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. 

Health IT Policy Committee’s safety workgroup convenes

The Health IT Policy Committee’s (HITPC’s) newly formed FDA Safety Innovation Act Workgroup (FDASIA) kicked off its first meeting on April 29, and began to pursue its statutory purpose: proposing strategies and recommendations for a risk-based regulatory framework for health IT that promotes innovation, protects patient safety and avoids regulatory duplication.

FDA Patient Network seeks to broaden communication channels on regulatory process

In an effort to more directly engage patients in the medical product regulatory process, the FDA launched the FDA Patient Network website on April 23.

Proposed inpatient payment rule focuses on cost, quality

The Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule that would update FY 2014 Medicare payment policies and rates for inpatient stays at general acute care and long-term care hospitals (LTCHs). Released on April 26, the proposed rule is designed to reduce the growth in healthcare costs while improving the quality of patient care, according to the agency.

AHA to ONC/CMS: Implement current programs, avoid new regulations

Instead of layering on additional regulations for exchanges, the American Hospital Association (AHA) urged the Centers for Medicaid & Medicare Services (CMS) and the Office of the National Commissioner for Health IT (ONC) to focus on facilitating the implementation of payment and delivery programs already underway in Stage 1 and Stage 2 of Meaningful Use EHR incentive programs.

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Four things to know about health IT this week

Another study indicates a disturbing lack of preparation for the transition to ICD-10, Marilyn Tavenner’s bid to be confirmed as head of the Centers for Medicare & Medicaid Services hits a roadblock and telemedicine is making great strides across the country. Those are a few things to know about health IT this week.

20% of smaller hospitals have not started ICD-10 training

Yet another survey indicates that healthcare providers are not progressing toward ICD-10 implementation at the recommended rate. One in five small- and mid-sized hospitals have not begun any education or training for the transition to ICD-10.

Senate panel approves Tavenner as CMS head but final vote is on hold

The Senate Finance Committee unanimously approved Marilyn Tavenner to head the Centers for Medicare & Medicaid Services (CMS) on April 23, but a vote by the full Senate has been blocked.

South Carolina senate committee endorses telemedicine reimbursement

The South Carolina Senate is one step closer to requiring state employee insurance plans to reimburse physicians for telemedicine diagnoses and treatments.The Senate Medical Affairs Committee approved on April 18 a bill, the South Carolina Telemedicine Act (S. 290), which requires such coverage of telemedicine services by the state public employee benefit program, and the establishment of a Telemedicine Advisory Council.

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.