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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Healthcare groups react to prior authorization proposed rule

Healthcare groups are largely excited by a new proposed rule from the Centers for Medicare and Medicaid Services (CMS) that aims to streamline prior authorization and reduce burden on healthcare providers.

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.

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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.

 

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Around the web

Cardiovascular Business
Cardiology groups cheer new bill that would improve access to Medicare claims data

If passed, this bill would help clinician-led clinical registries explore Medicare data for research purposes. The Society of Thoracic Surgeons and American College of Cardiology both shared public support for the bipartisan legislation. 

Cardiovascular Business
Watchdog group, fearful of fraud, wants more oversight for remote patient monitoring

Cardiologists and other physicians may soon need to provide much more information when ordering remote patient monitoring for Medicare patients.

Cardiovascular Business
Most recalled cardiovascular devices gained FDA approval with little to no clinical evidence

Why are so many cardiovascular devices involved in Class I recalls? One possible reason could be the large number of devices hitting the market without undergoing much premarket clinical testing. 

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