5 New Pharmacy Rules and Regulations to Watch

Drug Topics JournalDrug Topics January 2019
Volume 163
Issue 1

Changes coming to combat opioid addictions and overuse, as well as mitigate rising drug prices. 


Changes to Medicare plans for contract year 2019.

These are CMS’ new strategies to help Medicare Part D plans prevent and combat prescription opioid overuse through improved concurrent drug use review and became effective January 1. “There are changes to when a prescription can be filled, including several formulary-level opioid safety changes and modifications related to the point of sale,” says Ronna Hauser, PharmD, vice president of pharmacy policy and regulatory affairs at the NCPA. Medicare Advantage and Part D plans must follow this annual set of proposed rules, guidelines, and clarifications in order to participate in Medicare for the upcoming contract year.

One change, for example, is a care coordination safety edit. Under this edit, if a person’s cumulative morphine milligram equivalent (MME) per day across all of that person’s opioid prescriptions reaches or exceeds 90 MME, “sponsors should instruct the pharmacist to consult with the prescriber, document the discussion, and if the prescriber confirms intent, use an override code that indicates the prescriber has been consulted,” according to CMS.

“Combating opioid abuse has been at the forefront of the Trump Administration’s healthcare agenda and the Medicare Part D space is a federal program where many of the administration’s policy changes can make a difference,” Hauser tells Drug Topics. “CMS states that its formulary-level modifications seek to combat opioid abuse without impacting access to medically-necessary drugs and hindering a patient’s relationship with their healthcare team.”

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT for Patients and Communities Act).

This act encompasses a wide range of issues, including access to treatment for substance use disorder and additional policies that are intended to balance patients’ pain management needs with prevention efforts.

“The new law aims to combat the opioid crisis, advance treatment and recovery efforts, improve prevention, protect communities, and guard against deadly illicit synthetic drugs (such as fentanyl),” says Jenna Ventresca, JD, director of health policy at APhA. “Pharmacists should be aware of ongoing federal efforts to address the opioid epidemic as these efforts will directly impact the care pharmacists provide to patients and communities.”

One of the many provisions of the act will require electronic prescribing for Medicare Advantage and Part D schedule II through V controlled substance prescriptions as a way to help deter prescription fraud and diversion. “This would not necessarily limit pharmacists’ ability to dispense prescriptions that are not electronically prescribed or a plans’ ability to cover otherwise valid prescriptions,” she says. “Another facet of the law requires HHS to establish a standard and a secure electronic prior authorization system for covered Part D drugs to streamline care.

Prescription drug plan sponsors and Medicare Advantage organizations are required to provide for electronic prior authorization requests from prescribers and subsequent responses by January 2021.”

Since President Trump signed the act into law on October 24, regulatory activity is forthcoming which will provide further details and compliance requirements. “Given the broad scope of the law, it will be important for pharmacists to monitor communications from their professional associations and regulatory entities at the state and federal levels,” Ventresca says.

CMS Hospital Outpatient Prospective Payment Proposed Rule CY 2019 (OPPS).

This proposed rule further expands cuts to the 340B Drug Pricing program made in 2018 and institutes a site-neutrality payment policy for hospital outpatient departments by cutting reimbursement by 40% for the most commonly reimbursed G-codes in order to match payment under the Physician Fee Schedule, says Jillanne Schulte Wall, JD, director of federal regulatory affairs at the ASHP. The proposed rule also includes a request for information related to a potential Competitive Acquisition Program for Part B drugs and biologics, which would run through the Center for Medicare and Medicaid Innovation.

“The change to the federal 340B program reflects CMS’ continued insistence that the 340B program contributes to high drug prices, while the site-neutrality provision reflects CMS’ efforts to reduce Medicare expenditures,” Schulte Wall says.

Pharmacists should be aware that 2017’s cuts to reimbursement for drugs purchased under the 340B program for use in hospitals are being extended to hospital outpatient departments.

Therefore, drugs purchased for the 340B program for use in hospital outpatient departments will now be reimbursed at the average sales price (ASP) minus 22.5%, rather than ASP plus 6%, she says. Final OPPS rules generally take effect on January 1.

Know the Lowest Price Act.

This act was signed into law on October 10 and will become effective either on or after January 1, 2020. The act 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, says Ken Majkowski, PharmD, chief pharmacy officer at FamilyWize, which aims to help consumers save money on prescription drugs.

The act was implemented to increase price transparency for consumers covered under Medicare or Medicare Advantage. “Many consumers don’t know to ask if a lower prescription price is available,” Majkowski says. “When a pharmacist knows that a patient is overpaying but can’t share this information, the patient loses a chance to save and pharmacists feel like they aren’t performing to the best of their abilities. Consumers aren’t given the opportunity to make educated choices surrounding healthcare costs.”

Pharmacists can help patients find better pricing by advising that there are options available to them, Majkowski says. Pharmacists may also want to remind patients that if they don’t use their Medicare benefit, they may not be able to apply that purchase to their deductible, if one exists.

Proposed regulations on drug price disclosures in advertisements.

This is the latest proposal in a series of newly proposed congressional bills and FDA regulations that require pharmaceutical companies to disclose their prices in drug advertising, says Edward J. Buthusiem, managing director, Berkeley Research Group, a global consulting firm.

“The new regulation would require pharmaceutical manufacturers to include the wholesale acquisition cost (WAC) of a drug or biologic for a typical month of therapy in televised direct-to-consumer advertisements,” says Jeremy Schafer, PharmD, MBA, senior vice president of director-payer access solutions at Precision for Value, a pharmaceutical consulting firm. “The regulation would impact any drugs or biologics eligible for payment under Medicare or Medicaid-essentially nearly all pharmaceuticals and biologics-with the exception of those with a WAC below $35 per month.”

“HHS Secretary Alex Azar has stated that the intended goal of the new regulation is to reduce the price to consumers of prescription drugs and biologics,” Schafer says. “Increasing price transparency by educating consumers on the cost of drugs so they can make informed decisions is part of the justification for this rule.”
Ahead of this regulation, Buthusiem says pharmacists should be prepared to articulate answers to pricing questions and fill in gaps that advertisements miss. “In a typical in-person interaction, a pharmacist will be the first point of contact and needs to have a deep understanding of the various details, regulations, and plans to provide accurate information to patients,” he says.

Along these lines, Schafer says pharmacists should be aware that patients may ask them about the cost of a drug they saw on TV and what, if any, portion of that the patient may be responsible for. Pharmacists may also be asked if there are less costly alternatives, so pharmacists should be aware of alternatives, whether the therapy and its alternatives may be appropriate, and what the cost may be.

The comment period ended in December, so the rule, as written or modified, could go into effect at any time this year.


Karen Appold is a medical writer in Lehigh Valley, PA.

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