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.

Six hospital groups urge UnitedHealth to take responsibility for Change Healthcare hack notifications
In a public letter, the groups are urging UnitedHealth Group to announce a timeline for notifying patients about what personal data was stolen in the breach of Change Healthcare's systems.
Ohio doctor gets 7 years in prison for violating Controlled Substances Act
The Department of Justice said Thomas Romando, MD, illegally prescribed over 137,000 pills to nine patients over a five-year period.
UPMC settles $38M whistleblower lawsuit for Medicare fraud
Surgeons at the health system were accused of performing unnecessary procedures and receiving bonuses as kickbacks. UPMC does not admit wrongdoing.
FDA announces new recall of delivery catheters after patient’s death
The recall includes specific lots of five different medical devices used to treat stroke and other neurovascular diseases.
FDA warns against use of troubled heart devices, citing ‘continued concerns’ after multiple recalls
The agency is urging healthcare providers to transition away from these devices and seek out alternatives. It is even working with other manufacturers to try and get similar products on the market as quickly as possible.

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

December 7, 2022

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.

December 7, 2022

Tiny fragments of plastic are commonly found deep inside the human body. Heart surgery, it seems, is one of many ways these microplastics are reaching their destination. 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.

December 5, 2022

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.

December 2, 2022

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.

December 2, 2022

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.

December 1, 2022

Survival on the rise among high-risk pulmonary embolism patients.

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.

November 29, 2022

WHO renames monkeypox disease

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

November 28, 2022

Around the web

Cardiovascular Business

FDA announces new recall of delivery catheters after patient’s death

The recall includes specific lots of five different medical devices used to treat stroke and other neurovascular diseases.

Cardiovascular Business

FDA warns against use of troubled heart devices, citing ‘continued concerns’ after multiple recalls

The agency is urging healthcare providers to transition away from these devices and seek out alternatives. It is even working with other manufacturers to try and get similar products on the market as quickly as possible.

Cardiovascular Business

The push for an independent cardiology board continues

Jeffrey Kuvin, MD, one of the leading voices behind efforts to create a new Board of Cardiovascular Medicine, spoke with Cardiovascular Business about where things stand today.