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DEA Issues Final Rule Up-Scheduling Hydrocodone Combination Products from Schedule III to Schedule II

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...more

Health Care Reform Implementation Update August 2014

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

New Data Disposal Law in Delaware Requires Action by Impacted Businesses

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

Don’t Put Off That New HIPAA Business Associate Agreement: September 23, 2014 Deadline Looms

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

HIPAA For Lawyers And Law Firms: What you need to know to prevent your law firm from paying MILLION$

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

OIG Rejects Specialty Pharmacy Request to Pay “Per-Fill” Payents to Retail Pharmacies

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

Health Update - August 2014 #5

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

Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process

On August 14, the Food and Drug Administration (FDA) issued a draft guidance titled “De Novo Classification Process (Evaluation of Automatic Class III Designation).”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

Prescription Drugs: Refocusing the False Claims Act Microscope on the Rest of the Transaction

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

OIG Rejects Pharmacy’s Plan for Per-Fill Referral Fees, Or Be Careful What You Ask For

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

FDA Notifies Congress of Framework for Long-Awaited Guidance on Laboratory Developed Tests and Issues Final Guidance on Companion...

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

Driving Down the Cost of Health Care Through Next Generation Networks

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

Deadline For Business Associate Agreement And Data Use Agreement Compliance Is September 22, 2014

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

OIG Finds Risk of Abuse in Specialty Pharmacy’s Per-Fill Fee Proposal

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

News from the Health Law Gurus™

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

Sunshine Act Implementation Proceeds; CMS Re-opens the Open Payments System

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

Physicians Write Letter to FDA Regarding Biosimilar Naming Concerns

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

CMS Reopens Open Payments System, Extends Review/Dispute Period and 15-Day Correction Period

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

Georgia Composite Medical Board Issues New Telemedicine Rules

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

Whistleblower Receives More Than $17 Million in Omnicare Case

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

FBI Warning to Health Care Sector Holds True

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

FDA Approves Cancer Screening Test as First Device Under Parallel Review Pilot

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

FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices

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

Here Comes the Sunshine Act

The Centers for Medicare and Medicaid Services (CMS) released a guide for physicians to prepare for the Dispute Resolution period of the Physician Payments Sunshine Act. The CMS guide is available on the CMS Open Payments...more

Massive Data Breach Affects 4.5 Million Patients in 29 States

Community Health Systems, Inc. (the “Company”), one of the largest hospital organizations in the country, announced via a public filing (Form 8K) made yesterday with the Securities and Exchange Commission (“Report”) that the...more

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