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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Ed Gaines, JD, CCP, vice president of regulatory affairs and industry liaison, Zotec Partners, discusses the No Surprises Act on radiology at the Radiological Society of North America (RSNA) 2022 meeting. Gaines works with RSNA on billing and Medicare issues and spoke in sessions at the RSNA 2022 meeting. Insurance companies have weaponized the No Surprises Act in an effort to cut their costs, he said.

VIDEO: Insurance companies have weaponized the No Surprises Act, may impact patient care

Ed Gaines, JD, CCP, vice president of regulatory affairs and industry liaison, Zotec Partners, discusses the impact of the No Surprises Act on healthcare and medical imaging at the RSNA 2022 meeting

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CMS proposes rule on prior authorization

Prior authorization, which requires healthcare providers to get approval from insurance providers before giving certain treatments to patients, has been long-hailed as extremely burdensome to physicians, even causing delays in patient care.

Surgeons Operating On Patient

Integra LifeSciences to acquire SIA in deal worth up to $140M

Integra LifeSciences Holding Corporation, a global medical technology company, has agreed to acquire Surgical Innovation Associates (SIA), which is known as the manufacturer of monofilament mesh for plastic and reconstructive surgery. The deal is valued up to $140 million.

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Amazon’s $3.9B acquisition of One Medical under review in Oregon

The state of Oregon is taking a hard look at the proposed acquisition of One Medical by Amazon. The deal is valued at $3.9 billion.

As FDA approaches decision on Alzheimer's drug, 2 deaths raise concerns

Japanese pharmaceutical company Eisai has denied that two deaths that have sparked concerns about a new Alzheimer's disease drug treatment are attributed to its trials.

High copays keep many heart failure patients from filling needed prescriptions

Researchers examined data from more than 900 patients, presenting their findings in the Journal of the American Heart Association.

CMS issues workplace violence memorandum for hospitals

CMS has fined hospitals in the past for failing to meet the standards of safe settings under the Medicare Hospital Conditions of Participation.

 

WHO renames monkeypox disease

Human monkeypox disease was given its name in 1970, before WHO established best practices for naming diseases in 2015.

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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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