s COVID-19 vaccine seek Emergency Use Authorization (EUA) by February. J&J could see the first results in the beginning of January and AstraZeneca’s could see results in the second half of January.
On December 15, CMS updated its Medicare coding and payment for COVID-19 vaccines, following the EUA of Pfizer’s COVID-19 vaccine.
On December 15, CMS and Internal Revenue Service (IRS) temporarily suspended action to take health care benefits away from individuals impacted by tax processing delays until early 2021. Due to IRS processing delays, some Americans were not able to register and qualify for advanced premium tax credits to lower monthly health insurance premiums.
On December 15, the FDA issued an EUA for Ellume’s COVID-19 Home Test, a rapid, over-the-counter, fully at-home antigen diagnostic test for COVID-19.
On December 15, HHS Secretary Azar predicted that most Americans will be able to receive a COVID-19 vaccine between the end of February and the end of March, though the timeline is dependent on the approval of other company’s vaccines.
On December 15, the Centers for Disease Control & Prevention (CDC) awarded $140 million for vaccine preparedness, and $87 million for COVID-19 tracking and testing to all 50 states.
On December 16, the FDA issued an EUA for the BinaxNOW COVID-19 Ag Card Home Test, a prescription at home rapid COVID-19 diagnostic test. The test is priced at $25.
On December 16, the Health Resources and Services Administration (HRSA) awarded$24.5 billion to over 70,000 providers from Phase 3 of the Provider Relief Fund (PRF).
On December 16, the HHS Office of the Assistant Secretary for Health and the HHS Office of the Chief Information Officer selected 16 winning designs from the HHS COVID-19 At-Anywhere Diagnostics Design-a-thon, a project created to increase speed, quality, comprehensiveness, and utility of COVID-19 diagnostic test data.
On December 16, pharmacists discovered that Pfizer’s COVID-19 vaccine vials hold a sixth or seventh dose, rather than the five doses, as advertised. The FDA has yet to release official guidance allowing extra doses to be used but the agency told state vaccine providers to use “full dose obtainable,” potentially increasing supply by up to 40%.
On December 16, Abbott received FDA Emergency Use Authorization (EUA) for an at-home virtually guided rapid COVID test.
On December 17, the National Institutes of Health (NIH) began two Phase III clinical trials to evaluate VIR-7831, a monoclonal antibody developed by GlaxoSmithKline and Vir Biotechnology, and the combination of BRII-196 and BRII-198, two neutralizing monoclonal antibodies manufactured by Brii Biosciences, to treat people hospitalized with moderate COVID-19.
White House
On December 15, White House Press Secretary Kayleigh McEnany announced that the Administration is attempting to secure an additional 100 million doses of Pfizer’s COVID-19 vaccine in Q2 2021. The Administration is negotiating with Pfizer to increase access to raw materials to produce more COVID-19 vaccines faster by ordering vaccine material suppliers to prioritize Pfizer’s orders.
On December 18, Vice President Mike Pence, Second Lady Karen Pence, and Surgeon General Jerome Adams received Pfizer’s COVID-19 vaccine. President Trump tweeted that he is “not scheduled to take the vaccine, but look[s] forward to doing so at the appropriate time” and has reversed the decision to vaccinate White House staff early.
Other
On December 14, Russia’s Gamaleya National Research Center for Epidemiology and Microbiology announced that the Russian COVID-19 vaccine, Sputnik V, was over 90% effective at preventing COVID-19.
On December 14, the Kaiser Family Foundation (KFF) released a report entitled How are States Prioritizing Who Will Get the COVID-19 Vaccine First? The report identified that all states have released updated prioritization criteria for Phase 1 distribution of the COVID-19 vaccine, following the CDC’s Advisory Committee on Immunization Practices (ACIP) deliberations and guidance. Most states are following ACIP’s Phase 1a recommendation and the majority of states are still developing criteria for subsequent Phase 1 prioritization, but there are already some differences from ACIP’s preliminary framework.
On December 14, Walgreens and CVS predicted that they would have COVID-19 vaccines available for the general public in early spring.
On December 15, KFF launched the KFF Covid-19 Vaccine Monitor and found that confidence surrounding COVID-19 vaccines has increased to 71% from 63% in September. 27% of the public remain vaccine hesitant due to possible side effects, lack of trust in the government to ensure the vaccines’ safety and effectiveness, concerns that the vaccine is too new, and concerns over the role of politics in the development process.
On December 15, the American Hospital Association, American Medical Association (AMA), and American Nurses Association (ANA) urged all health care professionals to take the COVID-19 vaccine.
On December 15, a study published in The BJM entitled Reserving coronavirus disease 2019 vaccines for global access: cross sectional analysis found that half of COVID-19 doses will go to high income countries, which represent 14% of the world’s population. Access to COVID-19 vaccines for low- and middle-income countries remains uncertain and dependent on high income countries scaling-up vaccine production and if high income countries share what they have procured.
On December 15, Pfizer announced that health care workers who participated in the company’s vaccine clinical trials and received the placebo are able to receive the vaccine, while continuing to be part of the trial.
On December 16, the California COVID-19 Vaccine Advisory Committee released the state’s next COVID-19 vaccine distribution priority list, including those in education and child care settings, emergency services, and the food and agricultural sectors.
On December 17, AstraZeneca announced that the COVID-19 vaccine candidate, AZD1222, two full-dose regime has a better immune response rather than a full-dose followed by a half-dose booster. After Phase III data initially showed efficacy was 90% for a half, then a full dose regime, AstraZeneca cited early trial data supported a two full-dose regime.
On December 18, Beckman Coulter launched a rapid point-of-care antigen test it will offer for $4. The company has not yet received emergency authorization.
On December 18, the AMA, ANA, and seven other medical groups called for governors, health departments, and hospitals to implement Crisis Standards of Care during the current COVID-19 surge.
On December 18, COVAX announced the organization has access to nearly two billion doses of COVID-19 vaccine candidates, on behalf of 190 participating countries, giving participating countries access to doses in the first half of 2021.
On December 18, the KFF released a report entitled Gaps in Cost Sharing Protections for COVID-19 Testing and Treatment Could Spark Public Concerns About COVID-19 Vaccine Costs. The report identified that regulatory loopholes have led to out-of-pocket costs for some people pursuing COVID-19 testing and there is a lack of comprehensive protections against out-of-pocket costs for COVID-19 treatment. KFF emphasized the importance of making sure that experiences with unexpected costs for COVID-19 testing or treatment do not deter people from getting vaccinated.
On December 20, the CDC ACIP held a meeting to discuss COVID-19 vaccine distribution priority groups. The panel voted 13-1 to recommend that next in line for limited supplies of COVID-19 vaccines should be people 75 and older and essential frontline workers including cops and firefighters, food workers, public transit and postal workers, among others (Group 1b), followed by remaining seniors under 75, other essential workers and people between the ages of 16-64 with high-risk conditions (Group 1c).
As of December 19, the U.S. had 17,805,599 confirmed COVID-19 cases resulting in 317,387 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
Pending Review
HHS-CMS
Conditions for Coverage for End-Stage Renal Disease Facilities-Third Party Payments (CMS-3337-P); Received 6/6/19
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; Received 2/18/20
Revisions to Medicare Part A Enrollments (CMS-4194) Proposed Rule; Received 9/9/20
Contract Year 2022 Policy and Technical Changes to the MA Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and PACE (CMS-4190); Final Rule; Received 9/28/20
Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value Based Payments (VBP) for Drugs Covered in Medicaid (CMS-2482); Final Rule; Received 12/7/20
Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" (CMS-3372); Final Rule; Received 12/14/20
HHS-IHS
Calendar Year 2021 Reimbursement Rates; Notice; Received 12/2/20
REPORTS
HHS Office of Inspector General (OIG)
On December 16, OIG released a report entitled Opioids in Medicaid: Concerns About Opioid Use Among Beneficiaries in Six Appalachian States. The report found that Medicaid beneficiaries across the six Appalachian States are at risk for opioid misuse or overdose, and the COVID-19 pandemic may be putting Medicaid beneficiaries at greater risk of opioid misuse or overdose in 2020 and beyond. OIG noted that measures taken to address the COVID-19 pandemic may have contributed to the dramatic increases in opioid-related overdoses and deaths in these States since the start of the pandemic. OIG committed to fighting the opioid crisis and protecting beneficiaries from prescription drug abuse and misuse by working with law enforcement partners to bring resources and expertise to these six States through the Appalachian Regional Prescription Opioid Strike Force. A summary of the report is available here.
On December 16, OIG released a report entitled Medicare Home Health Agency Provider Compliance Audit: Total Patient Care (TPC) Home Health, LLC. The report found that TPC did not always comply with Medicare billing requirements and incorrectly billed Medicare for services provided to beneficiaries who were not homebound or did not require skilled services, resulting in an estimated $1.7 million in overpayments. OIG recommended that TPC identify, report and return any overpayments, and strengthen its procedures to ensure that the homebound statuses of Medicare beneficiaries are verified and continually monitored and the specific factors qualifying beneficiaries as homebound are documented and beneficiaries are receiving only reasonable and necessary skilled services. A summary of the report is available here.
On December 18, OIG released a report entitled Medicare Hospital Provider Compliance Audit: Providence Medical Center. The report found that the Providence Medical Center did not fully comply with Medicare billing requirements for the remaining 13 claims, resulting in an estimated $325,241 in overpayments. OIG recommended that the hospital refund to the Medicare contractor the estimated overpayments; exercise reasonable diligence to identify, report, and return any overpayments; and strengthen controls to ensure full compliance with Medicare requirements. A summary of the report is available here.
OIG announced December OIG report topics.
Government Accountability Office (GAO)
On December 14, the GAO released a report entitled Drug Pricing Program: HHS Uses Multiple Mechanisms to Help Ensure Compliance with 340B Requirements. The report found that participation in the 340B Program has grown to 12,700 covered entities in 2020, from 9,700 in 2010. GAO also found that beginning in fall 2019, HRSA started issuing findings only when audit information presents a clear and direct violation of the requirements outlined in the 340B Program statute, arguing that the agency does not have enforcement authority beyond clear statutory violations. HRSA officials reported that since the 340B statute does not address contract pharmacy use, the agency is unable to determine whether drug companies failed to comply with guidance related to contract pharmacies. A summary of the report is available here.
On December 14, the GAO released a report entitled Substance Use Disorder: Reliable Data Needed for Substance Abuse Prevention and Treatment Block Grant Program. The report found that the number of substance use disorder (SUD) treatment facilities and services increased since 2009, but potential gaps in treatment capacity remain. GAO found that Substance Abuse and Mental Health Services Administration (SAMHSA) lacks consistent and relevant reliable data for the number of individuals served under the Substance Abuse Prevention and Treatment Block Grant (SABG) program. Though the agency plans to implement data quality improvements starting in FY 2021, it has not identified specific changes needed to improve the information it collects on individuals served. GAO recommended that SAMHSA identify and implement changes to the SABG program's data collection efforts to improve the consistency and relevance of data collected on individuals served. A summary of the report is available here.
On December 16, the GAO released a report entitled Medicaid Long-Term Services and Supports: Access and Quality Problems in Managed Care Demand Improved Oversight. The report found significant problems in State Medicaid managed long-term services and supports (MLTSS) programs with managed care organization (MCO) performance of care management. GAO found that CMS oversight of state implementation of its 2016 requirements, and of access and quality in MLTSS, was limited, hindering the agency's ability to hold states and MCOs accountable for quality and access problems beneficiaries may face. GAO identified that current CMS oversight mechanisms were not sufficient at detecting quality and access problems, and the lack of an oversight strategy risks the Agency being unable to identify and help address problems facing beneficiaries. GAO recommended that CMS develop a national strategy for overseeing MLTSS, and assess the nature and prevalence of MLTSS quality and access problems across states. A summary of the report is available here.
Congressional Budget Office (CBO)
On December 14, the CBO released a report entitled The Accuracy of CBO’s Budget Projections for Fiscal Year 2020. The report found that the CBO’s projections for revenues and outlays were too low, underestimating federal revenues by 9% and spending by 3%. The federal deficit for FY 2020 is $3.14 trillion, which is lower than the predicted $3.25 trillion deficit. A summary of the report is available here.
On December 15, the CBO released a report entitled Federal Net Interest Costs: A Primer. The report found that in FY 2020, the government’s net outlays for interest was $345 billion, which is equal to 1.6% of gross domestic product and accounts for 5.3% of total spending. Although the federal government has increased its borrowing from the public by $12 trillion in the past 10 years, net annual outlays for interest rose by $149 billion because interest rates fell to historically low levels. A summary of the report is available here.
Congressional Research Service (CRS)
On December 14, the CRS released a report entitled Issues Raised by a Federal Government Shutdown: Grants to State and Local Governments and the COVID-19 Pandemic. The report identified disruptions to grant administration activities if Congress and the President fail to pass the regular annual appropriations acts, including: delays in state Coronavirus Aid, Relief, and Economic Security (CARES) Act funding technical assistance, delays in awarding new grants and renewing existing awards, and delays in payments for existing grant awards.
UPCOMING HEARINGS
Senate
None of note.
House
None of note.
OTHER HEALTH POLICY NEWS
On December 14, the Urban Institute released a report entitled The Effects of Medicare Buy-In Policies for Older Adults on Health Insurance Coverage and Health Care Spending. The report found that a Medicare buy-in policy that targets adults 50 to 64 would not exceed 3 million in new enrollees, even for policies creating more generous subsidies than the Affordable Care Act. The Urban Institute estimated that buy-in policies can result in savings to national health spending overall because of lower provider payment rates and increases in federal spending shifting dollars from private payers to public payers. A summary of the report is available here.
On December 15, the AMA sent a letter to Congressional leaders opposing surprise billing legislation in the end of the year spending package, due to the bill’s potential to disadvantage physician practices that may not have the resources to participate in the Independent Dispute Resolution process.