Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Reed Smith
CMS has announced that it is holding a meeting of the Advisory Panel on Hospital Outpatient Payment on August 24-25, 2015.
McDermott Will & Emery
In a highly anticipated and scrutinized decision, the Centers for Medicare & Medicaid Services (CMS) released a new public data set on April 30, 2015, that includes detailed data regarding the prescribing patterns of physicians and other health care providers under the Medicare Part D Prescription Drug Program.
Nutter McClennen & Fish LLP
On April 13, 2015, the U.S. Food and Drug Administration (FDA) announced the availability of the Center for Diseases and Radiological Health's (CDRH) final guidance document entitled "Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions."
Reed Smith
Today the House Energy and Commerce Committee approved H.R. 6, the "21st Century Cures Act," by a bipartisan, unanimous 51-0 vote.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Other miscellaneous health care legislation moves forward as the Senate Finance Committee closed a request last week for non-controversial health care bills for possible markup during the June work period.
Day Pitney LLP
A May 19 article in Crain's Health Pulse, "Changes to Docs' Profiles," discusses a new rule that will be effective April 13, 2016 for New York physicians.
Foley & Lardner
For the second time in as many years, the Seventh Circuit has declined to grant Notre Dame's request for an injunction exempting the university from the contraception requirements of the Affordable Care Act.
Reed Smith
Based on 2012 data, the OIG determined that total rebates under Medicaid were substantially higher than total rebates under Medicare Part D...
Reed Smith
Under the final rule, organs from individuals infected with HIV may be transplanted into individuals who are infected with HIV before receiving such organs and who are participating in clinical research approved by an institutional review board.
Reed Smith
CMS is hosting a Special Open Door Forum call on May 27, 2015 to discuss eliminating the Certificate of Medical Necessity (CMN) and Durable Medical Equipment (DME) Information (DIF) forms.
Reed Smith
CMS is proceeding with the application process for the Medicare Shared Savings Program for the January 1, 2016 program start date.
Reed Smith
CMS has published a correction notice that clarifies that the comment deadline for the FY 2016 Medicare inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) PPS proposed rule is June 16, 2015.
Jones Day
In the May 1, 2015, Federal Register, APHIS announced receipt of a petition requesting to amend regulations to specify ethologically appropriate standards researchers must adhere to...
Jones Day
Several of the changes would be extended to the National School Lunch Program, School Breakfast Program, and Special Milk Program to increase consistency across all Child Nutrition Programs.
On Thursday, May 14, 2015, at a meeting of the American Bar Association's Healthcare Fraud Section, Leslie Caldwell, the Assistant Attorney General for the Department of Justice (DOJ) Criminal Division, declared stamping out healthcare "fraud and holding those who commit this fraud accountable are core missions of the Criminal Division and the Justice Department."
Foley & Lardner
The Meaningful Use Programs incorporate and require implementation of several key the HIPAA security requirements for ePHI.
Reed Smith
CMS published a proposed rule on May 5, 2015 that would update Medicare hospice payment rates and the wage index for fiscal year (FY) 2016.
Reed Smith
CMS published an interim final rule with comment period (IFC) on May 6, 2015 that modifies a previously-adopted regulatory requirement regarding qualifications to prescribe Part D drugs.
Strasburger & Price, L.L.P.
On May 18, 2015, the Food and Drug Administration posted "From our Perspective" providing materials for dispensers subject to the November 2013 Drug Supply Chain Security Act.
Fenwick & West LLP
Two blockbuster deals drove digital health financings to record levels in April. The month saw a total of nearly $790 million in deal flow.
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Fox Rothschild LLP
Last week, the IRS issued its "final" versions of the forms 1094-B, 1094-C, 1095-B and 1095-C along with instructions for the "B" forms and instructions for the "C" forms.
While the new law codifies payment for chronic care management under the Medicare physician fee schedule, effective immediately, it leaves many of the details largely to CMS’s discretion.
Patterson Belknap Webb & Tyler LLP
After a slow start for the biosimilar pathway, 2015 has been a landmark year.
McDermott Will & Emery
More than 80 percent of all deals in the pharmaceutical industry include an earnout structure that provides some type of contingent or delayed payment of proceeds to the sellers.
Reed Smith
Most notably, MACRA permanently repeals the statutory Sustainable Growth Rate (SGR) formula, achieving a goal that has eluded Congress for years.
Duane Morris LLP
On April 24, 2015, the Texas Supreme Court dismissed claims against a compounding pharmacy and its individual pharmacists which alleged negligence in compounding a lipoic acid medication.
The case concerns an incident where a patient suffered a severe adverse reaction while receiving intravenous injections of lipoic acid, an antioxidant supplement, for treatment of hepatitis C.
Venable LLP
3D printing, also referred to as "additive manufacturing" or "rapid prototyping," is the process of making three-dimensional objects from digital designs.
Troutman Sanders LLP
Late last month, generic pharmaceutical companies in the United States received a signal that the Department of Justice's ("DOJ") Antitrust Division may be widening the scope of its federal investigation...
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