MCCUE v. SECRETARY OF HEALTH AND HUMAN SERVICES
Filing
19
REPORT AND RECOMMENDED DECISION re 11 MOTION for Judgment on the Administrative Record filed by CARL D MCCUE. Objections to R&R due by 1/18/2019. By MAGISTRATE JUDGE JOHN C. NIVISON. (MFS)
UNITED STATES DISTRICT COURT
DISTRICT OF MAINE
CARL D. MCCUE,
Plaintiff
v.
SECRETARY OF HEALTH &
HUMAN SERVICES,
Defendant
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1:18-cv-00011-LEW
RECOMMENDED DECISION ON REQUEST FOR
JUDGMENT ON ADMINISTRATIVE RECORD
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
record1 (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.
1
In the alternative, Plaintiff asked the Court to remand the matter for further administrative proceedings.
(Motion at 18.)
In the response to Plaintiff’s motion for judgment, Defendant requested the Court affirm the administrative
decision.
2
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-ofnetwork 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
3
The First Circuit has described the statutory framework as follows:
Enacted in 1965, Medicare is a federally run health insurance program benefitting primarily
those who are 65 years of age and older. Before the recent extension of Medicare to cover
a portion of prescription drug costs, Medicare covered only inpatient care through Part A
and outpatient care through Part B. Parts A and B are fee-for-service insurance programs
operated by the federal government. 42 U.S.C. § 1395c et seq. (Part A); 42 U.S.C. § 1395j
et seq. (Part B). In 1997, Congress enacted Medicare Part C to allow Medicare
beneficiaries to opt out of traditional fee-for-service coverage under Parts A and B. 42
U.S.C. § 1395w–21 et seq. (Part C). Under Part C, beneficiaries can, inter alia, enroll in
“Medicare Advantage” plans, privately-run managed care plans that provide coverage for
both inpatient and outpatient services. Id. § 1395w–22(a)(1).
First Med. Health Plan, Inc. v. Vega–Ramos, 479 F.3d 46, 48 (1st Cir. 2007) (internal footnote omitted).
2
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 MRIguided 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 MRI Prostate Study Report dated November 24, 2014, reflects the findings were “moderately
suspicious for prostate cancer.” (R. 71.)
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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
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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
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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).
5
The MAC also concluded that the denial of coverage was appropriate because the record did not establish
that “the provider is enrolled as a Medicare provider.” (R. 7.) Because the record contains substantial
evidence to support the denial of coverage on other grounds, this recommended decision does not address
whether the procedure was performed in the Plan’s geographic area by an in-network provider.
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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. Reasonable and Necessary
“Under Medicare Part C, individuals qualified for Medicare enroll in a health plan
(MA plan) with a private insurance company. 42 U.S.C. §§ 1395w-21 – 1395w-29. The
MA Plan must enter into a contract with the Secretary of Health and Human Services, 42
U.S.C. § 1395w–27, and agree to provide the same benefits an individual is eligible to
receive under Medicare, 42 U.S.C. § 1395w–22(a)(1)(A).” Fournier v. Sebelius, 839 F.
Supp. 2d 1077, 1081 (D. Ariz. 2012), aff’d, 718 F.3d 1110 (9th Cir. 2013). Medicare does
not cover services that “are not reasonable and necessary for the diagnosis or treatment of
illness or injury or to improve the functioning of a malformed body member[.]” 42 U.S.C.
§ 1395y(a)(1)(A). Accordingly, “the Secretary may not provide reimbursement for services
that are ‘not reasonable and necessary for diagnosis or treatment of illness or injury.’”
Exec. Dir. of Office of Vermont Health Access ex rel. Carey v. Sebelius, 698 F. Supp. 2d
436, 440 (D. Vt. 2010) (quoting New York ex rel Holland v. Sullivan, 927 F.2d 57, 58–59
(2d Cir. 1991)).
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The Secretary of Health and Human Services decides “whether a particular
medical service is ‘reasonable and necessary’ ... by promulgating a generally
applicable rule or by allowing individual adjudication.” Heckler v. Ringer,
466 U.S. 602, 617 (1984) (emphasis added). The former course involves a
“national coverage determination” that announces “whether or not a
particular item or service is covered nationally.” 42 U.S.C. § 1395ff(f)(1)(B).
In the absence of a national coverage determination, local Medicare
contractors may issue a “local coverage determination” that announces
“whether or not a particular item or service is covered” by that contractor.
Id. § 1395ff(f)(2)(B).
The latter course allows “contractors [to] make individual claim
determinations, even in the absence of [a national or local coverage
determination], ... based on the individual’s particular factual situation.” 68
Fed. Reg. 63,692, 63,693 (Nov. 7, 2003). In making an individual claim
determination about whether to reimburse a medical provider, “[c]ontractors
shall consider a service to be reasonable and necessary if the contractor
determines that the service is: [ (1) ] Safe and effective; [ (2) ]
Not experimental or investigational ...; and [ (3) ] Appropriate.” Centers
for Medicare & Medicaid Services (“CMS”), Medicare Program Integrity
Manual § 13.5.1 (2015) (describing local coverage determinations); see also
id. § 13.3 (incorporating § 13.5.1’s standards for individual claim
determinations).
United States ex rel. Polukoff v. St. Mark’s Hosp., 895 F.3d 730, 735 (10th Cir. 2018)
(emphasis in original).
In this case, Plaintiff’s claim is governed by the second course described by the
Tenth Circuit. In essence, Plaintiff argues the procedure should be covered because,
according to his providers, the treatment was necessary and successful. The mere fact that
Plaintiff’s physicians determined that the procedure was necessary or successful is not
controlling. “A form of treatment may be necessary and completely successful in a
particular case yet still be per se unreasonable and unnecessary under 42 U.S.C. §
1395y(a)(1)(A) if the treatment is properly deemed experimental and investigational as a
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general rule by someone with the authority to do so.” Smith v. Thompson, 210 F. Supp. 2d
994, 1000 (N.D. Ill. 2002).
Here, Defendant’s determination that Plaintiff’s treatment was experimental and
investigational is supported by substantial evidence. In fact, Dr. Sterling’s records suggest
the procedure was not widely accepted. According to Dr. Sterling’s records, Dr. Sterling
advised Plaintiff that “the standard treatment for clinically significant cancers is radical
prostatectomy or radiation therapy,” and that although “[s]everal studies over the years
have suggested that focal or targeted ablation of prostate cancer may yield long-term
disease-free survival for some ‘clinically significant’ cancers,” laser ablation has not been
“FDA approved for the specific indication of focal ablation of prostate cancer.” (R. 66.) In
addition, the expert opinion generated during the review by MAXIMUS described the
“focal laser ablation of the prostate” as “experimental/investigational.” (R. 87.) In short,
a review of the record reveals substantial evidence to support the conclusion that the laser
ablation of cancerous or precancerous prostate cells was still in trial stages and was not yet
generally accepted for the treatment of the condition.
B. Individualized Assessment, Administrative Guidance, and EOC Definition
Plaintiff contends that Defendant did not provide an individualized assessment of
his claim for coverage and failed to consider regulatory guidance and the Evidence of
Coverage definition of “experimental,” which definition Plaintiff contends favors
coverage. (Plaintiff’s Appeal Brief and Motion for Judgment at 7–14.)
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1. MPIM guidance
A Medicare contractor may use Medicare manuals for guidance to make a coverage
determination. Plaintiff argues Defendant failed to apply the Medicare Program Integrity
Manual (“MPIM”), which provides guidance in the determination of whether items or
services are “reasonable and necessary for the diagnosis or treatment of illness.” MPIM,
CMS Pub. No. 100–08, Ch.13.6
Federal regulations specify that ALJs and the MAC are not “bound” by these
guidance manuals, but must give “substantial deference” to them “if they are applicable to
a particular case.” 42 C.F.R. § 405.1062(a). The MPIM provides in relevant part:
Contractors may review claims on either a prepayment or postpayment basis
regardless of whether a [national coverage determination], coverage
provision in an interpretive manual, or [local coverage provision] exists for
that item or service. . . . . An item or service may be covered . . . if it meets
all of the conditions listed in § 13.5.1, Reasonable and Necessary Provisions
in LCDs.
MPIM § 13.3. The MPIM states that an item or service is covered by Medicare only if it
comports with the statutory requirements of 42 U.S.C. § 1395y(a)(1)(A). MPIM § 13.5.1.
Most significantly, the item or service must be “reasonable and necessary”:
Contractors shall consider a service to be reasonable and necessary if the
contractor determines that the service is:
• Safe and effective;
• Not experimental or investigational ...; and
6
Available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-OnlyManuals-IOMs-Items/CMS019033.html (last visited on January 2, 2019).
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• Appropriate, including the duration and frequency that is considered
appropriate for the service, in terms of whether it is:
○ Furnished in accordance with accepted standards of medical practice
for the diagnosis or treatment of the patient's condition or to improve the
function of a malformed body member;
○ Furnished in a setting appropriate to the patient's medical needs and
condition;
○ Ordered and furnished by qualified personnel;
○ One that meets, but does not exceed, the patient's medical need; and
○ At least as beneficial as an existing and available medically appropriate
alternative.
Id.
The MPIM also instructs contractors to use the “strongest evidence available” and
provides a list of evidence in order of preference:
• Published authoritative evidence derived from definitive randomized
clinical trials or other definitive studies, and
• General acceptance by the medical community (standard of practice), as
supported by sound medical evidence based on:
○ Scientific data or research studies published in peer-reviewed medical
journals;
○ Consensus of expert medical opinion (i.e., recognized authorities in the
field); or
○ Medical opinion derived from consultations with medical associations
or other health care experts.
MPIM § 13.7.1. The MPIM further provides:
Acceptance by individual health care providers, or even a limited group of
health care providers, normally does not indicate general acceptance by the
medical community. Testimonials indicating such limited acceptance, and
limited case studies distributed by sponsors with financial interest in the
outcome, are not sufficient evidence of general acceptance by the medical
community. The broad range of available evidence must be considered and
its quality shall be evaluated before a conclusion is reached.
Id.
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The MPIM cautions that determinations that “challenge the standard of practice in
a community and specify that an item or service is never reasonable and necessary shall be
based on sufficient evidence to convincingly refute evidence presented in support of
coverage.” Id. Finally, the MPIM states: “Less stringent evidence is needed when allowing
for individual consideration.” Id.
Plaintiff relies upon the “less stringent evidence” language to support his contention
that Defendant did not appropriately consider Plaintiff’s individual claim. The language
of the regulation does not compel a different result. Instead, the language is consistent with
the entire regulation, which is designed to allow the adjudicator some discretion to assess,
in accordance with 42 C.F.R. § 405.1062(a), how various factors inform the coverage
determination, such as the general acceptance of a procedure within a particular coverage
area, even in the absence of authoritative studies and publications.7 In this case, Defendant
noted the absence of both definitive studies and evidence of general acceptance. To apply
the “less stringent evidence” language of the MPIM as Plaintiff urges would ignore the
MPIM’s caution that “[a]cceptance by individual health care providers, or even a limited
group of health care providers normally does not indicate general acceptance by the
medical community.”
The regulations do not mandate that the ALJ or the MAC quote or discuss the “less stringent evidence”
provision in a written decision.
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2. Evidence of Coverage definition of experimental
Plaintiff also contends the Evidence of Coverage definition of experimental items
and services as “those items and procedures determined by our plan and Original Medicare
to not be generally accepted by the medical community” (R. 9–10) requires a different
result. Contrary to Plaintiff’s argument, the definition is consistent with the requirements
of the applicable Medicare statute, regulations, and guidance.
C. Scope and Weight of the Evidence
Plaintiff contends that the reference by the ALJ and the MAC in their decisions of
a “review” of the MRI-guided ablation procedure by the Plan demonstrates that they relied
on information that was not part of the record evidence. (Plaintiff’s Brief at 14–15.)
Regardless of whether Plaintiff was aware of the Plan’s review or the ALJ’s reference to
the review, the record evidence, without reference to or reliance on the Plan’s review,
constitutes substantial evidence to support the determination. As referenced above, the
evidence presented by Plaintiff’s own physicians sufficiently supports the determination.
Finally, Plaintiff asserts that the MAC improperly required him to present
“scientific data or research studies published in peer-reviewed medical journals” to sustain
his claim. (Id. at 17, citing R. 10.) An objective review of the MAC’s decision reveals
that the MAC did not consider scientific data or research to be essential. Rather, the MAC
referenced the lack of scientific data and research as one reason it did not find the letters
submitted by Plaintiff’s physicians to be persuasive. In that context, the MAC’s reference
was understandable and reasonable. The MAC did not, as Plaintiff contends, apply an
improper standard of proof.
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CONCLUSION
Plaintiff’s investigation of treatment options is understandable. As the MAC
explained, however, “Medicare is a defined benefit program” and “[n]ot all items and
procedures are covered.” (R. 11.) A review of the record reveals that the administrative
decision is supported by substantial evidence and that Defendant did not otherwise err in
the decision-making process. Accordingly, based on the foregoing analysis, I recommend
the Court affirm Defendant’s final administrative decision.
NOTICE
A party may file objections to those specified portions of a magistrate
judge’s report or proposed findings or recommended decisions entered
pursuant to 28 U.S.C. § 636(b)(1)(B) for which de novo review by the district
court is sought, together with a supporting memorandum, and request for oral
argument before the district judge, if any is sought, within fourteen (14) days
of being served with a copy thereof. A responsive memorandum and any
request for oral argument before the district judge shall be filed within
fourteen (14) days after the filing of the objection.
Failure to file a timely objection shall constitute a waiver of the right
to de novo review by the district court and to appeal the district court’s order.
/s/ John C. Nivison
U.S. Magistrate Judge
Dated this 4th day of January, 2019.
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