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Jan. 26, 2017

Issue Spotlight

Physician work helps halt insurance merger, preserve competition

A federal judge this week handed down his decision to block Aetna's acquisition of Humana, ruling that the proposed health insurer merger violates federal merger law because it is likely to lessen competition in the health insurance marketplace. This caps 18 months of physician advocacy opposing the merger, during which time a coalition of medical societies provided state attorneys general and the Department of Justice (DOJ) with compelling evidence to challenge the merger in court.

U.S. District Judge John D. Bates Monday ruled that the proposed merger would greatly erode competition in the sale of individual Medicare Advantage plans in 364 counties. Additionally, the court held that the merger violates antitrust law in individual commercial insurance markets on the public exchanges in three counties in Florida where Humana and Aetna compete.

The court's ruling sets a notable legal precedent by recognizing Medicare Advantage as a separate and distinct market that does not compete with traditional Medicare. This characterization of Medicare Advantage as a separate and distinct market in which competition is important was a focus of AMA state and federal advocacy in Congressional hearings and state departments of insurance. And this point also proved influential with state attorneys general and the DOJ that ultimately brought the legal challenge. In support of its position, the AMA secured the opinions of 20 leading academic health economists with expertise in health insurance competition.

Judge Bates found that the merger would threaten the quality, accessibility and affordability of health care for millions of seniors. Judge Bates' ruling acknowledges the important role of antitrust in protecting consumers within health insurance markets.

"Federal regulation would likely be insufficient to prevent the merged firm from raising prices or reducing benefits," Judge Bates wrote. "The court is unpersuaded that the efficiencies generated by the merger will be sufficient to mitigate the anticompetitive effects for consumers in the challenged markets."

"Aetna's strategy to eliminate head-to-head competition with rival Humana posed a clear and present threat to the quality, accessibility and affordability of health care for millions of seniors," AMA President Andrew W. Gurman, MD, said in a statement. "A spokesman for Aetna reportedly said the company is "giving serious consideration to an appeal."

Physicians join forces, provide evidence
The Aetna- Humana merger was announced in July 2015, as was a separate merger involving two other health insurance giants, Anthem and Cigna. In September of that year, the AMA released the 14th edition of its report, Competition in Health Insurance: A Comprehensive Study of U.S. Markets. The study offered the largest and most complete picture of competition in health insurance markets for 388 metropolitan areas, as well as the 50 states and the District of Columbia.

In that same month, AMA leaders testified against the mergers. Barbara L. McAneny, MD, member of the AMA Board of Trustees, testified at the Sept. 10 hearing of the House Judiciary Committee arguing for the need to provide patients with more choices for health care services and coverage. AMA President Andrew W. Gurman, MD, testified at the Sept. 29 hearing of that committee on examining the proposed mergers and the consequent impact on competition. He urged a close scrutiny of the mergers.

AMA representatives met with the DOJ Antitrust Division to discuss the "Competition in Health Insurance" report late in the fall. In November, the AMA submitted responses to supplemental questions from the House Judiciary Committee on the state of competition in the health care marketplace. The answers highlighted past consolidation experiences and the negative consequences for patients. And later that same month, the AMA, in a comprehensive letter addressing all of the issues today decided by Judge Bates, publicly urged the DOJ to block the proposed megamergers.

In December, a coalition to oppose the mergers began forming. The AMA convened all state and national specialty societies to propose a comprehensive advocacy strategy, urged the National Association of Attorneys General (NAAG) and its merger work group to work within their respective authority to block the mergers, identified states to focus grassroots strategy and held multiple calls with state medical associations in high-concentration states.

The AMA continued to engage the NAAG last year in an effort to convince key state attorneys general to join the DOJ in blocking the mergers. In coordination with state medical societies across the country, the AMA conducted extensive physician surveys, to gauge the mergers' potential impact on patient care. Included in this effort were nationally recognized economists and legal experts who offered support for physician arguments. Some of these experts testified and attended meetings with state regulators alongside AMA and state medical society representatives opposing the mergers.

The release of the 15th edition of "Competition in Health Insurance: A Comprehensive Study of U.S. Markets" in September of last year appears to have been a final nail in the coffin. The study presented clearly the most complete picture of competition in the market and helped to identify the markets where the proposed mergers would erode competition.

"The AMA's stand against this anticompetitive merger shows again that when doctors join together, the best outcome for patients and doctors can be achieved," Dr. Gurman said. "Given the troubling consolidation trends in health insurance industry, the AMA will continue to advocate on behalf of patients and physicians to foster more competitive health insurance markets."

What's next?
With one megamerger stopped in its tracks, U.S. District Judge Amy Berman Jackson is expected to soon deliver her decision on Anthem's proposed acquisition of Cigna. Much of the evidence that led the DOJ and state attorneys general to file to block the Anthem-Cigna merger came from physician efforts to prove it was anticompetitive.

The main argument of the Anthem-Cigna merger, however, is that it would grant Anthem monopsony power, which is "a buyer with too much buyer power," Rich Feinstein, former director of the Bureau of Competition at the Federal Trade Commission said recently. Feinstein is one of many experts who supported physician efforts to block the mergers.

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National Update

President Trump issues ACA executive order

On his first day in office President Trump signed an executive order to minimize the economic burden of the Patient Protection and Affordable Care Act (ACA). While the executive order grants appropriate cabinet secretaries and agency heads the authority to minimize the "burden" caused by the ACA, it also requires White House officials to comply with the Administrative Procedure Act.

Consequently, the White House must go through the notice and rulemaking process to change ACA policies. The executive order is very broad and it is unclear at this time exactly which ACA policies the Trump Administration plans to modify. The AMA will continue to closely monitor the situation and engage the new administration as it moves forward to modify the ACA. 

New guidance issued on how HIPAA permits disclosures of PHI

The U.S. Department of Health and Human Services Office of Civil Rights (OCR) recently released a series of clarifying guidance documents on how the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule permits disclosures.

The new FAQs clarifies that physicians may disclose protected health information (PHI) to a patient's loved ones, regardless of whether they are recognized as relatives under applicable law (e.g., a patient's partner to whom he/she is not married). The FAQs make clear that the permissive disclosures are not limited by the sex or gender identity of the person. Concurrently, OCR is in the process of updating existing guidance to make clear that the terms marriage, spouse, and family member include, respectively, all lawful marriages, whether same-sex or opposite-sex, lawfully married spouses and the dependents of all lawful marriages, and clarifies certain rights of individuals under the Privacy Rule.

The OCR and the Office of the National Coordinator for Health Information Technology  also released a Fact Sheet explaining HIPAA permits disclosures of PHI to support public health activities conducted by public health agencies, as authorized by state or federal law. It provides a few examples of sharing PHI in support of public health policies.

The AMA has consistently urged policymakers to increase their education efforts to assist physicians in their understanding of how HIPAA permits clinicians to share PHI. The AMA has also created a toolkit on related aspects of HIPAA, which includes requirements around privacy and security.

Final rule permits increased access to substance abuse data

The U.S. Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) recently issued a final rule easing existing restrictions on how clinicians may share substance abuse treatment records with one another.

The new rule, 42 CFR Part 2—commonly known simply as "Part 2"—now permits clinicians to obtain a single authorization from their patients to establish which information their clinician shares with other clinicians. Formerly, clinicians needed to obtain patient authorization for each disclosure, which was burdensome for both physicians and patients.

The AMA strongly supported SAMHSA's efforts to modernize the Part 2 rules to better align them with the current health care delivery system, while simultaneously preserving important patient privacy protections. In particular, the AMA agreed with SAMHSA's goal of enabling patients with substance use disorders to benefit from new integrated health care models without exposing them to adverse consequences that could act as a deterrent to their seeking needed care.

The new rule becomes effective Feb. 17.

AMA weighs in again on VA's new full-practice authority policy

In a Jan. 13 letter, the AMA continued to register its concern with the Department of Veterans Affairs (VA) decision to allow full practice authority for most Advanced Practice Registered Nurses (APRN). The final rule requested additional comments on the VA's decision to exclude Certified Registered Nurse Anesthetists (CRNA) and, specifically, whether advanced practice authority for CRNAs would bring further access improvements to anesthesia providers.

The AMA urged the VA to maintain the CRNA exclusion largely because the VA's own workforce data supports it. According the VA's 2015 Mission Critical Occupations Report, access to anesthesiologists is improving and the specialty is not among the top five that are difficult to recruit and retain. The AMA also supported maintaining the CRNA exclusion for patient safety reasons and so as not to undermine states' rights—45 states and the District of Columbia require CRNAs to practice with or be supervised by physicians.

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State Update

Four states introduce legislation to join Interstate Medical Licensure Compact

So far in 2017, Interstate Medical Licensure Compact bills have been filed in Mississippi, Nebraska, North Dakota and Washington. If passed, these states would join the 18 states that will allow physicians to participate in the Compact's expedited licensure process. The Interstate Medical Licensure Compact Commission—the entity charged with administering the Compact—hopes to start accepting applications for physicians to be licensed through the Compact process by the end of this month.

At the same time, four states—Colorado, Minnesota, Montana and Nevada—are pursuing or will pursue legislative fixes to the Compact to clarify that each state's medical board, not the Commission, will be the entity to access the Federal Bureau of Investigation's criminal background check system, as the Compact requires. Legislation has been filed in Minnesota; similar legislation or regulation is expected in the other states.

The AMA supports the Compact and will support any state medical association interested in pursuing Compact legislation. For more information please contact Kristin Schleiter of the AMA.

Bills introduced to grant APRN independence

Almost 100 pieces of legislation have been introduced so far in 2017 to expand the scope of practice of advanced practice registered nurses (APRN). These bills range from minor changes to APRN rules and regulations, to expansions of prescriptive authority, to bills granting APRNs the authority to practice independent of physician collaboration, supervision or oversight.

One bill in particular stands out from the pack in its grant of authority for nurse practitioners to perform vasectomies.

The AMA is here to help state and specialty medical associations address any and all of these issues. Contact Kristin Schleiter for more information or resources.

PAs continue efforts toward "collaboration"

Physician assistants (PA) will continue recent efforts to move from "supervision" to "collaboration", with legislation expected in states, including New Mexico. Only Michigan has enacted such legislation to date. At the same time, the American Academy of Physician Assistants (AAPA) Task Force on Full Practice Authority and Responsibility (FPAR) continues to solicit feedback from PAs regarding whether AAPA policy should support legislative movement towards full independence—full practice authority—for PAs. The task force is developing policy for consideration at the May 2017 meeting of the AAPA House of Delegates.

Please contact Kristin Schleiter if you anticipate PA legislative activity in your state.

Louisiana and Utah sign standing orders for naloxone

State health officials in Louisiana and Utah this week issued a "standing order" for naloxone to increase access to those who need the life-saving opioid overdose antidote. A standing order typically allows participating pharmacists to dispense naloxone—without a patient-specific prescription— to laypeople including caregivers, family and friends of a person at risk for overdose.

"This is an important step in our fight against the opioid epidemic," said Rebekah Gee, MD, MPH, secretary of the Louisiana Department of Health. "By making this medication and education widely available, people who overdose can get the antidote quickly and administer it safely. This will save lives."

"Opioid overdose can be reversed and death prevented by timely administration of naloxone," said Joseph Miner, MD, executive director of the Utah Department of Health. "As authorized by state law, this standing order is intended to increase access to naloxone for those who might be at risk of an overdose or who might be in a position to assist somebody at risk of an overdose."

Read the Louisiana standing order.

Read the Utah standing order or a press release issued Tuesday.

For additional information about standing orders, including an AMA legislative template, please contact Daniel Blaney-Koen at daniel.blaney-koen@ama-assn.org and visit the AMA website.

Anthem agrees to stop prior authorization for MAT

New York Attorney General Eric Schneiderman announced an agreement this week with Anthem that will end the payer's policy of requiring prior authorization for medication-assisted treatment (MAT) for opioid use disorder, which follows a similar agreement with Cigna in 2016.

The AMA Task Force to Reduce Opioid Abuse has urged increased access to MAT and requested payers provide comprehensive access to MAT, including for Medicaid patients, the incarcerated and those who have failed with previous treatments.

One encouraging sign is that more physicians continue to become trained to provide in-office buprenorphine for patients with substance use disorders. According to the U.S. Substance Abuse and Mental Health Services Administration, more than 36,000 physicians have the necessary training to provide MAT services. This includes more than 2,700 who can now treat up to 275 patients.

Pennsylvania health officials issue statewide synthetic opioid warning

Following recent deaths in the state, Pennsylvania's top health officials last week issued a statewide warning about the dangers posed by carfentanil, a synthetic opioid that is 10,000 times more powerful than morphine. The warning includes signs of carfentanil exposure and support for first responders to carry and administer naloxone.

The Pennsylvania Medical Society also promoted the statewide warning, highlighting the need for caution and how "carfentanil can be extremely dangerous to emergency and medical responders if exposed," said Charles Cutler, MD, President, Pennsylvania Medical Society. Dr. Cutler further emphasized the need for those with substance use disorders to seek treatment.

Read more about the medical society's efforts to reverse the opioid epidemic in the commonwealth.

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Judicial Update

Scope of practice should set limits on medical liability testimony

Which medical professionals are qualified to provide medical causation testimony before a court? In Frausto v. Yakima HMA, the Supreme Court of Washington will determine whether an advanced registered nurse practitioner (ARNP) is qualified to testify as to the causation of a patient's medical condition.

Rudy Frausto, a quadriplegic, presented to Yakima Regional Medical Center with symptoms of general body weakness, influenza and pneumonia. He was treated for 10 days and, during that time, developed decubitus ulcers.

Frausto sued the hospital for medical malpractice. To support his claim, Frausto offered an affidavit from Karen Wilkinson, an ARNP. Wilkinson's affidavit stated that the hospital had failed to provide Frausto with proper bedding, skin assessments and other care and had thus caused the bed sores.

A trial court noted that Wilkinson had practiced as a licensed nurse for more than 26 years, had taught other nurses and had extensive experience as a staff nurse. The court held that she was qualified to testify as to the standard of care. But the court also held that Wilkinson, as a nurse, was unqualified to testify about medical causation.

Frausto appealed to the Supreme Court of Washington.

"The ability to testify accurately regarding causation is dependent upon the ability to render a medical diagnosis identifying the etiology of a condition or injury," the Litigation Center of the AMA and several other medical societies argue in an amicus brief.

Why physician testimony is required
There are significant differences in the training requirements for ARNPs and physicians. For example, a family physician, following undergraduate education, undergoes four years of a doctoral program, three years of residency training and must have a minimum of 1,650 patient encounters before practicing independently, resulting in more than 20,000 total hours of training. An ARNP, after undergraduate education, undergoes 1.5 to three years of a master's program, resulting in 2,800 to 5,350 total hours of training. Neither residency training nor a minimum number of patient encounters is required.

"A family practice physician receives almost twice the amount of general education and over three times the amount of clinical experience obtained by an ARNP," the brief says. "The difference in experience and training has been shown to have an effect on the quality and nature of diagnoses and referral patterns."

The court, in light of these differences in education and training, should limit the ability to testify regarding causation of an injury arising from a physician's alleged breach of the standard of care to another physician, the brief says.

"While there may be some circumstances where an ARNP is qualified to testify regarding medical causation resulting from a breach of the nursing standard of care, these situations should be limited to those medical procedures or issues within the scope of that ARNP's certification and ability to practice, and consequently, diagnose independently," the brief says.

"Unlike a nursing diagnosis, which focuses on the patient's response to an illness in an effort to provide the most appropriate nursing care, a medical diagnosis involves the identification of the ultimate cause of a patient's illness."

The Litigation Center argues that only a physician will have the appropriate diagnostic training and clinical experience necessary to "opine whether a physician's breach of the standard of care has caused the medical injury in question."

Briefing in the Supreme Court has now been completed and oral argument has been set for Feb. 21.

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Other News

AMA-convened workgroup releases principles to reduce burdensome prior-authorization practices

In an effort to reduce the negative impact of prior authorization on patient care, the AMA convened a workgroup of state and specialty medical societies, national provider associations and patient representatives to create a set of best practices related to prior authorization, step therapy and other utilization management requirements. The workgroup identified the most common patient and provider issues surrounding utilization management programs and recently issued the Prior Authorization and Utilization Management Reform Principles to address these concerns. 

The 21 common-sense principles were designed to improve the application of utilization management programs and cover five broad categories:

The principles will form the basis of a widespread, multi-faceted 2017 advocacy campaign seeking to reform prior authorization practices and improve the quality and efficiency of health care. As part of this campaign, the AMA will directly advocate with health plans, benefit managers, accreditation organizations, legislators and standards organizations.

For additional information on the AMA's advocacy on this topic, visit the "Addressing Prior Authorization Issues" web page.

FDA publishes discussion paper on LDTs

The Food and Drug Administration (FDA) issued a "Discussion Paper" on laboratory-developed testing services and procedures (LDT) on Jan. 13. The FDA had announced in late 2016 that it would not issue final guidance on the Agency's oversight of LDT to allow further discussion and provide time for a legislative solution.

The paper attempts to address broad areas of concern raised by stakeholders, including the AMA and a number of national medical specialty societies, and offer a proposed approach to oversight without issuing final guidance. The FDA proposes a new hybrid approach that provides a specific role for the Centers for Medicare & Medicaid Services under that agency's Clinical Laboratory Improvement Act Amendment authorities.

Many of the proposed changes are consistent with recommendations suggested by physician organizations, but ongoing dialogue will be needed to address remaining issues of concern that could impede innovation, particularly for rapidly evolving testing services and procedures used to detect infectious disease outbreaks.

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Upcoming Events

Feb. 17 – 19, 2017:
Whether you want to run for public office or campaign for a candidate who supports issues that are important to medicine, AMPAC, the AMA's bipartisan political action committee, offers the hands-on training you need. The Candidate Workshop is designed to help you make the leap from the exam room to the campaign trail and give you the skills and strategic approach you will need to make a run for public office. Please note participants are responsible for their registration fee, hotel accommodations at the Hyatt Regency Washington on Capitol Hill and travel to and from Washington, D.C. Faculty, materials and all meals during the meeting are covered by the AMA. Learn more or apply today.

Feb. 27 – March 1, 2017:
The 2017 National Advocacy Conference will take place in Washington, D.C. Participants in this year's conference will gain important insights from industry experts, political insiders and members of Congress. Conference participants will leave more well-informed and empowered to advocate for patients, the medical profession and the future of health care. Learn more and register today.

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