This Week in Washington: Drug Enforcement Administration extends COVID-19 era flexibilities for telehealth for second time; House considers new leadership.

Congress

House

• Speaker Pro Tempore Role Limited
• House Members Send Letter Concerning Hospice Special Focus Program

Senate

• Appropriations Consideration

Administration

• HHS OIG Releases Report on Impact of Biosimilars on Medicare Part B Costs
• CMS to Host Medicare Drug Price Negotiation Listening Sessions
• CMS Sends Letter to States Regarding Medicaid and CHIP Continuous Coverage for Children
• DEA Extends COVID-19 Telehealth Flexibilities for Second Time
• FDA Seeking Public Feedback on How Individuals Get Medication Information
• FDA Issues Draft Guidance Regarding Stimulant Use Disorder Treatment Development
• FDA Authorizes Updated Novavax COVID-19 Vaccine
• FDA Announces Public Workshop to Define “Candy-Like” Drug Products
• FDA Releases Final Guidance Regarding Drug and Biological Product Dose Banding
• FDA Approves RNAi Primary Hyperoxaluria Type 1 Therapy
• FDA Grants Marketing Authorization to In Vitro Multi-Cancer Diagnostic Test
• SAMHSA Awards $35 Million to Strengthen Behavioral Health and HIV Prevention Services

Proposed Rules

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

Final Rules

• CMS Final Rule Streamlines Medicare Savings Program Enrollment Process
• CMS Final Rule Mandates Medicaid and CHIP Program Core Set Measures Reporting
• DEA Releases Temporary Rule Extending COVID-19 Telemedicine Flexibilities
• CMS Finalizes 2024 Medicare Advantage and Part C and D Payment Policies
• FDA Issues Final Rule Regarding Mammography Quality Standards
• FDA Delays Tobacco Product Required Warning Final Rule Effective Date

Reports

• GAO Releases Report Regarding Office of National Drug Control Policy Community Project Funding
• GAO Releases Report Regarding Incentives to Spur Development of Antiviral Drug

House – Will return this week to choose a new Speaker

Senate – In recess

Congress

House

Speaker Pro Tempore Role Limited

After the vote that led to Speaker McCarthy losing his position, a Speaker pro tempore was appointed.

However, Rep. McGovern (D-MA), ranking member of the House Rules Committee, took the unusual step of sending out a history and summary of the Speaker pro tempore’s role. The summary states:

The authority of the acting Speaker pro tempore is strictly ministerial and the position’s sole role is to guide the House toward the election of a new Speaker or Speaker pro tempore:

• The position was created following the 9/11 terrorist attack to ensure continuity of government, and specifically, to provide for the rapid election of a new Speaker, who is second in the presidential order of succession.

• Clause 8(b)(3) of rule I ensures there is a Member with the clear authority to quickly convene the House and preside over a Speaker election if the Speaker is killed or incapacitated.

• The plain language of the rule and the legislative history are clear: the acting Speaker pro tempore has no authority other than taking steps necessary and appropriate to further the election of a new Speaker.

• In fact, the rule contemplates the election of a Speaker pro tempore instead of a Speaker in the event the House cannot quickly elect a Speaker, an unnecessary provision if the acting Speaker pro tempore had the power to oversee the House’s regular business, for example.

• Evidence of this limited role will be clear, since bills introduced after the Office of Speaker became vacant will not be referred to committees—a basic legislative task required of the Speaker by clause 2 of rule XII.

• In short, the acting Speaker pro tempore’s authority is limited to actions that help the House elect a new Speaker.

House Members Send Letter Concerning Hospice Special Focus Program

On Oct. 4, Reps. Van Duyne (R-TX), Blumenauer (D-OR), Wenstrup (R-OH) and Panetta (D-CA) wrote to the Centers for Medicare and Medicaid Services (CMS) and the Office of Management and Budget concerning CMS’ proposal for how to identify hospices that should be in the Hospice Special Focus Program. The members state that the proposal would not adequately identify hospices that are truly struggling with performance because it would be based on survey data that is incomplete.

The HOSPICE Act of 2020 directs CMS to improve hospice oversight. In response CMS created the hospice special focus program, which would require certain hospices to improve deficiencies in 18 months or be terminated from the Medicare program.

In the 2024 proposed home health payment rule, CMS said it would use Medicare hospice data including surveys and claims data to identify hospices that should be in the program and rank hospices.

The members who signed the letter believe the CMS metrics often have missing data.

Senate

Appropriations Consideration

While the House focuses on its leadership crises, the Senate is turning back to consider appropriations. The Senate Appropriations Committee has approved all 12 of its bills but none have passed the full Senate. The committee is aiming to get their three-bill minibus moving again. This legislation had been teed up to be considered prior to the House’s surprise move of approving a continuing resolution to avoid a government shutdown.

The mini-omnibus would contain the Agriculture, Military Construction-VA and State-Foreign Operations appropriations bills. Because it was a short week in the Senate so that members could attend the funeral services for Sen. Dianne Feinstein (D-CA) and they are in recess this week, movement is not imminent.

Administration

HHS OIG Releases Report on Impact of Biosimilars on Medicare Part B Costs

On Oct. 2, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report regarding biosimilars and the impact they are having on spending for the Medicare Part B program and enrollees.

The report found that increased biosimilar competition has reduced the costs of biosimilar products and their reference products but that further cost reductions are likely possible through the use of more affordable biosimilars and the implementation of different payment policies.

For more information, click here.

CMS to Host Medicare Drug Price Negotiation Listening Sessions

Beginning Oct. 30, the Centers for Medicare and Medicaid Services (CMS) will host a series of public listening sessions as part of the Medicare Drug Price Negotiation Program. The sessions will focus on gathering patient, beneficiary and other stakeholder input on the drugs selected for the first round of price negotiations. CMS is seeking information on how the selected drugs compare to therapeutic alternatives, address unmet needs and impact specific populations.

For more information, click here.

CMS Sends Letter to States Regarding Medicaid and CHIP Continuous Coverage for Children

On Sept. 29, the Centers for Medicare and Medicaid Services (CMS) sent a letter to state health officials reminding them that states must provide 12 months of continuous coverage for children under the age of 19 who are covered through Medicaid and the Children’s Health Insurance Program (CHIP) beginning Jan. 1, 2024. The letter also reminds states that they may extend the continuous coverage period by requesting Section 1115 demonstration authority.

For more information, click here.

DEA Extends COVID-19 Telehealth Flexibilities for Second Time

On Oct. 6 the Drug Enforcement Administration (DEA) released a rule to be published on Oct. 10 to extend the COVID-19 era flexibilities for the prescription of controlled substances using telehealth for new patients until the end of 2024. The extension will take effect on Nov. 11, when the DEA’s first temporary rule, promulgated earlier this year, will expire. The temporary rules states that the DEA will issue new standards or safeguards by the fall of 2024 for telehealth prescribers.

For more information, click here.

FDA Seeking Public Feedback on How Individuals Get Medication Information

On Oct. 4, the Food and Drug Administration (FDA) announced that it was seeking public feedback to better understand how people obtain information regarding their over-the-counter and prescription medications. The FDA is primarily interested in where people get their information, what sources they primarily trust and what questions regarding their medications remain unanswered.

For more information, click here.

FDA Issues Draft Guidance Regarding Stimulant Use Disorder Treatment Development

On Oct. 4, the Food and Drug Administration (FDA) released draft guidance regarding the development of stimulant use disorder treatments. The draft guidance contains recommendations on clinical trial designs, development programs and treatment response evaluations for stimulant use disorder drugs.

For more information, click here.

FDA Authorizes Updated Novavax COVID-19 Vaccine

On Oct. 3, the Food and Drug Administration (FDA) authorized the updated Novavax COVID-19 vaccine. The vaccine is formulated to target the currently circulating COVID-19 variant XBB 1.5 and may be administered to individuals 12 years and older.

For more information, click here.

FDA Announces Public Workshop to Define “Candy-Like” Drug Products

On Oct. 3, the Food and Drug Administration (FDA) announced that it would hold a public workshop aimed at defining characteristics of candy-like drug products. The workshop will include discussion on formulation considerations for developing palatable drug products, and on the implications of candy-like characteristics on medication adherence among pediatric and geriatric populations.

For more information, click here.

FDA Releases Final Guidance Regarding Drug and Biological Product Dose Banding

On Oct. 2, the Food and Drug Administration (FDA) released guidance regarding dose banding of drug and biological products. The guidance intends to inform applicants on how to properly label injectable drug products that vary in dosage based on an individual’s weight or body surface area. The guidance also applies to drug products that come in ready-to-use containers and various dosage strengths.

For more information, click here.

FDA Approves RNAi Primary Hyperoxaluria Type 1 Therapy

On Oct. 2, the Food and Drug Administration (FDA) approved Rivfloza, a once-monthly subcutaneous ribonucleic acid interference (RNAi) therapy that was shown to lower urinary oxalate levels for primary hyperoxaluria type 1 (PH1) patients ages 9 and older. PH1 is a progressive metabolic disorder that affects the kidneys and can lead to progressive kidney damage.

For more information, click here.

FDA Grants Marketing Authorization to In Vitro Multi-Cancer Diagnostic Test

On Sept. 29, the Food and Drug Administration (FDA) granted de novo marketing authorization to the Invitae Common Hereditary Cancers Panel, an in-vitro diagnostic test capable of detecting genetic variants associated with an increased risk of cancer development. The test is capable of analyzing the DNA of a blood sample and identifying variants in 47 genes.

For more information, click here.

SAMHSA Awards $35 Million to Strengthen Behavioral Health and HIV Prevention Services

On Oct. 4, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced that it had awarded $35 million in grants to support behavioral health and human immunodeficiency virus (HIV) prevention services for underserved populations.

The grants include:

• $21.9 million for the Minority AIDS Initiative: Substances Use Disorder Treatment for Racial/Ethnic Minority Populations at High Risk for HIV/AIDS, to increase engagement in care for racial and ethnic underserved individuals;
• $10.5 million for the Minority AIDS Initiative: Substance Use and Human Immunodeficiency Virus Prevention Navigator Program for Racial/Ethnic Minorities, to provide substance use and HIV prevention services to high-risk minority populations; and
• $1.9 million for the Minority HIV/AIDS Fund: Integrated Behavioral Health and HIV Care for Unsheltered Populations Pilot Project, to provide comprehensive care services to underserved people experiencing homelessness.

For more information, click here.

Proposed Rules

CMS Proposed Rule Increases No Surprises Act IDR Administrative Fee

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

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

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

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

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

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

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

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

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

CMS Proposed Rule Establishes Minimum Staffing and Payment Reporting Standards

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

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

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

FDA Proposes Rule Regarding Laboratory Developed Tests

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

Public comments will be accepted until Dec. 1, 2023. For more information, click here.

FDA Proposes Rule to Broaden Prescription Drug Labeling Regulations

On May 30, the Food and Drug Administration (FDA) released a proposed rule that would amend human prescription drug product labeling regulations for medication guides. The proposed rule would require prescription drug and biological product applicants to include a new one-page medication guide known as the Patient Medication Information (PMI) along with products that are used, dispensed or administered in an outpatient setting. Blood and blood components transfused in an outpatient setting would also require a PMI. The PMI would include essential information such as the product’s name, important safety information, common side effects and directions for use.

Public comments will be accepted until Nov. 27, 2023. For more information, click here.

OCR Proposed Rule Strengthens Protections Against Disability Discrimination

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

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

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

Final Rules

CMS Final Rule Streamlines Medicare Savings Program Enrollment Process

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

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

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

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

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

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

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

DEA Releases Temporary Rule Extending COVID-19 Telemedicine Flexibilities

On May 10, the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) released a temporary rule that extends telemedicine flexibilities adopted during the COVID-19 public health emergency (PHE). The temporary rule follows two Notices of Proposed Rulemaking (NPRM) regarding the virtual prescribing of controlled substances that the DEA released in March 2023, which received more than 38,000 public comments. The temporary rule specifically:

• Extends through Nov. 11, 2023, the COVID-19 PHE controlled substance prescribing flexibilities that allow practitioners to prescribe controlled substances via telemedicine without having to evaluate patients in person.
• Implements a one-year grace period through Nov. 11, 2024, for practitioners and patients who have or who develop a telemedicine relationship on or before Nov. 11, 2023. A “telemedicine relationship” is considered to exist if a practitioner has already issued a prescription for a controlled substance to a patient.

The temporary rule will stay in effect through Nov. 11, 2024. For more information, click here.

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

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

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

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

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

FDA Issues Final Rule Regarding Mammography Quality Standards

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

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

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

FDA Delays Tobacco Product Required Warning Final Rule Effective Date

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

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

Reports

GAO Releases Report Regarding Office of National Drug Control Policy Community Project Funding

On Sept. 29, the Government Accountability Office (GAO) released a report regarding the use of appropriated funds that the Office of National Drug Control Policy (ONDCP) received from the Consolidated Appropriations Act of 2023. The GAO was interested in learning how the ONDCP intends to distribute the $10.5 million it received for community project funding. The GAO interviewed ONDCP officials and asked them how the funds will be monitored.

The GAO found that the ONDCP has existing grant management policies and monitoring processes in place to ensure that funds are spent properly and was informed that it does not anticipate any significant challenges in distributing and monitoring community project funds. The GAO conducted this study because a provision in the Consolidated Appropriations Act of 2023 asked it to review federal agency implementation of community project funding and congressionally directed spending.

For more information, click here.

GAO Releases Report Regarding Incentives to Spur Development of Antiviral Drugs

On Sept. 29, the Government Accountability Office (GAO) released a report examining policy options aimed at incentivizing the investment and development of antiviral drugs to combat future pandemics. The GAO interviewed antiviral drug development stakeholders and experts and reviewed relevant economic and scientific literature.

The GAO found that despite the National Institutes of Health (NIH) identifying numerous viral families capable of causing future pandemics, no antiviral drugs aimed at targeting these viruses have been approved or are currently underdoing clinical tests as of May 2023. The GAO also found that streamlined policy strategies are needed to induce and maximize antiviral drug development. The GAO conducted this study because a provision in the Coronavirus Aid, Relief, and Economic Security (CARES) Act directed it to report on the federal response to the COVID-19 pandemic.

For more information, click here.