Regulatory and Washington

The federal agency in charge of Medicare is pushing for a major overhaul of its Medicare Part D drug benefit program for seniors. Those changes, if adopted, could help level the competitive playing field for pharmacy retailers in Part D plan networks, reduce competitive advantages for preferred pharmacy networks and mail-order pharmacies, and put a tighter squeeze on pharmacy benefit managers.

Thus, the proposals by the Centers for Medicare and Medicaid Services for the 2015 federal fiscal year could spell big changes for retail pharmacies. Among the most far-reaching are:

NEW YORK — Lawmakers in Florida are looking into ways to ease regulatory limitations for telemedicine in an effort to increase access to care and create “a fertile ground” for the technology to be used, according to a local report.

SILVER SPRING, Md. — After meeting for two days earlier this week, the Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 16-9 against changing the label of naproxen to highlight a lower cardiovascular risk profile as compared to other NSAIDs, according to published reports. 

Those advisory panels who voted against the change felt the data were insufficient to say naproxen was safer than other NSAIDs.

MARQUETTE, Mich. — A study released by the Centers for Disease Control establishes that consuming too much added sugar — often found in regular soda, cakes, cookies and candies — significantly increases the risk of death from heart disease.

WASHINGTON — Led by former U.S. Senate Majority Leaders Tom Daschle, D-S.D., and Trent Lott, R-Miss., and former Senator John Breaux, D-La., the Alliance for Connected Care has been launched to promote policy reform around telehealth and remote patient monitoring.

Board members of the Alliance include CVS Caremark, Walgreens, Teladoc, HealthSpot, Doctor on Demand, Welch Allyn, MDLIVE, Care Innovations, Cardinal Health, Verizon and WellPoint.

WASHINGTON — A coalition of associations representing supplement manufacturers on Tuesday expressed their support of the Designer Anabolic Steroid Control Act of 2014 by Sens. Sheldon Whitehouse, D-R.I., and Orrin Hatch, R-Utah.

WASHINGTON — A Medicare proposed rule change limiting the number of prescription drug plans that insurers may offer in the Part D market could require 39% of all enhanced plans to be eliminated in 2016, according to an analysis from Avalere Health that was released Wednesday. The change, which limits standalone PDP sponsors to one basic and one enhanced plan per region, was proposed by the Centers for Medicare and Medicaid Services in a January proposed regulation. 

NEW YORK — The National Advertising Division has recommended that Trinity Sports Group discontinue certain claims for the company’s “NeuroImpact” dietary supplement, including claims that the product has been clinically tested.

NAD noted, however, that the advertiser provided a reasonable basis for “carefully qualified ingredient claims regarding the ability of certain ingredients,” in NeuroImpact “to support healthy brain function.”