Federal Health Policy Update for Thursday, November 4

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, November 4.  Some of the language used below is taken directly from government documents.

New Federal Vaccination Requirements

CMS has unveiled its new COVID-19 vaccine requirements for health care providers that receive reimbursement from the federal government.  The highlights include:

  • CMS is requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs.
  • The staff vaccination requirement applies to the following Medicare and Medicaid-certified provider and supplier types:  ambulatory surgery centers, community mental health centers, comprehensive outpatient rehabilitation facilities, critical access hospitals, end-stage renal disease facilities, home health agencies, home infusion therapy suppliers, hospices, hospitals, intermediate-care facilities for individuals with intellectual disabilities, clinics, rehabilitation agencies, public health agencies as providers of outpatient physical therapy and speech-language pathology services, psychiatric residential treatment facilities, Programs for All-Inclusive Care for the Elderly Organizations (PACE), rural health clinics/federally qualified health centers, and long-term care facilities.
  • Facilities covered by this regulation must establish a policy ensuring that all eligible staff have received the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by December 5, 2021.  All eligible staff must have received the necessary shots to be fully vaccinated – either two doses of Pfizer or Moderna or one dose of Johnson & Johnson – by January 4, 2022.  The regulation also provides for exemptions based on recognized medical conditions or religious beliefs, observances, or practices.
  • The regulation addresses who, among health care facilities’ employees, are subject to this requirement.  These requirements, it notes, must apply to the following facility staff, regardless of clinical responsibility or patient contact and including all current staff as well as any new staff who provide any care, treatment, or other services for the facility and/or its patients:  facility employees; licensed practitioners; students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangement.
  • These requirements are not limited to those staff who perform their duties within a formal clinical setting, as many health care staff routinely care for patients and clients outside of such facilities, such as home health, home infusion therapy, hospice, PACE programs, and therapy staff.
  • Further, there may be staff that primarily provide services remotely via telework that occasionally encounter fellow staff, such as in an administrative office or at an off-site staff meeting, who will themselves enter a health care facility or site of care for their job responsibilities.  CMS has concluded that it is necessary to require vaccination for all staff that interact with other staff, patients, residents, clients, or PACE program participants in any location, beyond those who physically enter facilities, clinics, homes, or other sites of care.
  • Transplant centers, psychiatric hospitals, and swing beds are governed by the infection control conditions of participation for hospitals and are thus subject to the staff vaccination requirements issued in this rule.
  • Individuals who provide services 100 percent remotely, such as fully remote telehealth or payroll services, are not subject to the vaccination requirements of this rule.  Providers should identify and monitor these individuals as a part of implementing the policies and procedures of this rule.
  • The rule encompasses administrative staff, facility leadership, volunteer or other fiduciary board members, housekeeping and food services staff, and others.  Regulators considered excluding individual staff members who are present at the site of care less frequently than once a week from these vaccination requirements but were concerned that this might lead to confusion or fragmented care, so any individual who performs their duties at any site of care, or has the potential to have contact with anyone at the site of care, including staff or patients, must be fully vaccinated.
  • Regulators noted that many infrequent services and tasks performed in or for a health care facility are conducted by “one off” vendors, volunteers, and professionals.  Providers and suppliers are not required to ensure the vaccination of individuals who infrequently provide ad hoc non-health care services (such as annual elevator inspection), delivery, or repair personnel.
  • When determining whether to require COVID-19 vaccination of an individual who does not fall into the categories established by this rule, facilities are told to consider frequency of presence, services provided, and proximity to patients and staff.  For example, a plumber who makes an emergency repair in an empty restroom or service area and correctly wears a mask for the entirety of the visit may not be an appropriate candidate for mandatory vaccination. On the other hand, a crew working on a construction project whose members use shared facilities (restrooms, cafeteria, break rooms) during their breaks would be subject to these requirements because they are using the same common areas used by staff, patients, and visitors.
  • To learn more, please consult the following resources:
  • OSHA has announced a new emergency temporary standard to protect more than 84 million workers from the spread of COVID-19 on the job.  Under this standard, covered employers (those with 100 or more employees) must develop, implement, and enforce a mandatory COVID-19 vaccination policy unless they adopt a policy requiring employees to choose either to be vaccinated or to undergo regular COVID-19 testing and wear a face covering at work.  Learn more from this OSHA news release and the agency’s formal Emergency Testing Standard, as published in the Federal Register.

New Medicare Regulations

CMS has released a number of final Medicare regulations.  The following are those final rules and links to additional information about them.

  • Hospital outpatient prospective payment system, ambulatory surgical center prospective payment system, price transparency, and radiation oncology model rule – changes include a two percent rate increase; restoration of the inpatient-only procedure list and most procedures that were removed from that list last year; continuation of 340B payments at average sale price minus 22.5 percent; changes in the hospital price transparency rule that leave hospitals with more than 30 beds subject to fines of up to $5500 a day or more than $2 million a year; changes in the quality reporting program, including a measure for COVID-19 vaccination rate among health care workers; and some changes in the Radiation Oncology Model program that begins on January 1, 2022, including invoking its “Extreme and Uncontrollable Circumstances Policy” for the program.  To learn more, see the following resources:
  • For more on the “Extreme and Uncontrollable Circumstances Policy” and its application to the Radiation Oncology Model, go here and scroll down.
  • Physician fee schedule – changes include an overall reduction of nearly nine percent in physician payments; a reduction of the conversion factor from the current $34.89 to $33.59; and provisions for the expanded use of telehealth.  To learn more, see the following resources:
  • Home health prospective payment system – changes include a 3.2 percent rate increase, changes in the Medicare conditions of participation, and provisions for expanded use of telehealth.  To learn more, see the following resources:
  • CMS has issued a final rule that updates payment rates under the End-Stage Renal Disease (ESRD) Prospective Payment System for renal dialysis services furnished to beneficiaries on or after January 1, 2022.  This rule also finalizes updates to the Acute Kidney Injury program dialysis payment rate for renal dialysis services furnished by ESRD facilities.  It also finalizes modifications to the ESRD Treatment Choices Model policies to encourage certain health care providers to reduce disparities in rates of home dialysis and kidney transplants among ESRD patients with lower socioeconomic status.  To learn more, see the following resources:

The White House

Congress

  • Yesterday, House Democrats released the text of its reconciliation bill, H.R. 5376 – the Build Back Better Act.  This bill includes a provision that provides a glide-path to ending the enhanced 6.2% Medicaid federal matching percentage established by the Families First Coronavirus Response Act passed in March last year.  The enhanced FMAP would be phased out as follows:
    • April 1, 2022, the enhanced FMAP lowered  to 3.0 percentage points;
    • July 1, 2022, enhanced FMAP lowered to 1.5 percentage points;
    • October 1, 2022, enhanced FMAP expires.
  • House Speaker Nancy Pelosi hopes the House will vote on the domestic spending reconciliation bill as early as this evening, to be followed by a vote on the bipartisan, Senate-passed infrastructure bill on Friday.  House Democrats have continued to negotiate changes in the reconciliation bill to gain more support, though it is unclear whether those changes have persuaded enough Democrats in the House to support the bill at this time.  Also unclear is whether the House bill will comply with the Senate’s procedural rules or whether this bill will have the support of all 50 Democratic senators.

Provider Relief Fund:  Phase 3 Payment Reconsideration

  • The Health Resources and Services Administration (HRSA) is accepting requests for reconsideration from providers that believe their Provider Relief Fund Phase 3 payments were incorrectly calculated.  Providers may not revise or correct their submitted application and the reconsideration will address only the calculation itself and not objections to the calculation methodology.  Go here for further information.  The deadline for submitting requests for reconsideration of Phase 3 payments is November 12.

Department of Health and Human Services

Health Policy News

  • HHS has proposed eliminating the “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) regulation, adopted in January of this year, that would have eliminated department regulations after ten years unless HHS took specific action to renew them.  In proposing to reverse the rule, HHS cited its previous failure to consider stakeholder objections to the rule, the burden it would place on the agency, and its potentially negative effect on medically vulnerable populations.  See HHS’s proposed rule overturning the SUNSET regulation in this Federal Register notice.
  • HHS has awarded $3.37 billion in relief funds through the Low Income Home Energy Assistance Program (LIHEAP) to help low-income individuals and families afford home heating costs this winter and cover unpaid utility bills.  This supplements $4.5 billion in LIHEAP funds from the American Rescue Plan Act that were released in May.  Learn more about this new LIHEAP funding and how interested parties can apply for assistance in this HHS news release.
  • HRSA has issued an interim update to its strategic plan to ensure alignment with the administration’s and HHS’s priorities, such as their emphasis on health equity, and the expansion of HRSA’s program responsibilities.  Go here to learn about the updated interim plan.
  • HRSA has opened its application process for three of its loan repayment programs with the support of an additional $800 million made available through the American Rescue Plan.  Eligible clinicians providing primary medical, dental, behavioral health care services, or evidence-based substance use disorder treatment can qualify for loan repayment of up to:
  • $50,000 for the NHSC Loan Repayment Program
  • $75,000 for the NHSC Substance Use Disorder Workforce Loan Repayment Program
  • 100,000 for the NHSC Rural Community Loan Repayment Program

Go here to learn more about eligible clinicians.  Applications are due December 16.

  • HHS’s Indian Health Service has announced $46.4 million in funding opportunities to address suicide, domestic violence, and substance abuse and for support for an integrative approach to the delivery of behavioral health services for American Indians and Alaska Natives.  Go here to learn more about the funding opportunities.  Applications are due February 2.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has reminded eligible consumers and providers that coverage for COVID-19 vaccines for children from the ages of five to 11 is available without cost-sharing under Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and in the commercial market.  Under the terms of the CDC’s COVID-19 Vaccination Program Provider Agreement, health care providers and other entities administering COVID-19 vaccines must agree not to deny anyone a COVID-19 vaccination based on their health coverage status and also must agree to administer COVID-19 vaccines at no out-of-pocket cost to recipients.  Learn more from this CMS news release.
  • CMS has posted a quick start guide to CLIA certification for COVID-19 testing in the workplace and an accompanying FAQ.

Health Policy News

  • CMS has extended two deadlines affecting hospitals that participate in its Hospital Inpatient Quality Reporting Program and/or the Medicare Promoting Interoperability Program.  As described in this CMS notice,
  • The deadline for the submission of electronic clinical quality measure (eCQM) data for the calendar year 2021 reporting period, pertaining to the FY 2023 payment determination, has been changed from Monday, February 28, 2022 to Thursday, March 31, 2022 at 11:59 p.m. Pacific time.
  • The Medicare Promoting Interoperability Program attestation deadline for eligible hospitals and critical access hospitals has been changed from Monday, February 28, 2022 to Thursday, March 31, 2022 at 11:59 p.m. Pacific time.
  • CMS has posted the latest edition of MLN Connects, its online newsletter.  Included in the new release are articles about changes for Medicare Advantage plan claims for COVID-19 vaccines and monoclonal antibodies that will take effect on January 1, 2022; changes in Medicare billing practices; a new web-based training program on post-acute care quality reporting programs; and more.  Go here to see the latest edition of MLN Connects.
  • CMS has released an updated fact sheet, based on recent legislative changes, to help states and advocacy organizations understand what health coverage options are available to Afghan evacuees.  Find that fact sheet here.

Food and Drug Administration

Centers for Disease Control and Prevention

National Institutes of Health

  • The NIH’s Rapid Acceleration of Diagnostics initiative has announced the launch of the “When To Test Calculator for Individuals,” a companion to the version for organizations introduced last winter.  By responding to just a few prompts, the new online individual impact calculator indicates whether a person should get a test and when.  The calculator includes answers to frequently asked questions and links to resources on testing strategies and on obtaining supplies, including home tests.  Learn more from this NIH announcement.
  • The NIH will support a four-year follow-up study on the potential long-term effects of COVID-19 on women infected with the virus during pregnancy.  The study also will follow their offspring for any potential long-term effects.  Learn more from this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has updated “Payment Basics,” its series of brief overviews of how Medicare’s payment systems function.  The agency produces Payment Basics as a resource for policy-makers and others to better understand how Medicare pays for health care services.  Much of the update reflects COVID-19-related payment changes.  Find the series here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC met on Thursday, October 28 and Friday, October 29.  For a summary of the meeting and links to the agenda and presentations made during the meeting, go here.
  • MACPAC has published a new issue brief that describes the use and oversight of upper-payment limit (UPL) payments for hospitals, nursing facilities, and physicians based on its review of provider-level data submitted by states to CMS to demonstrate compliance with UPL requirements.  The brief concludes with a discussion of current policy issues, including the new requirement for CMS to make provider-level UPL data publicly available.  Find the brief here.

Government Accountability Office (GAO)

  • The GAO recently evaluated the effectiveness of the federal government’s organization of the distribution of COVID-19 vaccines and its communication about those efforts and has published its findings and recommendations in the new report “COVID-19:  HHS Agencies’ Planned Reviews of Vaccine Distribution and Communication Efforts Should Include Stakeholder Perspectives.”  Find a summary of the report here and the full report here.

Congressional Research Service

Stakeholder Events

Medicare Payment Advisory Commission (MedPAC) – November 8 and 9

MedPAC will hold virtual meetings on November 8 and 9.  For information about times, agenda, and how to join the meeting go here.

CMS – Medicare Clinical Laboratory Fee Data Collection and Reporting Webinar – November 10

CMS will hold a webinar on Medicare clinical laboratory private payer data collection and reporting on Wednesday, November 10 at 3:30 p.m. (eastern).  Go here to register to participate.

HHS – Monoclonals and More:  Issues and Opportunities with Early COVID-19 Treatment Options – November 12

HHS’s Office of the Assistant Secretary for Preparedness and Response will hold a webinar on COVID-19 treatment with monoclonal antibodies on Friday, November 12 at 12:30 p.m. during which it will address some of the most current recommendations for use of monoclonal antibodies, upcoming therapies, and the challenges and opportunities that new therapies may pose in conjunction with monoclonal antibodies and other treatments (e.g., prioritization and distribution).  Speakers also will highlight operational principles for a scaled strategy for use of these therapeutics in a scarce resource situation.  For more information about the webinar and to register, go here.

CMS – COVID-19 Vaccines and Rural Communities – November 15

CMS will hold a webinar on COVID-19 vaccines and rural communities for its community providers and partners working in rural areas.  Go here for further information about the webinar and to register to participate.

CDC – Antibiotic Prescribing and COVID-19 – November 18

The CDC will hold a webinar titled “What Clinicians, Pharmacists, and Public Health Partners Need to Know About Antibiotic Prescribing and COVID-19” on Wednesday, November 18 at 2:00 p.m. (eastern).  Go here for information about the webinar, the presenters, and how to participate.

Federal Health Policy Update for Friday, August 13

The following is the latest health policy news from the federal government as of 1:30 p.m. on Friday, August 13.  Some of the language used below is taken directly from government documents.

Food and Drug Administration

COVID-19

  • The FDA has amended the emergency use authorizations for both the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine to authorize administering an additional dose of those vaccines to certain immunocompromised individuals, including solid organ transplant recipients and those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
  • The FDA has revised its emergency use authorization for the monoclonal antibody REGEN-COV (casirivimab and imdevimab, administered together) to add an authorization of REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms) who are at high risk for progression to severe COVID-19, including hospitalization or death.  Learn more here.

The White House

  • The White House has posted a transcript of the August 12 press briefing given by its COVID-19 response team and public health officials. View press briefing slides here.
  • The White House announced a series of COVID-19-related initiatives, including:
  • $8.5 billion in American Rescue Plan funding in the coming weeks to help compensate health care providers that serve rural Medicare, Medicaid, and CHIP patients for lost revenue and increased expenses associated with COVID-19.
  • $500 million in American Rescue Plan funding to create the Emergency Rural Health Care Grant Program, which will provide at least $350 million to help rural hospitals and local communities improve access to COVID-19 vaccines and testing, medical supplies, telehealth, and food assistance, and support construction or renovation of rural health care facilities and up to $125 million in grants to plan and implement models that help improve the long-term viability of rural health care providers.
  • $52 million from the American Rescue Plan to train a range of health care workers to fill in-demand professions in rural areas affected by the pandemic. Applications for this funding will be available in the coming weeks.
  • A demonstration project to enhance access to pulmonary rehabilitation services in critical access hospitals that serve rural communities with high rates of chronic obstructive pulmonary disease.
  • Expanded Veterans Affairs training programs for rural providers.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS announced that people with Medicare who qualify for an additional dose of COVID-19 can receive it at no cost.  This is in response to the FDA’s recent action to authorize an additional dose of COVID-19 vaccine for immunocompromised individuals.  CMS will share more information and guidance in the coming days about billing and coding for the additional dose of the COVID-19 vaccine for immunocompromised patients.
  • CMS has written to state officials to outline how it will assist states with their planning to resume routine Medicaid, CHIP, and Basic Health Program operations for the eventual end of the COVID-19 public health emergency.  Specifically, this letter provides updated guidance that extends the timeframe for states to complete pending eligibility and enrollment work to up to 12 months after the public health emergency ends and requires states to complete a redetermination of eligibility after the public health emergency for all beneficiaries prior to taking any adverse action.
  • CMS has published the latest edition of MLN Connects, its online weekly bulletin.  This week’s edition includes articles about CMS resuming the Targeted Probe & Education program and new waived laboratory tests, effective October 1. For this and more, go here.

Health Policy News

Department of Health and Human Services

COVID-19

  • HHS announced that it will require more than 25,000 members of its health care workforce to be vaccinated against COVID-19.  This includes staff at the Indian Health Service, the NIH, and members of the U.S. Public Health Service Commissioned Corps.  Read the press release here.

Centers for Disease Control and Prevention

COVID-19

Stakeholder Events

Monday, August 23 – CMS

Advisory Panel on Hospital Outpatient Payment

Monday, August 23 from 9:30 a.m. to 5:00 p.m. (eastern)

CMS’s Advisory Panel on Hospital Outpatient Payment will meet virtually to advise the agency about the clinical integrity of the Ambulatory Payment Classification groups and their associated weights and about supervision of hospital outpatient therapeutic services.  The advice provided by the panel will be considered as CMS prepares its annual updates for the hospital outpatient prospective payment system.

The public may participate in this meeting by webinar or teleconference.  Teleconference dial-in and webinar information will appear on the final meeting agenda, which will be posted here when available.

 

Federal Health Policy Update for Thursday, July 22

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, July 22.  Some of the language used below is taken directly from government documents.

White House

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has published its proposed calendar year 2022 Medicare outpatient prospective payment system regulation.  Among other subjects, the proposed regulation addresses hospital outpatient and ambulatory surgery center payment rates, hospital price transparency, the section 340B prescription drug discount program, changes in the inpatient-only list and ambulatory surgery center covered procedures list, changes in the hospital outpatient and surgery center quality reporting programs, the newly created rural emergency hospital provider type, the Radiation Oncology Model, temporary flexibilities implemented to facilitate the response to COVID-19, and more.  Stakeholder comments are due by September 17.  Learn more from the following resources.
  • CMS’s Center for Medicare and Medicaid Innovation has updated the web page of its Radiation Oncology Model to reflect changes in the program addressed in the newly published proposed Medicare outpatient prospective payment system regulation.  The updated web page includes links to additional resources about the Radiation Oncology Model.
  • CMS has published the latest edition of MLN Connects, its online weekly bulletin.  This week’s edition includes a description, billing information, a fact sheet, and more for the monoclonal antibody tocilizumab, which recently received FDA emergency authorization for use in treating COVID-19 patients; information on ICD-10-CM codes for FY 2022; a change in the national coverage for a (CAR) T-cell therapy; and more.  For this and more, go here.
  • CMS has published an advisory to alert certain clinicians who are qualifying alternative payment model (APM) participants and eligible to receive APM incentive payments that CMS does not have the current billing information it needs to send them their payments.  The advisory tells these clinicians how to update their billing information to receive their payments.  Affected physicians must submit updated billing information by November 1.  Read the notice here.
  • CMS has released an informational bulletin informing states that the Department of Homeland Security’s  2019 public charge rule has been vacated and is no longer in effect.  The notice explains that effective March 9, 2021, the Department of Homeland Security started applying the 1999 interim field guidance for public charge inadmissibility determinations, which is the policy that was in place before the 2019 public charge final rule.  Under that 1999 guidance, that agency will not consider an individual’s receipt of Medicaid benefits as part of the public charge determination except for individuals who are institutionalized on a long-term basis (such as nursing facility residents) and are receiving Medicaid coverage for their institutional services.  HHS has published a news release with the same information.

Department of Health and Human Services

COVID-19

  • HHS has renewed for 90 days its declaration of the public health emergency caused by COVID-19.
  • HHS will spend more than $1.6 billion from the American Rescue Plan to support testing and mitigation measures in high-risk congregate settings to prevent the spread of COVID-19 and detect and stem potential outbreaks.  $100 million will be spent to expand dedicated testing and mitigation resources for people with mental health and substance use disorders; $80 million will go to support state and local COVID-19 testing and mitigation measures among people experiencing homelessness, residents of congregate settings including group homes and encampments; and $169 million will be spent for testing and mitigation in federal prisons.  Learn more from the HHS news release.
  • HHS has distributed nearly $100 million in American Rescue Plan money to rural health clinics to support outreach efforts to increase vaccinations in their communities.  The funds will go to nearly 2000 Rural Health Clinics, which will use these resources to develop and implement additional vaccine confidence and outreach efforts in medically underserved rural communities.  See HHS’s news release for more information and for a link to a list of how much money was distributed on a state-by-state basis.

Health Policy News

  • HHS’s Health Resources and Services Administration (HRSA) has announced a change in user fees charged to individuals and entities authorized to request information from the National Practitioner Data Bank.  The new fee will be $2.50 for both continuous and one-time queries and $3.00 for self-queries.  Learn more about this increase and other changes in use of the National Practitioner Data Bank in this Federal Register notice.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has formally accepted Pfizer’s application for full approval of its Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 in individuals 16 years of age and older and has granted the application priority review.  Currently, the vaccine is authorized for emergency use in individuals ages 12 and older.  Learn more here.

Government Accountability Office

Medicaid and CHIP Payment and Access Commission (MACPAC)

State Medicaid programs are required to cover certain mental health services for adults while other mental health services are optional.  In a new compendium, MACPAC documents coverage of selected mental health services available to Medicaid beneficiaries in each state and the District of Columbia.  Find a link to the report here.

Stakeholder Events

Wednesday, August 4 – Centers for Disease Control

Zoonoses and One Health Update (ZOHU) Call

Wednesday, August 4 at 2:00 – 3:00 pm ETClick here for more information

ZOHU Calls are one-hour monthly webinars that provide timely education on zoonotic and infectious diseases, One Health, antimicrobial resistance, food safety, vector-borne diseases, recent outbreaks, and related health threats at the animal-human-environment interface.

Monday, August 23 – CMS

Advisory Panel on Hospital Outpatient Payment

Monday, August 23 from 9:30 a.m. to 5:00 p.m. (eastern)

CMS’s Advisory Panel on Hospital Outpatient Payment will meet virtually to advise the agency about the clinical integrity of the Ambulatory Payment Classification groups and their associated weights and about supervision of hospital outpatient therapeutic services.  The advice provided by the panel will be considered as CMS prepares its annual updates for the hospital outpatient prospective payment system.

The public may participate in this meeting by webinar or teleconference.  Teleconference dial-in and webinar information will appear on the final meeting agenda, which will be posted here when available.

 

MACPAC Meets

The Medicaid and CHIP Payment and Access Commission met for two days last week in Washington, D.C.

The following is MACPAC’s own summary of the sessions.

MACPAC kicked off its April meeting with a review of a draft chapter for the June 2021 report to Congress and recommendations on addressing high-cost specialty drugs. Since 2017, the Commission has been working to identify potential models that could help states address the challenges of high prices. The presentation focused on drugs that have been approved by the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway. Such approvals are based on whether the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit; however, unlike under the traditional pathway, the clinical benefit has yet to be verified.

On Friday, the Commission voted to approve two recommendations* that address Medicaid payment for such drugs. The recommendations would increase the rebates under the Medicaid Drug Rebate Program on accelerated approval drugs until these drugs have verified the clinical benefit. Once the FDA converts the drugs to traditional approval, the rebates would revert back to the standard amounts.

Commissioners then turned their attention to ways states can integrate care through Medicare Advantage dual eligible special needs plans (D-SNPs) using contract authority under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA, P.L. 110-275). The draft chapter for the June report describes why MACPAC is focused on D-SNPs, MIPPA strategies available to states, state ability to use these strategies, and MACPAC’s plans for future work on specific strategies that if made mandatory could give further momentum to state efforts.

The Commission then discussed two additional draft chapters for the June 2021 report related to behavioral health services. Staff presented a draft chapter and recommendations on improving access to mental health services for adult Medicaid beneficiaries, followed by a draft chapter and recommendations on improving access to behavioral health services for children and youth.

Commissioners on Friday approved recommendations* that call on the Secretary of the U.S. Department of Health and Human Services to:

  • direct relevant agencies to issue joint subregulatory guidance that addresses how Medicaid and the State Children’s Health Insurance Program (CHIP) can be used to fund a crisis continuum for beneficiaries experiencing behavioral health crises;
  • direct a coordinated effort to provide education, technical assistance, and planning support to expand access to such services;
  • direct relevant agencies to issue joint subregulatory guidance that addresses the design and implementation of benefits for children and adolescents with significant mental health conditions covered by Medicaid and CHIP; and
  • direct a coordinated effort to provide education, technical assistance, and planning support to expand access to such services.

After a break on Thursday, Commissioners discussed a draft chapter for the June 2021 report to Congress on how electronic health records (EHRs) can be used to strengthen clinical integration and improve patient care.  Adoption of EHRs remains low among behavioral health providers. The chapter provides an overview of MACPAC’s work to date on clinical integration for behavioral and  physical health services, and discusses how data-sharing can improve the quality of care for beneficiaries with behavioral health conditions. It concludes by identifying ways to strengthen EHR uptake among Medicaid’s behavioral health providers.

Next, Commissioners reviewed a draft chapter on non-emergency medical transportation (NEMT). In recent years, policymakers at the state and federal levels have begun to re-examine this benefit. As part of a congressionally mandated request, MACPAC conducted a multi-pronged study of NEMT that will be published as a chapter in the June 2021 report to Congress. This presentation included the key findings of MACPAC’s study and an overview of the topics covered in the draft chapter.

On Friday, the day kicked off with a discussion of the challenges that states face in providing more care through home- and community-based services (HCBS). As of fiscal year (FY) 2018, HCBS spending as a percentage of long-term services and supports spending remained under 50 percent in 18 states and the District of Columbia. To understand why some states have made less progress in rebalancing, MACPAC contracted with RTI International and the Center for Healthcare Strategies. This presentation summarized the results of the work, as well as proposed policy considerations.

The Commission then heard a staff presentation on key Medicaid and CHIP managed care quality requirements, as well as quality improvement and measurement activities conducted by states, plans, and the Centers for Medicare & Medicaid Services. Staff also provided a summary of preliminary findings on state performance over time on selected core set measures and managed care plan performance on performance improvement projects, which suggest the effectiveness of these efforts is unclear. Staff and Commissioners identified potential areas for future MACPAC work related to quality of care in Medicaid and CHIP.

After the Commission voted on several recommendations, staff provided an update on the current state of Transformed Medicaid Statistical Information System (T-MSIS) data submissions and MACPAC’s work to validate and analyze the data. MACPAC found that data submissions have improved since 2016, but some challenges remain.

The meeting concluded with a panel discussion about Medicaid’s use of telehealth services, which expanded during the COVID-19 pandemic. Commissioners heard from Chethan Bachireddy, chief medical officer for the Virginia Department of Medical Assistance Services; Tracy Johnson, Medicaid director for the Colorado Department of Health Care Policy and Financing; and Sara Salek, chief medical officer for the Arizona Health Care Cost Containment System. Panelists described the use of telehealth during the pandemic, considerations for post-pandemic telehealth policies, and challenges to the use and adoption of telehealth in Medicaid and how these states are addressing them.

*All recommendations were approved as presented in draft.

Supporting the discussion were the following briefing papers:

  1. High-Cost Specialty Drugs Review of Draft Chapter and Recommendations
  2. Strategies for State Contracts with Dual Eligible Special Needs Plans
  3. Access to Mental Health Services for Adults: Draft Chapter and Recommendations
  4. Access to Behavioral Health Services for Children and Adolescents: Draft Chapter and Recommendations
  5. Electronic Health Records as a Tool for Integration of Behavioral Health Services
  6. Mandated Report: Non-Emergency Medical Transportation Benefit
  7. Progress on Rebalancing: Lessons from States
  8. Ensuring Medicaid and CHIP Quality
  9. Update on Transformed Medicaid Statistical Information System (T-MSIS)
  10. Panel Discussion: What States are Learning from Expanded Use of Telehealth

Because they serve so many Medicaid and CHIP patients – more than the typical hospital – MACPAC’s deliberations are especially important to private safety-net hospitals.

MACPAC is a non-partisan legislative branch agency that provides policy and data analysis and makes recommendations to Congress, the Secretary of the U.S. Department  of Health and Human Services, and the states on a wide variety of issues affecting Medicaid and the State Children’s Health Insurance Program.  Find its web site here.

Medicaid Work Requirements on the Way Out?

Medicaid work requirements appear to be going away in the wake of the Supreme Court agreeing to a Biden administration request to postpone arguments in a case brought by the Trump administration seeking to reverse previous court rulings blocking implementation of such requirements.

To date, 12 states have received federal approval to implement Medicaid work requirements although only one such effort, in Arkansas, ever got off the ground.  All of the efforts eventually stalled in the face of legal challenges and administrative obstacles.  Upon taking office, the Biden administration informed the 12 states that it was considering withdrawing their approvals to proceed, and now, the Justice Department has told the Supreme Court that the administration will be reversing the approvals and asked the court not to hear arguments to enable those states to proceed.  As a result, the Supreme Court canceled oral arguments for the case that were scheduled for later this month.

NASH has long been skeptical about Medicaid work requirements, concerned that safety-net hospitals could be left with large amounts of uncompensated care provided to former Medicaid patients who have lost their eligibility for benefits under Medicaid work requirements.

Learn more about the latest development in the long-running effort to introduce Medicaid work requirements – and the almost-as-long campaign to prevent such requirements – in the Healthcare Dive article “SCOTUS drops Medicaid work requirement arguments at Biden administration’s request.”

2019 Change in Public Charge Rule to Disappear

Shortly after taking office the Biden administration stopped enforcing 2019 changes in the so-called public charge rule and now the Supreme Court has agreed to a Justice Department request to dismiss an upcoming case challenging that rule.

The public charge rule, as updated in 2019, calls for all legal immigrants enrolled in Medicaid and certain other safety-net programs to be designated public charges and denied access to permanent U.S. residency and green card status.  Hospitals – including private safety-net hospitals and the National Association of Safety-Net Hospitals – feared that the revised rule would have a chilling effect on the willingness of some legal citizens and legal non-citizens to seek out government health care programs for which they legally qualify.  This, they feared, could lead to many low-income legal citizens and non-citizens choosing not to seek the care to which they are entitled by law and ignoring serious illnesses and injuries until they become a crisis.  This could lead to continuing health problems for such individuals and a potential surge of uncompensated care for the safety-net hospitals to which such individuals turn when their medical conditions absolutely require medical attention – a surge that could jeopardize jobs at those hospitals and access to care in the generally low-income communities safety-net hospitals serve.

Between this action by the Justice Department and the Supreme Court agreement not to hear the case, it appears that the next step will be for the administration, which has already directed its agencies to review such regulations, either to revise or rescind the 2019 changes in the public charge rule.

NASH expressed its opposition to the 2019 changes in the public charge rule on several occasions, including in this letter to the Department of Homeland Security when the changes were proposed and in this 2019 position statement.

Learn more about the public charge rule and recent actions affecting it in the article “Supreme Court agrees to dismiss challenge to Trump public charge rule,” from the online publication The Hill.

Administration to Review Public Charge Rule

President Biden has ordered a review of the federal public charge rule.

The controversial rule, which would limit immigration to the U.S. for people who might at some point become dependent on public aid programs, has been the subject of litigation since it was proposed in 2019.

The White House executive order directs

…the Secretary of State, the Attorney General, the Secretary of Homeland Security, and the heads of other relevant agencies, as appropriate…[to] review all agency actions related to implementation of the public charge ground of inadmissibility…

The officials were ordered to report their findings to the president within 60 days.

The public charge rule authorizes the U.S. Citizenship and Immigration Services to deny a green card to any immigrant who receives certain public benefits – such as food stamps, public housing vouchers, welfare, or Medicaid – for more than 12 months within any three-year period.  The expressed purpose of the rule is to deny green cards to individuals who may become dependent on publicly funded services – a so-called “public charge.”

Health care advocates feared the rule would discourage some immigrants to whom the rule does not even apply from seeking to participate in certain public aid programs and even encourage some to whom the rule does not apply to disenroll from the public aid programs, such as Medicaid, in which they are already legally enrolled.

NASH has expressed its opposition to the public charge rule on a number of occasions, including in this position statement.

Implementation of the rule, which was proposed in 2019 and took effect in September of last year, was delayed in November by a federal court.

Learn more about the administration’s latest action in this presidential executive order.

MACPAC Meets

The Medicaid and CHIP Payment and Access Commission met for two days last week in Washington, D.C.

The following is MACPAC’s own summary of the sessions.

The October 2020 MACPAC meeting opened with a panel discussion on restarting Medicaid eligibility redeterminations when the public health emergency ends.  It included Jennifer Wagner, director of Medicaid eligibility and enrollment at the Center on Budget and Policy Priorities; René Mollow, deputy director for health care benefits and eligibility at the California Department of Health Care Services; and Lee Guice, director of policy and operations at the Department for Medicaid Services, Kentucky Cabinet for Health and Family Services.

After a break, Commissioners heard a panel discussion with Kevin Prindiville, executive director at Justice in Aging; Mark Miller, executive vice president of healthcare at Arnold Ventures; and Charlene Frizzera, senior advisor at Leavitt Partners, on creating a new program for dually eligible beneficiaries. Later, staff presented preliminary findings from a mandated report on non-emergency medical transportation. The day concluded with a report on nursing facility acuity adjustment methods.

On Friday, the day began with a session on access to mental health services for adults in Medicaid. It was followed by a related panel discussion on mental health services with Sandra Wilkniss, director of complex care policy and senior fellow at Families USA; Melisa Byrd, senior deputy director for the District of Columbia Department of Health Care Finance; and Dorn Schuffman, director of the CCBHC Demonstration Project at the Missouri Department of Mental Health.

Next, the Commission considered the merits of extending Medicaid coverage for pregnant women beyond 60 days postpartum. Staff then provided an update on a statutorily required analysis of disproportionate share hospital (DSH) allotments, as well as an analysis of addressing high-cost drugs and the challenges they present to Medicaid.

The meeting concluded with comment on the Secretary’s report to Congress on Reducing Barriers to Furnishing Substance Use Disorder (SUD) Services Using Telehealth and Remote Patient Monitoring for Pediatric Populations under Medicaid. The Commission decided to send a letter to Congress and the Secretary commenting on this report.

Supporting the discussion were the following briefing papers:

  1. Mandated Report on Non-Emergency Medical Transportation: Work Plan and Preliminary Findings
  2. Changes in Nursing Facility Acuity Adjustment Methods
  3. Access to Mental Health Services for Adults in Medicaid
  4. Considerations in Extending Postpartum Coverage
  5. Required Annual Analysis of Disproportionate Share Hospital (DSH) Allotments
  6. Addressing High-Cost Drugs and Pipeline Analysis
  7. Comment on Secretary’s Report to Congress on Reducing Barriers to Substance Use Disorder Services Using Telehealth for Pediatric Populations under Medicaid

Because they serve so many Medicaid and CHIP patients – more than the typical hospital – MACPAC’s deliberations are especially important to private safety-net hospitals.

MACPAC is a non-partisan legislative branch agency that provides policy and data analysis and makes recommendations to Congress, the Secretary of the U.S. Department  of Health and Human Services, and the states on a wide variety of issues affecting Medicaid and the State Children’s Health Insurance Program.  Find its web site here.

MFAR is Dead

At least for now.

The controversial Medicaid Fiscal Accountability Regulation, slated for implementation this fall over the objections of many health care stakeholders, will not move forward at this time.

In a tweet earlier this week, Centers for Medicare & Medicaid Services Administrator Seema Verma wrote that

We’ve listened closely to concerns that have been raised by our state and provider partners about potential unintended consequences of the proposed rule, which require further study.  Therefore, CMS is withdrawing the rule from the regulatory agenda.

If implemented, opponents maintained, the regulation would have:

  • Deprived states of important, established policy-making prerogatives.
  • Created major new administrative burdens for state governments and hospitals.
  • Inappropriately regulated financing of the state share of Medicaid spending.
  • Introduced new, unspecified standards for state Medicaid programs.

While CMS maintained that MFAR would have enhanced the transparency of state Medicaid programs, the rule’s opponents maintained that it could lead to a major reduction of resources for serving the Medicaid population.

NASH was among those opponents, arguing that the regulation could have hurt private safety-net hospitals and others that serve low-income communities by inappropriately regulating how states can finance their Medicaid programs.  CMS proposed the rule last November and  submitted formal comments expressing its opposition in January and endorsed legislation to prohibit the rule’s implementation in July.

It is worth noting that in “withdrawing the rule from the regulatory agenda,” Verma did not preclude the possibility of reintroducing MFAR at some point in the future.

Learn more from article “Trump administration backing off Medicaid rule that states warned would lead to cuts” in the online publication The Hill.

 

CMS Provides Guidance on Medicaid DSH Calculations

State Medicaid program accounting for hospital uncompensated care when calculating hospital-specific Medicaid disproportionate share limits is the subject of new guidance from the Centers for Medicare & Medicaid Services.

In the guidance, the Centers for Medicare & Medicaid Services explains that because of several court rulings, states can decide for themselves whether to offset third-party payer payments from costs in their Medicaid DSH calculations for periods prior to June 2, 2017 but that beginning with that date,  CMS will enforce its own interpretation of the policy.

In new guidance, CMS presents two methodologies for accounting for its mid-year policy change and reminds stakeholders about its new methodology for calculations after June 2, 2017.  Learn more from this Medicaid notice and from its accompanying CMS informational bulletin “Treatment of Third Party Payers (TPP) in Calculating Uncompensated Care Costs (UCC).”