Biopharma Insights: New Federal Opioid Legislation Has Potential Impacts for All Pharmaceuticals

Sweeping new legislation was signed into law on October 24, pulling together 70 bills from both sides of the aisle to address various aspects of the opioid epidemic. The new law is the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act’’ or the ‘‘SUPPORT for Patients and Communities Act” (aka HR6 and Public Law 115-271).

The SUPPORT Act contains provisions that directly impact how drugs will be prescribed through mandates concerning electronic prescribing (ePrescribing), electronic prior authorization (ePA) and prescription drug monitoring programs (PDMPs).

ePrescribing. Section 2003 mandates that prescriptions for all controlled substances covered under Medicare Part D must be transmitted electronically beginning on January 1, 2021, with a few exceptions.

The impacts: Requiring electronic prescribing of controlled substances (EPCS) will give a needed shot in the arm to use of this transaction. Controlled substance prescriptions account for about 15% of all prescriptions. Roughly one fifth were prescribed electronically in 2017, representing 77.33 million ePrescriptions for controlled substances.  Most of that was due to mandates in New York, Connecticut, Maine and Minnesota.

We expect prescribers who are required to use EPCS for Part D prescriptions will ePrescribe for all prescriptions. Physicians will want to have one workflow for all prescriptions because nearly 80% of noncontrolled substances are already being ePrescribed. In addition, private payers and states are likely to follow suit and require EPCS for all controlled substance prescriptions, not just a subset related to opioids.

Now physicians (the vast majority of whom treat Medicare patients) will have to get on board. The impact of adoption should be minimal. Virtually all electronic health records (EHRs) — the most frequently used method for ePrescribing — are already compliant with EPCS standards required by the Drug Enforcement Administration (DEA).

Electronic prior authorization. ePA has been around for a while but has not experienced the adoption uptick originally expected. The new law should change that. Section 6062 mandates that all covered Part D drugs requiring prior authorization (PA) must be electronically submitted to Part D sponsors and processors electronically — and responded to electronically — by January 1, 2021. Those ePA transactions must use an as yet-to-be named standard specified by the Secretary of the Department of Health and Human Services (DHHS). In addition, facsimiles, proprietary payer portals that do not meet standards specified by the Secretary, or electronic forms don’t count as complying with the law.

The impacts: We think the Act’s provisions will have far-reaching impacts on how prior authorizations are obtained.

• Payers and pharmaceutical benefit managers (PBMs) will have to fill data gaps and fix inaccuracies in formulary and benefit (F&B) files, as described below. Prescribers often do not trust the F&B information, which has been a barrier to ePA adoption.
• In the near term, the standards vacuum will lead to more retrospective PA. Retrospective PA is better than fax, phone and paper but nonetheless a burdensome, usually proprietary process in which PA is sought after the prescription has been rejected at the pharmacy by the payer. Retrospective PA frequently results from missing or incomplete data in the current ePrescribing process. In an electronic health record, ePA is triggered based upon an indicator, or flag, in the formulary and benefit (F&B) file provided by the payers and PBMs. However, the PA flag is frequently not populated by commercial payers. Even when the flag is provided, the need for PA is not always accurately presented. These inaccuracies, plus the traditional manual paper and fax-based PA process, result in delays and frustration.
• The Act’s provisions will accelerate innovative solutions. Several are on the horizon. Artificial intelligence (AI) is one that some organizations are testing to predict if a PA will be required. Another is the real-time pharmacy benefit check (RTPBC), which provides real-time patient-level information at the point of prescribing, pulled directly from the payer’s claims system, which is where the most accurate and timely information is stored. It enables the prescriber to see patient-specific plan restrictions (such as PA and step therapy), true out-of-pocket costs for a medication (specific copay/coinsurance amount) and specific deductible information. This will prevent dispensing delays caused by inadvertent prescribing of a drug that is not covered by the patient’s insurance or requires an expensive copayment. Even with these innovations, the need for F&B files will not go away with the advent of RTPBC. Rather, they will evolve to support RTPBC by consistently alerting prescribers of the need to perform a PA due to mitigating factors, such as noncovered drugs. Thus, eligibility-informed formulary is still important because it helps determine whether a PA is needed. The bottom line is that payers must address the shortcomings in F&B data at the same time as they are innovating with AI and RTPBC.

PDMPs. PDMPs are state-specific databases of controlled substance prescriptions. Electronic consultation of PDMPs before the prescriber “writes” the prescription is viewed as an effective way to prevent drug diversion, overprescribing and doctor shopping.

The SUPPORT for Patients and Communities Act has numerous provisions related to making PDMPs more interoperable. Grants are in the offing to states and other jurisdictions to implement, enhance, and improve various PDMP functionalities. These include improved and interoperable sharing and accessing of controlled substance prescribing data across the states; integration of PDMP data into EHRs and the “health IT infrastructure” workflow; and “integration of automated queries into clinical workflow to improve the use of such data analytics by practitioners and dispensers.” Other interoperability-related provisions include sharing dispensing data across state lines in real time and linking PDMP data to other data systems within the states, such as those for coroners, the Department of Veterans Affairs and the Department of Indian Affairs. The statute also allows the DHHS Secretary to issue guidelines specifying a uniform electronic format for the reporting, sharing, and disclosure of information pursuant to PDMPs.

The impacts: Receipt of the grant money requires that a state must have a PDMP program in place, which likely puts additional pressure on Missouri as the sole state without a true state-wide PDMP program. These provisions will require states to revisit their legislation to sync up with the requirements in the SUPPORT for Patients and Communities Act. We expect that states will also revisit legislation due to Section 1016. This addresses PDMP data sharing for Medicaid, granting authority for state laws to permit sharing of data among providers, as permitted by state law.

Want to know more? The SUPPORT for Patients and Communities Act has numerous other provisions of interest to stakeholders, including expanding use of telehealth in Medicare for substance abuse treatment and expanding eligibility for medication therapy management for beneficiaries at risk for substance abuse. Contact Keith Fisher (keith.fisher@pocp.com), who co-leads our Regulatory Resource Center (RRC). We can provide a complete look at the act’s provisions, as well as explain the depth of information available from the RRC on laws and regulations pertaining to ePrescribing, ePA, and other topics of interest. Drop me a line (brian.bamberger@pocp.com) if you’d like to know more about the changing health IT landscape and what it means for your company.