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. 

Federal-state MOU to integrate care for Medicare-Medi Cal beneficiaries

CMS and the California Department of Health Care Services announced on March 27 that they have entered into a Duals Demonstration Memorandum of Understanding (MOU) to integrate care for dual eligible Medicare and Medi-Cal beneficiaries as part of California’s Coordinate Care Initiative. Under the agreement, contractor plans are required to provide for Medicare and Medicaid-covered services under a capitated model of financing.

ONC platform seeks public input on health IT strategic planning

The Office of the National Coordinator for Health IT (ONC) is seeking public input as it sets out to update its Federal Health IT Strategic Plan. ONC announced that from March 25 to May 9, it is open to receiving comments on its new web platform, Planning Room, which it launched in collaboration with Cornell University.  

Woven Into the Fabric

The 2013 Healthcare Information and Management Information Society (HIMSS) annual convention was a busy, informative and insightful time in New Orleans. During the Physicians’ IT Symposium, co-hosted by AMDIS, I was particularly struck by the realization that we are at the point where the vision of the pioneers in this field has begun to be realized.

Experts urge entities to gear up for new privacy and security rules

With new Omnibus federal privacy and security rules effective March 26 with an upcoming compliance date of Sept. 23, two privacy experts urged covered entities to build an action plan and design an implementation timeline to ensure they are prepared. 

Grant aimed to expand efforts to use healthcare wisely

The Institute for Clinical Systems Improvement (ICSI) and the Minnesota Health Action Group (The Action Group) are among 21 state medical societies, specialty societies and regional health collaboratives that have received grants from the ABIM Foundation to help physicians engage patients in conversations aimed at reducing unnecessary medical tests and procedures.

ONC updates approved test methods

The Office of the National Coordinator for Health Information Technology (ONC) has released an update of its approved test methods for clinical quality measures under the 2014 Edition of the Meaningful Use program.

A closer look at the CMS eHealth initiative

The Centers for Medicare & Medicaid Services recently launched its new eHealth initiative, designed to align the various quality and reporting projects facing providers, including ICD-10, Meaningful Use, physician quality reporting and e-prescribing.

FDA to Congress: Final mobile medical app guidance coming by end of fiscal year

In the third of three Senate Energy & Commerce Committee hearings on health IT, Christy Foreman, director of device evaluation in FDA’s Center for Devices and Radiological Health, promised the release of the agency's final guidance on its oversight over medical mobile apps (MMAs) by the end of this fiscal year. Looming regulatory uncertainty dominated discussion with healthcare and mobile industry witnesses during the past two hearings, with many urging FDA to finalize its 2011 draft guidance detailing its oversight approach.

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.