This Week in Washington: Congress passes Continuing Resolution to keep the government funded until Nov. 17; CMS announces premium increase for Medicare Advantage plans in FY 2024; HHS releases shutdown contingency plan

Upcoming Hearings

Congress

House

• House Passes 45-Day Continuing Resolution
• House Passes Three Appropriations Bills
• House Energy and Commerce Committee Chairmen Warn NIH and HHS Over Possible Subpoenas

Senate

• Senate Finance Committee Chairman to Investigate MCO-Prior Authorization Denials
• Senate HELP Committee Ranking Member Requests Information on CDC Reform and 340B Drug Program Revenue
• Senators Oppose In-Person Visit Requirement in Expected DEA Telehealth Final Rule
• Sen. Markey Expresses Concern Over Prohibition of Facility Fees for Telehealth Providers
• Modernizing and Ensuring PBM Accountability Act Introduced

Administration

• White House OMB Concludes Review of FDA Laboratory Developed Test Proposed Rule
• HHS Issues RFI on Coverage of OTC Preventative Services
• HHS Releases Contingency Staffing and Operations Plan
• HHS Secretary Urges Providers to Cover COVID-19 Boosters for Insured Recipients
• ARPA-H Announces $104 Million in Funding for Antimicrobial Resistance Research
• CDC Recommends Latest RSV Vaccine
• CMS Requests Comments on Questions Regarding Processes Used to Assess Medicaid and CHIP Program Mental Health Parity
• CMS Medicare Drug Price Negotiation Deadline Pressures Pharmaceutical Companies
• CMS Releases Sickle Cell Disease Action Plan
• CMS Releases New Medicaid Transportation Coverage Guide
• CMS Expects Medicare Advantage Premium Increases in FY 2024
• CMS Announces Health Equity Data Access Program Grant Awardees
• FDA Launches Pilot Program to Accelerate Rare Disease Therapy Development
• FDA Fines Retailers for Selling Illegal E-Cigarettes
• FDA Releases Guidance Regarding Medical Device Cybersecurity
• FTC Announces Additional Workshops on 2023 Draft Merger Guidelines
• HRSA Awards $103 Million to Expand Maternal Health Services
• SAMHSA Awards $42.6 Million to Strengthen Substance Use Prevention
• SAMHSA Awards $232.2 Million to Strengthen Behavioral Health Programs

Proposed Rules

• CMS Proposed Rule Increases No Surprises Act IDR Administrative Fee
• CMS Extends Comment Period for Proposed Rule Strengthening Coverage of Mental Health Insurance Benefits
• CMS Proposed Rule Establishes Minimum Staffing and Payment Reporting Standards
• FDA Proposes Rule Regarding Laboratory Developed Tests
• FDA Proposes Rule to Broaden Prescription Drug Labeling Regulations
• OCR Proposed Rule Strengthens Protections Against Disability Discrimination

Final Rules

• CMS Final Rule Streamlines Medicare Savings Program Enrollment Process
• CMS Final Rule Mandates Medicaid and CHIP Program Core Set Measures Reporting
• 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

Reports

• GAO Releases Report Regarding USAID Global COVID-19 Vaccination Efforts
• GAO Releases Report Regarding Limitations in CMS Data to Identify Private Equity Ownership of Nursing Homes

CBO Cost Estimates

• CBO Releases Report Regarding the Federal Budgetary Effects of CMMI Activities
• CBO Releases Report Regarding Federal Subsidies for Health Insurance
• CBO Releases Presentation on 2023 Long-Term Budget Projections

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Upcoming Hearings

House

The House has recessed for its October district work period.

October 4

Senate

Senate Committee on Veterans’ Affairs Full Committee Hearing: “VA Accountability and Transparency: A Cornerstone of Quality Care and Benefits for Veterans”
3:00 p.m., Russell Senate Office Building 418
Witnesses to be announced.

House

House Passes 45-Day Continuing Resolution

On Sept. 30, the House of Representatives passed a Continuing Resolution that keeps the government open until Nov. 17. It was passed with the support of Democratic members. The CR is a “clean” CR which contains no funding cuts, and includes funding for disaster relief. It also extended the FAA authority until Dec. 31. It is likely that Ukraine funding will be considered with border security issues in the coming days. The Senate also passed the CR in a vote of 88 to 9 with no debate.

House Passes Three Appropriations Bills

On Sept. 28, House Republicans passed the Defense, State-Foreign Ops and Homeland Security appropriations bills.

Debate began on Sept. 26 and included the Agriculture-Food and Drug Administration (FDA) appropriations bill as well. However, the Agriculture-Food and Drug Administration (FDA) failed to pass because of issues related to the abortion pill and other funding matters.

House Republican leaders had hoped that by allowing debate and amendments on the appropriations bills, they would be able to convince holdouts among their conference to support a short-term continuing resolution that Speaker McCarthy brought to the floor on Friday in the hopes of averting a government shutdown. However, the House rejected the CR in a 198-232 vote.

House Energy and Commerce Committee Chairmen Warn NIH and HHS Over Possible Subpoenas

On Sept. 28, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chairman Brett Guthrie (R-KY) and Subcommittee on Oversight and Investigations Chairman Morgan Griffith (R-VA) sent letters to National Institutes of Health (NIH) Acting Director Lawrence Tabak and Secretary of the Department of Health and Human Services (HHS) Xavier Becerra stating that the committee would be forced to issue subpoenas against the agencies if they fail to comply with previously issued requests for documents and information.

The chairmen are seeking information on the NIH’s involvement in virus mutation and manipulation research and the appointment and reappointment of NIH institute and center directors.

For more information, click here.

Senate

Senate Finance Committee Chairman to Investigate MCO-Prior Authorization Denials

On Sept. 28, Senate Finance Committee Chairman Ron Wyden (D-OR) and House Energy and Commerce Committee Ranking Member Frank Pallone (D-NJ) launched a bicameral investigation into Medicaid managed care organization (MCO) prior authorization practices and sent letters to large MCOs, requesting that they submit information on their rate of prior authorization approvals, partial denials and full denials. They are also requesting information on the rate of appeals and on the prior authorization algorithms used by insurers.

The Chairman and Ranking Member are concerned about findings of a recent Department of Health and Human Services (HHS) Office of Inspector General (OIG) report that revealed MCOs are denying Medicaid prior authorizations at nearly twice the rate of Medicare Advantage prior authorizations.

Senate HELP Committee Ranking Member Requests Information on CDC Reform and 340B Drug Program Revenue

On Sept. 26, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) sent a letter to stakeholders requesting information regarding how the Centers for Disease Control and Prevention (CDC) can be modernized. The Ranking Member is seeking input on how data-sharing and transparency partnerships between the CDC, federal agencies and the private sector can be broadened and how innovation and collaboration can be strengthened. Public comments will be accepted until Oct. 20.

In addition, the Ranking Member sent letters to two 340B-eligible hospitals on Sept. 28, requesting that they provide information on the revenue they generate from the 340B program. The Ranking Member is concerned over reports that entities are not passing on the revenue they generate from the 340B program to improve healthcare services for low-income patients.

For more information on the request for information on CDC reform, click here.

For more information on the request for information on 340B program revenue, click here.

Senators Oppose In-Person Visit Requirement in Expected DEA Telehealth Final Rule

On Sept. 12 and 13, Drug Enforcement Administration (DEA) leaders met with a number of stakeholder groups to discuss a DEA flexibility that allows providers to prescribe controlled substances via telehealth to patients who have not conducted a prior in-person visit. The flexibility, originally issued during the COVID-19 pandemic, is set to expire on Nov. 11. The DEA has announced that it will release a final rule addressing the flexibility this fall.

Following the listening sessions, a group of senators including Sens. Cassidy (R-LA), Thune (R-SD), Feinstein (D-CA), Markey (D-MA) and Warren (D-MA) met with telehealth stakeholders and announced that they will apply pressure and oversight on the DEA if the agency’s final rule requires providers to conduct an in-person visit with a patient before they are able to prescribe controlled substances via telehealth.

Sen. Markey Expresses Concern Over Prohibition of Facility Fees for Telehealth Providers

On Sept. 21, the Senate Health, Education, Labor and Pensions (HELP) Committee marked up the Primary Care and Health Workforce Act, which would reauthorize community health and medical education programs and address primary care and health workforce challenges. The legislation contains a provision that would prohibit hospitals from billing facility fees for telehealth and evaluation and management services.

During the markup, Sen. Markey (D-MA) expressed his concern over the provision, noting that it would create barriers for individuals who rely on telehealth services to receive care, particularly disabled, elderly and low-income patients. Many hospital stakeholders also expressed their concerns and noted that it would be detrimental to telehealth.

Modernizing and Ensuring PBM Accountability Act Introduced

On Sept. 28, Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) introduced the Modernizing and Ensuring PBM Accountability Act. The legislation aims to increase the accountability and transparency of pharmacy benefit manager (PBM) practices. It would:

• Prohibit PBM compensation in Medicare Part D from being tied to the price of a drug;
• Allow Part D plan sponsors to audit their PBM for compliance with contract requirements;
• Require the Secretary of the Department of Health and Human Services (HHS) to implement standard Part D measures to assess the performance of network pharmacies;
• Ban PBM spread pricing in Medicaid;
• Require retail community pharmacies to participate in the National Average Drug Acquisition Cost (NADAC) Survey; and
• Implement stricter PBM reporting requirements.

For more information, click here.

Administration

White House OMB Concludes Review of FDA Laboratory Developed Test Proposed Rule

On Sept. 26, the White House Office of Management and Budget (OMB) concluded its review and approved of a proposed rule that the Food and Drug Administration (FDA) submitted in July, that seeks to restore the FDA’s jurisdiction to regulate and oversee laboratory developed tests (LDTs) as medical devices. The FDA was previously authorized to regulate LDTs but was blocked from doing so in a policy issued by the Department of Health and Human Services (HHS) in 2020. The FDA released the proposed rule on Sept. 29.

HHS Issues RFI on Coverage of OTC Preventative Services

On Sept. 29, the Department of Health and Human Services (HHS) issued a request for information (RFI) regarding the coverage of over-the-counter (OTC) preventative services such as contraceptives, smoking cessation products and breastfeeding supplies. HHS is interested in understanding how providers may be able to expand access and coverage of OTC preventive products that do not require a prescription.

In addition the HHS, the Department of Labor and the Department of the Treasury are issuing the RFI.

For more information, click here.

HHS Releases Contingency Staffing and Operations Plan

On Sept. 26, the Department of Health and Human Services (HHS) released a staffing and operations contingency plan explaining the changes that will occur among the various HHS operating divisions in the event of a government shutdown. The plan outlines which employees will be furloughed and which agency activities will cease operation. If the government shuts down after the current 45-day continuing resolution, this is likely the plan that HHS will use.

Notably, the contingency plan for the Health Resources and Services Administration (HRSA) states that in the event of a shutdown, it will use fiscal year (FY) 2023 carryover funding to keep community health centers running past Sept. 30, when funding for the Community Health Center Fund is set to expire. In addition, carryover funds would be used to fund the Teaching Health Center Graduate Medical Education program and the National Health Service Corps.

For more information, click here.

HHS Secretary Urges Providers to Cover COVID-19 Boosters for Insured Recipients

On Sept. 22, Department of Health and Human Services (HHS) Secretary Xavier Becerra sent a letter to pharmacies, healthcare providers and insurers stating that they must cover the cost of a COVID-19 vaccine administered in-network to individuals with health insurance. The Secretary and HHS are concerned over reports of pharmacies charging insured patients for receiving a booster shot.

For more information, click here.

ARPA-H Announces $104 Million in Funding for Antimicrobial Resistance Research

On Sept. 28, the Advanced Research Projects Agency for Health (ARPA-H) announced that it would award up to $104 million in funding to support research on antimicrobial resistance. The funding will go toward the Defeating Antibiotic Resistance through Transformative Solutions (DARTS) project, an academic research collaboration between research institutions and Harvard Medical School that aims to spur the development of a diagnostic tool that can individually analyze high volumes of bacteria and identify problematic strains.

In addition, ARPA-H announced that it would award $115 million in funding to support three cancer research programs focused on developing innovative cancer therapies and devices and a nationwide health-innovation network called ARPANET-H aimed at bringing cancer and disease treatment, detection and prevention services to underserved communities.

For more information on ARPA-H funding for antimicrobial resistance, click here.

For more information on ARPA-H funding for cancer initiatives, click here.

CDC Recommends Latest RSV Vaccine

On Sept. 22, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommended that all pregnant women receive the latest respiratory syncytial virus (RSV) vaccine Abrysvo. The vaccine has been shown to reduce the risk of RSV hospitalization for babies six months or younger by 57 percent.

For more information, click here.

CMS Requests Comments on Questions Regarding Processes Used to Assess Medicaid and CHIP Program Mental Health Parity

On Sept. 29, the Centers for Medicare and Medicaid Services (CMS) announced that it was seeking public comments on a series of questions regarding processes used to assess compliance with mental health parity and addiction equity in the Medicaid and Children’s Health Insurance Program (CHIP) programs. Public comments will be accepted until Dec. 4.

For more information, click here.

CMS Medicare Drug Price Negotiation Deadline Pressures Pharmaceutical Companies

The deadline for pharmaceutical companies to agree to participate in negotiations with the Centers for Medicare and Medicaid Services (CMS) over the price of drugs selected under the Medicare Part D Drug Negotiation Program is Oct. 2. According to CMS, companies that do not agree to enter into negotiations will have an excise tax as high as 95 percent applied to the sales of their drug in the U.S. As an alternative to paying the tax, companies may withdraw all of their drugs from coverage under the Medicare and Medicaid programs.

Of the 10 companies that manufacture drugs selected by CMS for negotiation, four have indicated they will participate in the process. This includes AstraZeneca, Merck, Bristol Myers Squibb and Boehringer Ingelheim. The companies have all filed lawsuits against the negotiation program, claiming that it violates First and Fifth Amendment protections and restricts rare disease drug research.

CMS Releases Sickle Cell Disease Action Plan

On Sept. 28, the Centers for Medicare and Medicaid Services (CMS) Office of Minority Health released a Sickle Cell Disease Action Plan. The action plan aims to improve health outcomes for individuals living with sickle cell disease and seeks to address and eliminate barriers they may encounter among CMS programs.

For more information, click here.

CMS Releases New Medicaid Transportation Coverage Guide

On Sept. 28, the Centers for Medicare and Medicaid Services (CMS) released a new Medicaid Transportation Coverage Guide. The guide, outlined in a letter sent to state Medicaid directors by CMS Center for Medicaid and CHIP Services Director Daniel Tsai, highlights Medicaid transportation requirements and flexibilities and outlines new policies aimed at addressing extended wait times and long-distance trips that Medicaid beneficiaries often encounter when accessing services.

For more information, click here.

CMS Expects Medicare Advantage Premium Increases in FY 2024

On Sept. 26, the Centers for Medicare and Medicaid Services (CMS) announced that premiums for Medicare Advantage (MA) plans are expected to increase by an average of 64 cents to $18.50 per month in fiscal year (FY) 2024. CMS also announced that the number of MA plans is expected to rise from 5,674 to more than 5,700.

CMS Announces Health Equity Data Access Program Grant Awardees

On Sept. 25, the Centers for Medicare and Medicaid Services (CMS) Office of Minority Health announced the winners of the 2023 Health Equity Data Access Program (HEDAP). The winners include the George Washington University, University of Kansas Medical Center Research Institute and the University of Missouri System. Each winner will receive $90,000 and three years of access to CMS-restricted data used in minority health research.

For more information, click here.

FDA Launches Pilot Program to Accelerate Rare Disease Therapy Development

On Sept. 28, the Food and Drug Administration (FDA) announced that it will launch the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program. The program seeks to improve communication between rare disease therapy sponsors and the FDA to highlight clinical development issues. Program participants will be able to receive FDA advice regarding clinical study design and control group and patient population selection.

The FDA will accept applications for the program between Jan. 2 and March 1, 2024.

For more information, click here.

FDA Fines Retailers for Selling Illegal E-Cigarettes

On Sept. 28, the Food and Drug Administration (FDA) issued civil monetary penalty (CMPs) complaints against 22 retailers for illegally selling Elf Bar/EB Design e-cigarettes. Retailers have 30 days to respond to the complaints and can either agree to pay the penalty, enter into a settlement agreement or request an extension of time to submit an answer or request a hearing. The FDA is seeking the maximum CMP penalty of $19,192.

In addition, the FDA sent 168 warning letters to retailers who were found selling Elf Bar/EB Design e-cigarettes. Retailers have 15 days to respond and explain how they will correct their violation.

For more information, click here.

FDA Releases Guidance Regarding Medical Device Cybersecurity

On Sept. 27, the Food and Drug Administration (FDA) released guidance regarding medical device cybersecurity. The guidance outlines cybersecurity device design, labeling and documentation that the FDA recommends industry stakeholders include in their premarket device submission requests submitted to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).

For more information, click here.

FTC Announces Additional Workshops on 2023 Draft Merger Guidelines

On Sept. 27, the Federal Trade Commission (FTC) announced that it would hold two additional workshops in collaboration with the Department of Justice (DOJ) to facilitate discussion on the 2023 Draft Merger Guidelines. The guidelines aim to enhance transparency and promote awareness of how the FTC monitors mergers and acquisitions for antitrust and anticompetitive practices.

For more information, click here.

HRSA Awards $103 Million to Expand Maternal Health Services

On Sept. 27, the Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) announced that it would award more than $103 million in funding to expand maternal health services. The funding will be used to launch new initiatives that seek to reduce the rate of maternal mortality.

The funding includes:

• $12.5 million to expand and diversify the perinatal workforce, train more nurse midwives and support university nurse midwifery programs;
• $34 million to expand access to maternity care in underserved and rural areas, establish maternal health task forces and strengthen pregnancy and postpartum health and social services;
• $32 million to support OB/GYN and midwife behavioral health training, assist mothers and their families with the Medicaid redetermination process and implement “patient safety bundles” through the Alliance for Innovation on Maternal Health (AIM) program; and
• $10 million to establish new research networks aimed at identifying disparities in maternity health outcomes and crafting innovative strategies to address them.

In addition, HHS announced the formation of the Task Force on Maternal Mental Health, which will focus on identifying and evaluating recommendations aimed at improving coordination activities addressing maternal mental health and substance use disorders.

For more information, click here.

SAMHSA Awards $42.6 Million to Strengthen Substance Use Prevention

On Sept. 28, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced that it had awarded $42.6 million in grants to support states and communities in developing and delivery substance use prevention and mental health promotion strategies.

The grants include:

• $21.9 million for Strategic Prevention Framework-Partnerships for Success for Communities, Local Governments, Universities, Colleges and Tribes/Tribal Organizations to strengthen the development and implementation of substance use prevention and mental health services; and
• $20.7 million for Strategic Prevention Framework-Partnerships for Success for States to build and expand local community prevention providers and programs.

For more information, click here.

SAMHSA Awards $232.2 Million to Strengthen Behavioral Health Programs

On Sept. 27, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced that it had awarded $232.2 million in grants to support suicide prevention and behavioral health for at-risk communities.

The grants include:

• $177.4 million for states and territories to build local 988 capacity, improve local response, enhance recruiting, strengthen training and develop comprehensive communication plans;
• $18.3 million for tribal nations and organizations to improve response to 988 contacts, ensure access to culturally competent 988 crisis center support and improve the integration of 988 crisis centers; and
• $5 million for 988 crisis centers to enhance follow-up care, streamline coordination of crisis stabilization and improve connections with high-risk populations.

For more information, click here.

Proposed Rules

CMS Proposed Rule Increases No Surprises Act IDR Administrative Fee

On Sept. 21, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would increase the administrative fee for disputes initiated within the No Surprises Act independent dispute resolution (IDR) process. The proposed rule would:

• Increase the IDR administrative fee from $50 to $150 per party per dispute;
• Increase the fee range for certified IDR entities by 20 percent for single determinations; and
• Increase the fee range for certified IDR entities by 25 percent for batched determinations.

In addition, the Internal Revenue Service (IRS) and the Employee Benefits Security Administration are proposing the rule.

Public comments will be accepted until Oct. 26, 2023. For more information, click here.

CMS Extends Comment Period for Proposed Rule Strengthening Coverage of Mental Health Insurance Benefits

On Sept. 21, the Centers for Medicare and Medicaid Services (CMS) announced that it would extend the comment period for a proposed rule that would implement amendments relating to the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). The proposed rule would:

• Clarify that the MHPAEA ensures an individual’s right to access mental health and substance use disorder benefits in parity with medical/surgical benefits;
• Provide examples that make clear that plans and issuers may not use restrictive prior authorization and other medical management techniques or standards related to network composition for mental health and substance use disorder benefits;
• Clarify that certain factors may not be used to determine out-of-network reimbursement rates for mental health and substance use disorder providers;
• Require plans and issuers to gather and analyze outcomes data and take action to resolve material differences in access to mental health and substance use disorder benefits and medical/surgical benefits;
• Codify a requirement that directs plans and issuers to conduct meaningful comparative analyses to measure the impact of nonquantitative treatment limitation (NQTL); and
• Implement a sunset provision adopted in the Consolidated Appropriations Act of 2023, that allows self-funded, non-federal government plan elections to opt out of compliance with MHPAEA.

In addition to CMS, the Internal Revenue Service and the Employee Benefits Security Administration are proposing the rule. The agencies are also seeking comments and information on proposed new data requirements for limitations related to the composition of a health plan’s or issuer’s network.

Public comments will be accepted until Oct. 17, 2023. For more information, click here.

CMS Proposed Rule Establishes Minimum Staffing and Payment Reporting Standards

On Sept. 1, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would establish minimum nursing staffing standards for long-term care (LTC) facilities and implement provisions aimed at increasing transparency of Medicaid institutional payments. The proposed rule would:

• Require nursing facilities participating in Medicare and Medicaid to provide at a minimum, 0.55 hours of care from a registered nurse (RN) per resident per day and 2.45 hours of care from a nurse aide per resident per day;
• Require nursing facilities to maintain at least one nurse on-site at all times;
• Implement new nursing facility assessment requirements; and
• Require states to publicly report on the percentage of Medicaid payments for home and community-based services that are spent on compensation for direct care workers.

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

FDA Proposes Rule Regarding Laboratory Developed Tests

On Sept. 29, the Food and Drug Administration (FDA) released a proposed rule that would amend regulations and classify in vitro diagnostic products (IVDs) as medical devices under the Federal Food, Drug and Cosmetic (FD&C) Act. The proposed rule also clarifies that the FDA will phase out the general enforcement discretion approach for laboratory developed tests (LDTs) and states that LDTs will fall under the same enforcement approach as other IVDs.

Public comments will be accepted until Dec. 1, 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.

OCR Proposed Rule Strengthens Protections Against Disability Discrimination

On Sept. 7, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a proposed rule that seeks to strengthen access to healthcare and human services for individuals with disabilities. It also aims to prohibit discrimination on the basis of a disability among healthcare and human services programs. The proposed rule would:

• Clarify the application of Section 504 and ensure its consistency with the Americans with Disabilities Act, the Rehabilitation Act and case law;
• Clarify obligations for mobile, web and kiosk accessibility;
• Establish standards for accessible medical equipment;
• Prohibit the use of value assessment methods that negatively assess individuals with disabilities and limit their access to aids, benefits and services; and
• Clarify obligations to provide services to disabled persons in integrated and appropriate settings.

Public comments will be accepted until Nov. 13, 2023. For more information, click here.

Final Rules

CMS Final Rule Streamlines Medicare Savings Program Enrollment Process

On Sept. 19, the Centers of Medicare and Medicaid Services (CMS) released a final rule that would streamline enrollment into the Medicare Savings Program (MSP) and align it with other public program requirements and processes. It would:

• Automatically enroll the majority of Supplemental Security Income (SSI) recipients into the Qualified Medicare Beneficiary eligibility group;
• Require states to use Medicare Part D low-income subsidy (LIS) program data when making QMP eligibility determinations; and
• Eliminate duplicative paperwork; and
• Reduce the cost of prescription drugs.

The final rule will go into effect on Nov. 17, 2023. For more information, click here.

CMS Final Rule Mandates Medicaid and CHIP Program Core Set Measures Reporting

On Aug. 31, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would establish mandatory state reporting requirements for the following quality measures:

• Core set of Children’s Health Care Quality measures under Medicaid and the Children’s Health Insurance Program (CHIP);
• Behavioral health measures on the Core Set of Adult Health Care Quality Measures for Medicaid; and
• Core Sets of Health Home Quality Measures for Medicaid.

The final rule will go into effect on Jan. 1, 2024. 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 allow 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.

Reports

GAO Releases Report Regarding USAID Global COVID-19 Vaccination Efforts

On Sept. 27, the Government Accountability Office (GAO) released a report regarding efforts the U.S. Agency for International Development (USAID) undertook to assist with COVID-19 vaccination efforts in more than 125 countries. The GAO was interested in understanding the progress and challenges that the USAID faced in pursuing this goal. To conduct this study, the GAO interviewed USAID officials and reviewed USAID, Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) laws, funding and guidance documents.

The GAO found that the USAID faced demand, supply and other challenges including vaccine hesitancy among individuals. The USAID also faced challenges with addressing vaccine site access barriers. The GAO conducted this study because a provision in the Coronavirus Aid, Relief, and Economic Security (CARES) Act requires it to monitor the federal government’s response to the COVID-19 pandemic.

For more information, click here.

GAO Releases Report Regarding Limitations in CMS Data to Identify Private Equity Ownership of Nursing Homes

On Sept. 22, the Government Accountability Office (GAO) released a report regarding limitations that exist in data that is collected by the Centers of Medicare and Medicaid Services (CMS) seeking to reveal private equity ownership of nursing homes participating in the Medicare program. To conduct this study, the GAO reviewed CMS nursing home data, interviewed CMS officials and reviewed relevant documentation.

The GAO found that many nursing homes do not have all their owners listed in CMS’ data and that CMS data does not provide a means to readily identify private equity firms. The GAO conducted this study because it was asked to review CMS nursing home ownership data for information on private equity owners.

For more information, click here.

CBO Cost Estimates

CBO Releases Report Regarding the Federal Budgetary Effects of CMMI Activities

On Sept. 28, the Congressional Budget Office (CBO) released a report outlining the projected impact it believes activities by the Center for Medicare and Medicaid Innovation (CMMI) had on the federal budget and spending between 2011 and 2020.

The CBO estimates that CMMI activities between 2011 and 2020 increased direct spending by $5.4 billion. The CBO had originally projected that CMMI activities would reduce net federal spending. Between 2021 and 2030, the CBO projects that CMMI activities will increase net federal spending by $1.3 billion.

For more information, click here.

CBO Releases Report Regarding Federal Subsidies for Health Insurance

On Sept. 28, the Congressional Budget Office (CBO) released a report that outlines the baseline projections that the CBO and the Joint Committee on Taxation (JCT) have prepared regarding federal subsidies for health insurance between 2023 and 2033.

The report indicates that federal subsidies for health insurance are estimated to equal $1.8 trillion in 2023. The CBO and JCT predict that net subsidies will grow significantly to equal $3.3 trillion in 2033. Over the next 10 years, the CBO predicts subsidies to equal a total of $25 trillion. Medicare subsidies are projected to equal $11.7 trillion and Medicaid and Children’s Health Insurance Program (CHIP) subsidies are projected to equal $6.3 trillion.

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CBO Releases Presentation on 2023 Long-Term Budget Projections

On Sept. 22, the Congressional Budget Office (CBO) released a presentation outlining the 2023 CBO Long-Term Budget Projections. The presentation shows the predictions the CBO has for federal revenues, deficits and debt over the next 30 years. It also shows the estimated effects of demographic trends, economic developments and healthcare costs on federal spending.

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