Pharmacy

OCR Announces Another HIPAA Settlement and Warns Not to Forget About Paper Records

Posted by Gregory M. Fliszar on May 04, 2015
HHS, HIPAA, OCR / No Comments

On April 27, 2015, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced that Cornell Prescription Pharmacy (“Cornell Pharmacy”) had entered into a resolution agreement to settle, without an admission of liability or wrongdoing, potential HIPAA violations. As part of the resolution agreement Cornell Pharmacy will pay $125,000 and enter into a two-year corrective action plan (“CAP”) focused on correcting the alleged deficiencies in its HIPAA compliance program.

Cornell Pharmacy is a small, single store pharmacy located in Denver, Colorado that specializes in compound medications and providing services for local hospice agencies. OCR began an investigation into the pharmacy after it received a media report from a Denver news agency that protected health information (“PHI”) belonging to Cornell Pharmacy was apparently disposed of and found in an unlocked, publically accessible dumpster. The documents were not shredded and contained the PHI of approximately 1,610 of Cornell Pharmacy’s patients.   After conducting its investigation, OCR concluded that Cornell Pharmacy failed to implement any written policies and procedures as required by HIPAA’s Privacy Rule, and further failed to provide training on the Privacy Rule to its workforce members.

This settlement is instructive as OCR again highlights the importance of having updated and comprehensive HIPAA policies and procedures in place, including policies on the proper disposal of PHI, and on training all staff on those policies and procedures.   Further, in this year of massive cyber-attacks and other breaches of electronic data, this HIPAA settlement serves to remind covered entities and business associates not to forget about protecting their paper records as well.   As stated by OCR in its press release, “Even in our increasingly electronic world, it is critical that policies and procedures be in place for secure disposal of patient information, whether that information is in electronic form or on paper.” As discovered by Cornell Pharmacy, a breach or other improper disclosure of paper PHI can also result in significant consequences.

For further information please contact the author, Gregory M. Fliszar (Philadelphia, PA), or other members of Cozen O’Connor’s healthcare team.

Gregory M. Fliszar

Greg focuses his practice on health law and handles a variety of health law litigation and regulatory and compliance matters for a number of different types of health care providers, including hospitals, hospices, mental health providers and physician groups. He has significant experience with HIPAA and privacy issues and has counseled insurance company clients on understanding their obligations under the Medicare Secondary Payer Act.

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UPDATE: Congress Drafts Legislation that would Expand the FDA’s Role in Regulating Compounding Pharmacies

Posted by William P. Conaboy Jr. on May 02, 2013
Food and Drug Law, Pharmacy / No Comments

UPDATE

The Senate Health, Education, Labor, and Pensions (HELP) committee approved a bill on May 22 that largely tracks the Draft Legislation.  As outlined below, the bill would create a new category for large-scale compounders – known as “compounding manufacturers” – and give the FDA greater authority over compounding pharmacies. Continue reading…

William P. Conaboy Jr.

Bill Conaboy is an associate in the firm’s Healthcare Law Group. Prior to working with the firm Bill earned a Doctor of Pharmacy degree (Pharm D), and is currently a licensed pharmacist and attorney in both Pennsylvania and New Jersey. Bill focuses on regulatory and litigation matters related to many areas of healthcare law.

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Pharmaceutical Manufacturers and Consumers, and Congressional Democrats and Republicans AGREE to Increase, Expand and Extend the FDA User Fee Program

Posted by William P. Conaboy Jr. on August 15, 2012
Uncategorized / 1 Comment

President Obama recently signed a bipartisan bill that authorizes Food and Drug Administration (“FDA” or “Agency”) user fees for five more years and establishes new user fees for the FDA’s review of generic drugs and biosimilar products.[1]  The bill reauthorizes the Prescription Drug User Fee Act (“PDUFA” or the “Act”), a law originally passed by Congress in 1992.  PDUFA permits the FDA to collect user fees from drug manufacturers to fund, among other FDA endeavors, new drug and medical device approval.  The most recent reauthorization of the bipartisan bill, which increases the amount of money drug and device manufacturers must pay the FDA to review a new drug or device application, has gained the support of both Congress and the pharmaceutical industry.

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William P. Conaboy Jr.

Bill Conaboy is an associate in the firm’s Healthcare Law Group. Prior to working with the firm Bill earned a Doctor of Pharmacy degree (Pharm D), and is currently a licensed pharmacist and attorney in both Pennsylvania and New Jersey. Bill focuses on regulatory and litigation matters related to many areas of healthcare law.

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