Pharmaceuticals and PBMs

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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 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…

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…

The Telephone Consumer Protection Act (TCPA), which imposes a penalty of $500-$1,500 per violation for pre-recorded or auto-dialed calls to cell phones, contains two statutory exceptions to liability:

  • where the recipient of the call provided his or her prior express consent to be called, or
  • where the call was placed for an “emergency purpose.”

47 U.S.C. § 227 (b)(1). While much attention has been focused on “consent,” the FCC’s definition of “emergency purpose” has remained relatively untested in TCPA litigation.

That landscape may be beginning to change. The federal district court’s recent decision in the putative class action lawsuit Roberts v. Medco Health Solutions, et al., No. 4:15 CV 1368 CDP (E.D. Mo., July 26, 2016) recognized that consistent with the FCC’s promulgated definition, the emergency purpose exception must be interpreted broadly to cover any calls that may affect the health and safety of a consumer.
Continue Reading Calls and text messages from healthcare organizations: New developments under the TCPA’s ’emergency purpose’ exception