June 28, 2018
Issue SpotlightAnticompetitive CVS-Aetna merger should be blocked
On June 19, 2018, AMA President Barbara L. McAneny, MD, presented testimony in a hearing before the California Department of Insurance (DOI) and California Insurance Commissioner David Jones urging regulators to block the proposed CVS-Aetna merger. The AMA commends the California DOI and Commissioner Jones for their leadership in holding this hearing to examine this massive health care merger. "After very careful consideration over the past months, the AMA has come to the conclusion that this merger would likely substantially lessen competition in many health care markets, to the detriment of patients," said Dr. McAneny at the hearing.
A CVS-Aetna deal would allow the combined corporate entity to fortify dominant positions in health insurance, pharmaceutical benefit management, retail and specialty markets that already lack competition. Dr. McAneny, an oncologist, noted that the merger "could pose a very serious threat to the quality of care and safety of cancer patients in my practice, and across the country, because of the merger's potential impact on the specialty pharmacy market."
CVS is one of the two largest players in the pharmacy market and operates one of the two largest PBMs, a position that has allowed them "to effectively force many patients and third-party payers to utilize CVS as their specialty pharmacy," Dr. McAneny said.
Following the hearing AMA will file a post-hearing memorandum outlining its concerns, noting the potential negative consequences for health care access, quality and affordability. The filing will outline the merger's potential negative consequences for health care access, quality and affordability, including:
- An expected increase in premiums due to a substantial increase in market concentration in 30 of 34 Medicare Part D regional markets.
- An anticipated increase in drug spending and out-of-pocket costs for patients as Aetna and CVS fortify their dominant positions in the health insurance, pharmaceutical benefit management, retail and specialty pharmacy markets that already lack competition.
- Reduced competition in health insurance markets that will adversely affect patients with higher premiums and contribute to a decline in the quality of insurance.
- A foreseeable failure to realize proposed efficiencies and benefits because the merger faces enormous implementation challenges, and those efficiencies have a questionable evidence base.
To ensure patients are better served by dynamic and competitive health care markets, the AMA will endeavor to persuade federal and state regulators to oppose the merger.
Read more at AMA Wire®.
National UpdateAMA urged Trump administration to withdraw "zero tolerance" immigration policy
The administration's "zero tolerance" immigration policy and the impact of separating children from their families was discussed during the 2018 AMA Annual Meeting. AMA delegates expressed significant concern that the administration's policy will do great harm to children and their parents or caregivers.
After the Annual Meeting, AMA CEO James Madara, MD, sent a letter to the secretaries of the Homeland Security and Health and Human Services departments, as well as the U.S. attorney general. The letter pointed out that childhood trauma and adverse childhood experiences created by inhumane treatment often create negative health impacts that can last an individual's entire lifespan.
The AMA urged the administration to withdraw its "zero tolerance" policy that requires the separation of migrating children from their parents or caregivers, The president subsequently issued an executive order reversing the administration's position on separating children. The AMA is closely monitoring the reunification of parents and children.
After months of development and deliberation, the U.S. House of Representatives completed its efforts to address the opioid epidemic by passing more than 60 bills over the last two weeks. On June 22, the House passed the "Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act" (H.R. 6) by a 396-14 vote. H.R. 6 is a comprehensive package that includes the majority of the bills previously passed by the House.
The package contains policies impacting Medicare, Medicaid, public health and public safety programs that are intended to curb abuse, improve access to substance abuse treatment, and support law enforcement efforts. Other bills direct federal agencies to produce studies, reports and guidelines related to opioid use, abuse, and treatment among other matters. If enacted, many of the proposals would still require separate appropriations of necessary funds to be implemented.
The Senate Committees on Health, Education, Labor and Pensions (HELP); Finance; Judiciary; and Commerce, Science and Transportation have also approved multiple bills to address the opioid epidemic. The Senate is expected to consider a consolidated bill combining the work of these committees later this summer.
On June 26, the Senate Committee on Health, Education, Labor and Pensions (HELP) approved S. 808, the "Sports Medicine Licensure Clarity Act," which was introduced by Senators John Thune (R-SD) and Amy Klobuchar (D-MN), on a voice vote. Under current law, many states do not provide legal protection for sports medicine professionals when traveling to a secondary state, and medical liability insurance carriers are not required to cover sports medicine professionals when they travel with their teams to a state where they are not licensed to practice.
This bill would remedy this problem by clarifying medical liability rules for sports medicine professionals to ensure they are properly covered by their professional liability insurance while traveling with athletic teams in another state. This will ensure that injured athletes have access to health professionals who are familiar with their medical histories and help preserve continuity of care. Companion legislation (H.R. 302) was passed by the House earlier this Congress.
In a letter of June 21, AMA CEO Jim Madara, MD, asked the Department of Health and Human Services (HHS) to take another look at the 10 alternative payment models (APMs) recommended by the Physician-focused Payment Model Technical Advisory Committee (PTAC). Instead of working with PTAC and proposal developers to refine and test APMs for patients with needs ranging from primary care to renal disease to palliative care, HHS indicated that the Centers for Medicare & Medicaid Services (CMS) is designing its own APMs. The AMA letter described several defects in the HHS response to PTAC:
- Its assumption that few patients with chronic kidney disease are insured by Medicare before they develop end-stage renal disease.
- The absence of a pathway for replicating a successful Medicare Advantage hospital-at-home model for patients in traditional Medicare.
- A lack of appreciation for the degree to which current CMS data relies on the same physician input that would supply functional status data for patients who require palliative care.
- The hesitation to adapt a proven private sector specialty medical home APM for patients with Crohn's disease for use with Medicare patients with a variety of chronic diseases.
Dr. Madara's letter concluded by observing that physicians have grown increasingly enthusiastic and even passionate about the benefits of APMs in helping them overcome the problems they and their patients face in the fee-for-service payment system. When Congress encouraged physicians to submit APM proposals and created the PTAC to review them, there was an expectation and hope that CMS would fully embrace the opportunity to pilot these innovative models, so the AMA urged HHS to demonstrate its commitment to innovation by revisiting and implementing the PTAC-recommended proposals.
Subsequent statements from the CMS Administrator and the PTAC Chair indicate that CMS values the PTAC's guidance and that the PTAC members and CMS are working to build a stronger collaboration.
The deadline for registering as a group via the CMS Web Interface and/or by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Survey has been extended from June 30, 2018, to July 2, 2018, at 3 p.m. EDT, since the original deadline falls on a Saturday. For 2018, only groups of 25 or more eligible clinicians that have registered can report via the CMS Web Interface. Groups that participate in MIPS through qualified registry, qualified clinical data registry, or electronic health record (EHR) data submission mechanisms do not need to register. For 2018, only groups of 2 or more eligible clinicians that have registered can participate in the CAHPS for MIPS survey.
Please note, if your group was registered to participate in MIPS in 2017 via the CMS Web Interface, CMS automatically registered your group for 2018 CMS Web Interface participation. You may edit or cancel your registration at any time during the registration period. Automatic registration does not apply to the CAHPS for MIPS survey. You will need a valid Enterprise Identity Management (EIDM) account to register. If you do not have an EIDM account, please create one as soon as possible. To learn more about group registration, visit the Quality Payment Program website and review the CAHPS for MIPS Survey and CMS Web Interface Registration Guide.
On June 19, the U.S. Department of Labor (DOL) released a final rule expanding the ability of employers to join together to create Association Health Plans (AHPs). The final rule closely mirrors the language that was released in the DOL's earlier proposed rule. The AMA submitted formal comments raising concerns about certain provisions in the proposed rule.
Specifically citing that it did not maintain key consumer protections, nor did it meet the AMA's key principles on health system reform; such as ensuring meaningful coverage, assisting individuals with low-incomes or unusually high medical costs in obtaining health insurance coverage, and meeting cost-sharing obligations, resulting in substandard health insurance coverage. The AMA supports efforts to maximize health plan choices for individuals and small businesses seeking coverage in the individual and small group markets. The final rule released by the DOJ falls short of this goal.
The DOL will stagger the implementation dates for the AHP expansion as follows:
- All associations (new or existing) may establish a fully-insured AHP on September 1, 2018.
- Existing associations that sponsored an AHP on or before June 19 may establish a self-funded AHP on Jan. 1, 2019.
- All other associations (new or existing) may establish a self-funded AHP on April 1, 2019.
The AMA will continue to analyze the final rule and remain actively engaged with the DOL as the federal agency begins to implement the final rule and will continue to keep AMA members abreast of any guidance documents released by the agency related to this issue.CMS makes long-awaited updates to the Quality Payment Program website
CMS recently updated the Explore Measures section of the Quality Payment Program (QPP) website for the 2018 performance period, including Merit-based Incentive Payment System (MIPS) measures and activities. The AMA along with specialty societies sent a letter to CMS in April raising concern with CMS' lack of timeliness on updating the QPP website with 2018 information and urging CMS to reduce the 2018 MIPS reporting period to a minimum of 90 days.
The increased flexibility would not prevent physicians who have already started reporting on 2018 MIPS data from reporting for a full year, but would allow small practices and medical group practices that manage reporting for dozens or even hundreds of clinicians under the program a better opportunity for success and would reduce clinician burden.
Note: The Explore Measures tool is for informational purposes only; it cannot be used to submit or attest to measures and activities. For more information on MIPS measures and activities, visit the 2018 Resources webpage.
CMS has announced that new Medicare cards may have a square code, also known as a "QR Code," on them for security purposes. The codes, which may be on the back or the front of the card, are to ensure that the new cards are sent to the right beneficiaries. The codes will not have any use for providers, but practices should be aware that these cards are legitimate, official Medicare cards. Learn more about the new Medicare card here and on the AMA's New Medicare Card webpage.OCR releases new guidance on uses and disclosures of patient information for research
The U.S. Office for Civil Rights (OCR), which enforces HIPAA, has released guidance on uses and disclosures of protected health information for research. The guidance is in response to a requirement under the 21st Century Cures Act of 2016 and clarifies the following:
- General authorization requirements and expiration of authorizations.
- Sufficient descriptions of the purpose of a use or disclosure for future research authorizations.
- Expiration of authorizations for future research.
- The process of revoking authorization.
The guidance is available here.HHS finalizes Common Rule delay
Researchers will not have to comply with changes to regulations surrounding research on human subjects until January 21, 2019, per a final rule the Department of Health and Human Services published last week. The one exception to this general rule is that institutions will be permitted (but not required) to implement, for certain research, three burden-reducing provisions of the 2018 Requirements during the delay period (July 19, 2018, through January 20, 2019).
Revisions to the so-called Common Rule would simplify the process by which researchers obtain consent from research subjects to use their data and biospecimens. Despite several delays, the final rule provides a concrete compliance timeline for researchers.
State UpdateAMA urges Illinois governor to sign parity bill
The AMA last week urged Illinois Gov. Bruce Rauner to sign a bill that would increase patients' access to mental health and substance use disorder treatment by strengthening the state's mental health and substance use disorder parity laws.
The bill which was passed with overwhelming bipartisan support in the Illinois General Assembly and Senate, would make several improvements in Illinois law. It would remove administrative barriers, including step therapy and prior authorization requirements that are not supported by clinical criteria from medical organizations such as the American Society of Addiction Medicine. It also would strengthen the state's ability to investigate potential parity violations, and it would make the findings of those investigations public.
Read the AMA's letter to Gov. Rauner here.
Michigan Gov. Rick Snyder signed legislation on June 22 to add work requirements to the state's Medicaid program. Under the new law, the state will submit a waiver proposal to the federal government to require certain beneficiaries to participate in 80 hours per month of qualifying activities, such as employment, community service or job training.
Certain categories of beneficiaries will be exempt, such as pregnant women, the disabled, full-time students, and caretakers of young children. The waiver proposal will also require beneficiaries to pay premiums up to 5 percent of household income. If the bill's requirements are not approved or are otherwise cancelled or invalidated, the bill requires that the entire Medicaid expansion program be terminated. Approximately 670,000 low-income patients gained coverage from Michigan's Medicaid expansion program, which was first implemented in 2014.
Judicial UpdateHospital incident reports at risk of discovery in Illinois
If a trial court ruling that instructed a hospital to turn over "patient safety work product" is not overturned on appeal, hospitals in Illinois would be less likely to produce voluntarily reports that help patient safety organizations (PSOs) analyze adverse events and look for ways for hospitals to make patients safer.
The question of what is discoverable to plaintiffs in medical malpractice cases in Illinois stems from a 2013 incident where Rosalie Jones, who was admitted to Ingalls Memorial Hospital in Chicago's south suburbs for renal failure, died from injuries after prolonged hypoglycemia.
Staff at the hospital were responsible for monitoring Jones' blood glucose levels. When her level was 203, she received insulin. Later, nurses drew blood for a comprehensive test that showed a blood glucose level of 16, but Jones' treatment team was not told about the test result and she was later found unresponsive and suffered irreversible brain damage, court records show.
Ingalls staff members submitted incident reports from Jones' case to Clarity Patient Safety Organization, a federally and state-certified PSO that collects reports from numerous hospitals to identify what changes can be made to improve patient safety and quality of care.
After Terri Daley—the independent administrator of Jones' estate—sued the hospital for medical malpractice, an Illinois trial court ruled that as part of the discovery process, Ingalls had to turn over the report sent to the Clarity PSO.
The hospital has appealed that ruling to the Illinois Appellate Court, First District, saying the federal Patient Safety and Quality Improvement Act (PSQIA) protects the report because it is a "patient safety work product." Attorneys for the hospital argue that the trial court improperly relied on state law—the Illinois Medical Studies Act—when it ruled the materials must be turned over.
The Litigation Center of the American Medical Association and State Medical Societies, along with the Illinois Health and Hospital Association, the Illinois State Medical Society and others, filed an amicus brief in the case, Daley v. Teruel and Ingalls Memorial Hospital, supporting the hospital's position. The friend-of-the-court brief notes that Congress created a safeguarded patient safety process under the PSQIA to encourage hospitals to submit patient safety outcomes without "fear of increased liability risk."
Read more at AMA Wire.
Without a meaningful care plan in place, those released from detention centers are "at risk of serious harm, including risk of death."
Read more at AMA Wire.
Experts ensure sound science in the courtroom. Without them, false compensation and patient care is at stake, an AMA Litigation Center amicus brief says.
Read more at AMA Wire.
If juries can't hear testimony about known complications, physicians could be liable for injuries even if they did everything right, physicians tell court.
Read more at AMA Wire.
Other News3rd ReachMD podcast on Medicare payment available now
The third in a series of six podcasts produced in partnership with Reach MD on Medicare payments is now available. This week's episode is an interview with Harold D. Miller, president and CEO of the Center for Healthcare Quality and Payment Reform on physician-focused APMs in 2018. Listen here.Back to Top
July 25: EHRs—Usability and optimization
Electronic health records have transformed health care over the last decade. While they have improved some aspects of clinical practice, they are still often associated with physician burnout and patient safety concerns. This webinar, noon–1 p.m. CDT—will provide an overview of the AMA's initiatives focused on improving the usability of EHRs through research, guiding principles and collaboration. It will also cover resources and best practices available to physicians and practices to support optimization. Register.