MOA Action Alerts & Updates!
NEW: DHHS Clarifies Opioid Prescribing and Dispensing Rules, July 28, 2017
The Electronic Prescribing Clarifications are here, and the Opioid Dispensing Clarifications are here.
Note: Since these documents have not gone through the rule-making process, they do not legally have the force of law; however, they do describe the Department’s interpretations of the rules, so they may be used as guidance by prescribers and dispensers trying to figure out how the Department will enforce the rules.
What's Been Clarified:
- Pharmacists are not expected to verify the existence of a waiver, and they may dispense from “otherwise valid written, oral or fax prescriptions.”
- The clarifications also list “Exceptional Circumstances” when a written prescription may be used: Temporary technological or electrical failure, a PMP approved waiver, dispensing by pharmacies outside the state or within the VA or IHS systems, or when the prescriber “reasonably determines that it would be impractical for the patient to obtain the medication in a timely manner, and such delay would adversely impact the patient’s medical condition.”
- The Department also states that written prescriptions may be used for patients with a foreign address. The same is true for homeless patients who do not have an available address. The Department recommends using shelters or street names as addresses in these cases, which would apparently then require electronic prescriptions.
- There is no long-term care facility exception to the E-prescribing mandate, but the Department states that prescriptions for Schedule II medications may be faxed to the pharmacy from these facilities. It is unclear how these two statements are reconciled with each other.
- The PMP does not currently allow entry of ICD-10 and exemption codes by pharmacists. While they may wait until July 1, 2018 to upload this information, they are still currently required to document it.
What's Still Not Clear:
- In responding to a question about whether a pharmacist is allowed to fill a written prescription after August 1st, the document states, “No, however, a corresponding liability for the proper prescribing and dispensing of controlled substances rests with the pharmacist who fills the prescription.” Does this mean that a pharmacist who fills a written prescription without ensuring there is a waiver risks “liability?” We don’t know, and the Opioid Dispensing Clarifications document does not say.
UPDATE: Maine Gov. Shutdown
July 3, 2017 -
Governor Paul R. LePage has signed the biennial budget passed by the legislature into law. With an approved budget in place, the governor has rescinded the state’s civil emergency. Effective immediately, state government will resume normal operations.
State offices will be closed on Tuesday, July 4, 2017, in observance of the Independence Day holiday.
Members of the public can expect state offices to be open their normal business hours on Wednesday, July 5, 2017.
Special Alert to MOA Members re: Maine Gov. Shutdown
Saturday, July 1st 2017
Dear MOA Members,
As you have heard, the Maine state government offices partially shut down at 12:01 pm last night. Practicing physicians--Your patients on MaineCare should be unaffected. "TANF, SNAP and MaineCare payments will be made." See the Press Release from the Governor's office here for more details.
As for physician licensure, routine renewals can be made via the on-line system. This was confirmed by our Osteopathic Board of Licensure. However, complex renewals or applications for new licenses are not going to be processed during a shutdown.
If you have questions, please let us know. We will keep you posted if and when we learn additional information.
Important--Maine DHHS Updates on PMP and E-Prescribing Grace Period:
June 29, 2017
Dear Prescribers, Dispensers, Professional Boards and Societies, and other interested parties:
The Maine Department of Health and Human Services would like to thank you for your commitment to the people of Maine. Under Public Law Chapter 488, An Act to Prevent Opioid Abuse by Strengthening the Controlled Substances Prescription Monitoring Program (PMP), electronic prescribing becomes mandatory on July, 1, 2017 or individuals would face a penalty.
Penalties. An individual who violates this section commits a civil violation for which a fine of $250 per violation, not to exceed $5,000 per calendar year, may be adjudged. The Department of Health and Human Services is responsible for the enforcement of this section.
Under the Commissioner’s authority, the Department will be allowing a 31 day grace period regarding the enforcement of the penalties.
To be clear, this grace period only applies to the e-prescribing mandate. Chapter 488 Law is still fully in effect.
After this grace period, penalties for individuals who violate this section of the law will be enacted. If you need to apply for an e-Rx waiver, please visit the SAMHS PMP website to complete and submit your application: http://www.maine.gov/dhhs/samhs/osa/data/pmp/e-prescribing.htm
Additionally, please find an overview of guidance around opioid prescriptions, exemptions, and special information for veterinarians online:http://www.maine.gov/dhhs/samhs/osa/data/pmp/index.htm
For any additional questions, please do not hesitate to contact the PMP email at SAMHS.PMP@maine.gov.
Christopher J. Pezzullo, DO
State Health Officer, MOA Past President
MOA NOTE: Please View the USER GUIDE which addressed Exemption Codes, important definitions and more!
Maine CDC Publishes Modified Opioid/PMP Rule
Friday, March 31st, saw the Maine CDC publish its "final" version of the opioid prescribing and PMP use rule. You can read the entire rule here.
Here are some of the new changes:
- the definition of "opioid medication" includes all controlled substances containing opioids, not just Schedule II drugs.
- the term "administer" is now defined.
- a prescriber's duty to review the PMP check done by a delegate is defined.
- prescriptions must include notations of the prescriber's DEA number; whether the pain being treated is acute or chronic; a notation of "acute" when prescription is for "acute on chronic" pain; and as any exemption being claimed
- notation of ICD-10 codes is only necessary when claiming the palliative care exemption
- a new exemption has been created for situations where a patient proves intolerant of a prescribed opioid and must get another (Code H)
- the rule sets out the types of information the CDC is looking for when reviewing PMP information
All physicians who prescribe opioids should review the new rule as soon as possible.
Electronic Opioid Prescribing Waiver Applications Now Available from Maine CDC
Maine's new opioid law, PL 2015 c. 488, includes a requirement that all opioid prescriptions be done electronically. Of course, there will be circumstances where that is either impossible, extremely difficult or burdensome. The Maine CDC has now (as of April 3, 2017) issued a waiver application that is available online at http://www.maine.gov/dhhs/samhs/osa/data/pmp/E-Prescribing-Waiver-and-Policy_Individual.pdf .
This is what the CDC says about the waiver requirements:
- "Waivers may be granted based on documentation by a practitioner that his or her ability to issue an electronic prescription is unduly burdened by: technological limitations that are not reasonably within the control of the practitioner; or other exceptional circumstances demonstrated by the practitioner. Detailed evidence of, technological limitations and other exceptional circumstances must be provided, including all steps that are being taken, in the interim, to meet this mandate. A waiver may be granted for a period determined appropriate by the department not to exceed twelve (12) months, although the Department may renew the waiver upon a new demonstration that the practitioner’s ability to issue an electronic prescription is unduly burdened."
CMS Releases New Resources to Help Clinicians Successfully Participate in QPP
CMS has recently revamped the look of the QPP website and also posted new resources to help clinicians successfully participate in the first year of the QPP. The following new resources have been posted to the website:
MIPS quick start guide: Outlines the steps clinicians participating in the Merit-based Incentive Payment System (MIPS) need to take between now and March 2018 to prepare for and participate in MIPS, including checking participation status, choosing to participate as an individual or as part of a group, deciding how to submit data, and selecting measures and activities.
Medicare Shared Savings Program and QPP fact sheet: Explains how the Shared Savings Program and the QPP align reporting requirements for participating ACOs and MIPS clinicians, and how certain tracks in Shared Savings Program ACOs meet Advanced Alternative Payment Model (APM) criteria under the QPP.
MIPS APM fact sheet: Provides an overview of a specific type of APM, called a "MIPS APM," and the special APM scoring standard used for those in MIPS APMs.
CMS releases "CAHPS for MIPS" conditionally approved survey vendor list
Physicians who plan on reporting the CAHPS for MIPS measure as one of their quality measures to satisfy MIPS requirements in 2017 must use a CMS-approved CAHPS for MIPS survey vendor. As conditionally approved survey vendors, these organizations have demonstrated they have the facilities, project experience and staff expertise required to conduct the 2017 survey administration with appropriate rigor, given the demands of the survey procedures and timeline.
Final approval of these organizations is dependent on satisfactory completion of CMS training and submission of a Quality Assurance Plan. A final list of the CAHPS for MIPS survey vendors approved by CMS to administer the 2017 survey will be made publicly available this summer.
Keep in mind, physicians who are reporting the CAHPS for MIPS measure must register and inform CMS by June 30, 2017.
An Update on Opioid Health Homes
MaineCare's new Opioid Health Home (OHH) program has begun accepting applications from organizations wishing to be considered for the designation. Amy MacMillan (previously Dix) at MaineCare can be reached at Amy.MacMillan@maine.gov. Currently, Section 93 Emergency Rule is in effect at https://www1.maine.gov/sos/cec/rules/10/ch101.htm/ Comments are being taken until May 18th. We encourage groups to submit comments at http://www.maine.gov/dhhs/oms/rules/proposed.shtml#anchor741339.
In addition, the Maine Office of Substance Abuse and Mental Health Services has a program to cover uninsured for MAT treatment. The coverage will be provided through contracts to agencies that are approved as providers for Opioid Health Homes. As applications are received and approved, the Office of Substance Abuse and Mental Health Services will reach out to OHHs to encumber funds. Mike Parks, Associate Director, DHHS, Office of Substance Abuse and Mental Health Services, can be reached at firstname.lastname@example.org for questions about this part of the program.