NCPA-commissioned study: DIR fees could cost CMS $3.4B in next 10 years
ALEXANDRIA, Va. — Retroactive pharmacy payment reductions, a portion of direct and indirect remuneration fees, could cost the federal government $3.4 billion between 2018 and 2027. That’s according to a new study from Wakely Consulting Firm that the National Community Pharmacists Association commissioned and whose results it shared Thursday.
“This new Wakely study is vitally important in showing that DIR legislation will actually save taxpayers $3.4 billion over 10 years without subtracting any benefits seniors currently receive,” NCPA CEO Doug Hoey said. “For pharmacies, banning these after-the-fact fees is the fair way to achieve predictability in the reimbursement for the medications they buy and dispense.”
The report evaluates the impact of the Improving Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, which has been introduced in both the Senate and House of Representatives and prohibits retroactive pharmacy payment reductions as claims without any defect, impropriety or fraud in Medicare Part D.
If the legislation were enacted, it would save the Centers for Medicare and Medicaid service from spending that $3.4 billion over the coming 10 years. The report also notes that CMS would spend less on federal reinsurance and low-income cost-sharing subsidies. Under the legislation, the decrease in total drug cost at point of sale would lower the number of claim dollars in the catastrophic phase of the Part D benefit, the report said. The legislation is part of NCPA’s efforts to end DIR Fees, which make up a small amount of overall DIR within Medicare Part D, the majority of which is made up of manufacturer rebates, and Hoey said the results underscore the need for a legislative answer to the issue.
“This new Wakely study is robust in its scope and thoroughness and points clearly to significant cost savings to the federal government if H.R. 1038/S.413 were passed into law,” said Hoey. “We urge Congress to move quickly to schedule hearings and advance this important legislation.”
FDA approves first generic from Vitruvias Therapeutics, Sunny Pharmtech
SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic from Taiwan-based drug development company Sunny Pharmtech and generic development company Vitruvias Therapeutics. The companies announced the approval of its generic lidocaine ointment, 5%.
“We are pleased to have received such a timely approval with our first jointly filed application,” Sunny Pharmtech CEO and chairperson Yon-Lian Wu said. “It is a testament to competence and capabilities of both companies’ development and regulatory groups that our first application was approved so quickly.”
The generic is the first drug approved under the two companies’ joint development agreement that includes eight products.
“It is very exciting to receive our first joint approval, and we are looking forward to beginning the commercial phase of our business plan,” Vitruvias GM Carl Whatley said. “This approval represents our transition from a purely developmental company to one that can discover, develop and commercialize technically complex generics."
FDA takes aim at online pharmacies
SILVER SPRING, Md. — Working with international law enforcement agencies and regulators, the Food and Drug Administration recently acted against some 500 websites selling illegal and unapproved versions of such prescription drugs as opioids, epinephrine injections and antibiotics directly to American patients.
“These rogue online pharmacies are often run by sophisticated criminal networks that knowingly and unlawfully distribute illicit drugs, including counterfeit medicines and controlled substances,” FDA commissioner Dr. Scott Gottlieb said. “Consumers go to these websites believing that they are buying safe and effective medications, but they are being deceived and put at risk by individuals who put financial gains above patient safety.”
The actions —including warning letters to the operators of targeted sites and the confiscation of certain websites in partnership with internet registrars — were part of Operation Pangea X, led by Interpol as part of the 10th International Internet Week of Action, which seeks to combat the illegal online sale and distribution of possibly counterfeit or substandard medical products.
“The ease with which consumers can purchase opioid products online is especially concerning to me, given the immense public health crisis of addiction facing our country,” Gottlieb said. “Some of the websites sold unapproved versions of multiple prescription opioids directly to U.S. consumers. This easy and illegal availability of these controlled substances fuels the misuse and abuse of opioids.”
As part of the agency’s broader effort to fight illegal online pharmacies, Gottlieb said the FDA is developing a comprehensive Enforcement Operations Work Plan aimed at combating foreign unapproved drugs being sold to U.S. consumers and increasing the scope of the agency’s operations related to these operations.