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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Slow progress on ICD-10

While the ICD-10 delay afforded organizations an additional year to prepare for the transition, many organizations are not taking advantage of that time, reports Workgroup for Electronic Data Interchange (WEDI).

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Congress urges HHS to update HIPAA mHealth guidance

The Department of Health and Human Services is long overdue to update its HIPAA guidance to better regulate the rapidly evolving mobile health industry market, according to two House representatives.

CMS schedules three testing weeks for ICD-10

The Centers for Medicare and Medicaid Services has announced that it will hold three separate testing weeks to allow trading partners (including physician practices, hospitals and other healthcare providers) the opportunity to try out submitting claims using International Classification of Diseases, 10th Revision (ICD-10) codes.

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AHA seeks changes in House bill to reduce fraud, waste and abuse in Medicare

The American Hospital Association (AHA) this week submitted comments to the U.S. House Committee on Ways and Means, Subcommittee on Health about the Protecting the Integrity of Medicare Act (PIMA), a bill that seeks to save the government money by making it harder to successfully defraud the system.

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Pharma pushes back against CMS implication that industry is behind problems with Open Payments system

As issues continue with the Centers for Medicare and Medicaid Services (CMS) system for collecting data on industry payments to physicians and making a physician-verified version of that data available to the public by September 30, the Pharmaceutical Research and Manufacturers of America (PhRMA) industry group says don’t blame industry for data problems.

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CMS to conduct three weeks of ICD-10 acknowledgment testing

The Centers for Medicare & Medicaid Services is planning three weeks of ICD-10 acknowledgment testing for covered providers.

Beneficiaries now also suing about long wait for Medicare appeals hearings

Earlier this year, the American Hospital Association (AHA) and three hospital and healthcare systems sued the U.S. Department of Health and Human Services (HHS) over the long backlog in Medicare claim denial appeals. Now patients are joining in with a nationwide class action suit.

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Counihan to take helm of HealthCare.gov

The Centers for Medicare & Medicaid Services has hired Kevin Counihan, Connecticut’s Health Insurance Exchange CEO, to lead the national health insurance marketplace.

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.