Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion.
Day Pitney LLP
An August 17 article in Bloomberg BNA's Privacy Law Watch and other publications, "Wellmark's Iowa ACA Exchange Exit Prompts Civil Rights Complaint," discussed an administrative complaint filed with the Department of Health and Human Services' Office for Civil Rights (OCR) by three groups representing hemophiliacs. Day Pitney's Eric Fader was quoted in the article.
Foley Hoag LLP
An appeal recently filed in the United States Court of Appeals for the First Circuit could give further clarity regarding the CMS's ability to discount Medicaid DSH payments for hospitals that received funds from Medicare and private insurers.
Womble Carlyle
Healthcare attorney Jill Girardeau recently gave IT professionals an in-depth look at navigating the increasingly complicated waters of HIPAA compliance.
Dentons
Medicare reimbursement for physician services in teaching settings is contingent on satisfying certain supervision and documentation requirements
K&L Gates
On July 20 and 21, 2017, respectively, the Centers for Medicare & Medicaid Services ("CMS") released a proposed rule addressing changes to the hospital Outpatient Prospective Payment System...
Reed Smith
Signals Trump Administration's About-Face on Obama-Era Mandatory Innovation Models
Holland & Knight
In Marlow v. New Food Guy, Inc., No. 16-1134, 861 F. 3d 1157 (10th Cir. June 30, 2017), the court affirmed the district court's ruling, consistent with Cumbie v. Woody Woo
Holland & Knight
The Usable Security & Privacy Group at Berkeley has published a website entitled AppCensus which purports to give a privacy health check for Android mobile apps.
Holland & Knight
In this memorandum, Holland & Knight's Healthcare & Life Sciences Team summarizes recent U.S. Senate action on healthcare legislation and provides an outlook on upcoming issues and possible actions.
Ostrow Reisin Berk & Abrams
Being a physician is a demanding job. It entails handling serious responsibilities, enduring long hours, navigating a complex and constantly shifting health care system and dealing with a built-in level of failure.
Holland & Knight
The Food and Drug Administration (FDA) continues to flesh out its ideas for regulation of digital health.
Dickinson Wright PLLC
Preventing unintended or unauthorized disclosure of protected health information is an ever-present goal of all covered entities and business associates.
Reed Smith
Risperdal, an antipsychotic drug prescribed to treat serious mental conditions – schizophrenia, manic depression, and autism – allegedly causes some male users to develop abnormal breast tissue growth.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
In the recently published proposed rule related to the CY 2018 Hospital Outpatient Prospective Payment System, the Centers for Medicare & Medicaid Services announced that it is considering...
BakerHostetler
When Sen. John McCain (R-Ariz.) cast the deciding vote against a slimmed-down bill eliminating parts of the ACA...
Reed Smith
Not even three weeks ago, back on July 28, we discussed the court's rigorous application of Daubert in excluding expert medical causation opinions in Smith v. Terumo Cardiovascular Sys. Corp., a federal case in the district of Utah.
Thompson Coburn LLP
The relationship between "added sugar" and adverse health outcomes has been a subject of debate.
Sheppard Mullin Richter & Hampton
On June 20, 2017, CMS released its proposed rule updating MACRA's Quality Payment Program for CY 2018.
Seyfarth Shaw LLP
This is the one hundred and eleventh issue in our series of alerts for employers on selected topics on health care reform.
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Jones Day
As Jones Day analyzed last month, the government has increased scrutiny of Medicare incentive payments for meaningful use of EHR technology.
Day Pitney LLP
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) does not provide for a private right of action allowing affected individuals to sue to enforce its provisions.
Thompson Coburn LLP
The legalization of cannabis in California raises significant questions as to whether employers can enforce policies prohibiting cannabis use by employees.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
As the costs of providing health insurance continue to rise, employers have sought—with limited success—to find options to hold down costs.
Ogletree, Deakins, Nash, Smoak & Stewart
Although efforts to pass Affordable Care Act (ACA) repeal-and-replace health care reform have ground to a screeching halt, there is still quite a bit of buzz surrounding health care matters.
Jones Day
Stakeholders have until August 21, 2017, to direct comments on the draft guidance to FDA.
Arnold & Porter Kaye Scholer LLP
VALUeHEALTH was concerned with ensuring the sustainable interoperability of European eHealth services beyond 2020.
Foley & Lardner
New Jersey has a new telemedicine law, recently signed by Governor Chris Christie. The law cements the validity of telehealth services in the Garden State, establishes telemedicine practice standards, ...
Day Pitney LLP
An August 3 article in Bloomberg BNA's Privacy Law Watch, "DNA Testing Company Shakes Alaska Privacy Claims," discussed the decision by an Alaska federal court in Cole v. Gene by Gene Ltd. to reject the attempt by a group of customers to sue a genetic testing kit company in a class action. Day Pitney's Eric Fader was quoted in the article.
Reed Smith
Pennsylvania's burgeoning medical-marijuana industry is and will be carefully regulated. When purchasing insurance, medical-marijuana dispensaries should pay careful attention to the Commonwealth's regulations...
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