AHA recommends FDA actions to ease regulation, improve device security

AHA News Now

AHA again urged the Food and Drug Administration today to allow health system pharmacies to distribute compounded products to other system facilities located more than one mile away. “The AHA is concerned that the one-mile radius limitation [included in draft guidance last year] is not workable for many... read more

Topic: Advocacy and Public Policy
Tags: Drug Compounding, Cybersecurity, regulation

FDA issues guidance on its digital health regulatory policies

AHA News Now

The Food and Drug Administration today released for comment draft guidance clarifying what types of clinical and patient decision support software would no longer be regulated by the agency as a medical device under the 21st Century Cures Act. FDA Commissioner Scott Gottlieb, M.D., said the guidance... read more

Topic: Advocacy and Public Policy
Tags: physicians, nurses, regulation

CMS proposes changes to MA, prescription drug programs

AHA News Now

The Centers for Medicare & Medicaid Services late this afternoon released a proposed rule that would make programmatic and operational changes to the Medicare Advantage and prescription drug benefit programs for contract year 2019. According to the agency, the rule would revise program regulations to... read more

Topic: Advocacy and Public Policy
Tags: Medicare, Coverage, regulation

Hospital groups file lawsuit to stop OPPS payment cut for 340B hospitals

AHA News Now

The AHA joined by the Association of American Medical Colleges and America’s Essential Hospitals today filed a federal lawsuit to prevent the Centers for Medicare & Medicaid Services from reducing Medicare payments for hospital outpatient drugs under the 340B Drug Pricing Program by nearly 30%. Eastern... read more

Topic: Advocacy and Public Policy
Tags: 340B, Medicare, regulation

340B Supports Essential Hospital Services

Blog

Millions of Americans worry about the high costs of life-saving prescription drugs. That’s why 25 years ago, Congress created the 340B Drug Pricing Program to help hospitals expand access to prescription drugs and support essential services for our most vulnerable patients.

The program constitutes less... read more

Topic: Advocacy and Public Policy
Tags: 340B, Drug Pricing Program, Medicare, access, regulation

Senators reintroduce bill to provide EHR meaningful use flexibility

AHA News Now

Sens. John Thune (R-SD), Lamar Alexander (R-TN), Mike Enzi (R-WY), Pat Roberts (R-KS), Richard Burr (R-NC) and Bill Cassidy (R-LA) today introduced the EHR Regulatory Relief Act (S. 2059), legislation that would provide regulatory flexibility and hardship relief to hospitals and eligible professionals in... read more

Topic: Advocacy and Public Policy
Tags: EHRs, Electronic Health Records, regulation

CMS issues final outpatient PPS rule

AHA News

The Centers for Medicare & Medicaid Services Nov. 1 announced it will update the hospital outpatient prospective payment system rates by 1.35% in calendar year 2018 compared to CY 2017. The rule also finalizes CMS’s proposal to drastically cut Medicare payment for drugs that are acquired under the 340B... read more

Topic: Advocacy and Public Policy
Tags: 340B, Drug Pricing Program, Medicare, regulation, home health

CMS announces initiative to reduce quality reporting burden

AHA News Now

Centers for Medicare & Medicaid Services Administrator Seema Verma today announced a “Meaningful Measures” initiative to reduce the burden of quality reporting on health care providers. “The ultimate goal of Meaningful Measures is to direct efforts on high-priority areas,” Verma said, addressing the... read more

Topic: Advocacy and Public Policy
Tags: quality, Medicare, regulation

HHS issues proposed rules for 2019 health insurance marketplaces

AHA News Now

The Department of Health and Human Services today issued proposed rules for the health insurance marketplaces for plan year 2019. HHS proposes a number of policy changes for both the individual market and the Small Business Health Options Program. The proposed changes include providing states with... read more

Topic: Advocacy and Public Policy
Tags: Coverage, regulation

Accreditor issues guidance on environmental safeguards to prevent suicide

AHA News Now

The Joint Commission today issued guidance to help hospitals and surveyors determine what constitutes adequate environmental safeguards to protect patients with suicidal ideation from self-harm. Developed by an expert panel including representatives from provider organizations and the Centers for Medicare... read more

Topic: Advocacy and Public Policy
Tags: regulation, Behavioral health, prevention

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