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Maryland's New Prescription Drug Legislation - What It Means for Health Care Providers

August 2019

By: Matthew C. Nelson

Earlier this year, the Kaiser Family Foundation reported that nearly one in four Americans had difficulty in affording their prescription drugs.  With little substantive action taken on the federal level to address rising prescription drug costs, the spotlight has turned to the states for a solution.

Under legislation signed by Governor Hogan on July 1, 2019, Maryland is taking steps to reduce the burden that the cost of prescription drugs has placed on both the state and individuals in three ways: (1) the creation of the Prescription Drug Affordability Board (the “Board”), (2) the protection of long-term medication for chronic conditions from drug formulary changes, and (3) the reauthorization of the Prescription Drug Monitoring Board (“PDMP”).  Each program is discussed below.

Prescription Drug Affordability Board

Maryland has become the first state to implement a Board to address drug costs.  The Board is charged with determining potentially unaffordable prescription drugs and making policy recommendations to the General Assembly focused on reducing drug prices.  After completing a study of the price of prescription drugs in Maryland, the Board is permitted to draft a plan that recommends a ceiling on the price of prescription drugs purchased by state, county, or municipal government employees.  If the Board decides to make recommendations, the General Assembly must review them and, if it approves the recommendations, it must do so by January 2022.

Protecting Medication for Chronic Conditions and Changes To Drug Formulary

The legislature also addressed long-term medication coverage and changes to the drug formulary.  First, the legislation recognizes that individuals who are on long-term medication for chronic conditions may change insurers, and the new insurers often require patients to seek a new authorization in order to receive their medication.  This can often result in patients not being able to get the medication for a period of time.  Under this legislation, a patient’s new health insurer may no longer require reauthorization for a medication for the shorter of one year or the standard course of treatment for the specific chronic condition.  This will result in physicians no longer having to provide authorizations for a patient’s new insurer involving the use of drugs aimed at treating chronic conditions. 

Second, physicians will now be notified when a health insurer removes a drug from its drug formulary or changes the patient to a different prescription drug covered by the drug formulary.  Upon receiving this notice, the physician will be able to respond to the proposed drug change.  If the physician determines that there is no lower-tiered drug available or that the replacement medication would be ineffective or may cause harm to the patient, the insurer must allow the patient to receive the original drug, regardless of the coverage change.

These new requirements will apply to all health insurance policies delivered or renewed in Maryland, effective on January 1, 2020.

Prescription Drug Monitoring Program

Governor Hogan has also reauthorized the Prescription Drug Monitoring Program.  The PDMP was created in 2011 by the Maryland Department of Health and Mental Hygiene, and serves to assist state health care providers, public health officials, and law enforcement agencies in reducing the non-medical use and abuse of Schedules II through V controlled dangerous substances (“CDS”), including but not limited to oxycodone, methadone, anti-anxiety and sedative medications, and certain stimulants.  The PDMP formed an electronic database that provided these stakeholders with real-time information that records when a CDS is prescribed in Maryland.  The system is also designed to assist with identifying potential CDS abuse and prescription fraud.  When a CDS is prescribed, that prescriber or its representative  must report the prescription to the PDMP within 24 hours. 

It is important for a health care provider to note that the PDMP is required to review prescription-monitoring data.  In addition to monitoring patients for potential instances of CDS abuse, the PDMP also makes a record of a health care provider’s prescription history.  If there is an indication of misuse, violation of law, or a breach of professional standards by a health care provider, the PDMP must notify and educate the provider.  If the PDMP determines that reeducation would not appropriately address the violation, the PDMP is permitted to refer the matter to the Maryland Office of Controlled Substances Administration for investigation.

For more information, please contact Matt Nelson via email or at 410.752.9755 or any member of the Tydings health care practice group.

This alert has been prepared by Tydings for informational purposes only and does not constitute legal advice.

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