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Federal Health Policy Update for Thursday, January 13

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, January 13.  Some of the language used below is taken directly from government documents.

Supreme Court

  • The Supreme Court has ruled that the administration’s vaccine mandate for health care workers will remain in effect while the mandate is challenged in the lower courts.  See the court’s ruling here.

White House

  • The White House has announced new efforts to protect children from COVID-19 and keep schools open.  The new measures include:
    • Sending more point-of-care and lab-based PCR tests to schools.
    • Deploying federal surge testing units at community testing sites to support free testing access for students, school staff, and families.
    • Connecting schools with COVID-19 testing providers to set up school testing programs.
    • Providing new training, resources, and materials.

Learn more from this White House fact sheet.

Medicare Payment Advisory Commission

MedPAC met today and voted on its recommendations for Medicare payment updates for the next fiscal year.  The recommendations adopted by the MedPAC commissioners are:

  • hospital inpatient payments – a 2.5 percent increase
  • hospital outpatient payments – a 2.0 percent increase
  • long-term-care hospital payments – a market basket increase and a productivity adjustment that together amount to an effective increase of approximately 2.0 percent
  • independent rehabilitation facility payments – a 5.0 percent reduction
  • skilled nursing facilities – a 5.0 percent reduction
  • home health services – a 5.0 percent reduction
  • physicians and primary care – an update in line with current law and retention of the 5.0 percent bonus opportunity for participations in alternative payment models
  • ambulatory surgery centers – a 2.0 percent increase and requirement that such facilities be required to file cost reports
  • hospice – an update in line with statute and to lower the aggregate cap 20 percent

MedPAC’s recommendations are advisory only and, while generally respected, are not binding on the administration and CMS.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy Update

  • CMS has released a proposed National Coverage Determination (NCD) decision memorandum explaining that it will cover FDA-approved monoclonal antibodies for the treatment of Alzheimer’s disease only through coverage with evidence development, which means that FDA-approved drugs in this class would be covered for people with Medicare only if they are enrolled in qualifying clinical trials.  The policy’s most immediate application will be to limit Medicare coverage for the new Alzheimer’s drug Aduhelm (aducanumab).  Learn more about this policy in this CMS news release and the decision memorandum.  Interested parties have 30 days to submit written comments and CMS says it will announce its final decision by April 11.
  • CMS has posted the latest edition of MLN Connects, its online newsletter with information about Medicare reimbursement issues.  This edition includes articles about new guidance for safe nursing home visitation, vaccine access in long-term-care facilities, a new billing code for administering remdesivir in outpatient settings, the application process for new medical residency slots, and more.  Learn more in the latest edition of MLN Connects.
  • CMS’s Center for Medicare and Medicaid Innovation has posted the final annual reports for phase two of its initiative to reduce avoidable hospitalizations among nursing facility residents.  Go here to learn more about the program and find those annual reports.

Centers for Disease Control and Prevention

Food and Drug Administration

Stakeholder Events

MedPAC – January 14

The Medicare Payment Advisory Commission (MedPAC) will hold its next public meeting on January 14.  Go here for a meeting agenda and information about virtual participation.

CMS – January 18

CMS administrator Chiquita Brooks-LaSure and her leadership team will hold a national stakeholder call on Tuesday, January 18 during which they will review their key 2021 accomplishments and share their goals for 2022.  Go here to register to join the call.

MACPAC – January 20-21

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its next public meeting on January 20 and 21.  Go here for a meeting agenda and information about registering for the virtual meeting.

 

Federal Health Policy Update for Thursday, January 6

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, January 6.  Some of the language used below is taken directly from government documents.

Provider Relief Fund

The White House

Department of Health and Human Services

COVID-19 Hospital Data Reporting Requirements

  • HHS has written to health care providers to inform them of changes in its COVID-19 hospital data reporting requirements guidance; it has suspended reporting on some data elements and added some new ones.  The letter summarizes the changes, lists dates and times for webinars to learn about and ask questions about the changes, and offers telephone numbers and emails for support.  Find the letter here and find the revised reporting requirements here; changes in those requirements are highlighted.  HHS provided a preview of these changes to state officials; find its presentation to the states here.

COVID-19

  • HHS has amended a past COVID-19-related emergency declaration to authorize licensed pharmacists and pharmacy interns in good standing to order and administer flu vaccines in states in which they are not currently licensed and for such individuals to have liability protection under the Public Readiness and Emergency Preparedness (PREP) Act.  See the amended order in this Federal Register notice.

Health Policy Update

  • HHS’s Health Services and Resources Administration (HRSA) offers a number of funding opportunities with application deadlines in the coming weeks.  Go here to learn more about the various programs, what they offer, who can apply, and when applications are due.

Centers for Medicare & Medicaid Services

Health Policy Update

  • CMS has issued guidance to states and health insurers on state external review processes regarding requirements in the No Surprises Act, the federal surprise medical billing law that took effect on January 1.  See that guidance here.
  • CMS has published the latest edition of MLN Connects, its online newsletter with information about Medicare reimbursement issues.  The new issue includes items about changes in how Medicare Advantage plans will submit claims for monoclonal antibody treatments, the updated ambulatory surgical system payment system, a revised enrollment application for Medicare-covered opioid treatment, and more.  Go here to see the latest edition of MLN Connects.
  • CMS is seeking nominations for individuals to serve on several of its technical panels:  its technical expert panel for the Measurement Gaps and Measure Development Priorities for the Skilled Nursing Facility Value-Based Purchasing Program; for the CMS Quality Measure Development Plan and Quality Measure Index; and for its Dialysis Facility Quality of Patient Care Star Ratings Technical Expert Panel.  All of the nominations are due in the next few weeks.  Go here for further information about the individual panels, project summaries, and nomination criteria and deadlines.

Centers for Disease Control and Prevention

  • The CDC has updated its recommendation for when many people should receive a booster shot, shortening the interval from six months to five months for people who received the Pfizer vaccine.  This means that people can now receive an mRNA booster shot (Pfizer or Moderna) five months after completing their Pfizer primary series.  The booster interval recommendation for people who received the Johnson and Johnson vaccine (two months) and the Moderna vaccine (six months) has not changed.  Learn more from this CDC news release.
  • The CDC has endorsed its Advisory Committee on Immunization Practices’ recommendation to expand eligibility of booster doses to those 12 to 15 years old.  The CDC now recommends that adolescents ages 12 to 17 years old should receive a booster shot five months after their initial Pfizer vaccination series.  Find that announcement here.
  • The CDC now recommends that moderately or severely immunocompromised children between five and 11 years of age receive an additional primary dose of vaccine 28 days after their second shot.  At this time, the CDC has authorized only the Pfizer vaccine for this age group.  Learn more from the same CDC news release.
  • The CDC has updated its general guidance on COVID-19 vaccines and boosters for people who are moderately or severely immunocompromised.
  • The CDC has posted an explanation of why it has shortened its isolation and quarantine recommendations for individuals who are asymptomatic and mildly ill with COVID-19.  See the explanation here and the revised recommendations here.
  • The CDC has updated its overview and safety information about the Pfizer COVID-19 vaccine.
  • The CDC has updated its guidance on when people should be tested for COVID-19, when they do not need to be tested, and what they should do based on the results of such tests.
  • The CDC has published research on severe outcomes from COVID-19 among people who completed a primary vaccination regimen.  The research found that risk factors for severe outcomes included age 65 years or older, an immunosuppressed state, and six other underlying conditions.  All persons with severe outcomes had at least one risk factor; 78 percent of persons who died had at least four.  Go here to see the CDC’s report.

Food and Drug Administration

  • The FDA has approved an abbreviated new drug application for albuterol sulfate inhalation solution, which is used for the relief of bronchospasm in patients two to 12 years of age with asthma.  This preparation is sometimes used in the treatment of COVID-19.  See the FDA announcement of this approval here and technical information about albuterol sulfate here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • The Government Accountability Office (GAO) is now accepting nominations for individuals to serve as MACPAC commissioners.  Learn more from this Federal Register notice.  Nominations are due by January 27.
  • MACPAC has published the new issue brief “Medical Loss Ratios in Medicaid Managed Care,” which provides an overview of federal capitation rate setting standards and specific guidance regarding the medical loss ratio for Medicaid managed care plans and describes variations among the states that employ Medicaid managed care.  Find it here.

Stakeholder Events

MedPAC – January 13-14

The Medicare Payment Advisory Commission (MedPAC) will hold its next public meeting on January 13 and 14.  Watch this space for a meeting agenda and information about virtual participation.

MACPAC – January 20-21

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its next public meeting on January 20 and 21.  Watch this space for a meeting agenda and information about virtual participation.

 

Federal Health Policy Update for Thursday, December 16

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, December 16.  Some of the language used below is taken directly from government documents.

Provider Relief Fund

  • HHS’s Health Resources and Services Administration (HRSA) is releasing $9 billion in phase 4 Provider Relief Fund grants.  Payments will average $58,000 for what HHS is calling “small” providers, $289,000 for medium providers, and $1.7 million for large providers.  Learn more about the release of these funds from this HHS news release and go here for an explanation of how the agency calculated the payments.  The remainder of Phase 4 funding is expected to be distributed in January.
  • HRSA has updated its FAQ for its provider relief programs:  the Provider Relief Fund and American Rescue Plan rural payments.  The updated FAQ includes new information about reporting on mergers and acquisitions, reporting patient metrics, reporting on state and federal tax credits, and more.  The 12 new and modified questions, all dated 12/9/2021, can be found on pages 3, 10, 14, 15, 18, 34, and 36 of the updated Provider Relief Fund FAQ.

The White House

  • The Biden administration has issued an executive order on “Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government.”  The portion of the executive order that addresses health care directs the Secretary of Health and Human Services to:
    • continue to design and deliver new, personalized online tools and expanded customer support options for Medicare enrollees;
    • strengthen requirements for maternal health quality measurement, including measuring perinatal quality and patient care experiences, and evaluating the measurements by race and ethnicity to aim to better identify inequities in maternal health care delivery and outcomes;
      to the maximum extent permitted by law, support coordination between benefit programs to ensure applicants and beneficiaries in one program are automatically enrolled in other programs for which they are eligible;
    • to the maximum extent permitted by law, support streamlining State enrollment and renewal processes and removing barriers, including by eliminating face-to-face interview requirements and requiring prepopulated electronic renewal forms, to ensure eligible individuals are automatically enrolled in and retain access to critical benefit programs;
    • develop guidance for entities regulated pursuant to the Health Insurance Portability and Accountability Act (HIPAA) on providing telehealth in compliance with HIPAA rules, to improve patient experience and convenience following the end of the COVID-19 public health emergency;
    • test methods to automate patient access to electronic prenatal, birth, and postpartum health records (including lab results, genetic tests, ultrasound images, and clinical notes) to improve patient experiences in maternity care, health outcomes, and equity.
  • The White House has posted transcripts of December 10 and December 15 briefings given by its COVID-19 response team and public officials.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has updated its COVID-19 Medicare provider enrollment relief FAQ.  Find the updated FAQ here.  These updates are intended in part to assist both new providers and those that have temporarily expanded their facilities.

Health Policy Update

  • CMS has published a new edition of MLN Connects, its online newsletter of information about Medicare payments.  The latest edition includes articles about the two percent Medicare sequester that Congress recently delayed, changes in Medicare Advantage monoclonal antibody claims that take effect on January 1, changes in telehealth fees for originating sites, payments for opioid treatments, and more.  Go here to see the latest edition of MLN Connects.
  • CMS has sent a letter to state Medicaid directors to help them understand new requirements related to the Consolidated Appropriations Act of 2021, which established new requirements for state Medicaid programs, including new reporting requirements for non-disproportionate share hospitals (Medicaid DSH) supplemental payments and a change in the methodology for calculating the hospital-specific DSH limit.   Find that letter here.
  • CMS has sent a letter to state Medicaid directors urging them to encourage hospitals to consider implementation of evidence-based best practices for the management of obstetric emergencies, along with interventions to address other key contributors to maternal health disparities, to support the delivery of equitable, high-quality care for all pregnant and postpartum individuals.  The letter reminds Medicaid directors that beginning with October 1, 2021 discharges, CMS adopted a new structural quality measure for the Hospital Inpatient Quality Reporting (IQR) Program that asks hospitals to attest to whether they participate in a state-wide and/or national maternal safety quality collaborative and whether they have implemented patient safety practices or bundles to improve maternal outcomes.  Find the CMS letter here.  CMS has reinforced this message with this news release.

Department of Health and Human Services

Health Policy Update

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has published a discussion paper about 3D printing medical devices at the point of care, such as hospitals and doctors’ offices.  The purpose of the paper is to gather feedback from the public to inform future policy development.  Find the FDA announcement here and the discussion paper here.  The deadline for submitting comments is February 8.

National Institutes of Health

  • The percentage of adolescents reporting substance use decreased significantly in 2021, according to the latest results from the NIH’s “Monitoring the Future” survey of substance use behaviors and related attitudes among eighth, 10th, and 12th graders in the United States.  In line with continued long-term declines in the use of many illicit substances among adolescents previously reported by the Monitoring the Future survey, these findings represent the largest one-year decrease in overall illicit drug use reported since the survey began in 1975.   Learn more from this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • Members of the Medicare Payment Advisory Commission met virtually last week.  Among the subjects MedPAC commissioners and staff discussed were hospital inpatient services, hospital outpatient services, physician services, ambulatory surgical center services, outpatient dialysis, hospice care, skilled nursing facilities, home health, inpatient rehabilitation facilities, and long-term-care hospitals.  Go here to find the meeting presentations on these subjects and go here to see a transcript of the meetings.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • Members of the Medicaid and CHIP Payment and Access Commission met virtually last week.  Among the subjects MACPAC commissioners and staff discussed were directed payments in Medicaid managed care, “money follows the person” program residency criteria, monitoring access to care for Medicaid beneficiaries, behavioral health services, health equity, and nursing facility staffing issues.  For a summary of the meeting and links to the presentations made during the two days of meetings, go here.
  • MACPAC has released the 2021 edition of the MACStats:  Medicaid and CHIP Data Book, with updated data on national and state Medicaid CHIP enrollment, spending, benefits, and beneficiaries’ health, service use, and access to care.  Find this year’s data book here.

Government Accountability Office (GAO)

  • The CARES Act, the Consolidated Appropriations Act of 2021, and the American Rescue Plan all appropriate funds to address behavioral health challenges created by the COVID-19 pandemic and the CARES Act requires the GAO to report on the challenges these funds are addressing and the effect they are having.  The GAO’s findings can be found in its new report “Behavioral Health and COVID-19:  Higher Risk Populations and Related Federal Relief Fund.  Find a summary of the report here and the full report here.

Federal Health Policy Update for Monday, December 6

The following is the latest health policy news from the federal government as of 2:45 p.m. on Monday, December 6.  Some of the language used below is taken directly from government documents.

NASH Advocacy

  • NASH has submitted formal comments to the Department of Health and Human Services, Department of Labor, Department of the Treasury, and federal Office of Personnel Management in response to those agencies’ publication of a second regulation describing how the No Surprises Act will be implemented. In its letter NASH focuses on problems with the manner in which providers will be required to prepare good-faith estimates for those seeking care without benefit of insurance, the regulation’s Independent Dispute Resolution process, and the manner in which the regulation addresses resolving fee disputes between providers and patients.  NASH raises concerns about all of these processes, suggests better approaches to addressing them, and asks the federal agencies to suspend enforcement of the new requirements while they consider ways to improve the current approach to implementing the surprise billing law that was enacted late last year.  Go here to read NASH’s comment letter.

The White House

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has announced that it will require states to cover COVID-19 vaccine counseling during which health care providers talk to families about the importance of vaccines for children. Under this policy CMS will now consider certain COVID-19 vaccine counseling visits for children and youth to be COVID-19 vaccine administration for which state expenditures can be federally matched at 100 percent through the last day of the first quarter that begins one year after the end of the COVID-19 public health emergency.  CMS will match COVID-19 vaccine counseling-only visits at the 100 percent federal match rate only when they are provided to children and youth under age 21 as part of the Medicaid Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit.  Learn more from this CMS news release.
  • CMS has announced a series of steps it will take to encourage Medicare beneficiaries to receive COVID-19 vaccines. Read about these steps in this CMS news release.

Health Policy Update

Department of Health and Human Services

Health Policy Update

  • A new HHS report found a significant increase in the use of telehealth during the COVID-19 pandemic, with specialists like behavioral health providers seeing the highest telehealth utilization relative to other providers. The report found that the share of Medicare visits conducted through telehealth in 2020 increased 63-fold, from approximately 840,000 in 2019 to 52.7 million.  States with the highest use of telehealth in 2020 included Massachusetts, Vermont, Rhode Island, New Hampshire, and Connecticut while states with the lowest use of telehealth that year were Tennessee, Nebraska, Kansas, North Dakota, and Wyoming. The report also identified trends in the kinds of services Medicare beneficiaries sought through telehealth.  Learn more from this HHS news release and go here to see the report itself.

Centers for Disease Control and Prevention

Food and Drug Administration

Stakeholder Events

CMS – Open Door Forum on No Surprises Act – December 8

CMS will host an open door forum to discuss provider requirements under the No Surprises Act on Wednesday, December 8 at 2:00 p.m. (eastern).  The forum will be held by conference call only and interested parties can dial into the event at 1-888-455-1397; the conference ID is 8604468.

Center for Medicare and Medicaid Innovation – Roundtable on Health Equity Strategy – December 8

CMMI will hold a roundtable event on Wednesday, December 8 at 1:30 p.m. (eastern) to discuss how it can carry out its strategic objective of advancing health equity.  The agency also invites written comments on the subject.  For further information about the roundtable and to register to participate, go here.

CDC – Molecular Approaches for Clinical and Public Health Applications to Detect Influenza and COVID-19 Viruses – December 9

The CDC will hold a webinar on Thursday, December 9 to share with clinicians information about molecular approaches for clinical and public health applications to detect the influenza virus and COVID-19.  Go here to learn more about the webinar and how to participate.

MEDPAC – commission meeting – December 9-10

Members of the Medicare Payment Advisory Committee will meet virtually on December 9 and 10.  The two days of meetings will consist of four separate sessions.  For agendas for those sessions and information on how to register to participate, go here.

MACPAC – commission meeting – December 9-10

Members of the Medicaid and CHIP Payment and Access Commission will meet virtually on December 9 and 10.  To see the meeting agenda and register to participate, go here.

Federal Health Policy Update for Wednesday, December 1

The following is the latest health policy news from the federal government as of 3:00 p.m. on Wednesday, December 1.  Some of the language used below is taken directly from government documents.

Omicron Variant

  • The CDC has confirmed the first case of the COVID-19 omicron variant on U.S. soil.  Learn more from this CDC news release.

Health Care Employee Vaccine Mandate

COVID-19

  • A federal court has issued a preliminary injunction blocking enforcement of the federal government’s requirement that health care workers receive COVID-19 vaccines by December 6.  Find the court’s ruling here.  The ultimate ruling will be made by a higher court.

No Surprises Act

  • CMS has released a series of documents addressing implementation of the No Surprises Act, the surprise medical billing law that takes effect on January 1.  Go here for a link to a zip file of those documents.
  • A reminder:  stakeholder comments on the most recent regulation implementing the No Surprises Act are due this coming Monday, December 6,

The White House

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has issued guidance to inform Medicare Part D sponsors of permissible flexibilities during the COVID-19 public health emergency related to oral antiviral drug(s) for COVID-19 if such drug(s) become available under FDA emergency use authorization and are procured by the federal government.  Find that guidance here.
  • CMS has updated its compendium of Medicare emergency declaration blanket waivers for health care providers with two changes:  one, on page 21, addresses requirements for individuals employed as directors of food and nutrition services in long-term-care facilities and another, on page 33, alters Medicare ground ambulance data collection reporting requirements.  Find the revised blanket waivers document here.

Health Policy Update

  • CMS has published a request for public comments on potential changes in the requirements that transplant programs, organ procurement organizations, and end-stage renal disease facilities must meet to participate in the Medicare and Medicaid programs.  Learn more about what CMS seeks in this Federal Register notice.  Stakeholder comments are due in 60 days.
  • CMS has announced that it will not move forward with the Seriously Ill Population component of its Primary Care First Model.  That component was designed to have advanced primary care practices coordinate care for high-need, seriously ill beneficiaries.  After review, CMS concluded that the program’s outreach methodology was unlikely to result in sufficient beneficiary participation to allow for model evaluation.  Learn more from this CMS announcement.
  • CMS has published two documents addressing Medicaid and CHIP in the post-COVID-19 world:  “Strategies States and the U.S. Territories Can Adopt to Maintain Coverage of Eligible Individuals as They Return to Normal Operations” and “Connecting Kids to Coverage: State Outreach, Enrollment and Retention Strategies.”
  • CMS has posted the latest edition of MLN Connects, its online publication addressing Medicare payment matters.  This edition includes items on new 2022 web pricers for inpatient prospective payment system hospitals, inpatient rehabilitation facilities, and long-term-care hospitals; information about the 2022 physician fee schedule rule; news about telehealth originating site facility payments; information about disproportionate share hospital (DSH) payments; and more.  Go here for the new MLN Connects.

Department of Health and Human Services

Health Policy Update

  • HHS has launched a website for the HHS 405(d) Aligning Health Care Industry Security Approaches Program.  The purpose of the site is to provide the health care and public health sectors “…with useful, impactful, and vetted resources, products, videos, and tools that help raise awareness and provide cybersecurity practices, which drive behavioral change and move toward consistency in mitigating the most relevant cybersecurity threats to the sector.”  The website features health care-focused resources such as cybersecurity posters and infographics, installments of a bi-monthly newsletter, webinar recordings, and threat-specific products to support cybersecurity awareness and training.  Learn more from this HHS news release and go here to find the new site.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has updated its guidance on the use of the monoclonal antibodies amlanivimab and etesevimab when administered together, expanding their authorized use to all U.S. states and territories.  Find that guidance here.
  • The FDA has issued emergency use authorization for the emergency use of the unapproved monoclonal antibody product sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct COVID-19 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death.  Go here for an FDA fact sheet on the drug’s use.
  • The FDA has issued a statement outlining its efforts to investigate and address the potential impact of the COVID-19 omicron variant.  Find that statement here.

Stakeholder Events

CMMI – The Value-Based Insurance Design Health Equity Business Case for Medicare Advantage Organizations – December 2

The Center for Medicare and Medicaid Innovation (CMMI) is sponsoring a series of webinars for current and potential Medicare Advantage Organization participants in its Value-Based Insurance Design Model.  The first webinar in the series will provide an overview of the model’s health equity incubation sessions effort, articulate a business case for Medicare Advantage organizations to leverage Value-Based Insurance Design Model components to address health inequities in their member populations, and provide specific guidance and clarification on the full extent of health equity-focused flexibilities that fall under the model’s waiver authority.  The first webinar will be held on Thursday, December 2 at 2:30 p.m. (eastern).  Go here for more information about the webinar and to register to participate.

Center for Medicare and Medicaid Innovation – Roundtable on Health Equity Strategy – December 8

CMMI will hold a roundtable event on Wednesday, December 8 at 1:30 p.m. (eastern) to discuss how it can carry out its strategic objective of advancing health equity.  The agency also invites written comments on the subject.  For further information about the roundtable and to register to participate, go here.

CDC – Molecular Approaches for Clinical and Public Health Applications to Detect Influenza and COVID-19 Viruses – December 9

The CDC will hold a webinar on Thursday, December 9 to share with clinicians information about molecular approaches for clinical and public health applications to detect the influenza virus and COVID-19.  Go here to learn more about the webinar and how to participate.

MEDPAC – commission meeting – December 9-10

Members of the Medicare Payment Advisory Committee will meet virtually on December 9 and 10.  Information about how to join the meeting will be forthcoming; when it is, that information will be posted here.

MedPAC Looks at Outpatient Payments

The question of whether Medicare should pay different rates for outpatient services delivered in different types of settings was very much on the minds of Medicare Payment Advisory Commission members during their public meetings last week.

The issue has been around for a while:  are there valid reasons for some facilities to be paid more for certain outpatient services than other facilities?  Or should the payment rate for a given service be the same regardless of where that service is delivered?  Does the site of the service matter – or should it?

At issue are Medicare payments made to private physician offices, hospital outpatient departments, and ambulatory surgical centers and whether they should be adjusted based on some of the underlying costs associated with those facilities or the matter of who owns them – or whether a service is a service that should be reimbursed at the same rate regardless of where it is delivered.  Underlying this issue is whether providers should be compensated for such services through Medicare’s outpatient prospective payment system or its physician fee schedule.

It matters where MedPAC ultimately comes down on this issue.  While the agency’s primary role is to advise Congress on Medicare payment issues, its views are highly respected in health policy circles and often find their way into new public policies.

Learn more about the issues involved and what MedPAC commissioners think about them in the MedPage Today article “Should Medicare Pay the Same Amount Regardless of Where a Service Is Provided?

Federal Health Policy Update for Monday, October 25

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, October 25.  Some of the language used below is taken directly from government documents.

NASH Advocacy:  MedPAC and Safety-Net Hospitals

On the heels of a recent meeting of the Medicare Payment Advisory Commission (MedPAC) during which commission members discussed the challenges inherent in attempting to identify safety-net hospitals, NASH has written to the agency to suggest that it consider a different approach to addressing that matter.  In the letter, NASH suggests that MedPAC urge Medicare to look not at individual hospitals and what kinds of patients they serve but to focus instead on vulnerable communities and then to identify the hospitals that are caring for meaningful proportions of the residents of those communities.  Go here to see NASH’s letter to MedPAC.  In response to this letter, MedPAC scheduled a meeting with NASH to discuss this concept.

NASH Advocacy:  Surprise Billing Regulation

Representatives Suozzi (D-NY), Wenstrup (R-OH), Ruiz (D-CA), and Bucshon (R-IL) are leading a bi-partisan congressional sign-on letter to HHS Secretary Becerra and others, urging the administration to revise the Surprise Billing, Part II interim final rule’s (IFR) implementation of the independent dispute resolution (IDR) process.

The letter states that

…we urge you to revise the IFR to align with the law as written by specifying that the certified IDR entity should not default to the median in-network rate and should instead consider all of the factors outlined in the statute without disproportionately weighting one factor.

NASH is listed among the supporters of this letter.

Action required:  NASH members should contact their House members today to ask them to sign on to the Suozzi-Wenstrup-Ruiz-Bucshon letter to support the successful implementation of Congress’s surprise billing ban.  The deadline for representatives to sign onto the letter is this Friday, October 29.

If you would like more information about the letter or if you need contact information for your representatives, contact Kate Finkelstein.

Provider Relief Fund:  Deadline for Submission is Tuesday, October 26

  • The Health Resources and Services Administration (HRSA) will accept applications for $25.5 billion in health care relief funds until October 26.  Go here for further information.
  • HRSA has modified some of the terms for applying for assistanceAll applicants must complete the first step of the application process (i.e., submitting their Tax Identification Number (TIN) and associated information for Internal Revenue Service (IRS) validation no later than October 26, 2021 at 11:59 PM EST.  The required IRS validation that occurs after completion of the first step may take a few days.  If an applicant submits their TIN for validation by the October 26, 2021 deadline and that TIN is subsequently validated by the IRS, the applicant will have until November 3, 2021 at 11:59 PM EST to complete and submit their application.
  • The Provider Relief Fund FAQ has been updated with seven modified or new questions on pages 4, 9, 10 (two questions), 37, and 58 (two questions); all are dated 10/20/2021.  Entities that have received Provider Relief Funds in the past and/or intend to apply for Phase 4 funds should review these changes carefully.

The White House

  • In anticipation of the FDA’s independent advisory committee meeting on October 26 and the CDC’s independent advisory committee meeting on November 2-3, the administration has unveiled a plan to ensure that if a vaccine is authorized for children ages 5-11 it is quickly distributed and made conveniently and equitably available to families across the country.  Learn more from this White House fact sheet.
  • The White House has posted transcripts of the October 20 and October 22 press briefings given by its COVID-19 response team and public officials.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has issued guidance to states about the statutory requirement for them to cover COVID-19-related treatment without cost-sharing in Medicaid and CHIP for many seniors, low-income adults, pregnant women, children, and people with disabilities who receive health coverage through these programs.  This coverage includes care for conditions that could complicate the treatment of COVID-19 in patients who are presumed positive for the virus or have been diagnosed with COVID-19.  Find a news release about the guidance here and find the guidance itself here.
  • CMS has posted a new edition of MLN Connects, its online newsletter.  This latest edition includes features on new/modifications of the place of service codes for telehealth, a prescriber’s guide to Medicare prescription drug opioid policies, and more.  Go here to find these and other items.
  • In a separate, special edition of MLN Connects, CMS presents new Medicare rates and billing information for Moderna and Johnson & Johnson booster vaccines.
  • The CMS Innovation Center has published a document that shares its strategic direction for the coming years.  Driving Health System Transformation – A Strategy for the CMS Innovation Center’s Second Decade reviews the lessons the agency has learned over the past ten years and lays out its objectives for the next ten.  Find it here.
  • CMS’s Center for Medicare and Medicaid Innovation has posted the fourth evaluation report and performance year 5 (2020) financial and quality results for its Next Generation ACO Model.  Find the report by going here and scrolling down to “Performance Year 5 (2020 (XLS).”
  • CMS’s “Medicare & You” handbook is now available in Chinese, Korean, and Vietnamese.  Go here for the agency’s announcement and links to the new handbooks.

Department of Health and Human Services

Health Policy News

  • HHS is awarding $797.5 million in American Rescue Plan funding to support survivors of domestic violence and sexual assault and their children.  The funds will cover COVID-19 testing, vaccines, mobile health units, and other support for domestic violence services programs and increase support for sexual assault service providers and culturally specific services.  Learn more about the new spending and how it will be distributed in this HHS news release and additional program resources.
  • HHS proposes repealing two final rules:  “Department of Health and Human Services Good Guidance Practices,” published in the Federal Register on December 7, 2020; and “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions,” published in the Federal Register of January 14, 2021, maintaining that “…they create unnecessary hurdles that hinder the Department’s ability to issue guidance, bring enforcement actions, and take other appropriate actions that advance the Department’s mission.”  Learn more about the rules that would be repealed and HHS’s rationale for doing so in this Federal Register notice.

Centers for Disease Control and Prevention

  • The CDC has taken a series of actions to address COVID-19 booster vaccines, deciding that:
    • The use of a single booster dose of the Moderna COVID-19 vaccine that may be administered at least six months after completion of the primary series to individuals 65 years of age and older; 18 through 64 years of age at high risk of severe COVID-19; and 18 through 64 years of age with frequent institutional or occupational exposure to COVID-19.
    • The use of a single booster dose of the Johnson & Johnson vaccine may be administered at least two months after completion of the single-dose primary regimen to individuals 18 years of age and older.
    • Each of the available COVID-19 vaccines may be use as a booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.  This is now being referred to by many as “mixing and matching.”
    • A single booster dose of the Pfizer vaccine may be administered at least six months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to COVID-19.

Stakeholder Events

CDC – Information about Recent Updates to CDC’s Recommendations for COVID-19 Boosters – October 26

On Tuesday, October 26 the CDC will provide an overview for clinicians of the most recent recommendations for administering COVID-19 booster vaccines and updates about the latest recommendations and clinical considerations for administering those boosters.  Go here for further information about the webinar and how to participate.

CDC – Pediatric COVID-19 Vaccines – November 4

The CDC will hold a webinar on Thursday, November 4 to provide an overview of its recommendations and clinical considerations for administering COVID-19 vaccines to children between the ages of five and eleven years old.  Go here for further information about the webinar and how 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.

NASH Urges MedPAC to Reconsider “Safety-Net Hospital”

Following a recent meeting of the Medicare Payment Advisory Commission during which commission members discussed the challenges inherent in attempting to identify safety-net hospitals, NASH has written to the agency to suggest that it consider a different approach to targeting such hospitals.

In its letter, NASH urges MedPAC to recommend that Medicare look not at individual hospitals and what kinds of patients they serve but to focus instead on vulnerable communities and then to identify the hospitals that are caring for meaningful proportions of the residents of those communities.  NASH also points MedPAC to data that could be used in such an approach:  the “PLACES” data developed by the Centers for Disease Control and Prevention.

Such a change in approach, NASH writes in its letter, “…would lay a much-needed foundation for changes in the Medicare payment system that reduce barriers to access to care by making it more feasible for hospitals to serve vulnerable populations.”

Go here to see NASH’s letter to MedPAC.

Federal Health Policy Update for Thursday, September 9

The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, September 9.  Some of the language used below is taken directly from government documents.

The White House

Congress

  • Democrats on the House Energy and Commerce Committee today introduced their contribution to their party’s anticipated $3.5 trillion dollar spending bill.  Their portion of the reconciliation bill addresses expanding Medicaid in non-expansion states, reducing prescription drug prices, increasing federal spending on home-based care, and more.  Find their summary of their proposals here.

Provider Relief Fund

  • HHS’s Human Resources and Services Administration (HRSA) has published a notice explaining how Provider Relief Fund payments can be used for a wide variety of direct and indirect costs of recruiting and retaining personnel during the COVID-19 emergency.  Find the notice here.
  • With the next deadline for health care providers to report on their use of Provider Relief Fund grants coming up on September 30, HRSA will hold an “office hours” web event on Friday, September 10 at 1:00 (eastern) to address issues involving Provider Relief Fund reporting and auditing requirements.  For information about how to join the event and more about reporting and auditing requirements, go here.

Department of Health and Human Services

COVID-19

  • HHS Secretary Xavier Becerra has released a new plan to reduce prescription drug prices.  One of the key policies in this effort is legislation that would enable the Secretary of HHS to negotiate Medicare Part B and Part D drug prices directly with pharmaceutical companies and make those prices available to other purchasers.  Learn more about this plan from the HHS announcement, an HHS fact sheet, and the full plan.
  • The Office of the Assistant Secretary for Preparedness and Response has announced a new Notice of Funding Opportunity to establish Partnership(s) for Enhanced Efforts To Strengthen The Nation’s Healthcare And Public Health Preparedness, Response, And Recovery To Disasters And Other Emergencies.  This program seeks to fund up to seven new cooperative agreements to enable the agency’s broad collaboration with public health and health care sectors and emergency management services to ensure that local governments, communities, private sector entities, non-governmental organizations, academia, and individuals can optimally coordinate their respective national health security roles and responsibilities to achieve community health resilience and strengthen health care, public health, and emergency management systems in preparation of, response to, and recovery from disasters and other emergencies.  $20 million in grants will be awarded, with a maximum grant of $4 million.  The deadline for applications is September 22.
  • HHS’s Office of the Assistant Secretary for Planning and Readiness has updated its information on planning considerations for the administration of monoclonal antibodies.  Find the updated information here.
  • The Office of the Assistant Secretary for Planning and Readiness has published guidance to hospitals on how to address a surge of patients with behavioral health challenges during the COVID-19 pandemic.
  • HHS’s Office of the Inspector General has published a report that describes the complex care needs of beneficiaries hospitalized with COVID-19.  The report focuses on surges in COVID-19 hospitalizations in six localities and builds upon prior OIG work that describes the extent to which hospitals have been strained by COVID-19.  Find the report here.
  • Another report by HHS’s OIG found that the COVID-19 case and death data submitted by nursing homes to the federal government is incomplete and inaccurate despite CMS’s efforts to require such data reporting weekly.  Find the report here.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has posted two new editions of MLN Connects, its online newsletter.  Subjects addressed in the September 2 edition include changes in Medicare provider enrollment processes, information about CMS’s planned implementation of its ambulance prior authorization model, the hospice quality reporting program, and more.  Go here to see the September 2 edition of MLN Connects.
  • The September 9 edition of MLN Connects includes information about a payment update on outpatient clinic visit services at excepted off-campus provider-based departments, the Medicare fee-for-service response to the COVID-19 emergency, skilled nursing facility consolidated billing web-based training, and more.  Find the September 9 edition of MLN Connects here.
  • CMS is distributing $452 million in federal funding to support 13 states’ efforts to improve access to affordable, comprehensive health insurance coverage through section 1332 state-based reinsurance waivers.  As a result of changes made in the American Rescue Plan Act of 2021, residents in states implementing reinsurance waivers may have access to more affordable health insurance coverage.  States also will have more pass-through funding to implement their waiver.  Learn more about the funding, how it will be used, and which states will receive it in this HHS news release.
  • CMS’s Center for Medicare and Medicaid Innovation has posted the annual report for its Comprehensive Care for Joint Replacement Model.  Go here to see the annual report and here for more information about and resources for the program.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has revised its guidance on the authorized use of the monoclonal antibodies bamlanivimab and etesevimab when administered together.  The Emergency Use Authorization now authorizes the use of bamlanivimab and etesevimab, administered together, only in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to five percent.  The FDA has posted a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together are currently authorized and a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together, are not currently authorized and will periodically update both lists as new data becomes available.
  • The FDA has posted a letter to veterinarians and retailers informing them of the danger of treating people for COVID-19 with animal ivermectin.
  • The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on September 17 to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (booster) dose of the Pfizer vaccine to individuals 16 years of age and older.  Learn more here.

National Institutes of Health

  • An investigational HIV vaccine tested in a clinical trial co-sponsored by the NIH posed no safety concerns but did not provide sufficient protection against HIV infection among women, according to a preliminary analysis of the study data.  Learn more from this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has written to CMS to convey its views on CMS’s proposed physician fee schedule and changes to Medicare Part B regulation.  Find its letter here.
  • MedPAC’s commissioners met last week for two days to discuss Medicare payment issues.  During the meetings MedPAC addressed the following issues:
    • The effects of the COVID-19 emergency and considerations on MedPAC’s 2022 assessment of Medicare payment adequacy.
    • Potential reforms of the Part D low-income premium subsidy.
    • A report on designing a value incentive program for post-acute care.
    • A report on the impact of Bipartisan Budget Act of 2018 changes to the home health prospective payment system.

For briefs and presentations on these subjects go here; for a transcript of the MedPAC meetings go here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

American Medical Association

  • The AMA has announced eight new CPT codes for COVID-19 vaccine administration.  Learn more from this AMA notice.
  • The AMA has issued its annual update of CPT codes.  The update includes 405 editorial changes, including 249 new codes, 63 deletions, and 93 revisions.  Learn more from this AMA news release.

Stakeholder Event

FDA – Workshop Addressing Response to the Opioid Crisis – October 13

The FDA will hold a workshop entitled “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS)” to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS effort.  The public workshop will be held on October 13 from 1 p.m. to 5 p.m. (eastern) and October 14 from 1 p.m. to 4:05 p.m.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.

 

 

Federal Health Policy Update for Monday, August 30

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, August 30.  Some of the language used below is taken directly from government documents.

Temporary Suspension of COVID-19 Data Reporting Requirements for Some Hospitals

  • The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response has announced that federal hospital COVID-19 reporting requirements for the entire state of Louisiana and parts of Mississippi have been suspended for seven days in response to Hurricane Ida.  While hospitals in the affected areas may still report their data if they wish they are not required to do so and reporting for this period is not expected to be back-filled.  The office will continue to monitor the storm’s impact and this suspension could be extended or expanded to additional areas depending on conditions in the region.

Department of Health and Human Services

  • HHS has declared a state of public emergency in Louisiana and Mississippi because of the effects of Hurricane Ida.  See the HHS announcement for more about what this means.
  • HHS has issued guidance with essential information for states as they navigate the options available to advance COVID-19 vaccination and testing and the Medicaid program’s broader aim of providing health coverage for millions of eligible individuals.  To help states support families and communities and to continue to address health disparities, CMS is providing guidance to states about additional American Rescue Plan funding to promote the importance of COVID-19 vaccination for eligible children and adults enrolled in Medicaid.  Among the areas the new guidance addresses are COVID-19 testing in schools, coverage of habilitation services, enhancing access to COVID-19 vaccines, incentives for states to expand Medicaid, and reducing health disparities.  Learn more from this HHS news release, which includes links to several documents HHS has issued in support of this initiative.
  • HHS has established an Office of Climate Change and Health Equity in response to President Biden’s executive order calling for tackling the climate crisis at home and abroad.  The office is charged with:
    • Identifying communities with disproportionate exposures to climate hazards and vulnerable populations.
    • Addressing health disparities exacerbated by climate impacts to enhance community health resilience.
    • Promoting and translating research on public health benefits of multi-sectoral climate actions.
    • Assisting with regulatory efforts to reduce greenhouse gas emissions and criteria air pollution throughout the health care sector, including participating suppliers and providers.
    • Fostering innovation in climate adaptation and resilience for disadvantaged communities and vulnerable populations.
    • Providing expertise and coordination to the White House, Secretary of Health and Human Services, and federal agencies related to climate change and health equity deliverables and activities, including Executive Order implementation and reporting on health adaptation actions under the United Nations Framework Convention on Climate Change.
    • Promoting training opportunities to build the climate and health workforce and empower communities.
    • Exploring opportunities to partner with the philanthropic and private sectors to support innovative programming to address disparities and health sector transformation.
  • HHS’s Health Resources and Services Administration (HRSA) has extended the deadline for providers, FQHCs, and associations to apply for grants under its “Promoting Resilience and Mental Health Among Health Professional Workforce” program from August 30 to September 20.  $29 million in grant funding is available.  Learn more about the grants and the application process here.
  • HRSA has extended the deadline for applications for another public safety workforce resiliency training program from August 30 to September 20.  This program, which will award up to $68 million in grants, is part of a program to plan, develop, operate, or participate in health professions and nursing training activities using evidence-based or evidence-informed strategies, to reduce and address burnout, suicide, mental health conditions, and substance use disorders and promote resiliency among health care students, residents, professionals, paraprofessionals, trainees, public safety officers, and employers of such individuals in rural and underserved communities.  Learn more about the program and the grant opportunity here.
  • HRSA has awarded $10.7 million from the American Rescue Plan to expand pediatric mental health care access by integrating telehealth services into pediatric care.  Learn more about the programs funded by these resources and the recipients of this grant in this HHS announcement.
  • HRSA will publish a notice in the Federal Register announcing changes in the agency’s organization and operations.  See a pre-publication version of the notice here.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • CMS has published the latest edition of MLN Connects, its online newsletter.  The latest edition has an article on revised ICD-10 code sets, an update on monoclonal antibodies, and more.  Find it here.
  • CMS announced that Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program in 2020 earned performance payments (shared savings) totaling nearly $2.3 billion while saving Medicare approximately $1.9 billion.  Learn more about the performance of ACOs in the Medicare Shared Savings Program from this CMS news release,
  • CMS has announced three new major appointments:   Dr. Ellen Montz as Deputy Administrator and Director of the Center for Consumer Information and Insurance Oversight; Dr. Natalia Chalmers as its first-ever Chief Dental Officer in the Office of the Administrator; and Dara Corrigan as Deputy Administrator and Director of the Center for Program Integrity.  Learn more about the new officials and the positions to which they have been appointed in this CMS news release.

Food and Drug Administration

  • The FDA has approved a first-of-its-kind drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic strokes.  Learn more about this new technology and its application in this FDA news release.

National Institutes of Health

  • The NIH has begun a clinical trial to assess the antibody response to an extra dose of an authorized or approved COVID-19 vaccine in people with autoimmune disease who did not respond to an original COVID-19 vaccine regimen.  The trial also will investigate whether pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine in this population.  Learn more in this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has submitted formal comments to CMS on that agency’s proposed end-stage renal disease (ESRD) prospective payment system for 2022.  Read its letter here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

MACPAC has posted a fact sheet on Medicaid coverage of qualified residential treatment programs for children in foster care.

Stakeholder Event

MedPAC Meeting – September 2 and 3

MedPAC will hold its September public meetings remotely on Thursday, September 2 and Friday, September 3.  To register to view the Thursday, September 2 session (from 1:15 to 5:15 eastern) go here and to register to view the Friday, September 3 session (9:30 until noon eastern) go here.  To see the agenda for the two sessions and find supporting materials, go here.