The Food and Drug Administration (FDA) announced last Thursday that A COVID-19 breathalyzer test with the ability to provide diagnostic results in three minutes has won FDA emergency use authorization. The test, made by Frisco, Texas-based InspectIR Systems, is authorized for those 18 and older and in settings where samples are both collected and analyzed, such as doctor’s offices, hospitals, or mobile testing sites. The device is about the size of a piece of carry-on luggage, the FDA said and works by detecting chemical compounds in breath samples associated with SARS-CoV-2 infection.

The 2022 Healthy Grants Workshop web series is for current HRSA award recipients and will offer multiple presentations on how to successfully manage your HRSA award. In addition to presentations by HRSA’s Office of Federal Assistance Management, this year’s workshop will feature presentations by the Grants Quality Service Management Office and the Office of the Inspector General. Other HRSA bureaus and offices will also be present, including the Office of Civil Rights, Diversity, and Inclusion and the Office of Information Technology.

The Federal Trade Commission (FTC) recently announced it is soliciting public input on the ways that practices by large, vertically integrated pharmacy benefit managers (PBMs) are impacting prescription drug affordability and access. The Request for Information (RFI) covers a wide range of issues, including contract terms, rebates, fees, pricing policies, steering methods, conflicts of interest, and consolidation. NACHC’s long template and short template letters raise a concern about PBMs’ unfair and anti-competitive business practices that impede health centers’ ability to serve the most vulnerable patients. The templates also discuss how PBMs target 340B covered entities and institute discriminatory practices pickpocketing 340B savings. Comments are due by May 25 on regulations.gov.

Consumers must verify sources of income for some types of coverage. Pennie has created a Self-Attestation Form for consumers with no documentation available. The document requires projected yearly annual income for consumers to receive financial assistance to pay for health coverage. The attestation acknowledges that consumers provide financial information to be used for the determination of eligibility, must report income changes within 30 days, and understand that if they receive too much Advance Premium Tax Credit (APTC) during the benefit year, they may have to pay some or all of the excess back to the IRS when federal income taxes are filed for the benefit year. Documents can be submitted via email, fax or mail.

Consumers have new billing protections when getting emergency care, non-emergency care from out-of-network providers at in-network facilities, and air ambulance services from out-of-network providers. Through the No Surprises Act, new rules aimed to protect consumers, excessive out-of-pocket costs are restricted, and emergency services must continue to be covered without any prior authorization, regardless of whether or not a provider or facility is in-network. Previously, if consumers had health coverage and got care from an out-of-network provider, their health plan usually would not cover the entire out-of-network cost. This left many with higher costs than if they had been seen by an in-network provider. This is especially common in an emergency, where consumers might not be able to choose the provider. Even if a consumer goes to an in-network hospital, they might get care from out-of-network providers at that facility. For more, view this article

Sections 120 and 402 of the Consolidated Appropriations Act, 2021 (CAA) made two key changes to Medicare enrollment rules.

First, Medicare coverage will become effective the month after enrollment for individuals enrolling in the last three months of their initial enrollment period or in the General Enrollment Period, thereby reducing any potential gaps in coverage. Currently, if individuals enroll in Medicare in the last three months of their Initial Enrollment Period or in the General Enrollment Period, they may have to wait several months for Medicare coverage to begin.

Second, the proposed rule also establishes a new immunosuppressive drug program that would extend Medicare immunosuppressive drug coverage to certain individuals who have had a kidney transplant. If finalized, the proposed rule would promote accessibility to vital life-saving drugs.

This rule, if finalized, would become effective January 1, 2023, and implement changes made by the CAA

Press Release: https://www.cms.gov/newsroom/press-releases/cms-proposes-updates-reduce-barriers-coverage-simplify-medicare-enrollment-and-expand-access

Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/implementing-certain-provisions-consolidated-appropriations-act-2021-and-other-revisions-medicare-1

Federal Register: https://www.cms.gov/files/document/cms-4199-p.pdf

Medicare enrollees who have limited income and resources may get help paying for their premiums and out-of-pocket medical expenses from Medicaid. Eligibility is based on the 2022 Federal Poverty Limits. Medicaid also covers additional services provided under Medicare, including nursing facility care beyond the 100-day limit or skilled nursing facility that Medicare covers, prescription drugs, eyeglasses, and hearing aids. Services covered by both programs are first paid by Medicare with Medicaid filling in the difference up to the state’s payment limit. For more information consumers can contact their local PA MEDI Office, formally APPRISE.

Politico reports that the Department of Health and Human Services (HHS) is preparing to scrap a Trump-era rule that allows medical workers to refuse to provide services that conflict with their religious or moral beliefs. The so-called conscience rule, unveiled in 2018 and finalized in 2019, was blocked by federal courts after dozens of states, cities, and advocacy groups sued and has never been implemented. Had it gone forward, it would have allowed doctors, nurses, medical students, pharmacists, and other health workers to refuse to provide abortions, contraception, gender-affirming care, HIV and STD services, vasectomies, or any procedure to which they object.

Pennsylvania limits the opportunity to serve as governor to two terms and Gov. Wolf is in the last year of his second term. Consequently, as with previous administrations, this means that key members of the team are leaving as opportunities present. The newest departure is Keara Klinepeter who served as acting secretary of the Department of Health since her predecessor, Alison Beam, left at the end of 2021. Gov. Wolf announced that his physician general, Dr. Denise Johnson, will take over the leadership of DOH. Read more.

A bipartisan bill in Harrisburg aims to permanently allow pharmacists and trained pharmacy staff members to vaccinate children. The temporary privilege is set to expire whenever the COVID-19 public health emergency ends. Read more.