My colleague Lee T. Polk authored Epstein Becker Green’s recent issue of its Take 5 newsletter. This Take 5 features five considerations suggesting the advantages of employee benefit plans as programs that are beneficial to both employers and employees.
- Tax Aspects of Qualified Retirement Plans Can Save Money For Both Employers and Employees
- The Benefits of a Contractual Claims Limitation Period
- The Benefits of a Contractual Venue Selection Clause
- The Standard of Judicial Review in the Context of Top Hat Plan Benefit Disputes
- Fiduciary Exception to the Attorney-Client ...
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:
- Deleted the provision exempting certain payments to CME providers from the reporting requirements;
- Added three new forms of payment designations;
- Made the reporting of the marketed name of a covered device no longer optional; and
- 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 ...
As Ebola has become a worldwide threat, the U.S. Government has provided guidance to prepare numerous agencies and entities that may become involved or affected by Ebola. On November 7, 2013, the Office of Personnel Management (OPM) issued guidance to Federal Employee Health Benefit Program (FEHBP) carriers on their responsibilities for handling members who have been exposed to or infected with the Ebola virus. FEHB Program Carrier Letter No. 2014-26 is available at http://www.opm.gov/healthcare-insurance/healthcare/carriers.
OPM instructs carriers that special ...
Late last month, the FDA finalized a new guidance document, explaining the agency's current thinking on the circumstances that may arise in connection with an establishment inspection that it would consider to impose an inappropriate limitation on its inspection authority. The Food and Drug Administration Safety and Innovation Act (FDASIA) deems a drug or medical device adulterated if it has been manufactured processed, packed, or held in any factory, warehouse, or establishment that delays, denies, or limits an inspection, or refuses to permit entry or inspection.
The ...
Everyone is talking about Ebola, including the risk of contracting it, treatment for those who do contract it, and protection for those who treat patients who have it. There has been very little discussion, though, about how to pay for the costs of treating Ebola patients, including whether health insurance will cover the treatment and pay the providers.
Most health insurance coverage that complies with the ACA minimum essential coverage standards will cover the costs of medically necessary hospitalization and physician services. However, many of those policies have significant ...
In something of a surprise, the Supreme Court today granted certiorari 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. In doing so, the Supreme Court rebuffed the Solicitor General's request that the Court decline cert. as various cases worked their way through the Courts of Appeals.
It was only a few days ago that the government had filed a brief in ...
On October 29, 2014, the Office of Medicare Hearings and Appeals ("OMHA") hosted its second Medicare Appellant Forum ("Forum") to address the status of the Medicare appeals backlog and related processing delays of Administrative Law Judge ("ALJ") appeals, which are the third level of the Medicare appeals process that is available to suppliers, providers, and Medicare beneficiaries to challenge denied claims. Last week's Forum was a follow-up to OMHA's February 2014 Appellant Forum, which offered few assurances to stakeholders at the time that any effective remedies to the ...
The Ebola virus disease (“Ebola”) has become a worldwide threat, which, among many other effects, has forced employers to think about how to protect their employees. Employers also must consider how Ebola might impact employment policies and procedures, including, but not limited to, those addressing attendance, leaves of absence, discipline, and medical testing.
My colleagues and I have written a detailed Act Now advisory providing legal framework of best practices and legal risks pertaining to Ebola.
Click here to read the advisory in its entirety.
WHEN: November 17, 2014
TIME: 2:00pm – 3:30pm EST
To register for this webinar, please click here.
Please join us for a complimentary webinar addressing the professional and business challenges encountered by health care providers dealing with Ebola and other infectious diseases. This webinar will offer a clinical overview as well as a review of the guidelines which offer protocols for addressing concerns over Ebola and similar diseases, the health regulatory and risk management issues providers might consider in developing a response strategy, and the resulting labor and ...
WHEN: November 17, 2014
TIME: 2:00pm – 3:30pm EST
To register for this webinar, please click here.
Please join us for a complimentary webinar addressing the professional and business challenges encountered by health care providers dealing with Ebola and other infectious diseases. This webinar will offer a clinical overview as well as a review of the guidelines which offer protocols for addressing concerns over Ebola and similar diseases, the health regulatory and risk management issues providers might consider in developing a response strategy, and the resulting labor and ...
Who knew?! Buried among more than 1,000 pages of a new final rule with comment period on payments to physicians, released on October 31, 2014, the Centers for Medicare & Medicaid Services (“CMS”) finally has given telehealth providers a glimpse of its plans to expand reimbursement for telehealth services provided to Medicare beneficiaries.
The final rule includes a provision that would cover remote chronic care management using a new current procedural terminology (“CPT”) code, 99490 (with a monthly unadjusted, non-facility fee of $42.60). This new CPT code can be ...
As you may recall, a DC Circuit panel held that the Affordable Care Act makes federal premium tax credits available to taxpayers only in States where the State has established an exchange – which is what the ACA literally provides. On the same day, the Fourth Circuit issued a contrary decision in King v. Burwell, accepting the government's argument that where HHS sets up an exchange in a State, that is a State exchange. The same argument is being made by the appellant (the government lost in District Court) in Oklahoma ex rel. Scott Pruitt v. Burwell, which is pending before the 10th ...
In early October, FDA held a public workshop to discuss the challenges of regulating medical devices made through additive manufacturing (also known as 3-D printing). Additive manufacturing gives designers the ability to build devices directly from 3-D images, like patient CT or MRI scans. As the push toward personalized medicine continues, 3-D printed devices hold incredible potential for advancing the ball. While additive manufacturing isn't completely mainstream yet, FDA and industry stakeholders expect to see major growth in this field in coming years. Experts project ...
Epstein Becker Green is pleased to announce that Valerie Butera, an accomplished Occupational Safety & Health (OSHA) lawyer, has joined as a Member of the Firm based in the firm's Washington, D.C., office. Valerie is OSHA 30 certified and has substantial training and experience in process safety management (PSM). Valerie represents clients from numerous industries, including health care and life sciences and focuses on OSHA and other workplace safety and health issues. For more information, click here.
The Ebola virus disease ("Ebola") has become a worldwide threat, which, among many other effects, has forced employers to think about how to protect their employees. Employers also must consider how Ebola might impact employment policies and procedures, including, but not limited to, those addressing attendance, leaves of absence, discipline, and medical testing.
Employers are generally tasked with maintaining safe and productive workplaces for their employees, and the Ebola scare has brought many challenges in this regard. In particular, employers' desire to maintain safe ...
In response to the ongoing threat of the Ebola Virus Disease ("EVD" or "Ebola") and the increased risk of individuals traveling from the affected countries to the United States, The Joint Commission recently launched an Ebola Preparedness Resources portal on its website. The portal contains information addressing various safety actions for health care providers to consider, such as ensuring that all staff and clinicians who may come in contact with Ebola patients are educated and trained on Ebola guidance, re-evaluating infection control plans to ensure proper guidelines ...
Blog Editors
Recent Updates
- HHS Extends the Antidiscrimination Provisions of the Affordable Care Act to Patient Care Decision Support Tools, Including Algorithms
- It’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs) as Medical Devices Has Arrived
- Medical Clinic’s Use of NDAs to Suppress Negative Online Reviews Violates Federal Consumer Review Fairness Act, Washington Federal Judge Finds
- Breaking Down the Legal Challenges Surrounding State Licensure Restrictions for Telehealth Providers
- Interested in Opening a Medical Spa? Here’s What You Need to Know