The Trump administration released a proposed rule on Oct. 15 that would require pharmaceutical manufacturers to disclose the list prices of their products in direct-to-consumer television commercials. The proposal would mandate that brand manufacturers clearly state in all television advertisements the wholesale acquisition cost (WAC) of either a 30-day regimen or "typical" treatment regimen of any drug where that price is over $35.

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The proposal would not require disclosure in print, radio or social media ads. The move, which follows calls from the AMA to include this information in direct-to-consumer advertising efforts, is expected to be challenged by the pharmaceutical industry.

In addition, the Centers for Medicare & Medicaid Services (CMS) is seeking comment on other approaches that could be utilized by the agency to increase transparency, including creation of a new drug-pricing counseling payment code for use by physicians and use of artificial intelligence methods to help beneficiaries select the lowest cost Part D drug plans. The proposal is open for public comment until Dec. 17.

In a new report on the opioid epidemic (PDF), Surgeon General Jerome Adams, MD, highlights the need for a cultural shift in the nation's perception of substance-abuse disorders (SUDs). He emphasizes that SUDs are chronic-but-treatable diseases.

To remedy the problem, Dr. Adams, an AMA member, suggests that physicians and policymakers focus on evidence-based treatments— both medications and behavioral therapies—that can save lives and restore people's health and wellbeing. The AMA agreed that there is a great need to recognize that patients suffering "require medical intervention, not moral judgment." Here are ten major takeaways from the report:

  • Only 1 in 4 people, (28.6 percent) with opioid-use disorder (OUD) received specialty treatment for illicit drug use in the past year, 45.5 percent of people with a SUD also have a mental disorder, but only half (51.0 percent) receive treatment for either disorder.
  • Individuals receiving buprenorphine with counseling have significantly lower total health care costs than individuals receiving little or no treatment for their OUD ($13,578 compared to $31,055). As of September 2018, 44,968 physicians and 8,825 nurse practitioners and physician assistants, are approved to prescribe buprenorphine.
  • Research has found that, for every dollar spent on prevention programs, the program returns between $0.62 and $64.18 in reduced costs.
  • Incorporating treatment for multiple SUDs can be beneficial and is associated with a 25 percent increase in the likelihood of maintaining long-term abstinence from alcohol and drug misuse.
  • Evaluation studies have clearly shown that syringe services programs are effective in reducing HIV and HCV transmission and do not increase rates of community drug use. They help individuals engage in treatment to reduce, manage, and stop their substance use when appropriate.
  • The introduction of illicitly manufactured fentanyl and other highly potent synthetic opioids to the drug supply makes immediate access to naloxone crucial to effective overdose death prevention. Although regulations vary, most states have passed laws expanding access to naloxone without a patient-specific prescription.
  • Multiple factors create barriers to widespread use of MAT. These include provider, public, and client attitudes and beliefs about MAT; lack of an appropriate infrastructure for providing medications; payment policies; need for staff training and development; and legislation, policies, and regulations that limit MAT implementation.
  • An abstinence-only philosophy that avoids the use of medications for opioid treatment is not scientifically supported. Research clearly demonstrates that opioid-agonist therapy leads to better treatment outcomes compared to behavioral treatments alone. Decades of research have shown that the benefits of opioid agonist therapy greatly outweigh the risks associated with diversion.
  • A public health approach to the opioid crisis will also reduce other harmful consequences, such as infectious disease transmission and neonatal abstinence syndrome.
  • Effective integration of prevention, treatment, and recovery services across health care systems is key to addressing opioid misuse and its consequences, and it represents the most promising way to improve access to and quality of treatment.

President Trump signed into law on Oct. 5, the FAA Reauthorization Act of 2018 (P.L. 115-254), which included the "Sports Medicine Licensure Clarity Act of 2018." The bill, which was supported by the AMA, extends the malpractice insurance coverage of a state-licensed medical professional to another state when the professional provides medical services to an athlete, athletic team or team staff member pursuant to a written agreement.

Prior to providing such services, the medical professional must disclose to the malpractice insurer the nature and extent of the service. This extension of malpractice coverage does not apply at a health care facility or while a medical professional is transporting the injured individual to a health care facility.

Athletes include individuals participating in a sporting event for which the individual may be paid, participating in a sporting event that is sponsored or sanctioned by a national governing body, or for whom a high school or university provides a medical professional.

A letter (PDF) was sent to Labor Department Sec. Alexander Acosta requesting that his department consider changes to the Family and Medical Leave Act (FMLA) regulations, expanding the categories of individuals for whom an employee may use leave. New policy was adopted at the 2018 AMA House of Delegates Annual Meeting that advocated for the "blood or affinity model," which allows FMLA-equivalent benefits for chosen family, domestic partners, and individuals who are dependent or mutually interdependent on the employed individual.

This policy reflects the needs and realities of today's diverse workforce, specifically as it pertains to LGBTQ employees. Several states, including Arizona, Hawaii, Maine, New York, and Oregon, as well as the District of Columbia, have expanded FMLA regulations in favor of the "blood or affinity" model and the AMA believes that FLMA regulations and policies should be likewise expanded at the federal level.

In a comment letter (PDF) responding to the "Pathways to Success" proposed rule for Medicare accountable care organizations (ACOs), the AMA urged CMS not to retire the Track 1 shared savings-only ACO model, as it has proposed. Under the CMS proposal, all ACOs would be required to take two-sided risk after a short period of time as a shared savings-only model.

The AMA letter points out that, in every year since the Medicare ACO program was first created, the majority of Track 1 ACOs have reduced Medicare spending relative to CMS benchmarks without being subject to downside risk. In 2017, the total net savings generated by the 433 Track 1 ACOs was 12 times the net savings generated by Track 2 and 3 ACOs.

The letter also notes that the many physicians who use their Track 1 ACO participation as a means of participating in the Merit-based Incentive Payment System (MIPS) would lose this option under the proposed rule. The AMA recommends several potential modifications to Track 1 that could increase Medicare savings from the ACO program without requiring all ACOs to take downside financial risk. These include allowing ACOs to take accountability for the specific types of spending they can control instead of total Medicare spending on their assigned patient population.

Other recommended changes from the CMS proposal include:

  • Linking risk requirements to the services that ACO participants deliver or order themselves instead of arbitrary classifications of low-revenue and high-revenue ACOs
  • Providing additional upfront payments to ACO participants
  • Excluding MIPS incentive payments from calculations of ACO savings and losses
  • Focusing quality measures intended to help end the opioid epidemic on the quality of pain management and substance-use care instead of the dose of prescribed opioid analgesics

In response to a joint request (PDF) from the AMA and the American Heart Association, CMS has reopened the Medicare coverage policy on ambulatory blood pressure monitoring (ABPM) coverage and is seeking public comments until Nov. 8. Current Medicare policy only covers ABPM for patients with suspected white coat hypertension.

The request urged CMS to align its policy with the 2016 recommendation of the U.S. Preventive Services Task Force (USPSTF) by covering ABPM as the reference standard for diagnosis of hypertension. The USPSTF found convincing evidence that ABPM is the best method for diagnosing hypertension. Although the criteria for establishing hypertension varied across studies, there was significant discordance between the office diagnosis of hypertension and 12- and 24-hour average blood pressures using ABPM, with significantly fewer patients requiring treatment based on ABPM. The AMA encourages other medical societies to submit comments in support of expanding Medicare coverage for ABPM.

Recently, CMS announced private-sector cooperative agreements to partner with the agency in developing quality measures for Medicare's Quality Payment Program (QPP). These cooperative agreements, authorized under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), represent the first funding initiative supporting public-private efforts to develop measures for the QPP.

The AMA was instrumental in ensuring MACRA included funding authorization for quality measure development. However, the AMA is extremely disappointed that CMS only issued a single announcement, funding only seven projects. Some of the awards were given to large provider systems and existing Medicare contractors, rather than adhering to the intent of the law and being given physician-led specialty organizations and PCPI®. In addition, much of the work involves re-specifying and/or re-tooling existing measures, which is traditionally work handled by CMS' existing measure development and support contractors.

Therefore, the AMA sent a letter to CMS Administrator Seema Verma (PDF) voicing physician concern and urging the administrator to issue additional cooperative agreements that would focus on small projects by physician-led organizations. The AMA also requests that CMS ensure that current and future projects are coordinated with specialty societies and that practicing physicians are actively involved during the development, specification and testing of the measures. Key to achieving MACRA's goals is the availability of an adequate portfolio of appropriate quality measures that allows for all physicians, regardless of specialty or subspecialty, to meaningfully participate in the program.

The AMA wrote (PDF) to CMS in response to a recent report (PDF) on the topic of prior authorization (PA) prepared for CMS by the Government Accountability Office (GAO). The report recommended that CMS continue PA by extending current demonstrations and expanding PA to additional items and services to decrease program costs.

The AMA urged CMS to not follow the report's recommendations, but rather to carefully consider the care delays associated with PA and the resulting impact on the health of beneficiaries when evaluating any additional PA requirements for Medicare. It included stories from both patients and physicians around the country about how prior authorization affects patients, which the AMA has collected on its grassroots website https://fixpriorauth.org.

The AMA will continue to urge CMS to refrain from expanding Medicare PA or demonstrations before carefully considering the evidence that the process harms patients and burdens health care professionals.

The AMA participated in a listening session on drug shortages held Oct. 12 by the Drug Shortages Task Force that was newly convened by the Food and Drug Administration (FDA). Staff from the FDA, CMS, Defense Department, and other federal agencies convened a number of stakeholders over the course of several days to provide input as to how drug shortages are impacting clinical practice. They also heard recommendations on how the FDA and other agencies can craft solutions that may help mitigate and alleviate shortages.

The AMA provided a statement on the breadth of the impact of drug shortages, noting that a significant number of providers are impacted by at least one drug shortage every day. The AMA also provided information on how patient care is compromised by ongoing shortages of critical drug products and offered a number of policy recommendations.

The task force will host its first public meeting to receive input on drug shortage policy Nov. 27 in Washington, D.C. The FDA will be accepting public comments on this issue until Jan. 11.

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