Below is part two of the ‘Clearing Off the Desk’ series. Read part one here.
As we prepare for a busy period in Washington before the August recess, it is an excellent time to touch on a few newsworthy topics impacting 340B stakeholders.
Although it is only June, there have already been a whopping 14 announcements on HRSA’s Office of Pharmacy Affairs (OPA) website of instances where drug companies either owe money to 340B entities for overcharges or have implemented limited distribution plans. For the entire 2018 year, there were only eight notices posted. Medicines Company is the latest manufacturer to announce it has recalculated 340B ceiling prices for several products over a two-year period and will be issuing refunds.
My hunch for the uptick in manufacturer notices: When HRSA announced it would move forward on the rule giving the agency the ability to impose civil monetary penalties against drug manufacturers and to post prices on the OPA web site, drug manufacturers took a closer look at the prices they have been charging. Purdue Pharma has posted two different notifications this year alerting covered entities that they will be receiving credits through their wholesalers for overpayments. The drugs include many of its opioid products, including OxyContin, and span a number of years. In its announcement, Purdue acknowledges that it miscalculated the price charged to the Medicaid program and therefore owes refunds to the 340B entities. Both the Medicaid rebate program and the 340B program use the same discount methodology.
Purdue and many other drug companies who have announced repayments in 2019 are working with Apexus, the 340B prime vendor, to process the refunds. Purdue says Apexus is validating wholesaler pharmacy account information for each affected entity. “Once validated, Apexus will work with the wholesalers to facilitate the processing of credit for overpayments that the Covered Entity was charged during the specified periods. If no active wholesaler account can be found, Apexus will work to issue payment directly to those affected Covered Entities,” says Purdue.
With the number of manufacturer notifications growing, it is important to review the Manufacturer Notice page on OPA’s website regularly. While many of the notifications on the site are not dated, it is worth bookmarking. Some manufacturers, like The Medicines Company, appear to be handling the matter on their own. In its announcement, the New Jersey-based company said it will be contacting the authorizing official at affected covered entities unless the amount owed is less than $1,000. In those instances, your institution will need to contact Marisa DeChiaro at 973-290-6032 or [email protected]
Robert Pear, the renowned New York Times reporter known as the Dean of Health Care Journalism, passed away last month at the age of 69. Pear, whose byline appeared in more than 6,700 articles during his 40-year career at the Times, was the go-to reporter when a healthcare story needed covering.
Pear was a quiet, unassuming man who avoided appearing on Sunday-morning TV. Yet, “He was the most important reporter in Washington you have never heard of,” said Alan Dodds Frank, a veteran journalist who was quoted in Pear’s obituary in the Times.
One of the most diligent and fair scribes in the business, Pear worked hard to hear both sides and include various perspectives. While he did not perceive his purpose as making or changing policy, he played an instrumental role in protecting the 340B program at its most vulnerable time. It was 1995, and Newt Gingrich and his revolution had hit Washington. Gingrich and his colleagues had come to Washington promising to shake things up. Unfortunately, one of the bills that his caucus drafted was to make the 340B program voluntary for drug manufacturers.
It was an idea pushed by the drug industry, and it looked like it was certain to pass the House and potentially the Senate. It was panic time for the 340B community. 340B Health founder Bill von Oehsen made a call. That Sunday, there was a front-page story in the Times describing this giveaway to big Pharma. NBC Nightly News soon picked up the story, and suddenly, von Oehsen received a call from the staff director of the House Energy and Commerce Committee informing him that the provision would be dropped from the bill.
Pear continued to make his mark and wrote several stories about 340B developments during the next 24 years. He was particularly engaged during our long battle to expand 340B discounts to children’s and rural hospitals. I will never forget his unique 202 area code phone number. When it lit up on my screen, I always picked up the phone regardless of how busy I was. He will be dearly missed.
While hospitals await a final court decision on Medicare Part B cuts, as well as potential regulatory changes to the 340B program, lawmakers and the administration are poised to act on healthcare legislation as soon as this summer. Voters are particularly concerned about the high cost of care, which remains the top issue on the minds of Americans – ahead of immigration, the economy, national security, climate change, and other hot button topics.
Get the latest on the fast-moving developments affecting 340B stakeholders during a breakfast forum hosted by PSG on July 15 from 7 to 8 a.m. at the Marriott Wardman.
Registration for this event is now closed.
The forum addressed:
Speakers included three healthcare leaders and observers in drug pricing policy and cost management: