Feb. 9, 2018

Issue Spotlight

Congress approves fifth spending bill, including important health provisions

Early in the morning on Feb. 9, the Senate and House passed the Bipartisan Budget Act of 2018, which President Donald Trump then signed into law. In addition to continuing to fund the federal government through March 23, the most recent continuing resolution (CR) addressed a broad range of health, supplemental spending, budget, and tax matters.

The legislation included technical corrections to the Medicare Access and CHIP Reauthorization Act (MACRA) that were sought by the AMA and other medical societies, such as:

Other provisions of interest to physicians include the following:

Bipartisan agreement was also reach on providing additional funds to address the opioid crisis, to rebuild and improve U.S. Department of Veterans Affairs hospitals and clinics, and for the National Institutes of Health.

The AMA sent a letter to the Senate and House leadership on Feb. 8 urging passage of the bill.

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National Update

AMA calls for improving pain care and practice workflows

Policymakers should not limit their focus to reducing the supply of opioids, said AMA Trustee Patrice A. Harris, MD, MA, during her Jan. 30 testimony at a Food and Drug Administration (FDA) public meeting. At the meeting, entitled "Opioid Policy Steering Committee: Prescribing Intervention—Exploring a Strategy for Implementation," the FDA sought stakeholder input on several ideas for improving the safe use of opioid analgesics and curbing overprescribing to decrease the occurrence of new addictions as well as drug diversion. 

"Our focus cannot be limited to just reducing the supply of opioids." Dr. Harris said. "We must also improve care for patients with pain, which means we have to make sure there is access to non-opioid, non-pharmacologic options for pain." American Academy of Pain Medicine President Steven Santos expressed a similar view, and voiced concern that arbitrary dose thresholds may contribute to stigmatization of pain management with opioids.  

Dr. Harris also focused on the need to reduce barriers to electronic prescribing of controlled substances (EPCS) and to better integrate EPCS, electronic health records (EHRs), and prescription drug monitoring programs into physicians' practice workflows—a theme that was echoed by several other participants.

CMS updates 2017 extreme & uncontrollable circumstances policy for MIPS clinicians

The Centers for Medicare and Medicaid Services (CMS) again updated its extreme and uncontrollable circumstances policy. Merit-based Incentive Payment System (MIPS)-eligible clinicians in Federal Emergency Management Agency-designated areas affected by Northern California wildfires and hurricanes Harvey, Irma, Maria and Nate will be automatically identified.  Eligible clinicians in these identified areas will be exempt from MIPS scoring for 2017. They do not have to take any action. 

If, however, an eligible clinician is in one of the designated areas and chooses to participate in MIPS—as either an individual or group—they must submit data on two or more MIPS performance categories.  They will then be scored on those performance categories.  The AMA had urged CMS to create this policy and is grateful that the agency has continued to update it as events develop. 

AMA pushes for change on in-office compounding; UDI implementation

In response to an FDA request for recommendations on how to relieve regulatory burdens, the AMA urged the agency to change its proposals for regulating drug-preparation activities in physician offices and for collection of the Unique Device Identifier (UDI).

The AMA, in a Feb. 5 letter, called for new policy proposals concerning the oversight of physician offices that prepare sterile drug products for administration to patients. The current FDA proposal calls for physician offices that prepare any sterile drug products to meet the same equipment and facility requirements as pharmacies, something not tenable for physician practices. The AMA maintains that preparation of sterile drug products for administration to patients at the point of care is not a drug-compounding activity and called for the FDA to exempt these activities from the proposed requirements.

The FDA has indicated a willingness to find a new path forward for physician offices. Its recently released Compounding Policy Priorities Plan acknowledges that physician activities in many cases pose negligible risks to patients and should therefore not be subject to the same compliance policy as compounding pharmacies.  Physicians can expect the FDA to issue new guidance to this effect sometime this year.  The AMA also provided comments on this issue to the Federation of State Medical Boards, which will be considering new policy on physician compounding at its House of Delegates' annual meeting April 28 in Charlotte, N.C.

In addition, the AMA recommended the FDA reconsider its stance on the capture of the UDI on administrative claims forms. While strongly supportive of implementing the UDI system, the AMA favors capture of the full UDI in a patient's electronic health record and in registries, as opposed to on the claim form.  Claims information does not necessarily follow patients throughout their lives and would not capture complete product information from the UDI.  Consequently, the AMA recommended that patient safety would be better served by capture in these other locations.

FDA considers new framework for regulating software

Holding a public meeting on digital health innovation served as the first step taken by the FDA toward a proposed new oversight structure for software functioning as a medical device. AMA Vice President of Healthcare Quality Kathleen Blake, MD, attended the Jan. 30-31 meeting and participated in a panel discussion with health care stakeholders.  

The FDA has proposed a new regulatory structure for the oversight of software as a medical device, as there are serious questions as to whether the current review system would be able to accommodate the rapid pace of development and change in the software industry. The FDA is proposing a streamlined system of review that would begin with "pre-certification" of software developers meeting certain quality and safety standards.

Dr. Blake provided the physician perspective on this new proposal, raising questions about how the indication system would work and about the importance of post-market surveillance. The FDA "pre-cert" program is currently in a pilot stage, with more details to be released as the agency works towards finalization at the end of the year.

White House hosts meeting on interoperability

The White House Office of American Innovation (OAI) held a small meeting on EHR interoperability last week. Among the senior administration officials who attended were OAI leader Jared Kushner, CMS Administrator Seema Verma and National Coordinator for Health Information Technology Donald Rucker, MD.  

Representing the AMA was Trustee Jesse Ehrenfeld, MD, MPH, who emphasized the critical need to improve the movement of data in and out of EHRs.  Dr. Ehrenfeld outlined two ways to improve interoperability: Prioritize specific clinical or business use cases and remove the federal requirements that are driving problematic EHR design.  The administration expressed a strong commitment to make headway on this critical topic. 

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State Update

"Share Your Story" initiative to gather stories of barriers to ending opioid epidemic

The AMA launched a new effort this week to gather physician and patient stories about obstacles they encounter when trying to access multidisciplinary pain care and comprehensive treatment for a substance-use disorder.  As part of the AMA opioid microsite, physicians can share their stories about treatment, using prescription drug monitoring programs, co-prescribing naloxone and more. The new initiative also includes a digital toolkit where medical societies can download social media messages, graphics, blog posts and other information for their own use.

"We know that prior authorization and other administrative tools used by health insurers can impede appropriate, necessary care—resulting in unnecessary harms and sometimes fatal consequences—for a patient with a substance-use disorder," said Patrice A. Harris, MD, chair of the AMA Opioid Task Force. "These stories will enable us to identify the unique challenges faced by patients and physicians and share them with health insurers and policymakers in support of solutions to increase access to care. Without proper treatment and access to care, this crisis will only get worse."

For information about how your medical society can become part of the Share Your Story initiative, please contact Daniel Blaney-Koen, AMA senior legislative attorney.

Indiana to require Medicaid beneficiaries to work

Indiana has become the second state to gain federal approval to implement a work requirement for Medicaid beneficiaries. In 2015, the Obama administration blocked a similar waver proposal to require work as a condition of Medicaid eligibility, and instead the state implemented a voluntary work referral program.

Under the new waiver program, adults under the age of 60 will be required to participate in 20 hours per week of community-engagement activities. The requirement can be met through employment, job search activities, education, volunteering or public service, caregiving or other qualified activities. Review of a beneficiary's activities will occur every December and compliance will be required for 8 months of the year. Beneficiaries who do not meet the work requirements will be disenrolled.

Exempt populations include pregnant women, beneficiaries identified as medically frail, beneficiaries undergoing active treatment for a substance use disorder, full- and part-time students, primary caregivers of a child under six or a disabled dependent, the homeless, individuals incarcerated within the last six months, and beneficiaries with a temporary illness or incapacity as documented by a third party.

The AMA opposes work requirements as a condition of Medicaid eligibility. For information, please contact Annalia Michelman, AMA senior legislative attorney.

AMA supports Interstate Medical Licensure Compact bills in Georgia, Maryland

Quite a few states are seeking to join the 22 states that are currently members of the Interstate Medical Licensure Compact. The compact is a licensing option under which qualified physicians seeking to practice in multiple states would be eligible for expedited licensure in all participating states. The AMA supports the compact because it streamlines the process for physicians to obtain licenses in multiple states.  This expedited process will help facilitate license portability and allow physicians to practice medicine—including telemedicine—in a safe and accountable manner while protecting patients and expanding access to care, particularly in rural and underserved areas. 

The AMA submitted testimony in Georgia and Maryland to this effect, and encouraged legislators there to join. Please contact Kristin Schleiter, AMA senior legislative attorney, for support in passing compact legislation in your state.

AMA urges Vermont legislature to maintain APRN collaborative practice

Last week, the AMA submitted testimony in Vermont, urging legislators to not weaken state law requiring advanced practice registered nurses (APRN) to practice in collaboration with a physician for the first two years or 2,400 hours of clinical practice. APRNs' education and training simply does not prepare APRNs to practice without physician collaboration, the AMA stressed, especially for new APRNs, for which physician collaboration and mentorship are essential to gain the clinical expertise that is critical to success.

This collaboration is essential to ensuring quality patient care, and deserves careful consideration before any collaboration requirements are removed. Please contact Kristin Schleiter, AMA senior legislative attorney, for assistance with APRN independence legislation in your state.

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Other News

1 in 3 physicians has been sued; by age 55, 1 in 2 hit with a lawsuit

New research details how the threat of medical liability litigation hovers over physicians like a cloud and imposes rising costs on the nation's health system. More than one in three physicians, 34 percent, have had a medical liability lawsuit filed against them at some point in their careers, says one of three trend reports published by the AMA's Division of Economic and Health Policy Research. The longer physicians are in practice, the likelier it is that they will have experienced a lawsuit.

Nearly half of physicians 55 and older report having been sued, compared with just 8 percent of doctors younger than 40. Female physicians are less likely to be sued than their male counterparts, part of which is attributable to differences in age and specialty.

More of the facts you need to know to address the broken medical liability system are available in the 2018 edition of a 36-page AMA resource, "Medical Liability Reform Now!"

The resource explores the independent research estimating that defensive medicine costs the nation's health system at least tens of billions of dollars each year.

Read more at AMA Wire®.

Medicare audits could take less punitive approach in 2018

One thing physicians may notice in 2018 is the government taking a less punitive and more educational approach to correcting Medicare billing errors.

The AMA and the Centers for Medicaid and Medicare Services (CMS) have been holding monthly meetings to discuss issues concerning Medicare Administrative Contractors (MACs) and Recovery Audit Contractors (RACs)—and the effort appears to be bearing fruit.

Previous AMA-advocated improvements included requiring RACs to have medical directors, certified coders and a web presence on which physicians can look up the status of audits. Also, RAC contingency fees must be paid back if an appeal is lost. More recent improvements have also been made.

Read more at AMA Wire.

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Upcoming Events

Feb. 12–14, 2018:
Registration is open for the AMA National Advocacy Conference being held in Washington, D.C., at the Grand Hyatt Washington.

Feb. 21, 2018:
Quality improvement (QI) looks different for every practice, and there are a number of models that can be applied to help your practice implement QI processes and practices. Equally as important as having the tools that you need, however, is developing the culture of quality improvement. In this 1-hour webinar, held from 1–2 p.m. Eastern, "Developing a quality improvement culture in a practice setting," attendees will learn about what is needed to develop a QI culture so that their team may achieve future successes in their QI projects. Meghan Kwiatkowski, MAIO, Senior Practice Transformation Advisor will be the presenter. Click here to register.

Feb. 26, 2018:
The Center for Medicare & Medicaid Innovation (CMMI) recently announced the administration's first new Medicare alternative payment model, Bundled Payments for Care Improvement Advanced, a voluntary model that includes 32 clinical episodes.  The AMA is hosting a free 1-hour webinar on the model from 8–9 p.m. Eastern, featuring CMMI Senior Advisor and Medical Officer Steven Farmer, MD.  Applications to participate in the model are due two weeks after the webinar.  Click here to register and click here for information about the model.

April 2, 2018:
Physicians and practice staff are invited to join the AMA and HITRUST at a cybersecurity workshop April 2 from 6—8:30 p.m. Eastern in Cleveland. Dinner will be provided. Learn more and register today.

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