Washington Healthcare Update

August 29, 2022

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This Week in Washington: Administration focuses on mental health and monkeypox issues

Congress

House

Administration

Proposed Rules

Final Rules

Congress

The House and Senate are in Recess

House

Restoring Hope for Mental Health and Well-being Act

The House recently passed the Restoring Hope for Mental Health and Well-being Act, which is designed to support mental health care, prevention, education and workforce training programs.

In addition to promoting compliance with mental health parity laws, the legislation would allocate $14 million each year through 2025 and $30 million each year for 2026 and 2027 for the Pediatric Mental Health Care Access grant program. That funding would permit every state to establish a program if they want to improve the integration of pediatric primary care providers with behavioral health providers by telehealth. A bipartisan group of House members is now holding discussions with key senators to create momentum for the Senate to pass the legislation when the Senate returns.

Administration

CMS Delays Radiation Oncology Model

On Aug. 25, the Centers for Medicare and Medicaid Services (CMS) announced that it will delay the radiation oncology demonstration. Providers have opposed the demonstration because it would reduce payments severely.

CMS Says There is No National Coverage Determination for Monkeypox Tests

On Aug. 19, the Centers for Medicare and Medicaid Services (CMS) clarified that there currently is no Medicare national coverage determination that monkeypox testing is medically necessary, so it is up to Medicare Administrative Contractors as well as state Medicaid programs to decide whether and when to cover the tests.

Also on Aug. 19, the administration announced it was increasing the availability of monkeypox vaccine and drugs as well as tests with the goal of expanding the capacity of orthopoxvirus tests from 6,000 tests per week to 80,000 tests per week.

Laboratories are concerned that the current Medicare Administrative Contractors’ monkeypox testing payment rates are inadequate and could impact patient care. Laboratories are asking CMS to require MACs to reimburse monkeypox testing at about $77 to pay for the increased safety protocols and tools necessary to process the tests. 

CMS Issues Guidance on How States Can Fund Behavioral Intervention Services

On Aug. 18, the Centers for Medicare and Medicaid Services (CMS) issued guidance on how states can use Medicaid and the Children’s Health Insurance Program to fund youth behavioral intervention services, a checklist concerning implementing the Medicaid in Schools Program and a proposed rule to create a new core set of children’s healthcare quality measures in Medicaid.

The first guidance released by CMS reiterates that states have an obligation to cover Early and Periodic Screening, Diagnostic and Treatment benefits. State Medicaid programs are required to cover prevention, screening, assessment and treatment for mental health and substance use disorders, CMS says. The new guidance lists ways states can improve prevention and treatment as well as expand provider capacity and increase integration of behavioral health and primary care.

The second guidance CMS released provides a checklist for how schools can leverage Medicaid funding to pay for the mental health services they’re providing their students.

CMS is also proposing mandatory state reporting requirements to standardize quality measures across Medicaid and CHIP for children nationally. The core sets would include a range of measures to determine how well Medicaid and CHIP provide affordable, high-quality, person-centered healthcare coverage to low-income Americans.

In addition, the Biden administration is also encouraging state Medicaid programs to share eligibility data with the Department of Agriculture to connect kids with free and reduced meal programs in schools.

BARDA and Monkeypox

The Biomedical Advanced Research and Development Authority has ordered 5.5 million vials of the Jynneos vaccine from Bavarian Nordic to be filled, finished and delivered from a U.S. government-owned supply of the vaccine in Denmark. Bavarian Nordic agreed to a technology transfer that would allow 2.5 million of those vials to be filled and finished in the United States.

The agency is partnering with drug manufacturer Grand River Aseptic Manufacturing (GRAM) to increase production of Bavarian Nordic’s monkeypox vaccine, Jynneos. The goal of this partnership is to increase the current monkeypox response and enhance smallpox preparedness and the partnership will increase the capacity to fill and finish government-owned doses.

No National Coverage Determination Concerning Monkeypox Testing

On Aug. 19, the Center for Medicare and Medicaid Services (CMS) clarified that there currently is no national coverage determination under Medicare that monkeypox testing is medically necessary. Therefore it is up to Medicare Administrative Contractors as well as state Medicaid programs to decide whether and when to cover the tests. The White House has announced that it was expanding the capacity of orthopoxvirus tests from 6,000 tests per week to 80,000 tests per week. 

FDA Authorizes Novavax’s COVID-19 Vaccine for 12-17-year-olds

The Food and Drug Administration (FDA) authorized Novavax’s COVID-19 vaccine for people ages 12 to 17, following its authorization of the vaccine for people aged 18 and over.

Novavax’s shot is now one of three coronavirus vaccines available for use in the 12- to 17-year-old age group. Pfizer’s and Moderna’s two-dose mRNA shots also are available for teens.

IRS Adjusts the Employer Shared Responsibility Provisions (Employer Mandate)

In a recent Revenue Procedure, the IRS announced an adjustment to the employer shared responsibility provision (known as the employer mandate). The employer shared responsibility provision requires large employers to pay an assessment if they fail to offer health coverage to their full-time employees that meet certain criteria.

The announcement stated that based on recent data, there would be a significant decrease in the percentage for 2023. The new percentage will be 9.12 percent. As a result, some employers may find the contributions that low-wage employees must pay for coverage under their health plans in 2023 will cause that coverage to be deemed unaffordable. If that occurs, the employer will need to pay an assessment for each full-time employee who forgoes employer coverage and instead obtains subsidized coverage through an Affordable Care Act marketplace.

The employer mandate applies only to employers with at least 50 full-time employees (or part-time employees, where a part-time employee counts as a fraction of a full-time employee based on hours worked).

NIH Grant Program to Establish Four Academic Centers on Delivery Cancer Care Via Telehealth

The National Institutes of Health (NIH) announced a new grant program through which they will award $23 million to establish four academic centers that will conduct research on delivering cancer care via telehealth.

According to NIH, there has been limited research conducted on the best ways to use the technology in treating cancer patients. 

The awards, from the National Cancer Institute, will create the first Telehealth Research Centers of Excellence as part of an initiative supported by the White House’s Cancer Moonshot program to accelerate cancer cures. The grants will go to four institutions and will be distributed over five years. Each center will have a different focus. 

The Telehealth Research and Innovation for Veterans with Cancer (THRIVE) Telehealth Research Center at NYU Grossman School of Medicine will work with the Veterans Health Administration to examine how social determinants of health affect delivery of telehealth to veterans.

The Scalable Telehealth Cancer Care (STELLAR) Center at Northwestern University will study the use of telehealth to reduce cancer risk behaviors like smoking.

The University of Pennsylvania Telehealth Research Center of Excellence (Penn TRACE) will focus on telehealth strategies for lung cancer screening and testing.

The Making Telehealth Delivery of Cancer Care at Home Effective and Safe (MATCHES) Telehealth Research Center at Memorial Sloan Kettering Cancer Center will study remote patient monitoring for prostate and breast cancer treatment.

Proposed Rules

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.

Final Rules

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 Medicare and Medicaid Services 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 percent 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.

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.