CMS Recommends Cost Savings Be Passed Along to Medicare Part B Beneficiaries

The US Centers for Medicare & Medicaid Services (CMS) recently released a report recommending that cost savings from lower-than-expected Medicare Part B spending be passed along to individuals with Medicare Part B coverage in the calculation of the 2023 Part B premium.

CMS’s recommendations are based upon the development of the Part B premium and the potential effects of factors that have changed since a premium was announced on a drug used for the treatment of Alzheimer’s disease. CMS builds in a reserve to ensure the Medicare Supplementary Medical Insurance (SMI) Trust Fund remains adequately financed for the year. In 2021, CMS built in a reserve to ensure the SMI Trust Fund could cover the potential costs of the Alzheimer’s disease drug and similar drugs.

Read McDermott’s latest Healthcare Regulatory Check-Up newsletter here.




Monkeypox Declared a National Public Health Emergency

On August 4, 2022, the Biden administration declared monkeypox a public health emergency (PHE), a step that will allow the federal government to work with more agility to combat the spreading outbreak, including via expedited vaccine distribution and expanded testing.

The PHE declaration follows the recent appointment of federal officials to head up the monkeypox response team, including Robert Fenton of the Federal Emergency Management Agency as White House national monkeypox response coordinator, and Dr. Demetre Daskalakis of the US Centers for Disease Control and Prevention as White House national monkeypox response deputy coordinator.

The administration also began holding what will be a recurring weekly briefing with congressional staff on August 4. A press release from the US Department of Health and Human Services (HHS) on the PHE declaration can be found here.

Read more here.




Navigating Data Privacy Questions Post-Dobbs

The US Supreme Court’s recent decision to overturn Roe v. Wade in Dobbs v. Jackson Women’s Health Organization has raised many questions about potential efforts by law enforcement agencies to obtain data from healthcare and other service providers to detect the performance of a possibly unlawful abortion. For example, data collected by period-tracking apps, patients’ self-reported symptoms, or diagnostic-testing results might be used to establish the timeframe in which an individual became pregnant, and then demonstrate that a pregnancy was terminated, as part of investigative or enforcement efforts against individuals or organizations allegedly involved in such termination.

On June 29, 2022, the office within the US Department of Health and Human Services (HHS) that is responsible for enforcing the Health Insurance Portability and Accountability Act (HIPAA), the Office for Civil Rights (OCR), issued guidance addressing how HIPAA limits disclosures by covered entities and business associates to law enforcement agencies in the absence of a court order or other legal mandate. The guidance provides helpful insight on how OCR may use HIPAA enforcement to discourage unauthorized disclosures of protected health information (PHI) to law enforcement officials in the wake of new state laws outlawing abortion. The guidance also implicitly confirms, however, that HIPAA does not provide a complete shield against law enforcement and litigation-driven requests for abortion-related information.

Read more here.




No Surprises Act to Prevent Millions of Surprise Bills

Effective January 1, 2022, the No Surprises Act protects healthcare consumers from surprise medical billing under certain circumstances. 

Two health insurance advocacy organizations recently surveyed more than 80 commercial health insurance companies and received responses from 31 companies, which collectively represent 115 million commercial health plan members. These companies reported receiving 600,000 claims covered by the No Surprises Act (NSA) in January and February 2022. However, based on claims experiences from prior years and factoring in processing delays this year, the two organizations estimate the true number of NSA-eligible claims in the first two months of 2022 was actually more than 2 million. The two organizations project that the No Surprises Act could prevent more than 12 million surprise bills in 2022 alone.

Read more here.




US House Passes Telehealth Extension Through 2024

The US House of Representatives approved a bipartisan bill that would extend Medicare telehealth flexibilities through the end of 2024; immediate US Senate action on the bill is unlikely, however.

On July 27, 2022, the US House of Representatives approved the Advancing Telehealth Beyond COVID-19 Act (H.R. 4040) by a wide bipartisan margin of 416–12. This bill would extend Medicare telehealth flexibilities through the end of 2024, including geographic and originating site flexibilities, expanded eligible practitioners, reimbursement for federally qualified health centers and rural health clinics, delay of the in-person telemental health requirement, continued use of audio-only telehealth and flexibility to use telehealth to satisfy Medicare face-to-face requirements.

Immediate US Senate action on H.R. 4040 is not likely, as the Senate is working on other priorities heading into the August recess. In addition, given the limited number of legislative days on the calendar before the midterm elections, additional action on telehealth extensions is more likely to occur during Congress’s lame-duck session at the end of the year. These same provisions were extended for 151 days beyond the end of the public health emergency (PHE) through the enactment of the Consolidated Appropriations Act of 2022, making it less urgent for Congress to act on an extension before the end of the year—although this bill has significantly increased chances of Congress doing so.

Read more here.




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