The Centers for Medicare and Medicaid Services (“CMS”) recently published a proposed rule entitled Secure Electronic Prior Authorization for Medicare Part D, which is intended to update the prior authorization (“PA”) process for Medicare Part D beneficiaries. If finalized, the rule would modify the Part D e-prescribing program to adopt standards that “ensure secure transmissions and expedite prior authorizations.”
The Medicare Prescription Drug, Improvement and Modernization Act of 2003, which established the Medicare Part D prescription drug benefit program, implemented certain electronic prescribing (eRx) standards for electronic prescriptions and prescription-related transactions. Further, these eRx standards must be “compatible” with HIPAA standards. Currently, for a Medicare Part D beneficiary to receive PA for a particular drug, the healthcare provider must submit a drug referral certification and authorization request to the Part D sponsor. However, eRx systems do not have a HIPAA compliant method of transmitting the PA request information. As a result, the PA requests must be completed through different systems (e.g., telephone calls, facsimiles, or payer-specific web portals), resulting in delays for patients trying to access the medication.
In October 2018, the Substance-Use Disorder Prevention that Promotes Opioid Recovery and Treatment (“SUPPORT”) for Patients and Communities Act was enacted. One of the SUPPORT Act provisions requires Part D eRx programs to “ensure secure ePA request and response transactions between prescribers and part D plan sponsors” by January 2021. In order for Part D plan sponsors to meet this deadline, non-HIPAA compliant eRx systems will have to be utilized. CMS acknowledges this, but then states that the SUPPORT Act “allows us to propose the adoption of an ePA standard for Part D-covered drugs to Part D-eligible individuals notwithstanding any other provision of law.” Thus, CMS asserts that the HHS Secretary can require the “use of standards in lieu of any other applicable standards,” such as HIPAA requirements, for “electronic transmission of an ePA.” Instead of HIPAA, the ePA process will be governed by standards developed by the National Council for Prescription Drug Programs “to ensure secure transmissions and expedite prior authorizations.”
CMS Administrator Seema Verma noted that the proposed rule would “reduce the time it takes for a patient to receive needed medications and ease the prescriber burden by giving the clinicians the flexibility and choice to complete prior authorization transactions electronically.” CMS also said that the new ePA process will convey information to the plan in real time and that typically will allow the “patient to access a medication subject to PA the same day that the prescription and ePA are submitted.” CMS is accepting public comments on the proposed rule until August 16, 2019.