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This Week in Washington: Debt Ceiling Continues to Loom Over the Capitol; DEA Extends COVID-19 Controlled Medications Prescribing Telehealth Flexibilities

Upcoming Hearings

Congress

House

• House Ways and Means Health Subcommittee Holds Hearing on Therapy Access and Medical Innovation

Senate

• Senate HELP Committee Advances PBM and Generic Drug Bills
• Senate Finance Committee Holds Hearing on Pharmaceutical Manufacturers and International Tax Policy
• Senate HELP Committee Holds Hearing on Insulin Product Prices

Administration

• HHS Releases Fact Sheet on COVID-19 PHE Telehealth Flexibilities
• HHS Releases Fact Sheet on COVID-19 PHE Unwinding
• CMS Releases FAQ Addressing Medicaid and CHIP Issues Related to Continuous Enrollment
• FDA Approves First Drug to Treat Dementia Agitation Symptoms
• FDA Loosens Blood Donation Restrictions
• FDA Updates Boxed Warning for Prescription Stimulants
• FDA Releases Two Discussion Papers on Role of AI in Drug Development
• FDA Releases Consumer Fact Sheet on OTC Hearing Aids
• FDA Issues Guidance on Testing of High-Risk Drug Components
• FDA Issues Guidance on Implementation of Prescription Drug User Fee Amendments

Proposed Rules

• 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
• CMS Proposed Rule Updates Inpatient Psychiatric Facility (IPF) PPS Rates
• CMS Proposed Rule Updates Skilled Nursing Facility PPS Rates
• CMS Proposed Rule Updates Inpatient Rehabilitation Facility PPS Rates
• CMS Releases Hospice Index, Payment Rate and Aggregate Cap Proposed Rule
• FDA Proposes New Tobacco Product Manufacturing Practices Requirements

Final Rules

• DEA Releases Temporary Rule Extending COVID-19 Telemedicine Flexibilities
• CMS Releases Notice of Benefit and Payment Parameters for 2024 Final Rule
• CMS Finalizes Changes to Medicare Advantage, Part D, Cost Plan and PACE Regulations
• 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

• Federal Court Decision Places No-Cost Mammogram Screenings At-Risk

Reports

• GAO Releases Report Regarding 340B Drug Discount Program
• GAO Releases Report on HHS’ Role in Public Health Emergency Preparedness
• GAO Releases Report on Midwifery Care and Education
• GAO Releases Report on VA Electronic Health Records System Challenges

CBO Cost Estimates

• CBO Releases Presentation on Long-Term Projections of Health Care Spending

Upcoming Hearings

May 16

House Ways and Means Committee Full Committee Hearing: “Health Care Price Transparency: A Patient’s Right to Know”
10:00 a.m., Longworth House Office Building 1100
Witnesses to be announced.

May 17

Senate Health, Education, Labor and Pensions Committee Primary Health and Retirement Security Subcommittee Hearing: “A Crisis in Mental Health and Substance Use Disorder Care: Closing Gaps in Access by Bringing Care and Prevention to Communities”
10:00 a.m., Dirksen Senate Office Building 430
Witnesses to be announced.

House Ways and Means Committee Health Subcommittee Hearing: “Why Health Care is Unaffordable: Anticompetitive and Consolidated Markets”
2:00 p.m., Longworth House Office Building 1100
Witnesses to be announced.

Senate Finance Committee Health Care Subcommittee Hearing: “Improving Health Care Access in Rural Communities: Obstacles and Opportunities”
2:30 p.m., Dirksen Senate Office Building 215
Announced witnesses are:

• Erin Aune, MBA, CRHCP, Vice President of Strategic Programs at Frances Mahon Deaconess Hospital
• Sara Rich, President and CEO of Choptank Community Health System
• David Herman, MD, CEO of Essentia Health
• Mark Holmes, Director of the University of North Carolina at Chapel Hill Cecil G. Sheps Center for Health Services Research

House

House Ways and Means Health Subcommittee Holds Hearing on Therapy Access and Medical Innovation

On May 10, the House Ways and Means Health Subcommittee held a hearing to examine policies that inhibit medical innovation and patient’s access to therapies. Witnesses included:

• Tony Gonzales, National Early-Stage Advisor at the Alzheimer’s Association
• Ted Okon, Executive Director of Community Oncology Alliance
• Darius Lakdawalla, Professor of Pharmaceutical Economics and Public Policy at the USC Leonard D. Schaeffer Center for Health Policy and Economics
• Joshua Makower, MD, Director of the Stanford Byers Center for Biodesign at Stanford University
• Aaron S. Kesselheim, MD, JD, MPH, Professor of Medicine at Harvard Medical School

During the hearing, Republican subcommittee members raised concerns about oversight of the Center for Medicare and Medicaid Innovation (CMMI). The Center creates payment and service delivery models that seek to save money within the Medicare program has been controversial since its inception. Subcommittee members pointed out that few of the payment models have been incorporated into Medicare. CMMI recently released three payment models the goal of which would be to lower drug prices. One would pay a lower amount for drugs that are approved through the Food and Drug Administration’s accelerated pathway. Republican subcommittee members argued at the hearing that such an approach would devalue drugs that use the accelerated pathway.

For more information, click here.

Senate

Senate HELP Committee Advances PBM and Generic Drug Bills

On May 11, the Senate Health, Education, Labor, and Pensions (HELP) Committee concluded the markup of legislation concerning drug prices and pharmacy benefit managers (PBMs). Originally, the markup was to occur early in the month, but a compromise developed by the Chair and the ranking member fell apart and the markup was delayed. The following bills were considered:

• 1067, the Ensuring Timely Access to Generics Act of 2023

• This bill would allow the Food and Drug Administration (FDA) to deny citizen petitions that are submitted to intentionally prevent generic drug approval. It would also allow the FDA to deny citizen petitions that do not raise valid scientific of regulatory issues. The committee voted 21-0 in favor of the bill as amended.

• 1114, the Expanding Access to Low-Cost Generics Act of 2023

• This bill would seek to put an end to an anti-competitive drug practice known as “parking.” “Parking” refers to a practice in which a brand-name drug manufacturer agrees to not sue a generic drug manufacturer in exchange for the delayed release of the generic drug manufacturer’s product to the market. During this time, no other generic drug manufacturer may bring a drug to the market for a period of 180 days. The committee voted 20-1 in favor of the bill as amended.

• 1214, the Retaining Access and Restoring Exclusivity (RARE) Act

• This bill would specify that a seven-year orphan drug market exclusivity period for rare disease drugs outlined in the Food, Drug and Cosmetic (FD&C) Act, bans only the approval of other drugs with the same approved use or indication, not drugs that seek to treat the same disease or condition. The committee voted 21-0 in favor of the bill as amended.

• 1339, the Pharmacy Benefit Manager Reform Act.

• This bill would restrict ban pharmacy benefit manager (PBM) spread pricing, require all rebates to be passed to insurance plans, and strengthen annual PBM reporting requirements. The committee voted 18-3 in favor of the bill as amended.

It is unclear when the full Senate will take up this legislation, but it is expected to be soon.

For more information, click here.

Senate Finance Committee Holds Hearing on Pharmaceutical Manufacturers and International Tax Policy

On May 11, the Senate Finance Committee held a hearing on pharmaceutical manufacturers and U.S. International Tax Policy. Witnesses included:

• Brad W. Setser, Senior Fellow at the Council on Foreign Relations
• Diane M. Ring, Professor of Law and Distinguished Scholar at the Boston College Law School
• William Morris, Global Tax Policy Leader at PwC
• Daniel Bunn, President and CEO of the Tax Foundation

Committee members discussed tax practices used by U.S pharmaceutical companies to lower their tax bill. Committee Chair Ron Wyden (D-OR) criticized pharmaceutical companies for moving their profits overseas, in an effort to obtain tax breaks, and denounced them for also placing their intellectual property in other countries. He also criticized a 2017 Republican tax law that cut taxes for some U.S pharmaceutical companies by more than 40 percent.

The Chair also announced the release of new findings from an ongoing investigation into drug company tax practices. The Senate Finance Committee majority staff have been investigating the tax practices of pharmaceutical companies since 2021. The findings of their work demonstrate that U.S pharmaceutical companies report more than 75 percent of their taxable income as offshore income. Additionally, the findings show that pharmaceutical companies are making use of profit shifting structures to circumvent certain taxes.

The findings of the Chairman’s report are available here.

The committee’s hearing on U.S. international tax policy is available here.

Senate HELP Committee Holds Hearing on Insulin Product Prices

On May 10, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on the pricing of insulin and other diabetes medication. Witnesses included:

• David Ricks, Chair and Chief Executive Office at Eli Lilly and Company
• Lars Fruergaard Jørgensen, President and Chief Executive Officer at Novo Nordisk
• Paul Hudson, Chief Executive Officer at Sanofi
• David Joyner, Executive Vice President and President of Pharmacy Services at CVS Health
• Adam Kautzner, President at Express Scripts
• Heather Cianfrocco, Chief Executive Officer at OptumRx

Committee members questioned witnesses on the prices they charge for diabetes medications and discussed how complicated pricing is hurting patients. Chairman Bernie Sanders (I-VT) criticized witnesses for increasing the price of insulin products despite making record profits and stated that the high price of insulin was contributing to the deaths of thousands of Americans who cannot afford it. Several committee members pressed witnesses on the role of pharmacy benefit managers (PBMs) and criticized PBMs for placing higher list prices on insulin products to generate more rebates that are not being passed along to patients.

For more information, click here.

Administration

HHS Releases Fact Sheet on COVID-19 PHE Telehealth Flexibilities

On May 10, the Department of Health and Human Services (HHS) released a fact sheet explaining telehealth flexibilities that were implemented during the COVID-19 public health emergency (PHE). The fact sheet provides brief explanations of telehealth flexibilities that apply to Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and private health insurance plans. It also explains the Drug Enforcement Administration’s (DEA) temporary rule that extends the prescribing of controlled substances via telehealth through Nov. 11, 2024.

For more information, click here.

HHS Releases Fact Sheet on COVID-19 PHE Unwinding

On May 9, the Department of Health and Human Services (HHS) released a fact sheet regarding the changes that will occur to waivers and flexibilities following the expiration of the COVID-19 public health emergency (PHE) on May 11. The fact sheet mentions COVID-19 vaccines and treatments, COVID-19 data reporting and surveillance, Medicare and Medicaid waivers, telehealth services, and more.

For more information, click here.

CMS Releases FAQ Addressing Medicaid and CHIP Issues Related to Continuous Enrollment

On May 12, the Centers for Medicare and Medicaid Services (CMS) released a frequently asked questions document concerning changes made to the Medicaid continuous enrollment condition under the Families First Coronavirus Response Act (FFCRA) by the Consolidated Appropriations Act of 2023 (CAA, 2023). Topics addressed include questions relating:

• Returned mail condition for states claiming the increased FMAP available under FFCRA:
• Reestablishment of premiums in Medicaid and CHIP:
• Renewal requirements for individuals who receive Social Security Income;
• Medicaid and CHIP agency capacity to share beneficiary data with enrolled providers to support renewals; and,
• Eligibility changes to the former foster care children group made by the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act.

For more information, click here.

FDA Approves First Drug to Treat Dementia Agitation Symptoms

On May 11, the Food and Drug Administration (FDA) approved Rexulti (brexpiprazole), the first treatment of agitation associated with dementia due to Alzheimer’s disease. Agitation symptoms are commonly found in patients with dementia due to Alzheimer’s disease and often characterized by pacing, restlessness, and verbal and physical aggression. The FDA decided to grant Rexulti approval after a two 12-week, randomized, double-blind, placebo-controlled, fixed dose clinical study revealed a decrease in the frequency of certain agitative behaviors in dementia patients who took the drug.

For more information, click here.

FDA Loosens Blood Donation Restrictions

On May 11, the Food and Drug Administration (FDA) finalized recommendations for assessing blood donor eligibility and loosened blood donation restrictions for men who have sex with men (MSM). The FDA announced that it will eliminate time-based deferrals and remove screening questions that are specific to MSM, and women who have sex with MSM, from its blood donation eligibility questionnaires. All prospective blood donors will now answer the same risk-based questions to determine donation eligibility, regardless of their sexual orientation, sex, or gender. All prospective donors who report having a new sexual partner or more than one sexual partner and anal sex in the past three month, will continue to be deferred from donation to reduce the risk of HIV. Individuals who are taking HIV medication, who have a history of non-prescription injection drug use, who have exchanged sex for money or drugs, or who previously tested HIV-positive from donating, will be deferred as well.

For more information, click here.

FDA Updates Boxed Warning for Prescription Stimulants

On May 11, the Food and Drug Administration (FDA) announced that it would require all boxed warnings on prescription stimulants to be updated. The FDA is planning to make stimulant prescribing information consistent across the entire class of medicines and intends on adding information to stimulant boxed warnings that describe the risks of misuse, abuse, addiction, and overdose. The FDA is particularly concerned about the prevalence of nonmedical use of stimulant drugs.

For more information, click here.

FDA Releases Two Discussion Papers on Role of AI in Drug Development

On May 10, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) released two discussion papers intended to spark discussion on the possible application of artificial intelligence (AI) and machine learning (ML) in drug development and manufacturing. The first discussion paper, written in collaboration with the FDA Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health, evaluates how AI/ML could be used in the development of drugs, biologics, and medical devices. The second discussion paper evaluates how AI/ML could be used to support pharmaceutical manufacturing and advanced manufacturing technologies.

For more information, click here.

FDA Releases Consumer Fact Sheet on OTC Hearing Aids

On May 9, the Food and Drug Administration (FDA) released a fact sheet for consumers on over the counter (OTC) hearing aids. The fact sheet explains how OTC hearing aids work and explains who can buy them and where they can be purchased. It also informs individuals how they can report problems with OTC hearing aids and allegations of regulatory misconduct to the FDA.

For more information, click here.

FDA Issues Guidance on Testing of High-Risk Drug Components

On May 9, the Food and Drug Administration (FDA) issued a guidance for industry on the testing of high-risk drug components such as glycerin, propylene, glycol, and others, for contamination of diethylene glycol (DEG) and ethylene glycol (EG). The FDA has been receiving an increasing number of reports of fatal poisonings that are linked with the consumption of liquid drug products which were manufactured with DEG and EG-contaminated components. The guidance intends to alert pharmaceutical manufacturers, repackers, and suppliers of the health hazard and outlines current good manufacturing practice (CGMP) requirements and recommendations.

For more information, click here.

FDA Issues Guidance on Implementation of Prescription Drug User Fee Amendments

On May 5, the Food and Drug Administration (FDA) released a guidance for industry that outlines what stakeholders should consider when implementing the Prescription Drug User Fee Amendments (PDUFA VII) of 2022. The guidance explains what types of user fees are authorized by the PDUFA VII and how stakeholders can submit payments to the FDA. It also outlines how requests for a user fee assessment reconsideration can be submitted and explains what the consequences for failing to pay PDUFA fees are.

For more information, click here.

Proposed Rules

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.

CMS Proposed Rule Updates Inpatient Psychiatric Facility (IPF) PPS Rates

On April 4, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Inpatient Psychiatric Facility (IPF) Prospective Payment System’s (PPS) Medicare payment policies and rates, as well as the IPF Quality Reporting Program (QRP), for fiscal year (FY) 2024. The proposed rule would:

• Result in a 1.9 percent (approximately $55 million) payment increase for IPFs in FY 2024, based on a 3.0 percent increase in the IPF PPS payment rate;
• Adopt a 2021-based IPF market basket;
• Update and increase the labor-related share (LRS) to 78.5 percent;
• Make it easier for hospitals to open new IPF units, by allowing them to open new units at any time during the cost reporting period, so long as they notify their CMS Regional Office and Medicare Administrative Contractor within 30 days; and
• Make changes to the IPF QRP measures.

Public comments will be accepted until June 5, 2023. For more information, click here.

CMS Proposed Rule Updates Skilled Nursing Facility PPS Rates

On April 4, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Skilled Nursing Facility (SNF) Prospective Payment System’s (PPS) Medicare payment policies and rates, as well as the SNF Quality Reporting Program (QRP) and SNF Value-Based Purchasing (VBP) Program, for fiscal year (FY) 2024. The proposed rule would:

• Result in a 3.7 percent (approximately $1.2 billion) Medicare Part A payment increase for SNFs in FY 2024, based on a 2.7 percent market basket update; a 3.6 percent increase in the market basket forecast error adjustment; a 0.2 percent decrease in the productivity adjustment; and a 2.3 percent decrease in the FY 2024 SNF PPS rates; and
• Make multiple changes to the SNF QRP measures.

Public comments will be accepted until June 5, 2023. For more information, click here.

CMS Proposed Rule Updates Inpatient Rehabilitation Facility PPS Rates

On April 3, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Inpatient Rehabilitation Facility (IRF) Prospective Payment System’s (PPS) Medicare payment policies and rates, as well as the IRF Quality Reporting Program (QRP), for fiscal year (FY) 2024. The proposed rule would:

• Result in a 3.0 percent payment increase for IRFs, based on the proposed market basket update of 3.2 percent minus the 0.2 percentage point productivity adjustment;
• Increase IRF outlier payments by 0.7 percent;
• Make it easier for hospitals to open IRF units by allowing them to immediately start billing under the IRS PPS at any time during the cost reporting period, so long as they notify the CMS Regional Office and Medicare Administrative Contractor in writing within 30 days; and
• Make changes to the IRF QRP measures.

Public comments will be accepted until June 2, 2023. For more information, click here.

CMS Releases Hospice Index, Payment Rate and Aggregate Cap Proposed Rule

On March 31, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would make changes to hospice wage index rates, payment rates and aggregate cap amounts for fiscal year (FY) 2024. The proposed rule intends to inform patients and caregivers on hospice utilization trends, hospice center ownership information and Medicare hospice and non-hospice spending amounts. The proposed rule will:

• Codify the Hospice Quality Reporting Program (HQRP) data completion threshold policy;
• Provide an update on future Quality Measures (QM) development and health equity efforts;
• Provide an update on the Consumer Assessment of Healthcare Providers and Systems, Hospice Survey Mode Experiment; and
• Require physicians who order or certify hospice services for Medicare beneficiaries to be enrolled in Medicare or validly opted-out.

Public comments will be accepted until May 30, 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

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 over 38,000 public comments. The temporary rule specifically:

• Extends the COVID-19 PHE controlled substance prescribing flexibilities that allows practitioners to prescribe controlled substances via telemedicine without having to evaluate patients in person, through Nov. 11, 2023.
• 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 Changes to Medicare Advantage, Part D, Cost Plan and PACE Regulations

On April 5, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will finalize revisions made to the Medicare Advantage (MA), Prescription Drug Benefit and Cost Plan program regulations, as well as the Programs of All-Inclusive Care for the Elderly (PACE) regulations, for calendar year (CY) 2024. The final rule will:

• Require that MA plans comply with national coverage determinations (NCDs), local coverage determinations (LCDs), and general coverage and benefit conditions included in Traditional Medicare regulations;
• Require that coordinated care plan prior authorization policies may only be used to confirm the presence of diagnoses or other medical criteria and/or ensure that an item or service is medically necessary;
• Require coordinated care plans to provide a minimum 90-day transition period to enrollees who are undergoing treatment and switch to a new MA plan;
• Require all MA plans to establish a Utilization Management Committee and review policies to ensure consistency with Traditional Medicare guidelines;
• Require that approval of a prior authorization request be valid for as long as medically reasonable and necessary;
• Prohibit MA plan television ads from using words, imagery or names that may mislead or confuse beneficiaries;
• Expand access to behavioral healthcare by adding clinical psychologists and licensed clinical social workers to the list of evaluated specialties;
• Promote equitable care by adding a health equity index to the Star Ratings program and require MA and Part D plans to provide care to underserved populations; and
• Implement certain provisions of the Inflation Reduction Act (IRA), the Consolidated Appropriations Act (CAA) of 2021 and the Bipartisan Budget Act (BBA) of 2018.

The rule will go into effect on June 5, 2023. For more information, click here.

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

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

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

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

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

FDA Issues Final Rule Regarding Mammography Quality Standards

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

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

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

FDA Delays Tobacco Product Required Warning Final Rule Effective Date

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

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

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

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

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

Courts

Federal Court Decision Places No-Cost Mammogram Screenings At-Risk

On March 30, 2023, the U.S. District Court in the Northern District of Texas struck down a portion of the Affordable Care Act (ACA) that requires insurers to offer certain essential preventative services with no cost sharing. Preventative services include mammograms, colonoscopies, and mental health screenings. A recently released analysis by the Urban Institute found that more than 22 million women may lose access to no-cost mammogram screenings. Mammogram screenings can cost patients up to $560 in out-of-pocket expenses and the loss of no-cost preventative screenings would place a significant barrier on women who cannot afford to pay the out-of-pocket cost.

For more information, click here.

Reports

GAO Releases Report Regarding 340B Drug Discount Program

On May 11, the Government Accountability Office (GAO) released a report regarding the 340B drug discount program. The report looks at how the Health Resources and Services Administration (HRSA) managed 340B exceptions that were submitted by hospitals. The 340B program allows hospitals to purchase outpatient drugs at discounted prices, but only if they treat a minimum percentage of low-income Medicare and Medicaid patients. Congress pass an exception to this requirement in 2022 due to the COVID-19 pandemic. The exception only applied to disproportionate share hospital (DSH) percentages from hospital cost-reporting periods that began during fiscal year (FY) 2020 and ended no later than Dec. 31, 2022. The GAO reviewed HRSA documents related to the 340B exception process and looked at the manner in which HRSA oversaw the exception process.

The GAO found that within days of the 340B exception provision becoming law, HRSA had developed a standard operating procedure to guide the exception review and approval process and had shared information about the exception to potentially eligible hospitals and stakeholder groups. The GAO conducted this study because it was asked to review the exception process and provide information on hospitals that received a 340B exception.

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GAO Releases Report on HHS’ Role in Public Health Emergency Preparedness

On May 11, the Government Accountability Office (GAO) released a report regarding the role of the Department of Health and Human Services (HHS) in preparing for public health emergencies. Over the past several years, the GAO has been monitoring HHS leadership for any deficiencies in coordinating a response to public health emergencies. In Jan. 2022, the GAO put out a report that showed several shortcomings in the manner in which HHS responded to the COVID-19 pandemic.

In its latest report, the GAO found that persistent deficiencies remain within HHS’ ability to coordinate and lead public health emergency preparedness efforts. HHS continues to struggle in providing clear and consistent communication, providing transparency and accountability, establishing clear roles and responsibilities, collecting, and analyzing information, and understanding partner capabilities and limitations. The GAO conducted this study because it identified HHS deficiencies when responding to previous public health emergencies such as the COVID-19 pandemic, the H1N1 influenza pandemic, and the outbreak of Zika and Ebola.

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GAO Releases Report on Midwifery Care and Education

On May 8, the U.S. Government Accountability Office (GAO) released a report regarding midwifery care and education. The report examines the use of midwives, the state of midwifery educational programs, and the challenges that exist in accessing midwifery care in the U.S. The GAO analyzed data from federal agencies and midwifery organizations and also interviewed researcher and officials about maternal care quality measures.

The GAO discovered that pregnant women face persistent challenges in obtaining midwifery care and that midwives themselves, are often subject to work barriers due to varying state limitations on their scope of practice. Additionally, the GAO discovered that nurse-midwifery students face challenges accessing midwifery education and clinical training placements. The GAO conducted this study because it was asked to examine midwifery education and access to midwifery care.

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GAO Releases Report on VA Electronic Health Records System Challenges

On May 9, the U.S. Government Accountability Office (GAO) released a report examining challenges the Department of Veterans Affairs (VA) has faced in implementing a new information technology (IT) system used to maintain veterans’ health records. Since 2017, the VA has been working towards fully implementing its Electronic Health Record Modernization (EHRM) initiative, which seeks to replace the complex, costly and out-of-date Veterans Health Information Systems and Technology Architecture (VistA) software that the VA relied on previously to manage healthcare for its patients. To evaluate the VA’s progress in implementing the EHRM initiative, the GAO examined whether the VA has been consistently following organizational management leading practices, and whether system issues have been identified and addressed.

After interviewing system users and conducting user surveys, the GAO determined that the VA has not been fully consistent in following leading practices and that it has not identified and addressed system issues. The GAO conducted this study because it was asked to determine the extent to which the VA has followed EHRM implementation and improvement practices.

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CBO Cost Estimates

CBO Releases Presentation on Long-Term Projections of Health Care Spending

On May 5, the Congressional Budget Office (CBO) released a presentation on the long-term projections of health care spending and the implications it would have on the federal budget. The presentation contains projections for total federal spending on healthcare programs and expresses them as a percentage of U.S. Gross Domestic Product (GDP).

The CBO predicts federal spending on major health care programs to grow by more than one percent of GDP in the next 10 years. Additionally, the CBO predicts federal subsidies for employment-based health insurance coverage to increase. The presentation also shares information on the composition of growth in outlays for major health care programs and social security through 2052 and on projected aging of the U.S. population.

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