The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from July 12 - July 18. 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 July 12, the Appropriations Labor, HHS, Education, and Related Agencies Subcommittee held a hearing entitled Fiscal Year (FY) Appropriations 2022 Markup: Labor, Health & Human Services (HHS), Education, and Related Agencies. The Subcommittee advanced by voice vote its FY2022 spending bill. On July 15, the Appropriations Committee approved 33-25 its FY2022 Labor-HHS-Education spending bill. The measure would provide $119.8 billion in discretionary appropriations for HHS. Notably, the proposed budget bill advanced without the Hyde Amendment, which bans federal funding for abortions, an issue that will likely arise when the Senate considers the package. The bill text is available here.
On July 12, Oversight & Reform Committee Chair Carolyn Maloney (D-NY) and Energy & Commerce Committee Chairman Frank Pallone (D-NJ) called for Biogen to provide the committees with information on clinical and safety data, information on the Food & Drug Administration (FDA) approval process, marketing, and pricing calculations for its Alzheimer's treatment drug, Aduhelm, as part of the committees’ investigation to promote transparency into the process for Aduhelm’s approval; Biogen’s pricing; and the implications for future Alzheimer’s treatments and research, patients, providers, and federal health care programs.
On July 13, the Energy & Commerce Committee held a Member Day Hearing. Members discussed the COVID-19 vaccination effort, expanding access to health care, supporting the Federal Trade Commission (FTC) to combat scams and fraud, modernizing infrastructure, and combating climate change.
On July 14, a group of 15 vulnerable Democratic Representatives called for House and Senate Democratic leaders to include allowing Medicare to negotiate drug prices and address high drug prices in the "human infrastructure” package.
On July 15, the Energy & Commerce Health Subcommittee marked up the following bills, all of which were favorably reported to the fully committee via voice vote:
· H.R. 4369, the "National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act"
· H.R. 654, the "Drug-Free Communities Pandemic Relief Act"
· H.R. 2051, the "Methamphetamine Response Act of 2021"
· H.R. 2379, the "State Opioid Response Grant Authorization Act of 2021"
· H.R. 2364, the "Synthetic Opioid Danger Awareness Act"
· H.R. 2355, the "Opioid Prescription Verification Act of 2021"
· H.R. 2503, the "Social Determinants Accelerator Act of 2021"
· H.R. 4026, the "Social Determinants of Health Data Analysis Act of 2021"
· H.R. 3743, the "Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act"
· H.R. 550, the "Immunization Infrastructure Modernization Act"
· 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. 951, the "Maternal Vaccination Act"
· H.R. 925, the "Data to Save Moms Act"
· H.R. 4387, the "Maternal Health Quality Improvement Act of 2021"
· H.R. 3742, the "Vaccine Information for Nursing Facility Operators Act" or the "Vaccine INFO Act"
· H.R. 1978, the "Protecting Seniors Through Immunization Act"
· H.R. 2347, the "Strengthening the Vaccines for Children Act"
· H.R. 3894, the "Collecting and Analyzing Resources Integral and Necessary for Guidance for Social Determinants Act of 2021" or the "CARING for Social Determinants Act of 2021"
· H.R. 4406, the "Supporting Medicaid in the U.S. Territories Act"
On July 15, Majority Leader Steny Hoyer (D-MD) confirmed that the House will take up its first fiscal year 2022 spending package during the week of July 26, including Labor-HHS-Education, Agriculture-FDA, Energy-Water, Interior-Environment, Military Construction-Veterans Administration, Transportation-Department of Housing and Urban Development and Financial Services.
On July 15, Rep. Jim Banks (R-IN) and the Republican Study Committee released a bill entitled RSC China Bill to continue to compete with and tackle China, including identifying FDA regulatory barriers to domestic manufacturing of medical products, including pharmaceutical ingredients, that are critical to public health during a public health emergency.
Senate
On July 13, the Judiciary Competition Policy, Antitrust, and Consumer Rights Subcommittee held a hearing entitled A Prescription for Change: Cracking Down on Anticompetitive Conduct in Prescription Drug Markets. Members and witnesses supported allocating more resources to the FTC and Department of Justice (DOJ) to address anticompetitive and antitrust practices. Chair Amy Klobuchar (D-MN) advocated for addressing the following issues: cracking down on pay-for-delay deals, product hopping, and sham petitions; allowing the importation of drugs; increasing funding for the agencies that address these concerns, and allowing Medicare to negotiate drug prices, and passing her legalization (S. 1428) to address these issues. Members and witnesses also discussed rebate traps, patent thickets, increased transparency around Pharmacy Benefit Managers (PBM), and other strategies to tackle high drug costs.
On July 13, the Finance Committee voted 28-0 to approve Melanie Egorin to HHS Assistant Secretary for Legislation. The nomination will head to the Senate floor for final confirmation.
On July 14, Budget Committee Democrats announced the $3.5 trillion partisan "human infrastructure” framework. The package includes tax credits, climate, housing, education and health care policies, including expanding Medicare coverage to include dental, vision and hearing care, though other details regarding expanding home care through Medicaid, reducing prescription drugs costs, and expanding Medicaid coverage in states that have not expanded have not yet been released. They propose partially paying for the package by allowing Medicare to set drug prices based on placed paid by other countries and with higher taxes on high-income earners.
On July 16, Sens. Bob Menendez (D-NJ) and Bill Cassidy (R-LA) reintroduced the Seniors Prescription Drug Relief Act, which would strengthen Medicare Part D, cap seniors’ out-of-pocket costs at $3,100 a year, allow patients to make copays in monthly installments rather than a lump sum, and reduce coinsurance from 25% to 20% in the initial coverage period.
On July 12, Sens. Raphael Warnock (D-GA), Jon Ossoff (D-GA), and Tammy Baldwin (D-WI) introduced the Medicaid Saves Lives Act, which would provide health insurance to Americans with low incomes in the 12 states that have not expanded their Medicaid programs. The bill would create and stand up a federal Medicaid look-alike program, which would provide the same full, essential benefits of Medicaid, but would be run and administered at the federal level for those who fall in the Affordable Care Act (ACA) coverage gap. A fact sheet on the bill is available here.
NON-CORONAVIRUS REGULATORY UPDATE
On July 12, CMS released a brief regarding the Accountable Health Communities (AHC) Model entitled Planning for Sustainability and Advancing Health Equity during the Public Health Emergency. The brief discussed strategies to optimize AHC Model implementation, sustain the AHC work beyond the cooperative agreement period, and highlighted the importance of health equity to advance and sustain the AHC Model activities.
On July 12, White House Office of Management & Budget (OMB) received a final rule from CMS entitled Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2022 Rates (CMS-1752).
On July 13, CMS issued a proposed rule entitled Calendar Year (CY) 2022 Payment Policies under the Physician Fee Schedule (PFS) and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; Provider and Supplier Prepayment and Post-payment Medical Review Requirements. Among other policies, the rule proposes updates to:
Part B payment policies to reflect changes in medical practice, relative value of services, and changes in the statute;
Medicare Shared Savings Program requirements;
Quality Payment Program;
Medicare coverage of opioid use disorder treatment furnished by opioid treatment programs;
Medicare provider enrollment policies;
Prepayment and postpayment medical review requirements;
Electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan, or a Medicare Advantage Prescription Drug plan;
Medicare coverage of certain behavioral health services via audio-video and audio-only telehealth granted for COVID-19;
Medicare Ground Ambulance Data Collection System;
Medicare Diabetes Prevention Program (MDPP) expanded model to boost supplier enrollment; and
Amendments to the physician self-referral law regulations.
A fact sheet on the CY 2022 Medicare PFS Proposed Rule is available here. A fact sheet on the proposed policies for the MDPP Expanded Model for the CY 2022 Medicare PFS is available here. A summary of the rule is available here. Comments are due September 13.
On July 13, CMS initiated a National Coverage Determination (NCD) analysis to review and determine whether Medicare will establish an NCD for monoclonal antibodies targeting amyloid for the treatment of Alzheimer’s disease. The NCD would cover Biogen’s Aduhelm treatment as well as any future monoclonal antibodies that also target amyloids to treat Alzheimer’s disease. CMS will accept public comments on initiating an NCD until August 11, and also host two public listening sessions on the topic on July 22 and July 27. CMS will propose a decision on a potential NCD within six months and make a final determination three months later in 2022.
On July 13, HHS Office of the National Coordinator for Health IT plans announced that the Trusted Exchange Framework and Common Agreement, created to advance the secure exchange of electronic health information and other data among health information networks that was included in the 21st Century Cures Act, will launch in early 2022.
On July 13, Health Resources and Services Administration (HRSA) announced $398 million through the Small Rural Hospital Improvement Program to 1,540 small rural hospitals for COVID-19 testing and mitigation.
On July 13, CMS announced $15 million in funding to help states strengthen system capacity to provide community-based mobile crisis intervention services for those with Medicaid and allow Medicaid agencies to assess community needs and develop programs to bring crisis intervention services directly to individuals experiencing a mental health or substance use related crisis outside a hospital or facility setting.
On July 14, OMB received a proposed rule from CMS entitled Reassignment of Medicaid Provider Claims (CMS-2444).
On July 14, CMS announced the availability of two new Research Identifiable Files that contain data from the Comprehensive ESRD Care (CEC) Model with enrollment data for beneficiaries and identifying information about the providers participating in the CEC Model.
On July 14, the CDC released Provisional Drug Overdose Death Counts data showing that there was an increase in drug overdose deaths in 2020 (93,331 reported deaths, an increase from 70,980 deaths in 2019). Almost 75% of overdose deaths were due to opioids.
On July 15, the National Institutes of Health National Institute on Drug Abuse released a study in JAMA Network Open finding that high-dose buprenorphine therapy provided through emergency departments is safe and well tolerated in people with opioid use disorder experiencing opioid withdrawal symptoms. Lower doses of buprenorphine are the current standard of care whereas elevated doses of buprenorphine may provide an extended period of relief to people after being discharged that may help them navigate barriers to obtaining medications and accessing treatment of opioid use disorder.
On July 15, HRSA awarded $144 million to 102 HRSA Health Center Program look-alikes (LALs) to respond to and mitigate the spread of COVID-19, and enhance health care services and infrastructure in communities across the country. This funding from the American Rescue Plan will aid in providing primary health care services to underserved communities and vulnerable populations.
On July 15, CMS announced that more than two million people signed up for health coverage during the 2021 Special Enrollment Period which will run from February 15 to August 15, 2021. A summary of the report is available here. To continue this effort, CMS announced it will spearhead the Summer Sprint to Coverage campaign, including integrated paid media placements and increased community outreach to encourage Americans who need coverage to sign up for health coverage.
On July 15, CMS appointed Beth Lynk as CMS Office of Communications Director and Senior Advisor of External Affairs to Administrator Chiquita Brooks-LaSure.
On July 16, HRSA announced $103 million over a three-year period to reduce burnout and promote mental health among the health workforce. This funding will help health care organizations increase wellness among the health and public safety workforce and will support training efforts that build resiliency for those at the beginning of their health careers.
On July 16, FDA announced that it created new product codes for certain medical devices authorized under Emergency Use Authorizations.
On July 16, CMS released the Hospice Quarterly Update for the second quarter of 2021.
The CMS Advisory Panel on Outreach and Education will hold a virtual meeting on July 28 to advise and make recommendations to the HHS Secretary and CMS Administrator on opportunities to enhance the effectiveness of consumer education strategies for the Affordable Care Act (ACA) Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP).
NON-CORONAVIRUS WHITE HOUSE UPDATE
On July 14, President Joe Biden nominated former West Virginia Health Commissioner Rahul Gupta as the White House Office of National Drug Control Policy Director and coordinator of the federal response to the opioid crisis. President Biden also nominated Atul Gawande as USAID Assistant Administrator of the Bureau for Global Health focusing on the COVID-19 response and efforts to re-strengthen public health systems worldwide.
CORONAVIRUS UPDATE
House
On July 14, the Science Investigations and Oversight Subcommittee held a hearing entitled Principles for Outbreak Investigation: COVID-19 and Future Infectious Diseases. Chairman Bill Foster (D-IL) called for greater transparency in order to determine the origins of COVID-19 and establish federal and global guidelines for investigating future diseases. Witnesses included: David Relman, MD, Thomas C. and Joan M. Merigan Professor, Stanford University School of Medicine, Senior Fellow, Center for International Security and Cooperation, Stanford University; Stanley Perlman, MD, Professor of Microbiology and Immunology, University of Iowa; Connie Price, MD, Chief Medical Officer, Denver Health, Professor of Medicine, Division of Infectious Diseases, University of Colorado School of Medicine; and Suzan Murray, MD, Program Director, Smithsonian Global Health Program, Smithsonian National Zoo & Conservation Biology Institute.
Senate
None of note.
Regulatory
On July 12, the FDA added a warning for Johnson & Johnson’s (J&J) COVID-19 vaccine, that the vaccine may cause an increased risk of Guillain-Barré syndrome, a rare neurological disorder. A fact sheet for recipients and caregivers is available here. A summary of the label changes is available here.
On July 13, the FDA released an additional batch of J&J COVID-19 vaccines manufactured at the Emergent BioSolutions facility, following contamination and manufacturing issues discovered at the plant earlier this year.
On July 13, FDA Center for Drug Evaluation and Research published a blog on the FDA’s Clinical Methodologies Group’s HHS award, which will fund the expansion of the CURE ID platform, which allows automated anonymized data collection from electronic health records and clinical disease registries for COVID-19 and other diseases.
On July 15, Surgeon General Dr. Vivek Murthy issued a Surgeon General's Advisory to warn the American public about the urgent threat of health misinformation, especially around COVID-19 vaccines.
On July 16, Pfizer and BioNTech announced that FDA will use the Priority Review process to evaluate full approval of its COVID-19 vaccine in patients ages 16 and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022. Acting FDA Commissioner Janet Woodcock tweeted that she expects the FDA to come to a decision “far in advance” of that date.
The COVID-19 Health Equity Task Force will hold a virtual meeting on July 30 to consider interim recommendations addressing future pandemic preparedness, mitigation, and resilience needed to ensure equitable response and recovery in communities of color and other underserved populations.
HHS’ Office of the Assistant Secretary for Preparedness and Response will hold a meeting with COVID-19 test makers and labs on July 22 to prepare for the next phase of the pandemic and discuss potential strategies to maintain preparedness efforts.
The CDC Advisory Committee on Immunization Practices will hold a meeting on July 22 to consider COVID-19 vaccine safety, review scientific data, and vote on vaccine recommendations regarding COVID-19 boosters for immunocompromised people. The draft agenda is available here.
White House
None of note.
Other
On July 12, World Health Organization Director-General Tedros Adhanom Ghebreyesus called for Pfizer and Moderna to prioritize supply of vaccines to low- and middle-income countries, rather than focus on booster shots in high-income countries.
On July 12, Gavi signed agreements with Chinese COVID-19 vaccine manufacturers Sinopharm and Sinovac to immediately supply COVAX with 110 million doses immediately available to participants of the COVAX Facility, with options for additional doses.
On July 12, Israel's Ministry of Health began third dose Pfizer COVID-19 vaccines to severely immunocompromised adults, making Israel the first nation to begin administering booster shots.
On July 16, the Commonwealth Fund released a report entitled As the Pandemic Eases, What Is the State of Health Care Coverage and Affordability in the U.S.? The report found that 10% of adults ages 19 to 64 were uninsured during the first half of 2021 and 6% of working-age adults reported they lost their employer health coverage because of COVID-19-related job loss. The report also found that people directly affected by COVID-19 reported having higher rates of medical bill and debt problems than those not directly affected.
As of July 18, more than 186 million people in the U.S. have received the first dose of COVID-19 vaccines (more than 161 million have received both doses) and more than 390 million doses have been distributed, according to the CDC COVID Data Tracker.
As of July 18, the U.S. had more than 34 million confirmed COVID-19 cases resulting in 609,001 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 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1753); Proposed Rule; Received 5/11/21
Basic Health Program; Federal Funding Methodology for Program Year 2022 (CMS-2438); Final Rule; Received 5/12/21
FY 2022 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1748); Final Rule; 7/6/21
Reporting Requirements Related To Air Ambulance and Agent and Broker Services and HHS Enforcement Provisions; Proposed Rule; 7/7/21
Most Favored Nation (MFN) Model (CMS-5528); Proposed Rule; 7/7/21
FY 2022 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1750)’ Final Rule; 7/7/21
FY 2022 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1754); Final Rule; Received 7/8/21
Reassignment of Medicaid Provider Claims (CMS-2444); Proposed Rule; Received 7/13/21
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; Received 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; Received 5/26/21
REPORTS
HHS Office of Inspector General (OIG)
On July 12, OIG released a report entitled Medicare Hospital Provider Compliance Audit: Lake Hospital System. The report found that the Hospital did not fully comply with Medicare billing requirements for all claims, resulting in an estimated $4.4 million in overpayments. OIG recommended that the Hospital exercise reasonable diligence to identify, report, and return any overpayments and strengthen controls to ensure full compliance with Medicare requirements. The Hospital disagreed with most of the findings and recommendations. A summary of the report is available here.
On July 12, OIG released a report entitled Indiana Received Over $22 Million in Excess Federal Funds Related to Unsupported Community Integration and Habilitation (CIH) Waiver Services at 12 Selected Service Providers. The report found that Indiana did not ensure that all CIH Waiver services were provided in accordance with Federal, State, and waiver requirements, resulting in at least $33.5 million in overpayments. OIG recommended that Indiana refund the overpayments identified in the report and improve its monitoring of the CIH Waiver program to ensure that service providers comply with Federal, State, and CIH Waiver requirements. The State agency generally did not agree with the findings and recommendations. A summary of the report is available here.
On July 12, OIG released a report entitled Medicare Hospice Provider Compliance Audit: Mission Hospice & Home Care, Inc. The report found that Mission received Medicare reimbursement for hospice services that did not comply with Medicare requirements, including the clinical record not supporting the beneficiary's terminal prognosis, and did not support the level of care billed to Medicare, resulting in at least $10.5 million in unallowable Medicare reimbursement for hospice services. OIG recommended that Mission return overpayments and strengthen its policies and procedures to ensure that hospice services comply with Medicare requirements. Mission disagreed with some of the findings and recommendations. A summary of the report is available here.
On July 14, OIG released a report entitled Medicare Hospice Provider Compliance Audit: Partners In Care, Inc. The report found that Partners received Medicare reimbursement for hospice services that did not comply with Medicare requirements, and either did not support the beneficiary's terminal prognosis, or the clinical record did not support the level of care claimed for Medicare reimbursement, resulting in at least $11.2 million in unallowable Medicare reimbursement for hospice services. OIG recommended that Partners refund payments that did not comply with Medicare requirements and strengthen its policies and procedures to ensure that hospice services comply with Medicare requirements. Partners generally did not concur with the recommendations. A summary of the report is available here.
On July 14, OIG released a report entitled Audit of Medicare Part D Pharmacy Fees: Group Health Cooperative, Inc. (GHC) The report found that GHC did not have adequate support for the point-of-sale fees that its PBMs charged to pharmacies, for CYs 2014 and 2015. Due to the lack of documentation, OIG could not validate whether the amounts GHC reported to CMS were accurate. For CY 2016, GHC's PBM did not charge pharmacy fees. For CY 2017, OIG determined that GHC correctly reported the pharmacy fees collected by its PBM. OIG recommend that Kaiser Permanente, which acquired GHC in 2017, validate the point-of-sale fee amounts for CYs 2014 and 2015 and refile the CY 2014 and 2015 DIR reports if appropriate, and develop written policies and procedures to validate the amounts its PBM discloses before submitting the DIR reports to CMS. Kaiser Permanente agreed with the recommendations. A summary of the report is available here.
On July 14, OIG released a report entitled Review of Medicare Administrative Contractor Information Security Program Evaluations for Fiscal Year 2020. The report found 99 gaps at the 7 MACs for FY 2020, which was 21 percent less than the number of gaps for the same 7 MACs in FY 2019. OIG advised that CMS should continue its oversight visits and ensure that the MACs remediate all gaps to improve the MACs' information technology security. The report contained no recommendations. A summary of the report is available here.
On July 14, OIG released a report entitled FY 2020 Health Care Fraud and Abuse Control Program Report
Congressional Research Service (CRS)
On July 15, CRS released a report entitled HHS FY2022 Budget Request. The report outlines the estimated $1.662 trillion in outlays in FY2022 for HHS, which is $115 billion more than estimated HHS outlays in FY2021. The proposed HHS outlays are split between Medicare (46%), Medicaid (34%), other mandatory spending (9%), and discretionary spending (10%).
Government Accountability Office (GAO)
On July 14, GAO released a report entitled Firearm Injuries: Health Care Service Needs and Costs. The report found that hospital costs for initial gun injury care were just over $1 billion a year, according to hospital data from 2016 and 2017 and Medicaid and other public coverage patients accounted for more than 60% of the costs for this care. GAO noted that costs associated with physicians' fees could add 20% to that total and studies that estimate lifetime costs of these injuries are no longer reliable indicators of costs because they are dated. GAO also found that survivors often face barriers to receiving needed care, such as being denied care when it is not covered by their insurance. A summary of the report is available here.
UPCOMING CONGRESSIONAL HEARINGS
House
None of note
Senate
HELP Committee – The Path Forward: The Federal Perspective on on the COVID-19 Response
10 a.m., July 20
Acting FDA Commissioner Janet Woodcock, CDC Director Rochelle Walensky, Biden’s chief medical adviser Anthony Fauci and Assistant HHS Secretary for Preparedness and Response Dawn O’Connell
· HELP Committee – Addressing Disparities in Life Expectancy
10 a.m., July 21,
Witnesses: TBA
OTHER HEALTH POLICY NEWS
On July 13, a study published in JAMA Network found that treatment of opioid use disorder increased among Medicaid enrollees in 11 U.S. states, from 2014 through 2018.
On July 13, the Kaiser Family Foundation released a report finding that Medicaid could face substantial costs for covering Aduhelm, even with rebates, and high per enrollee costs could lead Aduhelm to have a large aggregate impact on Medicaid drug spending.
On July 14, West Virginia Attorney General Patrick Morrisey said he will oppose Purdue Pharma’s bankruptcy plan, arguing that the settlement agreement would fail to recognize the disproportionate harm caused by opioids in the state.
On July 14, Cleveland Clinic and Mount Sinai announced that they will not administer Aduhelm, the Alzheimer’s treatment, to patients due to safety and efficacy concerns. On July 15, UnitedHealth announced that it is waiting on more information before making a coverage decision regarding Aduhelm.
On July 14, Urban Institute released a report entitled Filling the Medicaid Gap with a Public Option. The report found that a public option that pays Medicare rates instead of marketplace benchmark premiums would reduce federal premium tax credits for people in the Medicaid gap by about 28%. Urban Institute estimated that federal spending over 10 years would be $199-$217 billion with marketplace benchmarks, compared to $136- $148 billion with the public option. A summary of the report is available here.
On July 15, a panel of medical experts convened by the Institute for Clinical and Economic Review (ICER) unanimously voted (15-0) that there is no evidence to suggest Biogen’s Aduhelm offers patients any health benefits beyond the usual care and is not worth the $56,000 list price.
On July 16, MedPAC released its 2021 data book on health care spending and the Medicare program. The data book includes information on the following topics: