Though continued political uncertainty threatens to cloud the New Year, medication trends are clearly up. Experts predict considerable growth in U.S. medication spending, and improved insurance coverage is driving increased medication use.
At the same time, a growing number of patients are abandoning their prescriptions at the pharmacy counter because of higher copays. Generic drugs account for about 90% of all prescriptions and a growing proportion of brand introductions are specialty products.
Against this overall backdrop of uncertainty, here are seven key challenges—and opportunities—for pharmacy for 2018.
Retroactive direct and indirect remuneration (DIR) fees are a growing problem for many pharmacists.
“Pharmacy benefit managers are pulling money back months down the road,” said Marvin Moore, PharmD, Owner and President of The Medicine Shoppe in Two Rivers, WI. “The toughest part is that DIR fees are not transparent to us. We just get PBM reports saying they have pulled dollars back. You don’t know what factors are being evaluated over what period. It is out of our control.”
The NCPA and other pharmacy groups have been pushing legislative and regulatory reforms for years and the Centers for Medicare and Medicaid Services (CMS) is listening. CMS’s proposed Part D rule for 2019 calls for pharmacy price concessions to be included in the negotiated price.
The proposed rule would eliminate retroactive DIR fees for the roughly one-third of prescriptions covered by Part D. The Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, a legislative fix that is stalled in Congress, would ban retroactive DIR fees altogether.
The CMS change would save federal payers $3.4 billion over 10 years according to a study sponsored by the NCPA. CMS noted that banning retroactive DIR fees would also save patients $10.4 billion and give community pharmacies greater financial predictability.
“It is hard to dispense a medication and not know your ultimate reimbursement for months,” Moore told Drug Topics. “It would help to have the fees become transparent and even more to have them at the point of sale.”
Consolidation and Vertical Integration
The pharmacy world seems to believe that bigger is more profitable: Manufacturers are consolidating, pharmacy chains are consolidating, payers and insurers are consolidating, PBMs are consolidating. The industry is integrating vertically as well, with pharmacy chains acquiring PBMs and insurers acquiring PBMs.
The latest step is CVS’ proposed acquisition of Aetna. If approved by regulators, the deal would integrate one of the largest pharmacy chains, CVS—which has one of the largest PBMs, Caremark—and one of the largest health insurance companies, Aetna.
“We did a double take,” said Joe Hill, Director of Government Relations for the ASHP. “This is one more step in a continuing trend of the big players getting both bigger and fewer. At this point, it’s hard to predict the outcome, but it is clearly an important question for five-year strategic planning.”
Industry analyst Adam Fein, PhD, noted that the deal could help CVS protect itself from other vertically integrated PBMs, including OptumRx (part of UnitedHealth), Humana (with an internal PBM), and Prime Therapeutics (owned in part by 14 Blue Cross and Blue Shield plans).
Hill added that vertical integration could offer opportunities for pharmacy to highlight their growing role in patient care.
Moore isn’t convinced. “Patients are being limited more and more in where they can go,” he said. “People want to come here, but it’s a challenge when they have to pay more. Growing consolidation and ever more-restricted networks is frustrating for patients and frustrating for us.”
Many pharmacies could not survive without technicians. And as pharmacists focus more on direct patient care, well-trained technicians have the capabilities to assume new responsibilities.
“Technicians are taking an ever-expanding role in almost every health care and pharmacy setting,” said Glen Gard, CPhT, Manager of Pharmacy Compliance for the home infusion provider Option Care. “Their roles include medication reconciliation, quality control and patient satisfaction, pharmacy compliance oversight, blood draws in anticoagulation clinics, medication therapy management, patient preadmission workups, and more traditional roles. As our pharmacists have become more integrated into clinical care, their other roles are being assumed by techs.”
For a preview of where technicians are headed, look to pharmacists. Just as the Board of Pharmacy Specialties is raising the bar for pharmacy specialists, the Pharmacy Technician Certification Board (PTCB) unveiled a beta version of its first specialty certification in late 2017, the PTCB Certified Compounded Sterile Preparation Technician (CSPT) program.
“Sterile compounding is a familiar role for technicians, but the CSPT certification is a new measure of competence,” said PTCB Executive Director and CEO William Schimmel. “We are looking at similarly common sets of knowledge and skills in community pharmacy and other areas.”
Technician practice is advancing steadily at the state level, he added. Idaho recently became the first state to allow technicians to administer immunizations. Early results from Iowa’s community pharmacy tech-check-tech program shows a sharp decline in pharmacist time devoted to dispensing duties and a corresponding increase in direct patient care with no change in error rates.
“More than 90% of Americans live within two miles of a pharmacy,” Schimmel said. “That is a huge opportunity to expand patient care. As pharmacists evolve their practice, technicians are ready to backfill the tasks they leave behind, as well as manage and lead pharmacy initiatives.”
Specialty pharmacy doesn’t get many kind words. Community pharmacists complain that specialty is poaching patients. Health-system pharmacists complain that specialty complicates everything from patient care to inventory and continuity of care.
“Specialty pharmacy isn’t looking to steal patients,” said Sheila Arquette, RPh, Executive Director of the National Association of Specialty Pharmacy. “The move to specialty pharmacy is driven by the payer. There is no choice involved for either the patient or the prescriber.”
Arquette said NASP would like to see a synergistic relation with other pharmacists.
Specialty pharmacy is no more able to deal with patients’ nonspecialty needs than other pharmacies can meet specialty needs. She would like to see specialty and nonspecialty pharmacists share information to improve patients’ overall care.
There are few—if any—formal information- or patient-sharing arrangements, but some community pharmacists are proactively tracking specialty use, noted Lynnae Mahaney, BSPharm, MBA. She is ASHP’s Director of Pharmacy Accreditation and facilitates specialty pharmacy accreditation for the group’s Center for Pharmacy Practice Accreditation (CPPA).
But expansion into specialty pharmacy is possible and is being done. Community and health-system pharmacies are successfully providing a variety of HIV, hepatitis C, rheumatoid arthritis, and other specialty products. The key is working with CPPA to become an accredited specialty pharmacy, Mahaney said.
“Whether you are a health system or an independent, you can build a very successful specialty business if you invest the time and the effort,” she said. “Good pharmacy care can be provided anywhere and the key is providing services that help patients achieve desired, cost-effective outcomes from their specialty medications.”
Activity monitors and other wearable technology are already moving into clinical trials to reliably evaluate changes in activity and other physical outcomes. Other trials are evaluating the use of cell phones and other mobile tech to improve medication adherence in diabetes and other chronic conditions. Pharmacy is next.
The ASHP Foundation Pharmacy Forecast 2018 predicts that health insurers will offer incentives to beneficiaries who can document that they are meeting goals for health behaviors by using wearables. Incentives for using wearables could open the door to entirely new categories of devices, software and training for activity monitoring and reporting products. There is also the potential for new counseling opportunities in the most appropriate use of wearables and activity reporting.
Information sharing is another area ripe for pharmacist action. Pharmacists are being called on to take more active roles in patient care, but providing quality care requires quality patient data. Few pharmacists have reliable access to patient medical data.
“We have technology to share patient data, but we don’t have the policy to make effective data sharing happen,” said Tom Bizzaro, RPh, Vice President of Health Policy and Industry Relations for pharmacy data provider FDB. “All of the health-care providers who touch a patient need access to patient information at their own point of care. Pharmacy should be taking a lead in making sure we have standardized access to information using standardized vocabularies when we talk about health care.”
Provider status for pharmacists has arrived, at least in a few states. Federal legislation has the backing of more than half the House and half the Senate, but companion bills HR 592 and S 109 have been stalled by partisan politics.
“It’s been a tough year to get anything accomplished in Washington,” said Tom O’Donnell, Senior Vice President for Government Affairs and Public Policy at the NACDS. The NACDS, NCPA, ASHP, the American Pharmacists Association, and other groups have backed repeated attempts to have pharmacists added to the short list of Medicare providers.
The Patient Access to Pharmacists’ Care Coalition is gearing up for another attempt at passage in 2018, O’Donnell added. This bill would give Medicare beneficiaries access to pharmacist-provided services in medically underserved areas based on state scope of practice laws. Pharmacists, like other non-physician practitioners, would be reimbursed at 85% of the physician fee schedule.
“It is unprecedented for a bill to have that kind of cosponsorship,” said Christopher Topoloski, ASHP Director of Federal Legislative Affairs. “This is a bill that everyone can rally around. It is good health policy.”
Both NACDS and ASHP are encouraging pharmacists to contact their representatives and senators to push for action on the respective bills. The next legislative step is hearings in both the House Energy and Commerce Committee and the Senate Finance Committee. Every congressperson and a third of senators are looking for positive positions they can use during midterm elections in 2018.
“It is pharmacists, constituents, voters, who move that process,” Topoloski said. “When it comes to dealing with Congress, pharmacists can be their own best advocates.”
Opioids and PDMPs
Abuse of prescription opioids shows no signs of abating. Data released in late 2017 showed drug-related deaths fueled a second successive year of declining life expectancy for Americans.
NCPA warned that pharmacists can expect an expansion of programs to limit initial fills of controlled substances, expanded electronic prescribing for controlled substances, and increased efforts around the disposal of controlled substances. Prescription drug monitoring programs (PDMPs) will remain a key tool in combating misuse.
PDMPs are being developed at the state level to deal with state-specific issues. The Prescription Drug Monitoring Program Training and Technical Assistance Center at Brandeis University reports that as of November, 2017, 25 states require prescribers to query the state PDMP before prescribing controlled substances. PDMPs can be highly effective in limiting inappropriate dispensing, but PDMP reports are outside the normal workflow and can slow operations. Fourteen states require both prescribers and dispensers to check the state database, while 13 states do not require checking a PDMP.
Minnesota is one of the states that require prescribers to check the state database before prescribing controlled substances. “For years, we had to call prescribers every time we saw a patient come in with multiple prescriptions or who we suspected was doctor shopping,” Moore said. “Now that those questionable prescriptions aren’t being written, we don’t have to play good cop-bad cop or go back and forth with physician offices.”