Advocacy Update

Sept. 20, 2018: National Advocacy Update


On Sept. 17, the United States Senate passed comprehensive legislation to address opioid abuse, the "Opioid Crisis Response Act of 2018" (H.R. 6), by a vote of 99 to 1. The House of Representatives previously passed its version of H.R. 6 in June.

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This package is a combination of many individual bills to address the opioid epidemic that were previously approved by the Senate Committees on Health, Education, Labor and Pensions (HELP); Finance; Judiciary; and Commerce, Science and Transportation. Within the package are policies affecting Medicare, Medicaid, public health, access to substance-abuse treatment, law-enforcement efforts and public safety programs that are intended to curb abuse.

The House and Senate are currently working to reconcile the differences between their two packages. It is possible that final opioid abuse legislation could be considered during the next few weeks.

Also on Sept. 17, the Senate passed S. 2554, the "Patients Right to Know Drug Prices Act of 2018," by a vote of 98 to 2. This legislation, which was introduced by Sen. Susan Collins, R-Maine, would prohibit health insurers and pharmacy benefit managers from using gag clauses that prevent pharmacists from sharing with patients the lower cost options when purchasing medically necessary medication.

The legislation will ensure that the Federal Trade Commission (FTC) will have the necessary authorities to combat anti-competitive pay-for-delay settlement agreements between manufacturers of biological reference products and follow-on biologicals. The Senate recently passed legislation (S. 2553) that would apply similar gag clause protections to Medicare and Medicare Advantage plans. The AMA sent a letter of support (PDF) for this legislation as AMA policy supports legislation that will not only allow, but require pharmacies to inform patients of the actual cash price as well as the formulary price of any medication prior to purchase.

The House Energy and Commerce Committee approved similar gag clause legislation, HR. 6733, the "Know the Cost Act of 2018," by voice vote on Sept. 13. This bill, which the AMA also supports (PDF), applies to both private insurance plans and Medicare Advantage plans. The full House is expected to consider this legislation after it returns from recess.

On Sept. 7, the AMA and 93 state medical associations and national medical specialty societies raised extensive concerns (PDF) with CMS regarding its new policy allowing Medicare Advantage (MA) plans, starting in 2019, to utilize step-therapy protocols for physician-administered drugs covered under Medicare Part B.

The letter points out that many patients receiving drugs under Part B are suffering with serious or life-threatening conditions. Consequently, delays in getting appropriate treatment can mean prolonged symptomatic periods and irreversible damage.

Furthermore, the communication highlights the significant burden step therapy places on physician practices. Because electronic health records do not make patient benefit or formulary information available at the point of prescribing, it is extremely difficult for physicians to determine what treatments are preferred by payers.

In addition, the payer exemption and appeals process can be extremely complicated and lengthy, which adds significant burden for patients and physicians. For all these reasons, the AMA urges CMS to reinstate its 2012 policy prohibiting MA plans from using step-therapy protocols for Part B physician-administered medications.

In response to a request for comments on whether gender alterations should be included in the medical benefits package for the Department of Veterans Affairs (VA) the AMA sent a letter (PDF) urging the VA to amend its medical regulations by removing a provision that excludes gender alterations from its medical benefits package.

The effect of this change would be to authorize gender alteration surgery as part of VA care when medically necessary. The AMA supports the rights of all eligible veterans to receive medically necessary care, and acknowledges that medical and surgical treatments for gender dysphoria as determined by shared decision-making between patient and physician are medically necessary.

Recently, CMS released physicians' 2017 Merit-based Incentive Payment System (MIPS) performance feedback and upon release opened the targeted review process. Based on the AMA flagging calculation error concerns and the initial targeted review requests CMS received, CMS has revised the scoring logic and reissued the 2017 MIPS final scores for the physicians who were impacted. In addition to ensure CMS maintains the budget neutrality that is required by law under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), some physicians will see slight changes in their payment adjustment because of the reapplication of budget neutrality.

The revisions were made to the performance feedback on the Quality Payment Program website on Sept. 13. The AMA encourages physicians and groups to sign in to the Quality Payment Program website as soon as possible to review their performance feedback. If a physician believes an error still exists with your 2019 MIPS payment adjustment calculation, the targeted review process is available.

To offer additional time for physicians, groups, and APM entities and their participants to access and review their performance feedback, CMS is extending the targeted review deadline to Oct. 15, 8 p.m. Eastern time. CMS also has several resources available on the Quality Payment Program Resource Library website to help physicians and practices understand their performance feedback and the targeted review process. For additional assistance physicians can reach out to the Quality Payment Program Service Center by phone at 1-866-288-8292, (TTY) 1-877-715-6222 or by email at [email protected], or contact their local technical assistance organization for free support.

The Physician-focused Payment Model Technical Advisory Committee (PTAC) held its most recent meeting Sept. 6–7 and reviewed four APM proposals. PTAC commended all four proposals but only recommended one for implementation, the Acute Unscheduled Care Model submitted by the American College of Emergency Physicians.

In public comments (PDF) supporting the Acute Unscheduled Care APM, the AMA said the model fills an important gap in the current APM portfolio. The AMA noted that the fee-for-service system allows emergency physicians only a short amount of time to make what are often high-stakes decisions about patient diagnosis and treatment, and there are no payments to support the time and staffing needed beyond face-to-face encounters to help emergency physicians evaluate the timeliness and quality of care a patient would receive in the community if they were discharged from the emergency department.

At its September meeting, the PTAC also sought public feedback on certain aspects of its process. In response, the AMA and the American Society of Radiation Oncology made public comments on the need for the committee to expand on its plans for providing technical assistance and data analyses to physicians and organizations developing proposals to facilitate stakeholders' development of better APM proposals for the committee.

This month CMS began accepting information from physicians on APMs supported by their state's Medicaid programs for inclusion in calculations of all-payer APM participation during the 2019 QPP performance period. Earlier this year, CMS sought information on Medicaid APMs from the states and developed a list of four states with Medicaid APMs that qualify as Other Payer APMs under the QPP.

For 2019, the threshold APM participation level increased from 25 to 50 percent for practices to earn the five percent APM incentive payment payable in 2021. Practices that receive more than 25 percent but less than 50 percent of their total revenues through Medicare Advanced APMs can make up the difference by participating in qualified Other Payer APMs. Physicians wishing to inform CMS of Medicaid APMs in which they will be participating during 2019 must submit a completed form to CMS by Nov. 1.