This Week in Washington: HHS announces lowest national uninsured rate, CDC recommends RSV antibody for infants, CMS releases rules on inpatient and long-term care hospitals and skilled nursing facilities

Congress

House

• House Energy and Commerce Chairmen Send Letter Concerning Gain-of-Function Research
• One Hundred and One Representatives Send Letter Concerning Medicare Physician Payment Reform

Senate

• Senate Finance Committee Chairman Sends Letter Concerning ADHD Drug Shortages

Administration

• HHS Report Reveals Lowest National Uninsured Rate
• HHS Establishes Office of Long COVID Research and Practice
• CDC Recommends RSV Antibody for Infants
• CMS Announces Extension of Appendix K HCBS Waivers
• CMS Releases CY 2024 Medicare Part D Premium and Bid Information
• CMS Innovation Center Releases New Dementia Care Model
• FDA Seeks White House Approval for LDT Jurisdiction Proposed Rule

Proposed Rules

• CMS Proposed Rule Strengthens Coverage of Mental Health Insurance Benefits
• CMS Proposed Rule Contains RFI on Episode-based Payment Model
• CMS Proposed Rule Updates CY 2024 Medicare PFS Payments
• CMS Proposed Rule Revises FY 2024 Medicare Hospital OPPS and ASC Payment Systems
• CMS Proposed Rule Updates Medicare Home Health PPS Rates for CY 2024
• CMS Proposed Rule Outlines Remedy to 340B Program Payment Adjustments
• CMS Proposed Rule Modifies Definition of Short-term Health Plans
• CMS Proposed Rule Updates and Revises ESRD PPS for CY 2024
• FDA Proposes Rule to Broaden Prescription Drug Labeling Regulations
• FDA Proposes New Tobacco Product Manufacturing Practices Requirements
• OCR Proposed Rule Reaffirms Federal Discrimination Protections in HHS Grants

Final Rules

• CMS Final Rule Updates Inpatient and Long-Term Care Hospital PPS Rates in FY 2024
• CMS Final Rule Updates PPS Rates for Skilled Nursing Facilities in FY 2024
• CMS Final Rule Updates Hospice Wage Index and Payment Rate in FY 2024
• CMS Final Rule Updates PPS Rates for Inpatient Psychiatric Facilities in FY 2024
• CMS Final Rule Updates PPS Rates for Inpatient Rehabilitation Facilities in FY 2024
• CMS Final Rule Clarifies Medicare DSH Payment Adjustment Part C Days
• 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

• MedPAC Releases 2023 Data Book
• GAO Releases Report Regarding DOD and VA Behavioral Healthcare Screenings
• GAO Releases Report on Traditional Health Insurance Alternatives 

Note

• McGuireWoods Consulting Telehealth Flexibility Guidance Now Available

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Congress

House

The House has recessed for its August district work period. House Energy and Commerce Chairmen Send Letter Concerning Gain-of-Function Research On Aug. 1, 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 a letter to the Government Accountability Office (GAO) requesting that it gather information on the risks and benefits of gain-of-function research involving pathogens with pandemic potential. The members are also requesting information on how gain-of-function research is being defined and used across federal agencies. For more information, click here. One Hundred and One Representatives Send Letter Concerning Medicare Physician Payment Reform On July 28, Rep. Bera (D-CA) led a group of 101 representatives in sending a letter to House Speaker Kevin McCarthy (R-CA) and House Minority Leader Hakeem Jeffries (D-NY) urging the leadership to work with them to create reform of Medicare physician payments to stabilize the system and pay for health outcomes. In their letter, the members argue that the Medicare Access and CHIP Reauthorization Act (MACRA) Merit-Based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs) have logistical challenges for providers resulting in lower uptake of these models. The members point to incentive payments in APMs that are temporary and underutilized and state that thresholds to qualify for APM payment adjustments are steep. For more information, click here.

Senate

The Senate has recessed for its August state work period. Senate Finance Committee Chairman Sends Letter Concerning ADHD Drug Shortages On Aug. 3, Senate Finance Committee Chairman Ron Wyden (D-OR) sent a letter to attention deficit hyperactivity disorder (ADHD) drug manufacturers urging them to either increase their production of ADHD medications or relinquish their remaining amphetamine product quota allotment to allow other manufacturers to produce more than their production limit. The Chairman is also asking manufacturers to report voluntary and required production information to the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) to help track the ongoing shortage of ADHD medications. The letter is the Chairman’s response to a joint statement issued by FDA Commissioner Robert Califf and DEA Administrator Anne Milgram, which stated ADHD drug manufacturers produced just 70 percent of their allotted amphetamine product quota in 2022. The DEA and FDA acknowledged that production rates remain under permitted limits thus far in 2023. For more information on the Chairman’s letter, click here. For more information on the joint statement, click here.

Administration

HHS Report Reveals Lowest National Uninsured Rate On Aug. 3, the Department of Health and Human Services (HHS) Assistant Secretary for Planning and Evaluation (ASPE) Office of Health Policy released a report that analyzes data from the National Health Interview Survey and the American Community Survey. The report revealed that the national uninsured rate had reached an all-time low of 7.7 percent in early 2023. It also revealed that a record 16.3 million people had signed up for health coverage under the Affordable Care Act (ACA) marketplace during the 2023 Open Enrollment Period. For more information, click here. HHS Establishes Office of Long COVID Research and Practice On July 31, the Department of Health and Human Services (HHS) announced the formation of the Office of Long COVID Research and Practice. The Office will be housed within the HHS Office of the Assistant Secretary for Health and will be tasked with coordinating Long COVID response efforts across federal agencies. It will also oversee the implementation of the National Research Action Plan on Long COVID. In addition, the National Institutes of Health (NIH) announced that it will begin accepting participants for phase 2 clinical trials aimed at developing Long COVID treatments. The trials are part of the NIH’s Research COVID to Enhance Recovery (RECOVER) Initiative. For more information, click here. CDC Recommends RSV Antibody for Infants On Aug. 3, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) met and voted unanimously to recommend the administration of Beyfortus (nirsevimab), a respiratory syncytial virus (RSV) antibody, in infants 8 months or younger. The committee also recommended that children between the ages of 8 and 19 months with an increased risk of severe RSV disease receive a second dose. Beyfortus received FDA approval last month and is expected to be available in the fall. For more information, click here. CMS Announces Extension of Appendix K HCBS Waivers On Aug. 2, the Centers for Medicare and Medicaid Services (CMS) announced that it will allow states to extend their home- and community-based services (HCBS) Appendix K waivers past their original Nov. 11 expiration date, so long as states submit amendment proposals outlining how the Appendix K waivers will be incorporated into 1915(c) waiver programs. CMS clarified that states do not need to amend existing approved Appendix K applications for the extension to apply. For more information, click here. CMS Releases CY 2024 Medicare Part D Premium and Bid Information On July 31, the Centers for Medicare and Medicaid Services (CMS) released a fact sheet outlining projected Medicare Part D premium and bid information for calendar year (CY) 2024. The information aims to inform Part D plan sponsors about premium trends prior to the Medicare Open Enrollment Period. CMS projects that average total and supplemental premiums will decrease in 2024 and that the implementation of pharmacy price concession policies will lower beneficiary out-of-pocket prescription drug costs. For more information, click here. CMS Innovation Center Releases New Dementia Care Model On July 31, the Centers for Medicare and Medicaid Services (CMS) Center for Medicare and Medicaid Innovation announced the release of the Guiding an Improved Dementia Experience (GUIDE) care model. The model aims to standardize dementia care management and strengthen support for dementia patients and caregivers. Participants will be given access to care coordination, caregiver education and support, and respite services. CMS will launch the model in July 2024 and will begin accepting participant applications this fall. For more information, click here. FDA Seeks White House Approval for LDT Jurisdiction Proposed Rule On July 26, the Food and Drug Administration (FDA) sent a draft of a proposed rule to the White House Office of Information and Regulatory Affairs (OIRA) that would 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 announced that it will open a notice-and-comment period and will request device maker feedback if the rule is approved. For more information, click here.

Proposed Rules

CMS Proposed Rule Strengthens Coverage of Mental Health Insurance Benefits On July 25, the Centers for Medicare and Medicaid Services (CMS) released 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 comment 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. 2, 2023. For more information, click here. CMS Proposed Rule Contains RFI on Episode-based Payment Model On July 14, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that seeks comment through a request for information (RFI) on the design of a future CMS Center for Medicare and Medicaid Innovation episode-based payment model. The Center is considering designing and implementing a new episode-based payment model that would focus on healthcare equity, quality and costs. The Center is seeking information from individuals who have experience with bundled payments and noted that responses to the RFI may be used to inform potential future rulemaking and policy development. Public comments will be accepted until Aug. 17, 2023. For more information, click here. CMS Proposed Rule Updates CY 2024 Medicare PFS Payments On July 13, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that updates the Medicare physician fee schedule (PFS) payment rates for calendar year (CY) 2024. The proposed rule would:

• Decrease the conversion factor by 3.34 percent to $32.75;
• Delay implementation of a policy that defines the substantive portion of a split or shared visit based on the amount of time spent by a billing practitioner;
• Create a new benefit category for marriage and family therapists and mental health counselors under Medicare Part B;
• Establish new payment codes for mobile psychotherapy for crisis services;
• Implement five new optional Merit-based Incentive Payment System Value Reporting Pathways; and
• Extend several telehealth waivers.

Public comments will be accepted until Sept. 11, 2023. For more information, click here. CMS Proposed Rule Revises FY 2024 Medicare Hospital OPPS and ASC Payment Systems On July 13, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule concerning the Medicare hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for fiscal year (FY) 2024. The proposed rule would:

• Increase OPPS payment rates for hospitals that meet applicable quality reporting requirements by 2.8 percent. This is based off of a projected hospital market basket percentage increase of 3.0 percent minus a 0.2 percent productivity adjustment;
• Update the productivity-adjusted hospital market basket update factor to ASC rates by 2.8 percent and extend its application through calendar years (CYs) 2024 and 2025;
• Establish the Intensive Outpatient Program (IOP) under Medicare and implement various IOP service provisions;
• Update partial hospitalization program (PHP) Medicare payment rates;
• Strengthen hospital price transparency;
• Adopt and codify several standard quality program reporting policies; and
• Expand access to behavioral healthcare and promote safe and effective patient-centered care.

Public comments will be accepted until Sept. 11, 2023. For more information, click here. CMS Proposed Rule Updates Medicare Home Health PPS Rates for CY 2024 On July 10, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that updates the Medicare Home Health Prospective Payment System (PPS) rates for calendar year (CY) 2024. The proposed rule would:

• Apply a permanent PPS adjustment of negative 5.653 percent;
• Cut reimbursement rates for home health providers by 2.2 percent;
• Add and remove quality measures from the Home Health quality reporting program;
• Codify requirements for negative wound therapy;
• Establish regulations and implement the items and services payment for lymphedema compression treatment and home intravenous globulin services;
• Address concerns about unnecessary utilization, costs and care quality; and
• Add an informal dispute resolution (IDR) and special focus program (SFP) for hospice programs.

Public comments will be accepted until Aug. 29, 2023. For more information, click here. CMS Proposed Rule Outlines Remedy to 340B Program Payment Adjustments On July 7, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that outlines how 340B hospitals will be reimbursed for funds they did not receive due to an adjustment made to the Medicare payment rates for drugs acquired under the 340B program between calendar years (CY) 2018 and 2022. The adjustment was ruled unlawful by the U.S. Supreme Court last year when the Court unanimously agreed that the Department of Health and Human Services (HHS) had exceeded its statutory authority by adjusting the Outpatient Prospective Payment System (OPPS) payment rates for 340B hospitals without first conducting a statutorily mandated survey of hospitals’ acquisition costs. Under the proposed rule:

• CMS would pay back the outstanding reimbursement funds to applicable 340B hospitals in a one-time lump-sum payment. CMS projects this amount to total approximately $10.5 billion.
• CMS would recoup funds from hospitals that received increased rates for non-drug services between CYs 2018 and 2022. CMS plans to do this by adjusting the OPPS conversion factor by minus 0.5 percent beginning in CY 2025. This adjustment would remain in effect for an estimated 16 years or until all overpaid funds are recouped.

Public comments will be accepted until Sept. 11, 2023. For more information, click here. CMS Proposed Rule Modifies Definition of Short-term Health Plans On July 7, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would amend the definition of short-term, limited duration-insurance (STLDI) plans and modify conditions for hospital indemnity insurance to be considered an excepted benefit in group and individual health insurance markets. The proposed rule would:

• Restrict the length of STLDI plans to three months and implement a maximum coverage period of four months;
• Prohibit issuers from offering STLDI plans to consumers who have previously purchased plans from the same or a different issuer;
• Prohibit fixed indemnity excepted benefits coverage from paying benefits on a per-service basis in the individual market;
• Implement additional payment standards for fixed indemnity excepted benefits coverage in individual and group markets;
• Require that fixed indemnity excepted benefits be offered as independent, non-coordinated coverage; and
• Propose amendments to revise current notice language to clarify the differences between STLDI and fixed indemnity excepted benefits coverage and comprehensive coverage.

In addition to CMS, the Internal Revenue Service and the Employee Benefits Security Administration are proposing the rule. The agencies are also seeking comment and information on specified disease-excepted benefits coverage and level-funded plans. Public comments will be accepted until Sept. 11, 2023. For more information, click here. CMS Proposed Rule Updates and Revises ESRD PPS for CY 2024 On June 30, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that updates and revises the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2024. The proposed rule would:

• Increase payment rates for freestanding ESRD facilities by 1.6 percent and hospital-based facilities by 2.6 percent;
• Increase the ESRD PPS base rate to $269.99;
• Implement a transitional pediatric ESRD dialysis add-on payment adjustment for CYs 2024 to 2026;
• Implement a new three-year add-on payment for new renal dialysis drugs and biological products at the end of the Transitional Add-on Payment Adjustment two-year period;
• Waive low-volume payment amount attestation requirements for ESRD facilities that were impacted by disasters and emergencies;
• Create a new adjustment that increases payment to low-volume, geographically isolated and rural ESRD facilities; and
• Codify new quality reporting measures and remove older measures.

Public comments will be accepted until Aug. 25, 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. 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. OCR Proposed Rule Reaffirms Federal Discrimination Protections in HHS Grants On July 11, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the Office of the Assistant Secretary for Financial Resources (ASFR) released a proposed rule that reaffirms federal protections against discrimination in HHS-funded programs and services. The proposed rule would:

• Clarify that discrimination on the basis of sexual orientation and gender identity is prohibited by federal statutes administered by HHS;
• Confirm non-discrimination protections in HHS programs as well as services and grants relating to refugee and homelessness assistance, substance abuse treatment and prevention, community mental health, and maternal and child health; and
• Clarify that individuals with religious objections may seek an exemption from or modification of program requirement when appropriate.

Public comments will be accepted until Sept. 11, 2023. For more information, click here.

Final Rules

CMS Final Rule Updates Inpatient and Long-Term Care Hospital PPS Rates in FY 2024 On Aug. 1, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would update the Medicare hospital inpatient prospective payment system (PPS) and long-term care hospital (LTCH) PPS rates in fiscal year (FY) 2024. The final rule would also update the Hospital Value-Based Purchasing (VBP) Program and the Inpatient Quality Reporting Program (QRP). It would:

• Increase Medicare inpatient PPS rates by 3.1 percent. This is based on a 3.3 percent market basket increase and a decrease in productivity of 0.2 percent;
• Finalize changes to graduate medical education (GME) payments for Rural Emergency Hospitals;
• Extend the low wage index hospital policy that considers rural reclassified hospitals as geographically rural when calculating the wage index;
• End the New COVID-19 Treatments Add-on Payment (NCTAP) policy;
• Revise physician self-referral data and information and reinstate program integrity restrictions on certain physician-owned hospitals;
• Add one new measure to the Hospital VBP;
• Add three new measures to the Inpatient QRP; and
• Finalize a CMS proposal relating to the calculation of Medicaid 1115 demonstration days used in the Medicare disproportionate share hospital (DSH) adjustment.

The final rule will go into effect on Oct. 1, 2023. For more information, click here. CMS Final Rule Updates PPS Rates for Skilled Nursing Facilities in FY 2024 On July 31, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would update the prospective payment system (PPS) for skilled nursing facilities (SNFs) in fiscal year (FY) 2024. The final rule would also update the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program. It would:

• Increase SNF PPS payments by a net 4.0 percent;
• Codify changes to the Patient Driven Payment Model (PDPM) International Classification of Diseases, 10th revision, Clinical Modification codes;
• Finalize a requirement that would exclude marriage and family therapy and mental health counseling services from SNF Consolidated Billing;
• Add two new measures to the SNF QRP;
• Add four new measures to the SNF VBP Program; and
• Streamline CMS administrative procedures to strengthen its enforcement of nursing home quality compliance.

The rule will go into effect on Oct. 1, 2023. Two amendments in the rule will go into effect on Jan. 1, 2024. For more information, click here. CMS Final Rule Updates Hospice Wage Index and Payment Rate in FY 2024 On July 28, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would update the hospice wage index, payment rates and aggregate cap amount in fiscal year (FY) 2024. The final rule would also implement updates to the Hospice Quality Reporting Program (HQRP). It would:

• Codify hospice data submission thresholds for the HQRP;
• Implement updates to the CMS Hospice Special Focus Program (SFP);
• Update health equity and future quality reporting measures;
• Update the Hospice Outcomes and Patient Evaluation tool; and
• Require hospice certifying physicians to be Medicare-enrolled or to validly opt-out.

The rule will go into effect on Oct. 1, 2023. For more information, click here. CMS Final Rule Updates PPS Rates for Inpatient Psychiatric Facilities in FY 2024 On July 27, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would update the prospective payment system (PPS) rates for inpatient psychiatric facilities (IPFs) in fiscal year (FY) 2024. The final rule would also implement updates to the IPF Quality Reporting Program (QRP). It would:

• Update the IPF PPS payment rate by 3.3 percent;
• Adopt a 2021-based IPF market basket;
• Adopt four new QRP measures;
• Allow IPFs to open new units and be paid under the IPF PPS at any time during the cost reporting period;
• Remove two QRP measures beginning in FY 2025; and
• Adopt a data validation pilot program beginning in FY 2025.

The rule will go into effect on Oct. 1, 2023. For more information, click here. CMS Final Rule Updates PPS Rates for Inpatient Rehabilitation Facilities in FY 2024 On July 27, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would update the prospective payment system (PPS) rates for inpatient rehabilitation facilities (IRFs) in fiscal year (FY) 2024. The final rule would also implement updates to the IRF Quality Reporting Program (QRP). It would:

• Increase IRF PPS payment rates by an estimated 4 percent, approximately $355 million more relative to FY 2023. This is based off a market basket update of 3.6 percent, minus a 0.2 percentage point for productivity and a 0.6 percentage point increase in the outlier threshold;
• Allow hospitals to open a new IRF and receive payment under the IRF PPS at any time during the cost reporting period;
• Adopt a 2021-based IRF market basket and implement updated market basket cost weights, price proxies and labor-related share;
• Adopt two new QRP measures, modify one measure and remove three measures; and
• Finalize proposals that require the public reporting of four QRP measures.

The rule will go into effect on Oct. 1, 2023. For more information, click here. CMS Final Rule Clarifies Medicare DSH Payment Adjustment Part C Days On June 7, the Centers for Medicare and Medicaid Services (CMS) released a final rule that establishes a policy that governs how the hospital inpatient days of Medicare Part C beneficiaries should be considered when calculating a hospital’s disproportionate share (DSH) payment adjustment. The policy is intended to provide clarity on how Part C days will be treated for DSH calculations that are not governed by the FY 2014 inpatient prospective payment system (IPPS)/long-term care hospital (LTCH) prospective payment system (PPS) final rule. The rule will go into effect on Aug. 8, 2023. For more information, click here. 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

MedPAC Releases 2023 Data Book On July 26, the Medicare Payment Advisory Commission (MedPAC) released its July 2023 Data Book on healthcare spending and the Medicare program. The data book provides information on national healthcare and Medicare spending, Medicare beneficiary demographics, dual-eligible beneficiaries, quality of care in the Medicare program, and beneficiaries’ access to care. For more information, click here. GAO Releases Report Regarding DOD and VA Behavioral Healthcare Screenings On Aug. 2, the Government Accountability Office (GAO) released a report that analyzes the extent to which the Department of Defense (DOD) and the Department of Veterans Affairs (VA) screen and provide access to behavioral healthcare services to service members and veterans who experience unwanted sexual behavior. Service members who experience unwanted sexual behavior are more likely to leave the military. This is of particular concern to the DOD given ongoing recruitment and retention challenges. After analyzing DOD and VA behavioral healthcare data and guidance and interviewing officials at military installations and medical facilities, the GAO discovered that several obstacles are impeding service members’ access to behavioral healthcare over unwanted sexual encounters. The GAO found that the DOD does not have specific guidance on how to screen for sexual harassment, assault and abuse and that the requirement that service members obtain a referral to access long-term behavioral healthcare services may be deterring members from seeking care. For more information, click here. GAO Releases Report on Traditional Health Insurance Alternatives On Aug. 2, the Government Accountability Office (GAO) released a report that analyzes the benefits and features of alternative health plans such as Farm Bureau health plans, healthcare sharing ministries and fixed indemnity plans. These plans, also referred to as health coverage arrangements, are not subject to certain federal standards and minimum health insurance requirements. After reviewing plan documentation and interviewing plan sellers, the GAO found that the selected health coverage arrangements contained few consumer protections and that the type of medical services they covered varied. The GAO also found that sellers of these plans used various marketing practices. The GAO conducted this study because it was asked to review plan features, enrollment and marketing associated with alternatives to health insurance. For more information, click here.

NOTE:

McGuireWoods Consulting Telehealth Flexibility Guidance Now Available McGuireWoods Consulting has compiled a list of all the telehealth flexibilities that were issued during the COVID-19 public health emergency. The list outlines flexibilities relating to physicians, hospitals, home health agencies and other providers, and displays their current status. For more information, click here. Because of the congressional recess the next Washington newsletter will be Sept. 11.