Health Care Policy Update – Weekly Wrap-up and What’s Ahead

What’s Ahead: This Week

Notable Policy Events –

Wednesday, January 4
- The Washington Post, “Tripledemic: Leana Wen Takes Your Questions About Rising Cases of COVID-19, Flu and RSV.” Additional information
Thursday, January 5
- CMS, “Nursing Home Stakeholder Call.” Additional information
- HHS Office for Civil Rights (OCR), “Briefing on New Strengthened Conscience and Religious Nondiscrimination Proposed Rule.” Additional information
- Substance Abuse and Mental Health Services Administration (SAMHSA), “Webinar Review of the Revised Draft of the Certified Community Behavioral Health Clinic Criteria Update.” Additional information

Weekly Wrap-Up: Notable Health Care Developments Since December 19, 2022

Consolidated Appropriations Act, 2023

During the week of December 19, the Consolidated Appropriations Act, 2023 (H.R. 2617) was unveiled and passed by Congress. This $1.7 trillion appropriations bill will fund the government during the fiscal year 2023, and includes many health-related provisions: prevent the Pay-As-You-Go (PAYGO) Medicare four percent sequester for two years; extend for two years critical rural Medicare programs, telehealth flexibilities and the Acute Hospital Care at Home program; allow states to begin processing Medicaid redeterminations on April 1, 2023, while phasing down the COVID-19 public health emergency (PHE)-related enhanced Federal Medical Assistance Percentage (FMAP); require state Medicaid programs to provide 12 months of continuous coverage for children and permanently allow states to offer 12 months of coverage for postpartum women; reduce the physician fee schedule cut from 4.5 percent to two percent for 2023 and around three percent for 2024; maintain a ban on the creation of a national patient ID and; provide $350 million in flexible funding for public health infrastructure and capacity to bolster public health infrastructure and rebuild the workforce at the state and local level. It also includes several provisions related to social determinants of health and health equity, maternal health, HIV/AIDS prevention, clinical trials, and more. Bill Text Bill Summary Press Release President Biden Statement
- On December 22, the Senate passed the bill by a vote of 68-29 with amendments. Below are health-related amendments that were adopted. Press Release List of Amendments
  - An amendment to include the Pregnant Workers Fairness Act (H.R. 1065), which would put in place protections for pregnant workers against workplace discrimination. The amendment was adopted on a 73-24 vote. Amendment Text
  - An amendment to include the PUMP Act (H.R. 3110), which would require employers to provide employees with space in the workplace and time off to pump breast milk. The amendment was adopted on a 92-5 vote. Amendment Text
  - A proposal to give state and local officials more flexibility in how they spend coronavirus relief dollars. The amendment was adopted by voice vote. Amendment Text
- On December 23, the House passed the bill by a vote of 225-201. Press Release
- On December 29, the President signed the bill into law. Press Release

Medicare, Medicaid & Marketplaces –

On December 19, the HHS Office of Inspector General (OIG) released a report which found that Medicare Part B spending on lab tests increased from $8 billion in 2020 to $9.3 billion in 2021. Report Report in Brief
Also on December 19, HHS OIG released audit findings which found that providers did not always comply with Federal requirements when claiming Medicare reimbursement for bad debts. Report Report in Brief
Also on December 19, the U.S. Government Accountability Office (GAO) released a report on Medicare waivers and flexibilities in response to the pandemic, changes in Medicare provider enrollment after implementing waivers and flexibilities, and CMS’ oversight of waivers and flexibilities. Report Report in Brief
On December 20, HHS OIG released a report which found that medical reviewers were unable to confirm the diagnosis in the majority of records for Medicaid-enrolled children with a diagnosis of lead toxicity. Report Report in Brief
Also on December 20, HHS OIG released a mandated analysis of Medicare home health service utilization from January 2016 through March 2022. Report Report in Brief
Also on December 20, HHS announced that it is publicly releasing ownership data for the more than 7,000 Medicare-certified hospitals on the CMS website in an effort to promote transparency and competition in the health care system. Press Release
Also on December 20, CMS released a report based on responses from a request for information (RFI) on access to care and coverage in Medicaid and CHIP. RFI responses were received February 17 through April 18, 2022. Report Summary
On December 21, HHS OIG released a report which found that the National Government Services, Inc. claimed some unallowable Medicare postretirement benefit plan costs through its incurred cost proposals. Report Report in Brief
Also on December 21, HHS OIG released a report which found that the National Government Services, Inc. claimed some unallowable Medicare supplemental executive retirement plan costs through its incurred cost proposals. Report Report in Brief
Also on December 21, HHS OIG released a report which found that the National Government Services, Inc. claimed some unallowable Medicare nonqualified plan costs through its incurred cost proposals. Report Report in Brief
On December 27, the Biden Administration announced that 11.5 million people nationwide selected a health plan on the ACA Marketplace as of December 15, 2022. About 1.8 million more people have signed up for health insurance, or an 18 percent increase, from this time last year. Press Release President Biden Statement
Also on December 27, the Administration for Community Living (ACL) announced a notice of funding opportunity (NOFO) for the Senior Medicare Patrol (SMP) program’s state and territorial projects. Press Release NOFO
Also on December 27, CMS sent a letter to state Medicaid directors providing guidance on section 9815 of the American Rescue Plan, which makes a 100 percent federal medical assistance percentage temporarily available for Medicaid services provided by certain Urban Indian Organizations and Native Hawaiian health care providers. Letter
Also on December 27, HHS OIG released a report which found most of the selected diagnosis codes that a Medicare Advantage organization submitted to CMS’ risk adjustment program did not comply with Federal requirements. Report Report in Brief
On December 29, CMS announced that New Mexico submitted an application to extend the state’s section 1115 demonstration, which authorizes a comprehensive managed care delivery system and home and community-based services Community Benefit Program. The comment period is open from December 29, 2022 through January 28, 2023. Pending Application Comments
On December 30, GAO published a request for nominations for Medicaid and CHIP Payment and Access Commission (MACPAC) appointments that will be effective May 2023. Notice

Payment & Delivery System Models –

On December 20, CMS released the evaluation for the first three years of the Maryland Total Cost of Care Model. The report found that from 2019 to 2021, the model reduced rates of all-cause acute care hospital admissions and total Medicare spending, and improved several quality-of-care measures. Report Two-Page Summary

Public Health Prevention, Surveillance & Data –

COVID-19 Data: To date, there are 100,622,056 total COVID-19 cases and 1,088,481 COVID-19 deaths in the United States. Also, 939,127,005 COVID-19 vaccines have been delivered and 663,822,575 individual COVID-19 vaccine doses have been administered. Data
FDA Action Update: To date, FDA has authorized 440 tests and sample collection devices under Emergency Use Authorizations (EUAs), including 297 molecular tests, 85 antibody tests and 57 antigen tests. FDA also continues to update COVID-19 FAQs.
On December 19, 25 Republican governors sent a letter to President Biden asking the President to allow the ongoing COVID-19 PHE to expire in April 2023. Letter
Also on December 19, ACL awarded two grants totaling $125 million to increase the number of older adults and people with disabilities who have received the updated COVID-19 vaccine and annual flu vaccine. Press Release
On December 20, the FDA issued emergency use authorizations (EUAs) for three new serial over-the-counter at-home COVID-19 antigen tests. EUAs
On December 21, HHS announced it is making additional supply of Tamiflu available to jurisdictions through Administration for Strategic Preparedness and Response (ASPR) Regional Teams to respond to an increased demand for the antiviral during this flu season, including through the Strategic National Stockpile (SNS). Press Release
Also on December 21, the FDA approved a new indication for Actemra injection for the treatment of hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Announcement
Also on December 21, Sens. Portman (R-OH), Peters (D-MI), and Stabenow (D-MI) sent a letter to Department of Homeland Security Secretary Mayorkas, Department of Veterans Affairs (VA) Secretary McDonough, and HHS Secretary Becerra requesting an update on the implementation of the Make PPE in America Act, which aims to strengthen efforts to onshore production of personal protective equipment (PPE). Press Release Letter
On December 23, HHS released a report that examines the utilization of oral antiviral medications, Paxlovid and Lagevrio, for the treatment of COVID-19. Report Report in Brief
On December 28, CDC announced that it will implement a requirement for a negative COVID-19 test or documentation of recovery for passengers boarding flights to the U.S. from China. Press Release

Health IT, Privacy, & Digital Health –

On December 19, GAO announced the appointment of seven members to the Health Information Technology Advisory Committee (HITAC). Press Release
Also on December 19, CMS issued a proposed rule, “Adoption of Standards for Health Care Attachments Transactions and Electronic Signatures, and Modification to Referral Certification and Authorization Transaction Standard,” which would adopt standards for “health care attachments” transactions. Fact Sheet Press Release Proposed Rule
Also on December 19, GAO published a report describing actions taken by federal agencies and non-federal cancer centers to facilitate enrollment of patients from diverse backgrounds in cancer clinical trials. The report found support for the use of telehealth in clinical trials to increase the proportion of patients from diverse backgrounds enrolled in federally funded cancer clinical trials, among other findings. Report Report in Brief
On December 20, the FDA published a blog on the Office of Digital Technology’s (ODT) Leadership Modernization Action Plan (LMAP) which lays out ODT’s plans to strengthen the technology leadership capabilities at the business, technology, data, and cybersecurity levels of the agency. Blog
Also on December 20, GAO released a report on the requirement of federal agencies to obtain written consent from individuals before disclosing personal information by November 2021. GAO found that as of August 2022, only one of 17 agencies had fully implemented this requirement. Report Report in Brief
Also on December 20, Rep. Eshoo (D-CA) wrote to Dr. David J. Skorton, President and CEO of the Association of Academic Medical Colleges (AAMC), to express privacy, economic, and national security concerns about medical schools and teaching hospitals using genomic sequencing machines manufactured by companies with ties to the People’s Republic of China (PRC). Press Release Letter
On December 21, the Health Resources and Services Administration (HRSA) Office for the Advancement of Telehealth released a best practice guide for HIV care via telehealth. This guide shares how to use telehealth to prevent, screen for and treat HIV. Guide
On December 22, the Sequoia Project, the Recognized Coordinating Entity (RCE) by the Office of the National Coordinator for Health IT (ONC) to support the Trusted Exchange Framework and Common Agreement (TEFCA), released the TEFCA Facilitated FHIR Implementation Guide (IG) Draft 2 and updated versions of the Qualified Health Information Network (QHIN) Onboarding & Designation Standard Operating Procedure (SOP) and QHIN Application. TEFCA Facilitated FHIR Implementation Guide, Draft 2 QHIN Onboarding & Designation SOP QHIN Application
Also on December 22, CMS released a data analysis which found that in the second quarter (Q2) of 2022, about 15 percent of Medicare beneficiaries used telehealth, down from 48 percent in Q2 of 2020. Data

Mental Health and Substance Use Disorder Policy –

On December 19, GAO released a report assessing the White House Office of National Drug Control Policy’s (ONDCP) strategy development plan for the 2022 National Drug Control Strategy, finding that the ONDCP met some strategy requirements but needs a performance evaluation plan. Report Report in Brief
On December 20, SAMHSA released an FAQ page on the 42 CFR Part 8 Notice of Proposed Rulemaking. This proposal would update the federal regulations that address opioid use disorder (OUD) treatment standards, as well as opioid treatment program (OTP) accreditation and certification standards. FAQ
On December 21, CDC released data on drug overdoses in the United States from 2001 to 2021. Data
Also on December 21, the Drug Enforcement Administration (DEA) announced the seizure of over 50.6 million fentanyl-laced, fake prescription pills and more than 10,000 pounds of fentanyl powder this calendar year. In 2021, 107,000 Americans died of drug overdoses, two thirds of which were caused by fentanyl, according to U.S. public health data. Press Release
On December 22, Senate Homeland Security and Governmental Affairs Committee Ranking Member Portman (R-OH) released a report examining the laws governing synthetic opioid interdiction, the synthetic opioid precursor supply chain from China to Mexico, and the finished-product supply chain from Mexico to the U.S. Press Release Report
Also on December 22, Sen. Warren (D-MA) and Rep. Blumenauer (D-OR) led a bipartisan and bicameral group of lawmakers in a letter urging the Biden Administration to deschedule marijuana. The letter comes after President Biden directed HHS and the Department of Justice (DOJ) to begin a formal review of the scheduling of marijuana. Letter Press Release
On December 23, SAMHSA released a request for comments on the initial revised draft of the update to the certified community behavioral health clinics certification criteria. Request for Comments

Prescription Drugs, Medical Devices, and Biomedical Research –

On December 19, the FDA announced that the U.S. District Court for the Western District of Oklahoma entered a consent decree against Qualgen LLC. that prohibits the company from directly or indirectly distributing adulterated drugs in interstate commerce. Press Release
On December 20, the White House Office of Science and Technology Policy (OSTP) announced a request for information (RFI) to help identify regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology. RFI
Also on December 20, HHS Secretary Becerra and FDA Commissioner Califf held conversations with senior leadership from major medicine manufacturers and distributors on the current production and distribution of over-the-counter pediatric medicines. Press Release
On December 22, the FDA approved Sunlenca, a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1). Press Release
Also on December 22, the FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics Trilogy 100 and Trilogy 200 ventilators. Safety Communication
On December 23, HHS OIG announced a new Work Plan Item titled “Implementation of Inflation-Indexed Rebates for Part B Drugs,” which is expected to be issued in 2023. This product will summarize insights from OIG’s previous work with the goal of assisting CMS in its implementation efforts of the Inflation Reduction Act. Work Plan Item
On December 28, the FDA approved Briumvi injection for treating patients with relapsing forms of multiple sclerosis (RMS) in adults. Information
On December 29, House Oversight & Reform Committee Chair Maloney (D-NY) and House Energy & Commerce Committee Chair Pallone (D-NJ) released a staff report following an 18-month investigation into the FDA’s regulatory review and approval process of Biogen’s Alzheimer’s disease drug Aduhelm, and Biogen’s pricing of Aduhelm. Press Release Report

Veterans Health and Military Health –

On December 29, the VA announced that it will begin processing PACT Act benefits claims for all Veterans and survivors on January 1, 2023. Press Release

Health Systems, Public Health & Health Equity –

On December 19, Rep. Spartz (R-IN) wrote an op-ed in The Hill, “Hospital monopolies are destroying health care value.” Op-Ed
Also on December 19, the Biden Administration released a federal strategic plan for preventing and ending homelessness in America, which sets a goal of reducing homelessness by 25 percent by 2025. Press Release Fact Sheet Strategic Plan
Also on December 19, HHS Secretary Becerra announced the annual release of the Department’s National Plan to Address Alzheimer’s Disease, from which HHS works to improve the trajectory of Alzheimer’s disease and related dementias (ADRD) research, support people living with dementia and their caregivers, and encourage action to reduce risk factors. Press Release Plan
Also on December 19, the FDA released findings and recommendations from an external evaluation assessing the Tobacco Program’s regulatory processes and agency operations. Press Release Evaluation
Also on December 19, the Agency for Healthcare Research and Quality (AHRQ) released a blog post, “Challenges and Opportunities in Home Health Quality Improvement.” Blog
On December 20, AHRQ released a blog post, “For Hospice Care, a Pressing Need to Ensure Quality for Patients and Families.” Blog
On December 22, CDC released a report that found mortality in the U.S. life expectancy for 2021 was 76.4 years, a decrease of 0.6 year from 2020. Heart disease, cancer, and COVID-19 remained the top three leading causes of death in 2021. Report
Also on December 22, House Education and Labor Committee Ranking Member Foxx (R-NC) sent a letter to HHS Secretary Becerra and multiple hospitals offering gender-transition interventions to children regarding compliance with the Child Abuse Prevention and Treatment Act and the Family Violence Prevention and Services Act. Press Release Letter
On December 29, the CDC noted that the number of young people under age 20 with diabetes in the United States is likely to increase more rapidly in future decades, according to a new modeling study published in Diabetes Care. Press Release Study
Also on December 29, HHS issued a Notice of Proposed Rulemaking (NPRM), entitled “Safeguarding the Rights of Conscience as Protected by Federal Statutes,” which proposes to restore the longstanding process for the handling of conscience complaints and provide additional safeguards to protect against conscience and religious discrimination in accessing care. Press Release NPRM
On December 30, HHS deployed a 14-member team from its National Disaster Medical System (NDMS) to the University of New Mexico (UNM) Children’s Hospital to help support the hospital emergency department due to the surge in pediatric patients. The team will directly help UNM Hospital’s staffing challenges, allowing existing staff needed relief and filling gaps in pediatric patient care. Press Release

Reproductive & Maternal Health –

On December 22, HHS published a blog on the Deputy Assistant Secretary for Population Affairs and Director, Office of Adolescent Health’s (OPA) public education campaign on access to reproductive health care services currently on digital platforms in five states across the U.S. Blog
On December 23, FDA released post market drug safety information for patients and providers for Plan B One-Step emergency contraceptive. Press Release

Misc. –

On December 20, FDA released guidance on best practices for convening a generally recognized as safe (GRAS) panel to independently evaluate if available scientific data, information, and methods establish that a substance is safe under the conditions of its intended use and if adding that substance to food is lawful under the GRAS provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Press Release Guidance Notice
On December 27, HHS released a report on the first two calendar quarters of operation for the Federal Independent Dispute Resolution portal, which is required by the No Surprises Act. Report
On December 28, the FDA issued the 2022 edition of the FDA Food Code, which provides guidance to state and local authorities and retailers to help mitigate foodborne illness risks at retail and provide a uniform set of national standards for retail food safety. The 2022 Food Code is part of the Biden Administration’s National Strategy on Hunger, Nutrition, and Health. Food Code 2022
On December 29, the Biden Administration released a 2022 Year in Review blog, outlining 12 achievements made by the Biden Administration in advancing equity, addressing hunger and nutrition, launching a whole-of-government mental health strategy, and other areas. Blog

Legislative Activity –

Votes and Committee Activity –

On December 20, the Cardiovascular Advances in Research and Opportunities Legacy Act (H.R. 1193) was signed into law by the President. The bill will establish a program under which the Director of the National Institutes of Health shall support or conduct research on valvular heart disease. Bill text Press release
Also on December 20, the Data Mapping to Save Moms’ Lives Act (S. 198) was signed into law by the President. The bill will require the Federal Communications Commission to incorporate data on maternal health outcomes into its broadband health maps. Bill text Press release
Also on December 20, the Rural Opioid Abuse Prevention Act (S. 2796) was signed into law by the President. The bill will provide for the eligibility of rural community response pilot programs for funding under the Comprehensive Opioid Abuse Grant Program. Bill text Press release
Also on December 20, the Early Hearing Detection and Intervention Act of 2022 (S. 4052) was signed into law by the President. The bill will reauthorize a program for early detection, diagnosis, and treatment regarding deaf and hard-of-hearing newborns, infants, and young children. Bill text Press release
On December 22, the Colonel Mary Louise Rasmuson Campus of the Alaska VA Healthcare System Act of 2022 (S. 5016) passed the House by a voice vote. This bill would designate the medical center of the Department of Veterans Affairs in Anchorage, Alaska, as the Colonel Mary Louise Rasmuson Campus of the Alaska VA Healthcare System. The bill now heads to the President to sign into law. Bill text Press release
Also on December 22, the Veterans Auto and Education Improvement Act of 2022 (H.R. 7939) passed the House by a vote of 380-35, as amended. This bill would provide permanent authority for the application of certain flexibilities to assist veterans with their educational assistance benefits during emergency situations (as declared by the President). The bill now heads to the President to sign into law. Bill text Press release
Also on December 22, the State Offices of Rural Health Program Reauthorization Act of 2022 (S. 4978) passed the House by a voice vote. The bill would reauthorize the State offices of rural health program. The bill now heads to the President to sign into law. Bill text Press release
Also on December 22, the Childhood Cancer STAR Reauthorization Act (S. 4120) passed the House by voice vote. This bill would reauthorize through FY2028 and modify pediatric cancer research and related programs, including to expand collection of and access to relevant biospecimens and to support the transition of pediatric cancer survivors to primary care. The bill now heads to the President to sign into law. Bill text Press release
Also on December 22, the Dr. Joanne Smith Memorial Rehabilitation Innovation Centers Act of 2022 (S. 2834) passed the House by a vote of 393-19. The bill would support rehabilitation facilities that lead the nation in medical research and complex treatment and would direct CMS to publish and biennially update a list of all rehabilitation innovation centers. The bill now heads to the President to sign into law. Bill text Press release
On December 23, the James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 (H.R. 7776) was signed into law by the President. The bill, which authorizes fiscal year appropriations for the Department of Defense, for Department of Energy national security programs, and for the Department of State, Department of Homeland Security, and the Intelligence Community, includes several health care provisions.. Bill text Press release
On December 27, the VA Peer Support Enhancement for MST Survivors Act (H.R. 2724) was signed into law by the President. The bill will provide for peer support specialists for claimants who are survivors of military sexual trauma. Bill text Press release
Also on December 27, H.R. 6064 was signed into law by the President. The bill will direct the Secretary of Veterans Affairs to seek to enter into an agreement with the National Academy of Sciences, Engineering, and Medicine (NASEM) for a review of examinations, furnished by the Secretary, to individuals who submit claims to the Secretary for compensation for mental and physical conditions linked to military sexual trauma. Bill text Press release
Also on December 27, the Faster Payments to Veterans’ Survivors Act of 2022 (H.R. 8260) was signed into law by the President. The bill will shorten the timeframe for designation of benefits under Department of Veterans Affairs life insurance programs and improve the treatment of undisbursed life insurance benefits by the Department of Veterans Affairs. Bill text Press release
Also on December 27, the Justice and Mental Health Collaboration Reauthorization Act of 2022 (S. 3846) was signed into law by the President. The bill will reauthorize the Justice and Mental Health Collaboration Program. Bill text Press release
Also on December 27, the Law Enforcement De-Escalation Training Act of 2022 (S. 4003) was signed into law by the President. The bill will provide for training on alternatives to use of force, de-escalation, and mental and behavioral health and suicidal crises. Bill text Press release

Introduced Legislation –

On December 19, Sen. Padilla (D-CA) introduced the Health Enterprise Zones Act (S. 5293), which would provide for the designation of areas as Health Enterprise Zones to reduce health disparities and improve health outcomes in such areas. Bill text Press release
Also on December 19, Sens. Klobuchar (D-MN) and Cardin (D-MD) introduced the Comprehensive Cancer Survivorship Act (S. 5295), which would address the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment. Bill text Press release Section by section One pager
On December 20, Reps. Schakowsky (D-IL), Quigley (D-IL), Fitzpatrick (R-PA), and Crow (D-CO) introduced the Medicare Payment Reform for People with ALS Act of 2022 (H.R. 9638), which would provide coverage of ALS-related services under the Medicare program for individuals diagnosed with amyotrophic lateral sclerosis. Press release
Also on December 20, Sens. Paul (R-KY) and Lummis (R-WY) introduced the Health Savings Accounts for All Act (S. 5302), which would increase the limitations on contributions to health savings accounts. Bill text Press release One pager
Also on December 20, Sens. Cornyn (R-TX) and King (I-ME) introduced the Behavioral Intervention Guidelines (BIG) Act (S. 5325), which would develop best practices for the establishment and use of behavioral intervention teams at schools. Press release
On December 21, Rep. Beyer (D-VA) introduced the National All-Payer Claims Database Act (H.R. 9644), which would award a contract to an eligible nonprofit entity to establish and maintain a health care claims database for purposes of lowering Americans’ health care costs. Bill text Press release

Health Care Policy Update – Weekly Wrap-up and What’s Ahead – January 3, 2023

Events: