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|OIG Releases Report on Medicaid Fraud Control Units|
Judith A. Waltz; Foley & Lardner LLP;
March 12, 2014, previously published on March 11, 2014The Department of Health and Human Services (HHS) Office of Inspector General (HHS-OIG) has released its Fiscal Year (FY) 2013 Annual Report (Report) on the performance of the Medicaid Fraud Control Units (MFCU) (OEI-06-13-00340, March 2014). As part of their state Medicaid plans, all states must...
|Ohio State Medical Board Issues New Regulations Covering Termination of Physician-Patient Relationships|
Bridget K. Cougevan, John T. Mulligan; McDonald Hopkins LLC;
March 12, 2014, previously published on February 28, 2014On Dec. 13, 2013 the Ohio State Medical Board (the Board) announced final regulations with respect to the process whereby Ohio physicians can terminate a physician-patient relationship. These regulations also addressed the notice of termination that a physician or a physician group must provide...
|HIPAA Covered Entities Face March 1 Deadline for Breach Reports|
James J. Giszczak, Rick L. Hindmand, Dominic A. Paluzzi, Rachel H. Yaffe; McDonald Hopkins LLC;
March 12, 2014, previously published on February 27, 2014HIPAA covered entities (healthcare providers, health plans or healthcare clearinghouses) that discovered a breach of Protected Health Information (PHI) in 2013 involving fewer than 500 individuals are required to report those breaches by March 1, 2014.
|Lanham Act Decision Suggests That Marketing Pursuant to ANDA Approval Does Not Preclude Liability When FDA Later Reverses Its Decision|
James P. Ellison; Hyman, Phelps & McNamara, P.C.;
March 12, 2014, previously published on March 11, 2014In a recent post we described the Generic Pharmaceutical Association’s amicus brief in the POM case, which urged the Supreme Court to “be cognizant of the differences” among FDA regulated products. In particular, GPhA urged that ‘[e]ven if petitioner is allowed to proceed...
|Notes On Increasing Acute and Post-Acute Integration|
Brian M. Daucher; Sheppard, Mullin, Richter & Hampton LLP;
March 11, 2014, previously published on March 5, 2014The focus of the AHLA Long Term Care Conference was on convergence of acute (hospital) and post-acute (SNF, home health, hospice) service delivery mechanisms.
|Florida’s False Claims Act - Did You Know It Changed Last Year?|
Robert H. Iseman, Myla R. Reizen; Foley & Lardner LLP;
March 11, 2014, previously published on March 10, 2014In June 2013, Florida’s legislature significantly amended Florida’s False Claims Act, Fla. Stat. §§ 68.081-68.092 (“FFCA”), effective July 1, 2013. Although these amendments have not received much publicity or commentary, they considerably expanded the FFCA’s...
|Do Prosecutions Outside The UK Affect Sentencing In The Courts Of England and Wales?|
Withers Bergman LLP/Withers LLP;
March 11, 2014, previously published on March 4, 2014The 2009 case of R v Bodycote HIP UK contains an important warning to multinational organisations in the UK in relation to the impact of health and safety prosecutions against their branches abroad.
|FDA Revises Draft Guidance Concerning Distribution of Scientific and Medical Publications for Drug and Device Manufacturers|
Elizabeth H. Kim, Scott S. Liebman; Loeb Loeb LLP;
March 11, 2014, previously published on March 2014Updating policies established in a 2009 Guidance, the Food and Drug Administration (FDA) has released a draft version of a proposed 2014 Guidance addressing the use of medical publications in promoting "off label" uses of approved drugs and devices. The draft 2014 Guidance, announced by...
|More Delays for the President's Healthcare Law|
McDonald Hopkins LLC;
March 11, 2014, previously published on March 7, 2014The Obama administration announced new delays for the president's healthcare law this week. On Wednesday, the administration announced that insurers can wait until 2016 before canceling plans that don't comply with law.
|To Fill or Not to Fill: Avoiding Pharmacist Liability Under the Controlled Substances Act|
Dressman Benzinger LaVelle psc;
March 11, 2014, previously published on February 2014Pharmacists should take a second (and third) look before filling prescriptions for large quantities of controlled substances. Recent criminal prosecutions demonstrate that law enforcement officials are now targeting pharmacies that fill scripts for large amounts of controlled substances. Previous...