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March 8, 2016
IOM Studies Regulatory Changes for Biomarker Tests in New Report
In a new report, the Institute of Medicine (IOM) published several recommendations to address clinical practice, regulatory and reimbursement policy, and data challenges in the field of biomarker tests.
The CAP applauded the IOM for studying the issue and releasing the March report titled Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. The CAP was pleased to join in sponsoring the study and providing testimony to the IOM study committee.
"Pathologists in the laboratory play a significant role in the care of patients receiving new targeted therapies by implementing the latest medical research and innovative diagnostic testing into clinical practice. Improvements in this field are needed but we must consider them carefully so to avoid disruption to patient care," said CAP President Richard C. Friedberg, MD, PhD, FCAP. "While the report's goals aim to resolve several issues, the CAP will continue to engage with stakeholders, including federal regulators and lawmakers, to ensure patients have access to diagnostic tests without additional regulatory burden to pathologists and laboratories developing the new innovative tests of tomorrow."
The CAP had testified during the initial IOM committee meeting in January 2015 and had provided the following recommendations
- The IOM committee should exercise care to prevent generalization of its recommendations for therapeutic biomarkers that establish a diagnosis. Establishing evidentiary standards for therapeutic biomarkers is intrinsically different from, and more straightforward than doing so for diagnostic biomarkers.
- The IOM committee should focus on standards of evidence used by the Centers for Medicare & Medicaid Services (CMS) and other payers to make coverage decisions.
- The Coverage with Evidence Development (CED) process should be upgraded. The CMS should pursue a transparent process that includes public input.
- While the CAP recognizes that regulation of laboratories is included in the IOM's Statement of Task, the CAP believes that the IOM Committee's efforts can make the greatest contribution in the area of establishing standards for evidence for coverage.
Discuss PAMA Requirements at the 2016 CAP Policy Meeting
The CAP is pleased to announce Medicare law and policy authority Paul Radensky, MD, JD, and top-ranked Medicare official Marc Hartstein as featured guest speakers at the 2016 CAP Policy Meeting May 2-4 in Washington, DC.
Dr. Radensky and Mr. Hartstein will provide important insights about the Centers for Medicare and Medicaid Services (CMS) implementation of new laboratory requirements during a panel discussion on: "Getting Ready for the New Protecting Access to Medicare Act (PAMA) Requirements for Laboratories." The panel will discuss:
- Reporting requirements for laboratories
- Data collection from applicable laboratories on private payer payments
- Coding implications for clinical laboratory fee schedule (CLFS) services
PAMA Regulation Not Yet Final
The CMS proposed its PAMA regulation in September 2015 but has not finalized provisions and deadlines for data collection and reporting. For example, the proposed rule detailed a requirement for collection of private reimbursement data covering July 1-December 31 2015. The proposal indicated the data would need to be submitted to the CMS by March 31, 2016. The CMS has not finalized this or other deadlines in the proposed rule, so laboratories are not expected to meet the requirement.
Hear the Latest on PAMA at the Policy Meeting
CAP members attending the policy meeting will receive the latest news on the status of implementing the PAMA law from Mr. Harstein and Dr. Radensky.
Mr. Hartstein is the director of the CMS Hospital Ambulatory Payment Group and has worked at the agency for more than two decades. He worked on the original Medicare physician fee schedule and later as a hospital payment policy analyst. He manages four Divisions that set payments for more than $260 billion of Medicare expenditures that affect over 900,000 Medicare providers of hospital care, physician, laboratory and other services.
Dr. Radensky is a partner of the law firm of McDermott Will & Emery and a principal of McDermott+Consulting, based in the firm's Washington office. He is a Medicare law and policy authority who is board-certified in internal medicine and who represents some of the country’s most innovative developers of pharmaceuticals, biologics, medical devices, and diagnostics before Congress and federal agencies.
Join your colleagues at the 2016 CAP Policy Meeting in Washington, DC. Focus on the issues most important to pathologists now and in the future. The CAP's Annual Hill Day will take place on May 4.
Collaborate. Advocate. Take Action.
CMS Fails to Adopt Network Adequacy Standards for Hospital-Based Physicians
The CMS, in a final regulation to govern the federal and state health insurance exchanges, declined to implement changes, recommended by the CAP, to remedy narrow qualified health plan (QHP) networks by ensuring patients have access to adequate numbers of in-network hospital-based physicians within QHPs offered in the health exchanges.
The CMS finalized several polices for health plans in its Notice of Benefit and Payment Parameters regulation with the changes taking effect in 2018. While the final rule does not eliminate balance billing, it expresses support for the National Association of Insurance Commissioners (NAIC) network adequacy model bill which does restrict balance billing, and is thus opposed by the CAP.
In comments to the proposed version of the regulation, the CAP had urged the CMS to ensure sufficient pathologist network adequacy and prohibit insurers from establishing narrow and ultra-narrow networks. The CMS did not take action on the CAP's recommendations. In the final regulation published February 29, the CMS stated:
- Default standards are not intended to prohibit certification of plans with narrow networks or otherwise impede innovation in plan design.
- States that do not review for network adequacy can use a standard involving use of time and distance at the county level. (The CAP opposes the time-and-distance standard as a relevant measure of network adequacy for hospital-based providers.)
While the CMS did not accept the CAP's recommendations, the agency did acknowledge concern regarding hospital-based provider out-of-network charges at in-network facilities and hospitals. Further, the CMS will permit balance billing of patients but will require out-of-network costs to count toward annual limits for patient cost sharing when QHPs fail to notify enrollees of their potential to pay more for out-of-network services. Beginning in 2018, QHPs must notify patients, prior to a scheduled procedure, of financial responsibility for using out-of-network physicians practicing at in-network facilities.
"While not a solution to all adverse financial consequences of receiving treatment from an out-of-network provider in this situation, we believe the policy we are finalizing will help provide transparency and ensure that consumers receive notice of the possible consequences where an out-of-network ancillary provider may be seen and are provided some mitigation of these consequences where proper, timely notice is not provided by the issuer," the CMS stated. "We believe that this policy provides a measure of financial protection for consumers against surprise out-of network cost sharing, while maintaining the larger part of the QHP's cost-sharing structure and avoids significant impacts on premiums."
In its comments to the proposed regulation, the CAP concurred that out-of-network charges should apply to annual patient out-of-pocket limits. However, the CAP urged the agency to address the serious situation of health plans deliberately failing to ensure adequate network of physician providers at in-network facilities and in-network hospitals. Many health plans create narrow, or ultra-narrow, networks designed to exclude certain providers, including pathologists and laboratories from plan participation. This increases the potential for balance billing of enrollees by non-participating providers.
After Pathologist and Hospital Opposition, Balance Billing Prohibition Blocked in NH
New Hampshire lawmakers are deferring action on legislation to prohibit balance billing of patients from moving forward following strong opposition by pathologists and other stakeholders.
Action on the legislation (HB 1516) was postponed indefinitely by a House Health Committee vote of 18-0. The bill would authorize the New Hampshire Department of Insurance to set all out-of-network payment rates for every hospital-based medical specialty. In the fiscal note on the bill, the Department of Insurance estimated it would only require $50,000 a year for an outside consultant to set the rates for every hospital-based specialist.
During a January 19 House Commerce and Consumer Affairs Committee hearing, the New Hampshire Society of Pathologists (NHSP) pointed out that it had attempted to convince the department to consider physician pathology services in its network adequacy assessment rules, now under development for over a year. The department has resisted including any assessment of physician pathology services in its approval of health plans, resulting in no pathology services listed in the list of minimum services required for assessment to determine insurance network adequacy.
Other stakeholders such as the New Hampshire Hospital Association (NHHA) also voiced opposition to the House bill. The legislation takes aim at pathologists, anesthesiologists, and radiologists who work in a hospital but are not employed by hospitals. Hospital-based physicians typically contract with health insurers on their own. The association also questioned if the legislation is needed in New Hampshire.
"Furthermore, it is our understanding that this bill is addressing an issue that rarely occurs in New Hampshire," the NHHA said. "While the bill is requested by the Insurance Department it is unclear to what extent this is an issue in New Hampshire. The fiscal note states that 'The Department does not have information regarding this type of activity, but suspects it is not a significant problem….' We question, if this is not a significant problem, why would the legislature intervene in a business arrangement between two entities and allow for rate setting?"