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.

The neverending policy issue

The big health IT news this week is the likelihood that National Coordinator Karen DeSalvo, MD, MPH, MSc, is likely moving on now that she’s been nominated as assistant secretary of the Department of Health and Human Services.

May 8, 2015

Survey finds providers skeptical of training, readiness for ICD-10

Another ICD-10 readiness survey finds that just 11 percent of respondents are "highly confident" their employees will be adequately trained and 13 percent are "highly confident" their business will be prepared.

May 6, 2015

Bill aims to prevent switch to ICD-10

It's not over yet folks--a bill has been introduced in the U.S. House of Representatives that would prohibit the Secretary of the Department of Health and Human Services from replacing ICD-9 with ICD-10.

May 5, 2015

Less than one-third have conducted ICD-10 revenue impact testing

Just over a quarter (28 percent) of respondents of a survey about ICD-10 readiness have performed revenue impact testing, according to software testing firm QualiTest. 

April 30, 2015

Allscripts exec on ICD-10: 'Appropriate calm'

CHICAGO—Finally. It is finally time for ICD-10. Implementation will happen on Oct. 1 and “for the majority, I think it will go off without a hitch,” said John Beck, Allscripts vice president of revenue cycle solutions, speaking to Clinical Innovation + Technology.

April 19, 2015

Latest WEDI ICD-10 readiness survey shows delay didn't help

The latest ICD-10 readiness survey from the Workgroup for Electronic Data Interchange (WEDI) found that many organizations did not take advantage of the additonal time afforded by the one-year implementation delay.

April 6, 2015

American Hospital Association CEO agrees with SGR repeal legislation

American Hospital Association CEO Rich Umbdenstock sent letters to members of Congress on March 24 saying the organization agreed with bipartisan legislation to repeal the Sustainable Growth Rate (SGR) formula.

March 25, 2015

More than 16 million uninsured people gain coverage since 2010

Since the passage of the Patient Protection and Affordable Care Act five years ago, 16.4 million uninsured people have obtained coverage.

March 19, 2015

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.