This Week in Washington: FDA funding bill passes House Appropriations Committee, MedPAC and MacPAC release June 2023 report to Congress, RSC budget blueprint brings back premium support concept for Medicare

Upcoming Hearings

Congress

House

• RSC Releases FY2024 Budget Blueprint
• House Appropriations Committee Marks Up FDA Funding Bill
• House Energy and Commerce Committee Chairman and Senate Finance Committee Ranking Member Request Information on Drug Shortages

Senate

• Patients Before Middlemen Act Introduced
• No Free TRIPS Act Introduced
• Senate HELP Committee Chairman Releases Report on Prescription Drug Prices
• MedPAC Releases Report to Congress and Announces Leadership Change
• MacPAC Releases June 2023 Report to Congress

Administration

• HHS Secretary Sends Letter to Governors Regarding Medicaid Redeterminations
• HHS Releases Fact Sheet on Medicare Extra Help Program
• HHS Launches $15 Million Pediatric Specialty Loan Repayment Program
• President Nominates CDC Director
• CMS Seeking Members for Air Ambulance and Patient Safety Advisory Committee
• CMS Office of the Actuary Releases National Health Expenditure Projections
• CMS Releases No Surprises Act Consumer Information Website
• FDA Selects COVID-19 Strain for Fall 2023 Vaccines
• FDA Updates Off-Patent, Off-Exclusivity Drug List
• HRSA Awards $9 Million to Support Behavioral Health Services

Proposed Rules

• ACL Proposed Rule Updates Older Americans Act Program Regulations
• 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
• 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 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

• U.S. 5th Circuit Court of Appeals Grants Partial Stay in ACA-Preventive Care Case

CBO Cost Estimates

• CBO Releases Cost Estimate on H.R. 2813, Self-Insurance Protection Act
• CBO Releases List of CBO Health Analysis Division Presentations

Upcoming Hearings

June 21

House

House Energy and Commerce Committee Health Subcommittee Legislative Hearing: “Responding to America’s Overdose Crisis: An Examination of Legislation to Build Upon the SUPPORT Act”
10:00 a.m., Rayburn House Office Building 2322
Announced witnesses are:

• Matthew Strait, Deputy Assistant Administrator of the Drug Enforcement Administration Office of Diversion Control
• Christopher Jones, PharmD, DrPH, MPH, Director of the Centers for Disease Control and Prevention National Center for Injury Prevention and Control
• Tom Coderre, Acting Deputy Assistant Secretary of the Substance Use and Mental Health Services Administration
• Diana Espinosa, MPP, Principal Deputy Administrator of the Health Resources and Services Administration
• Jonathan Blum, MPP, Principal Deputy Administrator and Chief Operating Officer for the Centers for Medicare and Medicaid Services

House Education and Workforce Committee Subcommittee on Health, Employment, Labor and Pensions Hearing: “Competition and Transparency: The Pathway Forward for a Stronger Health Care Market”
10:15 a.m., Rayburn House Office Building 2175
Announced witnesses are:

• Greg Baker, CEO of Affirmed RX
• Sophie Tripoli, Director of Health Care Innovation at Families USA
• Gloria Sachdev, President, CEO and Board Chair of Employers’ Forum of Indiana
• Christine Monahan, Assistant Research Professor at the Georgetown University Center on Health Insurance Reforms (CHIR)

Senate

Senate Veterans’ Affairs Committee Full Committee Hearing: “Examining the Effectiveness of the Office of Integrated Veteran Care”
3:30 p.m., Russell Senate Office Building 418
Witnesses to be announced.

June 22

House

House Energy and Commerce Committee Oversight and Investigations Subcommittee Hearing: “MACRA Checkup: Assessing Implementation and Challenges that Remain for Patients and Doctors”
10:30 a.m., Rayburn House Office Building 2322
Witnesses to be announced.

Congress

House

RSC Releases FY2024 Budget Blueprint

On June 14, the Republican Study Committee (RSC) released its proposed budget plan for fiscal year (FY) 2024. The plan proposes to raise the age at which retirees can claim full Social Security benefits from 67 to 69, for individuals who turn 62 in 2033. It also calls for the adoption of a premium support concept for Medicare. The premium support concept is an approach to reforming Medicare that seeks to reduce growth in Medicare spending by increasing competition among health plans and providing a stronger incentive for beneficiaries to be cost conscious and incentivize beneficiaries to choose private health plans. These plans would run alongside traditional Medicare. Premium support was championed by Rep. Paul Ryan (R-WI) when he was in Republican leadership and by former President Trump. It was widely criticized by Democrats.

In addition, the plan would:

• Cut total spending by $16.3 trillion over the next 10 years;
• Increase defense spending to $969 billion by FY 2033;
• Decrease nondefense spending to $522 billion in FY 2024 and increase it to $553 billion by FY 2033;
• Implement $5.1 trillion in tax cuts over the next 10 years; and
• Eliminate funding for the Community Development Block Grant, National Endowment for the Arts and Corporation for Public Broadcasting programs.

For more information, click here.

House Appropriations Committee Marks Up FDA Funding Bill

On June 14, the House Appropriations Committee marked up and reported out of committee the fiscal year (FY) 2024 funding bill for the Food and Drug Administration (FDA). The bill would allocate $6.6 billion to the FDA in FY 2024, approximately $7.2 billion less than what the president had requested in his budget. Committee members were divided over riders and provisions that are included in the bill.

One provision would narrow prescribing requirements for the abortion pill mifepristone and prohibit the pill from being mailed to patients. Another would prevent the Department of Health and Human Services (HHS) from banning menthol cigarettes and prohibit the department from limiting the nicotine content of cigarettes. During the markup, Democratic committee members introduced two amendments to the bill but both failed.

For more information, click here.

House Energy and Commerce Committee Chairman and Senate Finance Committee Ranking Member Request Information on Drug Shortages

On June 12, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Senate Finance Committee Ranking Member Mike Crapo (R-ID) issued a request for information (RFI) on the rise of drug shortages throughout the country.

The RFI is directed at prescription drug supply chain stakeholders. The RFI contains a series of questions that the Chair and Ranking Member would like answered to understand why the shortages are occurring and what can be done to resolve them. Both the House Energy and Commerce and Senate Finance Committees have been working on legislation related to strengthening drug supply chains and increasing patient access to prescription drugs. Responses for the RFI are due by July 7, 2023.

For more information, click here.

Senate

Patients Before Middlemen Act Introduced

On June 14, Senate Finance Committee Chairman Ron Wyden (D-OR), Ranking Member Mike Crapo (R-ID) and Sens. Menendez (D-NJ), Blackburn (R-TN), Tester (D-MT) and Marshall (R-KS) introduced the Patients Before Middlemen (PBM) Act. The legislation would:

• Prohibit pharmacy benefit managers (PBMs) from receiving compensation based on the price of a prescription drug when entering into a contract with a Medicare Part D plan. PBM service fees will not be linked to the price of a drug, discounts, rebates or other fees; and
• Implement an enforcement measure that would require PBMs to pay the Secretary any amount that exceeds the designated service fees.

In April, the Chair and Ranking Member of the Senate Finance Committee released a legislative framework to address PBMs and issues with the prescription drug supply chain. It seeks to reduce prescription drug costs for patients and taxpayers by modernizing and reforming federal prescription drug programs. In 2021, the Senate Finance Committee released a report that concluded insulin manufacturers were raising prices to maintain formulary placements with PBMs.

For more information, click here.

No Free TRIPS Act Introduced

On June 15, Sens. Blackburn (R-TN), Lummis (R-WY) and Tuberville (R-AL) introduced the No Free Trade-Related Aspects of Intellectual Property (TRIPS) Act. The legislation would prohibit the president from negotiating or affirming any suspension, modification or withdrawal to the World Trade Organization (WTO) TRIPS agreement without the authorization of Congress. It seeks to protect the intellectual property (IP) of U.S. biopharmaceutical manufacturers and encourages American innovation and domestic investment.

For more information, click here.

Senate HELP Committee Chairman Releases Report on Prescription Drug Prices

On June 12, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) released a majority staff report that examines the cost of certain prescription drugs that were developed with support of federal government agencies such as the Department of Health and Human Services (HHS), the Department of Defense (DoD) and the Department of Veterans’ Affairs (VA).

The report highlights the market prices for prescription drugs in the U.S. and other countries and analyzes why the prices for the same drugs are higher in the U.S. than overseas. It also calls on a “reasonable pricing clause” to be implemented for all biomedical products developed with support of the federal government.

For more information, click here.

MedPAC Releases Report to Congress and Announces Leadership Change

On June 15, the Medicare Payment Advisory Committee (MedPAC) released its June 2023 report to Congress. Some of the recommendations in the report are:

• Congress should require the U.S. Department of Health and Human Services (HHS) secretary to cap the Medicare payment rate for Part B drugs and biologics that are approved under the accelerated approval program, under certain circumstances;
• Congress should give the HHS secretary the authority to establish a single average sales price-based payment rate for drugs and biologics with similar health effects;
• Congress should require the secretary to reduce add-on payments for costly Part B drugs and biologics paid based on average sales prices to minimize the relationship between average sales prices and add-on payments, and eliminate add-on payments for Part B drugs and biologics paid based on wholesale acquisition cost;
• Congress should repeal the existing Medicare wage index statutes, including current exceptions, and require the secretary to phase in new Medicare wage index systems for hospitals and other types of providers, based on provider type and metropolitan or rural areas, while smoothing wage index; and
• Congress should align fee-for-service payment rates across ambulatory settings. MedPAC cited recent growth in hospital acquisition of physician practices as a specific reason for the recommendation.

In addition, MedPAC announced that Executive Director James E. Mathews, Ph.D., will be departing the commission at the end of August. Dr. Mathews has been leading the commission since November 2017. MedPAC Chairman Michael Chernew, Ph.D., announced that he will be replaced by Paul Masi. Masi is the current unit chief of the health systems and Medicare cost estimates unit at the Congressional Budget Office (CBO) and has 15 years of health policy experience. He previously served as MedPAC’s Assistant Director from 2017 to 2019.

For more information concerning the June report, click here.

MacPAC Releases June 2023 Report to Congress

On June 15, the Medicaid and Children’s Health Insurance Program (CHIP) Payment and Access Commission (MacPAC) released its June 2023 report to Congress. MacPAC focused on federal medical assistance percentage (FMAP) and the metric set each year by the federal government that inversely dictates the maximum state governments can direct to fund DSH funding. The commission made four recommendations, some of which detach total DSH funding from changes in FMAP and streamline the process that the Centers for Medicare and Medicaid Services (CMS) follows to finalize annual DSH allotments. Other recommendations relate to integrating care for dually eligible beneficiaries, improving access to Medicaid coverage for adults leaving incarceration, and identifying Medicaid home and community-based (HCBS) services.

For more information, click here.

Administration

HHS Secretary Sends Letter to Governors Regarding Medicaid Redeterminations

On June 12, Department of Health and Human Services (HHS) Secretary Xavier Becerra sent a letter to state governors informing them of flexibilities HHS is offering to states to decrease avoidable Medicaid and Children’s Health Insurance Plan (CHIP) coverage losses. Due to states’ resuming Medicaid and CHIP program coverage renewals, the Secretary and HHS are concerned about individuals’ losing their coverage due to changing their home address or never receiving required paperwork. In his letter, the Secretary noted that HHS has issued the following new flexibilities:

• Managed care plans will be allowed to assist people with completing Medicaid renewal forms, including certain parts of the forms on the individual’s behalf;
• States will be allowed to delay their administrative termination of coverage for one month while conducting targeted outreach and reminding people to renew; and
• Pharmacies and community-based organizations will be allowed to reinstate coverage for individuals who were disenrolled for procedural reasons based on presumptive eligibility criteria.

For more information, click here.

HHS Releases Fact Sheet on Medicare Extra Help Program

On June 12, the Department of Health and Human Services (HHS) released a fact sheet outlining the efforts HHS, the Centers for Medicare and Medicaid Services (CMS) and the Administration for Community Living (ACL) have taken to help eligible seniors and people with disabilities enroll in the Extra Help Program. The program helps eligible low-income disabled people and seniors pay their Medicare Part D prescription drug premiums and cost-sharing. The fact sheet explains how individuals can enroll in the program and elaborates on recent data collection and outreach efforts undertaken by CMS.

For more information, click here.

HHS Launches $15 Million Pediatric Specialty Loan Repayment Program

On June 9, the Department of Health and Human Services (HHS) announced that it had launched the Pediatric Specialty Loan Repayment Program, a $15 million investment initiative that aims to recruit and retain clinicians who provide healthcare to children and adolescents. The program will provide up to $100,000 to pediatric medical subspecialty, pediatric surgical specialty, child and adolescent behavioral healthcare, and substance use, prevention and treatment clinicians who agree to work in a health professional shortage area for a period of three years. The deadline to apply is July 30, 2023.

For more information, click here.

President Nominates CDC Director

On June 16, President Biden nominated Dr. Mandy Cohen to be the next director of the Centers for Disease Control and Prevention (CDC). Dr. Cohen is the current executive vice president of Aledade and chief executive officer (CEO) of Aledade Care Solution. She formerly worked as health secretary of the North Carolina Department of Health and Human Services (HHS).

For more information, click here.

CMS Seeking Members for Air Ambulance and Patient Safety Advisory Committee

On June 2, the Centers for Medicare and Medicaid Services (CMS) announced that it was seeking nominations for charter members of the Air Ambulance Quality and Patient Safety Advisory Committee. The committee was established by the Department of Health and Human Services (HHS) and the Department of Transportation (DOT) to develop patient safety and clinical quality and capability standards for each clinical capability level of air ambulances. The member nomination period will be open for 21 days.

For more information, click here.

CMS Office of the Actuary Releases National Health Expenditure Projections

On June 14, the Centers for Medicare and Medicaid Services (CMS) released its National Health Expenditures (NHEs) and health insurance enrollment projections for calendar years (CYs) 2022 to 2031. The projections reflect the expected impact of prescription drug price provisions included in the Inflation Reduction Act (IRA), which will soon begin going into effect. Notable projections include the following:

• Average NHE growth is expected to grow to 5.4 percent, which will exceed the projected annual growth in gross domestic product (GDP) of 4.6 percent. This is projected to increase the health spending share of U.S. GDP from 18.3 to 19.6 percent;
• The percentage of total U.S. population with health insurance is expected to remain at 92.3 percent through 2023. Medicaid redeterminations and the possible expiration of Affordable Care Act (ACA) provisions in 2025 are expected to decrease the insured share of the population to 90.5 percent in 2031;
• Inflation Reduction Act (IRA) prescription drug out-of-pocket saving provisions are projected to reduce out-of-pocket spending from 5.9 percent in 2024 to 4.2 percent in 2025 and 0.2 percent in 2026;
• Medicare average annual expenditure growth is projected to be 7.5 percent over the 2022-2031 period. Medicare spending is expected to grow 8.9 percent in 2025 and to slow down to 6.8 percent in 2030 and 2031 due to IRA Part D out-of-pocket spending caps;
• Medicaid expenditures are expected to grow by 5.0 percent over the 2022-2031 period. Medicaid enrollment is projected to increase an average of less than 1 percent through 2031;
• Private health insurance spending is expected to grow an average of 5.4 percent over the 2022-2031 period. Spending is projected to grow by 7.7 percent in 2023.
• Physician and clinical services are expected to grow by 5.3 percent over the 2022-2031 period;
• Retail prescription drug expenditures are expected to grow by 4.6 percent over the 2022-2031 period; and
• Hospital spending is expected to grow by 5.8 percent annually over the period of 2022-2031.

For more information, click here.

CMS Releases No Surprises Act Consumer Information Website

On June 14, the Centers for Medicare and Medicaid Services (CMS) announced that it had launched a new webpage intended to provide information to consumers on the No Surprises Act. The No Surprises Act protects group and individual health insurance plan beneficiaries from receiving surprise medical bills when utilizing certain healthcare services. The webpage aims to help consumers:

• Understand the rights and out-of-network billing protections granted to them by the No Surprises Act;
• Identify actions they can take if they receive an unexpected medical bill;
• Submit a complaint if they believe a facility, provider or insurance company is not complying with No Surprises Act rules;
• Dispute a bill if they are uninsured or didn’t use insurance and received a charge exceeding their good faith estimate; and
• Find guides on how to navigate medical billing questions.

For more information, click here.

FDA Selects COVID-19 Strain for Fall 2023 Vaccines

On June 15, the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to discuss which strain the fall 2023 COVID-19 vaccines should be composed of. The FDA is urging manufacturers to develop monovalent vaccines that target the COVID-19 XBB. 1.5 strain.

For more information, click here.

FDA Updates Off-Patent, Off-Exclusivity Drug List

On June 13, the Food and Drug Administration (FDA) updated its off-patent, off-exclusivity drugs without an approved generic (OPOE) list. The OPOE list reflects approved new drug applications (NDAs) for products that are not protected by patents or exclusivities and for which the FDA has not approved an abbreviated new drug application (ANDA) that references the NDA. The FDA updates the list every six months to improve transparency and encourage drug development and competition.

For more information, click here.

HRSA Awards $9 Million to Support Behavioral Health Services

On June 14, the Health Resources and Services Administration (HRSA) announced that it had awarded $9 million through its Integrated Substance Use Disorder Training Program (ISTP) to support and expand the behavioral health workforce in rural and underserved communities. The funding will go to 20 grantees and will be used to establish community-based programs that will train healthcare and social workers on how to provide mental health, substance use disorder and opioid use disorder treatment services.

For more information, click here.

Proposed Rules

ACL Proposed Rule Updates Older Americans Act Program Regulations

On June 15, the Administration for Community Living (ACL) released a proposed rule that would update regulations for the Older Americans Act (OAA) programs. The proposed rule aims to enhance benefits for OAA participants and improve program service delivery. It also seeks to:

• Clarify requirements for state and area plans on aging;
• Detail requirements for care coordination among tribal, state and local programs;
• Specify the range of people who can receive services and how funds can be utilized;
• Clarify required state and local policies and procedures;
• Update definition and flexibilities and clarify senior nutrition program guidelines; and
• Address OAA program emergency preparedness and response measures.

Public comments will be accepted until Aug. 15, 2023. For more information, click here.

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.

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 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

U.S. 5^th Circuit Court of Appeals Grants Partial Stay in ACA-Preventive Care Case

On June 13, the U.S. 5^th Circuit Court of Appeals issued a partial stay on a ruling issued by Judge Reed O’Connor of the U.S. District Court for the Northern District of Texas that sought to eliminate preventive care provisions granted under the Affordable Care Act (ACA). The partial stay ensures that individuals can continue accessing low-cost preventive care services, which include cancer and behavioral health screenings and contraceptive and HIV prophylaxis medications. A panel of 5^th Circuit judges heard arguments from both sides last week to consider whether it should issue a stay. The court clarified that the preventive service mandate cannot be enforced on the case’s plaintiffs.

CBO Cost Estimates

CBO Releases Cost Estimate on H.R. 2813, Self-Insurance Protection Act

On June 15, the Congressional Budget Office (CBO) released a cost estimate for H.R. 2813, the Self-Insurance Protection Act. The legislation would amend the Employee Retirement Income Security Act of 1974 (ERISA) and would exclude stop-loss policies from the bill’s definition of health insurance coverage. It would also impose an intergovernmental mandate that would preempt state laws from prohibiting group health plans from obtaining stop-loss policies.

The CBO and the Joint Committee on Taxation (JCT) project that the legislation would have insignificant effects on direct spending, revenues and deficits over the next 10 years. The CBO and JCT also project that the bill’s state law preemption mandate would only impact a few people since only a handful of states prohibit the sale of stop-loss policies.

For more information, click here.

CBO Releases List of CBO Health Analysis Division Presentations

On June 12, the Congressional Budget Office (CBO) released a list of presentations recently created by the CBO Health Analysis Division. The presentations are part of CBO’s effort to make its data analysis methods and findings more transparent. The presentations are focused on the following topics:

• Estimating Group Effects;
• The Effect of Expanded Access to Telehealth and Medicare Spending and Utilization;
• The Effect of Pandemic Maintenance of Eligibility Policy on Medicaid Spending and Enrollment; and
• How the Prices Nongroup and Small Group Health Plans Pay to Providers Compare to the Prices Medicare Pays.

For more information, click here.