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.

Mangione now faces federal charges, death penalty in murder of UHC CEO
After Luigi Mangione, the man accused of killing UnitedHealthcare CEO Brian Thompson, was extradited to New York, federal prosecutors unsealed a new set of murder charges.
FDA issues Class I recall on counterfeit infusion pump batteries
ICU Medical alerted customers to knockoff batteries being circulated by suppliers. Due to a risk of the batteries not holding a charge, the recall has been given the FDA’s most serious designation.
FDA issues alert on PCNL sheath safety after patient death
Trokamed sent a letter to customers warning them to never use its Mini PCNL Sheaths for suction and irrigation, due to a risk of kidney rupture.
DOJ sues CVS over unlawful opioid prescriptions and reimbursement
The U.S. Department of Justice said policies at CVS Health forbade pharmacists from discussing patients and providers who may be prescribing opiates in violation of the Controlled Substance Act.
FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders
The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

New Republican healthcare bill keeps parts of ACA while repealing mandates

Rather than attempting to fully repeal the Affordable Care Act, a new proposal from two Republican members of Congress would keep certain provisions while getting rid of mandates on individuals to have insurance and for employers to provide it.

May 24, 2016

Minn. county complains about cost of 'ineffective' IT system

Hennepin County, the most populous county in Minnesota, said it will be forced to hire 92 new employees because of new requirements involving the MNSure health insurance exchange, which the county labels “an ineffective system,” reported the Minneapolis Star-Tribune.

May 24, 2016

State news roundup: Vt. mandates vasectomy coverage, Medicaid expansion dead in Okla.

Here are some highlights of healthcare news from Vermont, Oklahoma, Minnesota and Arizona.

May 24, 2016

Telemedicine may take advantage of Supreme Court ruling on med boards

Individual members of state medical boards can be sued for antitrust violations thanks to the Supreme Court’s decision in North Carolina State Board of Dental Examiners v. Federal Trade Commission, which has now led to at least five such suits against health licensing boards across the country,

May 23, 2016

CMS: Small, rural practices can ‘soon’ apply for $100M in technical MACRA assistance

Seeking to ease the fears for small and rural practices of being penalized under the new Merit-based Incentive Payment System (MIPS), CMS plans to soon release its request for proposals for the $100 million in technical assistance provided for those practices.

May 23, 2016

Syphilis patients may be most affected by penicillin shortage

Pfizer’s “unanticipated manufacturing delay” involving the recommended treatment for syphilis will pose problems for the growing number of patients with the sexually transmitted infection.

May 23, 2016

Okla. lawmakers may challenge veto on bill to jail physicians for abortions

Despite being vetoed by Republican Okla. Gov. Mary Fallin, state legislation to imprison and strip medical licenses from physicians who perform abortions isn’t dead yet.

May 23, 2016

State news roundup: Ill. considers managed care audit, Okla. may strip licenses over abortions

Here are some highlights of healthcare news in Illinois, Oklahoma, Oregon, New Hampshire, Kansas and Mississippi.

May 20, 2016

Around the web

Cardiovascular Business

FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

AI in Healthcare

From Capitol Hill to a hospital near you? 5 federal recommendations for healthcare AI policy

The 24 members of the House Task Force on AI—12 reps from each party—have posted a 253-page report detailing their bipartisan vision for encouraging innovation while minimizing risks.

Cardiovascular Business

Merck spends up to $2B to license new weight loss drug with potential heart benefits

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met.