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McCue v. Secretary of Health

United States District Court, D. Maine

January 4, 2019

CARL D. MCCUE, Plaintiff
v.
SECRETARY OF HEALTH & HUMAN SERVICES, Defendant

          RECOMMENDED DECISION ON REQUEST FOR JUDGMENT ON ADMINISTRATIVE RECORD

          JOHN C. NIVISON, U.S. MAGISTRATE JUDGE

         In this action, Plaintiff seeks judicial review of Defendant's decision to deny Plaintiff's request for Medicare Part C coverage of a MRI-guided laser ablation procedure. The matter is before the Court on Plaintiff's motion for judgment on the administrative record[1] (Motion, ECF No. 11), and Defendant's request to affirm the administrative decision.[2] (Response, ECF No. 12.)

         Following a review of the administrative record, and after consideration of the parties' arguments, I recommend the Court affirm Defendant's final administrative decision.

         Background

          Plaintiff is a Medicare beneficiary and Part C enrollee. Medicare Part C, also known as Medicare Advantage, enables private insurance companies to provide Medicare benefits. Medicare private health plans are known as Medicare Advantage (“MA”) Plans. Plaintiff acquired his MA Plan through Aetna Health Inc., which plan is entitled the Aetna Medicare Select Plan (HMO). (R. 123.)[3]

         The Plan provides that, “[a]s a Medicare health plan, [it] must cover all services covered by Original Medicare and must follow Original Medicare's coverage rules.” (2015 Evidence of Coverage Document, Ch. 3, § 1, R. 152.) Medical care is covered when it is included in the Plan's benefits chart (chapter 4), is considered medically necessary, and is provided by a network provider. (R. 152 - 53.) “In most cases, care … from an out-of-network provider … will not be covered, ” subject to three exceptions: (1) emergency care or urgently needed care; (2) necessary care that Medicare requires the Plan to cover, if network providers cannot provide the care; and (3) kidney dialysis at a Medicare-certified dialysis facility. (R. 153.) Additionally, the Plan does not cover “experimental medical procedures and items, ” meaning “items and procedures determined by [the] [P]lan and Original Medicare to not be generally accepted by the medical community.” (MAC Decision, R. 9 - 10.)

         In 2014, Plaintiff sought care from Michael Bedecs, D.O., following a diagnosis of benign prostatic hypertrophy. Dr. Bedecs recommended, and Plaintiff obtained, an MRI-guided biopsy, in November 2014, which biopsy demonstrated “early prostate cancer.”[4](R. 17.) In January 2015, on advice of Dr. Bedecs, Plaintiff received MRI-guided ablation of a precancerous or cancerous lesion on his prostate. (R. 18.) Dan Sperling, M.D., a radiologist in Yonkers, New York, performed the procedure.

         In December 2014 or January 2015, Plaintiff submitted the charges for the procedures to Aetna for payment. Plaintiff requested coverage for the laser ablation procedure in advance of the procedure, but on the eve of the scheduled procedure, he was advised that the cost of the procedure would not be covered under the Plan. (R. 21.) Plaintiff nevertheless underwent the procedure.

         Although Aetna denied coverage for the laser ablation procedure, Aetna approved coverage for the MRI diagnostic services associated with Dr. Sperling's care in November 2014, because “this procedure is used to diagnose prostate cancer per Centers for Medicare & Medicaid[] Services medical necessity criteria.” (R. 109.) In the narrative provided to the independent reviewing entity, MAXIMUS Federal Services, Aetna explained that the ablation services in January 2015 were not covered because the provider was “not enrolled or accredited by a designated CMS accreditation organization.” (R. 105.) Aetna further explained that the “focal laser ablation for prostate cancer treatment” was “experimental and investigational because its effectiveness has not been established.” (R. 106.)

         MAXIMUS Federal Services agreed that Aetna was not required to pay for the ablation procedure. Noting that under the Plan, Aetna covers items and services in accordance with Medicare rules, MAXIMUS concluded that the ablation procedure was not medically necessary and was experimental/investigational. (R. 78 - 80.) MAXIMUS did not address whether the care should have been excluded as out-of-network care.

         Plaintiff appealed from the decision and a hearing on the appeal was scheduled before an administrative law judge (ALJ). The ALJ described the issue as whether Aetna was “obliged to provide coverage for the MRI guided laser prostate ablation.” (R. 35.) The ALJ ruled against coverage, relying in part on Dr. Sperling's characterization of the procedure as a “newer thermal ablative technique [that] seems especially suited for prostate cancer.” (Id.) The ALJ observed that MRI-guided laser ablation is not a covered service for participants in Medicare Parts A and B, which provide the presumptive scope of coverage for Part C plans. According to the ALJ, although patients might prefer the procedure based on projected recovery time, the effectiveness of the procedure was unknown. The ALJ reasoned:

While there is sufficient data available to show that the MRI guided method results in less blood loss, less pain, and quicker recovery than either radiation or conventional surgery, the … question is whether the method produces a definitive cure and, if so, in what fraction of patients. If, for example, only a minority of all patients treated have to subsequently undergo surgery or radiation, the method may prove cost-effective. If the fraction encompasses either a significant minority - or a majority - of patients, the method may not be cost effective. And, Medicare is not obliged to provide coverage for all therapeutic avenues, and may permissibly base its coverage decisions on whether the procedure in question is cost-effective.

         (R. 39.) The ALJ concluded that MRI-guided laser ablation of prostate cells was not “medically reasonable and necessary, ” as that concept is understood in the context of the Medicare Act, and that the procedure was thus not reimbursable under the Act. (R. 40.)

         Plaintiff asked the Medicare Appeals Council (MAC) to review the ALJ's decision. Following a de novo review, the MAC agreed with the ALJ's basic conclusion. (R. 3.) The MAC, however, “modif[ied] the ALJ's decision to address relevant legal authority not discussed in the ALJ's decision and to clarify the basis for the coverage denial.” (Id.) The MAC also discussed two letters authored by Dr. Bedecs, dated August 6, 2015, and December 17, 2014, which letters the ALJ had not addressed in his decision. (R. 10.)

         Citing section 1862(a)(1)(A) of the Social Security Act, codified at 42 U.S.C. § 1395y(a)(1)(A), MAC observed that coverage under Part C requires that items and services must be within the defined benefit program, and otherwise must be “reasonable and necessary for the diagnosis or treatment of illness or injury” in a particular case. (R. 6 - 7.) Referencing Medicare Program Integrity Manual, Chapter 13, §§ 13.5.1 and 13.7.1, the MAC explained that to qualify as “reasonable and necessary, ” items and services must be “safe and effective” and “not experimental or investigational, ” based on “published authoritative evidence” and “general acceptance by the medical community, ” and not merely accepted “by individual health care providers, or even a limited group of health care providers.” (R. 7.)

         The MAC determined that there was insufficient evidence to demonstrate the procedure was not experimental or investigational.[5] (R. 7 - 9.) The MAC explained:

We recognize that the appellant has researched and weighed the potential risks and benefits in determining how to treat his diagnosis of prostate cancer. However, Medicare is a defined benefit program. Not all items and procedures are covered, and the requirements for coverage include those designed to ensure that relatively new devices, procedures, and treatments will have thoroughly demonstrated their safety and efficacy prior to being covered by Medicare.

         (R. 11.)

         Standard of Review

         A district court has the authority to review the Secretary's final decision under the Medicare Act. 42 U.S.C. § 405(g); 42 U.S.C. § 1395w-22(g)(5) (making 42 U.S.C. § 405(g) applicable to appeals of benefit denials under Medicare Part C); see also 42 C.F.R. § 422.612(b). Judicial review is limited to determining whether the Secretary's decision is supported by substantial evidence and whether the Secretary applied the proper legal standard. 42 U.S.C. § 405(g). Substantial evidence is defined as “relevant evidence a reasonable mind might accept as adequate to support a conclusion.” Richard v. Perales, 402 U.S. 389, 401 (1971).

         Discussion

         Plaintiff argues Defendant's final decision is erroneous because Plaintiff demonstrated the procedure was reasonable and necessary, and that MAC did not conduct the required individualized assessment, did not apply the EOC definition of experimental, relied on evidence not of record, and did not appropriately weigh the evidence. (Plaintiff's Appeal Brief and Motion for Judgment Based on the Administrative Record (“Plaintiff's Brief”), ECF No. 11.)

         A. ...


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