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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10 ICD-10 Questions Physician Senators Want CMS to Answer this Week

Concerned that the Centers for Medicare and Medicaid Services (CMS) plans for front-end testing of the ICD-10 system during the week of March 3 is too brief and too limited in scope, U.S. Senators and physicians Tom Coburn, M.D. (R-Okla.), John Barrasso, M.D. (R-Wyo.), John Boozman, O.D. (R-Ark.), and Rand Paul, M.D. (R-Ky.) have requested that the Centers for Medicare and Medicaid Services (CMS) answer their questions about the testing by February 26.

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ICD-10 debate rages on

The Centers for Medicare & Medicaid Service has responded to calls for more thorough ICD-10 testing, announcing that it will conduct end-to-end testing to a small sample group of providers this summer.

CMS to conduct end-to-end ICD-10 testing this summer

The Centers for Medicare & Medicaid Service (CMS) announced that it will conduct end-to-end ICD-10 testing to a small sample group of providers this summer.

GOP senators want info on CMS ICD-10 testing plans

Another group has called federal ICD-10 testing plans into question. This time, a group of Republican senators have sent a letter to Centers for Medicare & Medicaid Administrator Marilyn Tavenner warning that inadequate testing of ICD-10 code sets could result in "system-wide errors and delay[s]" similar to those that hampered the launch of HealthCare.gov.

Legislators: FDA regulatory process outdated, hurts innovation

A few days after initiating new legislation to decrease FDA’s regulatory authority over mobile health, Sens. Deb Fischer (R-Neb.) and Angus King (I-Maine) penned an editorial in USA Today asserting that the agency’s slow regulatory processes hinder innovation.

OIG to Look For Additional Kwashiorkor Fraudulent Billing in 2014

The 2014 Office of Inspector General (OIG) Workplan promises that the agency will look for more cases of hospitals miscoding malnutrition cases in Medicare patients as cases of kwashiorkor. Already this year, the agency has reached settlements with Mercy Medical Center, in Des Moines, Iowa, and Christus Saint Vincent Regional Medical Center, in Santa Fe, N.M., over incorrect billing for kwashiorkor in a combined total of 217 patients who actually did not have the disease.

New FDA rule requires electronic reporting of adverse events

FDA has issued a final rule requiring medical device manufacturers to electronically submit reports of adverse events associated with their products.

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MU, ICD-10 in the headlines again

Meaningful Use and ICD-10 dominated the headlines again this week. It seems this could be the case most weeks this year.

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Around the web

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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.