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. 

FDA to modernize, finalize 510(k) clearance pathway for medical devices

The FDA has announced plans to modernize and finalize its 510(k) clearance pathway as part of a continuing effort to advance the review of safety and effectiveness of medical devices, according to a recent statement from FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health (CDRH).

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CMS proposes new Medicare prescription drug rules

CMS proposed several new policies for 2020 that aim to lower prescription drug prices by revising how Medicare plans can cover medicines and negotiate prices.

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CVS-Aetna deal approved by all regulators

CVS Health received the final approval for its $69 billion merger with the nation’s third-largest health insurance provider, Aetna, on Nov. 26. CVS expects the deal to close Nov. 28, according to a new public filing.

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CMS reapproves Medicaid work requirements in Kentucky

After a federal judge blocked Kentucky’s Medicaid work requirements from going into effect earlier this year, CMS reapproved the program on Nov. 20.

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Health insurer based benefits on sleep habits

Health insurers are using new methods to monitor consumers enrolled in their plans, as one person discovered when his sleep habits unknowingly played a role in the benefits he received from his provider, ProPublica reported.

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Kentucky lawmakers announce bipartisan bill to let radiologists diagnose black lung cases again

State Reps. Angie Hatton and Robert Goforth have pre-filed legislation to roll back portions of Kentucky’s House Bill 2, which barred federally certified radiologists from reading x-rays in black lung compensation cases.

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Lawmakers to introduce bill to lower drug prices

Senator Bernie Sanders (I-Vt.) and U.S. Representative Ro Khanna (D-Calif.) are planning to introduce a bill that aims to “drastically” lower prescription drug prices once Congress is back in session.

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CVS-Aetna deal now likely to close after Thanksgiving

While the $69 billion merger between CVS Health and Aetna has moved through the regulatory review process, CVS executives now expect the deal to close after Thanksgiving, according to a new public filing. Executives previously anticipated the transaction would be completed before the holiday.