This Week in Washington: Debt-ceiling agreement passes, House Energy and Commerce Committee reports out legislation on site-neutral Medicare payments for certain drugs

Upcoming Hearings

Congress

House

• House Energy and Commerce Committee Holds Markup on 19 Bills

Senate

• Debt Ceiling Deal Passes House and Senate
• Senators Seek to Add Fentanyl Provision to National Defense Authorization Act

Administration

• HHS Awards $5.9 Million to Youth Suicide Prevention Programs
• CMS Announces Center for Medicaid and CHIP Services Reorganization
• CMS Releases Resources for Intellectual and Developmental Disability Care Strategies
• CMS Outlines How Medicare Will Cover Alzheimer’s Drugs
• FDA Awards Funding for New Tobacco Rapid Surveillance Center
• FDA Approves RSV Vaccine for Older Adults
• FDA Cracks Down on Illegal E-Cigarette Sales
• FDA Announces Patient Engagement Committee Meeting
• FDA Releases Guidance on Drug and Biological Clinical Trial Covariates
• FDA Releases Draft Guidance on Antidiabetic Drug Development
• FDA Approves First COVID-19 Oral Antiviral for Adults
• FDA Approves New Bacterial Pneumonia Treatment
• FDA Approves New Opioid Use Disorder Drug
• FDA Approves Opioid Overdose Reversal Nasal Spray
• FDA Approves First Dystrophic Epidermolysis Bullosa Topical Gene Therapy

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
• CMS Proposed Rule Updates Hospital Inpatient and Long-Term Care Hospital PPS Rates
• FDA Proposes New Tobacco Product Manufacturing Practices Requirements

Final Rules

• 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

CBO Cost Estimates

• CBO Releases Report Describing How It Constructs Baseline Projections
• CBO Releases Report Explaining How It Identifies Mandates in Legislation
• CBO Releases Presentation on Projected Shifts in Health Insurance Coverage

Upcoming Hearings

House

June 7

House Committee on Agriculture Full Committee Hearing: “Innovation, Employment, Integrity, and Health: Opportunities for Modernization in Title IV”
10:00 a.m., Longworth House Office Building 1300
Witnesses to be announced.

Senate

June 7

Senate Veterans’ Affairs Committee Full Committee Hearing: “An Abiding Commitment to Those Who Served: Examining Veterans’ Access to Long Term Care”
3:00 p.m., Russell Senate Office Building 418
Witnesses to be announced.

June 8

Senate Finance Committee Full Committee Hearing: “Consolidation and Corporate Ownership in Health Care: Trends and Impacts on Access, Quality, and Costs”
10:00 a.m., Dirksen Senate Office Building 215
Announced witnesses are:

• Zack Cooper, Ph.D, Associate Professor of Public Health and Economics at Yale University
• Shawn Martin, Vice President and Chief Executive Officer of the American Academy of Family Physicians
• Karen Maddox, MD, 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

Senate Health, Education, Labor and Pensions Full Committee Hearing: “Why Are So Many American Youth in a Mental Health Crisis? Exploring Causes and Solutions”
10:00 a.m., Dirksen Senate Office Building 430
Witnesses to be announced.

Congress

House

House Energy and Commerce Committee Holds Markup on 19 Bills

On May 24, the House Energy and Commerce Committee marked up 19 bills. The healthcare bills that were considered include:

• H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023

This legislation, a package of bipartisan bills, would implement various provisions to increase prescription drug price transparency and lower drug costs. This package includes a provision that would expand Medicare site-neutral payments for certain drugs administered in off-campus hospital outpatient departments. It would expand various Centers for Medicare and Medicaid Services (CMS) price transparency rules, bar spread pricing payment arrangements for Medicaid plans, strengthen oversight over pharmacy benefit managers (PBMs), mandate reporting of health-related entity ownership information, and extend various health programs including the Special Diabetes Program and Graduate Medical Education programs.

Additionally, it would eliminate planned Disproportionate Share Hospital (DSH) Payment Reduction cuts for fiscal years (FYs) 2024-2025.

• H.R. 1418, Animal Drug User Fee Amendments of 2023

This legislation would reauthorize ADUFA and AGDUFA for fiscal years (FYs) 2024 to 2028. It would also establish new transparency requirements for the Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM), allow for amendments to the “major species” definition and codify reporting dates for CVM antimicrobial development and stewardship.

• H.R. 2544, Securing the U.S. Organ Procurement and Transplantation Network Act

This legislation would allow for additional flexibilities within the Organ Procurement and Transplantation Network (OPTN) by amending Section 372 of the Public Health Service Act.

• H.R. 2666, Medicaid VBPs for Patients (MVP) Act

This legislation would permit pharmaceutical manufacturers and states to enter into value-based payment arrangements to offer an alternative means to cover high-cost, one-time cell and gene therapies in the Medicaid program. It would allow for multiple reporting of the drug’s best price and average manufacturer and sales price.

• H.R. 3284, Providers and Payers COMPLETE Act

This legislation would require the Department of Health and Human Services (HHS) to consider the implications its annual hospital and provider inpatient and outpatient care payment rules have on the horizontal and vertical consolidation of providers and payers in the healthcare system.

• H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program

This legislation would implement reporting requirements for hospitals participating in the 340B program, and would require hospitals to report total 340B savings.

In addition, the committee considered seven bills related to broadband issues and five related to energy issues.

For more information, click here.

Senate

Debt Ceiling Deal Passes House and Senate

The debt ceiling agreement announced Memorial Day weekend was passed by the House and Senate in time to avoid the June 5 date when the government would default. The agreement suspends the U.S. borrowing limit until Jan. 1, 2025. The legislation addresses discretionary spending—not mandatory spending programs like Medicare, Medicaid and Social Security. Discretionary spending while important is a smaller part of the federal budget.

Caps Nondefense Spending: The deal caps nondefense spending in fiscal year (FY) 2024 and increases it by 1 percent in 2025. The House Republican fact sheet says that nondefense discretionary spending would be limited to (FY) 2022 levels and topline federal spending would be limited to 1 percent annual growth for the next six years.

The breakdown of nondefense discretionary spending for (FY) 2024 is thought to be capped at about $700 billion of which $121 billion would be for veterans’ healthcare and $583 billion would be for other areas.

Work Requirements: Medicaid will not be subject to work requirements, but the agreement calls for broadening work requirements for certain adults receiving benefits from the Supplemental Nutrition Assistance Program (SNAP) formerly known as food stamps. The agreement increases the upper age limit to 55 in phases. The deal, however, would expand exemptions for veterans, people who are homeless and former foster youth. All changes would end in 2030. The agreement also tightens current work requirements in the Temporary Assistance for Needy Families (TANF) program. It appears that this will be achieved by primarily adjusting the work participation rate credits that states can receive for reducing their caseloads.

COVID-19 Funds: The agreement rescinds unobligated COVID-19 funds, which are estimated to be about $28 billion from more than 120 accounts—including the National Institutes of Health (NIH), the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC). However, $5 billion in funding to accelerate the development of COVID-19 vaccines and treatments, and vaccines for the uninsured is retained.

Last, the agreement also increases funds for healthcare fraud and abuse control by providing new budget authority for fiscal years 2024 and 2025. The administration had requested additional funding for fraud and abuse efforts in its budget, which are divided between the Department of Health and Human Services (HHS) and the Department of Justice (DOJ).

Administrative PAY-GO: Under the compromise package, federal agencies would be subject to an administrative version of PAY-GO rules through 2024. This is part of the “enforcement” effort to control spending.

Before finalizing a rule that would increase direct spending by more than $1 billion over 10 years or $100 million in any single year, federal agencies would have to submit a plan that reduces direct spending by an equal or greater amount. For agency actions mandated by law, agencies would have to identify a least costly implementation option for executive rulemakings. If a rule were to be finalized and hit the spending thresholds set up by the administrative PAY-GO structure, the bill would require the agency to send a written opinion from the general counsel of the agency explaining that the rule is legally required, along with a projection of the amount of direct spending under the least costly implementation option reasonably identifiable by the agency that meets the requirements under the statute. That opinion would go to the Director of the Office of Management and Budget (OMB). The OMB Director would be able to waive the requirements if an agency action is deemed necessary for the delivery of essential services of effective program delivery.

Senators Seek to Add Fentanyl Provision to National Defense Authorization Act

On May 16, Sens. Kaine (D-VA) and Ernst (R-IA) introduced the Disrupt Fentanyl Trafficking Act of 2023. The bill would declare fentanyl trafficking a national security threat and would direct the Pentagon to develop fentanyl-specific counter-drug strategies with Mexican defense officials. Additionally, it would require the U.S. Secretary of Defense to increase cooperation with the Mexican military and address coordination efforts between military and law enforcement agencies. Reps. Bice (R-OK) and Carbajal (D-CA) introduced a companion bill in the House.

The senators also announced their intention to introduce the bill as an amendment to the fiscal year (FY) 2023 National Defense Authorization Act (NDAA). The NDAA authorizes funding levels for the U.S. Department of Defense and specifies the department’s annual budget and expenditures. The Senate Armed Services Committee will hold a closed session to mark up the bill next month.

Administration

HHS Awards $5.9 Million to Youth Suicide Prevention Programs

On June 1, the Department of Health and Human Services (HHS) announced that it had awarded $5.9 million to strengthen youth suicide prevention programs. $3.6 million was awarded to states and tribes and will go toward supporting the Garrett Lee Smith State/Tribal Youth Suicide Prevention and Early Intervention Program. The remaining $2.3 million was awarded to college campuses and will go toward supporting the Garrett Lee Smith Campus Suicide Prevention Program. Both programs focus on enhancing mental health services and strengthening suicide treatment and intervention efforts.

For more information, click here.

CMS Announces Center for Medicaid and CHIP Services Reorganization

On June 2, the Centers for Medicare and Medicaid Services (CMS) announced that it will reorganize the CMS Center for Medicaid and Children’s Health Insurance Program (CHIP) Services. The center will establish a new group called the Managed Care Group (MCG), which will house two divisions from existing groups. These include the Division of Managed Care Policy (DMCP) from the Disabled and Elderly Health Programs Group (DEHPG) and the Division of Managed Care Operations (DMCO) from the Medicaid and CHIP Operations Group (MCOG). CMS also announced that the DEHPG will be renamed to the Medicaid Benefits and Health Programs Group (MBHPG) and that a fourth branch will be added to the DMCO.

For more information, click here.

CMS Releases Resources for Intellectual and Developmental Disability Care Strategies

On June 2, the Centers for Medicare and Medicaid Services (CMS) released a set of resources intended to assist state Medicaid and partner agencies with designing strategies for caregivers of adults with intellectual and developmental disabilities (I/DD). The resources contain information on how to strengthen I/DD care data management, partnerships, training, engagement and more.

For more information, click here.

CMS Outlines How Medicare Will Cover Alzheimer’s Drugs

On June 1, Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure made an announcement explaining how Medicare will cover Alzheimer’s drugs. The administrator clarified that Medicare Part B will cover Alzheimer’s drugs that receive traditional approval from the Food and Drug Administration (FDA) in appropriate settings if these drugs are part of a physician or clinical team-led study that gathers information on how the drugs work in the real world. This information would have to be submitted by clinicians into a nationwide, CMS-facilitated portal. In order to have the cost of their Alzheimer’s drugs covered, Medicare beneficiaries will have to:

• Be enrolled in Medicare Part B;
• Be diagnosed with mild cognitive impairment or early dementia caused by Alzheimer’s disease; and
• Have a qualified physician or clinical team participating in a registry and receive follow-up care.

For more information, click here.

FDA Awards Funding for New Tobacco Rapid Surveillance Center

On June 1, the Food and Drug Administration (FDA) announced that the FDA and the National Institutes of Health (NIH) had awarded funding for a new Center for Rapid Surveillance of Tobacco (CRST). The center will support the FDA’s data collection, analysis and reporting efforts on tobacco and will help enhance tobacco product marketplace and use pattern changes.

For more information, click here.

FDA Approves RSV Vaccine for Older Adults

On May 31, the Food and Drug Administration (FDA) approved Abrysvo, a vaccine intended to prevent respiratory syncytial virus (RSV) in adults aged 60 and older. This is the second RSV vaccine to receive FDA approval. The FDA decided to grant Abrysvo approval after late-stage clinical trial results indicated the vaccine was more than 66.7 percent effective at preventing mild cases of RSV and more than 85 percent effective at preventing moderate cases.

FDA Cracks Down on Illegal E-Cigarette Sales

On May 31, the Food and Drug Administration (FDA) issued warning letters to 30 e-cigarette retailers for illegally selling unauthorized tobacco products. The products in question include various types of Puff and Hyde brand disposable e-cigarettes. Puff and Hyde products are among the most popular tobacco products used by youth e-cigarette users in the U.S.

For more information, click here.

FDA Announces Patient Engagement Committee Meeting

On May 30, the Food and Drug Administration (FDA) announced that its Patient Engagement Advisory Committee (PEAC) will hold a meeting to discuss and make recommendations on advancing health equity in medical devices. The committee will discuss how access to medical devices can be improved for care inside a home setting, how FDA patient and caregiver communications can be increased across diverse demographic groups and more. The meeting will be held virtually on Sept. 6, 2023.

For more information, click here.

FDA Releases Guidance on Drug and Biological Clinical Trial Covariates

On May 25, the Food and Drug Administration (FDA) released guidance on how the statistical analyses of drug development program randomized clinical trials should be adjusted for covariates. The guidance primarily focuses on how prognostic baseline covariates such as demographic factors, disease characteristics and other trial participant information can be used to improve statistical efficiency when estimating and testing treatment effects.

For more information, click here.

FDA Releases Draft Guidance on Antidiabetic Drug Development

On May 25, the Food and Drug Administration (FDA) released a draft guidance intended to help with the development of antidiabetic drugs for adults and children with type 1 and type 2 diabetes mellitus. The guidance outlines the FDA’s current recommendations regarding how efficacy endpoints should be defined for antidiabetic drug clinical trials. Efficacy endpoints discussed in the guidance include A1C, hypoglycemia, fasting plasma glucose and continuous glucose monitoring (CGM)-based metrics.

For more information, click here.

FDA Approves First COVID-19 Oral Antiviral for Adults

On May 25, the Food and Drug Administration (FDA) approved Paxlovid, the first oral antiviral intended to treat mild-to-moderate COVID-19 in adults who are at high risk for developing a severe case of COVID-19. Paxlovid was granted emergency use authorization (EUA) by the FDA in December 2021.

The FDA decided to grant Paxlovid full approval after final results of a randomized, double-blind, placebo-controlled clinical trial showed the drug reducing the number of patients who were hospitalized for COVID-19 compared to those that did not receive any type of COVID-19 therapeutic monoclonal antibody treatment.

For more information, click here.

FDA Approves New Bacterial Pneumonia Treatment

On May 23, the Food and Drug Administration (FDA) approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for pneumonia induced by susceptible strains of the Acinetobacter baumannii-calcoaceticus complex (A. baumannii) bacterium. A. baumannii is a difficult-to-treat bacterium that is highly resistant to multiple antibacterial drugs. It can cause widespread infections within the body and spreads most frequently within healthcare settings.

The FDA decided to grant Xacduro approval after a multicenter, active-controlled, open-label, non-inferiority clinical trial showed the drug reducing the risk of death among patients with A.baumannii-induced pneumonia.

For more information, click here.

FDA Approves New Opioid Use Disorder Drug

On May 23, the Food and Drug Administration (FDA) approved Brixadi (buprenorphine), an extended-release injection used to treat moderate to severe opioid use disorder (OUD). A weekly and monthly formulary version of Brixadi will be available. Patients who have started OUD treatment with a single dose of a transmucosal buprenorphine product, or who are already being treated with buprenorphine, will be eligible for the weekly version. Those who have already been receiving treatment with buprenorphine will be eligible for the monthly version.

The FDA decided to grant Brixadi approval after a behavioral pharmacology study and a randomized, double-blind, active-controlled clinical trial showed the drug effectively curbing illicit opioid use among patients who received the drug versus those who received a placebo.

For more information, click here.

FDA Approves Opioid Overdose Reversal Nasal Spray

On May 22, the Food and Drug Administration (FDA) approved Opvee, the first nalmefene hydrochloride nasal spray used to treat an opioid overdose in adults or patients 12 years or older. Opvee is available by prescription only and is intended to be used in healthcare and community settings. The drug can quickly reverse common overdose symptoms such as respiratory depression, sedation and low blood pressure. The FDA decided to grant Opvee approval after various safety and pharmacokinetic studies proved the drug was safe and effective.

For more information, click here.

FDA Approves First Dystrophic Epidermolysis Bullosa Topical Gene Therapy

On May 19, the Food and Drug Administration (FDA) approved Vyjuvek, the first topical gene therapy for the treatment of dystrophic epidermolysis bullosa (DEB) wounds in patients 6 months and older. DEB is a serious genetic skin disorder that affects the connective tissues in the skin and nails, leading to painful blisters and wounds that can lead to medical complications and death. Vyjuvek is a topical gel that contains a genetically modified herpes-simplex virus that helps restore the COL7A1 gene in DEB patients, which improves the integrity of skin.

The FDA decided to grant Vyjuvek approval after a randomized, double-blind, placebo-controlled study showed the gel helped in healing DEB wounds faster.

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.

CMS Proposed Rule Updates Hospital Inpatient and Long-Term Care Hospital PPS Rates

On April 10, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the hospital inpatient prospective payment system (PPS) and long-term care hospital PPS for fiscal year (FY) 2024. The proposed rule would:

• Increase inpatient PPS payment rates by a net 2.8 percent;
• Increase the cost outlier threshold by 4.8 percent;
• Increase the federal capital by 4.5 percent;
• Exclude “dual reclass” hospitals from the rural wage index policy;
• Consider rural reclassified hospitals as geographically rural when calculating the wage index;
• Support graduate medical training in rural areas by allowing graduate medical education payments to go toward rural emergency hospitals;
• Restore program integrity restrictions on “high Medicaid facilities”;
• Add 15 and remove 16 Medicare Severity Diagnosis Related Groups (MS-DRGs);
• Allow web-based surveys to be used for Hospital Consumer Assessment of Healthcare Providers and Systems; and
• Seek public comment and information on supporting safety-net providers.

Public comments will be accepted until June 9, 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 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.

CBO Cost Estimates

CBO Releases Report Describing How It Constructs Baseline Projections

On May 25, the Congressional Budget Office (CBO) released a report that outlines the statutory foundations and requirements that it must adhere to when constructing baseline projections of federal revenues, spending, deficits, surpluses and debt. The report also includes a timeline that shows how federal legislation and rules have affected CBO baseline projections over time. The bills described in the report include:

• The Congressional Budget and Impoundment Control Act of 1974;
• The Balanced Budget and Emergency Deficit Control Act of 1985;
• The Federal Credit Reform Act of 1990;
• The Balanced Budget Act of 1997; and
• The Budget Control Act of 2011.

For more information, click here.

CBO Releases Report Explaining How It Identifies Mandates in Legislation

On May 25, the Congressional Budget Office (CBO) released a report that explains how it identifies mandates included in federal legislation. Although the CBO is primarily responsible for identifying the impact a bill may have on the federal budget, it is also required to examine the impact a bill may have on private-sector entities and state, local and tribal governments. This report explains the principles that CBO uses when analyzing mandates and describes the process that is used when creating cost estimates for them.

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CBO Releases Presentation on Projected Shifts in Health Insurance Coverage

On May 24, the Congressional Budget Office (CBO) released a presentation outlining projected shifts that will occur in healthcare coverage for individuals ages 65 and younger over the next 10 years. The presentation discusses how premium growth rates are projected to change, how income levels are expected to affect healthcare coverage and how temporary policy unwindings are expected to impact Medicaid and marketplace enrollment.

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