The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, February 3. Some of the language used below is taken directly from government documents.
Provider Relief Fund
- The reconsideration window for Provider Relief Fund Phase 4 payments and American Rescue Plan rural hospital payments is now open for providers to request reconsideration of their payments. This process is intended only for providers that believe their payment was not calculated correctly. They will not have an opportunity to submit an application if they missed a deadline; will not be able to revise or correct their original application; and will not be able to request reconsideration that would require a change of payment methodology or policy. Learn more about the process and how to apply for reconsideration from this Provider Relief Fund web page. The deadline for applying for reconsideration is May 2 but providers that have not yet received a grant or notice of rejection will have 45 days from the date of rejection to file for reconsideration even if that is after the May 2 deadline.
- HHS’s Health Resources and Services Administration (HRSA), which administers the Provider Relief Fund, has updated its database of providers that have received grant funding under the program. Find that database here.
- The White House has posted a transcript of the February 2 press briefing given by its COVID-19 response team and public officials.
- The White House has announced that it will relaunch the “Cancer Moonshot” that President Biden introduced in 2016, when he was vice president, and explains what this means in this fact sheet.
Centers for Medicare & Medicaid Services
- CMS has announced that people in either original Medicare or Medicare Advantage will be able to get over-the-counter COVID-19 tests at no cost starting in early spring. Under this initiative, Medicare beneficiaries will be able to obtain up to eight over-the-counter COVID-19 tests a month for free. Tests will be available through eligible pharmacies and other participating entities. Learn more from this CMS news release and an FAQ on the new policy.
- CMS has updated its FAQ on nursing home visitation. The updated guidance seeks to clarify aspects of past guidance, including that “…the bottom line is visitation must be permitted at all times with very limited and rare exceptions, in accordance with residents’ rights.”
- CMS administrator Chiquita Brooks-LaSure has sent a letter to health care facility administrators urging them to take steps to get all of their workers immunized against COVID-19 as soon as possible and advising that “Increasing the uptake of COVID-19 vaccines, including the booster shot, is the most important tool you have against staffing shortages.”
Health Policy Update
- In 2016, Congress passed legislation that required Medicare to implement a site-neutral payment system for outpatient services under which new hospital outpatient departments will be paid under the Medicare physician fee schedule rather than the higher-paying outpatient prospective payment system. The legislation included an exception to this new policy: hospitals that could demonstrate that they were in the process of creating outpatient departments at the time of the law’s passage would be given a “mid-build exception” that would enable services provided at those facilities, once opened, to be paid under the outpatient prospective payment system rather than the Medicare physician fee schedule. Over the next five years hospitals applied for these mid-build exceptions, CMS made decisions based on those applications, and hospitals appealed rejections of their applications. This week CMS’s contract auditor sent letters to all hospitals whose appeals were still under consideration with its decision on their applications. These decisions are final.
- CMS has released its Medicare Advantage and Part D Advance Notice with proposed payment policy changes for Medicare Advantage and Part D drug programs in 2023. CMS also is requesting input on a potential change of the Medicare Advantage and Part D Star Ratings that would take into account how well each plan advances health equity; on considerations for assessing the impact of using sub-state geographic levels of rate-setting for enrollees with end-stage renal disease; on a variety of payment updates; on a new measure concept to assess whether and how Medicare Advantage plans are transforming care by engaging in value-based models with providers; and on updates to risk-adjustment models to continue to pay appropriately for the people enrolled in Medicare Advantage and Part D plans. Learn more from this CMS news release; from a CMS fact sheet; and from the specific advance notice documents. The deadline for public comment March 4. The Medicare Advantage and Part D payment policies for 2023 will be finalized in the 2023 rate announcement, which will be published no later than April 4.
- CMS has written to hospitals to remind them that it offers a process for hospitals or facilities to request exceptions to the reporting of required quality data, including data for electronic clinical quality measures (eCQMs), for one or more quarters when a provider experiences an extraordinary circumstance beyond its control. Learn more from this CMS memo to providers.
- CMS has issued its January 2021 quarterly update to the inpatient prospective payment system (IPPS) and long-term-care hospital FY 2021 PPS pricers.
- CMS has posted a new edition of MLN Connects, its online newsletter with information about Medicare reimbursement matters. This week’s edition includes items on skilled nursing facility consolidated billing codes for 2022, a reminder of changes in Medicare Advantage billing for COVID-19 vaccines and monoclonal antibody treatments, expedited review for billing for hospital inpatients, and an updated lab fee schedule. Find this information and more in the latest edition of MLN Connects.
Department of Health and Human Services
Health Policy Update
- HHS, the Department of Labor, the Department of the Treasury, and the Office of Personnel Management have jointly released guidance on the independent dispute resolution process that is a major part of implementing the No Surprises Act. “Federal Independent Dispute Resolution (IDR) Process Guidance for Disputing Parties” seeks to provide direction to disputing parties that are seeking to resolve a claim for payment for out-of-network health care items or services through the independent dispute resolution process. This guidance provides information to those parties about how they may engage in open negotiation prior to the independent dispute resolution process, how to initiate the process, how to select a certified entity to adjudicate the dispute, and how to meet the requirements of the process. Also released is “Federal Independent Dispute Resolution (IDR) Process Guidance for Certified IDR Entities,” a manual to guide the arbiters of the dispute resolution process.
- HHS, clinicians, researchers, and policy experts have developed a standard clinical definition for opioid withdrawal in infants. The definition is accompanied by a set of foundational principles that outline bioethical uses for the definition based on identifying the clinical and supportive care needs of mothers and their infants and using an evidence-based, compassionate, and equitable approach. Learn more from this HHS news release.
- HHS has extended the application deadline for its “HHS Racial Equity in Postpartum Care Challenge,” which seeks proposals on innovative methods to improve equity of postpartum care for Black or African American and American Indian/Alaska Native women enrolled in Medicaid or CHIP, including follow-up care for diabetes, postpartum depression and/or postpartum anxiety, hypertension, and substance use disorders. The new application deadline is February 28. Go here to learn more about this funding opportunity and a February 9 webinar for prospective applicants.
- HHS’s Office of the Assistant Secretary for Planning and Evaluation has published a report analyzing the use of telehealth services in 2021 and documenting disparities in the use of audio-only versus joint audio-video services. The study found notable disparities by race, ethnicity, income, age, and insurance status in access to video-enabled telehealth. Find the report here
- HHS’s Agency for Healthcare Research and Quality (AHRQ) has developed new tools for nursing homes to use to track the vaccination status of their staff and residents.
Centers for Disease Control and Prevention
- The CDC has updated its infection prevention and control recommendations for health care workers during the COVID-19 pandemic. The updated guidance addresses recent changes in when quarantine is needed and for how long it should be used and when respirators should be used and points health care workers to other resources. Find the updated guidance here.
- CMS has updated its infection prevention and control recommendations to prevent the spread of COVID-19 in nursing homes and other long-term-care facilities. The updated guidance addresses recent changes in when quarantine is needed and for how long and points health care workers to other resources.
- The CDC has updated its overview and information about the Moderna vaccine to reflect its full approval by the FDA. It also has updated its fact sheet for the vaccine’s recipients and their caregivers.
- The CDC has updated its data on the risk for COVID-19 infection, hospitalization, and death based on race and ethnicity.
- The CDC has updated its information about the omicron variant: how to guard against it, how it affects people infected by it, and how it is treated. It also has posted updated information about COVID-19 variants.
- The CDC has updated its information about COVID-19 booster vaccines: who needs them, which vaccine they should receive, and how the vaccine might affect them.
- The CDC has posted data on COVID-19 vaccination coverage and vaccine confidence based on sexual orientation and gender identity.
- The CDC has posted information about identifying, disposing of, and reporting COVID-19 vaccine waste.
- The CDC has created a new web page and materials for health care professionals serving pregnant and postpartum patients. Find the CDC’s announcement about the new web page here and go here to see the page itself.
Food and Drug Administration
- The FDA has granted full approval for the Moderna COVID-19 vaccine, removing the “emergency use authorization” descriptor that has always accompanied it. The approval is for use in individuals 18 years of age and older. Moderna intends to market the vaccine as “Spikevax.” Learn more about the approval, including the FDA’s rationale for issuing it, in this FDA news release.
- The FDA has added the first four bulk drug substances to the list of bulk drug substances that may be used in compounding by outsourcing facilities. Learn more from this FDA news release and a notice in the Federal Register.
National Institutes of Health
- The FDA has announced that it is sponsoring and funding a study to assess the antibody response to an additional dose of a COVID-19 mRNA vaccine in kidney and liver transplant recipients, either alone or with a concurrent reduction in immunosuppressive medication. The clinical trial will enroll people for whom two to four doses of a COVID-19 mRNA vaccine did not elicit a detectable antibody response.
MedPAC and MACPAC
- The Medicare Payment Advisory Commission (MedPAC) and Medicaid and CHIP Payment and Access Commission (MACPAC) have released a newly updated data book: “Beneficiaries Dually Eligible for Medicare and Medicaid.” This book quantifies the dually eligible population’s composition, service use, and spending in 2019; compares subgroups of dually eligible beneficiaries, including those with full versus partial benefits and those under age 65 versus those ages 65 and older; and compares dually eligible beneficiaries with non-dually eligible Medicare and Medicaid beneficiaries.
The Patient-Centered Outcomes Research Institute (PCORI)
- PCORI, an independent non-profit, non-governmental organization funded by the federal government, has launched a health systems implementation initiative. This is a dissemination and implementation program through which PCORI will provide up to $50 million in funding over five years to participating health care delivery systems and provider-affiliated health plans to undertake implementation projects directly in their care delivery settings. Learn more about the program and funding opportunity here. PCORI’s call for proposals will open on February 15.
Center for Medicare & Medicaid Innovation Listening Session – February 9
CMS’s Center for Medicare and Medicaid Innovation (CMI) will hold a listening session titled “Incorporating Beneficiary Perspectives into Model Testing, Implementation, and Evaluation” on Wednesday, February 9 at 2:00 (eastern). During the session, representatives from patient advocacy groups and foundation and research experts will share insights on how CMMI can incorporate beneficiary perspectives into model testing, implementation, and evaluation. Learn more about the session, including how to submit questions beforehand and register to participate, from this CMMI notice.
CDC – Multisystem Inflammatory Syndrome in Children (MIS-C) – February 10
The CDC will hold a clinician outreach call on what clinicians need to know about multi-system inflammatory syndrome in children (MIS-C) on Thursday, February 10 at 2:00 (eastern). MIS-C is a rare but severe condition associated with COVID-19 infection. Learn more about the event, the presenters, and how to join the call in this CDC announcement.
CMS – February 17 and March 31
CMS will hold public listening sessions on transitional coverage for emerging technologies on Thursday, February 17 at 3:00 (eastern) and Thursday, March 31, also at 3:00 (eastern). The purpose of these sessions is to obtain feedback to help inform CMS’s development of an alternative coverage pathway to provide transitional coverage for emerging technologies following the repeal of the January 2021 Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule. For additional information about the listening sessions and to register to participate, go here.
CMS – Provider Compliance Group – February 24
On Thursday, February 24 at 1:00 (eastern), CMS’s Center for Program Integrity’s Provider Compliance Group will offer interactive virtual presentations to address medical review and claims issues and help providers stay informed about the latest policies, programs, and activities. It also will solicit feedback via a question-and-answer session during this event about what the agency can do to communicate better, improve its processes, and eliminate unnecessary requirements. Go here to learn more and register. Registration closes on February 18.