On March 7, 2019, the Centers for Medicare & Medicaid Services (CMS) announces plans to consolidate the competitive bidding areas (CBAs) included in the Round 2 Recompete and Round 1 2017 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program into a single round of competition named Round 2021. Round 2021 contracts are scheduled to become effective on January 1, 2021, and extend through December 31, 2023.

The proposed regulation would exclude rebates from safe harbor protections that currently protect drug manufacturers’ rebates from penalties under the federal Anti-Kickback Statute, and would create a new safe harbor for discounts offered direct to patients, as well as fixed-fee service arrangements between drug manufacturers and PBMs.

On October 10th, the U.S. Justice Department’s Antitrust Division announce its approval of the $67 billion acquisition of Aetna, the third largest U.S. health care insurer (covering 23 million lives) by CVS Health, the largest U.S. PBM, mail order and chain drug store corporation (covering 94 million pharmacy patient and 27 percent of all U.S. prescriptions). This combination operating under CVS control is promoting their value as one stop shopping for a coordinated health care option with over 1,100 Medic-clinics in CVS’ s 9800 stores nationwide. Plans have been announced since the merger approval to expand the number CVS in-store medical clinics. The only condition on the merger was for Aetna to sell its stand-alone Part D plan, which it has already announced with its sale to Wellpoint.

Trump signs S. 2553, which outlaws so-called gag clauses for Medicare, and S. 2554, addressing employer and individual market plans.

PC encourages all members to contact Rep. Doug Collins (R-GA) and thank him for his recent efforts to stand up for independent pharmacies nationwide. He recently submitted an inspiring letter to the editor which was published in the Wall Street Journal. Please contact the Congressman’s Office and convey your appreciation for his support of independent pharmacy: His office number is 202-225-9893 in Washington.

CMS decided to “kick the can down the road” on DIR fees at this time, but noted that the President’s Fiscal Year 2019 Budget included language that all price concessions should be at the point-of-sale. CMS believes the statute provides them with discretion to require that Part D sponsors apply at least a portion of the manufacturer rebates and all pharmacy price concessions they receive to the price of a Part D drug at the point of sale. Any new requirements regarding the application of rebates at the point of sale will be proposed through notice and comment in future rulemaking.