On September 10, 2018, the federal Food & Drug Administration (”FDA”) released its revised draft standard Memorandum of Understanding (“MOU”) between states and the FDA addressing the interstate distribution of compounded drug products. See 83 Fed. Reg. 175, 45631 et seq. (Sept. 10, 2018). The draft is the latest in the FDA’s decades-long effort to clarify state and federal roles in investigating and responding to complaints related to compounded drug products shipped between states. Continue Reading FDA publishes revised draft MOU addressing state and federal oversight of 503A compounding pharmacies
The growth in prescription drug coverage has led to increased complexity in the delivery and reimbursement of medications. PBMs are organizations which address this complexity by impacting most aspects of the pharmaceutical supply chain. Continue Reading Pharmacy Benefit Managers 101: Who They Are and What They Do
The National Association of Specialty Pharmacy (NASP) recently issued its comments in response to the Department of Health and Human Services’ (HHS) request for information related to HHS’s Drug Pricing Blueprint. The Blueprint is part of the Trump Administration’s initiative to lower prescription drug prices. Center for Medicare and Medicaid Services (CMS) Administrator Seema Verma has said that “[l]owering drug prices is a top priority for the President and CMS, and the agency is committed to finding innovative ways to increase competition and lower out-of-pocket costs for consumers.” Continue Reading NASP Comments on the HHS Drug Pricing Blueprint
The Inspector General took an unprecedented step Tuesday, rescinding a favorable Advisory Opinion first issued in 2006 that had provided assurances to the patient assistance charity, Caring Voice Coalition, that its drug subsidy program would not expose the organization to liability under the Anti-Kickback Statute. Continue Reading OIG Rescinds Favorable Advisory Opinion for Patient Assistance Charity, Caring Voice Coalition
Recent press reports are speculating that CVS Health Corporation is seeking to acquire the health insurer Aetna. The rumored transaction would create a new type of health care company that doesn’t currently exist: one that combines a commercial health insurer with a retail pharmacy chain and a pharmacy benefit manager (PBM). According to most reports, CVS would pay $66 – $70 billion to acquire Aetna (with Aetna stockholders receiving cash and CVS stock). It’s said that the parties are trying to enter into a definitive agreement by year-end. Continue Reading CVS Health – Aetna Transaction: Understanding the Business and Legal Issues
The 2017 National Defense Authorization Act, Pub. L. No. 114-328 (Dec. 23, 2016), introduces major changes to the Defense Department healthcare program known as TRICARE. By this time next year, we’ll see a new program to contain the cost of prescription drugs at retail pharmacies, contractual incentives for improving the quality of healthcare and reducing “per-capita cost,” and the first major step toward privatizing the delivery of healthcare to military members.
This is the third article in our series on the effect of a “slow repeal” of the ACA. This week’s discussion focuses on the potential impact of a slow repeal of the ACA on the pharmaceutical industry (Pharma).
Unlike many of the players detailed in our prior articles on the slow repeal of the ACA, Pharma has not made a lot of noise regarding a repeal of the ACA. In fact, Pharma and biotech stocks soared—generally 3 percent to 10 percent—on November 8, 2016, largely because the industry had been preparing for a Clinton victory. A recent quote attributed to one Pharma industry official—“I actually think the Republican Party is a far less certain bet for the pharmaceutical industry”—reflects some of the unease surrounding the change in administration, and the likely repeal of the ACA. Continue Reading Slow Repeal of the ACA and Its Effect on the Pharmaceutical Industry
A California federal court handed down a decision last Friday that may further influence how healthcare entities should approach the Telephone Consumer Protection Act’s (TCPA) “emergency purpose” exception as applied to calls or texts related to patient health and safety. In St. Clair v. CVS Pharmacy, Inc., No. 16-CV-04911-VC, 2016 WL 7489047, at *1 (N.D. Cal. Dec. 30, 2016), the plaintiff alleged that CVS Pharmacy called him multiple times about his prescriptions after he told a customer representative that he no longer wished to be called. CVS moved to dismiss the lawsuit by claiming that all of the calls at issues fell under the emergency purpose exception contained in the statute, and therefore were not subject to the TCPA. Continue Reading St. Clair v. CVS Pharmacy, Inc. and healthcare calls under the TCPA’s emergency purpose exception
The U.S. Department of Treasury’s Office of Foreign Assets Control (OFAC) and the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) recently announced additional rule amendments intended to continue improving relations between the U.S. and Cuba by allowing even greater commerce and humanitarian efforts between the two countries. These new OFAC and BIS rules took effect last week. Continue Reading Revised Cuba rules allow medical collaboration, ease some pharmaceutical trade
On September 12, 2016, the EPA issued its Strategy for Addressing the Retail Sector under RCRA’s Regulatory Framework (Strategy Document), which addresses growing concerns about the application of federal hazardous waste regulations to pharmacies and retail operations. The Strategy Document takes into account practices common to pharmacies (e.g., reverse distribution) that present unique compliance issues which are of significant concern given EPA’s enforcement actions during the past few years over similar practices at retail operations like Whole Foods and Wal-Mart.