This Week in Washington: Fallout from debt ceiling holds up House floor action; SCOTUS rules to allow patients to sue nursing homes

Upcoming Hearings

Congress

House

• House Speaker Faces Backlash Over Debt Ceiling Agreement
• House Ways and Means Committee Marks Up Nine Bills
• SCREENS Act Introduced

Senate

• Senate Finance Committee Holds Hearing on Healthcare Ownership and Consolidation
• Wyden and Pallone Urge CMS to Prevent More Coverage Losses Under Medicaid Redeterminations

Administration

• HHS Releases STI Federal Implementation Plan
• CMS Releases List of 43 Part B Drugs with Potentially Lower Coinsurance Costs
• CMS Names Medicare Drug Price Negotiation Program Acting Director
• CMS Releases Innovation Center Quality Measure Information
• CMS Announces New CMMI Primary Care Model
• FDA Submits 2022 Drug Shortages Report to Congress
• FDA Issues Guidance on Oral Contraceptive Clinical Drug Interactions
• FDA Grants Cue COVID-19 At-Home Test Marketing Authority
• FDA Releases Clinical Trial Modernization Draft Guidance and Request Comments
• SAMHSA Publishes National Model Standards for Peer Support Certification

Proposed Rules

• FDA Proposes Rule to Broaden Prescription Drug Labeling Regulations
• CMS Proposes Rule to Strengthen Medicaid Drug Price Transparency and Verification
• CMS Proposes Rule Concerning Medicaid Access
• CMS Proposed Rule Seeks to Improve Access to Medicaid Services
• HHS OCR Proposed Rule Modifies HIPAA and HITECH Privacy Rule
• HHS ONC Proposed Rule Updates Electronic Health Information Infrastructure
• FDA Proposes New Tobacco Product Manufacturing Practices Requirements

Final Rules

• CMS Final Rule Clarifies Medicare DSH Payment Adjustment Part C Days
• CMS Final Rule Eliminates COVID-19 Healthcare Worker Vaccination Requirement
• DEA Releases Temporary Rule Extending COVID-19 Telemedicine Flexibilities
• CMS Releases Notice of Benefit and Payment Parameters for 2024 Final Rule
• CMS Finalizes 2024 Medicare Advantage and Part C and D Payment Policies
• FDA Issues Final Rule Regarding Mammography Quality Standards
• FDA Delays Tobacco Product Required Warning Final Rule Effective Date
• CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

Courts

• Supreme Court Preserves Patients’ Right to Sue Nursing Homes
• Appeals Court Considers Lifting Freeze on ACA-Preventive Care Provision Ruling
• Merck Sues HHS Over Medicare Drug-Price Negotiation Law

Reports

• GAO Releases Report on HHS Public Health Leadership Concerns
• GAO Releases Report on Zoonotic Disease Risks

---

Upcoming Hearings

June 13

House

House Committee on Education and the Workforce Full Committee Hearing: “Examining the Policies and Priorities of the Department of Health and Human Services”
10:15 a.m., Rayburn House Office Building 2175
Announced witnesses are:

• The Honorable Xavier Becerra, Secretary of the U.S. Department of Health and Human Services

House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic Hearing: “Oversight of CDC Policies and Decisions During the COVID-19 Pandemic”
10:30 a.m., Rayburn House Office Building 2154
Witnesses to be announced.

House Committee on Veterans’ Affairs Subcommittee on Health Oversight Hearing: “Care Coordination: Assessing Veteran Needs and Improving Outcomes”
1:00 p.m., Cannon House Office Building 390
Announced witnesses are:

• M. Christopher Salso, Ph.D., Assistant Undersecretary of Health/Chief Nursing Officer at the Veterans Health Administration Office of Patient Care Services
• Sachin Yende, M.D., Chief Medical Officer at the Veterans Health Administration Office of Integrated Veteran Care
• Jennifer Strawn, Ph.D., Deputy Chief Nursing Officer/Executive Director at the Veterans Health Administration Office of Nursing Services
• Jill Debord, Executive Director at the Veterans Health Administration Office of Care Management and Social Work Services
• Julie Kroviak, M.D., Principal Deputy Assistant Inspector General of Health Inspections at the Department of Veterans Affairs Office of the Inspector General
• Andrea Sawyer, Advocacy Director at the Quality of Life Foundation
• Matt Brady, Director of the Wounded Warrior Project Complex Case Coordination Program
• Roscoe Butler, Senior Health Policy Advisor at Paralyzed Veterans of America

Senate

June 14

House

Senate

Senate Committee on Veterans’ Affairs Full Committee Hearing: “Connections to Care: Improving Substance Use Disorder Care for Veterans in Rural America and Beyond”
3:00 p.m., Russell Senate Office Building 418
Witnesses to be announced.

Congress

House

House Speaker Faces Backlash Over Debt Ceiling Agreement

Led by members of the conservative House Freedom Caucus, a group of 11 Republicans broke with their party on a routine procedural vote and paralyzed the House floor, tossing the week’s schedule into disarray. It is the first procedural vote to fail since 2002.

The members said the recently passed debt ceiling agreement, both in substance and in process, violated the promises McCarthy made to conservatives during the speakership vote in January.

The unhappy members have prevented votes on four GOP bills scheduled to be considered by the House. The House adjourned for the week with no path forward outlined.

However, the longer-term implications of this opposition are significant. The speaker and the House leadership will need to unite the Republican caucus in order to move crucial legislation like funding the government.

House Ways and Means Committee Marks Up Nine Bills

On June 7, the House Ways and Means Committee marked up nine bills. The healthcare bills that were considered include:

H.R. 3799, Custom Health Option and Individual Care Expense Arrangement (CHOICE) Act This legislation would codify a 2019 rule that allows employers to provide tax-advantaged funds when reimbursing employees for buying their own health insurance on the individual market.

H.R. 3798, Small Business Flexibility Act

This legislation would require the U.S. Treasury to notify businesses of various flexible healthcare coverage options available to them, including custom health option and individual care expense (CHOICE) arrangements, qualified small employer health reimbursement arrangements and the small business healthcare tax credit.

H.R. 3800, Chronic Disease Flexible Coverage Act

This legislation would codify chronic disease management flexibilities and allow beneficiaries with high-deductible health plans in connection with health savings accounts to access 14 preventative care services related to chronic disease management. Beneficiaries would be able to access these services at no cost and before their minimum deductible is reached.

H.R. 1843, Telehealth Expansion Act of 2023

This legislation would amend the Internal Revenue Code of 1986 and permanently extend the exemption for telehealth services from certain high-deductible health plan rules. It would allow beneficiaries with high-deductible health plans to access telehealth services before they hit their minimum deductible.

H.R. 3797, Paperwork Burden Reduction Act

This legislation would allow employers to access 1095-B and 1095-C forms online and would end the requirement that both forms be mailed to employees. These forms are used to verify employee health insurance coverage.

H.R. 3801, Employer Reporting Improvement Act

This legislation would make changes to the Affordable Care Act (ACA) annual health insurance coverage data reporting requirement. It would grant employers more flexibility when providing personal information for employees, spouses and children to the Internal Revenue Services (IRS) and would extend the appeal window for incorrectly submitting information to the IRS to a minimum of 90 days. It would also implement a six-year statute of limitations on the IRS’s ability to assess penalties on small businesses.

In addition, the committee considered three bills related to identity theft and Social Security protections.

For more information, click here.

SCREENS Act Introduced

On June 7, Reps. Fitzpatrick (R-PA) and Morelle (D-NY) introduced the Screening for Communities to Receive Early and Equitable Needed Services (SCREENS) for Cancer Act. The legislation would reauthorize the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) through 2028 and would help make cancer screening services more accessible. Sens. Baldwin (D-WI) and Collins (R-ME) introduced a companion bill in the Senate.

For more information, click here.

Senate

Senate Finance Committee Holds Hearing on Healthcare Ownership and Consolidation

On June 8, the Senate Finance Committee held a hearing on corporate healthcare ownership and consolidation. Witnesses included:

• Zack Cooper, Ph.D., Associate Professor of Public Health and Economics at Yale University
• Shawn Martin, Executive Vice President and Chief Executive Officer of the American Academy of Family Physicians
• Karen Maddox, M.D., MPH, Associate Professor of Medicine at Washington University
• Chris Thomas, FACHE, President and Chief Executive Officer of Community Hospital
• Caroline Pearson, Executive Director of Peterson Center on Healthcare

For more information, click here.

Wyden and Pallone Urge CMS to Prevent More Coverage Losses Under Medicaid Redeterminations

Senate Finance Committee Chair Ron Wyden (D-OR) and ranking House Energy and Commerce Committee member Frank Pallone (D-NJ) wrote the Centers for Medicare and Medicaid Services (CMS) to urge the agency to use all the tools Congress has provided to prevent more coverage losses in states where early reports show thousands of Medicaid beneficiaries have lost coverage for procedural reasons. The members also requested that CMS immediately release the redetermination data that states must report that the agency has yet to produce.

Administration

HHS Releases STI Federal Implementation Plan

On June 8, the Department of Health and Human Services (HHS) released the Sexually Transmitted Infections (STI) Federal Implementation Plan. The plan details the actions various federal agencies and departments have taken to improve public health in the U.S. and outlines the steps HHS has taken to address and combat the rise of STIs. It also explains how federal agencies will work toward preventing new STI infections, reducing adverse STI outcomes, accelerating STI research and innovation, and addressing STI-related health disparities and inequities.

For more information, click here.

CMS Releases List of 43 Part B Drugs with Potentially Lower Coinsurance Costs

On June 9, the Centers for Medicare and Medicaid Services (CMS) published a list of 43 Medicare Part B drugs that it believes will have lower coinsurance costs for Medicare Part B beneficiaries between July 1 and Sept. 30, 2023. The listed drugs are subject to a provision in the Inflation Reduction Act (IRA) that requires manufacturers to pay a rebate to Medicare if they increase the price for their drugs faster than the rate of inflation. CMS believes the coinsurance costs will be lower for the announced drugs since their prices rose faster than the rate of inflation in a benchmark quarter.

In addition, the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) released a report on Medicare Part B drug spending that occurred between 2008 and 2021. The report analyzes the major drivers of drug spending, specifically spending on biologics and specialty oncology, ophthalmology and rheumatology drugs. It also discusses the impact of current payment system incentives and highlights IRA provisions that aim to decrease prescription drug prices.

For more information on the Part B Drug List, click here.

For more information on the ASPE Drug Spending Report, click here.

CMS Names Medicare Drug Price Negotiation Program Acting Director

On June 6, the Centers for Medicare and Medicaid Services (CMS) named Christina Ritter Acting Director of the Medicare division responsible for implementing the Medicare drug price negotiation program. She most recently worked as the director of the Center for Medicare and Medicaid Innovation (CMMI) Patient Care Models Group.

CMS Releases Innovation Center Quality Measure Information

On June 9, the Centers for Medicare and Medicaid Services (CMS) released detailed quality measure information for 12 CMS Innovation Center models and demonstrations. The information, which is available under the CMS Measures Inventory Tool (CMIT), shows what measures CMS uses to strengthen healthcare quality and improvement.

For more information, click here.

CMS Announces New CMMI Primary Care Model

On June 8, the Centers for Medicare and Medicaid Services (CMS) announced a new voluntary CMS Innovation Center model called the Making Care Primary (MCP) model. The MCP model is a 10.5-year multipayer model with three participation tracks that build upon previous primary care models such as the Comprehensive Primary Care (CPC), Comprehensive Primary Care Plus (CPC+) and Primary Care First (PCF) models.

The MCP model aims to improve care coordination and management, equip primary care clinicians with resources to form partnerships with healthcare specialists, and strengthen patient health-related social needs (HRSNs) such as housing and nutrition. CMS will launch the program on July 1, 2024, and will begin accepting applications in late summer 2023. The program will be tested in eight states, specifically CO, MA, MN, NC, NJ, NM, NY and WA.

For more information, click here.

FDA Submits 2022 Drug Shortages Report to Congress

On June 8, the Food and Drug Administration (FDA) submitted its calendar year (CY) 2022 Drug Shortages Report to Congress. The report provides background on actions taken by the FDA to prevent and mitigate drug shortages and includes analysis of data that was collected by the FDA Center for Biologics Evaluation and Research (CBER) and the FDA Center for Drug Evaluation and Research (CDER). It also summarizes ongoing FDA drug shortage mitigation activities.

For more information, click here.

FDA Issues Guidance on Oral Contraceptive Clinical Drug Interactions

On June 8, the Food and Drug Administration (FDA) released final guidance intended to help sponsors of investigational new drug applications (INDs) and new drug applications (NDAs) evaluate the drug-drug interaction (DDI) of their drugs on combined oral contraceptives (COCs). The guidance focuses on recommendations relevant to metabolism-based drug interactions with COCs and aims to help pharmaceutical makers with designing DDI studies and communicating DDI study results and risk mitigation strategies via labeling.

For more information, click here.

FDA Grants Cue COVID-19 At-Home Test Marketing Authority

On June 6, the Food and Drug Administration (FDA) granted marketing authority to the Cue COVID-19 Molecular At-Home Test. The test is a molecular nucleic acid amplification test (NAAT) that is capable of detecting genetic material from the SARS-COV-2 virus present in nasal swabs of adults. It is the first over-the-counter (OTC) COVID-19 test to be granted marketing authorization using a traditional premarket review pathway. The Cue COVID-19 test was 98.7 percent accurate at identifying negative COVID-19 cases and 92.9 percent accurate at identifying positive ones.

For more information, click here.

FDA Releases Clinical Trial Modernization Draft Guidance and Request Comments

On June 6, the Food and Drug Administration (FDA) issued a draft guidance outlining good clinical practices (GCPs) that seek to support the modernization of medical product clinical trials. The GCPs are aimed at improving the efficiency and safety of clinical trials and increasing the implementation of innovative trial designs and health technologies.

The draft guidance also outlines principles that encourage the use of risk-based and proportionate clinical trial data collection, monitoring and quality management. The FDA is requesting comments on the draft guidance and will consider comments submitted by Sept. 5, 2023.

For more information, click here.

SAMHSA Publishes National Model Standards for Peer Support Certification

On June 6, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a guide outlining national model standards for substance use, mental health and family peer workers. The standards seek to facilitate the adoption, recognition and integration of peer workers across the healthcare system, and were developed with the input of federal, state, tribal, territorial and local partner feedback.

For more information, click here.

Proposed Rules

FDA Proposes Rule to Broaden Prescription Drug Labeling Regulations

On May 30, the Food and Drug Administration (FDA) released a proposed rule that would amend human prescription drug product labeling regulations for medication guides. The proposed rule would require prescription drug and biological product applicants to include a new one-page medication guide known as the Patient Medication Information (PMI) along with products that are used, dispensed or administered in an outpatient setting. Blood and blood components transfused in an outpatient setting would also require a PMI. The PMI would include essential information such as the product’s name, important safety information, common side effects and directions for use.

Public comments will be accepted until Nov. 27, 2023. For more information, click here.

CMS Proposes Rule to Strengthen Medicaid Drug Price Transparency and Verification

On May 23, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that seeks to increase the transparency of Medicaid prescription drug costs. The proposed rule would implement new policies in the Medicaid Drug Rebate Program (MDRP) and would revise and modify MDRP administrative provisions and definitions. It would:

• Designate a time limitation on drug manufacturers’ initiating audits with states;
• Clarify and establish requirements for state fee-for-service (FFS) pharmacy reimbursement;
• Codify certain conditions relating to states’ claiming Federal Financial Partnership (FFP) for physician-administered drugs (PADs);
• Clarify requirements for accumulating price concessions when determining best prices;
• Improve drug price verification and transparency through data collection;
• Propose two new contracting requirements between states and their Medicaid managed plans; and
• Revise third-party liability regulation.

Additionally, the proposed rule would require pharmacy benefit managers (PBMs) that contract with Medicaid to disclose the prices they pay for medications, and would establish a Drug Price Verification Survey Process that would require manufacturers and wholesalers of certain high-cost Medicaid drugs to share drug pricing information with CMS.

Public comments will be accepted until July 25, 2023. For more information, click here.

CMS Proposes Rule Concerning Medicaid Access

On May 3, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that seeks to strengthen and improve access to care, quality and health outcomes for Medicaid and Children’s Health Insurance Program (CHIP) managed care enrollees. Among the changes in the Ensuring Access to Medicaid Services are requirements to:

• Establish national maximum standards for certain appointment wait times for Medicaid and CHIP managed care enrollees;
• Establish stronger state monitoring and reporting requirements related to access and network adequacy for Medicaid and CHIP managed care plans;
• Establish a quality rating system for Medicaid and CHIP managed care plans;
• Require states to conduct annual enrollee experience surveys for Medicaid managed care plans;
• Implement new standards for states that use in lieu of services and settings (ILOSs) to promote effective utilization; and
• Specify medical loss ratio (MLR) requirements.

Public comments will be accepted until July 3, 2023. For more information, click here.

CMS Proposed Rule Seeks to Improve Access to Medicaid Services

On May 3, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that seeks to improve access to Medicaid fee-for-service (FFS), managed care delivery system, and in-home and community-based services (HCBS) programs. The proposed rule would:

• Increase program transparency and accountability;
• Standardize program data and monitoring;
• Create opportunities for states to promote active beneficiary engagement; and
• Strengthen how states use state Medical Care Advisory Committees.

Public comments will be accepted until July 3, 2023. For more information, click here.

HHS OCR Proposed Rule Modifies HIPAA and HITECH Privacy Rule

On April 12, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a proposed rule that would modify the Standards for Privacy of Individually Identifiable Health Information “privacy rule” under the Health Insurance Portability and Accountability Act of 1996 (HIPPA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009. The proposed rule would limit the use and disclosure of an individual’s protected health information (PHI) if it relates to an individual accessing lawful reproductive healthcare services. It would specifically prohibit the disclosure of such information for criminal, civil or administrative investigations or proceedings against individuals or regulated entities.

Public comments will be accepted until June 19, 2023. For more information, click here.

HHS ONC Proposed Rule Updates Electronic Health Information Infrastructure

On April 11, the Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released a proposed rule that would make several changes to the nationwide health information technology infrastructure. The proposed rule would:

• Implement the Electronic Health Record Reporting Program and make it a requirement for health information technology (Health IT) developers who are seeking certification;
• Modify and expand exceptions in information blocking regulations;
• Make revisions to the ONC Health IT Certification Program criteria;
• Adopt the United States Core Data for Interoperability (USCDI) Version 3 as standard for the ONC Health IT Certification Program; and
• Update implementation specifications and standards.

Public comments will be accepted until June 20, 2023. For more information, click here.

FDA Proposes New Tobacco Product Manufacturing Practices Requirements

On March 8, the Food and Drug Administration (FDA) released a proposed rule that would improve the manufacture, design, packing and storage of tobacco products. The proposed rule seeks to ensure that tobacco products comply with the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA has noted that it will help minimize and prevent tobacco product contamination, as well as inconsistencies in e-cigarette liquid concentrations and labeling. The proposed rule will also:

• Establish tobacco product design and development controls;
• Ensure that tobacco products meet established specifications;
• Crack down on tobacco products that do not meet specifications;
• Require manufacturers to take action in cases of product contamination;
• Require investigations of products that do not meet specifications; and
• Establish the ability to trace all components, ingredients, additives and materials used by tobacco product manufacturers.

Public comments will be accepted until Sept. 6, 2023. For more information, click here.

Final Rules

CMS Final Rule Clarifies Medicare DSH Payment Adjustment Part C Days

On June 7, the Centers for Medicare and Medicaid Services (CMS) released a final rule that establishes a policy that governs how the hospital inpatient days of Medicare Part C beneficiaries should be considered when calculating a hospital’s disproportionate share (DSH) payment adjustment. The policy is intended to provide clarity on how Part C days will be treated for DSH calculations that are not governed by the FY 2014 inpatient prospective payment system (IPPS)/long-term care hospital (LTCH) prospective payment system (PPS) final rule.

The rule will go into effect on Aug. 8, 2023. For more information, click here.

CMS Final Rule Eliminates COVID-19 Healthcare Worker Vaccination Requirement

On May 31, the Centers for Medicare and Medicaid Services (CMS) released a final rule that eliminates the COVID-19 vaccination requirement for healthcare workers. The vaccination requirement, which required all staff working in long-term care (LTC) facilities to receive an initial COVID-19 vaccine, was originally proposed in a Nov. 2021 interim final rule. The rule faced a series of legal challenges and officially went into effect in Jan. 2022, following a ruling by the U.S. Supreme Court.

Although the vaccination requirement is eliminated, the final rule will still require LTC facilities to provide education about COVID-19 vaccines and to offer them to residents, clients and staff. CMS announced that it will rely on proposed quality reporting measures to encourage providers to stay up to date on vaccines.

The rule will go into effect on Aug. 4, 2023. For more information, click here.

DEA Releases Temporary Rule Extending COVID-19 Telemedicine Flexibilities

On May 10, the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) released a temporary rule that extends telemedicine flexibilities adopted during the COVID-19 public health emergency (PHE). The temporary rule follows two Notices of Proposed Rulemaking (NPRM) regarding the virtual prescribing of controlled substances that the DEA released in March 2023, which received more than 38,000 public comments. The temporary rule specifically:

• Extends through Nov. 11, 2023, the COVID-19 PHE controlled substance prescribing flexibilities that allows practitioners to prescribe controlled substances via telemedicine without having to evaluate patients in person.
• Implements a one-year grace period through Nov. 11, 2024, for practitioners and patients who have or who develop a telemedicine relationship on or before Nov. 11, 2023. A “telemedicine relationship” is considered to exist if a practitioner has already issued a prescription for a controlled substance to a patient.

The temporary rule will stay in effect through Nov. 11, 2024. For more information, click here.

CMS Releases Notice of Benefit and Payment Parameters for 2024 Final Rule

On April 19, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will finalize standards for issuers that offer qualified health plans (QHPs) through federally-facilitated exchanges (FFEs) and state-based exchanges on the federal platform (SBE-FPs), and changes made to the payment parameters and provisions of the Department of Health and Human Services (HHS)-operated risk adjustment and risk adjustment data validation programs. The final rule will:

• Make it easier for individuals losing Medicaid or Children’s Health Insurance Program (CHIP) coverage to obtain health coverage by granting them a special enrollment period (SEP) 60 days before or 90 days after losing coverage;
• Grant healthcare plan assisters permission to provide enrollment assistance to individuals;
• Add Substance Use Disorder Treatment Centers and Mental Health Facilities to the essential community provider (ECP) list;
• Extend the requirement to contract with at least 35 percent of available ECPs in a service area to Federally Qualified Health Centers and Family Planning Providers;
• Refine health plan designs for standardized plan options; and
• Limit the number of non-standardized plan options offered by issuers of qualified health plans (QHPs) to four in each service area.

The rule will go into effect on June 18, 2023. For more information, click here.

CMS Finalizes 2024 Medicare Advantage and Part C and D Payment Policies

On March 31, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will finalize the calendar year (CY) 2024 payment policies for the Medicare Advantage (MA) and Medicare Part C and D programs. The final rule implements several changes that were made with regard to the Medicare programs listed above, which are outlined in a Rate Announcement released by CMS. The final rule will:

• Finalize technical changes and updates made to the MA risk adjustment model, which include transitioning the model to reflect International Classification of Diseases 10 (ICD-10) condition categories and updating the model with recent Medicare data years. CMS intends on phasing in the updated model over the next three years.
• Finalize changes to the Medicare Part C and D Star Ratings. CMS will provide a list of the eligible disasters for the extreme and uncontrollable circumstances adjustment and of non-substantive updates made to several measure specifications.

CMS’ rate announcement update reflects a 3.32 percent increase in MA payments, equivalent to approximately $13.8 billion. Additionally, the update reflects a 2.28 percent increase in the MA payment effective growth rate, a 1.24 percent decline in star ratings and a 4.4 percent increase in the MA risk score trend.

The rule will go into effect on Jan. 1, 2024. For more information, click here.

FDA Issues Final Rule Regarding Mammography Quality Standards

On March 9, the Food and Drug Administration (FDA) issued a final rule that updates the regulations implemented by the Mammography Quality Standards Act of 1992. The FDA has decided to update the regulations due to advancements made in mammography technology and information. The final rule will:

• Improve the delivery of mammography services;
• Strengthen communication of healthcare information;
• Require mammography facilities to provide patients with additional health information;
• Ensure the availability of qualified mammography personnel;
• Bolster medical outcome audits;
• Modernize technological aspects of mammography services; and
• Implement enforcement tools to deal with noncompliant facilities.

The rule will go into effect on Sept. 10, 2024. For more information, click here.

FDA Delays Tobacco Product Required Warning Final Rule Effective Date

On Nov. 25, the Food and Drug Administration (FDA), in compliance with an order issued by the U.S. District Court for the Eastern District of Texas, delayed the effective date of a final rule published on March 18, 2020, titled “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements.” The rule, which was originally supposed to go into effect on June 18, 2021, establishes new cigarette health warnings for cigarette packages and advertisements.

The rule will go into effect on Nov. 6, 2023. For more information, click here.

CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

On Nov. 17, the Centers for Medicare and Medicaid Services (CMS) corrected a technical error that was found in a final rule published in the Federal Register on July 11, 2022. The final rule updates proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to address analytes and newer technologies.

The rule goes into effect July 11, 2024. For more information, click here.

Courts

Supreme Court Preserves Patients’ Right to Sue Nursing Homes

On June 8, the U.S. Supreme Court ruled 7-2 to protect the right of patients to sue nursing homes that violate patient civil rights that are granted under Medicaid through the Federal Nursing Home Reform Act. The case, Health and Hospital Corp. of Marion County v. Talevski, was brought by Gorgi Talevski, a dementia patient who sued his nursing home after he alleged that he had been inappropriately subjected to psychotropic drugs and involuntary transfers.

Two lower courts affirmed Talevski’s right to sue, but the Health and Hospital Corp. of Marion County appealed the lower court rulings to the U.S. Supreme Court in Nov. 2021, arguing that they allowed patients to second-guess routine medication and transfer decisions.

Appeals Court Considers Lifting Freeze on ACA-Preventive Care Provision Ruling

On June 7, a panel of judges from the 5th Circuit Court of Appeals heard arguments from plaintiff and defense attorneys engaged in an ongoing legal battle over whether an Affordable Care Act (ACA) provision that ensures certain preventive care services are provided at no cost should remain in effect or not.

The panel is considering whether to extend a partial stay it implemented in response to a March ruling issued by Judge Reed O’Connor of the U.S. District Court for the Northern District of Texas that struck down the provision. Judge O’Connor argued that the provision violates the U.S. Constitution’s Appointments Clause.

The panel is urging both defense and plaintiff to broker a compromise that would narrow the nationwide ruling without violating the rights of the plaintiffs. Should the stay be lifted, millions of people could lose access to no-cost physicals, cancer screenings and HIV-prophylaxis drugs.

Merck Sues HHS Over Medicare Drug-Price Negotiation Law

On June 6, pharmaceutical company Merck announced that it was suing the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) over the Medicare drug price negotiation program. Merck is arguing that a program provision that requires drug manufacturers to provide minimum discounts violates the Fifth Amendment’s takings clause. It also argues that the requirement to negotiate violates the First Amendment’s compelled-speech doctrine.

For more information, click here.

Reports

GAO Releases Report on HHS Public Health Leadership Concerns

On June 7, the Government Accountability Office (GAO) released a report outlining principles it would like the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) to adopt, in order to strengthen their respective federal public health emergency preparedness and response capabilities.

In January 2022, GAO added HHS to the GAO High-Risk List, due to systemic deficiencies it found in HHS’s ability to respond to previous public health emergencies such as the H1N1 influenza, Zika and Ebola outbreaks. The GAO found that HHS lacked clearly outlined roles and responsibilities, consistent data and communication practices, and transparency and accountability principles. This report details the latest leading practices that GAO has submitted to HHS.

For more information, click here.

GAO Releases Report on Zoonotic Disease Risks

On May 31, the Government Accountability Office (GAO) released a report regarding the risk that zoonotic diseases pose to human health. The report examines the settings where zoonotic diseases typically spread and analyzes efforts the federal government has undertaken to coordinate surveillance for zoonotic diseases in U.S. wildlife. It also examines existing federal regulation that is intended to prevent the introduction of zoonotic diseases from imported wildlife.

The GAO analyzed various zoonotic disease prevention strategies employed by agencies such as the Centers for Disease Control and Prevention (CDC), the Animal and Plant Health Inspection Service (APHIS) and the U.S. Geological Survey (USGS) and determined that the agencies face multiple obstacles in establishing clear preventive strategy objectives and outcomes. The GAO also discovered that current approaches used by the CDC are insufficient to prevent zoonotic disease outbreaks. The GAO was asked to review issues related to the emergence of zoonotic diseases by a congressional report.

For more information, click here.