Health system executives are finding it difficult to stay ahead of the multiple trends culminating at once—reimbursement pressures, rising drug costs, regulatory complexity (340B), and the central role of pharmacy in value-based care.
Ed Francis, a senior director of life sciences at West Monroe Partners, says changes in drug pricing represents a particularly important issue that health executives will need to watch out for in the coming year, starting with optimizing the drug rebate system.
“Congress and the executive branch have discussed everything from eliminating the system entirely to writing laws that increase pricing transparency,” he says. “Even without government intervention there has been movement with some new PBMs that offer rebates as 100% pass-through to consumer. Other companies have emerged that are offering online drug price comparisons in a local area. All of this will help to solve the problem.”
Here are five other policies to keep an eye on in the year ahead.
1. USP 800
Pharmacy expert Ernie Gates, president of Gates Healthcare Associates, believes that compliance with USP 800—the new workplace safety standard for pharmacy—will bedevil many healthcare organizations and the cost of non-compliance could be staggering.
USP 800 is about protecting the healthcare worker, patient, and environment from accidental exposure to hazardous drugs and requires changes to standard operating procedures across an organization, beginning with receipt of a hazardous drug and ending with disposal.
“Many pharmacies, including those inside of institutions such as hospitals, are not prepared to comply with USP 800, which goes into effect later this year,” he says. “This could be problematic for any healthcare organization that is dependent upon pharmacies, including health plans that operate or simply reimburse pharmacies.”
2. Drug Supply Chain Security Act (DSCSA)
The DSCSA was designed so an electronic system could track and trace certain prescription drugs in the United States. Katrina Harper, senior clinical manager, pharmacy for Vizient, says what’s important with DSCSA is compliance with current regulations to ensure the integrity of the pharmaceutical within the supply chain.
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“We are now starting to see enforcement actions in the form of fines,” she says. “One large wholesale distributor was the FDA’s first ever warning letter for non-compliance. They also need to be preparing to comply with the new aspects of this regulation that take effect in 2020.”
By 2020, all Rx products covered under DSCSA must be serialized, and all transactions can only involve serialized product.
3. The Lowest Price Act
This act was signed into law on October 10, 2018 and will become effective either on or after January 1, 2020. Brian Romig, director at Navigant, says it blocks Medicare Advantage plan providers or providers of a Medicare Part D prescription drug plan from using gag clauses that prohibit pharmacists from alerting Medicare customers of differences between their insurance copay and what the patient would pay without using health insurance coverage.