This Week in Washington: House and Senate not in session, U.S. reaches debt-ceiling limit

Congress

House

• Rep. Frank Pallone Questions FDA and NIH Over Federally Funded Clinical Trial Reporting Compliance

Administration

• FDA Seeking Public Comments on the Use of FDA Device User Fees
• FDA Grants 510(k) Clearance to SeluxDX in vitro Antimicrobial Resistance (AMR) Test
• FDA Rejects Eli Lilly Accelerated Approval Request for Alzheimer’s Drug Donanemab
• FDA Releases Update Regarding COVID-19 Test Expiration Dates
• FDA Announces Panel Meeting Date to Discuss iPLEDGE REMS Program for Isotretinoin Products
• FDA Updates Two COVID-19 Testing Guidelines
• FDA Signs U.S.-Switzerland Mutual Pharmaceutical Manufacturing Recognition Agreement
• CMS Announces New Steps to Strengthen Nursing Home Safety and Transparency
• HHS Releases 2023 Notice Regarding Annual Update of HHS Poverty Guidelines

Proposed Rules

• HHS Proposes Rule to Clarify Beneficiary Religious Protections
• HHS Office for Civil Rights Releases Proposed Rule Seeking to Clarify Health Care Provider Conscience Protection Rights
• SAMHSA Seeking Public Comments Regarding Opioid Use Disorder Treatment Medication Requirement Reforms
• SAMHSA Introduces Proposed Rule to Better Align SUD Patient Privacy with HIPAA
• CMS Releases Proposed Benefit and Payment Parameters for 2024
• CMS Releases Proposed Changes to Contract Year 2024 Medicare Program Plans
• CMS Proposes MA Plan Marketing, Part D Low-income Access, Prior Authorization and Behavioral Health Reforms
• CMS Proposes Healthcare Plan Exchange Rule for 2024
• CMS Requests Information on Essential Health Benefits Proposed Rule
• HHS Proposes Adopting Healthcare Attachments Standards
• FDA Proposed Rule Would Replace Investigational New Drug Annual Report
• FDA Proposes Exempting Certain Conventional Food, Dietary Supplements and Cosmetics From Investigational New Drug Requirements
• HRSA Proposed Rule Changes Concerning 340B Disputes

Final Rules

• CMS Final Rule Adds Items to DMEPOS Order List and Updates Healthcare Common Procedure Coding System (HCPCS)
• FDA Delays Tobacco Product Required Warning Final Rule Effective Date
• CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

Reports

• HHS OIG Reveals High Rate of COVID-19 Infections in Nursing Homes
• GAO Releases Report on HHS Oversight Over Enhanced Potential Pandemic Pathogens Research
• CMS Releases Initial Report on Federal Independent Dispute Resolution (IDR) Process
• CBO Releases Cost Estimate Showing Anticipated 2023 Consolidated Appropriations Act Budgetary Effects

Congress

House

Rep. Frank Pallone Questions FDA and NIH Over Federally Funded Clinical Trial Reporting Compliance

On Jan. 19, Rep. Frank Pallone (D-NJ) sent a letter to the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), raising concerns over whether medical product sponsors are submitting federally funded clinical trial results to the ClinicalTrials.gov database. Medical products sponsors are required to submit clinical trial results to the federal database, in order to provide healthcare providers and researchers with safety and efficacy information. A recent study revealed that up to 31 percent of clinical trials are going unreported.

Senate not in session

Administration

FDA Seeking Public Comments on the Use of FDA Device User Fees

On Jan. 19, the Food and Drug Administration (FDA) announced that it is requesting public comments regarding the use of FDA device user fees. A portion of fees is currently being used to support the National Evaluation System for Health Technology (NEST) premarket Real-World Evidence (RWE) activities. The FDA is asking stakeholders to suggest other ways the agency could distribute the user fee funds. Public comments are due by March 20, 2023.

FDA Grants 510(k) Clearance to SeluxDX in vitro Antimicrobial Resistance (AMR) Test

On Jan. 19, the Food and Drug Administration (FDA) granted 510(k) clearance to an in vitro antimicrobial resistance test developed by Selux Diagnostics. The test uses Selux Diagnostics’ Next Generation Phenotyping (NGP) System, which the company claims can deliver targeted results faster than other antimicrobial resistance tests on the market.

FDA Rejects Eli Lilly Accelerated Approval Request for Alzheimer’s Drug Donanemab

On Jan. 19, the Food and Drug Administration (FDA) rejected Eli Lilly’s request to grant accelerated approval to its Alzheimer’s drug donanemab. The FDA cited that it did not receive adequate safety data to grant the accelerated approval. The FDA is requesting that Eli Lilly submit data on at least 100 clinical trial patients who have been receiving the drug for a minimum of 12 months.

FDA Releases Update Regarding COVID-19 Test Expiration Dates

On Jan. 19, the Food and Drug Administration (FDA) Center for Devices and Radiological Health announced that the shelf life for three COVID-19 tests is longer than previously thought. The expiration dates of the Abbott Diagnostics Scarborough BinaxNOW COVID-19 Antigen Self-Test, the MaximBio ClearDetect COVID-19 Antigen Home Test and the iHealth Labs iHealth COVID-19 Antigen Rapid Test have now been extended. The extensions come after FDA reviewed new data provided by the manufacturers listed above, which showed the tests having similar levels of accuracy past their original expiration dates.

FDA Announces Panel Meeting Date to Discuss iPLEDGE REMS Program for Isotretinoin Products

On Jan. 14, the Food and Drug Administration (FDA) announced that the FDA Drug Safety and Risk Management Advisory and the Ophthalmic Drugs Advisory Committees would meet in March to discuss the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) Program for isotretinoin products. The iPLEDGE REMS Program was recently modified by the FDA and went into effect last month. Patients, providers and pharmacies have been experiencing problems and interruptions using the modified program.

For more information, click here.

FDA Updates Two COVID-19 Testing Guidelines

On Jan. 13, the Food and Drug Administration (FDA) updated the COVID-19 Policy for Coronavirus Disease-2019 Tests (Revised): Guidance for Developers and Food and Drug Administration Staff and the Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests: Guidance for Test Developers and Food and Drug Administration Staff testing guidelines. The updates outline information about new COVID-19 variants and detail specific actions the FDA has taken in response to them. The FDA also clarified that the testing guidelines will remain in effect as long as Section 564 of the Federal Food, Drug, and Cosmetic Act recommends the emergency use of in vitro diagnostic tests for the detection of COVID-19.

FDA Signs U.S.-Switzerland Mutual Pharmaceutical Manufacturing Recognition Agreement

On Jan. 12, the Food and Drug Administration (FDA) signed off on the Agreement on Mutual Recognition of Pharmaceutical Good Manufacturing Practice agreed upon by the United States and Switzerland. The mutual recognition will simplify the good manufacturing practice inspection process between the FDA and the Swiss Agency for Therapeutic Products (Swissmedic). The FDA and Swissmedic must both ensure that their respective good manufacturing practices meet U.S and Swiss requirements, before the mutual recognition agreement is allowed to go into effect.

For more information, click here.

CMS Announces New Steps to Strengthen Nursing Home Safety and Transparency

On Jan. 18, the Centers for Medicare and Medicaid Services (CMS) announced that it would take new action to strengthen nursing home safety and transparency. CMS plans to begin targeted, off-site audits to evaluate whether nursing homes are properly diagnosing residents with schizophrenia. CMS is concerned about nursing homes incorrectly diagnosing residents and prescribing them antipsychotics, which can have dangerous side effects. CMS also plans to begin publicly displaying survey citations that nursing home facilities are disputing, to increase transparency of facilities and help inform consumers who are looking for a nursing home.

HHS Releases 2023 Notice Regarding Annual Update of HHS Poverty Guidelines

On Jan. 12, the Department of Health and Human Services (HHS) released a notice regarding the update of HHS poverty guidelines used to determine eligibility criteria for Medicaid and other federal programs. HHS is required to update the poverty guidelines annually, to account for price changes driven by inflation. The update in poverty guidelines matches the annual increase in prices as measured by the Consumer Price Index (CPI). The guidelines in this notice reflect the 8.0 percent increase in prices that occurred between 2021 and 2022.

For more information, click here.

Proposed Rules

HHS Proposes Rule to Clarify Beneficiary Religious Protections

On Jan. 13, nine federal agencies, including the Department of Health and Human Services (HHS), released a proposed rule that seeks to clarify and restore religious liberty protections for individuals who receive federally funded social services. The proposed rule would require federal grantees who administer social service programs to notify individuals that they may not be discriminated against based on their religion. The rule would also advise federal agencies on how they can assist individuals with finding providers that are more reflective of their beliefs.

In addition to HHS, the Departments of Agriculture, Education, Homeland Security, Housing and Urban Development, Justice, Labor and Veterans Affairs and the U.S. Agency for International Development are proposing the rule.

Public comments will be accepted until March 14, 2023. For more information, click here.

HHS Office for Civil Rights Releases Proposed Rule Seeking to Clarify Healthcare Provider Conscience Protection Rights

On Jan. 5, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a proposed rule that seeks to partially rescind a 2019 final rule titled “Protecting Statutory Conscience Rights in Health Care; Delegations of Authority.” The proposed rule would keep a framework in place created by a 2011 final rule titled “Regulation for the Enforcement of Federal Health Care Provider Conscience Protection Laws.” Certain provisions of the 2019 final rule related to federal conscience protections would be retained, but those that are redundant and confusing would be eliminated.

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

SAMHSA Seeking Public Comments Regarding Opioid Use Disorder Treatment Medication Requirement Reforms

On Dec. 16, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice of proposed rulemaking, requesting public comments on its proposal to modify regulations for opioid use disorder treatment medications. The proposed rule seeks to make treatment in Opioid Treatment Programs (OTP) more accessible to patients, and easier to deliver to providers. The proposed rule also seeks to increase the uptake of evidence-based treatments for substance use disorders and is in line with the Department of Health and Human Services’ (HHS) Overdose Prevention Strategy.

Public comments will be accepted until Feb. 14, 2023. For more information, click here.

SAMHSA Introduces Proposed Rule to Better Align SUD Patient Privacy with HIPAA

On Nov. 28, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a proposed rule that would align certain policies in the Confidentiality of Substance Use Disorder Patient Records with the Health Insurance Portability and Accountability Act (HIPAA), per Congress’ instruction in the CARES Act.

The proposed rule would allow providers to disclose Part 2 records after patients give consent once, and that consent would apply to all future uses. They would also be able to redisclose those records as permitted by the HIPAA privacy rule. Additionally, the rule would give patients the ability to obtain a list of disclosure situations and the right to request restrictions on certain disclosures. It would also give the Department of Health and Human Services (HHS) new enforcement powers, like civil money penalties for those that violate Part 2 protections.

Public comments will be accepted until Jan. 31, 2023. For more information, click here.

CMS Releases Proposed Benefit and Payment Parameters for 2024

On Dec. 21, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that outlines proposed payments and provisions for risk adjustment and risk adjustment data validation programs, operated by the Department of Health and Human Services (HHS). The proposed rule also outlines proposed 2024 user fee rates for issuers offering qualified health plans (QHPs) through federally-facilitated exchanges (FFEs), and state-based exchanges on the federal platform (SBE-FPs).

The proposed rule would also introduce requirements related to:

• Updating standardized plan options
• Reducing plan choice overload
• Re-enrollment hierarchy
• Plan and plan variation marketing name requirements for QHPs
• Essential community provider (ECP) and network adequacy
• Failure to file and reconcile
• Special enrollment periods (SEPs)
• Annual household income verification
• Deadline for QHP issuers to report enrollment and payment inaccuracies
• State Exchange improper payment measurement program
• Requirements for agents, brokers and web-brokers assisting FFE and SBE-FP consumers

Public comments will be accepted until Jan. 30, 2023. For more information, click here.

CMS Releases Proposed Changes to Contract Year 2024 Medicare Program Plans

On Dec. 27, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would revise regulations for Medicare Advantage, Prescription Drug Benefit, Cost Plan and Programs of All-Inclusive Care for the Elderly (PACE) plans. The proposed rule would implement changes related to:

• Star Ratings
• Medication therapy management
• Marketing and communications
• Health equity
• Provider directories
• Coverage criteria
• Prior authorization
• Passive enrollment
• Network adequacy
• Identification of overpayments
• Formulary changes

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

CMS Proposes MA Plan Marketing, Part D Low-income Access, Prior Authorization and Behavioral Health Reforms

On Dec. 14, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that seeks to overhaul marketing practices for Medicare Advantage (MA) plans. The proposed rule comes after CMS told MA plan issuers that it was concerned with the manner in which MA plans were marketed, particularly on television and by third-party marketing organization ads.

Some of the proposed rule changes include:

• Prohibiting television advertisements that don’t specify a plan name.
• Prohibiting advertisements that use words and imagery that may mislead or confuse MA plan beneficiaries.
• Prohibiting the use of Medicare language or logos in advertisements.
• Prohibiting MA plan marketers from using the words “best” and “most” to describe their plans, unless they have documentation to support such statements.
• Banning sales presentations that immediately follow an educational event.
• Banning agent distribution and collection of Scope of Appointment and Business Reply Cards at educational events.
• Banning agents from conducting sales or enrollment meetings with beneficiaries within 48 hours after obtaining their consent.

Additionally, the proposed rule seeks to expand access to low-income Part D subsidies and biosimilars. CMS would like to grant Part D low-income subsidies to individuals who currently qualify for partial low-income subsidies. The agency wants to ensure that individuals who qualify for full low-income subsidies do not have to face deductibles, premiums or fixed copay requirements for certain drugs. CMS is also proposing that Part D plan sponsors be able to substitute brand drugs with lower-cost options.

The proposed rule also contains language regarding the prior authorization process and behavioral health reforms. CMS is incorporating several recommendations from a report on prior authorization request denials, issued by the Office of the Inspector General (OIG). The proposed rule also includes provisions that seek to grant MA enrollees access to behavioral health service providers. The proposed rule would require MA organizations to include behavioral health services in care coordination programs.

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

CMS Proposes Healthcare Plan Exchange Rule for 2024

On Dec. 12, the Centers for Medicare and Medicaid Services (CMS) released the 2024 proposed rule for plans in the exchange. The proposed rule includes key changes to network adequacy standards and will slightly lower user fees for 2024. In addition, the rule:

• Proposes to limit to two the nonstandardized plan options for each product network type and metal tier level, with an exception for catastrophic plans. This requirement only applies to HealthCare.gov, which residents in 38 states use to buy ACA plans. It does not apply to state-run marketplaces.
• Seeks to add to the standardized plan option requirements including a proposal to no longer include a standard option for the nonexpanded bronze plan tier.

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

CMS Requests Information on Essential Health Benefits Proposed Rule

On Dec. 2, the Centers for Medicare and Medicaid Services (CMS) issued a request for information on a proposed rule that relates to the essential health benefits (EHBs) included in the Patient Protection and Affordable Care Act (ACA). CMS is requesting comments to gain a better understanding of the coverage of EHBs in health plans, and to evaluate whether EHBs should be modified or updated to account for changes in medical evidence and scientific advancements.

Public comments will be accepted until Jan. 31, 2023. For more information, click here.

HHS Proposes Adopting Healthcare Attachments Standards

On Dec. 15, the Office of the Secretary of the Department of Health and Human Services (HHS) released a proposed rule that would implement standards for “health care attachments” transactions, to support healthcare claims and prior authorization transactions. The proposed rules would also implement a standard for electronic signatures and modify the standard for referral certification and authorization transactions.

Public comments will be accepted until March 21, 2023. For more information, click here.

FDA Proposed Rule Would Replace Investigational New Drug Annual Report

On Dec. 9, the Food and Drug Administration (FDA) released a proposed rule that would change the investigational new drug (IND) annual reporting requirement. The proposed rule would replace the IND annual report with a new report titled the Food and Drug Administration Development Safety Update Report (FDA DSUR). The FDA intends to make the new report consistent with the format and content of the development safety update report that is supported by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Public comments will be accepted until March 9, 2023. For more information, click here.

FDA Proposes Exempting Certain Conventional Food, Dietary Supplements and Cosmetics From Investigational New Drug Requirements

On Dec. 9, the Food and Drug Administration (FDA) released a proposed rule that seeks to exempt certain clinical investigations of lawfully marketed conventional foods, dietary supplements and cosmetics from the investigational new drug application (IND) requirement, when the clinical investigations are conducted for the purposes of studying the products’ potential use as a drug. Although these products would be exempt from IND requirements, they would still be subject to other investigations to ensure the rights and safety of individuals. The FDA believes the proposed rule will reduce regulatory burden on the agency.

Public comments will be accepted until March 9, 2023. For more information, click here.

HRSA Proposed Rule Changes Concerning 340B Disputes

On Nov. 29, the Health Resources and Services Administration (HRSA) released a proposed rule that outlines changes to how the administrative dispute resolution (ADR) process should be handled, for diversions, duplicate discounts and overcharges under the 340B program. HRSA aims to make the process less formal and more expeditious. The proposed changes include:

• Establishing a more accessible and timely ADR process, while structuring the process to be less formal and rigid.
• Eliminating the $25,000 minimum dispute threshold for drug makers and 340B providers to use the process.
• Restructuring the ADR panel to be composed of subject-matter experts from HRSA’s Office of Pharmacy Affairs.
• Requiring that covered entities and drug companies attempt to resolve disputes in good faith on their own before the ADR process is initiated.
• Allowing for a reconsideration process when either covered entities or drug companies are dissatisfied with the ADR panel’s decision.

Public comments will be accepted until Jan. 30, 2023. For more information, click here.

Final Rules

CMS Final Rule Adds Items to DMEPOS Order List and Updates Healthcare Common Procedure Coding System (HCPCS)

On Jan. 17, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will update the Healthcare Common Procedure Coding System (HCPCS) codes for required Face-to-Face Encounter and Written Order Prior to Delivery (F2F/WOPD) requirements applicable to Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) orders. The update follows CMS’ decision to add new non-statutorily required DMEPOS items to the F2F/WOPD list. CMS believes the addition of these items will protect Medicare enrollees and further reduce Medicare fraud, waste and abuse.

The rule is set to go into effect on April 17, 2023. 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 is now set to 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.

Reports

HHS OIG Reveals High Rate of COVID-19 Infections in Nursing Homes

On Jan. 20, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released a detailed report analyzing the high rate of COVID-19 infections in nursing homes during the spring and fall of 2020. HHS found that more than 1,300 nursing homes had COVID-19 infection rates of 75 percent or more during the spring and fall 2020 surges. Nursing homes that experienced extremely high infection rates also suffered high average mortality rates of roughly 20 percent. HHS conducted this study to determine whether these nursing homes complied with minimum Medicare nursing hour requirements, and whether they had been cited with any infection control violations.

For more information, click here.

GAO Releases Report on HHS Oversight Over Enhanced Potential Pandemic Pathogens Research

On Jan. 18, the Government Accountability Office (GAO) released a report that analyzed the Department of Health and Human Services’ (HHS) oversight over research involving enhanced potential pandemic pathogens. GAO reviewed HHS oversight policies and programs and analyzed HHS’ documentation of potential pandemic pathogens research grants. GAO found that HHS lacks a robust and effective oversight mechanism for this type of research, because the HHS Framework, which asks federal agencies to refer “reasonably anticipated” proposed research that may or will involve the use of potential pandemic pathogens, lacks a clear standard to determine what classifies as “reasonably anticipated” research. GAO is recommending that HHS adopt a standard for “reasonably anticipated” and assess the risk of statutory limitations.

For more information, click here.

CMS Releases Initial Report on Federal Independent Dispute Resolution (IDR) Process

On Jan. 18, the Centers for Medicare and Medicaid Services (CMS) released an initial report that analyzed how well the Independent Dispute Resolution (IDR) Process functioned between April 15 and Sept. 30, 2022. The federal IDR portal, which is used by healthcare providers and issuers to resolve payment disputes that fall under surprise billing protections outlined in the No Surprises Act (NSA), first came online on April 15, 2020. Since then, more disputes have been submitted than initially expected. 90,078 disputes were initiated by parties during the time frame specified above. These disputes were primarily for out-of-network (OON) emergency and non-emergency items and services and air ambulance services.

For more information, click here.

CBO Releases Cost Estimate Showing Anticipated 2023 Consolidated Appropriations Act Budgetary Effects

On Jan. 12, the Congressional Budget Office (CBO) released a cost estimate showing the estimated budgetary effects 2023 Consolidated Appropriations Act Divisions O through MM will have on health programs and other federal policy priorities. CBO estimates that the divisions will reduce the federal budget by $3.9 billion between 2023 and 2032.

For more information, click here.