Health Law Advisor

On November 13, 2014, the Health Resources and Services Administration ("HRSA") announced its plans to abandon the much anticipated "mega-reg" amid questions concerning HRSA's rule-making authority.  The "mega-reg" was expected to provide much needed clarity to the 340B drug discount program (the "340B Program") by addressing, among other things, the definition of an eligible patient, compliance requirements for contract pharmacy arrangements, hospital eligibility, and criteria for hospital off-site facilities.

HRSA submitted draft regulations to OMB in April 2014 ...

On November 13, 2014, the Food and Drug Administration ("FDA") announced a proposed study on spousal influence on consumer understanding and responses to direct-to-consumer prescription drug advertisements.  FDA notes that consumers are often thought of as individual targets for prescription drug advertisements, without considering the social contexts in which many treatment decisions are made.  For example, FDA notes that when spouses view an ad together a spouse "may influence their partner by expressing concern about risk and sides effects that might occur ...

Epstein Becker Green's slides from the "Eye on Ebola: A Discussion About the Health Regulatory, Risk Management, and Labor and Employment Issues Impacting Health Care Providers" webinar is featured on the American Hospital Association's Ebola Preparedness Resources - click here.

The November 17 webinar addressed the professional and business challenges encountered by health care providers dealing with Ebola and other infectious diseases, and featured 4 fantastic speakers.

• Bruno Petinaux, M.D., Associate Professor, Co-Chief of the Emergency Management Section ...

Epstein Becker Green’s slides from the “Eye on Ebola: A Discussion About the Health Regulatory, Risk Management, and Labor and Employment Issues Impacting Health Care Providers” webinar is featured on the American Hospital Association’s Ebola Preparedness Resources - click here.

The November 17 webinar addressed the professional and business challenges encountered by health care providers dealing with Ebola and other infectious diseases, and featured 4 fantastic speakers.

• Bruno Petinaux, M.D., Associate Professor, Co-Chief of the Emergency Management Section ...

Earlier this week the Department of Health and Human Services ("HHS") published its long awaited notice of proposed rulemaking regarding the registration of clinical trials.  The most significant change that would result from implementation of the proposed rule, and the one getting the most press, is the new requirement that results data be submitted for all applicable clinical trials, even those evaluating unapproved drugs and devices.   Although we agree that this new requirement is likely to have significant ramifications for drug, biologic and device manufacturers, here are ...

Health care employers doing business in New York City should take note of a new ordinance Mayor Bill de Blasio signed into law on October 20, 2014 – The Affordable Transit Act. 

The Affordable Transit Act (the “Act”) requires employers in New York City with 20 or more full-time employees to offer pre-tax transit benefits to employees. The Act allows employees to use up to $130 in tax free money towards their transit costs, which is the current IRS limit.  Full-time employees are defined as employees working an average of 30 hours or more per week. 

Penalties for violating the Act are ...

On November 10, 2014, FDA authorized emergency use of the RealStar® Ebolavirus RT-PCR Kit 1.0, an in vitro diagnostic device for the detection of Ebola viruses. This is the most recent in a series of measures taken by FDA in recent months to facilitate rapid access to drugs, biologics and medical devices with potential benefits in the prevention, diagnosis or treatment of infections with the Ebola virus.

Emergency Use Authorization

Pursuant to Section 564 of the Food Drug & Cosmetic Act (21 U.S. Code § 360bbb–3), The Secretary of the Department of Health and Human Services may ...

Earlier this week, the American Telemedicine Association reported an important clarification regarding the Centers for Medicare & Medicaid Services’ (“CMS’s”) plans for expanding reimbursement for telehealth services provided to Medicare beneficiaries.  The October 31, 2014 final rule with comment period regarding payments to physicians generated much excitement in the telehealth community, particularly because it opens a door, albeit only slightly, to possible Medicare coverage for remote patient monitoring services.

However, the ATA has clarified with CMS ...

On November 13, 2014, CMS published the 2015 Medicare Physician Fee Schedule ("MPFS") finalizing the following changes to the Sunshine Open Payments regulations.  The MPFS:

1. Deleted  the provision exempting certain payments to CME providers from the reporting requirements;
2. Added  three new forms of payment designations;
3. Made  the reporting of the marketed name of a covered device no longer optional; and
4. Deleted the definition of covered device.

These changes will be effective January 1, 2016, with reports to CMS in 2017.

(A summary of the final Open Payment regulations can be accessed ...

Only last week, we informed you of the Supreme Court's somewhat surprising grant of cert. in the Fourth Circuit case of King v. Burwell, in which the court of appeals had upheld the government's view that the Affordable Care Act makes federal premium tax credits available to taxpayers in all states, even where the federal government, not the state, has set up an exchange.

The Administration has taken something of a PR buffeting in the week following, after its principal ACA technical advisor's comments on this issue were made public.

In any event, we suggested that the scheduled DC ...