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Jan. 25, 2018

Issue Spotlight

Physicians, payers collaborate on prior-authorization relief

In the past, Jack Resneck Jr., MD, expected to fill out an occasional prior-authorization (PA) request if he ordered a new or unusually expensive medication or diagnostic test for his patients. But lately, he said, "the burden has grown exponentially." His practice has been inundated with requirements to submit PA forms—even for long-available generic drugs and for patients on an established medication regimen to manage a chronic condition.

"Sometimes, health plans deny reasonable prior-authorization requests for evidence-based treatments and instead send back 'suggested alternatives' that are completely inappropriate for the disease being treated," Dr. Resneck, chair-elect of the AMA Board of Trustees, told AMA Wire®.  "We also now have to submit prior-auth requests for many patients who are already stable on a therapy when their health plan suddenly changes the rules." 

To reverse this alarming trend, the AMA has undertaken numerous advocacy initiatives to reform prior authorization and reduce the burden on physicians and patients. Among these is the recent release of a consensus statement between the AMA, the insurance industry trade group America's Health Insurance Plans (AHIP), the Blue Cross/Blue Shield Association and other stakeholder organizations announcing their commitment to improving the prior-authorization process.

"I hope that this consensus statement, in combination with other actions we are taking, will help move us in the right direction to reduce the growing burden of prior authorizations," said Dr. Resneck, a health policy expert and professor of dermatology at the University of California, San Francisco.  "The growing time spent on prior authorization for appropriate drugs and procedures is consuming hours that we would rather spend with our patients."

Read more at AMA Wire®.

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National Update

Congress reinstates government funding but some programs remain in limbo

Since the current fiscal year began on Oct. 1, 2017, the federal government has operated on a series of temporary spending bills, known as continuing resolutions (CR), in lieu of enacting appropriations for the full fiscal year. A number of disagreements prevented the two parties from reaching a final agreement on final spending levels. While the two parties are in general agreement that the caps on spending that were adopted as part of the Bipartisan Budget Act of 2013 should be raised, they have been unable to come to agreement on the distribution of additional spending between defense and non-defense accounts. This issue, as well as disagreement over how to address other expiring programs and policies, led to expiration of the latest spending bill on Jan. 20 and a temporary shut-down of the federal government. 

On Jan. 22, agreement was reached to extend federal funding until Feb. 8, buying additional time for the parties to find common ground on outstanding issues. As part of that agreement, the Senate Majority Leader stated that if the government remained open past Feb. 8, and the parties had still not found common ground on immigration, the Senate would take up legislation addressing the fate of those immigrants who were brought here illegally by their parents when they were children but are currently protected from removal by the Deferred Action of Childhood Arrivals policy, as well as other immigration and border security policies.

The proposal agreed to on Jan. 22 includes funding the Children's Health Insurance Program (CHIP) for six years. Though the authorization for CHIP actually expired at the end of September, the program has continued to operate through of combination of funding rolled over from previous years, reallocations to states that were experiencing shortfalls, and a temporary extension included in the previous CR. The most recent CR also provides for delays in the implementation of several tax provisions, including a two -year delay on the tax on medical devices, a two-year delay in the "Cadillac tax" on high-cost health plans, and an exemption for health plans from the health insurance tax for 2019. (The health insurance tax has already been implemented for 2018.)
There are many more expired or expiring provisions which Congress intends to address during the period prior to Feb. 8. Critical to many communities is the renewal of funding for the Community Health Centers Fund (CHCF), which provides 70 percent of the federal support for Community Health Centers and 100 percent of the funding for the National Health Service Corps. Also expired is support for the Teaching Health Centers graduate medical education program that funds community based residency programs.

Congress must also address the so-called Medicare Extenders—temporary Medicare polices or delays in the implementation of other policies that Congress passes each year. These include extension of the work Geographic Practice Expense Index floor, a potential permanent repeal of therapy caps, and extension of certain hospital programs, such as the inpatient payment adjustments for certain low-volume hospitals and the Medicare-dependent hospital program, home health rural add-on payments, and others. The AMA continues to press Congress to provide technical corrections and extend certain flexibilities to facilitate the successful implementation of the Medicare Access and CHIP Reauthorization Act (MACRA).

Guidance issued for states seeking waivers on Medicaid work requirement

On Jan. 11, the Centers for Medicare & Medicaid Services (CMS) announced that the federal government, for the first time, will allow states to test work or community engagement requirements as a condition of eligibility for some Medicaid enrollees. The new policy was issued in the form of a 10-page State Medicaid Director Letter to the states, outlining CMS' expectations and detailed guidance for those states interested in adding work requirements to their Medicaid program through section 1115 waiver demonstration projects. Ten states have applied for a federal waiver to add a work requirement, and several other states have expressed interest. One of the states, Kentucky, received approval of its waiver the day after the guidance was issued. For more information on Kentucky's approval, read the complete story in the state section of this issue of AMA Advocacy Update.

In the guidance, CMS encourages states to align work or work-related requirements under Medicaid with work requirements under existing programs, particularly through their Temporary Assistance for Needy Families (TANF) program (e.g., welfare) and the Supplemental Nutrition Assistance Program (SNAP). Populations subject to work promotion/community engagement requirements include working-age, non-pregnant adult Medicaid beneficiaries who qualify for Medicaid on a basis other than a disability (e.g., many in the expansion population, for those states that have expanded).

However, states must comply with federal civil rights laws with respect to "non-disabled" Medicaid individuals who may have an illness or disability as defined by other federal laws (e.g., Americans with Disabilities Act, Section 504 of the Rehabilitation Act of 1973, Section 1557 of the Affordable Care Act, Title VI of the Civil Rights Act, and the Age Discrimination Act) that may interfere with their ability to meet the work requirements. States must ensure that individuals with disabilities are not denied Medicaid for inability to meet these requirements, and have mechanisms in place to ensure that reasonable modifications are provided to people who need them.

Exempt populations include children, pregnant women, the elderly, individuals eligible for Medicaid based on disability, and the medically frail. In light of the nation's opioid epidemic, states will be required to take steps to ensure that eligible individuals with opioid addiction and other substance use disorders have access to appropriate Medicaid coverage and treatment services. AMA policy opposes work requirements as a criterion for Medicaid eligibility.

HHS proposes protections for conscience rights and religious freedom

Last week, the U.S. Department of Health and Human Services (HHS) issued a proposed rule that would expand existing protections for the conscience rights of physicians and other health care professionals and personnel who object to performing or participating in certain health care procedures or services. The proposed rule is very broad in scope and covers a wide array of existing federal laws that provide conscience protections, including those related to abortion, sterilization, and certain other health services, to individuals and entities receiving federal financial assistance from HHS. The conscience protections extend, for example, to provision of or assistance with abortions, abortion training, referral for abortions or abortion training, or abortion accreditation standards; conscience protections under the Affordable Care Act (ACA) related to assisted suicide; and conscience protections related to the performance of advance directives.

The proposal would require certain recipients of federal funding from HHS, including grants, loans, Medicare (except for participation only in Part B), Medicaid, and CHIP, to provide notice to individuals, including patients, students, and employees, who are protected under the federal conscience and associated anti-discrimination laws of their rights. It would also require such entities to provide assurance and certification to HHS about their compliance with the requirements of these laws. This rule would not apply to physician offices whose only source of funding is Medicare Part B payments. The rule sets forth in more detail the investigative and enforcement responsibility of the Office of Civil Rights (OCR), the agency within HHS that will administer and enforce the rule.

The AMA is analyzing the current proposal to assess its potential impact on access to care and will submit comments, which are due by March 26.

MedPAC proposes MIPS alternative

Despite reservations from several of its members, the Medicare Payment Advisory Commission has agreed to call on Congress to kill the Merit-based Incentive Payment System (MIPS) and replace it with a sweeping new plan that would base payment adjustments on large-scale application of population measures, such as potentially preventable admissions and emergency room visits.

Due in part to heightened concern from several commissioners, the official recommendation is relatively general and would require further development if Congress unexpectedly adopts it. However, the basic concept remains unchanged. Under the Medicare Access and CHIP Reauthorization Act (MACRA), physicians can choose between participation in specific "advanced" alternative payment models (A-APM) or in MIPS, a performance-based fee-for-service system that incorporates elements of three prior programs and offers a number of exceptions and exemptions for practices that are small or have low Medicare volume.

MedPAC staff and commissioners argue that MIPS is too complex and administratively burdensome, relies too much on process measures that must be reported by physicians, has too many of these measures, and will reward or punish physicians based on very small differences in performance. They are also concerned that the possibility of very large MIPS bonuses will deter physicians from moving into A-APMs, which they believe provide more incentives for cost-effective care.  

The answer, as MedPAC sees it, is to replace the 300 or so MIPS condition-oriented quality measures with eight or nine claims-calculated measures that would be applied uniformly to physician groups or health systems that are large enough to make this concept statistically viable. Those that did not find and sign up with a group on their own would have the option of participating in regional groups established by the Centers for Medicare and Medicaid Services (CMS). To induce movement into this so-called Voluntary Value Program (VVP), the Commission had tentatively agreed to include a mandatory withhold from Medicare payments. Physicians who did not move into a VVP-type plan would forfeit the withhold. Those who did participate in the VVP would receive positive or negative payment adjustments based on how their performance on population-based measures compared with that of other groups.
Whether a withhold would be required and exactly how big it might be are uncertain.

MedPAC staff had laid out an "illustrative" plan using a 2 percent withhold. In earlier meetings, a number of commissioners had argued that 2 percent was too small. At the January meeting, several commissioners expressed concerns with a withhold, however, and some wondered if a withhold could be avoided altogether by co-opting the $500 million authorized for "exceptional" performers in MIPS. Exactly how big the VVP groups would need to be is also unclear. MedPAC staff has argued that they could be created by physician independent practice associations, county medical societies, hospital medical staffs or virtual groups. The intent, as expressed by several commissioners, is to force physicians to turn quality and efficiency improvement into "a team sport" and to create a system where beneficiaries would essentially be choosing between health systems rather than individual physicians.

No major physician organization has supported the MedPAC proposal, nor is there significant support for the proposal on Capitol Hill where MedPAC's suggestion is viewed as unrealistic, "late to the table," unfair and confusing to physicians who have already invested money and resources to participate in MIPS. Other concerns raised by the AMA and other physician groups include: many physicians wouldn't be able to find an APM that would take them; physicians who treat complex patients or expensive conditions would be especially vulnerable; access to care for patients with these conditions would be compromised because current risk adjusters are inadequate; the population measures MedPAC is advocating have not been tested and won't be helpful to patients who would rather know how an individual physician performs than how the health system performs; and most of the objections MedPAC has to MIPS would also be present in its replacement plan. In lieu of an abrupt about face and institution of a new and even more sweeping change in payment, the AMA and the vast majority of state and specialty medical societies are pressing Congress to adopt a more targeted proposal to provide CMS more time and flexibility to implement MIPS.

In each of the last three MedPAC meetings, only two Commissioners—Alice Coombs, MD, a practicing anesthesiologist and critical care physician and professor in Massachusetts and Virginia, and David Nerenz, director of the Center for Health Policy and Health Services Research at Henry Ford Health System in Detroit—voted against the Commission plan. Their passionate arguments, along with the complete lack of support from the medical profession, created significant doubts for several other commissioners. In response, MedPAC Chair Francis (Jay) Crosson removed any reference to the withhold or its size from the final MedPAC recommendation and promised that the Commission would lay out additional details if Congress adopts its plan.

Medicare adopts AMA-recommended drug policies

AMA recently submitted comments on proposed policies for Medicare Advantage and Part D prescription drug plans, many of which had been recommended earlier by the AMA. Once the new rules are finalized, Medicare drug plans will need to consult with patients' prescribing physicians and obtain their approval before placing patients in the special opioid management plans authorized by the Comprehensive Addiction and Recovery Act.

The proposed rule also implements several of the AMA's regulatory relief objectives by:

The AMA letter also recommended improving access to evidence-based medication-assisted treatment (MAT) for Medicare patients with opioid use disorder. The AMA urged that, in the same way that plans are currently required to cover all drugs in the six protected classes (i.e., anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants), they should be required to cover all approved medications for the treatment of substance use disorders. In addition, plans should eliminate barriers to multimodal treatment for pain by covering non-opioid analgesics and non-pharmaceutical treatments for pain.

Long-awaited updates to the Common Rule released with delayed implementation date

The interim final rule on Policy on Human Subject Protections (aka Common Rule) has been released and delays the effective date and general compliance date of the 2018 Requirements to July 19, 2018. The rule had been scheduled to go into effect Jan. 19, 2018, but research organizations now have until July 19 to comply with its changes. The delay should allow the U.S. Department of Health and Human Services (HHS) to better communicate the changes and allow organizations more time to comply.

The rule defines federal regulations intended to protect human subjects of research from unethical or unscrupulous scientists; in practice, many academics have felt the rules are overly bureaucratic and restrictive and the updated regulation addresses areas of historic vagueness. Studies initiated prior to July 19 would, as a default, continue to be subject to the pre-2018 requirements for their duration. The Obama administration published the final rule exactly a year ago following a long delay. The Trump administration withdrew it immediately along with other regulations when they first took office. HHS' Office for Human Research Protections and its partners are weighing whether to seek public comment on delaying its implementation even longer, until next January or later. Comments are due March 19.

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State Update

Kentucky implements Medicaid work requirement

On Jan. 12, Kentucky became the first state to receive federal approval to implement work requirements as a condition of eligibility for the Medicaid program. Beginning in July 2018, Kentucky's Medicaid expansions program, known as Kentucky HEALTH, will require non-disabled adult beneficiaries to complete 80 hours per month of community engagement activities, such as employment, education, job skills training and community service. Some populations are exempt from the new requirement: former foster care youth, pregnant women, primary caregivers of a dependent (limited to one caregiver per household), beneficiaries considered medically frail, beneficiaries diagnosed with an acute medical condition that would prevent them from complying with the requirements, and full-time students.

The approved waiver also includes provisions requiring beneficiaries to pay premiums and contribute to health care spending accounts. The accounts will be used to purchase otherwise uncovered benefits, including dental, vision, and over-the-counter medicine. Beneficiaries living at or above the federal poverty level who stop paying premiums will be disenrolled and subject to a non-eligibility period for six months. The waiver also eliminates retroactive eligibility for most populations and expands mental health and substance use disorder benefits for beneficiaries residing in an Institution for Mental Diseases.

On the same day as the approval, Governor Bevin signed an executive order directing the Health and Family Services Cabinet to terminate the Medicaid expansion program if any part of the Medicaid waiver is successfully challenged in court. Medicaid expansion in Kentucky covers over 400,000 people.

Kentucky estimates that the waiver will result in approximately 238,000 fewer Medicaid enrollees in the first year. The AMA opposes work requirements as a condition of Medicaid eligibility. For more information, contact the AMA Advocacy Resource Center.

To learn more about CMS' recent guidance issued for states seeking waivers on Medicaid work requirement, read the complete story in the national section of AMA Advocacy Update.

Medical associations urge treatment, not criminalization for substance use disorders

In response to a Montana prosecutor stating that his office will seek an order of protection restraining a pregnant female from any "non-medically prescribed use" of these substances, multiple national organizations have emphasized that treatment—not criminalization—is the optimal approach to treating patients with a substance use disorder. AMA policy has long held that treatment for a substance use disorder is a disease amenable to treatment rather than a criminal activity, and that "pregnant and breastfeeding patients with substance use disorders should be provided with physician-led, team-based care that is evidence-based and offers the ancillary and supportive services that are necessary to support rehabilitation." See examples of relevant AMA policy here and here.

In a released statement from the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, the American Society of Addiction Medicine, March of Dimes and the National Organization on Fetal Alcohol Syndrome: "While the risks associated with drug and alcohol use during pregnancy deserve greater attention and public investment, addiction is a chronic brain disease that needs medical treatment, not criminalization based on medical misinformation and stigma. There is a strong consensus among medical and public health organizations that a punitive approach during pregnancy is ineffective and harmful to both mothers and children."

On the ground in Montana, the state medical association stressed that "we recognize that Montana communities are faced with difficult challenges, making it critical that law enforcement and medical professionals work as partners to explore options that support treatment over incarceration in recognition that drug addiction is a disease."

For more information, please contact Jean Branscum, Montana Medical Association Chief Executive Officer.

AMA urges Nebraska legislature to oppose APRN Compact

On Jan. 16, the AMA urged the Nebraska Health and Human Services Committee to oppose Legislative Bill 687, which would enact the Advanced Practice Registered Nurse (APRN) Compact in the state. The AMA expressed that the bill would inappropriately authorize APRNs treating Nebraska patients through an APRN Compact license to practice and prescribe independently. This would undermine Nebraska law requiring Nebraska nurse anesthetists and nurse midwives to practice pursuant to a collaborative agreement with a physician, and would grant nurse anesthetists and nurse midwives prescriptive authority for the first time. The bill would also undermine Nebraska law requiring nurse practitioners to have 2,000 hours of clinical practice under physician or nurse practitioner supervision before becoming authorized to practice independently.

The AMA opposes enactment of the APRN Compact due its potential to supersede state laws that require APRNs to practice under physician supervision, collaboration, or oversight."

Contact Kristin Schleiter, senior legislative attorney, if you anticipate APRN Compact legislation in your state.

AMA urges opposition to assistant physician licensure legislation in New Hampshire

On Jan. 16, the AMA urged the New Hampshire House Health, Human Services and Elderly Affairs Committee to oppose House Bill 1506, which would create a new licensure category of "assistant physicians" for medical school graduates who have undertaken a residency. The AMA opposes special licensure pathways for physicians who are not currently enrolled in ACGME or AOA training programs, or who have not completed at least one year of accredited graduate medical education.

If you anticipate assistant physician licensure legislation in your state, contact Kristin Schleiter, senior legislative attorney.

AMA asks Alaska legislature to oppose expanding naturopaths' prescriptive authority

On Jan. 10, the AMA wrote to the Alaska Senate Labor and Commerce Committee, expressing the AMA's opposition to Alaska Senate Bill (S.B.) 120. The bill would inappropriately authorize naturopaths to prescribe medications in a manner beyond naturopaths' education and training. Because naturopathic training does not include meaningful pharmaceutical education or provide sufficient experience, the AMA believes that the bill's authorization of naturopath prescribing of prescription drugs threatens the health and safety of Alaska's patients. S.B. 120 also represents a dangerous step towards allowing naturopaths to prescribe controlled substances, authority being sought in several states across the country.

Please contact Kristin Schleiter, senior legislative attorney, for assistance in defeating naturopath licensure and prescriptive authority legislation.

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Other News

2018 Medicare value-based payment modifier bonuses total 6.6 to 19.9 percent

In its final year, the value-based payment modifier (VM) will reward 20,481 physicians and other clinicians with bonus payments ranging from 6.6 percent to 19.9 percent. Three-quarters of those who were subject to the VM had neither a positive or negative adjustment. The remaining one-fourth received penalties of 1 percent to 2 percent because they did not meet minimum quality standards.

One of the three legacy programs that the Medicare Access and CHIP Reauthorization Act (MACRA) folded into the new Merit-based Incentive Payment System (MIPS), the VM imposed a penalty on any physician or group that did not successfully report PQRS measures. Successful reporters were then eligible for penalties or rewards based on their performance on a blend of quality and cost measures. Adjustments in 2018 are based on 2016 performance and are the last that will be made before the VM is replaced by MIPS cost and quality measures.  

Due to advocacy by the AMA and other medical organizations, the Centers for Medicare and Medicaid Services (CMS) halved the size of previously-promulgated penalties for non-successful PQRS reporting and held any practice that met the Physician Quality Reporting System reporting requirements harmless from penalties that would otherwise have been imposed. This reduced the penalty assessment by $22 million.  About 7 percent of practices escaped penalties as a result.

. Some 53 practices received a maximum bonus of 19.9 percent because they were both low cost and high quality and were among those with the highest percentage of high-complexity patients. Another 4,485 practices received a 13.2 percent bonus and 11,692 received a 6.6 percent bonus.

CMS clarifies its stance on texting patient information

The Centers for Medicare and Medicaid Services (CMS) recently issued a memorandum to clarify its position on texting patient information among members of the health care team. In summary, CMS' policy includes the following:

Note that this memorandum pertains only to CMS policy. The AMA has met with the U.S. Department of Health and Human Services Office of Civil Rights (OCR) on several occasions to urge the agency to issue guidance on text messaging in accordance with AMA policy. OCR has indicated that the guidance is advancing through the agency's clearance process. The AMA will inform the federation when the final guidance is released.

FDA reacts to physician concerns on compounding issues

On Jan. 18, the U.S. Food and Drug Administration (FDA) released its 2018 Compounding Policy Priorities Plan. The plan outlines a number of the agency's key policy priorities as it continues to implement the Drug Quality and Security Act passed by Congress in 2012. Within the plan, the FDA notes that it has heard the concerns raised by the physician community in response to its proposed guidance on Insanitary Conditions in Compounding Facilities. That guidance, initially released in 2016, proposed to require all entities engaged in sterile drug manipulations (including physician offices) to meet a number of onerous requirements, including the requirement for sterile drug preparations to take place in ISO class 5 clean rooms.

Over the past year, the AMA convened specialty societies multiple times to discuss in-office compounding. The AMA met with the FDA on numerous occasions to outline the significant concerns of the physician community over this proposal and its potential to severely affect patient access to critical treatments. In response, the 2018 Compounding Policy Priorities Plan states that the FDA plans to release new draft guidance that will address these concerns, recognizing that some providers prepare small quantities of sterile drugs for administration to their patients that do not proposed a heightened risk to patients and should not be subject to the same compliance policy as other compounding entities. This signals a significant departure from the agency's earlier thinking and the AMA is cautiously optimistic that any new guidance will be a step in the right direction towards maintaining access to critical treatments for patients. The agency did not provide a specific timeline for release of this draft guidance.

In conjunction with the Compounding Policy Priorities Plan, the FDA also finalized three other compounding-related guidance documents, although they do not speak to the in-office preparation issue. These final guidance documents include rules restricting the compounding of drugs that are essentially copies of commercially available drugs and outline new FDA policy on the mixing, diluting, or repackaging of biological products.

ONC envisions a national "on-ramp" for interoperability

The Office of the National Coordinator for Health Information Technology (ONC), which oversees health information technology for the federal government, has recently released a plan to improve the sharing of clinical data among hospitals, clinics, physicians and patients. This draft "Trust Framework" lays out a set of principles, terms and conditions to better enable trusted exchange.

The Trust Framework is designed to bridge the gap between physicians' and patients' information systems and enable all types of health care stakeholders and health information networks (HINs) to share patient data. Central to this would be the ability for physicians to query, or "ask," for all or some of their patients' health information regardless of where it is stored. Additionally, because HINs would be required to create similar interfaces, the Trust Framework would also help decrease the cost and burden of connecting and exchanging data between electronic health records. The AMA has long advocated for increased attention by the federal government on interoperability. While the work is far from over, the AMA views this as an appropriate next step in helping physicians and patients access and use health information.

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Upcoming Events

Feb. 12–14, 2018:
Registration is open for the AMA National Advocacy Conference will be held in Washington, D.C., at the Grand Hyatt Washington.

Feb. 21, 2018:
Quality improvement (QI) looks different for every practice, and there are a number of models that can be applied to help your practice implement QI processes and practices. Equally as important as having the tools that you need, however, is developing the culture of quality improvement. In this 1-hour webinar, held from 1:00 to 2:00 p.m. Eastern time, "Developing a quality improvement culture in a practice setting," attendees will learn about what is needed to develop a QI culture in your office so that your team may achieve future successes in their QI projects. Meghan Kwiatkowski, MAIO, Senior Practice Transformation Advisor will be the presenter. Click here to register.

March 2–4, 2018:
Ever wonder how doctors get elected to Congress or your state legislature? Considering a run for office yourself? Then the AMPAC Candidate Workshop is for you. This one-and-a-half-day workshop—held March 24 in Washington, D.C.—will provide you with the skills and strategic approach you will need to make a run for public office. You will also learn how to run a winning political campaign.

Registration is now open. The deadline to register is Feb. 2. The program fills up quickly, so do not delay. The registration fee is $250 for AMA members, $1,000 for non-members, and is waived for students and residents. For more information visit AMPAC online. To apply, simply fill out the online registration form or email your questions to: politicaleducation@ama-assn.org.

April 2, 2018:
Physicians and practice staff are invited to join the AMA and HITRUST at a cybersecurity workshop on April 2, 6–8:30 p.m. EST in Cleveland. Dinner will be provided. Learn more and register today.

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