Jan. 10, 2019
Issue SpotlightIssues to watch in the 116th Congress
Under the shadow of a partial government shutdown, the 116th Congress convened on Jan. 3. The House is now under the leadership of Democrats and Speaker Nancy Pelosi (D-CA). In the Senate, Majority Leader Mitch McConnell (R-KY), finds himself with a slightly larger Republican majority than the one he enjoyed over the previous two years. Recent polling has continued to demonstrate that there are a handful of health care issues at the top of the minds of many voters and, consequently, their representatives in Congress. Among them are health care costs—particularly the cost of health insurance and prescription drugs.
Democrats in the House have already acted to preserve the ACA by taking steps to intervene in ongoing litigation (Texas v. Azar) in which a Federal District Court in Texas recently ruled the ACA was unconstitutional.
On the issue of prescription drug prices, there are some areas where Republicans and Democrats may find common ground. The new Chairman of the Senate Finance Committee, Charles Grassley (R-IA), expressed in a recent Senate floor speech a strong interest in stopping the exploitation of regulatory loopholes by industry which unfairly extends monopolies over drugs, reducing competition. Other areas that will likely see activity in the new Congress include a close examination of drivers of health care costs overall, as well as the issue of unanticipated medical bills from out-of-network physicians and other providers.
Despite the intense interest on these and other concerns in the health care sphere, the reality of a politically divided Congress will make enactment of significant new legislation a challenge.
On Dec. 20, the AMA submitted detailed comments 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 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 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:
- Telehealth services are precluded as a means of establishing network adequacy
- Telehealth does not include other virtual services which already are permitted for inclusion as part of the basic benefits
- 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 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 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 on the MIPS information blocking attestation.
Below is an excerpt from a Leadership Viewpoints column written by AMA President Barbara L. McAneny, MD:
Every day in America, about 130 people die of opioid-related drug overdoses, the majority of which are due to heroin and illicit fentanyl. That data from the Centers for Disease Control and Prevention (CDC) should spark our nation to move to eliminate every barrier to medically proven, lifesaving treatment for opioid-use disorder (OUD) and other substance-use disorders.
The Commonwealth of Pennsylvania last fall removed one of the most senseless and short-sighted forms of prior authorization that exists—one that delays access to medication-assisted treatment (MAT) for opioid-use disorder. Nearly 5,000 Pennsylvanians died of drug overdoses between March 2017 and March 2018, the CDC says.
When it comes to treating patients with OUD, we know what works. MAT for opioid-use disorder saves lives. MAT helps people maintain recovery, saves money, reduces crime, and helps people regain their health and their lives.
These are just some of the reasons why the U.S. surgeon general's Spotlight on Opioids report calls MAT the "gold standard" for treatment.
But time is of the essence, and payers across the nation commonly impose prior-authorization requirements that patients and physicians must meet before medications are available for treatment. When patients seek help, it is unconscionable to make them wait days or weeks for the right treatment.
There is no valid reason to delay or deny medically proven care that can help end the nation's opioid epidemic and improve patients' health and lives.
Continue reading here.
After seven years in private practice, Rachel Franklin, MD, returned to where she finished her residency in family medicine and saw a need to improve the way the family medicine center treated its pain patients. She started from the ground up. Taking on the role of medical director at the University of Oklahoma College of Medicine's Family Medicine Center, she "wanted to start over with the way we were teaching pain management as well as the clinic workflow so that we could actually provide an objectively assessed, mechanism-based management program for chronic pain."
Photo courtesy of Rachel Franklin, MD
Dr. Franklin and her colleagues created a peer-reviewed, structured curriculum that focused on improving patient outcomes. She implemented workflows where patients complete a self-assessment at each visit which includes their medical history, in addition to an opiate risk assessment at their initial visit. Their opioid risk is documented—as are any indications of misuse, non-adherence or diversion of their medication—and patients are then monitored regularly through standardized assessment tools. The clinic also established standard refill expectations, which "greatly improved the whole clinic environment," Dr. Franklin said. "Patients no longer walk in unannounced expecting a refill. We have built in structured expectations and we have seen great results for the patients who have stayed with us."
The objective assessment tools and mechanism-based treatment program are designed to try to help physicians avoid initiating opioids in an effort to balance patient safety with effective pain care.
"With the medical students, we talk about the socio-political aspects of pain management, we talk about the experience of pain, and we talk about a mechanism-based approach to pain. We discuss many different questions, such as: What is neurologic pain? What is functional pain? What is musculoskeletal pain? What is affective pain? And then what can we do within those mechanisms? Everything from acupuncture, physical therapy and biofeedback to complementary medications like magnesium and B-vitamins to the non-opiate medications."
Despite the progress they have seen locally, Dr. Franklin says there are still big changes that need to be made so that patients nationwide can get better, more multidisciplinary treatment: "Until you can give me a policy by which physical therapy, occupational therapy, massage therapy, acupuncture, biofeedback and behavioral health are as cheap as a five-dollar prescription for [an opioid] each month, I'm going to have problems."
Dr. Franklin also understands that legislative fixes may not always be as helpful as intended. "I teach medical students about the swinging of the political pendulum and how it influences practice in ways that aren't necessarily evidence-based. What we've tried to do with our curricular and advocacy efforts is to balance that pendulum, so that it doesn't swing so far from side to side."
To learn more about what physicians are doing to fight the opioid epidemic please visit the AMA's End the Opioid Epidemic website.
Thanks to the extensive advocacy from the New York State Psychiatric Association (NYSPA), the Medical Society of the State of New York (MSSNY) and more than two dozen statewide organizations and five national groups including the AMA, the Mental Health and Substance Use Disorder (MH/SUD) Parity Report Act (A.3694-C) was signed into law by Governor Andrew Cuomo on Dec. 21, 2018. The law requires insurers to submit key data to the Department of Financial Services for analysis and evaluation of compliance with the federal and state MH/SUD parity laws culminating in the publication of a public report.
"This is a tremendous victory for patients made possible in part by NYSPA working hand-in-hand with MSSNY, the broader MH/SUD community and national partners including the AMA, to generate an enormous volume of communications in support, including letters, phone calls and tweets," said Richard Gallo, NYSPA government relations advocate.
"This law puts New York on a path to achieving enhanced compliance and greater transparency with the MH/SUD parity laws, for which we and all of our national and statewide partnering organizations wish to thank Governor Cuomo, the sponsors of the bipartisan law, Assembly member Aileen Gunther, Senator Rob Ortt, and the entire New York Legislature for their overwhelming support."
In a letter of support, the AMA noted that the bill "will provide important data to better compare requirements for accessing benefits that are applied to mental health and substance use disorder treatment and coverage as compared with those applied to medical/surgical benefits."
MSSNY's Physician Advocacy website generated nearly 1,000 letters alone in support to the governor.
For more information, please contact MSSNY's Moe Auster.
Physicians are all for increasing patient access to health care, but a U.S. Labor Department rule expanding association health plans (AHPs) will do the exact opposite, doctors tell a federal court in an amicus brief.
The Trump Administration's rule will undermine ACA reforms by depriving patients of essential care, allowing insurers to discriminate against individuals based on pre-existing health conditions, destabilizing the insurance markets and exposing patients to fraud, physicians told the court.
The AMA has long advocated for health insurance coverage for all Americans, as well as pluralism, freedom of choice, freedom of practice and universal access for patients.
"The AMA strongly believes that the progress in expanding meaningful coverage to millions of previously uninsured Americans during the past decade should be maintained, but the AHP rule would reverse these gains," said AMA President Barbara L. McAneny, MD. "The AMA supports vacating the AHP rule" and supports a lawsuit "seeking to preserve federal patient protections that provide a crucial check on the historic problems of underinsurance and unaffordable medical expenses."
The AMA strongly objected to the rule on AHPs when it was proposed. Now the Litigation Center of the American Medical Association and State Medical Societies and the Medical Society of the State of New York (MSSNY) have joined forces to file a friend-of-the-court brief in State of New York v. U.S. Dept. of Labor. In the brief, they tell justices that that the rule is "unwise and unlawful."
Continue reading here.
Jan. 1 marks the start of the third year of the Medicare Quality Payment Program (QPP) and the beginning of the submission window for 2018 Merit-based Incentive Payment System (MIPS) performance data. To start the new year on the path to QPP success, the AMA recommends physicians and their teams consider the following QPP to-do list:
- Review program changes effective for 2019. CMS released program information relevant for MIPS and alternative payment model participants on the QPP website. Details about MIPS cost measures, including new episode-based measures, and quality measure specifications and benchmarks are available for review.
- Verify QPP account access. CMS recently rolled out a new account management system for QPP called "HARP" – HCQIS Access Roles and Profile System. Previously, QPP participants would use their Enterprise Identity Management (EIDM) accounts to access the system to report MIPS data, check eligibility and review scores. Users with an existing EIDM account should already have a HARP account that has been created automatically on their behalf. If necessary, the QPP Access User Guide provides a step-by-step guide to signing up for a HARP account.
- Submit 2018 MIPS data. Physicians and groups generally have until April 2 to submit 2018 MIPS data without incurring a payment penalty and earn a potential upward adjustment. Registered groups may submit CMS Web Interface data from Jan. 22 until March 22. March 2 is the MIPS claims data submission deadline.
CMS recognizes that clinicians living or practicing in an area affected by hurricanes and wildfires may experience difficulties collecting and submitting data for the MIPS on time during the 2018 MIPS performance period. Accordingly, CMS is extending its Extreme and Uncontrollable Circumstances Policy to those affected by Hurricane Florence, Hurricane Michael and California wildfires.
CMS will identify MIPS-eligible clinicians who are in CMS-designated areas that have been affected by an extreme and uncontrollable circumstance based on the address associated with the clinician in the Provider Enrollment, Chain, and Ownership System (PECOS).
MIPS-eligible clinicians who are subject to the policy will have all four performance categories weighted at zero percent. Clinicians will automatically receive a score equal to the performance threshold which will result in a neutral payment adjustment (neither a positive or negative adjustment) for the 2020 MIPS payment year unless:
- They submit data for two or more MIPS performance categories (Quality, improvement activities and/or promoting interoperability) as an individual
- They are part of a group or virtual group that submits data on behalf of its clinicians
Under the automatic extreme and uncontrollable circumstances policy, the cost performance category will always be weighted at zero percent, even if a clinician submits data for the other performance categories.
MIPS-eligible clinicians in APM entities who are subject to the APM scoring standard are not covered by this policy. However, a MIPS-eligible clinician who is subject to the APM scoring standard and identified as affected by an extreme and uncontrollable circumstance may apply for an exception in the promoting interoperability performance category.
More information can be found in CMS' MIPS Automatic Extreme and Uncontrollable Circumstances Policy fact sheet.
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 $1000 for non-members. Airfare and hotel accommodation 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.
The AMPAC Award for Political Participation recognizes an AMA or AMA Alliance member who has made significant personal contributions of time and talent in assisting friends of medicine in their quest for elective office at the federal and state levels. These can include volunteer activities in a political campaign or a significant health care-related election issue such as a ballot initiative or referendum.
The winning nominee will receive special recognition during the AMPAC Board Chair's speech before the House of Delegates or during the AMPAC luncheon at the AMA Annual Meeting in Chicago. Nominees must be a current member of the AMA or AMA Alliance as well as AMPAC with preference given to members with a demonstrated history of AMPAC involvement. The deadline to submit nominations is Jan. 31. The full criteria for the 2019 AMPAC Award for Political Participation, including how to submit a nomination, can be found here.
Two new podcasts are now available in AMA's series, "Inside Medicare's New Payment System." The first is a conversation with AMA President Barbara L. McAneny, MD, on what physicians need to know about updated Medicare payment policies for 2019. The second is a conversation with Peter Hollmann, MD, and Barbara Levy, MD, both of whom are co-chairs of the CPT Editorial Panel and Specialty Society RVS Update Committee, or RUC, Workgroup on Evaluation and Management Services, discussing changes to Medicare office visit documentation. Listen to both here.
The American College of Surgeons (ACS) has introduced two free continuing medical education (CME) courses for professionals on the College's learning management system. These are part of a full series of trainings on patient safety and opioid-sparing surgery education.
The first course explores ERAS (Enhanced Recovery after Surgery) protocols and how its perioperative components can help reduce costs and postoperative opioid consumption, as well as aid in recovery following surgery. The second course discusses and provides algorithms for pain management in opioid-tolerant patients. Both courses examine non-narcotic pain control options and their associated efficacies and adverse events. These courses may help to satisfy state CME requirements for pain management courses, which may be required for re-licensure.
Registration in the learning system is required, but no fee will be collected.
View the patient education brochure “Safe and Effective Pain Control”, pain plans, evaluation tools and other surgical pain management resources on the ACS website.
Held in Washington, DC, the AMA National Advocacy Conference, Feb. 11 – Feb. 13, is coming soon—register now to secure your spot. Hear the latest about key work on the Hill from industry experts, political insiders and members of Congress. Featured speakers include Margaret Brennan, moderator of CBS News' "Face the Nation" and CBS News senior foreign affairs correspondent, Indu Subaiya, co-founder, Health 2.0 & executive vice president, Healthcare Information and Management Systems Society (HIMSS), and Nicolle Wallace, political analyst and MSNBC anchor, New York Times best-selling author, and former White House director of communications.Back to Top