Strasburger & Price, L.L.P.
In August 2013, the Food and Drug Administration ("FDA") announced the Secure Supply Chain Pilot Program (the "Pilot Program")
The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments.
With the Open Payments System rollout, came the phased approach for data submission, requiring aggregate data in Phase 1 and detailed data reporting in Phase 2.
Ropes & Gray LLP
Prompted by citizen petitions filed by Ropes & Gray and by two other companies, FDA issued draft guidance proposed a change in the Agency's interpretation of 5-year new chemical entity ("NCE") exclusivity as applied to certain fixed-combination drug products ("fixed-combinations").
CMS posted additional guidance on its controversial "2 Midnight Rule" Medicare inpatient hospital admission and medical review criteria.
FDA has issued draft guidance revising its 2009 guidance on manufacturers' dissemination of "journal articles" and "scientific or medical reference publications" that address unapproved or "off-label" uses of drugs and devices.
Foley & Lardner
With few exceptions, the HIPAA Privacy Rule requires patient authorization prior to a disclosure of psychotherapy notes for any reason.
The ONC for Health Information Technology is seeking comments on revisions to health information technology certification regulations for 2015.
Federal health care fraud prevention and enforcement efforts resulted in the recovery of a record $4.3 billion in FY 2013.
A recent OIG report examines Medicare services provided during the Medicare Severity Diagnosis Related Group payment window.
CMS has released additional tools to help health plans, vendors, and providers demonstrate compliance with Administrative Simplification Transaction Testing standards.
The OIG released a report on March 3, 2014, "Adverse Events in Skilled Nursing Facilities: National Incidence among Medicare Beneficiaries".
A number of Congressional committees have held hearings recently to address various health policy issues.
CMS is pausing RAC audits in preparation for the procurement of new RAC contracts and to allow CMS to continue to refine and improve the Medicare Recovery Audit Program.
CMS has published a notice announcing the preliminary federal share disproportionate share hospital allotments for fiscal year 2014.
Waller Lansden Dortch & Davis
The Texas Sunset Advisory Commission is putting the state’s health agencies under a microscope, which may result in huge policy and regulatory changes.
Ropes & Gray LLP
On February 28, 2014, the Food and Drug Administration ("FDA") released a revised draft guidance for industry entitled "Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices" ("Revised Reprints Guidance").
Duane Morris LLP
Today, March 4, 2014, the U.S. Patent and Trademark Office (USPTO) issued its 2014 Procedure for Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/or Natural Products ...
On March 4, 2014, the Obama Administration released its proposed federal budget for fiscal year (FY) 2015.
Fox Rothschild LLP
"Not surprising." That was my response to the Health Care Fraud and Abuse Control Program Annual Report issued in February by the U.S. Department of Health and Human Services (HHS).