**The Lincoln Policy Group (LPG) is profoundly saddened by the passing of our colleague and dear friend, Robert Holifield. Robert was the Co-Founder and Managing Principal of LPG. He was a wonderful person who cared deeply for his colleagues, his family, and his community. The LPG family remains shocked and devastated by his passing. Robert is survived by his wife and three young children, who remain in our prayers. For Robert’s memorial page, including information about services, please visit: www.robertholifield.com.**
The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from June 14 - 19. 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 June 14, Budget Chair John Yarmuth (D-KY) introduced H. Res. 467 that would set a limit of $1.5 trillion in government funding for fiscal year 2022 and begin the appropriations process.
On June 15, Speaker Nancy Pelosi (D-CA) published a Dear Colleague naming the members of the Select Committee on Economic Disparity and Fairness in Growth:
Rep. Jim Himes (D-CT) as Chair;
Rep. Marcy Kaptur (D-OH);
Rep. Gwen Moore (D-WI);
Rep. Vicente Gonzalez (D-TX);
Rep. Pramila Jayapal (D-WA);
Rep. Angie Craig (D-MN);
Rep. Alexandria Ocasio-Cortez (D-NY); and
Rep. Sara Jacobs (D-CA).
On June 15, the Energy & Commerce Health Subcommittee held a hearing entitled Booster Shot: Enhancing Public Health through Vaccine Legislation. The subcommittee discussed the following legislation:
H.R. 550, the "Immunization Infrastructure Modernization Act"
H.R. 951, the "Maternal Vaccinations Act"
H.R. 979, the "Vaccine Fairness Act"
H.R. 1452, to direct the Secretary of Health & Human Services (HHS) to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes
H.R. 1550, the "Promoting Resources to Expand Vaccination, Education and New Treatments for HPV Cancers Act of 2021" or the "PREVENT HPV Cancers Act of 2021"
H.R. 1978, the "Protecting Seniors Through Immunization Act of 2021"
H.R. 2170, the "Helping Adults Protect Immunity Act" or the "HAPI Act"
H.R. 2347, the "Strengthening the Vaccines for Children Act of 2021"
H.R. 3013, the "COVID Vaccine Transportation Access Act"
H.R. 3655, the "Vaccine Injury Compensation Modernization Act"
H.R. 3742, the "Vaccine Information for Nursing Facility Operators Act" or the "Vaccine INFO Act"
H.R. 3743, the "Supporting the Foundation for the National Institutes of Health (NIH) and the Reagan-Udall Foundation for the FDA Act"
Witnesses included: Phyllis Arthur, Vice President, Infectious Diseases and Diagnostic Policy Biotechnology Innovation Organization; Rebecca Coyle, Executive Director, American Immunization Registry Association; Yvonne Maldonado, M.D., Chair, Committee on Infectious Diseases, American Academy of Pediatrics Professor of Pediatrics and of Epidemiology and Public Health, Stanford University Stanford University Center for Academic Medicine Pediatric Infectious Diseases; and Lijen Tan, Chief Strategy Officer, Immunization Action Coalition.
On June 16, the Education and Labor Committee held a hearing entitled Examining the Policies and Priorities of HHS. Members and sole witness HHS Secretary Xavier Becerra discussed the following topics: preparing for future pandemics and supporting a robust public health system; ensuring access to childcare and early childhood education programs; supporting heath care worker health and safety; addressing provider shortages; lowering drug costs while promoting innovation; supporting the access to affordable, robust health insurance; promoting health equity and maternal health; supporting substance use and mental health interventions and support; and other topics.
On June 17, more than 160 lawmakers urged Democratic leaders to permanently expand the postpartum Medicaid coverage extension to one year and address maternal mortality rates through the American Families Plan.
On June 17, 60 members of the Congressional Tri-Caucus, including members from the Congressional Asian Pacific American Caucus, Congressional Black Caucus, and Congressional Hispanic Caucus, urgedCongressional leadership and President Biden to expand coverage in states that have not increased Medicaid eligibility in the American Families Plan.
Senate
On June 16, Sen. Chuck Grassley (R-IA) met with a group of moderate House Democrats to discuss his Prescription Drug Pricing Reduction Act.
On June 16, the Health, Education, Labor & Pensions Committee held a markup to vote on the Nominations of Gwen Graham to be Assistant Education Secretary for Legislation and Congressional Affairs; Rajesh Nayak to be Assistant Labor Secretary for Policy; Taryn Mackenzie Williams to be Assistant Labor Secretary for Disability Employment Policy; Douglas L. Parker to be Assistant Labor Secretary for Occupational Safety and Health; Dawn Myers O'Connell to be Assistant HHS Secretary for Preparedness and Response; and Miriam E. Delphin-Rittmon to be Assistant HHS Secretary of Health for Mental Health and Substance Use.The committee advanced all six nominations for HHS, and the Departments of Education and Labor with bipartisan votes.
On June 17, Sens. Elizabeth Warren (D-MA), Sheldon Whitehouse (D-RI), Bernie Sanders (I-VT), and Tammy Baldwin (D-WI) requested information from Pharmaceutical Research and Manufacturers of America (PhRMA) Chief Executive Officer Stephen Ubl on PhRMA's lobbying efforts during COVID-19 to prevent the implementation of policies to lower drug costs, including negotiating prescription drug prices in Part D.
NON-CORONAVIRUS REGULATORY UPDATE
On June 14, CMS reported that over 1.2 million Americans signed up for health insurance through HealthCare.gov during the Marketplace Special Enrollment Period (SEP) between February 15 and May 31. The report also highlighted that over 1 million consumers selected a Marketplace plan with premiums of $10 or less per month, after advance payments of premium tax credits (APTC), following the American Rescue Plan’s (ARP)APTC expansion. ARP’s expanded premium tax credits have reduced premiums, increased savings, and given consumers access to quality, affordable health care coverage through the Marketplace. A summary of the report is available here. The SEP runs until August 15.
On June 15, HHS issued a proposed rule entitled Proposed Rescission of Executive Order 13937; Access to Affordable Life-Saving Medications. HHS is proposing to rescind a Trump-era final rule that requires federally qualified health centers to pass 340B discounts for insulin and injectable epinephrine to low-income patients.
On June 16, the HHS Office of the National Coordinator for Health Information Technology (ONC) released the Project US@ (USA) Draft Technical Specification Version 1.0 for public comment. The program was created to develop a unified, cross-standards, healthcare industry-wide specification for representing patient addresses to improve patient matching.
On June 16, the Food & Drug Administration (FDA) cleared 15 million additional doses of Johnson & Johnson's COVID-19 vaccine from the Emergent BioSolutions facility that has had contamination issues.
On June 17, HHS ONC established an $80 million Public Health Informatics & Technology Workforce Development Program to strengthen U.S. public health informatics and data science. Part of this program includes inviting colleges to apply for funding through a consortium that will develop the curriculum, recruit and train participants, secure paid internship opportunities, and assist in career placement at public health agencies, public health-focused non-profits or public health-focused private sector or clinical settings.
On June 14, the Office of Management & Budget (OMB) concluded its review of a prerule from FDA entitled Remanufacturing of Medical Devices; Draft Guidance for Industry and FDA Staff.
On June 16, CMS published the Long Term Care Hospitals (LTCHs) CARE Data Set Quarterly Q&As, and Inpatient Rehabilitation Facility (IRF) Patient Assessment Instrument Quarterly Q&As.
On June 18, the FDA held a public meeting discussing 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
None of note.
CORONAVIRUS UPDATE
House
None of note.
Senate
None of note.
Regulatory
On June 14, the Health Resources & Services Administration (HRSA) awarded $125 million to support 14 nonprofit private or public organizations to reach underserved communities in all states and territories to develop and support a community-based workforce that will engage in locally tailored efforts to build vaccine confidence and bolster COVID-19 vaccinations in underserved communities.
On June 14, the Centers for Disease Control and Prevention (CDC) released interim guidance for physicians evaluating and caring for patients with “long COVID.”
On June 17, HHS announced $3.2 billion for the Antiviral Program for Pandemics, to invest in the discovery, development, and manufacturing of antiviral medicines for COVID-19 and to better prepare the U.S. to face future viral threats. The program will bring together HHS, NIH, National Institute of Allergy and Infectious Diseases, Biomedical Advanced Research and Development Authority, and the HHS Office of the Assistant Secretary for Preparedness and Response.
On June 16 and 17, the HHS National Vaccine Advisory Committee discussed vaccine outreach, equity, hesitancy and the specter of COVID-19 variants.
CDC’s Vaccine Advisory Committee will hold a meeting on June 18 to assess cases of heart problems diagnosed in people who received Pfizer or Moderna COVID-19 vaccines and review how it plans to recommend booster vaccine doses.
The COVID-19 Health Equity Task Force will hold a virtual meeting on June 25 to consider interim recommendations addressing the inequities and the impact of long-COVID, and access to personal protection equipment, testing, and therapeutics.
White House
On June 14, The bipartisan group of senators referred to as the “G20,” including Sens. Rob Portman (R-OH), Mitt Romney (R-UT), Joe Manchin (D-WV), Bill Cassidy (R-LA), and Kyrsten Sinema (D-AZ), released a $1.2 trillion infrastructure package with $579 billion in new spending. On June 15, White House Counselor Steve Ricchetti indicated that negotiations would continue for a week to 10 days before assessing next steps.
On June 18, President Biden celebrated that the U.S. has administered 300 million vaccine doses.
Other
On June 14, Novavax announced that its COVID-19 vaccine, NVX-CoV2373, achieved 100% protection against moderate and severe COVID-19 and 90.4% efficacy overall in its Phase III trial.
On June 16, Moderna announced that the U.S. government purchased an additional 200 million doses of its COVID-19 vaccine for $3.3 billion, including the option to purchase other COVID-19 vaccine candidates from Moderna’s pipeline. This includes 110 million doses expected to be delivered in the fourth quarter of 2021 and 90 million expected to be delivered in the first quarter of 2022.
On June 16, Regeneron announced that its monoclonal antibody COVID-19 treatment reduced the risk of death by 20% in patients who had not mounted a natural antibody response on their own against COVID-19. Regeneron intends on requesting an expansion of its FDA emergency use authorization for the treatment of hospitalized, severe COVID-19.
On June 17, CureVac announced that its COVID-19 vaccine was 47% effective against COVID-19 in its Phase IIb/III study.
As of June 19, nearly 177 million people in the U.S. have received the first dose of COVID-19 vaccines (more than 149 million have received both doses) and more than 379 million doses have been distributed, according to the CDC COVID Data Tracker.
As of June 19, the U.S. had more than 33.5 million confirmed COVID-19 cases resulting in 601,717 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
Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Prerule; 5/26/21
REPORTS
Health & Human Services (HHS) Office of Inspector General (OIG)
On June 16, OIG released a report entitled California Did Not Ensure That Nursing Facilities Always Reported Incidents of Potential Abuse or Neglect of Medicaid Beneficiaries and Did Not Always Prioritize Allegations Properly. The report found that California did not ensure that nursing facilities always reported incidents of potential abuse or neglect of Medicaid beneficiaries transferred from nursing facilities to hospital emergency departments. Additionally, California complied with Federal requirements for recording allegations of abuse or neglect and generally complied with requirements for investigating allegations; however, California did not always comply with requirements for prioritizing allegations. OIG recommended that California strengthen guidance to nursing facilities on reporting incidents of potential abuse or neglect of Medicaid beneficiaries and ensure that its staff are regularly trained on updated Federal and State requirements to ensure that appropriate priorities are assigned to allegations of abuse or neglect. California agreed with the recommendations and described actions that it planned to take to implement our recommendations. A summary of the report is available here.
On June 14, OIG released a report entitled Nebraska Did Not Report and Refund the Correct Federal Share of Medicaid-Related Overpayments for 76% of the State's Medicaid Fraud Control Unit Cases. The report found that Nebraska did not report and return the correct Federal share of MFCU-determined Medicaid overpayments and Nebraska should have reported MFCU-determined Medicaid overpayments totaling $5.6 million. OIG recommended that Nebraska refund the unreported MFCU-determined Medicaid overpayments; for Nebraska to determine the value of overpayments that were not reported and report them to CMS; and improve relevant policies and procedures. Nebraska disagreed with the amount recommendation and noted that it would work with CMS to determine and report the amount owed. A summary of the report is available here.
On June 15, OIG released a report entitled Medicare Part B Drug Payments: Impact of Price Substitutions Based on 2019 Average Sales Prices. The report found that: CMS lowered Part B reimbursement for 18 drugs based on 2019 data; CMS' price-substitution policy saved Medicare and its beneficiaries $6.2 million over 1 year; and Medicare and its beneficiaries could have saved up to an additional $11.2 million over 1 year if CMS implemented a more expansive price substitution policy that allowed substitution for drugs that exceeded the 5% threshold in a single quarter. The report does not include any recommendations but OIG has previously recommended that CMS expand the price-substitution criteria. A summary of the report is available here.
On June 15, OIG released a report entitled Selected NIH Institutes Met Requirements for Documenting Peer Review But Could Do More To Track and Explain Funding Decisions. The report found that the NIH met its basic requirements for documenting first-level peer review but NIH institutes and centers documentation to justify funding grants out of rank order often appeared to fall short of the requirements in HHS' Grants Policy Administration Manual. OIG recommended that NIH centrally track and monitor data on funding out of rank order and update its policy and guidance to reflect the latest HHS grants policy on justifying funding out of rank order. NIH agreed with both recommendations. A summary of the report is available here.
On June 16, OIG released a report entitled Substance Abuse & Mental Health Services (SAMHSA) Is Missing Opportunities To Better Monitor Access to Medication Assisted Treatment (MAT) Through the Buprenorphine Waiver Program. The report found that in 2019, 77% of providers who were waivered at the 275-patient level did not submit required data to SAMHSA regarding the number of MAT patients they served. According to the limited data available, providers treated an average of 116 MAT patients-far below the 275-patient limit. Further, just 13% of providers waivered to prescribe to 275 patients reported being at or near that limit. However, OIG found that providers located in high-need counties reported treating more MAT patients on average than providers located elsewhere. SAMHSA says that it has opted to exercise its discretion and not enforce the reporting requirements because the opioid crisis is a public health emergency and it does not want to disrupt patients' access to MAT services. OIG recommended that SAMHSA develop methods to better measure access to MAT via office-based providers and improve data collection measures to better understand providers' MAT prescribing practices; monitor trends in the number of MAT patients being served; identify geographic areas where patients with opioid use disorder remain underserved; and target where to deploy its training and technical assistance resources. SAMHSA concurred with this recommendation. A summary of the report is available here.
Government Accountability Office (GAO)
On June 15, GAO released a report entitled the Department of Veterans Affairs (VA) COVID-19 Procurements: Pandemic Underscores Urgent Need to Modernize Supply Chain. The report found that the VA faced difficulties obtaining medical supplies particularly in the early stages of COVID-19. The VA has several initiatives underway to modernize its supply chain and prepare for future public health emergencies, but each faces delays and is in early stages. GAO has made 49 recommendations since 2015 to improve acquisition management at VA. VA agreed with those recommendations and has implemented 22 of them. In March 2021, GAO recommended, and VA concurred, that VA develop a comprehensive supply chain management strategy that, among other things, outlines how its various supply chain initiatives relate to each other. A summary of the report is available here.
On June 17, GAO released a report entitled Prescription Drugs: Medicare Spending on Drugs with Direct-to-Consumer Advertising. The report found that drug manufacturers spent $17.8 billion on direct-to-consumer advertising (DTCA) for 553 drugs from 2016-2018. GAO also found that nearly all DTCA spending was on brand-name drugs, with about two-thirds concentrated on 39 drugs, about half of which entered the market from 2014 through 2017. Medicare Parts B and D and beneficiaries spent $560 billion on drugs from 2016 through 2018, $324 billion of which was spent on advertised drugs. Among the top 10 drugs with the highest Medicare Parts B or D expenditures, four were also among the top 10 drugs in advertising spending in 2018: Eliquis, Humira, Keytruda, and Lyrica. GAO also found that DTCA may have contributed to increases in Medicare beneficiary use and spending among four selected drugs from 2010-2018. A summary of the report is available here.
HEARINGS
House
Energy and Commerce Health Subcommittee
Empowered by Data: Legislation to Advance Equity and Public Health
June 24, 10:30 a.m., 2123 Rayburn House Office Building
Legislation to be considered during the hearing includes:
H.R. 379, the "Improving Social Determinants of Health Act of 2021"
H.R. 666, the "Anti-Racism in Public Health Act of 2021"
H.R. 778, the "Secure Data and Privacy for Contact Tracing Act of 2021"
H.R. 791, the "Tracking COVID–19 Variants Act"
H.R. 831, the "Health Standards To Advance Transparency, Integrity, Science, Technology Infrastructure, and Confidential Statistics Act of 2021" or the "Health STATISTICS Act of 2021"
H.R. 925, the "Data to Save Moms Act"
H.R. 943, the "Social Determinants for Moms Act"
H.R. 976, the "Ensuring Transparent Honest Information on COVID–19 Act" or the "ETHIC Act"
H.R. 2125, the "Quit Because of COVID–19 Act"
H.R. 2503, the "Social Determinants Accelerator Act of 2021"
H.R. 3894, the "Collecting and Analyzing Resources Integral and Necessary for Guidance for Social Determinants of Health Act of 2021" or the "CARING for Social Determinants of Health Act of 2021"
H.R. 3969, to amend title XXVII of the Public Health Service Act to include activities to address social determinants of health in the calculation of medical loss ratios
H.R. ____, to require the Comptroller General of the United States to submit to Congress a report on actions taken by the Secretary of Health and Human Services to address social determinants of health
Senate
Health, Education, Labor and Pensions Committee
Vaccines: America's Shot at Ending the COVID-19 Pandemic
June 22, 10:00 a.m., 430 Dirksen Senate Office Building
Witnesses include: Susan Bailey, MD, Immediate Past President, American Medical Association; Jeanette Betancourt, Senior Vice President, U.S. Social Impact Sesame Workshop; Curtis Chang, Consulting Professor, Duke Divinity School; and Michelle Nichols, MD, Associate Dean of Clinical Affairs, Morehouse School of Medicine
Finance Committee
June 24, 10:30 AM, 215 Dirksen Senate Office Building
OTHER HEALTH POLICY NEWS
On June 14, Axios and Johns Hopkins University released an analysis finding that many top hospitals in America pursue patients with lawsuits and other predatory billing practices. The analysis found that 10 hospitals are responsible for 97% of court actions against patients and private hospitals have significantly higher markups than governmental or nonprofit hospitals.
On June 14, a new study published in JAMA Internal Medicine found that only 17% of 100 randomly-selected hospitals were in full compliance of the rule requiring hospitals to disclose the prices they negotiate with insurers.
On June 15, the Medicaid and CHIP Payment and Access Commission released its annual Report to Congress with discussions and recommendations regarding the following topics:
Access to Mental Health Services for Adults Covered by Medicaid;
Access to Behavioral Health Services for Children and Adolescents Covered by Medicaid and CHIP;
Integrating Clinical Care through Greater Use of Electronic Health Records for Behavioral Health;
Mandated Report on Non- Emergency Medical Transportation; and
On June 15, the Medicare Payment Advisory Commission released its annual Report to Congress with discussions and recommendations regarding the following topics:
Chapter 1: Rebalancing Medicare Advantage benchmark policy;
Chapter 2: Streamlining CMS’s portfolio of alternative payment models;
Chapter 3: Congressional request: Private equity and Medicare;
Chapter 4: Mandated report: Evaluating the skilled nursing facility value-based purchasing program;
Chapter 5: Congressional request: Medicare beneficiaries’ access to care in rural areas (interim report);
Chapter 6: Revising Medicare’s indirect medical education payments to better reflect teaching hospitals’ costs;
Chapter 7: Medicare vaccine coverage and payment;
Chapter 10: Mandated report: Relationship between clinician services and other Medicare services; and
An Executive Summary is available here.
On June 16, Delaware District Court Judge Leonard Stark rejected the Biden Administration’s request to dismiss AstraZeneca’s lawsuit against the HHS advisory opinion calling for manufacturers to continue 340B drug discounts to contract pharmacies.
On June 16, Altarum released a report finding that Biogen’s recently FDA approved treatment of Alzheimer’s disease, Aduhelm, would increase National Health Expenditures by more than 1%, increasing non-retail drug spending by more than 25% and increasing total prescription drug spending by more than 8%.
On June 17, the Supreme Court ruled 7-2 to uphold the Affordable Care Act (ACA) through California v. Texas. Chief Justice John Roberts, Justices Stephen Breyer, Elena Kagan, Sonia Sotomayor, Clarence Thomas, Brett Kavanaugh, and Amy Coney Barrett were the majority, arguing that Texas and the other plaintiffs lacked the standing necessary to raise the questions of the ACA’s validity. Justices Samuel Alito and Neil Gorsuch wrote in dissent.
On June 17, Georgetown's Center on Health Insurance Reforms released a study finding that though hospital prices are often top driver of health care costs for state health plans, plans instead focus on constraining enrollees’ use of health care services through deductibles and other benefit design strategies.
On June 17, the left-leaning Kaiser Family Foundation reported that Medicaid enrollment grew to more than 80 million, an all-time high. The report attributed the 9 million new beneficiaries in the last year alone to the pandemic and the federal requirement that Medicaid beneficiaries remain enrolled in the program through the public health emergency. Medicaid enrollment is now double what it was in 2001 (40 million), covering nearly one-in-four Americans.