|August 28, 2017
HHS Adopts Final Version of Major Substantive and Routine Technical Rules on Opioid Prescribing
The Legislature required the Department to make a number of changes in the provisionally adopted rule and the final rule includes those changes, as follows:
In Section 4, subsection A, paragraph b, division (i) in the portion of the rule that is a routine technical rule, Exception Code A for active and aftercare cancer treatment, the 6-month limit for aftercare cancer treatment post remission has been removed.
In Section 4, subsection A, paragraph 4, subparagraph b, division (i) in the portion of the rule that is a routine technical rule, Exemption Code H has been amended to provide that if an individual is prescribed a 2nd opioid after proving unable to tolerate a first opioid, the individual is not required to return the initial prescription to a pharmacy for collection prior to dispensation of the 2nd prescription. Language has also been added requiring dispensers to provide patients with guidance on proper disposal of the first opioid prescription;
In Section 4, subsection B of the rule, a new paragraph 3 has been added to allow for dispensers to provide an early refill of a prescription to an individual before the refill date if, in the judgment of the dispenser, the early refill does not represent a pattern of early refill requests by the individual;
In Section 4, subsection B of the rule, a new paragraph 4 has been added to allow for dispensers to contact prescribers by telephone to verify and document information about prescriptions;
In Section 4, subsection B of the rule, a new paragraph 5 has been added to establish a process for a dispenser who receives a prescription for an opioid medication from an out of state prescriber that does not comply with Department rules. The section allows the dispenser to fill the prescription if the dispenser records an oral confirmation with the validity of the prescription from the out of state prescriber and documents any missing information such as diagnosis code, exemption code, and acute or chronic pain notation and the dispenser or prescriber's agent, which may include a telephone call to the prescriber's telephone number listed in a telephone directory or other directory; and
In Section 5, subsection C, paragraph n of the rule, the requirement for dispensers to provide information to the PMP on the exemption code and ICD 10 code has been delayed until July 1, 2018 and a provision was added to authorize a waiver after that date from the Department for dispensers who are unable with good cause to comply with the requirement.
The final rule also makes changes to be consistent with the provisions in PL 2017, chapter 213 which became law on June 16, 2017. These changes included additions to the definition of palliative care, serious illness and dispenser. The changes to palliative care and serious illness were intended to clarify that palliative care did not always require a terminal diagnosis or referral to hospice. An example of neuropathic pain was added to the list of examples of serious illness and conditions. Other changes include:
Removing the requirement that dispensers must submit PMP information regarding controlled substances that are dispensed by a hospital emergency department during a period of 48 hours or less.
Clarifies that the requirement to check the PMP does not apply for surgical procedures, but it would apply for scripts written when the patient leaves the hospital. The 100 MME limit also does not apply to surgical procedures whether in patient or outpatient.
Adding to the list of statutorily allowed individuals who can access PMP information.
Removing the requirement that dispensers must notify the PMP program if the dispenser has reason to believe the prescription is fraudulent or duplicative, while maintaining the requirement that the dispenser contact the prescriber.
Clarifying that an opioid medication that, according to the federal Food and Drug Administration labeling, is to be dispensed only in a stock bottle with a supply exceeding 7 days, may be dispensed in accordance with the stock supply, so long as the amount dispensed does not exceed a 14 day supply.
The rule will be effective 30 days following filing with the Secretary of State's office or a later date to be announced by the Department. But because these changes are already part of the law, prescribers and dispensers should comply with these provisions now.
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