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Feb. 7, 2019

Issue Spotlight

AMA to court: Illegal firearm sales are public health emergency

A website specifically designed to facilitate the illegal sale of firearms cannot escape liability for the harm that results from those transactions, according to an amicus brief filed in the Wisconsin Supreme Court by the AMA and the Wisconsin Medical Society.

The brief, prepared by the Litigation Center of the AMA and State Medical Societies, cites AMA policy that declares firearm violence is a public health issue, advocates waiting periods and background checks for gun buyers, and highlights the need to bar high-risk individuals under domestic-violence restraining orders from possessing or purchasing a firearm.

The case, Daniel v. Armslist, seeks to hold the owners of an online marketplace responsible for the murders and injuries committed by Radcliffe Haughton, who bought the gun and ammunition he used after responding to a "for sale" post on the Armslist website. Haughton was prohibited from possessing a firearm by a state court domestic-violence injunction, according to the description of the case written by Wisconsin Appellate Judge Brian Blanchard.

"It's a public health crisis further exacerbated by illegal gun sales," said Wisconsin Medical Society CEO Clyde "Bud" Chumbley, MD. "That's why holding this company accountable is an important step to safeguard our patients and make it clear there are serious consequences for those who would undermine laws put in place to protect the public."

Haughton killed three women, including his wife, and injured four others before taking his own life at a Brookfield, Wisconsin, salon in October 2012. He purchased a semiautomatic handgun from a private seller who posted on Armslist. The seller was not required to conduct a background check or wait 48 hours to complete the sale as is demanded of licensed sellers. Also, no registration of the transaction was required, which allowed the buyer and the seller to remain anonymous. The deal took place in the parking lot of a fast-food restaurant.

One of the injured victims, Yasmeen Daniel, brought the suit both as an individual and on behalf of her mother's estate.

The case was initially dismissed by a lower court that agreed with Armlist's defense that the federal Communications Decency Act of 1996 gave the website immunity because of its status as a passive publisher of content created by third parties.

The state appellate court reversed that decision. It ruled that the allegations were not connected to the website's role as the publisher of third-party content.

The federal law "does not protect a website operator from liability that arises from its own conduct in facilitating user activity, as is the case here," Judge Blanchard wrote. "The claims and supporting allegations do not seek to hold Armslist liable for publishing another's information content. Instead, the claims seek to hold Armslist liable for its own alleged actions in designing and operating its website in ways that caused injuries to Daniel."

The amicus brief notes that facilitating illegal arms sales does not fall under "traditional publisher functions," and that the claim of aiding a murder "does not depend on whether Armslist is treated as a publisher."

Case law is cited that illustrates how, when a statute is ambiguous, its title can provide clarity and indicate legislative intent.

"The law at issue is entitled 'The Communications Decency Act,'" the brief states. "Immunizing Armslist would do nothing to advance communications decency. In fact, immunization would be an action of indecency."

"The do-nothing approach to firearm violence is particularly unacceptable to physicians because, alongside family and community members, physicians and the health care teams they lead bear the emotional weight of firearm violence," the brief says. "Physicians carry these invisible scars into their day-to-day lives."

AMA President Barbara McAneny, MD, elaborated on this point.

"Physicians are compelled to urge the court to consider illegal guns sales a public health emergency," Dr. McAneny said when the brief was filed. "We bear the emotional weight of treating the victims of gun violence everyday: Their wounds, paralysis, colostomies, brain injuries, depression, chronic infections and post-traumatic stress. Common-sense measures to support enacted laws can help prevent more carnage."

Oral arguments are scheduled for Feb. 14, the one-year anniversary of the shooting at Stoneman Douglas High School in Parkland, Florida, where 17 people were killed.

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National Update

CMS proposes step therapy, limiting access to some pharmaceuticals

Following a proposed rule released by the Centers for Medicare & Medicaid Services (CMS) at the end of 2018, the AMA submitted comments opposing several of the changes being considered. In the proposed rule, CMS suggests changes to Part D that would ultimately limit the number of on-formulary drugs for the six protected pharmaceutical classes. Given the vulnerable nature of patients receiving treatments included in the protected classes, the AMA is opposed to any policy changes that would result in limiting patient access to any drugs currently covered.

The proposed rule also seeks to formalize a 2018 CMS policy change that would allow Medicare Advantage plans to use step therapy protocols for Part B physician-administered drugs. The AMA strongly opposes increased application of step therapy protocols generally and finds the use of step therapy protocols for physician-administered drugs to be especially concerning. These concerns were communicated to CMS many times and led to a physician-community sign-on letter opposing the policy changes in 2018.

Despite the problematic nature of some aspects of the proposed rule, the AMA does support some of the changes suggested by CMS. For example, the proposal not only seeks to implement a new ban on pharmacy gag clauses, but also seeks to makes changes to the rules surrounding pharmacy price concessions that should help lower patients' out-of-pocket drug costs. Further, CMS has proposed to mandate real-time benefit tools that would provide a patient's drug benefit information to the provider at the point of care. Despite opposition to the protected class and step therapy proposals, the AMA expressed support for these changes.

Research and prevention efforts needed to curb youth tobacco use

In a letter to U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, the AMA provided comments in response to Eliminating Youth Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies. In the letter, the AMA recognizes the use of e-cigarettes and vaping as an urgent public health epidemic and states that while it is important to consider drug therapies for youth who are already addicted, preventing youth tobacco use and nicotine addiction must be the priority.

The AMA calls for the FDA to prohibit the use of flavoring agents in tobacco products including e-cigarettes in addition to closely monitoring youth access to these products. AMA policy also calls on the FDA to create a non-addictive nicotine level standard to be applied across all tobacco products.

If sufficient action is not taken there is great concern that e-cigarette users could progress to conventional cigarette smoking, a shift which would have the potential to undermine public health gains in combatting the smoking epidemic. The letter also notes that more research is needed on the trajectory of nicotine dependence for e-cigarette users as well as studies evaluating the role of drug therapies for youth tobacco cessation. The AMA is committed to working with the FDA and other relevant stakeholders to counteract the marketing and use of addictive e-cigarette and vaping devices.

2019 changes to Medicare Part D opioid management policies

The Medicare Part D prescription drug program has had an opioid overutilization management system in place for several years that is designed to improve patient care coordination. Under this system, Medicare Part D plans use data analysis to identify patients who are receiving relatively high doses of opioid analgesics from multiple pharmacies and prescribers. The plans are supposed to contact the prescribers to inform them if their patients are being dispensed these other medications and discuss whether all the prescriptions are medically appropriate.

For 2019, additional policies have been implemented in Part D that will affect many more patients and prescribing physicians. These policies are discussed in an MLN Matters article and will also be described in a Medicare Learning Network call on Feb. 14—register here.

There are three key elements of the new policies for 2019:

  1. Opioid-naïve patients will be limited to an initial seven-day supply. If a physician believes that the patient will need more initially, they can proactively request a coverage determination attesting to the medical need for a longer supply. The seven-day limit will only apply to the first prescription.

  2. When pharmacies receive a prescription that leads to the patient's cumulative daily morphine milligram equivalent (MME) dose reaching 90 MME or more, the pharmacist will receive an alert and may consult with the prescribing physician to confirm that the dose is medically necessary. This is not an MME limit. Similar to the system in previous years, the main idea is for physicians to be made aware that their patients have already been dispensed other opioid analgesics and that the cumulative dose has reached 90 MME or more.

  3. Medicare Part D plans may also implement drug management programs this year for patients determined to be at risk of opioid overutilization. These programs build upon the previous opioid policies by focusing on patients who obtain opioids from multiple pharmacies and prescribers. After completing several steps to coordinate the patients' care with the prescribing physicians, Part D plans may restrict some of these patients to particular pharmacies or prescribers, or limit their ability to fill prescriptions for certain opioid analgesics or benzodiazepines. Patients in long-term care facilities, those receiving hospice, palliative or end-of-life care, and those being treated for cancer-related pain are exempt from the drug management program.

New recommendations seek to reduce physician health IT burden

In late November 2018, the Office of the National Coordinator for Health Information Technology (ONC) and CMS released their draft "Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs." The strategy, which is required by the 21st Century Cures Act, outlines three overarching goals that aim to reduce physician burden: reduce the effort and time required to record health information in electronic health records (EHR); reduce the effort and time required to meet regulatory reporting requirements for clinicians, hospitals and health care organizations; and improve the functionality and intuitiveness of EHRs.

The draft strategy lays out four focus areas—including clinical documentation, health information technology (health IT) usability and user experience, EHR reporting, and public health reporting—setting forth dozens of recommendations to reduce administrative and regulatory burden.

The AMA supports the administration's focus on reducing administrative burden and physician burnout. The report's section on clinical documentation is particularly important to AMA members.

In the November Final Physician Fee Schedule Rule, CMS outlined payment and coding policy related to E/M documentation. While the AMA supports action to reduce documentation burdens, the AMA along with other physician groups are working on an alternative E/M code set and policy.

The clinical documentation section also discusses the efforts of the Current Procedural Terminology (CPT®)/RVS Update Committee (RUC) Workgroup on E/M to develop an alternative to the CMS policy.

The AMA also provided an extensive set of recommendations to improve ONC and CMS strategies, which include:

Prior authorization

  • Broad policy reforms needed to achieve meaningful reductions in the administrative hassles associated with prior authorization
  • An urgent need for national electronic prior authorization standards to reduce the burden associated with unique needs of each health plan
  • Tight integration of prior authorization request/response within EHRs
  • A call to industry to reduce the overall volume of prior authorizations

Health IT usability

  • The Administration's recognition of its reporting programs' (e.g., Quality Payment Program) impact on EHR design, function and use
  • Requiring EHR vendors to adhere to stronger usability, safety and engineering principles
  • Promoting guidelines and recommendations for medical application (app) development
  • Requiring EHR vendor transparency on costs and interoperability

EHR reporting

  • Simplifying scoring in the Quality Payment Program
  • Moving to a simplified yes/no EHR measure attestation approach and EHR vendor reporting
  • Linking new measures with targeted patient outcomes and improving physicians' return on investment
  • Adopting clinician-led efforts to improve the use and security of medical data

Public health

  • Seamless integration between prescription drug monitoring programs (PDMP) and EHRs
  • Leveraging pain management best practices to effectively use PDMP data and reduce electronic prescribing burden
  • Modernizing requirements for electronically prescribing controlled substances in a way that reduces costs and improves physician workflow
  • Developing a strategy to educate physicians and patients on state and federal privacy laws using common-sense scenarios

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State Update

Kentucky bill would remove prior authorization for MAT

The Kentucky Medical Association (KMA), the American Society of Addiction Medicine (ASAM) and AMA are supporting a bill that would prohibit prior authorization for medication-assisted treatment (MAT) for opioid use disorder. As introduced House Bill 121 would prohibit the practice by insurers doing business in the state as well as Medicaid and Medicaid managed care organizations. The bill would apply to any prescription drug that is used in the treatment of opioid use disorder, including methadone, buprenorphine and naltrexone.

"We have enacted many laws in Kentucky to help reverse the epidemic," said Kentucky Representative Kim Moser, the bill's chief sponsor. "Now it's time to take meaningful steps to remove barriers to evidence-based treatment for opioid-use disorder."

"Without question, this bill will save lives in Kentucky," said AMA Executive Vice President and CEO James L. Madara, MD, in a letter.

As part of the effort to help pass HB 121, the AMA and KMA developed a brief advocacy document on the issue for legislators and other stakeholders.

For more information about HB 121, please contact KMA's Cory Meadows.

The AMA encourages all states to consider introducing legislation to prohibit prior authorization of MAT as one of several policies to help end the nation's opioid epidemic. Contact Daniel Blaney-Koen to learn more about AMA model legislation on this issue.

Arizona to implement Medicaid work requirements

On Jan. 18 Arizona received federal approval to require certain Medicaid patients to meet "community engagement" requirements, such as work, education, job training or community service, as a condition of receiving Medicaid benefits. Beginning in 2020, Medicaid patients in Arizona will have report at least 80 hours per month of such activities. Patients who fail to report compliance will be locked out of the program for two months. The approved waiver does provide an exemption to members of federally recognized tribes and is the first approved waiver to include such an exemption. The state estimates that 120,000 Medicaid patients will be affected by the new rules. Arizona is the eighth state to receive permission to impose work requirements on Medicaid patients and it is estimated that 120,000 patients will be affected.

Arizona will also eliminate a three-month retroactive eligibility period for most Medicaid beneficiaries. The retroactive eligibility period provided reimbursement of medical bills incurred up to three months prior to a beneficiary's application date, a safeguard against medical debt and uncompensated care costs.

The AMA opposes Medicaid work requirements and lock-out periods, and supports retroactive eligibility. The AMA Litigation Center recently submitted an amicus brief challenging similar work requirements in Kentucky.

Prior authorization of non-opioid pain care prolongs patient suffering


A patient on long-term opioid therapy for the treatment of back pain was successfully tapered off all opioids after Illinois anesthesiologist David Walega, MD, implanted a temporary spinal cord stimulator (SCS) during a 10-day trial period. Objectively she was able to increase her quality time with her young children and husband, she was able to sleep restfully and uninterrupted by pain for the first time in five years, and told Dr. Walega that she was so happy "to finally get her life back." Prior to the SCS trial, she had lost her job due to the severity of pain and side effects from opioids, was mostly bed-ridden and deeply depressed.

Upon completion of the SCS trial, Dr. Walega submitted the required forms and letters of medical necessity to obtain prior authorization and approval to implant a permanent SCS system. The health insurer's specialty benefit management company, however, denied the SCS on the basis that the device and treatment was not "medically efficacious."

After months of appeals to the specialty benefit management company, which was located in California, and the physician reviewer, who was located in Florida, Dr. Walega was finally able to obtain approval to implant a permanent SCS for this patient. Yet, the appeals process—including the initial denial, follow-up denial and then peer-to-peer review by the health insurance company physician—took hours that Dr. Walega said cut into the time he was able to spend with patients.

"She went through eight months of additional pain, depression and anxiety when we had a proven treatment that was clearly helping her," said Dr. Walega. "But since the permanent implant, she's back to being a mom, goes on walks with her husband, and is working toward getting back in the job market. She is not using any opioids at all."

For Dr. Walega's other patients who would benefit from SCS, he reports that denials are increasingly common, and it is rare that the physician reviewer for the health plan is an anesthesiologist or pain specialist. In fact, a recent peer-to-peer review for a patient with neuropathic arm pain from myelomalacia was performed by a pediatrician.

"I have the deepest respect for my physician colleagues, but these health plans are using physicians to deny care when that physician has never practiced pain medicine, never trained as an anesthesiologist nor used SCS or other interventional therapies," Dr. Walega explained. "It's ludicrous and maddening."

Share your story on the AMA's End the Opioid Epidemic website. 

(Photo courtesy of David Walega, MD)

AMA President-elect touts AMA's advocacy priorities in Louisiana


Photo courtesy of Louisiana State Medical Society

AMA President-elect Patrice Harris, MD, made a recent visit to Louisiana to address physicians and medical students at the Louisiana State Medical Society (LSMS) Annual Meeting. She focused on six main areas in her speech: patients' access to care, the high cost of care, regulatory burdens on physicians, chronic disease, opioids and gun violence. She also highlighted the AMA's work to protect access to coverage. Learn more about the AMA's advocacy.

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Other News

New AMA prior authorization survey highlights significant patient harms and physician burdens

Newly released results from a December 2018 AMA survey of 1,000 practicing physicians highlight the significant negative impact that health plans' prior authorization (PA) programs have on the delivery of timely patient care and practice administrative burdens. The time spent waiting for PA decisions from health plans can impede care delivery, with 91 percent of surveyed physicians reporting that PA delays patient access to necessary care, and 75 percent indicating that PA can lead to patients abandoning a recommended course of treatment. These delays and interruptions can result in patient harms: 91 percent of physicians say that PA can have a negative impact on patient clinical outcomes, and more than one-quarter (28 percent) report that PA has led to a serious adverse event (e.g., death, hospitalization, disability/permanent bodily damage, or other life-threatening event) for a patient in their care.

In addition to these concerning effects on timely and effective treatment, the survey results also reveal the considerable administrative hassles associated with the PA process. Practices report completing an average of 31 PAs per physician per week, a workload that consumes the equivalent of nearly two business days (14.9 hours) of physician and staff time. PA's impact on physician practices is significant and growing, with 86 percent of physicians describing PA burdens as high or extremely high, and 88 percent reporting that PA burdens have increased over the last five years. To learn more about the AMA's advocacy efforts to reduce PA burdens, and to join the grassroots PA reform campaign, visit fixpriorauth.org.

Surgeon General Jerome Adams: Protect against the measles outbreak

U.S. Surgeon General Jerome Adams has shared a very important message about the current measles outbreak occurring throughout our country. Watch the Surgeon General's message and encourage your patients to get the MMR (measles, mumps, and rubella) vaccine.

Improving EHR safety and usability: What you can do

MedStar and the AMA launched today a new website, EHRSeeWhatWeMean.org, that showcases videos from the clinician's point of view that demonstrate the risks and challenges caused by poor EHR usability. The site specifically calls out what multiple stakeholders—policymakers, health care providers, EHR vendors and patients—can do.

Register by Feb. 8 for the AMPAC Candidate Workshop

Thinking about running for office? The 2019 AMPAC Candidate Workshop is designed to help physicians make the leap from the exam room to the campaign trail. The workshop will be taking place March 1-3 at the AMA office in Washington, DC.

The curriculum is targeted to AMA members, their spouses, residents, medical students and medical society staff who want to learn more about what it takes to be an effective candidate. You will learn:

  • How and when to make the decision to run
  • The importance of a disciplined campaign plan and message
  • The secrets of effective fundraising
  • What kinds of media advertising are right for your campaign
  • How to handle the inevitable crises that emerge for every campaign
  • The role of your spouse and your family
  • How to become a better public speaker

The registration fee is $250 for AMA members and $1,000 for non-members. Airfare and hotel accommodations are not included, but a discounted room block at the Washington Court Hotel on Capitol Hill is available.

Space is limited so register by Feb. 8.

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Upcoming Events

Advocate for the future of medicine at MARC

Join fellow medical students from across the U.S. at the 2019 AMA Medical Student Advocacy and Region Conference (MARC), held March 7–9, in Washington, DC. Attend to learn how to be a successful advocate, and meet with your senators and representatives.

Read more.

Veterans Health Administration is offering a new webinar

On Feb. 21 a webinar held by the Veterans Health Administration, "VHA Office of Community Care Overview" will provide an overview of community care programs and policies with a focus on how to file clean claims, top rejection reasons and other provider issues. Register now.

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