Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Foley & Lardner
In an August 7, 2014 opinion, the Eighth Circuit upheld the dismissal of a whistleblower’s suit alleging that a number of pain pump device makers had violated the False Claims Act by marketing their pain pumps for harmful off-label uses.
Foley & Lardner
The American Telemedicine Association released its new Clinical Guidelines for Telepathology this week
Jones Day
The traceback procedures will be fully implemented later this fall, but interested parties may submit comments on the recordkeeping proposal through September 22, 2014.
Reed Smith
On September 17, 2014 the Food and Drug Administration ("FDA") is holding a public hearing at the College Park Marriot Hotel and Conference Center, in Hyattsville, MD, to discuss the Agency’s implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and its obligations under GDUFA as set forth in the GDUFA Commitment Letter accompanying the legislation.
Reed Smith
CMS is seeking input on potential initiatives to test innovative models that increase the engagement of Medicare, Medicaid, and/or Children’s Health Insurance Program (CHIP) beneficiaries in their health and health care.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
As my colleague Brian Dunphy previously reported, CMS temporarily closed the Open Payments system earlier this month.
Thompson Coburn LLP
Cannabis industry hopefuls in Illinois are poised to begin the application process after the three state agencies administering Illinois’ medical marijuana law released long-awaited metrics on Aug. 8.
Jones Day
The notice invites industry, academia, and health care facilities to apply to participate in this formal training.
Jones Day
On August 1, 2014, FDA released draft guidance proposing to exempt from premarket 510(k) review many low-risk medical devices.
Ostrow Reisin Berk & Abrams
Before you dismiss the idea, keep in mind that it has been a well-established offering of many practices for years.
Ostrow Reisin Berk & Abrams
From the new Health Care Reform Act to this past year’s polar vortex, restaurateurs have recently faced a plethora of challenges.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
In addition to the sizeable settlement amount, the CHS settlement is notable for hospital systems and hospital management companies for a number of reasons.
Jones Day
On July 28, 2014, FDA issued its final guidance on evaluating substantial equivalence in 510(k) submissions.
Jones Day
On July 31, 2014, FDA issued its final guidance on the development, review, and approval or clearance of companion diagnostics, tests used to identify which patients will likely benefit or be harmed by treatment with a certain drug.
Reed Smith
On August 6, 2014, CMS published its final rule to update Medicare payment policies under the inpatient rehabilitation facility (IRF) PPS for FY 2015.
Fox Rothschild LLP
Because nursing facilities are required by federal regulations to keep records concerning allegations of abuse or neglect, the Department of Health and Human Services’ Office of Inspector General (OIG) recently completed a study of facilities’ records.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Last week, the American Telemedicine Association approved its new telepathology guidelines, which provide updated guidance on specific applications, practices, benefits, limitations, and regulatory issues that may arise in the practice of telepathology.
Fenwick & West LLP
The biggest take-away from Fenwick’s third annual Digital Health Investor Summit is that the industry is starting to mature – or as Xconomy put it, More Dollars, Fewer Bracelets.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
House Ways and Means Subcommittee on Health Chairman Kevin Brady released a discussion draft of the Protecting Integrity Medicare Act of 2014—the Committee’s expansive bill to address fraud in the Medicare and Medicaid systems.
Reed Smith
With regard to the IPPS, the final rule provides for a 1.4% operating payment rate update for hospitals that submit quality data and are meaningful Electronic Health Record (EHR) users.
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Troutman Sanders
This is the twenty-seventh in the series of alerts intended to keep employers up to date on the evolving requirements of Health Care Reform under the ACA.
Venable LLP
The Affordable Care Act (ACA) imposes new reporting requirements on employers and insurance companies offering health coverage.
Littler Mendelson
On January 10, 2014, the Internal Revenue Service released final regulations governing the employer shared responsibility provisions of the Affordable Care Act.
Waller Lansden Dortch & Davis
The United States Department of Justice recently filed a suit against Vitas Hospice Services, L.L.C. and its subsidiary entities, alleging that Vitas submitted false claims for hospice services which were excessive, unnecessary, or not provided, and also alleging that Vitas admitted patients to hospice who were not terminally ill.
Jones Day
The Affordable Care Act ("ACA") infuses new complexities into collective bargaining negotiations over health insurance benefits.
BakerHostetler
Although HIPAA does not create a private cause of action, a recent Indiana Superior Court jury verdict demonstrates that HIPAA still could play an important role in private causes of action in state court based on negligence and professional liability as it relates to confidentiality.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The American Bar Association Health Law Section’s July 2014 eSource publication includes an article by Dianne Bourque, Kimberly Gold, and me that provides examples of how risk assessments under the Breach Notification Rule have changed since the HIPAA Omnibus Rule went into effect in September 2013.
Littler Mendelson
For several years, nurses’ unions have lobbied, with varying success, for legislation implementing nurse-patient ratios.
Ropes & Gray LLP
The Food and Drug Administration took several significant actions to clarify its policies regarding regulation of certain in vitro diagnostic devices.
Ropes & Gray LLP
On July 3, 2014, CMS released its proposed Calendar Year 2015 Physician Fee Schedule Proposed Rule, to be published in the Federal Register on July 11, 2014.
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