The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from December 7 - December 13. 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 8, President-elect Joe Biden announced a three-part plan to administer 100 million COVID-19 vaccines, reopen schools, and require people to wear masks on interstate transportation and in federal buildings during his first 100 days in office.
An October document from the Cost Containment and Value Healthcare Delivery Reform Advisory Committee was leaked indicating the Biden Administration may be interested in accelerating the shift to value-based payment models, increasing access to primary care, and changing the way Medicare pays for primary care to a blended capitation and fee-for-service payment model.
Biden announced a series of appointments and nominations this week, including:
Susan Rice as the Domestic Policy Council Director. Rice served as the former United Nations ambassador and former National Security Advisor during the Obama Administration;
Rochelle Walensky for Centers for Disease Control & Prevention (CDC) Director;
Former Rep. Xavier Becerra (D-CA) for Health & Human Services (HHS) Secretary;
Gen. Lloyd Austin for Department of Defense (DoD) Secretary;
Denis McDonough for Veterans Affairs Secretary; and
Rep. Marcia Fudge (D-OH) for Housing & Urban Development Secretary.
NON-CORONAVIRUS LEGISLATIVE UPDATE
House
On December 9, the House passed (343-67) H.R. 8900, the Fiscal Year (FY) 2021 One-Week Continuing Resolution, to extend government funding until December 18. The bill would avert a government shutdown and give members more time to negotiate an omnibus spending bill and potential COVID-19 relief package. On December 11, the Senate also passed the bill by voice vote.
On December 11, Sens. Michael Bennet (D-CO) and Tim Kaine (D-VA) sent a letter to Biden and Vice President-elect Kamala Harris urging the incoming Administration to enact a public option through the ACA marketplaces.
On December 11, leaders from the House Committees on Energy & Commerce, Ways & Means, and Education & Labor and the Senate HELP Committee announced an agreement on surprise billing legislation. The committee leaders are requesting stakeholder feedback on the policy with the hopes it will be signed into law before Congress adjourns.
Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) indicated interest in pursuing additional legislation to build on the 21st Century Cures Act and make new treatments more accessible to more patients.
Senate
On December 10, Sens. John Boozman (R-AR), Kevin Cramer (R-ND), Cindy Hyde-Smith (R-MS), Tom Cotton (R-AR), and Susan Collins (R-ME) introduced legislation The Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020, that would reverse scheduled Medicare Physician Fee Schedule payment cuts for 2021 and 2022. The bill mirrors similar legislation introduced in the House by Reps. Ami Bera (D-CA) and Larry Bucshon (R-IN).
NON-CORONAVIRUS REGULATORY UPDATE
On December 7, the White House Office of Management & Budget (OMB) received a final rule from Centers for Medicare & Medicaid Services (CMS) entitled Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value Based Payments (VBP) for Drugs Covered in Medicaid (CMS-2482).
On December 7, OMB concluded its review of a final rule from CMS entitled 340B Drug Pricing Program; Administrative Dispute Resolution.
On December 9, CMS released the December 2020 quarterly refresh of Long-Term Care Hospital and Inpatient Rehabilitation Facilities Quality Reporting Programs from 2019. The annual update of the claims-based measures data and CDC infections measures from FY18 through FY19 are also available.
On December 9, CMS announced that 915,118 people selected plans through HealthCare.gov during the third week of enrollment, including 256,299 new enrollees. Thus far, 3,818,665 enrollees have selected plans through HealthCare.gov since enrollment opened on November 1.
On December 9, CMS released the Calendar Year (CY) 2022 Request for Applications for the Value-Based Insurance Design Model (VBID), including the CY 2022 for the Hospice Benefit Component of the VBID Model. Applications are due by April 16, 2021.
On December 10, HHS issued a notice of proposed rulemaking entitled Proposed Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement. The rule aims to support individuals’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the health care industry. The proposed changes address burdens that impede the transition to value-based health care by increasing care coordination and case management communications, while protecting patient privacy. A summary of the rule is available here.
On December 10, the Health Resources & Services Administration (HRSA) issued a final rule entitled 340B Drug Pricing Program; Administrative Dispute Resolution Regulation. The rule establishes a 340B Administrative Dispute Resolution Board to resolve 340B Program-related disputes.
On December 10, CMS issued a proposed rule entitled Reducing Provider and Patient Burden, and Promoting Patients' Electronic Access to Health Information to reduce provider and patient burden and improve the prior authorization processes, as well as promoting patient’ electronic access to health information. The rule would place new requirements on Medicaid and CHIP managed care plans, state Medicaid and CHIP fee-for-service programs, and Qualified Health Plans issuers on the Federally-facilitated Exchanges to improve the electronic exchange of health care data, and streamline processes related to prior authorization. The rule also requires increased patient electronic access to their health care information. Comments are due by January 4, 2021. If enacted as proposed, the policies will be effective January 1, 2023. A summary of the rule is available here. A fact sheet of the rule is available here. CMS Administrator Seema Verma’s blog post on the rule is available here.
On December 11, HHS issued a final rule entitled Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage. The rule provides greater flexibility for certain grandfathered health plans to make changes to certain types of fixed amount cost-sharing requirements without causing a loss of grandfather status under the Affordable Care Act (ACA). The rule will take effect January 11.
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
On December 9, it was reported that the White House has put together a revised plan to follow through on President Trump’s campaign promise to provide $200 in drug-discount cards to Medicare beneficiaries before he leaves office. However, the plan was recently determined to not meet the standards of the Special Interest Group for Inventory Information Approval System Standards (SIGIS), a consortium that develops standards to support Internal Revenue Service requirements for certain transactions that access FSA/HRA, and HSA accounts. The panel’s approval is essential for mass-producing millions of cards that work at retail locations.
CORONAVIRUS UPDATE
Legislative
On December 7, Sen. Josh Hawley (R-MO) called for President Trump to veto any relief package that does not contain direct relief payments to Americans. Sen. Bernie Sanders (I-VT) is working with Hawley to include direct relief payments in an omnibus spending bill and threatened to force a government shutdown if the payments are not included.
On December 7, Senate Homeland Security & Governmental Affairs Committee Ranking Member Gary Peters (D-MI) urged HHS Secretary Alex Azar and DoD Acting Secretary Christopher Miller to ensure that the distribution of COVID-19 vaccines is well coordinated between the federal and state level. Peters highlighted the recent GAO study that identified supply chain vulnerabilities and disruptions that may impact COVID-19 vaccination efforts. Peters also emphasized the need to instill public confidence in vaccines and the need to support states in vaccine delivery efforts, logistically and financially.
December 8, the Homeland Security & Governmental Affairs Committee held a hearing entitled Early Outpatient Treatment: An Essential Part of a COVID-19 Solution, Part II. Sen. Peters called to pass bipartisan legislation that provides financial relief to families, states, and small businesses. Witnesses included: Jane Orient, M.D., Executive Director, Association of American Physicians and Surgeons; Pierre Kory, M.D., Associate Professor of Medicine, St. Luke's Aurora Medical Center; Jean-Jacques Rajter, M.D., Pulmonologist, Broward Health Medical Center; and Ramin Oskoui, M.D., Vice President of Medica Staff, Sibley Memorial Hospital, Chief Executive Officer, Foxhall Cardiology
On December 9, Treasury Secretary Steven Mnuchin offered Speaker Pelosi and Senate Majority Leader Mitch McConnell (R-KY) a $916 billion COVID-19 relief package. Senate Minority Leader Chuck Schumer (D-NY) and Majority Leader McConnell voiced support for including $600 stimulus checks in a package. McConnell pushed to drop the two major points of contention in relief package negotiations, the liability protections and additional state and local funding, but Sen. Schumer rejected the offer.
On December 9, Sens. Joe Manchin (D-WV), Mitt Romney (R-UT), Susan Collins (R-ME), Lisa Murkowski (R-AK), Bill Cassidy (R-LA), Mark Warner (D-VA), Jeanne Shaheen (D-NH), Angus King (I-ME), and Maggie Hassan (D-NH), and Members of the House Problem Solvers Caucus released additional details of the Bipartisan Emergency COVID Relief Act of 2020, the $908 billion bicameral, bipartisan relief package that was introduced last week. The package allows states to develop their own liability reforms and protect businesses in the meantime. McConnell indicated that he would not support this package. The package also includes:
$82 billion for schools;
$2 billion for testing and contract tracing for nursing homes, long term care, HCBS, and assisted living facilities;
$7 billion for testing and contract tracing in states, territories, and tribes;
$3.42 billion for vaccine distribution for states, local, territories, and tribes;
$2.58 billion for CDC vaccine distribution and infrastructure;
$35 billion to the Provider Relief Fund;
$160 billion in state and local aid;
$300 billion for the Small Business Administration;
$300 a week in federal unemployment benefits into April 2021; and
Extending telehealth flexibility through December 31, 2021.
On December 10, the Commerce, Science, & Transportation, Transportation & Safety Subcommittee held a hearing entitled The Logistics of Transporting a COVID-19 Vaccine. The committee discussed the logistics of the vaccine distribution and the coordination required between the federal, state, and local levels of government. Witnesses included: Rachel Levine, Secretary of Health, Pennsylvania, President, Association of State and Territorial Health Officers; Richard Smith, Regional President, Americas, Executive Vice President, FedEx Express; Wesley Wheeler, President, Global Healthcare, United Parcel Service
Members were advised that votes on an omnibus and COVID-19 relief legislation could occur as early as December 15th.
Regulatory
On December 11, the FDA authorized Pfizer’s COVID-19 vaccine for emergency use for individuals 16 years of age and older. Earlier in the week, on December 8, the FDA Vaccines and Related Biological Products Advisory Committee released early meeting documents and on December 10, the Committee voted 17-4 to endorse the widespread use of the vaccine in individuals 16 years of age and older. During the meeting, Pfizer announced plans to file for full FDA approval by April 2021.
On December 7, HHS Secretary Azar announced that every American will be able to receive a COVID-19 vaccine by the second quarter of 2021.
On December 7, HRSA announced it will distribute $523 million in second round performance payments to over 9,000 nursing homes as a reward for reducing COVID-19 related infections and deaths between September and October. A list of incentive payment recipients is available here.
On December 7, HHS released facility level hospital COVID-19 capacity data. The data is expected to assist local and regional resource planning efforts and promotes transparency with COVID-19 related data. A summary of the release is available here.
On December 8, Operation Warp Speed Chief Operating Officer Gen. Gustave Perna predicted that COVID-19 vaccine administration will begin within 96 hours of an EUA. HHS Secretary Azar estimated that 20 million Americans would be able to receive a vaccine in the next several weeks and confirmed that the government is in discussion with Pfizer and Moderna about purchasing additional doses.
On December 9, CMS updated coverage and payment information for monoclonal antibodies to treat COVID-19 through a Therapeutics Coverage Infographic, FAQ, and Monoclonal toolkit and program guidance. The documents include general payment and billing guidance for therapeutics.
On December 9, FDA authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for at home COVID-19 testing that does not require a prescription. Users must send the sample for testing to LabCorp and will receive a response from a health care provider or via email.
On December 9, the DoD released the agency’s plans for a phased and coordinated strategic plan for distributing and administering the initial COVID-19 vaccines. The DoD is expected to receive around 44,000 doses of the Pfizer vaccine in the initial phase, as early as next week, for immediate use. The DoD plans to administer the first batch to health care providers and then in long-term care facilities, to high-risk populations, those in critical national capability positions, and lastly, healthy populations.
On December 10, CDC Director Robert Redfield warned that the daily death toll for the next 60 to 90 days will surpass the number of deaths from 9/11 or Pearl Harbor.
On December 11, the CDC Advisory Committee on Immunization Practices held an emergency meeting to discuss COVID-19 vaccines. The panel will meet again on December 13.
The FDA Vaccines and Related Biological Products Advisory Committee will hold a meeting to discuss the EUA of the Moderna COVID-19 vaccine on December 17.
White House
On December 8, the White House hosted the COVID-19 Vaccine Summit which included participation by Director of the FDA’s Center for Biologics Evaluation and Research (CBER) Peter Marks, HHS Secretary Azar, numerous governors and representatives from vaccine distributors and pharmacies. Representatives from Pfizer and Moderna did not attend the event.
On December 8, President Trump signed an executive order (EO) entitled EO on Ensuring Access to the United States Government COVID-19 Vaccines. The EO aims “to ensure that Americans have priority access to COVID-19 vaccines developed in the United States or procured by the United States Government.” There are two main directives under the EO:
Priority Access to Americans for U.S. Government COVID-19 Vaccines: The EO requires the HHS Secretary, in consultation with the Secretary of Defense and other agency heads, to ensure that Americans have "priority access" to U.S. Government COVID-19 vaccines, and that the most vulnerable populations have first access.
International Access to U.S. Government COVID-19 Vaccines: The EO also requires that -- after determining that a sufficient supply of COVID-19 vaccine doses for all Americans who choose to be vaccinated exists -- the HHS Secretary and the Secretary of State, in coordination with USAID, the U.S. International Development Finance Corporation, the Export-Import Bank, and other agencies, must facilitate international access to U.S. Government COVID-19 vaccines.
The EO is largely symbolic. Nevertheless, President Trump warned that although the government has worked well with vaccine manufacturers, he could -- if necessary -- use the Defense Production Act (DPA) to compel manufacturers to prioritize the federal government in its domestic factories. However, he added that at this time "we don't think it will be necessary." A fact sheet on the EO is available here.
Other
On December 8, AstraZeneca published an analysis in The Lancet on the company’s Phase III COVID-19 vaccine clinical trial findings. The study found that a two-dose regimen was 62% effective and the accidental-lower initial dose regimen was 90% effective. This is the first Phase III COVID-19 vaccine trial to undergo peer review.
On December 8, U.K. began vaccinating its population with Pfizer’s COVID-19 vaccine. The following day, the Medicines and Healthcare Products Regulatory Agency issued a warning to health care professionals that people with “history of a significant allergic reaction” should not receive the Pfizer vaccine. On December 10, FDA and U.K. regulators met to investigate the reactions.
On December 8, the United Arab Emirates approved the Chinese COVID-19 vaccine and reported that the vaccine is 86% effective based on preliminary data. Phase III clinical trial data has not been released.
On December 9, the European Medicines Agency announced that it had been subject to a cyberattack that targeted documents for the Pfizer COVID-19 vaccine.
On December 9, Johnson & Johnson announced it is reducing the company's COVID-19 vaccine trial from 60,000 volunteers to 40,000 volunteers, predicting that 40,000 participants will generate the data needed to determine the safety and efficacy of the vaccine.
On December 10, the Kaiser Family Foundation (KFF) published a report entitled Estimates of the Initial Priority Population for COVID-19 Vaccination by State. The report estimated that 7% of the U.S. population (17.6 million people) are health care workers with direct patient contact and residents in nursing facilities or assisted living facilities. KFF also identified that there are variations in the number of health care workers and long-term care residents across states which may result in uneven effects across states in their ability to immunize priority populations. Some states may not have an adequate supply to vaccinate their priority population and may need to further prioritize who receives the first doses of a COVID-19 vaccine.
On December 10, Moderna began a 3,000 person- COVID-19 vaccine trial for those 12 to 18, using the company’s vaccine candidate, mRNA-1273.
On December 10, KFF released a report entitled State of the U.S. Health System: 2020 Update. The report focused on the impact of COVID-19 on the U.S. COVID-19 is the third leading cause of death in the U.S. in 2020, and KFF estimated that it will shorten life expectancy in the U.S. and other hard-hit countries. Over the past few years, disease burden worsened in the U.S., due to substance use disorders and an increase in injuries, while continuing to improve in similar countries. The report found that the pandemic led to a historic decline in health spending and health care access problems.
On December 11, Sanofi and GlaxoSmithKline announced a delay in its Phase III COVID-19 vaccine trials to summer 2021 after Phase I/II trials resulted in an insufficient immune response. The trials showed immune responses comparable to patients who recovered from COVID-19 for those 18 to 49, but a low immune response in older adults.
On December 11, AstraZeneca announced it will begin clinical trials on a combination of its experimental COVID-19 vaccine, AZD1222, and Russia’s Sputnik V shot, to boost vaccine efficacy.
On December 11, HHS and DoD agreed to purchase an additional 100 million doses of Moderna’s COVID-19 vaccine candidate, mRNA-1273.
Kentucky, Mississippi, and New York deferred to hospitals to prioritize who should receive the first COVID-19 vaccine doses, instructing hospitals to create tiering systems to determine which employees should receive the vaccinations and potentially administer the vaccine to high-risk patients if there are extra.
As of December 12, the U.S. had 16,038,528 confirmed COVID-19 cases resulting in 297,697 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
HHS-IHS
Calendar Year 2021 Reimbursement Rates; Notice; Received 12/2/20
REPORTS
HHS Office of Inspector General (OIG)
On December 9, OIG released a report entitled Few Patients Received High Amounts of Opioids from Indian Health Service (IHS)-Run Pharmacies. OIG found that few patients received high amounts of opioids from IHS-run pharmacies and the IHS has taken a number of steps to ensure appropriate opioid use among its patients. The report found that the IHS could improve the efficiency of its opioid monitoring systems by automating its system for electronic health records (EHR). OIG recommended that the IHS should assess the costs and benefits of updating its EHR system to support more automated monitoring and request support from States and Federal partners to address challenges in using State run prescription drug monitoring programs. A summary of the report is available here.
On December 10, OIG released a report entitled The National Institutes of Health Administered Superfund Appropriations During FY 2019 in Accordance With Federal Requirements. The report found that the National Institutes of Health (NIH) administered Superfund appropriations in accordance with applicable Federal requirements during FY 2019. OIG also found that the NIH monitoring of Superfund grants generally ensured that grantees met requirements for financial, performance, and audit reporting. A summary of the report is available here.
On December 11, OIG released a report entitled New York Improved Its Monitoring of Its Personal Care Services Program But Still Made Improper Medicaid Payments of More Than $54 Million. The report found that New York improperly claimed Federal reimbursement for some personal care services that did not comply with certain Federal and State requirements. New York received reimbursement for personal care services when there were no valid nursing or social assessment, no independent medical review, no valid physician's order or the order was not timely, no documentation of services provided, and no plan of care. OIG also found that for some claims, the personal care aide who provided the associated services had not undergone a timely criminal history check or did not meet training requirements. OIG recommended that New York refund $54.5 million, continue to improve its monitoring of local districts, and reinforce with local districts and personal care services providers Medicaid requirements related to personal care services. A summary of the report is available here.
Government Accountability Office (GAO)
On December 7, the GAO released a report entitled Medicaid: CMS Needs More Information on States' Financing and Payment Arrangements to Improve Oversight. The report found a change in how states finance their Medicaid programs; states relied on provider taxes and local government funds for about 28%, or $63 billion, of the estimated $224 billion total non-federal share of Medicaid payments in state FY 2018, which is 7 percentage points more than state FY 2008. GAO estimated that states' reliance on provider taxes and local government funds decreased states' share of net Medicaid payments and effectively increased the federal share of net Medicaid payments by 5 percentage points in state FY 2018, resulting in smaller net payments to some providers after the taxes and local government funds they contribute to their payments are taken into account. The report also found that CMS does not properly collect some information on states' sources of funds and payments, which hinders the agency's oversight. GAO recommended that CMS collect and document complete and consistent information about the sources of funding for the nonfederal share of payments to providers. A summary of the report is available here.
Congressional Budget Office (CBO)
On December 8, CBO released a report entitled Monthly Budget Review for November 2020. The report estimated that the federal budget deficit totaled $430 billion in October and November 2020, $87 billion more than the same period in 2019. A summary of the report is available here.
On December 9, CBO released a report entitled Options for Reducing the Deficit: 2021 to 2030. The report proposed options to reduce federal spending in the areas of mandatory spending, discretionary spending, and revenues. A summary of the report is available here.
On December 10, CBO released a report entitled How CBO Analyzes the Costs of Proposals for Single-Payer Health Care Systems That Are Based on Medicare’s Fee-for-Service Program: Working Paper 2020-08. The report outlines five options to show how differences in payment rates, cost sharing, and coverage of long-term services and supports under a single-payer health care system based on Medicare fee-for-service would affect the federal budget in 2030 and other outcomes. CBO projects that federal subsidies for health care in 2030 would increase by between $1.5 trillion to $3.0 trillion under the proposed single-payer options. National health expenditures in 2030 would change by between a decrease of $700 billion to an increase of $300 billion due to lower payment rates for providers, reductions in payers’ administrative spending, and increased use of care. CBO also identified that health insurance coverage would be nearly universal and out-of-pocket spending on healthcare would be lower. A summary of the report is available here.
Congressional Research Service (CRS)
On December 8, the CRS released a report entitled Pandemic-Related Statutory Provisions Expiring in 2020. The report identified the provisions in the Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act that are set to expire by the end of CY 2020.
UPCOMING HEARINGS
Senate
None of note.
House
December 15, 10:00 a.m., virtual
Purdue Pharma's Role in the Opioid Epidemic
Witnesses include: Mortimer Sackler, Controlling share of Purdue Pharma, Richard Sackler, Controlling share of Purdue Pharma; David Sackler, Controlling share of Purdue Pharma; Kathe Sackler, Controlling share of Purdue Pharma; and Craig Landau, President, CEO, Purdue Pharma
OTHER HEALTH POLICY NEWS
On December 8, the KFF released a brief entitled Potential Health Policy Administrative Actions Under President Biden. The brief identified potential administrative actions \ spanning topics from COVID-19, to mental health and substance abuse, to the ACA.
On December 9, KFF released a report entitled How Has the Pandemic Affected Health Coverage in the U.S.? The report identified that declines in employer sponsored insurance are far less than overall declines in employment and the loss of employer-based coverage may have been offset by enrollment in Medicaid and Marketplaces, allowing the uninsured rate to stay relatively consistent.
On December 9, 95 health care organizations called for the Biden transition team to appoint a diverse CMS Administrator, Medicaid Director, FDA Director, HRSA Director, and other agency leaders to the incoming administration and advocated for agency heads to have progressive and diverse backgrounds.
On December 9, the Commonwealth Fund published a study in Health Affairs entitled Income-Related Inequality In Affordability And Access To Primary Care In Eleven High-Income Countries found that lower income adults in the US fare relatively worse on affordability and access to primary care than those in other countries, and income-related disparities across domains are relatively greater throughout. A summary of the report is available here.
On December 10, the U.S. Supreme Court ruled on Rutledge v. PCMA, voting unanimously in favor of the Arkansas law preventing prescription drug middlemen (PBMs) from paying less than the wholesale cost of a drug to community pharmacies.
On December 10, the WHO released a report entitled WHO’s 2019 Global Health Estimates. The report found that noncommunicable diseases make up seven of the top 10 causes of death.