Month: August, 2018

Supplemental Comments on the Voiding of the Medicaid Work Requirement

The decision of the Federal District Court for the District of Columbia in Stewart v. Azar voiding the approval of the Kentucky work requirements for Medicaid eligibility was the subject of a recent blog here on July 17. There are two subsequent publications worth noting to supplement discussion of the issue.

The judgment implementing Judge Boasberg’s ruling was entered on June 28, 2018. Pursuant to Rule 4 of the Federal Rules of Appellate Procedure, there is a 60-day period following entry of judgment in a matter in which the United States Government is a party for the filing of a notice of appeal as of right.

Although the time for appeal has not expired, from a July 30 Health Affairs blog reporting on the posting of an announcement at Medicaid.gov, it appears that rather than appealing Judge Boasberg’s ruling, CMS is reopening the comment period on the proposed waiver of Medicaid requirements in the Kentucky demonstration program at issue. The manifest purpose is to supplement and develop the record to show that the program is likely to assist in promoting Medicaid’s coverage objective.  This is the type of information that Judge Boasberg had indicated the agency had not obtained or utilized in the first place.

That blog author provides a comprehensive review of the deficiencies in the original administrative process and how the agency had “sidestepped” its obligations.

Rather than weighing the value of the project in light of its impact on coverage—which [Judge Boasberg] concluded, is Medicaid’s core purpose as stated in the statute itself—officials simply had created a new program objective, to improve health. Without citing to the statute or offering any supporting evidence, the HHS approval letter simply claimed that (1) Medicaid’s purpose is to improve health; (2) work improves health; and therefore (3) mandatory work requirements coupled with other coverage restrictions are likely to promote Medicaid’s purpose.

The blog goes on to identify several types of highly relevant evidence that should be developed to sustain the validity of the Section 1115 waiver analysis and decision-making. The first is the quantification of the cumulative impact of the key demonstration components, including the precise nature of a steady, year-round work requirement (hours worked per week; weeks worked per year); the premiums; the reporting rules; the lock-out periods; the reinstatement opportunities; and the benefit and coverage restrictions. The second would examine the impact of the loss of coverage among the affected population on their access and utilization of medical services resources and resulting health outcomes.  A third type of evidence concerns if, and to what extent, any of these work requirements for deeply impoverished people actually can result in gains in employment, income and financial independence of the type that makes health care and insurance coverage affordable, with access to coverage pathways. “In other words, what is required is solid evidence regarding the mitigating effects of a non-consensual experiment that places Medicaid coverage at high risk for tens of thousands, if not hundreds of thousands, of working-age adults. This evidence cannot simply be tautological claims about the health benefits of work and community engagement.”

This notion of “mitigating effects” of placing Medicaid coverage at risk was picked up and further developed in a very recent August 8 article in the New England Journal of Medicine entitled “Mitigating the Risks of Medicaid Work Requirements.”  The three authors are from the University of Michigan’s Medical School, School of Public Health, and the Gerald R. Ford School of Public Policy.  As a reminder, Michigan is one of the states in addition to the Kentucky program in the case before Judge Boasberg that had received Section 1115 waiver approval from the Secretary of HHS.

These physician authors identified several policy questions concerning the work requirements that “deserve more attention.” That list starts with a determination of the potential health consequences of work requirements for persons enrolled in Medicaid.  They question the role to be played by physicians in determining whether a person is to be exempted from work requirements on the basis of some medical reason. Lastly, they pose the question of how to reduce the medical risks for enrollees who could be harmed by losing their coverage as a result of the Medicaid work requirements.

They questioned the original observation by CMS that work and community engagement were “associated with better health” and that working would improve the health of Medicaid recipients, commenting that this asserted association could be due primarily to healthier adults being able to find employment rather than the work producing the improved health. In this circumstance, the health harms would outweigh uncertain health benefits for those who got jobs.  They cited their own 2016 survey of 4000 Medicaid expansion enrollees.  While nearly half were employed in some capacity, among the others who were either out of work or unable to work, the survey found that many were likely to be more than 50 years old and to report being in fair or poor health, having a mental health condition, or having health-related functional limitations.  They emphasized that while a work requirement might serve to motivate younger recipients, it presents a serious risk of harm to older enrollees or those with chronic conditions if they were to lose their Medicaid coverage under the Obamacare expansion and be unable to afford effective medical care and services.  Although some proposed providing for exemptions for “medically frail” persons, the standards and processes for determining such exemptions were undefined.  This lack of specific governmental guidance on exemptions potentially placed physicians, especially primary care physicians, in a difficult ethical situation of choosing between doing harm to patients or providing inaccurate and thus dishonest assessments of their condition and functionality.

The New England Journal of Medicine authors provided further commentary on ways that work requirements might be handled to mitigate medical risks.  In addition to narrative remarks, the article contains the following summary block:

RECOMMENDATIONS FOR STATE AND FEDERAL POLICYMAKERS TO REDUCE THE HEALTH RISKS ASSOCIATED WITH MEDICAID WORK REQUIREMENTS

Limit the initial implementation to adults under 50 years of age who are covered by Medicaid expansion, since they are less likely than older adults and those covered by traditional Medicaid to have chronic health conditions and functional limitations that will be adversely affected by loss of Medicaid coverage.

Provide clear guidance to physicians on health conditions, functional limitations, and caregiving responsibilities for household members with disabilities that will exempt enrollees from work requirements.

Provide job training, employment referrals, and support for work-related transportation and childcare for enrollees subject to work requirements.

Make the reporting of compliance with work requirements less frequent and more flexible to account for fluctuating work hours, seasonal employment, and temporary gaps in employment.

 Tempering criticisms of the Medicaid work requirements, they conclude that the programs need to focus on enrollees who are healthy and functionally able to work and on whether effective work-related training and supports are implemented. “Without such tailoring and support, the health risks for enrollees who lose Medicaid coverage are likely to substantially outweigh the economic and health benefits of blunt incentives for enrollees to work.” This would fail to promote the objectives of Medicaid and would be significantly contrary to the main purpose of Medicaid: to provide medical assistance to low-income adults under age 65.

 

CMS Proposes Expansion to Telehealth Reimbursement

CMS recently released its proposed 2019 Medicare Physician Fee Schedule and Quality Payment Program, containing several amendments meant to expand telehealth and remote patient monitoring. These proposed changes signal that CMS is recognizing that telemedicine (including remote patient monitoring) is going to play a role in the future of health care.

With regards to remote patient monitoring, CMS has introduced three new codes (CPT 999X0, 999X1, and 994X9). Currently, remote patient monitoring is billed under 99091 “Collection and interpretation of physiologic data (e.g., ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, qualified by education, training, licensure/regulation (where applicable) requiring a minimum of 30 minutes of time.” The current code is restrictive as it requires at least 30 minutes of time, and the services must be provided by a physician and/or qualified health care professional. The new codes reduce the timeframe to 20 minutes per calendar month, allow for clinical staff to provide the services, and also allows for reimbursement for work incident to providing services such as setting up the patient’s remote monitoring account, educating the patient on the application, and onboarding the patient into the system.

The fee schedule also introduced the concept of the virtual check-in (CPT GVC11), which is a brief face-to-face visit with a patient through a technology platform, allowing the provider to assess whether the patient requires an office visit. The virtual check in has some restrictions such as a limited timeframe of 5 to 10 minutes of evaluation and management; the patient must be an established patient; and the services cannot originate from a related e/m service provided within the past 7 days or cannot relate to services that are to be provided (in person) within the next 24 hours or at the soonest available appointment. If the virtual check-in is related to either a visit within the past 7 days or a future appointment, such services must be bundled with those in-person services.

Similarly, CMS expanded the fee schedule to include photo and video evaluations (CPT GRAS1). Unlike the previous edition, this new service will allow providers to bill for the review of previously recorded videos or images. The same restrictions apply regarding bundling. Further, if the photo and video evaluation leads to an in-person evaluation, such services must be bundled together and not separately billed.

The proposed codes for virtual check-ins and photo/video evaluations is a step in the direction from the rigidity of in-person health care to a more flexible style of providing health care to patients. Under the proposed rules, patients no longer have to make an appointment or visit an emergency department or urgent care center to have a simple question answered by a provider. Aside from the convenience provided to the patient, this change in the delivery of health care can also alleviate the problem of overcrowding in emergency departments and the inability to quickly obtain an appointment with a physician. The patient also is more likely to seek medical attention early before his or her condition worsens if the patient believes that he or she can obtain quick and efficient advice. Further, the interaction will be cheaper for the patient.

CMS also proposes to expand covered preventative services in office and outpatient settings, services that are reimbursable under the current fee schedule, to include codes for situations where the direct patient contact is prolonged. CPT code G0513 can be used for the first 30 minutes of the prolonged in-person visit while G0514 can be used for each additional 30minute period until the visit concludes.

Although many of the proposed changes appear to be small, the changes made under the fee schedule signal that CMS understands that telemedicine is an important tool that can be used to provide quality and timely health care to people not only in rural areas but throughout the country. It also signals that CMS understands the role that telemedicine will play in population health.

New Jersey Supreme Court Explicitly Adopts Federal Daubert Standard for Expert Testimony

In the unanimous opinion of In re Accutane Litigation (Docket No. A-25-17) released on August 1, 2018, the New Jersey Supreme Court embraced the federal standards for admissibility of expert opinion testimony developed in the decision of Daubert v. Merrill Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993) and its progeny. Daubert principles set aside the traditional requirement of “general acceptance” for the admissibility of expert opinion and moved to a multi-factorial approach evaluating an expert’s methodology in arriving at that opinion.   A key element in the Daubert approach was an emphasis on the “gate-keeping” function of the trial judge and frequent use of hearings pursuant to Rule 104 concerning admissibility of scientific and technical evidence.

There has been a long-standing view that the New Jersey standards for expert testimony are different and somewhat more relaxed. In May 2013, the Supreme Court had held a public hearing on the Report of the Committee on the Rules of Evidence requesting whether or not it should pursue a re-evaluation of the New Jersey jurisprudence that it had begun in 2002 and previously concluded “works well and should not be altered.”  No action was taken at that time.

In the extensive 85-page opinion authored by Justice Jaynee LaVecchia, the Court undertook a comprehensive review of Daubert generally and the New Jersey approach that had begun with Rubanick v. Witco Chemical Co., 125 N.J. 421 (1991) and Landrigan v. Celotex Corp., 127 N.J. 404 (1992).  Justice LaVecchia wrote:

We perceive little distinction between Daubert’s principles regarding expert testimony and our own, and believe that its factors for assessing the reliability of expert testimony will aid our trial courts in their role as the gatekeeper of scientific expert testimony in civil cases. Accordingly, we now reconcile our standard under N.J.R.E. 702, and relatedly N.J.R.E. 703, with the federal Daubert standard to incorporate its factors for civil cases.

Nevertheless, the Court commented that in adopting the use of Daubert factors, “we stop short of declaring ourselves a ‘Daubert jurisdiction.’”  In doing so, it preserved its claim to being a vanguard jurisdiction in the area of expert opinion evidence.  This also assured that both federal and other state decisions under Daubert would be persuasive authority at best and not binding on New Jersey judges.

The opinion summarized the pertinent but non-exhaustive list of factors for a court to consider as follows:

  1. Whether the scientific theory can be, or at any time has been, tested;
  2. Whether the scientific theory has been subjected to peer review and publication, noting that publication is one form of peer review, but is not a “sine qua non”;
  3. Whether there is any known or potential rate of error and whether there exists any standards for maintaining or controlling the technique’s operation; and
  4. Whether there does exist a general acceptance in the scientific community about the scientific theory.

It repeatedly emphasized the need for determining the reliability of the methodology used by the expert to reach the opinion and not the opinion’s conclusion.

This ruling was made in the context of toxic tort litigation where the primary issue was whether or not the drug Accutane caused the development of Crohn’s disease in patients using the drug to treat acne with significant use of epidemiological studies. The trial court had excluded plaintiff’s experts after conducting a two-week Rule 104 hearing and entered an order dismissing 2,076 claims with prejudice.  That determination was reversed by the Appellate Division in a published opinion.  451 N.J. Super. 153 (App. Div. 2017).  The Supreme Court in turn reversed the judgment that had reversed the exclusion of the experts’ testimony.

That product liability context may have implications for the future applicability of the decision and the use of Daubert factors. Moreover, the Court specifically noted that it was not incorporating this standard for admissibility of expert opinion into the criminal context.  “[T]o date, we retain the general acceptance test for reliability in criminal matters.”  In addition, the Daubert factors and virtually all of the New Jersey cases reviewed in the Accutane opinion involved issues of “medical cause-effect expert testimony.”

The applicability of Daubert to expert testimony concerning standard of care opinions has been variable in other jurisdictions in the relatively few decisions considering the issue.  In Berk v. St. Vincent’s Hosp. & Med. Ctr., 380 F. Supp. 2d 334, 352 (S.D.N.Y. 2005), the court concluded that the plaintiff’s expert report together with the expert’s testimony that the defendant surgeon had “departed from the applicable standard of care fail the Daubert reliability test” since it had “too great a gap between the data and the opinion.”   But on the other hand, in Reese v. Stroh, 907 P.2d 282, 286 (Wash. 1995), the Washington Supreme Court held that Daubert would not be applied to standard of care testimony that was based on the expert’s “experience and knowledge, not a novel scientific theory.”  Similarly, in Palandjian v. Foster, 108 842 N.E. 2d 916, 923 (Mass. 2006), Massachusetts’ highest court held that there was no need for a Daubert evaluation of standard of care testimony “based on the expert’s knowledge of the care provided by other qualified physicians, not on scientific theory or research: ‘How physicians practice medicine is a fact, not an opinion derived from data or other scientific inquiry by employing a recognized methodology.’”  (Quoting Cramm, Ascertaining Customary Care in Malpractice Cases: Asking Those Who Know, 37 Wake Forest L.Rev. 699, 725 (2002)). However, testimony as to increased risk similarly to diagnosis and causation might require such an evaluation since it requires the application of science to patient care.

These are issues that have yet to be dealt with in any reported New Jersey opinion. The Accutane decision may indeed be broadly applicable.  Certainly, aspects of the opinion should be readily transferrable.  These include the Court’s emphatic instruction that a trial court’s determination, after a full Rule 104 hearing, to exclude expert testimony on unreliability grounds was subject on appeal to an abuse of discretion standard and that the Appellate Division had “veer[ed] off” that standard and erred when it determined that a trial court’s determination regarding expert testimony was entitled to “somewhat less deference.” This should encourage the development of a record at the trial level with the kind of “robust analysis” of the expert opinions that had received the strong endorsement by the Court in Accutane. It provides a model to follow.