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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Study finds newly insured will not make up for ACA cuts to Disproportionate Share Hospitals

The expansion of health insurance under the Affordable Care Act (ACA) should mean fewer uninsured patients at Disproportionate Share Hospitals (DSHs), but estimates for just how many fewer such patients would need care might have been overly optimistic finds a new study on California hospitals appearing in Health Affairs.

Cleveland Clinic executive considered for VA top job

After a controversy of excessive wait times and IT struggles at the Department of Veterans Affairs spurred the resignation of Eric Shinseki, the White House now is considering a high profile hospital executive from Cleveland Clinic to take over the beleaguered agency, reports the Wall Street Journal.

CMS: Hold off on ICD-10 front-end testing until October

Providers, suppliers, billing companies and clearinghouses should delay acknowledgement testing for ICD-10 until after Oct. 6, 2014, when Medicare is expected to update its system, according to a notice from Centers for Medicare & Medicaid Services Niall Brennan, acting director, CMS Offices of Enterprise Management.

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ONC restructures as HITECH funding dries up

The Office of the National Coordinator for Health IT is moving forward with restructuring as HITECH’s health IT infrastructure and program investments draw to a close.

OIG: Physicians make mistakes in more than half of E/M claims

According to the OIG’s review of a random sample of 657 evaluation and management (E/M) Medicare claims from 2010, more than half (55 percent) had coding and/or documentation errors. Of these, vastly more were upcoded rather than downcoded. If the sample’s findings hold true for all Medicare E/M claims, it means the government is probably overpaying for E/M services by around $6.7 billion, the OIG concluded.

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Rep. Blumenauer tries once more for Medicare benefit expansion into hospital-to-home transition services

House Rep. Earl Blumenauer (D-Ore) re-introduced his bipartisan Medicare Transitional Care Act in the 113th Congress on Thursday. The bill seeks to create a new benefit to support and coordinate care for Medicare beneficiaries as they move from the hospital setting to their homes or other care setting.

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Register now to check accuracy of industry payments CMS will attribute to you under Sunshine Act

Physicians and teaching hospitals that want the chance to review information about payments or other transfers of value they’ve received from pharmaceutical, medical device and other industry groups before this information is made public should register with the Centers for Medicare and Medicaid Services (CMS) starting Sunday, June 1, 2014.

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Court ruling ends some hospitals’ discount on orphan drugs

Rudolph Contreras, judge for the U.S. District Court for the District of Columbia, has ruled the U.S. Department of Health and Human Services acted outside of its regulatory authority when it interpreted the law covering payments for pharmaceuticals with “orphan drug” status as not applying to payments when the drug was prescribed for a condition for which it was not an “orphan drug,” such as Prozac prescribed for depression (its most common use) instead of either of Prozac’s two orphan indications.

Around the web

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 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. 

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.