The Centers for Medicare & Medicaid (CMS) has released the Calendar Year 2022 Physician Fee Schedule Proposed Rule, which proposes to implement phase 2 of the Section 2003 of the SUPPORT Act requirement that Medicare Part D prescriptions for schedule II, III, IV, and V controlled substances be prescribed electronically. The statute provides the Secretary with discretion on whether to grant waivers or exceptions to the EPCS requirement and specifies several types of exceptions that may be considered. It also gives the Secretary authority to enforce non-compliance with the requirement and to specify appropriate penalties for non-compliance through rulemaking.
In this rule, we are proposing to implement the following proposed exceptions:
• Where the prescriber and dispensing pharmacy are the same entity;
• For prescribers who issue 100 or fewer controlled substance prescriptions for Part D drugs per calendar year; and
• For prescribers who are in the geographic area of a natural disaster, or who are granted a waiver based on extraordinary circumstances, such as an influx of patients due to a pandemic.
We are proposing that prescribers be able to request a waiver where circumstances beyond the prescriber’s control prevent the prescriber from being able to electronically prescribe controlled substances covered by Part D. We are proposing to initially enforce induce compliance by sending compliance letters to prescribers violating the EPCS mandate. In addition, we are seeking comment on different types of compliance actions, so that we may ensure prescribers electronically prescribe controlled substances covered under Part D without overly burdening them.
CMS is also proposing to extend the start date for compliance actions to January 1, 2023, in response to stakeholder feedback. However, we are soliciting comment on whether the original date of January 1, 2022 should remain, in light of the proposed exceptions to the mandate. We are also proposing to extend the compliance deadline for Part D prescriptions written for beneficiaries in long-term care facilities to January 1, 2025.
The proposed rule is available at https://www.govinfo.gov/content/pkg/FR-2021-07-23/pdf/2021-14973.pdf. Comments are due September 13, 2021.
E-Prescribing is a prescriber's ability to electronically send an accurate, error-free and understandable prescription directly to a pharmacy from the point-of-care - is an important element in improving the quality of patient care. The inclusion of electronic prescribing in the Medicare Modernization Act (MMA) of 2003 gave momentum to the movement, and the July 2006 Institute of Medicine report on the role of e-prescribing in reducing medication errors received widespread publicity, helping to build awareness of e-prescribing's role in enhancing patient safety. Adopting the standards to facilitate e-prescribing is one of the key action items in the governments plan to expedite the adoption of electronic medical records and build a national electronic health information infrastructure in the United States.
The MMA created a new voluntary prescription drug benefit under Medicare Part D. Although e-prescribing will be optional for physicians and pharmacies, Medicare Part D will require drug plans participating in the new prescription benefit to support electronic prescribing.
- On November 7, 2005, CMS published the first set of adopted standards known as the foundation standards. The foundation standards became effective on January 1, 2006. These standards apply to all electronic prescribing done under Part D of the MMA.
- MMA required CMS to implement pilot projects to test additional standards. These additional standards were pilot tested in 2006.
- On June 23, 2006 CMS published an interim final rule with comment to adopt NCPDP SCRIPT Standard version 8.1 on a voluntary basis to be used for e-prescribing.
- The results of the pilot test were announced in a report to Congress in April 2007 and were the basis for an NPRM proposing additional standards that was published on November 16, 2007.
- The final e-prescribing rule was published at the Federal Register on April 7, 2008. In this final rule CMS adopted 3 additional standards for use in e-prescribing under part D.
- On January 2009 CMS published a final rule, In this reg the Medicare Part D e-Prescribing foundation standards were updated to include:
o The National Council for Prescription Drug Programs Telecommunication Standard Specification, Version D, Release 0 for eligibility queries between dispensers and Part D sponsors.
o The Accredited Standards Committee X12N 270/271-Health Care Eligibility Benefit Inquiry and Response, Version 5010; For eligibility and benefits queries and responses between prescribers and Part D sponsors.
- On November 18, 2008 CMS Published the 2009 Physician Fee Schedule Payment Final Rule. In that payment reg CMS lifted the exemption to the Computer Generated Fax (CGF) exemption. CMS listed a date of January 1, 2012 for the elimination of the CGF exemption.
- On July 01, 2010 CMS published an interim final rule with comment to adopt NCPDP SCRIPT Standard version 10.6 on a voluntary basis to be used for e-prescribing.
- 2013 the PFS final rule adopted the Script Version 10.6 standard effective (10/1/13)
o Retires Version 8.1
o Lifted the Long Term Care Exemption effective(10/1/14)
- 2014 the PFS final rule adopted a newer version of the NCPDP Formulary and Benefits 3.0 transaction effective 2/28/15 and it also retires NCPDP Formulary and Benefits version 1.0 on 3/1/15.
- On April 16, 2018 CMS published a final rule (CMS-4182-F) to adopt a new NCPDP SCRIPT Standard Version 2017071(2017071) and retirement of current NCPDP SCRIPT Version 10.6 (10.6) for use in the Medicare Prescription Drug Benefit Program (Part D) program effective January 1, 2020.
- On May 23, 2019, CMS published a final rule (CMS-4180-F) requiring that Part D plans adopt one or more real time benefit tools (RTBTs) capable of giving prescribers clinically appropriate patient-specific real-time formulary and benefit information. This mandate is effective January 1, 2021.
- On August 4, 2020, CMS published a Request for Information (RFI) for Electronic Prescribing of Controlled Substances (EPCS) in Medicare Part D. The RFI sought input from stakeholders around implementation of Section 2003 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) which generally requires that prescriptions for controlled substances covered under a Medicare Part D prescription drug plan be transmitted by a health care practitioner electronically.
- On December 28, 2020, CMS published the 2021 PFS final rule, which requires that prescribers use the NCPDP SCRIPT standard version 2017071 for EPCS transmissions.
- On December 31, 2020, CMS published the Electronic Prior Authorization for Medicare Part D final rule. This rule allows Part D plans to use the NCPDP SCRIPT standard version 2017071 for electronic prior authorization transactions beginning January 1, 2021, and requires use of this standard for these transactions beginning January 1, 2022.
- On January 19, 2021, CMS published the Part C and D final rule requiring that plans implement a beneficiary real-time benefit tool (RTBT) by January 1, 2023.