Aug 15, 2022
Washington Healthcare Update
This Week in Washington: House Passes Inflation Reduction Act by a vote of 220-207
The Senate is in its Recess
Members Push FDA to Finalize Risk-Mitigation Strategy for Mifepristonea
On Aug. 3, Sens. Warren (D-MA), Hirano (D-HI) and Baldwin (D-WI) wrote a letter asking the FDA to quickly finalize updates to the risk-mitigation strategy for mifepristone that would make the medication abortion drug more accessible in the wake of the Supreme Court’s reversal of Roe v. Wade, and to also approve the drug for miscarriage procedures.
The FDA announced in December 2021 a series of risk mitigation strategies but has yet to officially approve them. The letter requests the FDA to expedite its review of the manufacturers’ plans to certify pharmacies and to finalize the updated REMS well before the 180-day statutory deadline.
FDA has said it is starting a certification process for pharmacies, including mail order pharmacies, to dispense mifepristone but has not finalized it yet, according to a policy professional who is involved with the Protecting Access to Medication Abortion Act.
The senators also ask FDA to review the remaining pieces of the REMS to determine whether any restrictions placed on the prescription and distribution of mifepristone, including patient consent forms, are medically unnecessary.
In addition, the senators ask FDA to work toward adding a miscarriage indication to the mifepristone with misoprostol label.
House Passes Inflation Reduction Act
Following the Senate passage of the Inflation Reduction Act (budget reconciliation), the House returned from its recess to pass the legislation. The rule by which the House considered the legislation did not permit any amendments. In addition to including Medicare negotiation of drug prices, and an extension of the ACA credits, the legislation would require adults enrolled in Medicare, Medicaid or CHIP to receive all vaccines by the Advisory Committee on Immunization Practices without cost sharing. This means Medicare beneficiaries would not have cost sharing for adult vaccine administration covered under Medicare Part D beginning in 2023.
Text of the legislation can be found https://rules.house.gov/bill/117/hr-5376-sa
In addition, prior to Senate consideration the Congressional Budget Office (CBO) released an estimate of the bill and answered other questions in a report that can be found at https://www.cbo.gov/publication/58366
President Announces Intention to Appoint Director of the National Cancer Institute
On Aug. 10, President Biden announced his intention to appoint Dr. Monica Bertagnolli as Director of the National Cancer Institute (NCI). She would be the first woman to the lead the NCI.
BARDA Buys Supply of Tecovirimat (TPOXX)
The Biomedical Advanced Research and Development Authority (BARDA) purchased 26 million dollars’ worth of the drug tecovirimat, the approved smallpox and experimental monkeypox treatment’s intravenous formulation from its manufacturer. The purchase will supply the federal government’s Strategic National Stockpile.
CMS Suspends the Georgia Access Program
On Aug. 9, the Center for Medicare and Medicaid Services (CMS) suspended Georgia’s plan to not use the federal health exchange outreach efforts and instead use private brokers to assist individuals selecting health insurance. Administrator Brooks-LaSure said Georgia did not submit a plan that would alter its model to meet the statutory coverage guardrail and ensure the Section 1332 waiver would not result in substantial projected coverage losses in the state.
The state could still submit a corrective action plan to resume the program in 2024. CMS held a public comment period soliciting feedback on whether the waiver should be allowed to proceed, while Georgia would not provide information on how the program would prevent residents from losing access to coverage. Georgia held that CMS did not have the authority to challenge a waiver that had already been granted.
Food and Drug Administration Expands Population of Who Can Receive Monkeypox Vaccine and Strategy for Stretching Out Doses
On Aug. 9, Health and Human Services Secretary Xavier Becerra declared a public health emergency under Section 564 of the Federal Food, Drug and Cosmetic Act. Earlier the secretary had declared a public health emergency for monkeypox under the Public Health Service Act.
Following the Section 564 announcement the Food and Drug Administration (FDA) authorized stretching out the supply of the two-dose JYNNEOS monkeypox vaccine and expanded the population of people who can receive the shot. Since the FDA’s announcement, public health officials and the drug’s manufacturer are concerned the decision to stretch out the doses was made using limited data.
The declaration under Section 564 allows for the FDA to use emergency use authorization for a smaller dose of JYNNEOS to be injected intradermally instead of subcutaneously in people under age 18. It also allows the vaccine to be administered in its subcutaneous form to people under 18 years of age who are at high risk for monkeypox infection. The smaller dose of JYNNEOS will allow the federal government to get up to five times the amount of doses from a single vial.
HHS Announces Proposed Rule to Implement Section 1557 of the ACA
On July 25, the Department of Health and Human Services (HHS) released a proposed rule to implement Section 1557 of the Affordable Care Act (ACA) that bans discrimination based on race, color, national origin, sex, age and disability in certain health programs and activities. The proposed rule expands civil rights protections for patients in certain federally funded programs by clarifying the scope and application of Section 1557. An HHS press release on the proposed rule can be found here.
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.
CMS Releases CY 2023 Physician Fee Schedule Proposed Rule
On July 7, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Medicare and Medicaid Programs: Calendar Year (CY) 2023 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies, Medicare Shared Savings Program Requirements, etc.” The proposed rule would make changes to the physician fee schedule (PFS) and Medicare Part B payment policies to better reflect the value of services. The proposed rule also would:
- Allow licensed professional counselors, counselors and therapists to provide behavioral health services under general supervision,
- Consider clinical psychologists and clinical social workers as part of a patient’s primary care team for payment purposes,
- Incorporate advance shared savings payments to certain new Medicare Shared Savings Program Accountable Care Organizations (ACOs),
- Improve access to colon cancer screening,
- Allow CMS to pay for dental services that are integral to covered medical services,
- Update the Medicare Economic Index (MEI) cost share weights,
- Solicit public feedback on ways to improve global surgical package valuation,
- Adopt changes to the Evaluation and Management (E/M) visit coding and documentation,
- Extend some services temporarily available via telehealth through CY 2023,
- Add new Healthcare Common Procedure Coding System (HCPCS) codes and valuation for chronic pain management,
- Provide Medicare coverage for opioid use disorder services provided by opioid treatment programs,
- Allow beneficiaries to access audiology services without a physician referral,
- Clarify Medicare fee-for-service payment policies for dental services,
- Change the coding, billing and payment rules for skin substitutes,
- Refine the payment amount for preventive vaccine administration under the Medicare Part B vaccine benefit and
- Update regulations on Medicare Ground Ambulance data collection.
Additional resources on the proposed rule can be found below:
Public comments will be accepted until Sept. 6, 2022.
CMS Publishes Proposed Rule on Rural Hospitals
On July 7, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Medicare and Medicaid Programs; Conditions of Participation (CoPs) for Rural Emergency Hospitals (REH) and Critical Access Hospital CoP Updates.” The proposed rule establishes the CoPs that REHs need to meet in order to participate in Medicare and Medicaid, with the objective of ensuring that REHs provide a high quality of care. In addition, the proposed rule would also change the Critical Access Hospital requirements for participation in Medicare and Medicaid.
Public comments will be accepted until Aug. 29, 2022.
CMS Publishes End-Stage Renal Disease Prospective Payment System Proposed Rule
On June 28, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Medicare Program: End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, etc.” The proposed rule would update the End-Stage Renal Disease (ESRD) Prospective Payment System and the payment rate for renal dialysis service provided by an ESRD facility for people with acute kidney injury for calendar year 2023. In addition, the rule includes requests for information on potential payment adjustments for new renal dialysis drugs and products and health equity issues.
Public comments will be accepted until Aug. 22, 2022.
CMS Releases FY 2023 Home Health Prospective Payment Systems Rate Proposed Rule
On June 17, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Calendar Year 2023 Home Health Prospective Payment System Rate Update.” The proposed rule would update Medicare payment policies and rates for home health agencies (HHAs). A CMS fact sheet says the rule would update home health payment and home infusion therapy rates for Fiscal Year 2023. In addition, the rule would end the suspension of non-Medicare and non-Medicaid data for HHA patients and expand the baseline years in the Expanded Home Health Value-Based Purchasing (HHVBP) Model.
Public comments will be accepted until Aug. 16, 2022.
CMS Publishes Final Rule to Update FY 2023 Hospice Payment Rate
On July 27, the Centers for Medicare and Medicaid Services (CMS) published a final rule titled “Medicare Program; FY 2023 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” The final rule makes updates to Medicare hospice payments and the aggregate cap amount for Fiscal Year (FY) 2023. The FY 2023 hospice payment update will be increased to 3.8% and a permanent budget-neutral 5% cap will be established on any decrease to an area’s wage index. The final rule also discusses the Hospice Outcomes and Patient Evaluation tool and provides an update on FY 2023 Quality Measures, the Consumer Assessment of Healthcare Providers and Systems, and Hospice Survey Mode Experiment. A press release on the final rule with additional information can be found here.
The final rule will go into effect on Oct. 1, 2022.
CMS Publishes FY 2023 Inpatient Psychiatric Facilities Prospective Payment System Final Rule
On July 27, the Centers for Medicaid published a final rule titled “Medicare Program: FY 2023 Inpatient Psychiatric Facilities Prospective Payment System; Rate Update and Quality Reporting; Request for Information.” The final rule will update Medicare payment rates for the Inpatient Psychiatric Facility Prospective Payment System (IPF PPS) for Fiscal Year (FY) 2023 and sets a permanent 5% cap. The rule does not make any changes to the IPF Quality Reporting Program. A press release with additional information can be found here.
The final rule will go into effect on Oct. 1, 2022.
CMS Issues FY 2023 Inpatient Rehabilitation Facility Prospective Payment System Final Rule
On July 27, the Centers for Medicare and Medicaid Services (CMS) issued a final rule titled “Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2023 and Updates to the IRF Quality Reporting Program.” The final rule updates payment policies under the Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) and the IRF Quality Reporting Program. The final rule includes a permanent cap on year-to-year wage index decreases and will expand the IRF quality data reporting requirements. A fact sheet about the final rule can be found here.
The final rule will go into effect on Oct. 1, 2022.
CMS Publishes Final Rule Updating CLIA Proficiency Testing Regulations for Analytes
On July 11, the Centers for Medicare and Medicaid Services (CMS) published a final rule titled “Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance.” The final rule makes changes to the proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The updates will address current analytes and new technologies. In addition, the final rule will make changes to the PT referral regulations to make sure they are aligned with the CLIA statute. The final rule will go into effect on Aug. 10, 2022, but amendments to Sec. Sec. 493.2 and 493.801 through 493.959 (amendatory instructions 2 and 5 through 21) will be effective on July 11, 2024.
HHS Issues Final Rule Withdrawing SUNSET Rule
On May 27, the Department of Health and Human Services (HHS) published a final rule to withdraw the “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET)” Final Rule of 2021. The SUNSET rule was originally set to go into effect on March 22, 2021, but was delayed until Sept. 22, 2022, following a lawsuit. The SUNSET rule would have required HHS to review every rule to determine if it was still applicable after 10 years, and any rules not reviewed within that time frame would be automatically eliminated. In its withdrawal of the SUNSET rule, HHS stated that the rule faced significant opposition from stakeholders and would not expedite rulemaking.
The rule is effective immediately.
CMS Releases Notice of Benefit and Parameters for 2023 Final Rule
On April 28, the Centers for Medicare and Medicaid Services (CMS) announced the 2023 Notice of Benefit and Payment Parameters Final Rule, which aims to strengthen plan coverage offered on the federal Marketplace. The final rule will require healthcare.gov plans to offer a standardized version of each product an issuer sells in each metal tier for plan year 2023. The final rule also finalizes exchange user fees, updates quality improvement standards related to health equity and reduces the number of verification requirements for special enrollment periods. The regulations went into effect on July 1, 2022.
A CMS fact sheet on the final rule can be found here.
Final Rule to Change Qualifications for Products to be Considered “Made in America” Released
On March 4, the Department of Defense, the General Services Administration and the Aeronautics and Space Administration announced a final rule that would increase manufacturing of critical supplies in the U.S. as part of President Biden’s “Made in America” policy. The final rule would require pharmaceutical companies that want their products to qualify as being “Made in America” for federal procurement purposes to increase the percentage of drug ingredients made in the U.S. from 55 percent to 75 percent in the next seven years. Specifically, the final rule would increase the threshold to 60 percent in 2022, 65 percent in 2024 and 75 percent in 2029. In addition, the rule will allow the government to apply price preferences to select drug products and components that will support the expansion of the domestic supply chain. The final rule will go into effect on Oct. 25, 2022.
The White House Fact Sheet on the final rule can be found here.
Long Covid Reports Disappoint Patient Advocates
Two major reports concerning the Biden administration’s plans to research long COVID and support those with the condition do not go far enough for some patient advocates. The National Research Action Plan on long COVID lays out gaps in knowledge about the condition and research priorities for further study. The Services and Supports for Longer-Term Impacts of COVID-19 report outlines resources available for people struggling with long COVID or other lingering effects of the pandemic like mental health issues or grief. Advocates are concerned that the reports fail to offer assistance and funding for patients.