Maryland generics pricing bill becomes law without Gov. Hogan’s signature
ANNAPOLIS, Md. — A bill passed by Maryland’s state legislature became law without Gov. Larry Hogan’s signature late last week. The bill is designed to allow the state’s attorney general to take action against drug makers that raise prices of a drug beyond a certain threshold, and generally seeks to increase transparency in how generics are priced, including itemizing the components of the cost of producing a generic.
And though the measure did become law, it also did so without the governor’s signature and with his trepidation about the bill noted in a letter he sent to the Maryland House speaker on May 26. Among his concerns is the broad basis on which the threshold for price increases is defined, using terms like “unconscionable” and “excessive.”
“These terms are at the heart of the legislation, and because they have been so broadly drafted, it is very difficult for manufacturers to know whether they are in violation of these provisions, leaving the decision entirely to the interpretation of the Attorney General.
Hogan also noted that for a bill that looks to address high costs of medicines, it does not address branded medication, focusing instead on off-patent and generic drugs.
“This legislation only addresses the pricing of generic and off-patent pharmaceuticals, and does nothing to address the cost of patented products and medical devices which may be associated with drug delivery,” Hogan said in the letter. “This oversight, whether inadvertent or deliberate, is troubling since the patented or brand-name pharmaceuticals make up a significant amount of the market and are often times the most expensive and essential pharmaceuticals.
According to the most recent report from the Association for Accessible Medicines, the generics industry makes up 89% of filled prescriptions and 27% of the cost.
“I am not convinced that this legislation is truly a solution to ensuring Marylanders have access to essential prescription drugs, and may even have the unintended consequences of harming citizens by restricting their access to these drugs,” Hogan’s letter said. “The legislation does have a laudable goal, to combat price-gouging of consumers for life-saving drugs, and I am supportive of that goal.”
The legislation is set to take effect on Oct. 1.
A case for using PDMPs to advance into clinical tools
The opioid abuse epidemic has justly garnered much of the nation’s attention. Reports show that on an average day, 91 deaths occur daily due to opioid-related overdoses in the U.S. As a society, we shoulder $55 billion annually in health and social costs related to prescription opioid abuse. Combine these facts and today we’re facing an incredibly emotionally charged situation that’s also a matter of heated political and social debate.
At the same time, we as pharmacists know that as severe as this situation is, these cases are the exception versus the rule. More than 650,000 opioid prescriptions are dispensed daily. The vast majority are valid, legitimate prescriptions. Our role is to ensure that people who truly need the medications have access to them.
The true purpose and use of prescription drug monitoring programs (PDMPs) continues to evolve from a tool for law enforcement to identify abuse and diversion, to a clinical tool to help practitioners assess patients more holistically. This seems to be working: the use of PDMPs in 49 states has been linked to the reduction in opioid-related death rates; one study, in particular, specifies that the impact has been one fewer death every two hours on average nationwide.
As we accumulate and share more data in state PDMP repositories, the data’s potential to transform into a point-of-care clinical tool increases. Most states, for instance, allow prescribers and pharmacists to obtain PDMP reports on patients when a prescription is going to be written or filled for a controlled substance. Our industry has begun to ask such questions as, “Is there value in providers looking at the PDMP information whether they are prescribing an opioid or not?” “Are there data assets that could enhance the clinical relevance of the PDMP data?” “Could predictive analytics assist with providing adherence scoring to potentially detect non-adherence that could lead to addiction?”
The discussion of PDMP transformation would not be complete without touching on a true pain point for practitioners whether prescribing or dispensing – accessing the PDMP data. Gaining access to this data today is outside of the workflow systems, and we still access them manually. Integration of the PDMP data, any other data assets and scoring that will help transform this information into a clinical tool will need to be a real-time pharmacy workflow- and EHR-integrated solution.
We’ve got work to do to get there, but the work that has been done to get these programs in place and the continued focus on improving utilization should be recognized. There is a need for solutions that go beyond displaying lists of transactional data. Enhancing interstate PDMP sharing, and combining the PDMP data with other sources of information for a richer context and more valuable insights while integrating seamlessly into the provider’s and pharmacist’s workflows is the challenge we currently face, but setting a clear goal is half the battle.
When it comes to the opioid epidemic, as a society, we all own it. As an industry and as a profession, we will be part of the solution.
PQA enhances platform through three new hires and addition of executive fellow
ALEXANDRIA, Va. — Pharmacy Quality Alliance on Tuesday announced three strategic hires and the installation of an executive fellow. Bill Lademann joins PQA as SVP strategic alliances and measure implementation; Irene Nsiah was named associate director research and analytics; Loren Kirk was named associate director member engagement; and Nicolette Mehas is joining PQA as its fifth executive fellow.
"As we continue to build out PQA's capacity as a multi-stakeholder, measure developer, we are excited to have Bill, Irene, Loren and Nicolette join the PQA team," stated Laura Cranston, executive director PQA. "Their combined expertise will continue to enable PQA to work collaboratively on meaningful measures that improve patient care through appropriate and safe medication use."
Lademann hails from United Health Group where he served as VP National HEDIS Medical Clinical Operations and established and managed four core Centers of Excellence. He brings more than three decades of experience in quality measurement and reporting, hospital pharmacy practice and health care administration.
Nsiah will take an active role in measure testing, research and analytics to support the measure development and endorsement initiatives. Prior to joining PQA, she worked as a research scientist at Comprehensive Health Insights, where she was responsible for conducting comparative effectiveness analyses, cost and utilization studies and burden of illness analyses to inform formulary decisions.
Kirk, meanwhile, recently completed an executive fellowship with the National Association of Chain Drug Stores. His focus will be to ensure the balance of the stakeholders as well as to foster an increased level of member engagement in measure development, implementation, research and educational initiatives.
And Mehas is joining PQA as its fifth executive fellow. She is a recent graduate of Purdue University.
Lademann will be filling a post held by Woody Eisenberg, who will be retiring at the end of the month, PQA stated. Eisenberg has played a key role within PQA over the past four years, with respect to the measures it develops, positioning them within a variety of new organizations, including state-based health alliances, accreditation programs and new and emerging models of care.