Jan. 10, 2019: National Advocacy Update

On Dec. 20, the AMA submitted detailed comments (PDF) on the Trump Administration's proposal to change the acquisition and payment structure for some Part B drugs. Dubbed the "International Pricing Index model" (IPI model), the administration released an Advanced Notice of Proposed Rulemaking (ANPRM) seeking input on several proposals in advance of the start of a formal rulemaking process.

In the proposal, the administration suggests the creation of a mandatory demonstration in which third-party vendors would become the purchasers of certain Part B drugs, with physicians acquiring the drug products directly from these vendors. Along with a new third-party vendor system for drug acquisition, the proposal seeks to reduce drug prices for some Part B drugs by indexing prices paid by Medicare to prices paid internationally. The proposal also recommends setting physician reimbursement for drugs in the demonstration at Average Sales Price (ASP) plus a six percent add-on, which would not be subject to sequestration.

The AMA is supportive of actions that would provide meaningful reduction in drug prices but commented on several areas of potential concern with the proposal. The AMA took issue with the mandatory nature of the proposal and the adequacy of the third-party vendor system. The AMA also expressed significant concern about continued reliance on ASP-based payment in a system designed to significantly lower a drug's ASP, and the impact inadequate payment may have on patient access to drug treatments.

The AMA submitted comments (PDF) to the U.S. Department of Homeland Security (DHS) in response to a proposed rule titled, "Registration Requirement for Petitioners Seeking to File H-1B Petitions on Behalf of Cap-Subject Aliens." The AMA voiced concern that the proposed rule may negatively impact the thousands of non-U.S. citizen international medical graduates (IMG) seeking to obtain an H-1B visa each year, many of whom work in rural and underserved areas, and further exacerbate the physician workforce shortage. The AMA strongly urged the administration to consider the possible unintended consequences the proposed rule may have on all non-US citizen IMGs. The AMA has policy advocating for timely processing of H-1B visas for physicians and trainees to prevent any negative impact on patient care.

The proposed new policy changes the rules of the lottery system used to determine who will receive an H-1B visa. Under the proposed rule, U.S. Citizenship and Immigration Services would reverse the order by which the agency selects H-1B petitions under the regular cap (of 65,000) or advanced-degree exemption (of 20,000). This will increase the number of selected H-1B beneficiaries with a master's degree or higher from a U.S. institution of higher education up to 16 percent (or 5,340 workers).

An analysis of 2016 data from the U.S. Department of Labor Office of Foreign Labor Certification reveals that U.S. employers were certified to fill approximately 10,500 H-1B physician positions nationwide. In 2016, of the 897,783 practicing physicians in the United States, 206,030 (23 percent) did not graduate from a U.S or Canadian medical school. Thus, the change in the H-1B visa beneficiary selection process could have the unintended consequence of limiting the ability of our non-U.S. citizen IMGs to obtain H-1B visas, as they did not receive an advanced degree from a U.S. institution of higher education and would not benefit from the changes in the H-1B selection order outlined in the proposed rule.

The AMA submitted comments (PDF) to the Centers for Medicare & Medicaid Services (CMS) in response to a proposed rule seeking to expand telehealth coverage in Medicare Advantage, and update the Medicare Advantage and Part D Quality Star Ratings program, among other topics. Some of these changes implement provisions of the Bipartisan Budget Act of 2018, which was passed by Congress earlier this year.

Telehealth: The AMA submitted extensive comments related to CMS' proposed changes to expand Medicare Advantage telehealth.

The AMA recommended the proposed requirements and regulatory definitions be finalized and that telehealth be included as a basic benefit for purposes of bid submission and payment. However, the AMA strongly recommended that CMS explicitly clarify that:

1. Telehealth services are precluded as a means of establishing network adequacy
2. Telehealth does not include other virtual services which already are permitted for inclusion as part of the basic benefits
3. All telehealth and virtual services—whether offered as part of the basic benefit or as a supplemental benefit—must comply with state licensure and medical practice laws where the patient is located when receiving such services.

Network directories: AMA comments expressed concerns about persistently high error rates in Medicare Advantage network directories and strongly encouraged CMS to take enforcement action for noncompliant Medicare Advantage plans. A series of CMS audits found that roughly half of all provider directories contain inaccuracies such as the physician not practicing at the listed location, incorrect phone numbers or physicians not accepting new patients when the directory indicated that they were. Despite these widespread errors, CMS has failed to issue any civil monetary penalties or enrollment sanctions. The AMA noted that Medicare Advantage experts consider accurate provider data a mission-critical foundation for a strong Medicare Advantage quality rating, with members being likely to struggle to access physicians or show up at the wrong location for appointments if directories are inaccurate.

Diabetes prevention: In contrast to the traditional Medicare program, Medicare Advantage plans may provide coverage of Medicare Diabetes Prevention Program (MDPP) services in a 100 percent virtual format. Research published in Diabetes and the Journal of Aging and Health has documented cost savings and improved health outcomes for Medicare Advantage patients receiving virtual MDPP services through their Medicare Advantage plan. AMA comments urged that CMS encourage Medicare Advantage plans to offer virtual MDPP services as a supplemental benefit and gather information from the Medicare Advantage experience that could be used to facilitate future expansion of coverage for virtual MDPP services to patients in traditional Medicare.

Other issues: The AMA also identified concerns and offered recommendations related to the Medicare Advantage and Part D Prescription Drug Plan Quality Rating System; Preclusion List requirements for prescribers in Part D and individuals and entities in Medicare Advantage, Cost Plans and the Program of All-Inclusive Care for the Elderly; and Medicare Part D exceptions. Additionally, AMA comments highlighted proposed positive steps to improve current regulations, such as CMS' proposal to enhance price accuracy in the Medicare Plan Finder (MPF) to improve the reliability of a contract's MPF advertised prices.

On Dec. 20, the AMA submitted comments (PDF) on the new guidance relating to State Relief and Empowerment Waivers (previously called state innovation waivers) under section 1332 of the ACA, which was issued on Oct. 22, 2018, by CMS and the U.S. Department of Treasury. The new guidance, effective on Oct. 22, replaces earlier guidance issued in 2015.

The AMA expressed its concern that the guidance, in conjunction with the "waiver concepts" subsequently released by CMS, will:

• Make it easier for states to sidestep important ACA coverage requirements
• Undercut crucial state and federal patient protections, especially for individuals with pre-existing conditions
• Result in substandard, inadequate health insurance coverage
• Disrupt and destabilize the individual health insurance markets

Most significantly, under the departments' guidance, states could use federal funds to subsidize non-ACA compliant plans, including short-term limited duration insurance, which would have skimpy benefits and fewer protections for individuals with pre-existing conditions. In addition, the AMA expressed its belief that these changes are contrary to both the statutory text and congressional intent, and that there are serious questions about whether the policy changes proposed by the departments can legitimately be made through informal guidance rather than through a full rulemaking process. Accordingly, the AMA urged that the departments withdraw the guidance and reconsider its far-reaching implications for consumers and other stakeholders.

The AMA submitted comments (PDF) on Dec. 20 to the National Institute of Standards and Technology (NIST) regarding its request for information about developing a cross-industry privacy framework. The AMA stressed the importance of patient consent as a core privacy practice. The AMA also identified that complying with numerous federal and state privacy and security requirements is a challenge in improving privacy protection. Moreover, AMA argued that the current regulatory and reporting requirements are too focused on physician measurement or compliance. Instead, the requirements should be focused on:

• Developing positive incentives to adopt better privacy and security practices
• Communicating the reasons for the requirements and how they are connected to patient care
• Ensuring that implementation of the requirements integrates into the workflow and does not add additional unnecessary administrative burden

As it relates to setting minimum attributes for a privacy framework, AMA commented that the framework should be scalable to organizations of all sizes, be technology-agnostic and customizable for different types of platforms. Thus, the framework should not create unnecessary or disproportionate burden on solo practitioners or small practices. Additionally, the framework should prioritize and support methods that enable individuals and entities to protect and securely share pieces of information on a granular, as opposed to document, level. Furthermore, the AMA stated that the framework should promote data access, including open access to appropriate machine-readable public data, the development of a culture to sharing data with external partners, and explicit communication of allowable use with periodic review of informed consent.

The Health Resources and Services Administration (HRSA) has launched a new loan repayment program that provides clinicians up to $75,000 for three years of full-time service at a health care facility that has been designated by HRSA as a National Health Service Corps-approved substance use disorder site. A part-time service option with a maximum award of $37,500 is also available. Clinicians may apply to the program online until Feb. 21. The new loan repayment program is intended to support recruitment and retention of health professionals needed in underserved areas, to expand access to comprehensive treatment for substance use disorder including medication and behavioral health counseling, and to prevent overdose deaths.

Since the passage of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and the first QPP final rule, CMS has required eligible clinicians participating in MIPS to show that they have not knowingly and willfully limited or restricted the compatibility or interoperability of their certified electronic health record (EHR) technology. MIPS-eligible clinicians must show that they are meeting this requirement by attesting to three statements about how they implement and use certified EHR technology (CEHRT). Together, these three statements are referred to as the "Prevention of Information Blocking Attestation." Until now, CMS guidance in this area has been limited.

The AMA has spoken to federal agencies about scenarios in which physicians—acting in good faith—may choose not to share information. In such instances, CMS should not consider them to be violating their Prevention of Information Blocking Attestation. For example, a patient may specifically request that a physician not send sensitive information to another clinician (e.g., sensitive test results or mental health information). The AMA explained that a physician should respect this patient's wishes if he or she believes it is in the patient's best interest. CMS agreed and states:

"While it is likely that [physicians] knowingly restricting interoperability, the restriction may be reasonable if the [physicians] reasonably believe, based on their relationship with the patient and their best clinical judgment, that the restriction is necessary to protect the patient's health or well-being. As long as the restrictions imposed by the MIPS eligible clinicians were based on their patient's best interests (rather than a general policy) and were not an excuse for restricting health information exchange, the MIPS eligible clinicians' conduct is unlikely to be a knowing and willful restriction of the compatibility or interoperability of CEHRT."

The AMA has also urged the federal government to not penalize physicians who block access to CEHRT or refuse to share information because of cybersecurity concerns related to their EHR or the recipient's EHR. CMS agrees:

"There might be circumstances where restricting access may be reasonable and necessary to protect the security of the CEHRT's information. It is unlikely to be a knowing and willful restriction of the CEHRT compatibility or interoperability if the restrictions were:

• Made in good faith
• In response to a bona fide threat
• Are necessary and reasonable
• Narrowly tailored to the identified threat"

CMS also noted that scheduled overnight maintenance may result in an inability to share data because of disabled functionality. They state that it "is unlikely" that this equates to information blocking.

The AMA will continue to advocate for CMS to recognize instances in which physicians may encounter difficulties with sharing information for reasons out of their control, including the need to pay excessive fees to exchange data. The AMA encourages all physicians participating in MIPS to review CMS' fact sheet (PDF) on the MIPS information blocking attestation.

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