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As we told you about here, the Centers for Medicare & Medicaid Services (CMS) has been dealing with issues related to its Open Payments database of payments and transfers of value reported by manufacturers and group...more
The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently refused to bless a specialty pharmacy's request to pay a per-prescription fee to retail pharmacies for "support services" to be...more
On August 22, 2014, the Drug Enforcement Administration (DEA) published a final rule upscheduling hydrocodone combination products (HCPs) under the Controlled Substances Act (CSA) from Schedule III to Schedule II.
The Centers for Medicare and Medicaid Services (CMS) made announcements this week regarding the Open Payments system and the availability of Affordable Care Act (ACA) Consumer Assistance Program grant funds, issued a request...more
While the federal government continues its inaction on data security bills pending in Congress, some U.S. states have been busy at work on this issue over the summer. A new Delaware law H.B. 295, signed into law on July 1,...more
It’s been a while, but we have another HIPAA deadline just around the corner: September 23, 2014.
September 23, 2014 is the date by which all HIPAA business associate agreements need to be in compliance with the...more
For years now lawyers and law firms providing professional services to health care providers or health insurance plans should have had in place essential safeguards to meet the responsibilities and requirements as business...more
In OIG Advisory Opinion 14-06, the Office of Inspector General (OIG) concluded that payment by a specialty pharmacy to a retail pharmacy on a “per-fill” basis for services provided by the retail pharmacy could violate the...more
The Five Megatrends Shaping Pharma’s Next Decade: Sustaining Success in a New Market Landscape -
Disruptive trends in the healthcare system will force companies to change their strategies. With new care models...more
On August 14, the Food and Drug Administration (FDA) issued a draft guidance titled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The draft provides guidance on a streamlined process for...more
Over the last decade, it has often felt as though the pharmaceutical industry has been the government’s and whistleblowers’ main, and at times only, target for False Claims Act (“FCA”) investigations. While manufacturers are...more
Advisory Opinion No. 14-06, issued August 15, addressed a plan by the chain to reimburse local pharmacies for referrals of patients in need of specialized drugs that the local pharmacies did not dispense. In the scenario...more
Laboratory Developed Tests -
After many years of promising that it would be providing guidance on the regulation of laboratory developed tests (LDTs), the Food and Drug Administration (FDA) provided notice to Congress...more
Current and future health care delivery models are quickly outgrowing legacy communications architectures, which lack the structural flexibility and, more importantly, the control and security of Next Generation Networks, or...more
September 22, 2014 is the deadline to have all business associate and data use agreements updated to conform to the new requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Final Omnibus...more
In an Advisory Opinion posted August 15, 2014, the Office of Inspector General (“OIG”) concluded that a proposed arrangement by a specialty pharmacy (“Requestor”) might generate prohibited remuneration under the Federal...more
Chinese Hackers Infiltrate Health System Network Affecting 4.5 Million Individuals – Community Health Systems, Inc. (“CHS”) reported this week that the information of approximately 4.5 million individuals has been affected by...more
On August 15, 2014, the Centers for Medicare and Medicaid Services (CMS) re-opened the Open Payments system for physicians and teaching hospitals to register, review, and, if needed, dispute information gathered to date. CMS...more
On Thursday, August 14, 2014, several physicians wrote a letter to Commissioner Hamburg of the U.S. Food and Drug Administration (FDA) expressing their concerns regarding the naming of biosimilar products in light of the...more
On Friday, August 15, 2014, CMS officially announced the reopening of its Open Payments system and an extension of the covered recipient review/dispute period and subsequent data correction period. Our understanding is that...more
The Georgia Composite Medical Board enacted a new regulation governing the standards for telemedicine practice. The regulation, titled Practice Through Electronic or Other Such Means, is found under Georgia Comp. Rules and...more
A decision has been made in the case against Omnicare, Inc. that will net a former Omnicare pharmacist more than $17.2 million in the ensuing settlement.
The settlement with the Department of Justice orders Omnicare,...more
In April of this year, the FBI issued a Private Industry Notification (PIN) to the health care industry warning of the “likely increase [in] cyber intrusions against health care systems.” In the same month, and into June of...more
On August 11, 2014, the Food and Drug Administration (FDA) issued a premarket approval (PMA) for Exact Sciences’ Cologuard, a colorectal cancer screening test, and the Centers for Medicare & Medicaid Services (CMS) issued a...more
In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices.
On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more
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