The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from May 17 – May 23. 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 May 17, the Rules Committee voted 9-4 to report H.R. 1629, the Fairness in Orphan Drug Exclusivity Act. The House passed the legislation (402-23) on May 19.
On May 18, the Oversight & Reform Committee held a hearing entitled Unsustainable Drug Prices. Oversight and Reform Chair Carolyn Maloney (D-NY) shared that the Committee obtained internal documents showing the tactics AbbVie uses to suppress competition for Humira and other drugs and maintain “monopoly pricing” in the U.S. Witnesses included: Tahir Amin, Co-Founder, Co-Executive Director, Initiative for Medicines, Access, and Knowledge; Craig Garthwaite, Herman Smith Research Professor in Hospital and Health Services, Kellogg School of Management, Northwestern University; Richard Gonzalez Chairman of the Board, CEO, AbbVie Inc; Aaron Kesselheim, MD, Professor of Medicine, Harvard Medical School.
On May 18, following the Oversight & Reform Committee hearing, Chair Maloney, Judiciary Committee Chairman Jerrold Nadler (D-NY), and Antitrust, Commercial, and Administrative Law Subcommittee Chairman David Cicilline (D-RI) sent a letter to Federal Trade Commission Acting Chair Rebecca Kelly Slaughter requesting a formal inquiry into AbbVie’s actions to delay U.S. biosimilar entry for Humira and to examine whether AbbVie engaged in other anticompetitive conduct to maintain its market share and pricing power for Humira.
On May 19, GOP leaders introduced the Surface Transportation Advanced through Reform, 6 Technology, and Efficient Review (STARTER) Act 2.0 as an alternative to President Biden’s infrastructure package. The package includes over $400 billion over five years for roads, road safety, and public transit.
The House will return to Washington on June 14.
Senate
On May 19, the Judiciary Competition Policy, Antitrust, and Consumer Rights Subcommittee held a hearing entitled Antitrust Applied: Hospital Consolidation Concerns and Solutions. Members broadly advocated for increasing competition but disagreed on how to do so. Members and witnesses also disagreed on the impacts of hospital mergers. Witnesses included: Martin Gaynor, E.J. Barone University Professor of Economics and Public Policy, Carnegie Mellon University; Beth McCracken, cancer patient; Michael Cannon, Director Of Health Policy Studies, Cato Institute; Rodney Hochman, MD, President, CEO, Providence, Chair, American Hospital Association; Ahmer Qadeer, Director Of Strategic Initiatives, Service Employees International Union; and Brian Miller, MD, Assistant Professor of Medicine, John Hopkins School of Medicine
On May 20, Health, Education, Labor and Pensions Primary Health and Retirement Security Subcommittee held a hearing entitled A Dire Shortage and Getting Worse: Solving the Crisis in the Health Care Workforce. Subcommittee Chairman Bernie Sanders (I-VT) called for additional funding for 14,000 new Medicare-supported graduate medical education programs, with a focus on primary care. Witnesses included: David Skorton, MD, President, CEO, Association of American Medical Colleges; Leon McDougle, MD, President, National Medical Association; Shelley Spires, CEO, Albany Area Primary Health Care; and James Herbert, President, University of New England.
On May 19, the Appropriations Labor, Health & Human Services, Education and Related Agencies Subcommittee held a hearing entitled Review of the Fiscal Year (FY) 2022 Budget Blueprint for the Centers for Disease Control and Prevention (CDC). CDC Director Rochelle Walensky argued that the U.S. would have been better at combating COVID-19 if the U.S had a more robust public health infrastructure. Witnesses included: Rochelle Walensky, MD. Director, CDC; and Anne Schuchat, MD. Principal Deputy Director, CDC.
On May 20, Sen. Chuck Schumer (D-NY) filed cloture on Chiquita Brooks-LaSure’s confirmation to be the next Administration of the Centers for Medicare & Medicaid Services (CMS). The Senate is slated to vote on May 24 on whether to invoke cloture. A successful cloture vote would limit floor debate on the confirmation, clearing the path for LaSure’s confirmation.
On May 21, 16 Democratic Senators urged President Biden to make Affordable Care Act premium tax credit improvements permanent and make an investment to reduce deductibles and out-of-pocket expenses for individuals and families.
On May 21, Sens. Mitt Romney (R-UT), Joe Manchin (D-WV), and eight other Democratic senators introduced the Life Budgeting for Opioid Addiction Treatment Act, which would establish a stewardship fee to provide and expand access to substance use treatment through the existing Substance Abuse Prevention and Treatment Block Grant and establish a one cent ($0.01) stewardship fee on each milligram of active opioid ingredient in a prescription pain pill to pay for this treatment.
NON-CORONAVIRUS REGULATORY UPDATE
On May 17, Health Resources & Services Administration (HRSA) ordered six pharmaceutical companies including, AstraZeneca, Lilly, Novartis, Novo Nordisk, Sanofi, and United Therapeutics, to restore 340B drug discounts to contract pharmacies by June 1 or face civil monetary penalties. HRSA deemed that the companies were in direct violation of the 340B statute by overcharging contract pharmacies for 340B covered drugs. Lilly subsequently filed a motion in federal court to halt the imposition of monetary penalties, arguing that there is no legal explanation or justification for the June 1 deadline.
On May 17, the Justice Department advised the public that they should not be asked to pay to receive the COVID-19 vaccine and warned COVID-19 vaccination providers not to seek payment from individual COVID-19 vaccine recipients.
On May 18, Substance Abuse & Mental Health Services (SAMHSA) announced $3 billion in American Rescue Plan funding for the Community Mental Health Services Block Grant Program and Substance Abuse Prevention and Treatment Block Grant Program to help communities address mental health and substance use needs during the COVID-19 pandemic.
On May 18, the Internal Revenue Service issued guidance for employers, plan administrators, and health insurers regarding the new credit available to them under the American Rescue Plan Act for providing continuation health coverage to certain individuals under Consolidated Omnibus Budget Reconciliation (COBRA) Act. A summary of the guidance is available here.
On May 20, HRSA announced $14.2 million from the American Rescue Plan to expand pediatric mental health care access by integrating telehealth services into pediatric primary care through the Pediatric Mental Health Care Access projects.
On May 21, CMS indicated that it will not extend the Next Generation Accountable Care Organization (ACO) demonstrations beyond 2021. CMS noted that participants in the Next Generation ACO demonstration may join the Global and Professional Direct Contracting (GPDC) Model in 2022.
The National Clinical Care Commission will hold a meeting on June 1, to evaluate and make recommendations regarding improvements to the coordination and leveraging of federal programs related to diabetes and its complications.
The Food & Drug Administration (FDA) will hold a virtual public meeting on June 18 to discuss the financial transparency and efficiency of the Prescription Drug User Fee Act, the Biosimilar User Fee Act and Generic Drug User Fee Amendments.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On May 21, President Biden presented a $1.7 trillion infrastructure counteroffer to Republicans.
President Biden is expected to unveil his full budget request on May 28. This submission will likely include proposed changes to Medicare, Medicaid, and drug pricing.
CORONAVIRUS UPDATE
House
On May 19, the Select Subcommittee on the Coronavirus Crisis held a hearing entitled Examining Emergent BioSolutions’ Failure to Protect Public Health and Public Funds. Select Coronavirus Crisis Subcommittee Chairman James Clyburn (D-SC) called for Emergent to return public funds following the company’s Johnson & Johnson (J&J) COVID-19 vaccine cross-contamination failures and the testing needed to confirm that other doses are safe to use. Emergent BioSolutions CEO Robert Kramer predicted that the company could resume J&J’s COVID-19 vaccine manufacturing “within days” and has made enough of a key ingredient to yield more than 100 million doses of the vaccine. The Select Subcommittee on the Coronavirus Crisis and Oversight and Reform Committee are conducting an investigation on manufacturing problems that led to millions of COVID-19 vaccines being contaminated, vaccine manufacturing contracts, and other business practices that have strained federal resources. Witnesses included: Fuad El-Hibri, Executive Chairman, Board of Directors, Emergent BioSolutions; and Robert Kramer, President, CEO, Emergent BioSolutions. A report on the preliminary findings from the investigation into Emergent BioSolution is available here.
Senate
On May 19, the Finance Committee held a hearing entitled COVID-19 Health Care Flexibilities: Perspectives, Experiences, and Lessons Learned. Chairman Ron Wyden (D-OR) and many of the members argued in favor of permanently expanding the telehealth flexibilities created during COVID-19. Multiple members advocated for expanding audio only telehealth coverage beyond COVID-19. Members also emphasized the benefits of telehealth, including increasing access to care for vulnerable populations and decreasing barriers to care. Witnesses include: Jessica Farb, Director, Health Care Government Accountability Office (GAO); Kisha Davis, M.D., Member, Commission On Federal And State Policy American Academy of Family Physicians; Linda DeCherrie, M.D., Clinical Director, Mount Sinai At Home And Professor, Geriatrics And Palliative Medicine, Icahn School Of Medicine At Mount Sinai, Mount Sinai Health System; Narayana Murali, M.D., Executive Director, Board Member, America’s Physician Groups Marshfield Clinic; and Robert Berenson, M.D., Institute Fellow Urban Institute.
Regulatory
On May 17, FDA announced that recent data does not support the clinical benefit of CytoDyn’s leronlimab for the treatment of COVID-19
On May 17, FDA issued industry guidance entitled COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention. The guidance detailed design, conduct, and statistical considerations of master protocols to determine the safety of COVID-19 drug treatments.
On May 18, CDC released a study that COVID-19 vaccination coverage was lower in rural counties than in urban counties and disparities continue to persist among age groups and by sex.
On May 19, Pfizer CEO Albert Bourla predicted that those vaccinated against COVID-19 could require a booster shot as early as September, between eight and 12 months after being vaccinated. FDA Center for Biologics Evaluation and Research Director Peter Marks agreed with the prediction that people will need COVID-19 booster shots within a year.
On May 19, National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci predicted that younger children (at least the age of 4) will likely be able to get COVID-19 vaccines by the end of this year or the first quarter of 2022.
On May 19, FDA authorized that undiluted, thawed Pfizer COVID-19 vaccines are able to be stored at refrigerator temperatures up to one month, an extension from five days.
On May 19, Health & Human Services (HHS) announced that HRSA Health Center Program-funded health centers and Health Center Program look-alikes have administered more than 10 million COVID-19 vaccine doses nationwide, with 61% provided to racial and ethnic minorities.
FDA Vaccines and Related Biological Products Advisory Committee will hold a virtual meeting June 10 to discuss the approach to issuing EUAs for children to receive COVID-19 vaccines.
White House
On May 17, White House Press Secretary Jen Psaki announced that the Administration will send an additional 20 million COVID-19 vaccine doses to countries in need. A total of 80 million doses will be sent out by the end of June.
On May 18, the White House told governors for the second week in a row that the J&J COVID-19 vaccine was not immediately available for states to order and states will not receive any doses of the J&J vaccine next week.
Other
On May 17, Sanofi and GSK released Phase II interim results supporting its COVID-19 vaccine’s ability to demonstrate a strong immune response in adults. A global pivotal Phase III study is expected to start in the coming weeks.
On May 17, UNICEF Executive Director Henrietta Fore urged G7 countries to donate supplies to COVAX to address a severe shortfall caused by disruption to Indian vaccine exports.
On May 19, the U.K. launched a trial to assess the AstraZeneca, Pfizer, Moderna, Novavax, Valneva, J&J, and CureVac COVID-19 vaccine booster shots.
On May 21, G20 leaders adopted a declaration recommending voluntary actions to increase COVID-19 vaccine production instead of supporting patent and intellectual property waivers.
As of May 23, over 162 million people have received the first dose of COVID-19 vaccines (more than 129 million have received both doses) and more than 357 million doses have been distributed, according to the CDC COVID Data Tracker.
As of May 23, the U.S. had more than 33 million confirmed COVID-19 cases resulting in 589,703 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (CMS-1762); Interim Final Rule; Received 2/26/21
CY 2022 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1751); Proposed Rule; Received 3/30/21
CY 2022 Home Health Prospective Payment System Rate Update, Home Infusion Therapy Services, and Quality Reporting Requirements (CMS-1747); Proposed Rule; Received 4/30/21
CY 2022 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1749); Proposed Rule; 5/3/21
CY 2022 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1753); Proposed Rule; 5/11/21
Basic Health Program; Federal Funding Methodology for Program Year 2022 (CMS-2438); Final Rule; 5/12/21
HHS-FDA
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry; Availability; Notice; 5/11/21
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability; Notice; 5/11/21
Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers; Guidance for Industry; Availability; Notice; 5/11/21
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability; Notice; 5/11/21
HHS-HRSA
Rescission of the Final Rule “Implementation of Executive Order on Access to Affordable Life-Saving Medications”; Proposed Rule; 5/10/21
REPORTS
HHS Office of Inspector General (OIG)
On May 17, OIG released a data tool entitled Behavioral Health-Medication-Assisted Treatment Viewer that compiles OIG’s opioid oversight work, the Office of Audit Services Opioid Reviews, county and state level opioid and treatment facility information, and areas in need.
On May 17, OIG released a report entitled U.S. Department of Health and Human Services Met Many Requirements, but It Did Not Fully Comply With the Payment Integrity Information Act (PIIA) of 2019 and Applicable Improper Payment Guidance for Fiscal Year 2020 A-17-21-52000. The report found that Ernst & Young (EY) determined that HHS met many requirements but did not fully comply with the PIIA. EY found that HHS did not report an improper payment estimate for the Temporary Assistance for Needy Families (TANF) program, reported improper payment rates in excess of 10% for Medicaid and the Children's Health Insurance Program (CHIP), and did not conduct recovery audits for the Medicare Advantage (MA) program. EY also found that HHS did not record an improper payment estimate for the Advanced Premium Tax Credit, and CDC, and Office of Head Start disaster relief programs. A summary of the report is available here.
On May 17, OIG released a report entitled CMS Needs to Strengthen Regulatory Requirements for Medicare Part B Outpatient Cardiac and Pulmonary Rehabilitation Services to Ensure Providers Fully Meet Coverage Requirements A-02-18-01026. The report found that CMS regulatory requirements related to Medicare outpatient cardiac and pulmonary rehabilitation services did not contain sufficient information to ensure that claims for these services met Medicare coverage requirements, estimating $2.7 million in overpayments. OIG recommended that CMS revise its regulations to provide sufficient guidance to ensure that providers meet coverage requirements for outpatient cardiac and pulmonary rehabilitation services. A summary of the report is available here.
On May 18, OIG released a report entitled Medicare Hospice Provider Compliance Audit: Alive Hospice, Inc. The report found that Alive received Medicare reimbursement for hospice services that did not comply with Medicare requirements due to Alive's policies and procedures being not effective in ensuring that the clinical documentation it maintained supported the terminal illness prognosis and that the appropriate level of care was provided. OIG recommended that Alive refund non-compliant overpayments and strengthen its policies and procedures to ensure that hospice services comply with Medicare requirements. A summary of the report is available here.
On May 18, OIG released a report entitled Medicare Hospice Provider Compliance Audit: Ambercare Hospice, Inc. the report found that Ambercare received Medicare reimbursement for hospice services that did not comply with Medicare requirements because Ambercare's policies and procedures were not effective in ensuring that the clinical documentation it maintained supported the terminal illness prognosis, resulting in at least $24.6 million in unallowable Medicare reimbursement for hospice services. OIG recommended that Ambercare refund overpayments for hospice services that did not comply with Medicare requirements and strengthen its policies and procedures to ensure that hospice services comply with Medicare requirements. Ambercare disputed nearly all of our findings and did not concur with our recommendations. A summary of the report is available here.
On May 18, OIG released a report entitled Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Fourth Quarter of 2020. The report found that in the fourth quarter of 2020, five drug codes met CMS' price substitution criteria by exceeding the 5% threshold for two consecutive quarters or three of the previous four quarters. OIG provided the five drug codes to CMS for its review and recommended that CMS review this information to determine whether to pursue price substitutions that would limit excessive payments for Part B drugs. A summary of the report is available here.
On May 18, OIG released three Advisory Opinions 21-03, 21-04, and 21-05 regarding whether an arrangement to incentivize certain Medigap plan policyholders to seek inpatient care from a hospital within the preferred hospital organization’s network violates certain fraud and abuse laws.
On May 19, OIG released a report entitled New York Did Not Have Adequate Oversight of Its Reported Temporary Assistance for Needy Families Program Expenditures. The report found that New York's oversight did not ensure that its reported TANF and State maintenance-of-effort (MOE) expenditures met Federal requirements and did not ensure the accuracy of the other expenditures reported to the Administration for Children and Families (ACF), resulting in $4.8 billion in TANF and MOE expenditures. OIG recommended that New York work with its local districts and TANF-funded State programs to develop financial management procedures that would enable it to determine if TANF and MOE expenditures are accurately reported to ACF and improve its oversight of the TANF program by providing additional guidance and training to ensure that its local districts accurately report expenditures and maintain adequate documentation to support TANF and MOE expenditures reported. A summary of the report is available here.
On May 20, OIG released a report entitled Medicare Hospice Provider Compliance Audit: Franciscan Hospice. The report found that Franciscan received Medicare reimbursement for hospice services that did not comply with Medicare requirements by not supporting the beneficiary's terminal prognosis and a lack of documentation to support the hospice services that Franciscan billed to Medicare, resulting in least $13 million in unallowable Medicare reimbursement for hospice services. OIG recommended that Franciscan refund the noncompliant hospice services overpayments and strengthen its policies and procedures to ensure that hospice services comply with Medicare requirements. A summary of the report is available here.
Government Accountability Office (GAO)
On May 17, GAO released a report entitled Medicaid: HHS's Preliminary Analyses Offer Incomplete Picture of Behavioral Health Demonstration's Effectiveness. The report found that the Protecting Access to Medicare Act of 2014 established the Certified Community Behavioral Health Clinics (CCBHC) demonstration. CCBHCs aim to improve the behavioral health services they provide, particularly for Medicaid beneficiaries. HHS has conducted preliminary assessments of the demonstration but GAO found data limitations that complicate HHS's efforts to assess the effectiveness of the demonstration, including a lack of baseline data, a lack of comparison groups, and a lack of detail on Medicaid encounters. GAO found that the lack of standardization across states limited HHS's ability to assess changes in a uniform way. A summary of the report is available here.
On May 17, GAO released a report entitled Veterans' Growing Demand for Mental Health Services.The report found that between FY 2006-2019, the VA's mental health budget increased from $2.4 to $8.9 billion. GAO will continue working on this issue and the report poses the following questions for future consideration: what actions could VA take to reduce barriers to accessing mental health services; what level of funding is sufficient to meet VA’s goals for increasing mental health access and improving outcomes; and how does VA envision the role of telehealth in meeting veterans’ increasing demand for mental health services. A summary of the report is available here.
On May 19, GAO released a report entitled COVID-19 in Nursing Homes: Most Homes Had Multiple Outbreaks and Weeks of Sustained Transmission from May 2020 through January 2021. The report found that nursing homes commonly experienced multiple COVID-19 outbreaks from May 2020 through January 2021. GAO found that nursing homes had an average of about three outbreaks during the review period, with most of the nursing homes experiencing more than one COVID-19 outbreak. A summary of the report is available here.
On May 19, GAO released a report entitled Medicare and Medicaid: COVID-19 Program Flexibilities and Considerations for Their Continuation. The report found that following CMS using Medicare and Medicaid waivers and other flexibilities to expand beneficiary access to care during COVID-19, there was an expansion of hospital capacity, the health care workforce, and the utilization of telehealth increased. GAO noted that these program flexibilities also increase certain risks to the Medicare and Medicaid programs and raise considerations for their continuation beyond the pandemic, including increased spending, program integrity concerns, and beneficiary health and safety concerns. A summary of the report is available here.
HEARINGS
House
Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee
FY2022 Budget Request for the National Institutes of Health
May 25th @ 10:00 a.m.
Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee
May 26, 10:00 a.m.
Energy and Commerce Oversight and Investigations Subcommittee
A Shot at Normalcy: Building COVID-19 Vaccine Confidence
May 26, 11:00 a.m.
Witnesses include: Nick Offerman, Actor, Woodworker; Saad Omer, Director, Yale Institute for Global Health, Yale University; J. Nadine Garcia, M.D., Executive Vice President, Chief Operating Officer, Trust for America's Health; Amy Pisani, Executive Director, Vaccinate Your Family; and Karen Shelton, M.D. Director, Mount Rogers Health District, Virginia Department of Health.
Senate
None of note.
OTHER HEALTH POLICY NEWS
On May 17, a study published by KNG Health Consulting estimating the effects of Affordable Care Act enhancements on health insurance coverage and health care spending. The study found that under ACA enhancements, the number of uninsured would fall significantly -- roughly 8.1 million (30%) and 9.6 million (34%) fewer people will be uninsured after the ACA enhancements in 2023 and 2032-- and that the Marketplace would see significant growth in enrollment, because of take-up by those previously covered by employer-sponsored insurance or who were uninsured.
On May 19, Altarum released a study entitled May 2021 Health Sector Economic Indicators Briefs. The study found that the national health spending rebound slowed to pre-pandemic growth rates in March 2021 and the economy wide price growth outpaced the health care sector in April.
On May 19, a study published by Avalere found that lowering the Medicare eligibility age from 65 to 60 could expand access to Medicare coverage for an additional 24.5 million individuals, but Medicare premiums may be less affordable in some cases than subsidized Exchange coverage.
On May 19, the Kaiser Family Foundation (KFF) released a report on the Medicare and telehealth coverage and use during COVID-19 and in the future. The report found that more than 1-in-4 Medicare beneficiaries had a telehealth visit between the summer and fall of 2020. Of these telehealth services, over half were audio only.
On May 20, the Commonwealth Fund released a report entitled The Economic and Employment Effects of Medicaid Expansion Under the American Rescue Plan. The report found that expanding Medicaid would increase federal revenue to the 14 states by $49 billion in 2022. Medicaid expansion would also create over one million jobs nationwide and would expand the 14 state’s economies by $350 billion from 2022 to 2025.
On May 20, the West Health Policy Center released a study estimating that H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act and allowing Medicare to negotiate drug prices could result in $195 billion reduction in employer costs and $98 billion in savings for workers.
On May 20, three Missouri residents who are eligible for Medicaid expansion coverage filed suit against the state for failing to expand Medicaid, following that state legislature passing a budget without earmarking funds to expand the Medicaid program.
On May 21, KFF released a report finding that lowering the Medicare eligibility age to 60 would likely have a modest effect on increasing the number of people with health coverage and would mostly impact people with private coverage.