STATLINE

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• President Trump's First Executive Order Helps Facilitate the Repeal and Replacement of ACA
• HHS Makes Changes to Common Rule Sought by the CAP on Biospecimens and Research
• Washington Pathologists and the CAP Oppose Legislation to Ban Balance Billing
• UnitedHealthcare's Laboratory Benefit Management Program Delayed Until Further Notice for Texas
• Register for the A Seat at the Table—The Impact Only You Can Make on the Future of Pathology Webinar
• Applicable Laboratories Must Report PAMA Data
• Register Now For The 2017 CAP Policy Meeting, April 24–26

The newly inaugurated President Donald Trump issued an executive order on his first day in office directing members of his administration to take steps that will facilitate the repeal and replacement of the Affordable Care Act (ACA).

The executive order's broad language gave federal agencies wide latitude to change, delay or waive provisions of the law that they deemed overly costly for insurers, drug makers, doctors, patients or states, suggesting that it could have wide-ranging impact. Specifically, the order has the potential to give the Administration the ability to not enforce some of the mandates created by ACA like the individual mandate and health plans' "essential benefits" requirements.

As a formal matter, there are limitations to how much an executive order can do. They are one means for the president to exercise the authority that has already been delegated to the executive branch. There are several outstanding questions created by this order that could fall to the responsibility of the new Health and Human Services secretary, Centers for Medicare and Medicaid Services administrator, Treasury secretary, IRS commissioner, and potentially the Labor Secretary. It is important to note that the ACA law gave broad authority for agencies to implement the bill which is why the new administration will be able to make broad changes through the same process.

The CAP is prepared to assess and exam any alternative health care plan proposals to understand its impact on patients and pathologists. The CAP would prefer that the Trump Administration, together with Congress, have a replacement plan to minimize the impact on patients, pathologists and the health care delivery system before the law is fully repealed.

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In response to CAP advocacy, the Department of Health and Human Services (HHS) removed proposed requirements for researchers to obtain consent before using non-identified biospecimens, but maintained current practice with respect to oversight of these specimens in a final regulation published on January 18.

Citing issues associated with the inclusion of biospecimens as human research subjects, the CAP had objected and opposed the HHS' draft "Common Rule" changes under the Federal Policy for the Protection of Human Subjects. In January 2016, the CAP urged the HHS to revise sections of the proposed regulation.

For studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking Institutional Review Boards (IRB) approval to waive the consent requirement. As under the current rule, researchers will still not have to obtain consent for studies on nonidentified stored data or biospecimens, the HHS stated.

The final rule established new exempt categories of research based on the level of risk they pose to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus their attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants protected under HIPAA rules. The HHS also removed a requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.

Pathologists interact with specimens in many ways, but are primarily involved—in the laboratory setting—with the evaluation and diagnosis of blood, body fluids or tissue specimens. These evaluations usually have prognostic implications. Once these evaluations are completed, there are, in many instances, residual specimens remaining. An expansion of the proposed human research requirements could have diminished the effectiveness of researchers by requiring overlapping and incongruent administrative activities that are counter to research activities conducted within academic institutions today.

In response to comments from the CAP and other organizations, the final Common Rule does not include the proposed standardized privacy safeguards for identifiable private information and identifiable biospecimens. Instead, in most respects, it retains the current approach to privacy standards. The final rule also does not adopt a proposal for more stringent criteria for obtaining a waiver of the consent requirements for identifiable biospecimens.

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The Washington State Society of Pathologists (WSSP), with the support of the CAP, is urging lawmakers not to pass legislation that would ban balance billing by out-of-network hospital-based physicians and tie out-of-network payments to a Medicare fee schedule.

Washington House Bill 1117 (HB 1117) would require out-of-network providers to request information from carriers on in-network cost sharing amounts and not hold covered persons responsible for more than that amount.

Under HB 1117, to determine the in-network cost-sharing amount for an out-of-network provider's services, the carrier must substitute for its contract rate 125% of the amount Medicare would reimburse for similar services or another method established by the Insurance Commissioner. If there is more than one level of cost-sharing, the amount most beneficial to the covered person must be used. Neither the out-of-network provider nor a health care facility may hold the covered person financially responsible for an amount in excess of the in-network cost-sharing program.

In testimony on January 18 before the Washington State Healthcare and Wellness Committee, Dominque Coco, MD, FCAP, WSSP Vice President, said the legislation fails to address the issue of network inadequacy, which leaves payers and providers in a bind. Dr. Coco testimony begins at 49:00.

"The balance billing problem is directly related to these narrow insurance plans, and in order to appropriately address balanced billing, state regulators must ensure that pathologists and the hospitals they work at are both part of plan networks," he said. "Unfortunately, our state regulators do not do this evaluation. The OIC (Office of the Insurance Commissioner), rather, only looks at whether the insurer contracts with physicians in the geographic area and does not look at their hospital affiliation."

Under current rules, it's possible the OIC would approve an insurance plan that included a hospital in its network, even if there were no in-network pathologists working there, noted Coco. If a patient bought that plan, they would find it very difficult or would be unable to arrange for in-network services at their in-network hospital.

The WSSP petitioned the OIC last fall, asking the agency to remedy this situation and adopt rules to evaluate hospital-based physicians as part of network adequacy, similar to what California does, but the petition was rejected the Department of Insurance. The CAP and its members have strongly advocated for state regulators to adopt such requirements, while opposing state legislation and regulation to limit balance billing that fails to ensure patient access to in-network hospital-based physicians.

"Without adequate networks, health insurance won't give patients the coverage they paid for and were misled into purchasing," said Coco. "It is a deception to tell patients that the plan has in-network physician specialists at that hospital. If you want to solve balanced billing, you need to address network adequacy, or lack thereof, first."

The WSSP is urging the legislature to:

• Require insurance carriers to show they have both hospital and hospital-based physician contracts before they can call the hospital "in-network;"
• Make it a deceptive trade practice to call a hospital “in-network” if the hospital-based physicians are not in network;
• At the very least, require insurers to warn patients if their network does not include hospital-based physicians at the in-network hospital (a warning they now get for out-of-network ER physicians, but not for pathologists or other hospital-based physicians).

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UnitedHealthcare (UHC) has delayed the expansion of the Beacon Laboratory Benefits Solutions® (Beacon LBS) program to Texas planned for March 1. Despite the delay, the CAP will continue to engage with UHC regarding concerns with the program as it has since long prior to the full launch of the program in Florida in 2014.

Voluntary participation began in Texas on January 1, 2017, but the claims "impact" or possible denial of laboratory services for reasons beyond the laboratories' control scheduled to take effect March 1 will be delayed until further notice. UHC will provide 90 days' notice prior to any implementation.

The CAP opposed the pilot program in Florida and remains actively engaged with UHC regarding the program. The CAP has expressed its longstanding concern to UHC that the program is fundamentally flawed and negatively affects patient access to services, delay results, increase administrative burden without a corresponding improvement in care, and create inconsistencies with current clinical practice, professional judgment and laboratory operations. For instance, the CAP continues to strongly object to the pilot's secondary review requirements that are inconsistent with a guideline developed by the CAP and Association of Directors of Anatomic and Surgical Pathology in May 2015 on timely second reviews leading to more accurate diagnoses and improved patient care. Other stakeholders, including the Texas Society of Pathologists, have also expressed concerns and engaged with UHC.

Although the claims impact/mandatory participation will be delayed, UHC has conveyed that network physicians may continue to access the Beacon LBS Physician Decision Support tool and encourages its use.

The program applies to fully insured UHC Commercial members in Texas and was piloted in Florida beginning October 1, 2014 with mandatory compliance delayed until April 15, 2015. Numerous stakeholders including the CAP had requested a retraction and/or delay in Florida. UHC will provide written notice of the delay to its network on or about February 1, 2017. Beacon LBS is a wholly owned subsidiary of Labcorp.

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With the new administration, the US government will pursue policies that are yet hard to predict. On February 21, 2017 at 1 PM ET/ noon CT the CAP will present the A Seat at the Table—The Impact Only You Can Make on the Future of Pathology Webinar.

If you ever had a doubt that your voice matters, this 60 minute webinar will present the facts and figures on the crucial impact you have on members of Congress. Learn how you can make a difference with data presented from Congressional Management Foundation surveys, the National Journal, and other reputable sources illustrating the importance of grassroots advocacy.

Get facts and figures along with down-in the-trenches insight from Joe Saad, MD, FCAP, the CAP Federal and State Affairs Committee Chair, and Michael Giuliani, CAP Advocacy Senior Director and former Hill staffer, on what drives members of Congress: who they listen to, how they make decisions, and the best ways to influence them.

Register now.

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Starting now the Protecting Access to Medicare Act (PAMA) requires certain laboratories to submit private payor rates for clinical laboratory tests. The CAP developed pathology-specific PAMA resources, including an informative infographic and podcast, to help laboratories understand regulatory requirements and upcoming deadlines. These resources and additional tools can be found on the CAP’ PAMA resources web page.

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Let your voice be heard at the 2017 CAP Policy Meeting with its theme of Protecting the Practice of Pathology and Our Patients. From April 24–26, CAP members can connect with government leaders and policy experts to discuss the impact of federal regulation on their pathology practices.

Registration is now open for the annual CAP Policy Meeting. Stay tuned for more updates.

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