Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

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UnitedHealth needs to be solely responsible for HIPAA notifications after Change Healthcare breach, letters demand

The ONC has fallen short of plainly stating that UnitedHealth is required to send the notifications, leaving providers in regulatory limbo.

There has been a growing shortage of cardiologists the past several years, but this has accelerated due to burnout from the pandemic, falling reimbursements and increasing administrative burdens. This prompted a joint session on this topic with the ACC and the Heart Rhythm Society at HRS 2024, with ACC President Cathie Biga, MSN, FACC, president and CEO of Cardiovascular Management of Illinois, former ACC president Ed Fry, MD, chair of the Ascension National Cardiovascular Service Line, and EP Parin Patel.

Addressing staffing shortages in cardiology

ACC President Cathie Biga, MSN, RN, Edward Fry, MD, and electrophysiologist Parin Patel, MD, discuss the growing cardiologist shortage.

CVS Health announces $10.6B acquisition of Oak Street Health

CVS generic drugs twice as likely to be recalled over safety concerns, investigation finds

CVS generics have been linked to more than 15 manufacturers cited for producing allegedly contaminated drugs.

Coalition seeks to simplify prior authorizations and improve Medicare Advantage coverage

More than 380 organizations have expressed support for the bipartisan Improving Seniors’ Timely Access to Care Act, which unanimously passed a House vote in 2022.

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Cardiologist-supported prior authorization reform reintroduced in Congress

The Improving Seniors’ Timely Access to Care Act has been considered by Congress multiple times, getting closer than ever in 2023. Will 2024 be the year it finally lands on the president's desk?

AMA wants insurers to be accountable when prior authorization harms patients

The American Medical Association (AMA) House of Delegates this week approved two policies aimed at increasing insurer accountability and transparency amid an explosion of prior authorization requirements.

FDA announces recall of Medline endotracheal tubes after three injuries

The Medline Sub-G endotracheal tubes with subglottic suction are defective and known to tear, potentially leading to serious injury or death.

The American Medical Association (AMA) House of Delegates today elected Bobby Mukkamala, MD, an otolaryngologist from Flint, Michigan, as president-elect of the AMA for the 2025-2026 term. Mukkamala will be inaugurated as AMA president in June 2025. Photo courtesy of the AMA

AMA elects new president heavily involved in Flint water contamination response

The American Medical Association (AMA) House of Delegates elected a new president and numerous other positions.

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Around the web

Cardiovascular Business
Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

Cardiovascular Business
Cardiologist compensation still rising, especially in invasive and interventional cardiology

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

Cardiovascular Business
FDA’s tirzepatide decision creates uncertainty for patients—and leads to a lawsuit

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

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