This Week in Washington: Congress returns to complete appropriations and year-end legislation.

Congress

House

• Expected Committee Changes in Health-Related Committees

Senate

• Senate Finance Committee Releases Discussion Draft on Mental Health
• Senate Finance Committee Democrats Urge CMS to Release New Medicare Advantage Marketing Rules Quickly

Administration

• Public Health Emergency to be Extended Once Again
• Becerra: Regs Will Push Culturally, Linguistically Competent Healthcare
• CMS Innovation Center Provides Update on its Strategy and Specialty Care Approach
• CMS Releases the FFY 2020 Annual Report to Congress (RTC) on Medicaid Drug Review and Utilization Requirements Under Section 1004 of the SUPPORT Act
• CMS Announces New Rural Health Framework
• CDC Panel Calls for Oversight of CLIA-Waived Labs
• FDA Considers Making Certain Naloxone Products Eligible for Nonprescription Use
• FDA Announces Cybersecurity Modernization Action Plan (CMAP)
• FDA Recommends Regional Partnerships for Medical Device Security

Other Activity

• MedPAC Considers Options for Standardizing MA Supplemental Benefits and Discusses Future Coverage of Social Determinants of Health

Proposed Rules

• FDA Releases Proposed Rule to Standardize the National Drug Code Format
• FDA Proposes Increasing Certification Service Fees and Amending Color Additive Certification
• FDA Extends Comment Period for Nonprescription Drug Product Proposed Rule
• FDA Extends Comment Period for Protection of Human Subjects and Institutional Review Boards and Cooperative Research Proposed Rules
• HHS Proposes Modifying Current Retail Pharmacy Transaction Standards

Final Rules

• HHS Issues Final Physician Payment Rule Emphasizing Access to Behavioral Health Services and Whole-Person Care
• Hospital Outpatient Final Rule Promotes Health Equity in Rural Care Access
• CMS Issues an Extension of Timeline for Publication of Medicare Final Rule
• CMS Issues Final Rule Implementing Certain Provisions of the Consolidated Appropriations Act of 2021 and Medicare Enrollment and Eligibility Rules
• CMS Issues Final Rule Implementing Updates to Medicare Home Health Payment System
• CMS Final Rule Updates and Revises the End-Stage Renal Disease (ESRD) Prospective Payment System for Calendar Year (CY) 2023
• CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

Reports

• GAO Report: Private Health Insurance: Markets Remained Concentrated through 2020, with Increases in the Individual and Small Group Markets.
• GAO Report: VA Nursing Home Care: Opportunities Exist to Enhance Oversight of State Veterans Homes.
• CBO Report: Policy Approaches to Reduce What Commercial Health Insurers Pay for Hospitals’ and Physicians’ Services. Nov. 14, 2022.
• Kaiser Family Foundation: Employer Plan Costs to Jump; Mental Health Demand Grows

Congress

House

Expected Committee Changes in Health-Related Committees

With party control changing in the House, there will be changes in who leads the health-related committees. At the House Ways and Means Committee, now-Chair Richard Neal (D-MA) will become the ranking member. Rep. Vern Buchanan (R-FL) is expected to become chair. For the last year, he has been the ranking member of the committee’s subcommittee on Health.

At the House Energy and Commerce Committee, now-Chair Frank Pallone (D-NJ) will become the ranking member, and the current ranking member, Rep. Cathy McMorris Rodgers (R-WA), will become chair. These changes will have to be approved by the Republican caucus.

The Senate will see some changes despite Democrats’ remaining in control. Sen. Patty Murray (D-WA) is expected to take the chairmanship of the Senate Appropriations Committee. That means that Sen. Bernie Sanders is next in line to be chair of the Health, Education, Labor and Pensions Committee. Because the current ranking member, Sen. Richard Burr (R-NC), is retiring, Sen. Bill Cassidy (R-LA) is expected to become ranking member of the HELP Committee. Sen. Cassidy is a physician and also serves on the Senate Finance Committee.

Senate

Senate Finance Committee Releases Discussion Draft on Mental Health

On Nov. 10, the Senate Finance Committee released its fourth discussion draft concerning mental health provisions for possible inclusion in an end-of-year bill.

The draft legislation would:

• Clarify that peer support specialists can provide behavioral health integration services to Medicare beneficiaries
• Increase Medicare payment rates for behavioral health integration services from 2026 through 2027
• Direct CMS to create a single global payment under the physician fee schedule to fund mobile crisis response team services including screening and assessment
• Require CMS to create bundled payments for crisis stabilization services for Medicare beneficiaries

For more information, click here.

Senate Finance Committee Democrats Urge CMS to Release New Medicare Advantage Marketing Rules Quickly

On Nov. 15, Democratic Senate Finance Committee members, led by Chair Ron Wyden (D-OR) and Bob Casey (D-PA), urged CMS to release regulations as soon as possible to enhance oversight of Medicare Advantage marketing. Earlier, the committee released a report revealing instances of Medicare Advantage marketing fraud in 14 states. Senate Democrats are urging CMS to increase consumer protections through notice-and-comment rulemaking as soon as possible. They are also calling on Congress to fully fund the Medicare State Health Insurance Assistance Program (SHIP) and the Senior Medicare Patrol (SMP).

For more information, click here.

Administration

Public Health Emergency to be Extended Once Again

On Nov. 11, the Department of Health and Human Services (HHS) signaled it will extend the COVID-19 public health emergency beyond Jan. 12. The department has repeatedly said it will give 60 days’ notice before officially ending the public health emergency. By their extending the PHE, states will have more time to prepare for the Medicaid redetermination process, which will restart once the emergency ends. The extension also gives Congress time to act on extending or making permanent some of the telehealth flexibilities put in place during the pandemic.

Becerra: Regs Will Push Culturally, Linguistically Competent Healthcare

On Nov. 7, Health and Human Services (HHS) Secretary Xavier Becerra announced that the HHS will use the regulatory process to ensure patients receive culturally and linguistically appropriate care, but he added that Congress may need to give the department the ability to enforce the requirements. A coalition of patient advocates recently urged Becerra to scrutinize networks for their ability to provide culturally and linguistically competent care as well as physically and programmatically accessible care in the 2024 exchange rule.

CMS Innovation Center Provides Update on its Strategy and Specialty Care Approach

On Nov. 7, the Centers for Medicare and Medicaid Services (CMS) Innovation Center released a one-year report on the implementation of its refreshed strategic vision and objectives, which were originally announced in fall 2021. The one-year report outlines actions taken to work toward better care for beneficiaries, through greater accountability for high-quality, person-centered care, more coordinated care, advancing health equity, increasing access and promoting transparency. Through its report, CMS revealed that it will continue execution of its strategy, by announcing and launching new accountable care models, developing strategies to better drive integration of primary and specialty care to serve those with chronic or serious conditions, and improving the way providers are incentivized. The one-year report also includes a focus on the role of specialty care in the delivery of high-quality accountable care.

For more information, click here.

CMS Releases the FFY 2020 Annual Report to Congress (RTC) on Medicaid Drug Review and Utilization Requirements Under Section 1004 of the SUPPORT Act

On Nov. 7, the Centers for Medicare and Medicaid Services (CMS) released the FFY 2020 Annual Report to Congress (RTC) on Medicaid Drug Review and Utilization Requirements Under Section 1004 of the SUPPORT Act concerning implementation of these Medicaid drug utilization review provisions. The RTC shows that the majority of programs have implemented opioid edits and other standards required by the amendments made by the SUPPORT Act or have a plan in place to implement those standards in the near future.

For more information, click here.

CMS Announces New Rural Health Framework

On Nov. 16, the Centers for Medicare and Medicaid Services (CMS) released a new set of guidelines for rural and tribal health, claiming it will boost access and equity goals. The guidelines outlined the following points:

• Apply a community-informed geographic lens to CMS programs and policies
• Increase collection and use of standardized data to improve healthcare for rural, tribal and geographically isolated communities
• Strengthen and support healthcare professionals in rural, tribal and geographically isolated communities
• Optimize medical and communication technology for rural, tribal and geographically isolated communities
• Expand access to comprehensive healthcare coverage, benefits and services, and supports for individuals in rural, tribal and geographically isolated communities
• Drive innovation and value-based care in rural, tribal and geographically isolated communities

For more information, click here.

CDC Panel Calls for Oversight of CLIA-Waived Labs

On Nov. 10, a Centers for Disease Control and Prevention (CDC) advisory panel recommended increasing oversight of clinical labs that have been granted a waiver under the Clinical Laboratory Improvement Amendments, to diagnose patients using CLIA-waived tests. The panel noted concerns that a lack of oversight could lead to lower-quality laboratory-developed tests. The panel also recommended that the FDA ensure specimens from self-collection devices originate from humans and that a new type of certificate be created for labs that analyze data for patient care. The certificate would be in compliance with all security regulations, including the Health Insurance Portability and Accountability Act (HIPAA). The use of virtual reality to train lab personnel was also discussed.

FDA Considers Making Certain Naloxone Products Eligible for Nonprescription Use

On Nov. 15, the Food and Drug Administration (FDA) announced that it is seeking comments from the public on whether there is data to support safe and effective nonprescription use of certain naloxone products and on the consequence of switching from prescription to nonprescription status.

The FDA says naloxone nasal spray measuring up to 4 milligrams and auto-injectors measuring up to 2 milligrams “may be approvable” for safe and effective nonprescription use. This, however, is not a final determination. To make its final determination, FDA needs additional information such as product-specific data on nonprescription user interface design including packages and labeling.

For more information, click here.

FDA Announces Cybersecurity Modernization Action Plan (CMAP)

On Nov. 17, the Food and Drug Administration (FDA) announced its Cybersecurity Modernization Action Plan (CMAP), the next phase of the FDA’s enterprise digital approach.

This cybersecurity modernization plan will serve as FDA’s roadmap to effectively transition to a Zero Trust model that will enhance and underpin the security and success of FDA’s ongoing IT, data and business process modernization. This transformation builds on the fundamental cybersecurity concepts and technologies with the goal to attain an optimal maturity level by upgrading, modernizing and enhancing security and cyber defenses to address evolving cyber threats, vulnerabilities and risks to the FDA’s IT infrastructure and sensitive data in direct support of FDA’s mission to protect and promote U.S. public health.

The key CMAP objectives are to:

• Establish a comprehensive Zero Trust approach to facilitate new digital services and modernization efforts
• Promote software assurance best practices to include security measures at every development life cycle stage
• Enhance interoperable and secure data exchange and collaboration across the FDA and its public health partners
• Leverage Artificial Intelligence and Machine Learning technologies to enhance cyber detection and response capabilities
• Integrate counterintelligence and insider risk principles with the Zero Trust model to enable an intelligence-driven approach
• Prioritize and invest in the FDA’s cybersecurity workforce

For more information, click here.

FDA Recommends Regional Partnerships for Medical Device Security

On Nov. 16, the Food and Drug Administration (FDA) released an updated version of their “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook,” which provides guidance for health organizations on using regional collaboration to address device security threats. The playbook focuses on medical device cybersecurity issues that impact the function of devices, especially those that endanger patient safety and have the potential to cause large-scale impacts. The updated playbook emphasizes the need for a diverse cybersecurity preparedness team. It also highlights how regional response models can help during a cyber incident and adds a resource appendix that directs organizations to other cybersecurity tools.

For more information, click here.

Other Activity

MedPAC Considers Options for Standardizing MA Supplemental Benefits and Discusses Future Coverage of Social Determinants of Health

As part of its November meeting, the Medicare Payment Advisory Commission (MedPAC) discussed how to standardize a set of three or four benefits—potentially hearing, vision and dental services—in Medicare Advantage for a future recommendation to Congress. MedPAC staff found that people have a more challenging time comparing plans when they have a variety of options. Commissioners could not reach a unanimous decision on what should be standardized. Some commissioners agreed that it would be best to standardize a core set of three or four benefits, ideally hearing, vision and dental benefits. Others argued that most of the innovation the commissioners seek to protect occurs internally, not in a way that beneficiaries would experience. Several commissioners said the current system of parsing through benefit offerings to select a plan is extremely complex to navigate for beneficiaries, even for experts.

Commissioners also discussed whether and how the Medicare program could address social determinants of health. Several commissioners urged MedPAC to explore covering services aimed at mitigating certain social risk factors—even though staff said social drivers of health were outside the purview of Medicare.

Proposed Rules

FDA Releases Proposed Rule to Standardize the National Drug Code Format

On July 25, the Food and Drug Administration (FDA) issued a proposed rule titled “Revising the National Drug Code Format and Drug Label Barcode Requirements.” The proposed rule would amend the National Drug Code (NDC) to require one standardized format for all NDCs.

Public comments will be accepted until Nov. 22, 2022.

FDA Proposes Increasing Certification Service Fees and Amending Color Additive Certification

On Nov. 2, the Food and Drug Administration (FDA) released a proposed rule that would amend the color additive regulation to increase the fee for certification services. The fees are intended to recover the full operational costs of the FDA’s color certification program. The change in fee would allow the FDA to continue maintaining an adequate color certification program as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Public comments will be accepted until Jan. 3, 2023.

FDA Extends Comment Period for Nonprescription Drug Product Proposed Rule

On Oct. 24, the Food and Drug Administration (FDA) issued an extension to the comment period for the proposed rule titled “Nonprescription Drug Product With an Additional Condition for Nonprescription Use,” originally published in the Federal Register on June 28, 2022. The proposed rule would establish requirements for a nonprescription drug product that have an additional condition for nonprescription use (ACNU).

Public comments will be accepted until Nov. 25, 2022.

FDA Extends Comment Period for Protection of Human Subjects and Institutional Review Boards and Cooperative Research Proposed Rules

On Nov. 14, the Food and Drug Administration (FDA) extended the comment period for two proposed rules, originally published in the Federal Register on Sept. 28, 2022. The two proposed rules, titled “Protection of Human Subjects and Institutional Review Boards” and “Institutional Review Boards; Cooperative Research,” seek to enhance protections for research participants and institutional review boards.

Public comments will be accepted until Dec. 28, 2022.

HHS Proposes Modifying Current Retail Pharmacy Transaction Standards

On Nov. 9, the Office of the Secretary of the Department of Health and Human Services (HHS) released a proposed rule that seeks to adopt updated versions of the retail pharmacy standards for electronic transactions, adopted under the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Apart from retail pharmacy transactions, the updated versions would modify healthcare claims or equivalent encounter information, health plan eligibility, referral certification and authorization, and benefits coordination. The proposed rule would also broaden the applicability of the Medicaid pharmacy subrogation transaction to all health plans. Additionally, it would rename and revise the definition of the transaction and adopt an updated standard that would be a modification for state Medicaid agencies and an initial standard for all other health plans.

Public comments will be accepted until Jan. 9, 2023.

Final Rules

HHS Issues Final Physician Payment Rule Emphasizing Access to Behavioral Health Services and Whole-Person Care

On Nov. 1, the Centers for Medicare and Medicaid Services (CMS) expanded access to behavioral healthcare, cancer screening coverage and dental care through the calendar year 2023 Physician Fee Schedule (PFS) final rule. The rule makes regulatory revisions to reduce barriers to behavioral health services for Medicare beneficiaries. Specifically, the rule makes an exception to the direct supervision requirement to allow behavioral health services to be provided under the general supervision of a physician or nonphysician practitioner (or NPP).

CMS is also clarifying that any service furnished primarily for the diagnosis and treatment of a mental health or substance use disorder can be furnished by auxiliary personnel under the general supervision of a physician or NPP who is authorized to furnish and bill for services provided incident to their own professional services.

The rule goes into effect Jan. 1, 2023. For more information, click here.

Hospital Outpatient Final Rule Promotes Health Equity in Rural Care Access

On Nov. 1, the Centers for Medicare and Medicaid Services (CMS) released the calendar year (CY) 2023 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period. The final rule will allow Critical Access Hospitals (CAHs) and small rural hospitals to convert to a Rural Emergency Hospital (REH), as an option for rural hospitals facing closure and supports access to care in rural and underserved communities. An REH is a new Medicare provider type that furnishes outpatient services, emergency services and observation care. In this rule, Medicare will also pay hospital outpatient departments to provide remote behavioral health services to people at home, which will improve access to care in rural communities and promote health equity.

The rule goes into effect Jan. 1, 2023. For more information, click here.

CMS Issues an Extension of Timeline for Publication of Medicare Final Rule

On Nov. 1, the Centers for Medicare and Medicaid Services (CMS) announced a three-month extension for the timeline for publication of a proposed rule titled “Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021,” originally published in the Federal Register on Nov. 1, 2018. As of Oct. 28, 2022, the timeline for publication of a rule to finalize the proposed rule is extended until Feb. 1, 2023. The Social Security Act requires HHS to publish a Medicare final rule no later than three years after the publication date of the proposed rule. HHS was unable to meet the Nov. 1, 2022, publication deadline due to ongoing delays, resulting from the agency’s focus on the COVID-19 public health emergency. The proposed rule discussed the HHS Secretary’s authority to extrapolate in the recovery of Risk Adjustment Data Validation (RADV) overpayments, starting with payment year 2011 contract-level audits, and their authority to not apply a fee-for-service (FFS) adjuster to the RADV overpayment determinations.

CMS Issues Final Rule Implementing Certain Provisions of the Consolidated Appropriations Act of 2021 and Medicare Enrollment and Eligibility Rules

On Nov. 3, the Centers for Medicare and Medicaid Services (CMS) issued a final rule, implementing provisions of the Consolidated Appropriations Act of 2021. The final rule also proposes removing references to specific Medicare forms from the text, to provide for greater administrative flexibility. It also updates various federal regulations that affect a state’s payment of Medicare Part A and B premiums for beneficiaries enrolled in Medicare Savings programs and other eligibility groups.

The rule goes into effect Jan. 1, 2023. For more information, click here.

CMS Issues Final Rule Implementing Updates to Medicare Home Health Payment System

On Nov. 4, the Centers for Medicare and Medicaid Services (CMS) issued a final rule that updates the Medicare home health payment rates for calendar year (CY) 2023, in accordance with existing statutory and regulatory requirements. The final rule also finalizes a methodology for determining the impact of the difference between assumed versus actual behavior change on estimated aggregate expenditures for home health payments. Additionally, the rule finalizes changes to the Home Health Quality Reporting Program (HHQRP) requirements, changes to the expanded Home Health Value-Based Purchasing (HHVBP) Model and updates to the home infusion therapy services payment rates for CY 2023.

The rule goes into effect Jan. 1, 2023. For more information, click here.

CMS Final Rule Updates and Revises the End-Stage Renal Disease (ESRD) Prospective Payment System for Calendar Year (CY) 2023

On Nov. 7, the Centers for Medicare and Medicaid Services (CMS) issued a final rule that updates and revises the ESRD Prospective Payment System for CY 2023. The rule also updates the payment rule for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. Additionally, the rule updates requirements for the ESRD Quality Incentive Program and finalizes changes to the ESRD Treatment Choices Model.

The rule goes into effect Jan. 1, 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

GAO Report: Private Health Insurance: Markets Remained Concentrated through 2020, with Increases in the Individual and Small Group Markets.

Nov. 7, 2022. GAO-23-105672

In November 2020, the Government Accountability Office (GAO) reported that, from 2010 through 2018, enrollment in private health insurance plans was concentrated, meaning a small number of issuers of those plans enrolled most of the people in a given market. Specifically, GAO considered a market concentrated in a state if three or fewer issuers held at least 80 percent of that market. GAO examined the individual (coverage sold directly to individuals), small group (coverage offered by small employers) and large group (coverage offered by large employers) markets and found that this pattern continued in 2019 and 2020. GAO found similar patterns of high concentration across individual market exchanges. GAO conducted the study to determine whether a concentrated health insurance market may lower consumers’ choice of issuers and premiums.

For more information, click here.

GAO Report: VA Nursing Home Care: Opportunities Exist to Enhance Oversight of State Veterans Homes.

Nov. 14, 2022. GAO-23-105167

On Nov. 15, the Government Accountability Office (GAO) released an analysis of nursing home quality standards data published by the Department of Veterans Affairs (VA). The analysis revealed an increase in both the number and severity of quality standards deficiencies found in state-operated veteran nursing homes. The VA regularly conducts inspections of veteran nursing homes, to ensure that they meet VA quality standards. The GAO analysis found that from 2019 to 2021, the total number of deficiencies increased from 424 to 766. The majority of the increase was in the quality of care and infection control categories, which cover accidents and staff hand hygiene. The GAO conducted this study in response to a joint explanatory statement accompanying the Consolidated Appropriations Act of 2021, which asked the GAO to provide information on VA’s oversight of state veterans homes. The GAO made four recommendations to the VA, largely urging the department to identify additional enforcement tools to ensure state veterans homes comply with quality standards. The GAO also urged the VA to seek legislative authority for them, as appropriate.

For more information, click here.

CBO Report: Policy Approaches to Reduce What Commercial Health Insurers Pay for Hospitals’ and Physicians’ Services. Nov. 14, 2022.

In a report released on Nov. 14, the Congressional Budget Office (CBO) revealed that the prices U.S commercial health insurers pay for hospitals’ and physicians’ services are much higher on average, and have been rising more quickly, than the prices paid by public health insurance programs. The CBO report found that promoting price transparency had very little effect on price reductions, promoting competition among providers had a small effect on price reductions and capping the level of growth of prices had a moderate to large effect on price reductions. The CBO was driven to investigate this due to Congress’ interest in finding policies that would reduce health insurance prices and premiums.

For more information, click here.

Kaiser Family Foundation: Employer Plan Costs to Jump; Mental Health Demand Grows

On Oct. 27, the Kaiser Family Foundation Employer Health Benefits Survey data was released and found that the annual family plan now costs $22,463, with workers contributing an average of $6,106 in premiums. This indicates a slight increase compared to 2021, when family plans averaged $22,221, with workers contributing $5,969. The increase in premiums is less than the 8 percent increase in inflation and 6.7 percent rise in wages that occurred during the same period.

For more information, click here.