Federal Health Policy Update for Tuesday, September 21

The following is the latest health policy news from the federal government as of 2:45 p.m. on Tuesday, September 21.  Some of the language used below is taken directly from government documents.

NASH Advocacy

  • NASH has submitted formal comments to CMS on the agency’s proposed outpatient prospective payment system regulation for calendar year 2022.  Writing from the perspective of private community safety-net hospitals, NASH addresses proposals and request for information about health equity, the section 340B prescription drug discount program, hospital price transparency requirements, proposed changes in Medicare’s inpatient-only procedures list, and the extension of provider flexibilities introduced in response to the COVID-19 public health emergency.  See NASH’s comment letter here.
  • In July the newly formed Congressional Social Determinants of Health Caucus invited stakeholders to respond to a series of questions designed to help the caucus learn more about social determinants of health and what Congress might do to address them more effectively.  Go here to read NASH’s response to the caucus’s questionnaire.

Provider Relief Fund

  • HHS has updated its Provider Relief Fund reporting portal’s frequently asked questions.  Find the updated FAQ here.
  • HHS has published a Provider Relief Fund reporting portal user guide.  Find the guide here.

The White House

Department of Health and Human Services

COVID-19

  • The federal government has responded to recent increases in COVID-19 cases by assuming control of the distribution of monoclonal antibodies used to treat the virus.  Learn more from the announcement of this new approach.  Federal officials also explain the new policy, why they are pursuing it, and how it will work in this video of a web event.

Health Policy News

  • HHS has extended the open enrollment period for people seeking health insurance on the federally facilitated marketplace and has extended the scope of services provided by navigators for that marketplace.  The department also has authorized state marketplaces to set their own open enrollment dates.  Learn more from this HHS news release.
  • HHS and its Health Resources and Services Administration (HRSA) have awarded $48 million to 271 HRSA-supported health centers in 26 states, Puerto Rico, and the District of Columbia to expand HIV prevention and treatment, outreach, and care coordination services.  To learn more about the awards, how the money will be used, and the award recipients, see this HHS announcement.
  • HHS and HRSA have awarded $350 million in grants to every state to support safe pregnancies and healthy babies.  Funding will be used expand home visiting services to families most in need, increase access to doulas, address health disparities in infant deaths, and improve data reporting on maternal mortality.  The money is being awarded through the Maternal, Infant, Early Childhood Home Visiting Program, the Healthy Start Initiative, and the State Systems Developmental Initiative.  To learn more about how HHS intends for the money to be spent, how much money is being allocated through these programs, and how much money individual recipients will receive, see this HHS announcement.
  • HRSA has announced the availability of funding to support continued access to comprehensive, culturally competent, high-quality primary health care services for communities and populations currently served by its Health Center Program.  Eligible organizations include domestic public or non-profit private entities that propose to serve an announced service area and its associated population(s) to ensure continued access to affordable, quality primary health care services.  Learn more from this HRSA announcement.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • The latest edition of the CMS online publication MLN Connects includes Medicare’s quarterly provider quality compliance newsletter and information about annual HPSA updates, flu vaccine payment allowances, updated clinical lab fees, and more.  Find the September 16 edition of MLN Connects here.
  • CMS has posted a pre-publication version of a final rule that sets forth revised 2022 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges and State-based Exchanges on the federal platform; repeals separate billing requirements related to the collection of separate payments for the portion of QHP premiums attributable to coverage for certain abortion services; expands the annual open enrollment period and Navigator duties; implements a new monthly special enrollment period for qualified individuals or enrollees, or the dependents of a qualified individual or enrollee, who are eligible for advance payments of the premium tax credit (APTC) and whose household income does not exceed 150 percent of the federal poverty level, available during periods of time during which APTC benefits are available such that certain applicable taxpayers’ applicable percentage is set at zero, such as during tax years 2021 and 2022 under the section 9661 of the American Rescue Plan Act of 2021; repeals the recent establishment of a Direct Enrollment option for Exchanges; and modifies regulations and policies related to section 1332 waivers.  Find the document here.
  • CMS has published three FAQs that explain that the agency will not take enforcement action against certain payers for the payer-to-payer data exchange provision of the May 2020 Interoperability and Patient Access final rule until future rulemaking is finalized.  CMS’s decision to exercise enforcement discretion for the payer-to-payer policy until future rulemaking occurs does not affect any other existing regulatory requirements and implementation timelines outlined in the final rule.  Go here to see the announcement and find links to the FAQs.
  • CMS has proposed repealing the Medicare Coverage of Innovative Technology and Definition of ‘”Reasonable and Necessary” final rule, which was published on January 14, 2021 and is scheduled to take effect on December 15.  The repealed rule was a response to concerns that breakthrough technologies were not being made available to the Medicare population in a timely manner but CMS now believes more care must be taken before authorizing the use of such technologies for Medicare patients.  Find the proposed rule here.
  • CMS has published its Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) Quarterly Q&As December 2020 document so inpatient rehabilitation facility (IRF) providers have the benefit of clarifications to existing guidance.
  • CMS has published the Long-Term-Care Hospital (LTCH) CARE Data Set Quarterly Q&As, September 2021, Consolidated September 2020 to September 2021 document so LTCH providers have the benefit of the clarifications to existing guidance.
  • CMS has awarded $15 million in planning grants to 20 states to support expanding community-based mobile crisis intervention services for Medicaid beneficiaries.  Learn more about the services the grants will underwrite and find a list of grant recipients in this CMS announcement.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has revised its emergency use authorization (EUA) for the monoclonal antibodies bamlanivimab and etesevimab, administered together, to include emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.  In this revision of the EUA, bamlanivimab and etesevimab, administered together, are authorized for use after exposure to the virus and are not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the COVID-10 virus.  Learn more from the FDA announcement, the revised EUA, and this fact sheet for providers.
  • The FDA has updated its enforcement policy for masks, barrier face coverings, face shields, surgical masks, and respirators during the COVID-19 public health emergency.  Find the updated policy here.

National Institutes of Health

  • The NIH has awarded $470 million to build a national study population of diverse research volunteers and support large-scale studies on the long-term effects of COVID-19.  Learn more from this NIH news release.

Stakeholder Events

MACPAC – September meetings – September 23 and 24

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its scheduled September meeting of commissioners on Thursday, September 23 and Friday, 24 to discuss federal Medicaid and CHIP policies.  The meetings will be held virtually.  Find the meeting agenda here and go here to register to view the sessions.

CDC – Evaluating and Supporting Patients Presenting With Fatigue Following COVID-19 – September 30

The CDC will hold a webinar on evaluating and supporting patients who present with fatigue following treatment for COVID-19.  The webinar will be held on Thursday, September 30 at 2:00 p.m. (eastern).  For further information on the subjects the webinar will cover, those who will be participating in the event, and how to join the webinar, go here.

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

The FDA will hold a workshop titled “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 4:00 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, September 13

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, September 13.  Some of the language used below is taken directly from government documents.

Provider Relief Fund

  • HHS and its Health Resources and Services Administration (HRSA) are making $25.5 billion in new funding available for health care providers affected by the COVID-19 pandemic.  This funding includes $8.5 billion in American Rescue Plan money for providers that serve rural Medicaid, Children’s Health Insurance Program (CHIP), or Medicare patients and an additional $17 billion for Provider Relief Fund Phase 4 grants for a broad range of providers that can document revenue loss and expenses associated with the pandemic.  To learn more about the funding to be distributed and how it will be distributed, see the following resources:

NASH members received a more detailed explanation about the availability of these funds last Friday, September 10.

The White House

Department of Health and Human Services

COVID-19

  • HHS has amended the Public Readiness and Emergency Preparedness (PREP) Act declaration to provide liability protection to licensed pharmacists, pharmacy technicians, and pharmacy interns to provide a pathway for increased access to COVID-19 therapeutics – specifically, monoclonal antibodies – especially in surge states with rising numbers of COVID-19 cases and in rural areas where access to inpatient and outpatient services may be more limited.  For more information about the health care professionals to which these protections have been extended and about the protections themselves, see this HHS announcement.  This amendment of the PREP Act also will be published in the Federal Register; go here to see a pre-publication version of the Federal Register notice.

Health Policy News

  • HHS, the departments of Labor and the Treasury, and the Office of Personnel Management have proposed rules that would require health plans, issuers, and providers of air ambulance services to submit detailed data regarding air ambulance services specified in the reporting requirements of the No Surprises Act.  The rules also outline CMS’s authority to fully enforce Title I (the No Surprises Act) and Title II (Transparency) of Division BB of the Consolidated Appropriations Act of 2021 in states that do not have the authority to enforce or fail to substantially enforce one or more of the provisions and seek to help consumers understand the compensation being paid to agents and brokers who help them select health insurance.  This is the latest regulatory action in a series of rulemaking implementing the No Surprises Act.  Learn more from the following resources:
  • HHS is awarding $20 million in American Rescue Plan grant funding to state-based marketplaces to increase consumer access to affordable, comprehensive health insurance coverage.  The grants will be used by 21 state-based marketplaces to modernize IT systems and/or conduct targeted consumer outreach activities to help make health care coverage enrollment simpler.  Learn more about how the money will be used and which state-based marketplaces will receive it in this HHS announcement.
  • HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) is awarding more than $123 million in funding through six grant programs to provide support to communities and health care providers to help combat the overdose epidemic.  Grants are being awarded through six existing programs:  Medication Assisted Treatment for Prescription Drug and Opioid Addiction; Tribal Opioid Response Grants; Screening, Brief, Intervention, and Referral to Treatment; Strategic Prevention Framework for Prescription Drugs; First Responder-Comprehensive Addiction and Recovery Act Grants; and Providers Clinical Support System – Universities.  Learn more about where the money will go and how it will be spent in this HHS news release.

Centers for Medicare & Medicaid Services

COVID-19

  • The administration announced that it will require COVID-19 vaccination of staff in all Medicare- and Medicaid-certified facilities.  CMS, in collaboration with the CDC, announced that emergency regulations requiring vaccinations for nursing home workers will be expanded to include hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, among others, as a condition for participating in the Medicare and Medicaid programs.  Go here to find an explanation of the new policy.

Health Policy News

  • CMS announced that it is rescinding audit determinations for providers notified in January of 2021 that they had failed to qualify for what is known as the “mid-build exception.”  The Bipartisan Budget Act of 2015 changed how off-campus provider-based departments are paid for items and services furnished to Medicare beneficiaries.  CMS will review each previously failing provider’s audit findings for compliance with statutory requirements and for accuracy and completeness and providers that received failing audit determinations are no longer required to report or return overpayments based on those determinations.  Each provider will receive a letter rescinding the previous determination.   An updated audit determination letter will be issued following the review of each provider’s audit.  A new overpayment return deadline for self-identified overpayments will be included in that letter should the provider receive a failing audit determination.  Learn more from this CMS announcement.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has approved an abbreviated new drug application for dexmedetomidine injection USP, 200 mcg/2 mL, indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting and sedation of non-intubated patients prior to and/or during surgical and other procedures.  The drug is often used on COVID-19 patients who need ventilators.  See the FDA’s announcement.

Stakeholder Events

 CDC – Evaluating and Supporting Patients Presenting With Fatigue Following COVID-19 – September 30

The CDC will hold a webinar on evaluating and supporting patients who present with fatigue following treatment for COVID-19.  The webinar will be held on Thursday, September 30 at 2:00 p.m. (eastern).  For further information on the subjects the webinar will cover, those who will be participating in the event, and how to join the webinar, go here.

 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 4:00 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.

 

 

Federal Health Policy Update for Thursday, August 26

The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, August 26.  Some of the language used below is taken directly from government documents.

NASH Advocacy

  • NASH has written to the chairs and ranking members of the congressional committees of jurisdiction over health care to ask them to prevent the anticipated January 1, 2022 tripling of the current Medicare sequester from two percent to six percent of all provider Medicare payments and to consider the challenges that community safety-net hospitals have long faced, and that they now continue to face to an unprecedented degree, when looking for budget savings to offset new federal spending during upcoming federal budget deliberations.  See NASH’s letter here.

Provider Relief Fund

The White House

Centers for Medicare & Medicaid Services

COVID-19

  • Health care providers can now receive additional payments from Medicare for administering vaccines to multiple residents in one home setting or a communal home setting.  Previously, CMS increased Medicare payments for vaccines administered in the home, and now, under this new policy, vaccine providers can receive the increased payment up to five times when fewer than ten Medicare beneficiaries receive the vaccine on the same day in the same home or communal setting.  Learn more from this CMS announcement.
  • CMS has written to Medicare Advantage organizations and Medicare-Medicaid health plans to inform them that in light of the recent surge of the COVID-19 delta variant and increased hospitalizations across the country, it strongly encourages those organizations to waive or relax plan prior authorization requirements and utilization management processes to facilitate the movement of patients from general acute-care hospitals to post-acute care and other clinically-appropriate settings, including skilled nursing facilities, long-term-care hospitals, inpatient rehabilitation facilities, and home health agencies.  The ability of hospitals to transfer patients to appropriate levels of care without unnecessary delays or administrative burdens, CMS writes, is critical to ensuring that hospitals have open acute-care beds to treat patients requiring emergency care.  See the CMS message here.
  • CMS has updated its Medicare provider enrollment relief FAQ.  Find it here.

Department of Health and Human Services

Health Policy News

  • Along with the Department of the Treasury and Department of Labor, HHS is vested with responsibility for implementing the 2020 law that requires health care payers to make available to the public machine-readable files for in-network rates and out-of-network allowed amounts and billed charges for plan years.  That information was to be available publicly by January 1, 2022, but now, the departments have delayed implementation of this requirement for six months.  Learn more from this HHS FAQ.
  • HHS’s Office of the Assistant Secretary for Preparedness and Response will award a single grant of $3 million to establish a new Regional Disaster Health Response System site.  It would be part of a tiered system that builds upon and unifies existing assets within states and across regions to support a more coherent, comprehensive, and capable health care disaster response system able to respond health security threats.  Entities eligible for grants include hospitals, local health care facilities, political subdivisions, states, emergency medical services organizations, and emergency management organizations.  Learn more about the funding opportunity here and here and about the Regional Disaster Health Response System here.  Applications are due September 20.
  • HHS’s Agency for Healthcare Research and Quality has published a statistical brief on diabetes-related inpatient stays in 2018.

Food and Drug Administration

COVID-19

  • The FDA has granted its first full (non-emergency use authorization only) approval of a COVID-19 vaccine.  The vaccine that has been known as the Pfizer-BioNTech COVID-19 Vaccine and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.  The vaccine also continues to be available under emergency use authorization for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.  Learn more from this FDA news release.
  • The FDA has posted updated information about COVID-19 booster shots, including when they will be available, who should get them, and when people should get them.  Find that information here.

Centers for Disease Control and Prevention

COVID-19

U.S. Citizenship and Immigration Services

  • Under provisions of the Immigration and Nationality Act, the Department of Homeland Security’s U.S. Citizenship and Immigration Services administers the public charge ground of inadmissibility as it pertains to applicants for admission to the U.S. and adjustment of status.  The agency has published an advance notice of proposed rulemaking to seek broad public feedback on the public charge ground of inadmissibility to the U.S. that will inform its development of a future regulatory proposal.  Find the Federal Register notice here.  Comments are due by October 22.

National Institutes of Health

  • A study funded by the NIH has found that drinking alcohol and smoking tobacco cigarettes throughout the first trimester of pregnancy is associated with nearly three times the risk of late stillbirth compared to women who neither drink nor smoke during pregnancy or quit both before the end of the first trimester.  Learn more from this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has submitted formal comments to CMS in response to CMS’s proposed home health prospective payment system regulation for 2022.  See MedPAC’s comment letter here.

Congressional Research Service

  • The Congressional Research Service has updated its report Finding Medicare Fee-For-Service (FFS) Payment System Rules:  Schedules and Resources.  Find it here.

 

Federal Health Policy Update for Thursday, August 19

The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, August 19.  Some of the language used below is taken directly from government documents.

The White House

Provider Relief Fund

Centers for Medicare & Medicaid Services

COVID-19

  • CMS and the CDC are developing an emergency regulation requiring staff vaccinations within the nation’s more than 15,000 Medicare- and Medicaid-participating nursing homes.  In announcing this new policy, CMS notes that “About 62% of nursing home staff are currently vaccinated as of August 8 nationally, and vaccination among staff at the state level ranges from a high of 88% to a low of 44%.  The emergence of the Delta variant in the United States has driven a rise in cases among nursing home residents from a low of 319 cases on June 27, to 2,696 cases on August 8, with many of the recent outbreaks occurring in facilities located in areas of the United States with the lowest staff vaccination rates.”  Learn more from the CMS announcement.
  • CMS has published a special edition of its online newsletter, MLN Connects, that presents information about codes and payments for the additional doses of COVID-19 vaccinations authorized by the FDA last week for selected at-risk individuals.  The American Medical Association has published similar information.
  • CMS has invited eligible Medicaid managed care organizations to participate in a data-sharing pilot project to facilitate increased care coordination for individuals dually eligible for Medicare and Medicaid during the COVID-19 emergency.  This pilot project is open to a maximum of 20 Medicaid managed care organizations that enroll dually eligible beneficiaries.  The application deadline is August 30.  Learn more about the program here.

Health Policy News

  • The Most Favored Nation Model introduced by CMS’s Center for Medicare and Medicaid Innovation (CMMI) sought to test a new way to lower prescription drug costs by paying no more for high-cost Medicare Part B drugs and biologicals than the lowest price that drug manufacturers receive in other, similar countries.  In the face of legal challenges that prevented implementation of the program as proposed, CMMI has announced that it will not implement the program without additional rulemaking.  Go here to learn more about the program and its change in status.
  • CMS has published the latest edition of its MLN Connects, its online newsletter.  This week’s edition includes features on updated web-based training on Medicare fraud and abuse prevention, detection, and reporting; webinars on Medicare ground ambulance data collection; updated instructional resources for inpatient rehabilitation facility and long-term-care hospital Quality Reporting Program documents; and more.

Department of Health and Human Services

COVID-19

Health Policy News

  • A study by HHS’s Office of the Inspector General has concluded that Medicare pays three times as much for the capital costs of new hospitals during their first two years of existence – an average of $1.3 million a year more – than it pays established hospitals for their capital costs.  The OIG recommended that CMS reevaluate this policy.  CMS concurred with the OIG’s recommendation.  Learn more from the OIG study.
  • HHS has awarded $19 million in grants to 36 recipients to strengthen telehealth services in rural and underserved communities and expand telehealth innovation and quality nation-wide.  Learn more about the specific grant recipients and the purposes for which they received awards in this HHS announcement.

Centers for Disease Control and Prevention

COVID-19

National Institutes of Health

Medicaid and CHIP Payment and Access Commission (MACPAC)

Government Accountability Office (GAO)

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 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, August 5

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, August 5.  Some of the language used below is taken directly from government documents.

Final Medicare Inpatient Prospective Payment System Regulation for FY 2022

CMS has published its final Medicare inpatient prospective payment system regulation for FY 2022.  Highlights include:

  • An increase in hospital inpatient rates of 2.5 percent and an increase in long-term hospital rates averaging 0.9 percent.
  • The Medicare disproportionate share (Medicare DSH) payments uncompensated care allocation has been cut $1.1 billion, to $7.2 billion, with distribution to be based on hospitals’ FY 2018 Medicare cost reports.
  • A reduction of the labor-related share of Medicare payments from 68.3 percent to 67.6 percent.
  • Repeal of the requirement that hospitals report median payer-specific negotiated charges with Medicare Advantage plans on their Medicare cost reports.
  • Extension of the COVID-19 treatment add-on payment through the end of the fiscal year in which the public health emergency ends.
  • A new requirement that hospitals include in their Medicare quality program reporting information about the vaccination status of their staffs.

CMS noted that this regulation is not comprehensive and that it will issue an additional regulation or regulations about the FY 2022 Medicare inpatient prospective payment system in the future.  Among other subjects, this regulation does not address graduate medical education, organ acquisition payment policies, and health equity.  To learn more about this final rule, see the following resources:

CMS’s news release

CMS’s fact sheet

the final rule itself

The White House

Provider Relief Fund

  • HHS has updated the “Reporting Requirements and Auditing” section of its Provider Relief Fund web page.  Find the updated web page here.

Department of Health and Human Services

COVID-19

  • HHS has invoked a provision in the Public Readiness and Emergency Preparedness (PREP) Act to authorize pharmacy technicians and interns to administer adult flu vaccines.  See the Federal Register notice announcing this policy.
  • HHS’s Office of the Assistant Secretary for Preparedness and Response has developed a “COVID-19 Monoclonal Antibody Therapeutics Calculator for Infusion Sites” (mAbs Calculator).  The mAbs Calculator is a free, data-informed decision support tool that is based on a comprehensive simulation framework.  The mAbs Calculator can be used to inform staffing decisions and resource investments needed for COVID-19 monoclonal antibody therapeutic infusion sites.  Learn more about this tool here.
  • HHS’s Office of the Assistant Secretary for Preparedness and Response has published a guide to resources on the role of medical support services in the response to COVID-19.
  • HHS’s COVID-19 Health Equity Task Force met recently to consider interim recommendations addressing future pandemic preparedness.  Go here to find a summary of the meeting and links to video of the proceedings.

Health Policy News

  • HHS announced that it is providing nearly $90 million to help rural communities combat opioid use disorders and other forms of substance use disorders and to improve access to maternal and obstetric care.  HHS’s Health Resources and Services Administration distributed this money through four programs:  the Rural Communities Opioid Response Program, the Rural Communities Opioid Response Program-Psychostimulant Support Program, the Rural Maternity and Obstetrics Management Strategies Program, and the Rural Northern Border Region Planning Program.  Learn more from this HHS announcement.

Centers for Medicare & Medicaid Services

Health Policy News

Centers for Disease Control and Prevention

COVID-19

  • The CDC has updated its guidance on how families can protect themselves from COVID-19 when they include members who have not been vaccinated or who have compromised immune systems.  Find this updated guidance here.

Food and Drug Administration

COVID-19

  • The FDA has revised its emergency use authorization for 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 FDA has revised its emergency use authorization for baricitinib (sold under the brand name Olumiant), now authorizing baricitinib alone for the treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Under the revised EUA, baricitinib is no longer required to be administered with remdesivir (Veklury).  Baricitinib is not FDA-approved as a treatment for COVID-19.  Learn more here.
  • The FDA has authorized an extension for the shelf life of the refrigerated Janssen (Johnson & Johnson) COVID-19 vaccine, allowing the product to be stored at 2-8 degrees Celsius for six months.  Learn more here.

National Institutes of Health

Stakeholder Events

Wednesday, August 11 – CMS

Price Transparency Stakeholder Webinar

Wednesday, August 11 at 2:00 p.m. (eastern)

This webinar will focus on how to meet the requirements of the Hospital Price Transparency Final Rule for posting standard charge information in a comprehensive machine-readable file.  For further information about the webinar go here and to register for the webinar go here.

Thursday, August 12 – CMS

Ambulance Open Door Forum

Thursday, August 12 at 2:00 p.m. (eastern)
The subject of this forum is the Medicare Ground Ambulance Data Collection System.  Learn about the Medicare Ground Ambulance Data Collection System, including current status and activities, information sampled that organizations need to collect and report, and proposed revisions and clarifications in the 2022 physician fee schedule proposed rule.  Go here for further information about the forum and how to participate.

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 Friday, July 30

The following is the latest health policy news from the federal government as of 2:45 p.m. on Friday, July 30.  Some of the language used below is taken directly from government documents.

Final Medicare Payment Regulations for FY 2022

CMS has published four final rules for Medicare payments in FY 2022:

(See also CMS’s fact sheet)

(See also CMS’s fact sheet)

(See also CMS’s fact sheet)

(See also CMS’s fact sheet)

The White House

  • The White House has announced new actions to get more people vaccinated and slow the spread of the COVID-19 delta variant.  Among those actions:  requiring federal employees and on-site contractors to attest that they are vaccinated or wear masks and undergo regular testing; providing reimbursement for small- and medium-sized businesses for paid leave needed for workers to get themselves and their families vaccinated; urging state and local governments to offer financial incentives for people to get vaccinated; and initiating a number of steps designed to increase the vaccination rate among students 12 years of age and older.  Find the White House news release outlining these and other steps here.

Provider Relief Fund

  • HHS has updated the “Reporting Requirements and Auditing” section of its Provider Relief Fund web page, adding slides and video from its July 14 and July 20 webinars about recent changes in those reporting and auditing requirements.  Find the updated web page here.

Department of Health and Human Services

COVID-19

  • HHS’s Office of the Assistant Secretary for Preparedness and Response has updated its “Action Report Resources and Examples” document with sample considerations that health care entities can use when documenting their ongoing After Action Report (AAR) process for COVID-19.  It also provides sample COVID-19 AARs that are currently available to the public.
  • HHS’s Office of the Inspector General has found that states’ backlogs of nursing home inspections have grown substantially during the COVID-19 pandemic.  Nationally, 71 percent of nursing homes had gone at least 16 months without a standard survey as of May 31, 2021.  See the OIG’s report on this situation.

Health Policy News

  • HHS’s Health Resources and Services Administration (HRSA) has announced that it will make available $76 million in Teaching Health Center Graduate Medical Education grants, to be awarded competitively, in three categories:
    • Teaching Health Center Graduate Medical Education New and Expanded Residency Program – up to 85 recipients will receive a total of approximately $46 million to support community-based medical and dental residency programs in rural and underserved communities.  Funding will go toward supporting new resident positions at new and existing teaching health centers.  Applications are due September 21, 2021.
    • Teaching Health Center Planning and Development Program – up to 50 grantees will receive a total of approximately $25 million over two years to create new community-based residency programs to increase the primary care workforce, including in rural and underserved communities.  Applications are due August 30, 2021.
    • Teaching Health Center Planning and Development Technical Assistance – one cooperative agreement recipient will receive approximately $5 million over three years to provide technical assistance to HRSA’s Teaching Health Center Planning and Development Program grant recipients.  Applications are due August 30, 2021.

Go here for further information about the HRSA announcement and for links to the individual grant programs.

  • HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) has awarded 100 grants worth $250 million to improve access to Certified Community Behavioral Health Clinics that provide community-based support for people in need of substance use disorder and mental health treatment services.  Learn more about the grants and the services they seek to support in this HHS news release.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has published the latest edition of MLN Connects, its online weekly bulletin.  This week’s edition includes articles about hospital price transparency requirements, ambulance service billing requirements, and other subjects.  For this and more, go here.
  • CMS has launched a new Infant Well-Child Visit Learning Collaborative, which is part of its Maternal and Infant Health Initiative, to support state efforts to increase the number of infants receiving high-quality well-child care.  This learning collaborative will offer technical assistance to state Medicaid and CHIP agencies and their partners.  Go here to learn more about CMS’s  Infant Well-Child Visit Learning Collaborative and its Maternal and Infant Health Initiative.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

Health Policy News

  • The FDA has approved the first interchangeable biosimilar insulin product to improve glycemic control in adults and pediatric patients with Type 1 diabetes and in adults with Type 2 diabetes.  Learn more from the FDA announcement.

U.S. Cybersecurity and Infrastructure Security Agency

  • The U.S. Cybersecurity and Infrastructure Security Agency has introduced a “COVID-19 Disinformation Toolkit” designed to help state, local, tribal and territorial officials bring awareness about misinformation, disinformation, and conspiracy theories appearing online related to COVID-19’s origin, scale, government response, prevention, and treatment.

Congressional Research Service

Stakeholder Events

Wednesday, August 4 – CMS

Hospice Quality Reporting Program Forum

Wednesday, August 4 at 2:00 p.m. (eastern)

CMS will host a webinar to share updates on the on the fiscal year 2022 hospice wage index and payment rate update and hospice quality reporting requirements final rule.  During this webinar, CMS staff will provide information on the FY 2022 hospice final rule summary and public display of quality measures and other hospice data updates.  Go here for additional information about the webinar and to register.

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.

Wednesday, August 11 – CMS

Price Transparency Stakeholder Webinar

Wednesday, August 11 at 2:00 p.m. (eastern)

This webinar will focus on how to meet the requirements of the Hospital Price Transparency Final Rule for posting standard charge information in a comprehensive machine-readable file.  For further information about the webinar go here and to register for the webinar go here.

Thursday, August 12 – CMS

Ambulance Open Door Forum

Thursday, August 12 at 2:00 p.m. (eastern)
The subject of this forum is the Medicare Ground Ambulance Data Collection System.  Learn about the Medicare Ground Ambulance Data Collection System, including current status and activities, information sampled that organizations need to collect and report, and proposed revisions and clarifications in the 2022 physician fee schedule proposed rule.  Go here for further information about the forum and how to participate.

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 Tuesday, July 27

The following is the latest health policy news from the federal government as of 4:00 p.m. on Tuesday, July 27.  Some of the language used below is taken directly from government documents.

CDC Updates Mask Guidance

  • The CDC has updated its guidance on the use of masks as a means of protection from COVID-19, encouraging even vaccinated people to wear masks indoors when they are in areas with a high rate of COVID-19 transmission.  It also calls on students and staff members of kindergarten–grade 12 schools and institutions of higher education, health care workers, residents and staff members of long-term-care facilities, incarcerated persons, homeless persons, and workers in high-density work sites to wear masks regardless of whether they have been vaccinated.  Go here to see the new guidance, which includes metrics for determining whether individual areas have a high rate of COVID-19 transmission.

Justice Department

  • The Justice Department has issued an opinion on whether section 564 of the Food, Drug, and Cosmetic Act prohibits entities from requiring the use of a vaccine available only under emergency use authorization.  The opinion says the provision does not prohibit private or public entities from requiring EUA-only authorized COVID-19 vaccines of workers and students.  See the opinion here.

White House

Department of Health and Human Services

COVID-19

  • HHS has awarded $121 million in grants to support community-based efforts to increase vaccinations in underserved communities.  These awards were made to community-based organizations that are working to build vaccine confidence, share factual information about vaccines, and answer people’s questions about getting vaccinated.  Go here to learn more about the awards and find a link to a list of recipients.

Health Policy News

  • HHS’s Office of the Assistant Secretary for Health’s Office on Women’s Health is launching the second phase of its “HPV VAX NOW” campaign to address a situation in which only 40 percent of young adults in the United States have received one or more doses of the human papillomavirus (HPV) vaccine and only 22 percent have completed the vaccine series.  The second phase of the program, the first phase of which was launched in January in three states (Mississippi, South Carolina, and Texas), will target young adults ages 18–26 in the same three states with the long-term goal of empowering all to complete the HPV vaccine series.  Learn more from this HHS news release.

Centers for Disease Control and Prevention

COVID-19

Health Policy News

  • The CDC has awarded $117 million to state and local health departments to help rebuild and begin to expand HIV prevention and treatment efforts and to advance innovation and health equity in the federal initiative to end HIV.  Go here to learn more about the grants and their purpose and for a link to the jurisdictions that received awards.

Federal Emergency Management Agency (FEMA)

COVID-19

Food and Drug Administration

COVID-19

  • The FDA has updated its list of emergency use authorizations (EUAs) for medical devices related to the COVID-19 public health emergency.  For a list of the authorizations issued – most of which are for diagnostic tests to determine the presence of COVID-19 – see this FDA Federal Register notice.
  • The FDA has issued an EUA for citrate plasma tubes used to collect, transport, and store blood samples for coagulation testing.  The device authorized under this EUA is for use in coagulation testing, performed by authorized laboratories, to aid in the identification and treatment of coagulopathy in patients, including patients with known or suspected COVID-19.  The FDA also posted an FAQ about sodium citrate blood specimen collection tubes.  For details on the EUA, see the FDA’s letter of authorization.

Stakeholder Events

Wednesday, July 28 – FEMA

Public Assistance Program Funding for Vaccination Advocacy

Wednesday, July 28 at 2:00 p.m. (eastern)

FEMA will hold a webinar to discuss funding for non-profit entities and governments to support COVID-19 vaccine advocacy.

For information about the webinar and to register, go here.

Wednesday, August 4 – CMS

Hospice Quality Reporting Program Forum

Wednesday, August 4 at 2:00 p.m. (eastern)

CMS will host a webinar to share updates on the on the fiscal year 2022 hospice wage index and payment rate update and hospice quality reporting requirements final rule.  During this webinar, CMS staff will provide information on the FY 2022 hospice final rule summary and public display of quality measures and other hospice data updates.  Go here for additional information about the webinar and to register.

 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.

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.