Your Pharmacy and Government Relations: Hot Issues in Federal and State – Part One

Feb 28, 2019 | Independent Pharmacy Insights, Pharmacy Growth

This year is already off to an eventful start, with a series of legislative changes on the federal and state level that have the potential to impact the way pharmacies, practices, hospitals, and other healthcare entities operate and interact.

In part one of this two-part series, we’ll focus on key federal issues that have been causing a stir in the industry. Then, in part two, we’ll highlight newsworthy issues and updates on the state level.

Some of the most hotly-debated federal issues include:

  • Further steps toward Medicare expansion, including a “Medicare at 50” act
  • Increased efforts in fighting the U.S. opioid epidemic, including Medicare Part D changes and new supply chain measures
  • Steps to standardize pharmaceutical quality and regulatory processes for new medications

Let’s take a look at these developments, and the potential impact they might have on your community pharmacy.

Proposed Medicare Expansion

On February 13, 2019, a measure was introduced to extend Medicare coverage. The measure would allow people aged 50 to 64 to buy into Medicare, alleviating some of the health coverage obstacles faced by early retirees and those who are laid off or forced out of their jobs before age 65.

The measure comes weeks before the Democratically-controlled House of Representatives is set to reveal a new “Medicare for All” proposal.

For pharmacies and other healthcare entities, the concept of Medicare for All — or at least “Medicare for More” — raises significant questions. Will these models result in more restrictive care and services offered to patients? Will care become rationed in the interest of managing the myriad of costs? Or will it become more agile to prevent future, larger, and more costly health problems for this age set?

It’s critical to keep an ear to the ground as these discussions develop and evolve.

Efforts to Combat the U.S. Opioid Epidemic

Medicare Part D Changes

As we discussed in a January post, Congress has been working toward curbing access to opioid abuse via new Medicare Part D changes. These include a seven-day supply limit for opioid-naive patients and “care coordination” alerts, which require pharmacists to contact a patient’s prescriber if their opioid prescription(s) reach or exceed 90 MME (morphine milligram equivalent) each day.

As a result of these changes, community pharmacies can expect to have more accountability in the fight against opioid abuse, which will likely impact interactions with patients, prescribers, and plans.

Strides Toward Standardizing Quality in Pharma

In February 2019, the Center for Drug Evaluation and Research (CDER) released a new draft guidance titled “Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.” This effort hopes to set “voluntary consensus standards” over the quality of pharmaceuticals, taking advantage of regulatory, industrial, and academic collaborative efforts for accepted drug quality standards.

Ultimately, the draft guidance aims to further advancements in drug development, while boosting the efficiency of drug product application review processes.

If this effort gains traction, pharmacies may see changes in the way pharmaceuticals are produced and brought to market — hopefully with the long-term impact of improving health outcomes for patients.

Closing Thoughts

Community pharmacies can expect to see some significant changes in the coming year. While the snowball effects of some may be less impactful, others — such as increased opioid management measures, changes are poised to cause direct and immediate changes in terms of daily operations and relationships with patients, prescribers, manufacturers, plans, and other stakeholders.

In an effort to help navigate this flurry of changes, while maintaining patient health priorities, stakeholder satisfaction, and your own pharmacy’s bottom line, learn more about how a partner like AlliantRx can help through a strong, collaborative effort of community pharmacies.

And, stay tuned for part two, where we’ll highlight key legislation and proposals on the state level.