Washington Healthcare Update

September 26, 2022

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This Week in Washington: Congress Comes Down to the Finish Line





Proposed Rules

Final Rules




Health Legislation

On Sept. 21, the House Ways & Means Committee passed two bills to improve Medicare’s inpatient psychiatric facility payment system and add intensive inpatient program coverage for beneficiaries with mental health and substance use disorders who need it. The legislation would also direct HHS to conduct two outreach campaigns related to opioid treatment programs and behavioral health integration codes as well as require Medicare to cover marriage and family therapists and mental health counselor services.

In addition, the committee reported out legislation to improve accuracy of private insurance provider directories and to note whether telehealth services are offered, and sent directly to the floor a bill named in memory of Rep. Jackie Walorski (R-IN) that reauthorizes a program that provides in-home services to vulnerable families and doubles the annual funding over five years.

The committee also approved several bipartisan bills to help consumers access mental health services and better understand covered benefits. The committee passed legislation that would ensure victims of sexual assault do not have to pay out-of-pocket costs for forensic exams. Prior to the vote, members agree that before the legislation is considered on the House floor, it will be revised to ensure assault victims do not face cost sharing for any of the medical treatment they may need beyond rape test kits and that benefit should be extended to apply to victims of domestic violence.

The committee also approved the Machine-Readable Coverage Expansion Act that requires plans to submit their Summary of Benefits and Coverage documents to the Department of Health and Human Services (HHS) for posting in a centralized location that is accessible to researchers and other stakeholders who want to analyze the data and identify potential gaps.

Last, the committee passed legislation that requires the Department of Health and Human Services and the U.S. Treasury to create a star rating or other similar system to measure the availability of mental health and substance abuse providers compared to other products in the same area.

The following legislation passed out of the Ways and Means Committee:

  • H.R. 8876, The Jackie Walorski Maternal and Child Home Visiting Reauthorization Act of 2022
  • Committee Print 117-1. Improvements to Medicare Inpatient and Outpatient Mental Health Services
    • H.R. 8879 (introduced by Reps. Dwight Evans and Jodey Arrington)
    • H.R. 8878 (introduced by Reps. Judy Chu, Bill Pascrell and Adrian Smith)
  • Committee Print 117-2. Improvements to the Medicare Program Related to Physician Services and Education.
    • H.R. 432 (introduced by Rep. Mike Thompson)
    • H.R. 8910 (introduced by Reps. Jason Smith, Brad Schneider and Drew Ferguson)
    • H.R. 8884 (introduced by Reps. Mike Kelly and Brian Higgins)
    • H.R. 8890 (introduced by Reps. Raul Ruiz, Greg Murphy, Don Beyer and Larry Buschon)
    • H.R. 8908 (introduced by Reps. Ron Estes and Jimmy Panetta)
  • Committee Print 117-3. Requiring Coverage of Forensic Medical Exams with No Cost Sharing
    • H.R. 8891 (introduced by Reps. Linda Sánchez, Gwen Moore and Carol Miller)
  • Committee Print 117-4. Improved Information in Provider Directories, Plan Definitions, and Crisis Services for Private Insurance Plans
    • H.R. 8885 (introduced by Reps. Dan Kildee, Brad Wenstrup and Kevin Hern)
    • H.R. 8886 (introduced by Reps. Gwen Moore and David Schweikert)
    • H.R. 8892 (introduced by Reps. Terri Sewell, Darin LaHood and David Kustoff)
  • Committee Print 117-5. Improved Information for Network Coverage and Plan Documents in Private Insurance Plans
    • H.R. 8881 (introduced by Reps. Steven Horsford and Vern Buchanan)
    • H.R. 8889 (introduced by Reps. Stacey Plaskett, Tom Rice and Lloyd Smucker)

House Select Subcommittee on the Coronavirus Crises Issues Report on For-Profit Nursing Homes and COVID

The House Select Subcommittee on the Coronavirus Crisis released a new report concerning the conditions inside for‑profit nursing home chains during the early months of the pandemic, including severe and allegedly deliberate understaffing, a lack of personal protective equipment from staff and residents and a lack of quarantine protocol for COVID-19–positive employees. The report is the select subcommittee’s latest update on its investigation into large for-profit nursing home chains and their response to the COVID-19 pandemic.

On Sept. 21, the subcommittee held a hearing and released its report. At the hearing, witnesses urged the subcommittee to focus on six issues as federal and state legislators work with nursing homes, including: addressing the workforce crisis through workforce development and funding; improving state survey processes for oversight of nursing homes; strengthening nursing home transparency; reimbursing the cost of care and reducing purchasing costs; prioritizing equity among racial and ethnic groups; and incentivizing adoption of certified electronic health records and information technology interoperability in nursing homes. Other witnesses also suggested following the recommendations of the National Academies of Sciences, Engineering and Medicine for both short-term and long-term solutions to understaffing. Those recommendations focused on improving pay, sick leave and benefits as well as career advancement opportunities, childcare access and access to training for workers. 

Rep. Carter Introduces Legislation to Permit Pharmacists to Refuse Filling Medications

Rep. Buddy Carter (R-GA) introduced a bill that would permit pharmacists to refuse to fill prescriptions for medications they believe could be used to end a pregnancy. The bill is counter to the U.S. Department of Health and Human Services guidance for pharmacies.

The Pharmacist Conscience Protection Act is cosponsored by 26 other House Republicans. 

Rural Access to Telehealth Services

A bipartisan group of legislators sent a letter praising the Centers for Medicare and Medicaid Services proposal to continue rural access to behavioral telehealth services after the COVID-19 public health emergency ends. CMS is proposing to allow permanent access to telehealth behavioral health care provided by the clinical staff of hospitals after the PHE ends. The representatives also have introduced legislation, the Rural Behavioral Health Access Act, to do the same as the proposed rule. The letter’s signatories include Reps. Daniel Kildee (D-MI), Brad Wenstrup (R-OH), Brian Fitzpatrick (R-PA), Adrian Smith (R-NE), Jared Huffman (D-CA), Ashley Hinson (R-IA), Elise Stefanik (R-NY), Troy Balderson (R-OH) and Ron Kind (D-WI).


Funding the Government: Continuing Resolution

With the fiscal year ending on Sept. 30, Congress has few days to finish negotiations and pass a continuing resolution (CR) to keep the government open until Congress returns for a lame-duck session after the election. While there is no appetite for a government shutdown this close to the election, the CR is facing obstacles. Regardless, the Senate wants to move forward with a CR this week. 

To secure his vote for the Inflation Reduction Act, Democratic leadership promised Sen. Joe Manchin (D-WV) Congress would pass legislation by the end of September to overhaul the permitting process for some infrastructure projects. This legislation is still being developed and would provide fast-track approval process for domestic energy projects, including natural gas pipelines. That promise has divided the party, and Republicans are still angry with Democrats for having circumvented them on the IRA. Senate Republicans are likely to try to have the Senate take up alternative legislation on permitting reform. Manchin is to release his own proposal and has dismissed the Republican proposal.

If the Senate fails to pass the CR with permitting reforms attached, it could take up a separate, “clean” version of the bill that strips those provisions. If the Senate does manage to pass the whole package, the House could opt to remove the Manchin bill and send the spending measure back to the Senate without it.

In addition, other additions to the CR are being discussed. This includes some extension of the FDA User Fee legislation and additional COVID funding. 

Senate Finance Committee Releases Discussion Draft on Mental Health Workforce Shortage

On Sept. 22, the Senate Finance Committee released a discussion draft concerning mental health workforce shortages, who can seek Medicare reimbursement and burnout across all healthcare sectors. Two more discussion drafts on crisis care and mental healthcare parity are expected soon. Earlier this year the committee created five work groups to focus on different aspects of mental healthcare and delivery. Prior to the draft released on Sept. 22, the committee released drafts on children’s mental health and telehealth.

The workforce shortage discussion draft, which was led by Sens. Debbie Stabenow (D-MI) and Steve Daines (R-MT), would add 400 additional Medicare Graduate Medical Education slots for psychiatrist residencies as well as increase Medicare’s Health Professional Shortage Area bonus payments for psychiatrists. The proposal also would permit psychologists, clinical social workers, marriage and family therapists, mental health counselors and other providers to receive bonus payments.

The proposal would also let licensed clinical social workers bill Medicare for health behavior assessment and intervention services, which the draft says are vital to ensure a patient’s consistent treatment for chronic conditions.

Senators propose requiring Medicare to cover mental health services provided by marriage and family therapists, as well as licensed professional counselors. CMS proposed similar policy in its 2023 Medicare physician fee schedule and the House Ways and Means Committee passed a similar proposal on Sept. 21.

The discussion draft would also create a new exception under the physician self-referral law, which generally prohibits providers from referring patients to an entity with which the physician has a financial relationship. The proposed exception would let hospitals and other systems provide evidence-based mental health programs for physicians to increase resiliency and prevent suicide.

Path Forward for FDA User Fee Legislation Still Difficult

Sens. Patty Murray (D-WA) and Richard Burr (R-NC) announced they have a deal for a “practically clean” reauthorization of FDA user fee programs that would be attached to a temporary government funding bill. However, Senate Minority Leader Mitch McConnell (R-KY) wants to eliminate even the few policy riders the two negotiated, according to press reports. The issue needs to be resolved soon since the Senate plans to act on a stop-gap funding bill this week.


White House to Host Conference on Hunger, Nutrition, and Health

The White House will host the Conference on Hunger, Nutrition, and Health on Sept. 28. The conference will bring together Americans from all walks of life to help accelerate progress to end hunger, improve nutrition and physical activity and reduce disparities. For additional details see https://health.gov/our-work/nutrition-physical-activity/white-house-conference-hunger-nutrition-and-health/conference-details

CMS Will Not Delay Implementation of Rule on MA Marketing

The Centers for Medicare and Medicaid Services (CMS) confirms it has no plans to delay implementation of the 2023 Medicare Advantage and Part D final rule that addresses aggressive MA marketing tactics, despite calls to do so from health insurance agents and brokers who object to being included in the definition of a third-party marketing organization (TPMO).

In its proposed rule, CMS increased oversight of third-party marketing, noting that a significant amount of the 40,000 complaints received in 2021 were about TPMOs. As part of the rule, which was finalized in April, CMS changed the definition of a TPMO to include agents and brokers, meaning that brokers and insurance agents would be required to record—and retain—their enrollment calls. The National Association of Health Underwriters (NAHU) has repeatedly asked CMS to either delay the rule or to carve agents from the definition of a TPMO.

NAHU has warned that if CMS doesn’t delay or revise the rule, fewer agents and brokers would participate in Medicare’s forthcoming Annual Enrollment Period (AEP).

CMS is concerned about allegations of aggressive marketing tactics used by TPMOs who make unsolicited sales calls to seniors to push Medicare Advantage plans. NAHU argues that in contrast to agents and brokers who take time to discuss which plan is best for a Medicare beneficiary based on lifestyle, networks and formularies, TPMOs will often push products that might not be appropriate. The marketers also allegedly mislead consumers by telling them they’re calling from Medicare—or a well-known insurer—or use other tactics to lure seniors to enroll in coverage regardless of whether it’s a good fit.

FDA Exempts Naloxone From DSCA Requirements

On Sept. 22, the Food and Drug Administration announced that it would exempt Naloxone products, specifically those that are distributed to harm reduction programs, from certain drug tracking, tracing and distribution requirements during the opioid public health emergency in order to increase access to Naloxone. 

The guidance released will go immediately into effect. The guidance, “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act (DSCSA) for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency,” provides exemptions for the distribution of Naloxone products.

The guidance is being implemented without public comment because of the urgent need created by the opioid PHE. The policies outlined in the guidance will end once the PHE ends.

For more information see https://www.fda.gov/regulatory-information/search-fda-guidance-documents/exemption-and-exclusion-certain-requirements-drug-supply-chain-security-act-distribution-fda

FDA Releases Draft Guidance on Covered Product Authorization

On Sept. 21, the Food and Drug Administration (FDA) published a draft guidance that explains how drug makers can obtain a covered product authorization to access product samples of reference drugs that are subject to a risk mitigation strategy. The CPA pathway was created under the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act that was enacted in December 2019.

CREATES allows makers of generic and 505(b)(2) drugs and biosimilars to sue brand companies that refuse to provide product samples that are needed to support the generic or biosimilar manufacturer’s drug application, but the requester must first prove that it has taken certain steps to actually obtain the product samples.

To read the guidance see https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-obtain-covered-product-authorization

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.

Final Rules

Homeland Security Issues Final Rule Reversing Trump “Public Charge” Rule

On Sept. 8 the administration issued final rules making it clear that the Department of Homeland Security will not refuse entry to non-citizens seeking admission to the U.S. or a green card due to their likelihood to receive Medicaid/CHIP or other health benefits except for long-term institutionalized care. The rule reverses the Trump administration’s public charge rules issued in 2019. 


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 percent and a permanent budget-neutral 5 percent 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.

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.


HHS OIG Report Urges CMS to Implement Recommendations on Opioids

On Sept. 22, the Office of Inspector General updated a previous report on combatting the opioid epidemic. More than 50,000 Part D beneficiaries experienced an opioid overdose—from prescription opioids, illicit opioids or both—during 2021, according to a new report from HHS’s Office of Inspector General, which urges CMS to implement recommendations the OIG made in December for better handling of the opioid crisis.

Around 81,500 people died from opioid-related overdoses in the United States in 2021, which OIG says is an all-time high. An average of 4,800 Part D beneficiaries overdosed a month in that timeframe, with spikes in Medicare-covered opioid overdoses as high as 5,000 a month between April and July 2021.

The OIG urges CMS to implement recommendations it made in December 2021 to improve beneficiaries’ access to overdose treatment. Additionally, the OIG encourages CMS to speed up its efforts to implement a new behavioral health strategy as well as its opioid use disorder treatment demo. 

For more information see https://oig.hhs.gov/reports-and-publications/featured-topics/opioids/