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Oct. 18, 2019

Issue Spotlight

Surprise medical bills: Physicians want market-based fixes

The AMA and 110 other organizations representing hundreds of thousands of American physicians have signed onto a letter urging Congress to refine surprise billing legislation to ensure the final version targeting unanticipated out-of-network care "represents a fair, market-based approach that treats all stakeholders equally while protecting patient access to care."

There are instances when unanticipated coverage gaps happen "and patients unknowingly or without a choice receive care from an out-of-network physician or other provider."

In those cases, the physicians' letter says, "patients should be held harmless for any costs above their in-network cost-sharing, and their cost-sharing should count toward deductibles and out-of-pocket maximums. Patients should be completely removed from any subsequent payment disputes between their health insurance company and an out-of-network provider when they experience an unanticipated coverage gap," says the letter, sent Oct. 15 to Congressional leaders and broadly shared with members of the U.S. House and Senate.

However, "rate-setting provisions in current bills further shift marketplace leverage to health insurers at the expense of providers." That "will likely lead to access problems for patients seeking hospital-based care from on-call specialists, as well as precipitate staffing shortages in rural areas and other underserved communities."

More than 80% of the budgetary impact of the rate-setting mechanism in the "Lower Health Care Costs Act" (S. 1895) "would arise from changes to in-network payment rates," according to the analysis conducted by the Congressional Budget Office, which reached a similar conclusion regarding another bill, the "No Surprises Act" (H.R. 2328).

The end result? "In-network providers who have not contributed to the problem will bear the impact of the rate-setting scheme," says the letter sent by the AMA and the other physician organizations.

Physicians point to the success that New York state has had with a law mandating an independent dispute-resolution (IDR) process to deal with medical bills arising from unanticipated out-of-network care. New York patients have saved $400 million-plus on emergency care alone and out-of-network billing has fallen 34% since 2015, according to New York State Department of Financial Services Supervisor Linda Lacewell.

The AMA and the other physician organizations signing onto the letter recommend specific fixes to the "No Surprises Act" to:

Congress is expected to act in the coming months.

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National Update

Key updates to the Quality Payment Program

The AMA has been urging the Centers for Medicare & Medicaid Services (CMS) to distribute 2019 incentive payments to qualifying participants in advanced alternative payment models (APM) based on 2017 APM participation. CMS is finally releasing the incentive payments. The APM incentive payment is a lump sum based on the paid amounts for Medicare Part B covered professional services furnished by the physician across all groups during calendar year 2018. CMS' fact sheet provides additional details. 

Additional updates and important dates to watch in the Quality Payment Program (QPP) program include:

  • The virtual group election process is underway for the 2020 Merit-based Incentive Payment System (MIPS) performance year. Solo practitioners and group practices with 10 or fewer clinicians have until Dec. 31 to submit a virtual group election to CMS. CMS has released a toolkit with instructions for interested physicians and groups. 
  • The deadline to submit a "Promoting Interoperability Hardship Exception" and/or "Extreme and Uncontrollable Circumstances" application is the end of the year. 
  • CMS updated its QPP status tool, which shows whether a physician is a qualifying participant in an advanced APM in 2019 and therefore will receive a 5% incentive payment and exemption from MIPS in 2021.

Administration action needed to improve Medicare Advantage networks

Responding to policies adopted by the AMA House of Delegates, the AMA is asking CMS Administrator Seema Verma to adopt a suite of policy proposals to enhance Medicare Advantage (MA) physician network adequacy, stability and directory accuracy, improve communication with patients about MA plans' physician networks, and ban no-cause network terminations. The AMA urges CMS to boost its efforts to ensure directory accuracy by requiring MA plans to submit accurate network directories to CMS every year prior to the Medicare open enrollment period and whenever there is a significant change to the status of the physicians included in the network.

CMS should also take enforcement action against MA plans that fail to maintain complete and accurate directories. To ensure that network adequacy standards provide adequate access for patients and support coordinated care delivery, CMS should require plans to report the percentage of physicians in the network, broken down by specialty and subspecialty, who actually provided services to plan members during the prior year. Citing a July 2019 Government Accountability Office report, the AMA notes that physician networks have been found to be important in Medicare beneficiary decisions about MA plans, and recommends that CMS improve the physician network information provided on the online Medicare Plan Finder website.

For calendar year 2020, the Medicare open enrollment period runs from Oct. 15 through Dec. 7, 2019. During this time, people with Medicare can compare coverage options like original Medicare and MA, and choose from among the MA and Part D prescription drug plans available in their locality for 2020. 

Stark and anti-kickback regulatory changes proposed

CMS and the Office of Inspector General at the Department of Health and Human Services separately issued proposed rules to modernize and clarify the regulations that interpret the physician self-referral law (often called the "Stark Law") and the anti-kickback statute. The proposed rules include provisions meant to advance the transition to a value-based health care delivery and payment system that improves the coordination of care among physicians in both the federal and commercial sectors.

The proposals also include clarifying key terms like "fair market value" and "commercial reasonableness," updating existing safe harbors and exceptions including the group practice exception and electronic health records safe harbor and exception, and creating new safe harbors and exceptions such as allowing the sharing of cybersecurity software and services. If finalized, the proposals may present significant opportunities for new financial arrangements but may also require revisions to current arrangements involving physicians, hospitals, patients and others involved in the health care industry. The proposed rules state that comments for each will be due 75 days from the date of publication in the Federal Register (which is currently scheduled for Oct. 17).

FDA releases updated draft guidance for clinical decision support software

Last month, the Food and Drug Administration (FDA) issued updated draft guidance outlining the agency's current thinking on regulation of clinical decision support (CDS) software. The updated draft guidance outlines the agency's proposed framework for regulating CDS tools, explaining which tools the FDA plans to review and which it will not. In a shift from the FDA's initial draft guidance, released in 2017, the updated version moves to use of a risk-based framework for determining review status. The 2017 version proposed to make review determinations based upon the level of human involvement with the CDS, meaning whether a physician was capable of independently reviewing the software's output.

Along with the updated CDS draft guidance, FDA also finalized guidance aimed at bringing existing FDA software policies in line with the 21st Century Cures Act. Notably, this final guidance outlines the types of products FDA will not consider to be medical devices and will therefore not regulate. These include items such as software for facility administration, electronic patient records, general health and wellness apps, and software intended for storing, transferring, formatting, or displaying data and results. 

AMA applauds federal ruling on the public charge

On Oct. 11, judges in separate cases before the U.S. District Courts for the Southern District of New York (SDNY) and Eastern District of Washington preliminarily enjoined the U.S. Department of Homeland Security (DHS) from implementing and enforcing the final rule related to the public charge ground of inadmissibility. The AMA submitted a comment letter to the DHS in December vigorously opposing the public charge proposed rule and the harm to immigrant children and families the proposal would cause if implemented. The public charge rule has already had a chilling effect, leading many immigrant families to avoid accessing vital health, nutrition and housing programs. The AMA also joined with other health care organizations in submitting amicus briefs (SDNY: amicus 1 and amicus 2; Wash.: amicus) in the separate cases. 

The DHS' final rule was slated to take effect on Oct. 15, but the two injunctions are nationwide and prevent the U.S. Citizenship and Immigration Services (a component of the DHS) from implementing the rule anywhere in the United States until there is final resolution in the cases. 

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State Update

First-generation physician bridges gap between the ED and long-term SUD care

Aakash Shah, MD's journey to become an emergency medicine physician started with a report card in a brown paper envelope. 

"My parents arrived in the United States with only $20 in their pockets and the name of a family friend they had never met," said Dr. Shah. "They wanted me to have a better future, so I was determined to work hard in school." His parents worked hard to make ends meet and were considering leaving the country.

"I still remember when I got my first report card in a brown paper envelope. My father scanned the folded yellow sheet and when he saw what my grades were they decided to stay. They knew my future would be better here."

Aakash Shah, MD

Aakash Shah, MD

Dr. Shah, a first generation American, continued his hard work through medical school and residency, and now says that he does "everything in my power to ensure that my parents' sacrifice was not in vain and to make sure the circle of opportunity that included my parents decades ago is still there for my patients." 

As an emergency medicine physician Dr. Shah is trained to treat the acute issues that bring patients to the emergency department (ED), but he has found that it has offered him a unique perspective on the chronic issues affecting the larger community: "So many of the interactions you have in the ED are a formative window into your community. When patients fall through cracks in the health care system the ED is where they land." 

A prime example are the patients who have been recently released from prison and end up in acute withdrawal. While the immediate needs of a withdrawal can be treated in the ED, in order to make lasting change, treatment must follow the patient out of the emergency department doors.

"In recent years, I have tried to find ways to reach beyond the four walls of the emergency room to help address the needs of the community to really tackle the opioid epidemic," Dr. Shah said. This led him to the New Jersey Re-entry Corp which serves 6,000 justice-involved individuals across New Jersey who are re-entering society and need job training, employment, stable housing and access to health care. The risk of opioid overdose death is 129 times greater during the first two weeks upon release than the general population so the need for treatment is acute, explained Dr. Shah.

"What this population – like so many others – needs is integrated care upon release at our sites," said Dr. Shah. "If you screen people for Hepatitis C and then ask them to go across the street for a follow up, you'll often lose two-thirds of the people who you identify as needing treatment. Every additional step you add to the path of robust coverage means that you will lose people along the way."

Barriers to care persist even with the best-designed programs, Dr. Shah says: "I still see the same stigma that has manifested in policy manifest in providers, I have seen providers in the ED refuse to initiate someone on buprenorphine for a variety of reasons, but the more we talk about it, the more we raise awareness, the more patients we can reach." 

A major barrier to treatment was removed when prior authorization requirements were repealed for medication-assisted treatment in New Jersey in 2019 for Medicaid enrollees. One week prior, Dr. Shah was a co-author of an op-ed calling for the policy action. The AMA praised the action, urging all states to follow the leadership of New Jersey's Medicaid agency. 

"That was a significant improvement—the vast majority of people we see are on Medicaid and they'd come to us in a moment of need, be willing to start treatment and then have to wait for days and navigate bureaucracy. That would often cost them their recovery, and sometimes even their life," said Dr. Shah. "New Jersey can serve as an example to other states that haven't taken this step yet. The repeal of prior authorization requirements is invaluable."

Learn more about what the AMA is doing to end the opioid epidemic, and share your story with the AMA. Have you experienced any barriers to care? Do you have a story to tell? We want to hear from you: opioidtaskforce@ama-assn.org.

Raising awareness about key issues surrounding the opioid epidemic other than mandates

While prescribing restrictions, continuing medical education (CME) and prescription drug monitoring program (PDMP) mandates tend to garner the most attention from policymakers, the AMA continues to work to raise awareness of key issues that do not always make it to the front pages of local newspapers. These include issues related to benzodiazepines, gender and dispelling myths of bystander overdose.

Concomitant use of benzodiazepines and opioids: The AMA believes it is important to raise the awareness of physicians and patients regarding the increased use of illicit benzodiazepine/opioid combinations leading to addiction and overdose death. In addition, the AMA wants to provide objective information to physicians and patients about the risks associated with concomitant use of benzodiazepines and opioids. A recent AMA Council on Science and Public Health Report highlights the use of these drugs and notes their use not only to induce a state of intoxication, but also for self-medication of anxiety disorders. 

A recent study indicated that benzodiazepine use among U.S. adults was higher than previously reported, and misuse accounted for nearly 20 percent of use overall. Studies have also noted that benzodiazepine misuse has reached epidemic levels and results in poor outcomes, particularly when combined with concomitant central nervous system depressants. Benzodiazepines are misused most commonly in combination with opioids and alcohol. Substance Abuse and Mental Health Administration reports that benzodiazepine-associated emergency department visits and related deaths have increased 137% in recent years. The National Institute on Drug Abuse at the National Institutes of Health states that more than 30% of overdoses involving opioids also involve benzodiazepines.

In 2016, after extensive review of the latest scientific evidence, the FDA announced a requirement for strong warnings for opioid and benzodiazepine labeling related to serious risks and death from combined use. 

Education on sex-based response to opioids: As part of its wide-ranging suite of educational materials, the AMA's eLearning series "Practical Guidance for Pain Management" is available on the AMA Ed HubTM. This series offers physicians and the broader care team access to educational content in a variety of topics, including sex-based differences in response to opioids. The modules are designed to be standalone, or can build into a curriculum, resulting in nine AMA PRA category 1 credits. 

An additional resource of note for gender-related education concerning opioids are several resources created and hosted by the American College of Obstetricians and Gynecologists, which are promoted via the AMA opioid microsite

Dispelling myths of bystander opioid overdose: The AMA also believes it is important to provide educational materials aimed at dispelling the fear of bystander overdose via inhalation or dermal contact with fentanyl or other synthetic derivatives. The American College of Medical Toxicology (ACMT) and the American Academy of Clinical Toxicology (AACT) issued a position paper and guidelines on the topic in 2017. ACMT and AACT note that inhalation and dermal exposure risk for fentanyl and other synthetic analogues is extremely low in the absence of mucous membrane exposure, incidental dermal absorption is unlikely to cause opioid toxicity, and nitrile gloves provide sufficient dermal protection for routine handling of the drug. An article in the Journal of Emergency Medical Services notes the public concern and misconceptions about fentanyl and also notes that legitimate use of fentanyl could be jeopardized.

The AMA encourages the sharing of this information with members and colleagues.

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Other News

2020 MIPS virtual group election period open until Dec. 31 

To participate in MIPS as a virtual group for the 2020 performance period, a virtual group election must be made before the 2020 performance period starts. This means that a virtual group election must be made by 11:59 p.m. eastern Time (ET) on Dec. 31. A virtual group is a combination of two or more Taxpayer Identification Numbers (TIN) assigned to one or more solo practitioners and/or groups consisting of 10 or fewer clinicians (including at least one MIPS eligible clinician). After an election is made, a virtual group has until Dec. 31 to revise or retract its virtual group election; a virtual group election cannot be revised or retracted once the performance period starts. 

A virtual group must identify an official representative and establish a formal written agreement between each solo practitioner and/or group that composes the virtual group for a minimum of one performance period. An approved virtual group election will remain valid for the entire performance period, even if the virtual group's composition changes during the performance period. If the virtual group experiences a change (like a composition change, for example) during the performance period, the virtual group's official representative must notify the QPP of these changes before the submission period opens. For more information visit QPP.CMS.gov

AMA hosts public policy discussion on augmented intelligence

On Oct. 11, the AMA hosted an "Introduction to Health care AI Public Policy" discussion for Federation members. There were 80 participants from state medical and specialty societies and expert speakers. The program included an overview of current and looming challenges in health care, the need for physician involvement in ideation, design, development, and deployment of technology solutions, and the current public policy debates concerning regulation and data uses. Physician innovators and other experts provided specific examples of clinical benefits as well as challenges.

The presentations and supporting materials are available online at the AMA's Physician Innovation Network. Additional AMA resources on AI can be found here.

The discussion will continue at the AMA's State Advocacy Summit, Jan. 9-11, Hyatt Regency Coconut Point Resort and Spa, Bonita Springs, Florida.

New podcast on "Medicare For All" now available

As the 2020 presidential election has kicked off in earnest, the term "Medicare For All" is being frequently used, but what does it really mean? What are the implications of a single-payer system and what is the AMA's position on it? Listen to ReachMD's conversation with AMA's VP of Government Affairs Cindy Brown to get the answers to these questions and more. 

14 digital health tech companies awarded for solving health care problems

More than 500 digital health organizations across the country submitted their new technologies for consideration for the inaugural University of California, San Francisco (UCSF) Digital Health Awards

Finalists were selected across 14 categories by a team of expert judges from the health care industry. When choosing finalists, judges referenced the mHealth App Guidelines from Xcertia, a nonprofit co-founded by the AMA. Submissions were open to qualified, mature health tech companies with in-market products that have been used by thousands of patients and have been verified in a validation study or clinical trial. 

Each digital health company was judged on how its technology can reduce the health care costs while improving health care. Ten finalists per category were chosen for the UCSF Digital Health Awards in collaboration with the AMA Physician Innovation Network and other organizations.

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Upcoming Events

National Prescription Drug Take Back Day

Oct. 26: The National Prescription Drug Take Back Day addresses a crucial public safety and public health issue. According to the 2018 National Survey on Drug Use and Health, 9.9 million Americans misused controlled prescription drugs. The study shows that a majority of abused prescription drugs were obtained from family and friends, often from the home medicine cabinet. The U.S. Drug Enforcement Administration's Take Back Day events provide an opportunity for Americans to prevent drug addiction and overdose deaths.

To locate the nearest collection site visit https://takebackday.dea.gov/.

What does augmented intelligence in health care mean for medical students, residents, and young physicians?

Oct. 28-Nov. 3:  As the future of medicine, medical students, residents and young physicians will be impacted by the rise of AI across the industry. Join the discussion to talk about the consequences of AI, and how physicians are engaging the technology and preparing it for clinical practice. Join the Physician Innovation Network's online discussion from Oct. 28 to Nov. 3.

Register now for 2020 AMA advocacy conferences and save 20%

The 2020 AMA State Advocacy Summit will be held in Bonita Springs, Florida, at the Hyatt Regency Coconut Point Resort and Spa, Jan. 9-11. The 2020 AMA National Advocacy Conference will be held in Washington, D.C., at the Grand Hyatt, Feb. 10-12. Register now for both meetings and use the code "SASNAC20" to save 20% on dual registration.

Register today for the Rx Drug Abuse and Heroin Summit

April 13-16: The Rx Drug Abuse & Heroin Summit is the largest and most-recognized conference committed to addressing the opioid crisis. Government officials, first responders, law enforcement personnel, clinicians, physicians, nurses, educators, public health and prevention officials, and families and people in recovery are represented. The conference agenda is designed with timely and relevant information to address what is working in prevention, treatment and law enforcement. This year's summit will take place in Nashville, TN, April 13-16.

Register today and save an additional $50 with code ALUM.

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