Health Care

In a blow to government efforts to regulate the 340B Drug Discount Program, U.S. District Judge Rudolph Contreras has ruled that HRSA lacks regulatory authority to promulgate regulations expanding access to 340B discounts for so-called orphan drugs.

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments. 

In the largest Health Insurance Portability and Accountability Act (HIPAA) settlement to date, two New York hospitals have agreed to pay $4.8 million to settle allegations that they failed to secure thousands of patients' electronic protected health information (ePHI) held on their shared network.

The FDA will hold a public workshop on May 13-15, 2014, to discuss the Proposed Strategy and Recommendations for a Risk-Based Framework issued by the Food and Drug Administration, National Coordinator for Health Information Technology, and Federal Communications Commission on April 3, 2014.

The FDA will hold a public workshop on May 13-15, 2014 to discuss the long-awaited report (the “Report”) issued on April 3, 2014 by the three federal agencies charged with regulating health information technology (“health IT”), the Food and Drug Administration (“FDA”),1 The Office of the Nation Coordinator for Health Information Technology (“ONC”)2 and the Federal Communications Commission (“FCC”)3 (collectively, the “Agencies”).

Last week, HHS’s Office of the Assistant Secretary for Planning and Evaluation published a Report offering health plan enrollment data for the state-based insurance marketplaces authorized by the Affordable Care Act (“Marketplaces”).

The Connecticut State Senate recently passed a bill that would impose additional disclosure and consent requirements on retailers offering pharmacy rewards programs to consumers.  If the bill passes the Connecticut House and becomes law in its current form, violations would expose retail providers of such programs to suit under the state’s consumer protection laws as soon as July 1, 2014.

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

On April 26, 2014, the Federation of State Medical Boards (“FSMB”) adopted a Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine (the “Model Policy”). 

Last week, our colleague Julie Korostoff posted on Mintz Levin’s Technology Matters blog recommendations for improving ongoing relationships with health IT vendors.  These suggestions are particularly helpful for providers working with vendors to meet certain meaningful use requirements. 

This week, the Sixth Circuit unanimously upheld the March 28, 2012 Federal Trade Commission (FTC) administrative decision that ordered ProMedica Health System, Inc. to divest itself of its August 2010 purchase of St. Luke’s Hospital in Lucas County, Ohio.

Two companies were hit with fines equaling a total of almost $2 million to settle alleged Health Insurance Portability and Accountability Act (HIPAA) violations involving stolen, unencrypted laptops, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced on Tuesday.

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments. 

The Accreditation Council for Graduate Medical Education (ACGME), American Osteopathic Association (AOA), and the American Association of Colleges of Osteopathic Medicine (AACOM) will be forming a unified, single accreditation system for allopathic and osteopathic physicians in 2015. 

The U.S. Department of Health and Human Services (HHS) announced on April 9th  a “historic” release of Medicare payment data to provide consumers with “unprecedented transparency on the medical services physicians provide and how much they are paid.” 

Earlier this week, CMS announced in its Final Call Letter that Medicare Advantage rates would rise an average of 0.4 percent in 2015, instead of falling 1.9 percent as proposed in February. 

The U.S. Department of Health & Human Services (“HHS”) announced last week that same-sex married couples can now qualify for Medicare Part A and Part B special enrollment periods and reductions in late enrollment penalties.

Today, the three federal agencies charged with regulating components of health information technology (“Health IT”) issued their long-awaited Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework (the “Report”). 

The Protecting Access to Medicare Act of 2014 (HR 4302), signed by President Obama yesterday, contains a number of provisions that are important to clinical laboratories.