Nov. 3, 2017: National Advocacy Update

On Nov. 2, the House of Representatives passed H.R. 849, the "Protecting Seniors' Access to Medicare Act of 2017," by a bipartisan vote of 307–111. This legislation, sponsored by Reps. Phil Roe, R-Tenn., and Raul Ruiz, D-Calif., would repeal the Independent Payment Advisory Board (IPAB). The $17.5 billion cost to repeal the IPAB was not offset with corresponding cuts in spending.

The IPAB is a panel that puts significant health care payment and policy decisions in the hands of unelected people with far too little accountability, and could adversely affect access to health care for millions of Medicare patients. Similar to the now-repealed sustainable growth rate (SGR) formula, the IPAB would be another arbitrary system that relies solely on payment cuts to reduce Medicare spending. The AMA sent a letter (PDF) to Congress strongly urging all members to support this legislation.

The AMA looks forward to working with Sens. John Cornyn, R-Texas, and Ron Wyden, D-Ore., the sponsors of similar legislation in the Senate, and others to secure final passage of IPAB repeal legislation and preserve seniors' access to their physicians.

President Donald Trump recently directed the Department of Health and Human Services to declare the opioid epidemic a public health emergency. With the move, aimed at tackling the epidemic tied to hundreds of daily overdose deaths across the nation, the president also ordered other federal agency and department leaders to use any appropriate emergency authority they have to address the problem.

The president specifically announced a plan "to overcome a restrictive 1970s-era rule that prevents states from providing care at certain treatment facilities with more than 16 beds for those suffering from drug addiction." He said several states had sought relief from this and other requirements and promised that "approvals to unlock treatment for people in need" would "come very fast, not like in the past." Waiving Medicaid's 16-bed federal limit to treat patients with a substance-use disorder was among the steps the AMA, in a September letter (PDF), recommended the president take in the context of an emergency declaration.

Read more at AMA Wire.

On Oct. 25, the House Energy and Commerce Committee held a hearing entitled, "Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA Initiatives." Witnesses included administration officials from the Drug Enforcement Administration, Food and Drug Administration (FDA), Substance Abuse, Mental Health Services Administration, Centers for Disease Control and Prevention (CDC), and National Institutes of Health, each of whom discussed their respective agencies' action plan to achieve Comprehensive Addiction and Recovery Act (CARA) directives and address the epidemic.

The AMA submitted a statement for the record (PDF) that calls for a national commitment to ensure that patients receive comprehensive, multimodal pain care and access to treatment for substance-use disorders. It urges Congress to ensure that the necessary resources are available to meet these goals. The statement notes the AMA's support for recommendations of the President's Commission on Combating Drug Addiction and the Opioid Crisis, such as easing regulatory burdens to access medication-assisted treatment (MAT) and enforcing existing substance abuse parity laws. Additionally, the statement highlighted actions that the AMA, partners on the AMA Opioid Task Force, and physicians across the nation have undertaken to combat the crisis. These include urging physicians to use prescription drug-monitoring programs, make judicious prescribing decisions, enhance their opioid education, and co-prescribe naloxone.

The Centers for Medicare and Medicaid Services (CMS) recently released guidance on the information-blocking attestation requirement for the advancing care information (ACI) component in the Merit-based Incentive Payment System (MIPS). All physicians participating in ACI must show that they are meeting this requirement by attesting to three statements about how they implement and use certified EHR technology (CEHRT).

To earn a score in ACI, physicians have to act in good faith when implementing and using CEHRT to exchange electronic health information. While the AMA views this attestation requirement as overly burdensome, the AMA was successful in alleviating the need for physicians to provide documentation to CMS showing they have acted in good faith. Per this guidance, physicians must only attest to complying with these requirements.

Furthermore, the AMA was successful in seeking clarification that physicians will not be held responsible for outcomes they cannot reasonably influence or control. For instance, it will not be viewed as data blocking if a physician's EHR is down for maintenance or if data are unavailable due to an EHR malfunction. Physicians who are participating in the ACI component of MIPS are encouraged to review this guidance from CMS. It is also recommended that physicians alert their EHR vendors to these requirements as many of them directly relate to EHR performance, setup and function.

The FDA recently released new health-professional educational materials that are aimed at helping prescribers gain a better understanding of biosimilars. Biosimilars are FDA-approved products that have no clinically meaningful differences from FDA-approved brand biological products.

The FDA materials include:

• An overview on biologics, biosimilars, and the approval pathways for each.
• Information on biosimilars and interchangeability with their biological reference products.
• Biosimilar product information.
• Links to online educational courses, webinars and presentations.

The release of these materials was accompanied by a blog post from FDA Commissioner Scott Gottlieb, MD, outlining the importance of biosimilars in creating competition in the drug marketplace and offering more options for patients. Biosimilars are expected to play an increasingly important role in treatment of many conditions where drug prices have been the highest.

Biosimilars have the potential to reduce prices by creating price competition for expensive products that previously had no competitors. However, for the relatively new and complex products to achieve successful uptake and adoption in the field, it is important for prescribers to fully understand the products and options available in the market. Learn more at the FDA website.

• Nov. 3, 2017: Advocacy spotlight on Health insurance markets are highly concentrated, new report reveals 
• Nov. 3, 2017: State Advocacy Update 
• Nov. 3, 2017: Judicial Advocacy Update