Following a proposed rule released by the Centers for Medicare & Medicaid Services (CMS) at the end of 2018, the AMA submitted comments (PDF) opposing several of the changes being considered.

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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 (PDF) 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.

In a letter to U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, the AMA provided comments (PDF) 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.

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 (PDF) 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:

  • 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.
  • 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.
  • 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.

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 (PDF) 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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