This Week in Washington: House and Senate pass continuing resolution; House Energy and Commerce Health Subcommittee reports out 21 healthcare bills; Senate Finance Healthcare Subcommittee holds hearing on telehealth flexibilities; White House launches Women’s Health Research initiative.
Congress
House
- House and Senate Pass Continuing Resolution
- House Considers Labor-HHS Appropriations Bill But Postpones Vote on Final Passage
- House Energy and Commerce Committee Subcommittee on Health Reports Out 21 Healthcare Bills
Senate
- Senate Finance Committee Subcommittee on Healthcare Holds Hearing on Telehealth Flexibilities
- Senate HELP Committee Ranking Member Requests Information on Use of 340B Program Revenue
Administration
- White House Releases Playbook to Address Social Determinants of Health
- White House Establishes Women’s Health Research Initiative
- HHS Establishes Secretary’s Advisory Committee on Long COVID and Seeks Member Nominations
- HHS Releases Language Access Plan
- HHS OIG Releases FY 2022 Health Care Fraud and Abuse Control Program Report
- HHS OIG Releases Report Regarding Premarket Tobacco Application Review Process
- CDC Announces Availability of Infant RSV Vaccine
- CMS Announces Notice of Funding Opportunity Application Period for AHEAD Model
- CMS to Begin Accepting Applications for GUIDE Model
- CMS Releases Information Bulletin on Coverage Options for Medicaid/CHIP Health-Related Social Needs Services
- FDA Principal Deputy Commissioner Announces Retirement
- FDA Publishes Product-Specific Guidances for Generic Drug Development
- FDA Approves First Chlamydia and Gonorrhea Sample Collection At-Home Test
- FDA Issues Warning Letter Concerning Distribution of Eye Drop Products
- FDA CDER to Restructure Office of Pharmaceutical Quality
- FDA Approves Metastatic Colorectal Cancer Treatment
- FDA Issues Warning Letter Over Unauthorized Dissolvable Nicotine Products
- FDA Approves Hypertension Renal Denervation Device
- SAMHSA Awards $74.4 Million to Strengthen Behavioral Health Programs
Proposed Rules
- CMS Proposed Rule Outlines Benefit and Payment Parameters for 2025
- CMS Proposes Rule to Strengthen Medicare Advantage, Part D and Behavioral Healthcare Access
- CMS Proposes Rule to Penalize Providers Who Block Electronic Health Information
- CMS Proposes Rule Regarding Federal IDR Process
- FDA Proposes Rule Regarding Laboratory Developed Tests
- FDA Proposes Rule to Broaden Prescription Drug Labeling Regulations
Final Rules
- CMS Final Rule Implements Nursing Home Ownership and Management Disclosure Requirements
- CMS Final Rule Outlines Remedy for 340B Payment Cuts Deemed Unlawful Between CYs 2018-2022
- CMS Final Rule Updates 2024 Medicare Physician Fee Schedule
- CMS Final Rule Updates 2024 Hospital OPPS and ASC Payment System
- CMS Final Rule Updates 2024 Home Health Prospective Payment System
- CMS Final Rule Updates 2024 ESRD Prospective Payment System
- CMS Final Rule Specifies When and How CMS Imposes Civil Money Penalties
- CMS Final Rule Mandates Medicaid and CHIP Program Core Set Measures Reporting
- CMS Finalizes 2024 Medicare Advantage and Part C and D Payment Policies
- FDA Issues Final Rule Regarding Mammography Quality Standards
CBO Cost Estimates
- CBO Releases Cost Estimate on H.R. 3843, Action for Dental Health Act of 2023
- CBO Releases Report on Distribution of Household Income in 2020
- CBO Releases Presentation on Distribution of Household Income from 1979 to 2020
Note
Congress
House
House and Senate Pass Continuing Resolution
Last week, the House and Senate passed a “laddered” continuing resolution (CR) that will extend funding at current levels through early next year. The CR, which was proposed by the Speaker of the House, will extend funding for Agriculture, Military Construction-VA, Energy-Water and Transportation-HUD appropriations until Jan. 19.
In addition, it will extend funding for Commerce-Justice-Science, Defense, Financial Services, Homeland Security, Interior-Environment, Labor-HHS-Ed., Legislative Branch and State-Foreign Ops appropriations until Feb. 2. If no long-term funding is approved, a 1 percent across-the-board cut will occur. This was agreed to as part of the deal reached to avoid the government defaulting earlier in the year.
House Considers Labor-HHS Appropriations Bill But Postpones Vote on Final Passage
On Nov. 15, the House was scheduled to vote on the Labor-HHS appropriations bill after it considered several amendments to the bill. However, House Republican leadership determined they would not vote on final passage and decided to recess early for the Thanksgiving break because it was unclear whether the bill would pass.
The Labor-HHS bill would cut social spending programs by $60 billion by implementing reductions to 50 programs and eliminating 60.
House Energy and Commerce Committee Subcommittee on Health Reports Out 21 Healthcare Bills
On Nov. 15, the House Energy and Commerce Committee Subcommittee on Health marked up and reported out of committee 21 healthcare bills. Among them were three bills concerning pharmacy benefit managers (PBMs) and one bill regarding home infusion drugs. They are:
H.R. 2880, Protecting Patients Against PBM Abuses Act
This legislation would ban PBM spread pricing and would delink PBM compensation from the cost of medications. It would also prohibit PBMs from compensating a network pharmacy less than affiliated pharmacies and would increase data transparency of PBM rebates and administrative fees.
H.R. 5393, To amend title XVIII of the Social Security Act to ensure fair assessment of pharmacy performance and quality under Medicare part D, and for other purposes
This legislation would require prescription drug plans (PDPs) to only use pharmacy performance measures that are established by the Secretary of the Department of Health and Human Services (HHS Secretary). It would also establish a process to allow PDPs to submit information about pricing prescription drug claims to their network pharmacies.
H.R. 5385, Medicare PBM Accountability Act
This legislation would strengthen reporting requirements for PBMs and would require them to submit to the HHS Secretary information on drug costs and pricing, generic and biosimilar formulary placement, PBM affiliates, conflicts of interest, drug dispensing and Part D drugs.
H.R. 5397, Joe Fiandra Access to Home Infusion Act of 2023
This legislation would codify a proposed Centers for Medicare and Medicaid Services (CMS) durable medical equipment (DME) policy that clarifies coverage of an external infusion pump under the Medicare DME benefit.
The other bills are:
H.R. 5372, Expanding Seniors’ Access to Lower Cost Medicines Act of 2023
This legislation would allow changes in insurance plan formularies for biosimilar products to be made mid-year beginning in 2025.
H.R. 5386, Cutting Copays Act
This legislation would set copays for generic drugs to $0 for low-income patients in the Medicare Low-Income Subsidy program.
H.R. 4881, To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program
This legislation would limit patient cost-sharing for Medicare Part D drugs beginning in 2027 and would limit beneficiary out-of-pocket costs to no more than what an insurance company pays for highly rebated drugs once all discounts are accounted for.
H.R. 5389, National Coverage Determination Transparency Act
This legislation would require the HHS Secretary to determine whether a request for a National Coverage Determination (NCD) is complete within 30 days of receiving a request. It would also require the Secretary to make all NCD applications public on the CMS website and would allow the Secretary to work directly with entities that submit NCD applications.
H.R. 133, Mandating Exclusive Review of Individual Treatments (MERIT) Act
This legislation would clarify that NCDs for Medicare-covered drugs and biologics must be made with respect to each drug or biologic and not the class of the drug or biologic.
H.R. 5396, Coverage Determination Clarity Act of 2023
This legislation would prohibit Local Coverage Determinations (LCDs) from being more restrictive than NCDs and would require the HHS Secretary to review LCDs annually to evaluate their consistency.
H.R. 5371, Choices for Increased Mobility Act of 2023
This legislation would clarify that expenses for titanium or carbon fiber materials used in the construction of wheelchair bases are not covered under Medicare Part B. It would also clarify that Medicare Part B beneficiaries may pay out-of-pocket for wheelchair upgrades if they wish.
H.R. 5388, Supporting Innovation for Seniors Act
This legislation would expand a flexibility under the Medicare Advantage (MA) Value-Based Insurance Design Model that allows MA plans to expand access to innovative medical devices and technologies using their existing supplemental benefit funds.
H.R. 5380, To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage
This legislation would require MA plans to report on the utilization of supplemental benefits by enrollees.
H.R. 3842, Expanding Access to Diabetes Self-Management Training Act of 2023
This legislation would require the Center for Medicare and Medicaid Innovation to test a model covering virtual diabetes outpatient self-management training services and would remove patient cost-sharing and deducible requirements for Medicare Part B diabetes outpatient self-management training services.
H.R. 6366, To amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program and to revise the phase-in of clinical laboratory test payment changes under such program
This legislation would delay cuts and reporting under the clinical lab fee schedule and would increase the work geographic index to 1.00 for any locality where the index would be less than 1.00, until Jan. 1, 2025.
H.R. 6369, To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models
This legislation would extend incentive payments for participation in eligible alternative payment (APM) models for one year and would adjust the size of payment to the length that a provider has participated in an APM.
H.R. 5555, DMEPOS Relief Act of 2023
This legislation would require the HHS Secretary to make payment adjustments to certain Medicare items and durable medical equipment included in the 2021 Durable Medicare Equipment, Prosthetics/Orthotics and Supplies competitive bidding program.
H.R. 6371, Provider Reimbursement Stability Act of 2023
This legislation would increase the Physician Fee Schedule budget neutrality threshold and require the HHS Secretary to update prices and rates for direct cost inputs for practice expense relative value units no less than every five years. It would also limit year-to-year conversion factor variance.
H.R. 6364, Medicare Telehealth Privacy Act of 2023
This legislation would prohibit the HHS Secretary from publicly disclosing the addresses of physician and practitioner residences from which telehealth services are provided.
H.R. 1352, Increasing Access to Biosimilars Act of 2023
This legislation would create a pilot program to evaluate the benefits of providing additional shared savings payments to Medicare biosimilar providers.
H.R. 1691, Ensuring Patient Access to Critical Breakthrough Products Act of 2023
This legislation would provide four years of temporary or transitional Medicare coverage to medical breakthrough devices and enable the HHS Secretary to assign coding for approved products.
For more information, click here.
Senate
Senate Finance Committee Subcommittee on Healthcare Holds Hearing on Telehealth Flexibilities
On Nov. 14, the Senate Finance Committee Subcommittee on Healthcare held a hearing to discuss telehealth flexibilities issued during the COVID-19 public health emergency and to evaluate whether flexibilities set to expire next year should be made permanent. Witnesses included:
- Nicki Perisho, BSN, R.N., Principal Investigator and Program Director of the Northwest Regional Telehealth Resource Center
- Eric Wallace, M.D., FASN, Professor of Medicine and Medical Director at UAB EMedicine, Co-Director of Home Dialysis and Director of the Division of Nephrology Rare Kidney Disease Clinic at the UAB Department of Medicine
- Chad Ellimoottil, M.D., M.S., Associate Professor and Medical Director of Virtual Care at the University of Michigan
- Ateev Mehrotra, M.D., MPH, Professor of Health Care Policy at the Harvard Medical School Department of Health Care Policy
For more information, click here.
Senate HELP Committee Ranking Member Requests Information on Use of 340B Program Revenue
On Nov. 16, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) sent letters to two federally qualified community health centers, requesting information on how they use the revenue they generate from the 340B Drug Pricing Program. The Ranking Member is concerned over reports that reveal some 340B entities are not passing on the revenue they generate from the 340B program to improve healthcare services for low-income patients.
For more information, click here.
Administration
White House Releases Playbook to Address Social Determinants of Health
On Nov. 16, the White House released the U.S. Playbook to Address Social Determinants of Health, which outlines actions federal agencies have undertaken to improve the social circumstances of individuals and communities to support equitable health outcomes.
In addition, the Department of Health and Human Services issued a Call to Action concerning social determinants of health and is urging states, territories and tribal and local communities to establish partnerships with private and public healthcare entities to address health-related social needs.
For more information on the Playbook, click here.
For more information on the Call to Action, click here.
White House Establishes Women’s Health Research Initiative
On Nov. 13, the White House announced the establishment of the Initiative on Women’s Health Research. The Initiative will be led by First Lady Jill Biden and the White House Gender Policy Council and will be tasked with drafting recommendations to improve women’s health research and advance research partnerships with stakeholders.
For more information, click here.
HHS Establishes Secretary’s Advisory Committee on Long COVID and Seeks Member Nominations
On Nov. 16, the Department of Health and Human Services (HHS) announced the establishment of the Secretary’s Advisory Committee on Long COVID. The committee will assist HHS in defining Long COVID research priorities and will help inform the agency on how to address and treat Long COVID patients. HHS is inviting stakeholders to submit nominations for the committee by Jan. 16.
For more information, click here.
HHS Releases Language Access Plan
On Nov. 15, the Department of Health and Human Services (HHS) released a Language Access Plan that seeks to improve access to healthcare and human services for people with limited English proficiency. The plan outlines guidance, best practices and action steps for HHS Operating and Staff divisions to consider when developing agency-specific language access plans.
For more information, click here.
HHS OIG Releases FY 2022 Health Care Fraud and Abuse Control Program Report
On Nov. 12, the Department of Health and Human Services (HHS) Office of Inspector General released the fiscal year (FY) 2022 Health Care Fraud and Abuse Control Program Report. The report outlines the amount of money transferred and deposited into the Medicare Trust Fund and details efforts undertaken by HHS and the Department of Justice to combat healthcare fraud.
For more information, click here.
HHS OIG Releases Report Regarding Premarket Tobacco Application Review Process
On Nov. 8, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report regarding the Food and Drug Administration Center for Tobacco Products’ (CTP) review of premarket tobacco applications (PMTAs) for electronic nicotine delivery systems.
The HHS OIG found that the CTP has made progress in reducing the backlog of PMTAs submitted in 2020 but that approximately 53,000 PMTAs remain outstanding.
For more information, click here.
CDC Announces Availability of Infant RSV Vaccine
On Nov. 16, the Centers for Disease Control and Prevention (CDC) announced the availability of more than 77,000 additional doses of Beyfortus (nirsevimab-alip), the respiratory syncytial virus (RSV) vaccine intended for use in infants. The CDC recently warned of a shortage of RSV vaccines in late October.
For more information, click here.
CMS Announces Notice of Funding Opportunity Application Period for AHEAD Model
On Nov. 16, the Centers for Medicare and Medicaid Services announced the opening of the first of two notice of funding opportunity application periods for the States Advancing All-Payer Health Equity Approaches and Development Model. The model seeks to improve population health, lower healthcare costs and reduce disparities in health outcomes.
Applicants interested in participating in the model are encouraged to submit a letter of intent. States in cohorts 1 and 2 may submit a letter by Feb. 5 and must submit an application by March 18. States in cohorts 3 and 4 may submit a letter by July 26 and must submit an application by Aug. 12.
For more information, click here.
CMS to Begin Accepting Applications for GUIDE Model
On Nov. 15, the Centers for Medicare and Medicaid Services (CMS) announced that it would begin accepting applications for the Guiding an Improved Dementia Experience Model. The model will test whether providing an alternative payment methodology for participating dementia programs can reduce expenditures and enhance care.
The deadline to apply is Jan. 30 and CMS will announce those who were selected to participate in spring 2024.
For more information, click here.
CMS Releases Information Bulletin on Coverage Options for Medicaid/CHIP Health-Related Social Needs Services
On Nov. 16, the Centers for Medicare and Medicaid Services released an informational bulletin intended to inform Medicaid and Children’s Health Insurance Program (CHIP) stakeholders of the coverage options available for clinically appropriate and evidence-based services that address health-related social needs.
For more information, click here.
FDA Principal Deputy Commissioner Announces Retirement
On Nov. 16, Food and Drug Administration Principal Deputy Commissioner Janet Woodcock announced that she will be retiring in early 2024. She previously served as director of the Center for Drug Evaluation and Research from 1994 to 2004 and 2007 to 2021.
FDA Publishes Product-Specific Guidances for Generic Drug Development
On Nov. 16, the Food and Drug Administration published product-specific guidances intended to inform stakeholders on the agency’s expectations concerning the development of generic drug products that are pharmaceutically equivalent to a reference listed drug.
For more information, click here.
FDA Approves First Chlamydia and Gonorrhea Sample Collection At-Home Test
On Nov. 15, the Food and Drug Administration granted marketing authorization to the LetsGetChecked Simple 2 Test, the first over-the-counter at-home diagnostic test for chlamydia and gonorrhea with a sample collection. The test is intended for use in adult patients 18 years and older.
For more information, click here.
FDA Issues Warning Letter Concerning Distribution of Eye Drop Products
On Nov. 13, the Food and Drug Administration (FDA) issued a warning letter to Amazon for its distribution of four eye drop products that are classified as “new drugs” under section 201(p) of the Federal Food, Drug and Cosmetic Act. In its letter, the FDA clarifies that Amazon may not introduce or deliver the eye drop products via interstate commerce without an approved application from the FDA.
For more information, click here.
FDA CDER to Restructure Office of Pharmaceutical Quality
On Nov. 13, the Food and Drug Administration Center for Drug Evaluation and Research (CDER) announced that it would restructure its Office of Pharmaceutical Quality (OPQ). The CDER plans on consolidating its research activities under a new OPQ and will combine its quality assessment efforts under the Deputy Director of Science.
FDA Approves Metastatic Colorectal Cancer Treatment
On Nov. 8, the Food and Drug Administration approved fruquintinib (Fruzaqla, Takeda Pharmaceuticals, Inc.) a treatment for adults with metastatic colorectal cancer who have undergone various types of chemotherapy.
For more information, click here.
FDA Issues Warning Letter Over Unauthorized Dissolvable Nicotine Products
On Nov. 7, the Food and Drug Administration (FDA) issued a warning letter to Nic Nac Naturals, LLC, for the marketing of unauthorized dissolvable nicotine products that are sold in packs resembling mints. The FDA is concerned that the products could appeal to youth and cause severe nicotine toxicity or death if ingested by young children.
For more information, click here.
FDA Approves Hypertension Renal Denervation Device
On Nov. 7, the Food and Drug Administration approved the Recor Medical Paradise Ultrasound Renal Denervation System, a device intended to treat patients who are unable to adequately control their blood pressure via lifestyle modifications and antihypertensive medications. The device uses ultrasound to disrupt nerves around kidney blood vessels to reduce blood pressure.
SAMHSA Awards $74.4 Million to Strengthen Behavioral Health Programs
On Nov. 16, the Substance Abuse and Mental Health Services Administration announced that it had awarded $74.4 million in grants to five programs seeking to improve behavioral health.
The grants include:
- $30.4 million for the Grants for Expansion and Sustainability of the Comprehensive Community Mental Health Services for Children with Serious Emotional Disturbances program, to increase resources for mental healthcare services provided to children and youth under the age of 21;
- $13.1 million for the Tribal Behavioral Health program, to support suicide, substance abuse, overdose and trauma prevention services for tribal youth under the age of 24;
- $15.5 million for the Strategic Prevention Framework – Partnerships for Success for States program, to support the development and delivery of state and community substance misuse prevention and mental health promotion services; and
- $15.5 million for the Strategic Prevention Framework – Partnerships for Success for Communities, Local Governments, Universities, Colleges, and Tribes/Tribal Organizations program, to support the development and delivery of substance misuse prevention and mental healthcare services at universities, colleges and local and tribal organizations.
For more information, click here.
Proposed Rules
CMS Proposed Rule Outlines Benefit and Payment Parameters for 2025
On Nov. 15, the Centers for Medicare and Medicaid Services released a proposed rule that would implement proposed standards for qualified health plans (QHPs) that are offered through the health insurance marketplace for 2025. It would also establish new requirements for health plan agents, brokers, direct enrollment entities and assisters. The proposed rule would:
- Require state marketplaces and state-based marketplaces on the federal platform (SBM-FPs) to establish quantitative time and distance QHP network adequacy standards;
- Allow states to add routine adult dental services as an essential health benefit;
- Revise certain prescription drug benefits;
- Enhance consumer protections and standards;
- Establish marketplace call center standards;
- Require state marketplaces and Medicaid/CHIP agencies to pay to access and use Verify Current Income Hub service income data;
- Implement a federally facilitated marketplace user fee of 2.2 percent and a SBM-FP user fee of 1.8 percent; and
- Implement a risk adjustment fee of $0.20 per member per month for the 2025 benefit year.
In addition, the proposed rule would grant states more flexibility when adopting income and resource disregards when determining financial eligibility for Medicaid for non-Modified Adjusted Gross Income populations.
Public comments will be accepted until Jan. 8, 2024. For more information, click here.
CMS Proposes Rule to Strengthen Medicare Advantage, Part D and Behavioral Healthcare Access
On Nov. 6, the Centers for Medicare and Medicaid Services released a proposed rule that would implement technical and policy changes to the Medicare Advantage (MA), Prescription Drug Benefit and Cost Plan programs in addition to the Programs of All-Inclusive Care for the Elderly (PACE) beginning in contract year (CY) 2025. The proposed rule would:
- Implement a $632 fixed payment for MA and Part D agents and brokers who assist individuals in enrolling in a MA or Part D plan;
- Establish a new MA facility-specialty type called “Outpatient Behavioral Health,” which will include marriage and family therapists, mental health counselors and other addiction and behavioral health providers;
- Encourage MA plans to increase engagement efforts and inform plan enrollees about supplemental benefits;
- Require MA plans to demonstrate that special supplemental benefits for the chronically ill (SSBCI) meet reasonable expectations of improving chronically ill enrollees’ health and well-being;
- Direct MA plans to analyze utilization management policies from a health equity perspective;
- Limit out-of-network cost sharing for dual eligible special needs plans; and
- Standardize the MA plan risk adjustment data validation (RADV) appeals process.
Public comments will be accepted until Jan. 5, 2024. For more information, click here.
CMS Proposes Rule to Penalize Providers Who Block Electronic Health Information
On Oct. 30, the Centers for Medicare and Medicaid Services released a proposed rule that would establish disincentives for healthcare providers who knowingly interfere with the access, exchange or use of electronic health information except when required by law or regulatory exception. The proposed rule would:
- Under the Medicare Promoting Interoperability Program, penalize hospitals that block information by reducing their annual market basket increase by 75 percent and reducing a critical access hospital’s payment to 100 percent of reasonable costs;
- Under the Merit-based Incentive Payment System Promoting Interoperability performance category, penalize clinicians or groups by awarding them a zero score for the category; and
- Under the Medicare Shared Savings Program, penalize accountable care organizations (ACO) and ACO participants, providers or suppliers by deeming them ineligible to participate in the program for at least one year.
Public comments will be accepted until Jan. 2, 2024. For more information, click here.
CMS Proposes Rule Regarding Federal IDR Process
On Oct. 27, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would amend requirements for the federal independent dispute resolution (IDR) process. The proposed rule would:
- Require group health plans and insurers to provide additional information at the time of an initial payment or notice of denial of payment for certain items and services covered by surprise billing protections;
- Implement changes to the IDR open negotiation process to incentivize stronger communication between disputing parties;
- Revise the process for initiating the federal IDR process; and
- Modify requirements related to IDR dispute eligibility review and the payment and collection of administrative and certified IDR entity fees.
In addition to CMS, the Employee Benefits Security Administration and Internal Revenue Service are proposing the rule.
Public comments will be accepted until Jan. 2, 2024. 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.
Final Rules
CMS Final Rule Implements Nursing Home Ownership and Management Disclosure Requirements
On Nov. 15, the Centers for Medicare and Medicaid Services released a final rule that implements stricter ownership and management disclosure and reporting requirements for nursing homes enrolled in Medicare or Medicaid. The final rule will require nursing homes to:
- Disclose additional information regarding their owners, operators and management, specifically the individuals and entities that provide administrative services or clinical consulting services to the nursing home;
- Disclose entities that exercise financial control over the facility;
- Report the names of individuals or entities that lease or sublease property to the facility, or who own a whole or part interest equal to or exceeding 5 percent of the total value of such real property; and
- Provide information on the organizational structures of disclosed parties.
In addition, the final rule defines a private equity and real estate investment trust and finalizes definitions to assist nursing homes in collecting the requested data.
The final rule will go into effect on Jan. 16, 2024. For more information, click here.
CMS Final Rule Outlines Remedy for 340B Payment Cuts Deemed Unlawful Between CYs 2018-2022
On Nov. 2, the Centers for Medicare and Medicaid Services (CMS) released a final rule that outlines how it will pay back hospitals that participate in the 340B Drug Pricing Program and were impacted by payment cuts between calendar years (CYs) 2018 and 2022, which were deemed unlawful. The final rule clarifies that:
- CMS will repay impacted 340B hospitals in a single lump-sum payment equal to the difference in what CMS paid hospitals for 340B drugs between CYs 2018-2022 and the amount they would have paid if the payment cuts had not been implemented; and
- CMS will establish a policy to recoup funds from hospitals that received higher rates for non-drug services. CMS intends to achieve this by annually adjusting the outpatient prospective payment system conversion factor by minus 0.5 percent beginning in CY 2026 until the full amount is offset. This is projected to take 16 years.
The final rule will go into effect on Jan. 7, 2024. For more information, click here.
CMS Final Rule Updates 2024 Medicare Physician Fee Schedule
On Nov. 2, the Centers for Medicare and Medicaid Services released a final rule that updates the Medicare Physician Fee Schedule (PFS) payment rates for calendar year 2024. The final rule will:
- Decrease the PFS conversion factor by 3.4 percent from $33.89 to $32.74;
- Decrease overall PFS payment rates by 1.25 percent;
- Finalize separate coding and payment for new caregiver and health equity services;
- Allow eligible marriage and family therapists and addiction counselors to enroll in Medicare starting Jan. 1, 2024;
- Allow payments to be made for certain dental services linked to specific cancer treatments; and
- Enhance the Medicare Diabetes Prevention Program (MDPP) Expanded Model and allow MDPP suppliers to continue using COVID-19 public health emergency flexibilities and offer services virtually through Dec. 31, 2027.
The final rule will go into effect on Jan. 1, 2024. For more information, click here.
CMS Final Rule Updates 2024 Hospital OPPS and ASC Payment System
On Nov. 2, the Centers for Medicare and Medicaid Services released a final rule that updates the hospital outpatient prospective payment system (OPPS) and the ambulatory surgical center (ASC) payment system for calendar year 2024. It also finalizes changes to the Hospital Outpatient Quality, ASC Quality and Rural Emergency Hospital Quality reporting programs. The final rule will:
- Increase hospital OPPS and ASC payment rates by 3.1 percent, based on an inpatient hospital market basket percentage increase of 3.3 percent and a 0.2 percent reduction in the final productivity adjustment;
- Modify and adopt new quality reporting measures;
- Establish payments for intensive outpatient program services under Medicare;
- Update payment rates for partial hospitalization program services;
- Modify community mental health center conditions of participation; and
- Establish the Rural Emergency Hospital (REH) provider type.
The final rule will go into effect on Jan. 1, 2024. For more information, click here.
CMS Final Rule Updates 2024 Home Health Prospective Payment System
On Nov. 1, the Centers for Medicare and Medicaid Services released a final rule that updates payment policies and rates for Medicare Home Health Agencies for calendar year 2024. It also finalizes changes to the Home Health Quality Reporting and Value-based Purchasing Programs. The final rule will:
- Increase home health payments by 0.8 percent, based on a projected 3.0 percent increase in home health payments, a 2.6 percent decrease in the permanent behavior assumption adjustment and a 0.4 percent increase in the fixed-dollar ratio for outlier payments adjustment;
- Implement a permanent prospective payment adjustment of minus 2.89 percent;
- Increase the home health market basket percentage by 3.0 percent;
- Establish an informal dispute resolution and special focus program for hospice programs; and
- Add new and updated quality reporting measures.
The final rule will go into effect on Jan. 1, 2024. For more information, click here.
CMS Final Rule Updates 2024 ESRD Prospective Payment System
On Oct. 27, the Centers for Medicare and Medicaid Services released a final rule that updates the payment policies and rates for the end-stage renal disease (ESRD) prospective payment system (PPS) for renal dialysis services covered under Medicare for calendar year (CY) 2024. It also updates the acute kidney injury dialysis payment rate and requirements for the ESRD Quality Incentive Program. The final rule will:
- Increase the ESRD PPS base rate by 2.1 percent to $271.02;
- Implement new ESRD PPS claims reporting requirements;
- Finalize a new transitional add-on pediatric ESRD dialysis payment adjustment for CYs 2024, 2025 and 2026;
- Discuss the responses CMS received to a request for information it issued related to a low-volume payment adjustment; and
- Implement a payment adjustment for new renal dialysis drugs and biological products after the Transitional Drug Add-on Payment Adjustment (TDAPA) period.
The final rule will go into effect on Jan. 1, 2024. For more information, click here.
CMS Final Rule Specifies When and How CMS Imposes Civil Money Penalties
On Oct. 11, the Centers for Medicare and Medicaid Services (CMS) released a final rule that specifies how and when it will calculate and impose civil money penalties (CMPs) when group and non-group health plan responsible reporting entities (RREs) fail to meet their Medicare Secondary Payer (MSP) reporting requirements. It also outlines CMP amounts and clarifies under which circumstances penalties will and will not be imposed.
The final rule will go into effect on Dec. 11, 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.
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.
CBO Cost Estimates
CBO Releases Cost Estimate on H.R. 3843, Action for Dental Health Act of 2023
On Nov. 17, the Congressional Budget Office (CBO) released a cost estimate for H.R. 3842, the Action for Dental Health Act of 2023. The legislation would reauthorize a Health Resources and Services Administration program that distributes grants to states to address dental workforce shortages.
The CBO estimates that the bill would increase spending subject to appropriation by $55 million between 2024 and 2028 and would cost $12 million after 2028.
For more information, click here.
CBO Releases Report on Distribution of Household Income in 2020
On Nov. 14, the Congressional Budget Office (CBO) released a report on the distribution of household income in 2020. The CBO found that income before transfers and taxes was more skewed toward the top of the income distribution in 2020 than in 2019, and that means-tested transfers were larger. The CBO also found that income after transfers and taxes was more evenly distributed and that transfers and taxes reduced income inequality in 2020 more than any other year.
For more information, click here.
CBO Releases Presentation on Distribution of Household Income from 1979 to 2020
On Nov. 14, the Congressional Budget Office (CBO) released a presentation on the distribution of household income from 1979 to 2020. The CBO found that between 1979 and 2020, households at the top of the income distribution received significantly more income than those at the bottom and that households in the lowest quintile received more than half of all means-tested transfers. The CBO also found that higher-income households paid a higher average federal tax rate and that income inequality rose.
For more information, click here.
NOTE:
Happy Thanksgiving
Due to the Thanksgiving holiday, there will be no Washington Health Update published on Nov. 27. The next issue will be published on Dec. 4.
