ARTURO C. PORZECANSKI, APPELLANT v. ALEX MICHAEL AZAR, II, SECRETARY, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, APPELLEE
No. 18-5222
Unitеd States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued September 5, 2019 Decided November 26, 2019
Jaynie Lilley, Attorney, U.S. Department of Justice, argued the cause for appellee. With her on the brief was Alisa B. Klein, Attorney. R. Craig Lawrence, Assistant U.S. Attorney, entered an appearance.
Before: HENDERSON and KATSAS, Circuit Judges, and SENTELLE, Senior Circuit Judge.
Opinion for the Court filed by Circuit Judge HENDERSON.
KAREN LECRAFT HENDERSON, Circuit Judge: Judicial review of claims arising under the Medicare Act is carefully circumscribed. A plaintiff must first present his claims to the Secretary of the United States Department of Health and Human Services (HHS) and exhaust administrative remedies, unless doing so would foreclose access to federal court. In this appeal we consider whether, after properly channeling a single claim for “medical and other health services” benefits, a Medicare beneficiary can obtain prospective equitable relief mandating that HHS recognize his treatment as a covered Medicare benefit in all future claim determinations. The district court concluded it could not issue such relief. For the reasons that follow, we affirm.
I. BACKGROUND
A
Medicare is a federally funded health insurance program that serves qualified elderly and disabled individuals. See Social Security Amendments of 1965 (Medicare Act), Pub. L. No. 89-97, 79 Stat. 286 (1965) (codified as amended at
health service” will not be covered under Medicare Part B unless it is also “reasonable and necessary for the diagnosis or treatment of illness or injury.”
The individualized nature of many coverage decisions is reflected in Medicare‘s elaborate claim determination and review regimen. To start, a Medicare Part B beneficiary must submit a claim for an “initial determination” of whether “the items and services furnished are covered or otherwise
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c13.pdf; see also
If the contractor denies the beneficiary‘s claim, the beneficiary is entitled to appeal his claim to HHS. See
B
Arturo Porzecanski was diagnosed with systemic capillary leak syndrome (SCLS) in 2005. SCLS, also known as Clarkson‘s disease, is a rare, life-threatening condition,
“characterized by debilitating episodes in which blood and proteins shift from blood vessels into nearby body cavities and muscles.” Porzecanski v. Azar, 316 F. Supp. 3d 11, 14 (D.D.C. 2018). SCLS has no known cure. Following his diagnosis, Porzecanski began a preventive course of theophylline and terbutaline but, within a few years, his episodes occurred more frequently. Id. at 15.
In 2009 Porzecanski started an experimental regimen of intravenous immune globulin (IVIG), a biological product. Id. The FDA has approved IVIG for certain indications; IVIG for the treatment of SCLS, however, is considered an off-label use. Although the body of research at that time comprised only a few published articles, anecdotal reports and unpublished case studies, IVIG showed promising results for controlling SCLS symptoms. The dearth of scientific testing is unsurprising: SCLS‘s deadliness and rаrity render clinical trials virtually impossible. Since starting on IVIG, Porzecanski has been symptom-free. Id. at 16. According to the National Institutes of Health, IVIG is now “the best available treatment” for SCLS patients. Id. at 19 n.4. Porzecanski‘s physicians recommend that he continue his IVIG infusion schedule—two
On December 16, 2014, Porzecanski underwent a round of IVIG therapy at Georgetown University Medical Center, for which the Medical Center billed $29,860.95. Id. at 16. He submitted a Medicare Part B claim for the treatment.2 The
initial contractor—Novitas Solutions—denied coverage. Novitas’ LCD then in effect did not include SCLS as an approved indication for IVIG. Id. at 16 & n.2, 20.
As mandated by the regulatory scheme, Porzecanski requested a redetermination and Novitas affirmed its initial denial. Id. at 16. He then sought a reconsideration by Maximus Federal Services, a qualified independent contractor. Id. Maximus also rejected his claim, in a decision the district court described as “not entirely clear.” Id. Porzecanski fared no better before an ALJ, who denied coverage as well. Id. Porzecanski then appealed to the Council and, after the ninety-day review period lapsed, informed the Council of his desire to escalate the appeal to federal court. Id. The Council acknowledged his request and confirmed it could not issue a decision within the required time frame, which permitted Porzecanski to proceed to federal court.
While Porzecanski pursued his claim through the lengthy administrative appeals process, he underwent monthly IVIG therapy and submitted Medicare claims for each treatment. Initial contractоrs continued to deny coverage. Unlike the December 2014 claim, however, each subsequent denial was eventually overturned by either a qualified independent contractor or an ALJ, obviating the need for judicial review of those claims. Id. Yet Porzecanski‘s success on agency review did not interrupt the initial denials. Because the review generally binds only the parties unless specifically designated as precedential, a favorable determination in one proceeding does not ensure that future claims will be approved. See
Porzecanski filed suit in district court on October 17, 2016. On summary judgment, Porzecanski sought to reverse the denial of benefits for his December 16, 2014 claim and, because HHS‘s favorable coverage rulings had done nоthing to stem the flow of adverse initial determinations, also requested “declaratory and injunctive relief . . . confirming his entitlement to Medicare coverage for his medically necessary and life-saving treatment, and requiring the Secretary, his agency, and its contractors to honor the agency‘s obligation to provide the Medicare benefits to which he is entitled.” Plaintiff‘s Memorandum in Support of Motion for Summary Judgment at 2-3, Porzecanski, 316 F. Supp. 3d 11 (No. 16-2064), ECF No. 15-1. The proposed order accompanying Porzecanski‘s motion asked the court to order the Secretary to “take all timely and appropriate actions necessary to ensure that [HHS], its contractors, and its administrative review officials will not deny Medicare Part B coverage for . . . future IVIG treatments furnished to [Pоrzecanski] for SCLS pursuant to a physician‘s order and incident to a physician‘s service to [Porzecanski].” Proposed Order at 2, Porzecanski, 316 F. Supp. 3d 11 (No. 16-2064), ECF No. 15-6 (emphasis added).
On May 30, 2018, the district court granted Porzecanski‘s motion in part, concluding
For benefits claims “arising under” the Medicare statute, “the sole avenue for judicial review” is
42 U.S.C. § 405(g) , which requires beneficiaries to first pursue their claims through the Medicare claims process before seeking review in federal court. Heckler v. Ringer, 466 U.S. 602, 615 (1984); see also42 U.S.C. §§ 405(h) ,1395ff(b)(1)(A) . That is, the Medicare statute “demands the ‘channeling’ of virtually all legal attacks through the agency.” Shalala v. Ill. Council on Long Term Care, Inc., 529 U.S. 1, 13 (2000).
Id. at 22. Porzecanski was therefore required to “initiate his claims for other IVIG treatments through the Medicare claims process.” Id. The district court noted, however, that Porzecanski was not “without recourse“: he could challenge the LCD “under which contractors have summarily denied his claims”3 or request that HHS issue a national coverage determination (NCD).4 Id. Porzecanski appeals the denial of his request for declaratory and injunctive relief.
Porzecanski also heeded the district court‘s advice. After filing this appeal, Porzecanski requested that Novitas revise its LCD to reflect coverage for IVIG when used to treat SCLS. Novitas updated its LCD, effective for services performed on or after September 9, 2018, and added SCLS as a covered indication for IVIG, albeit in limited circumstances. Appellee‘s Addendum at 8, 13. Although HHS does not argue with the partial grant of summary judgment ordering coverage for the December 16, 2014 IVIG treatment, it does maintain that the revised LCD has mooted Porzecanski‘s appeal. We must therefore consider whether Porzecanski‘s appeal is moot before we determine whether thе district court correctly declined to grant the requested equitable relief. We address each issue in turn.
II. MOOTNESS
HHS argues that the appeal “appears to be moot” as a result of Novitas’ revised LCD. Appellee‘s Br. at 11. Although HHS‘s brief cites no caselaw on this point, we have an “independent obligation” to ensure that cases before us are not moot. Am. Freedom Def. Initiative v. WMATA, 901 F.3d 356, 361 (D.C. Cir. 2018) (quotation marks omitted). This duty arises from Article III‘s requirement that federal courts “only adjudicate actual, ongoing
Conservation Force, 733 F.3d at 1204 (quotation marks and brackets omitted).
This case is not moot. Porzecanski seeks an equitable remedy to stop the nearly automatic coverage denials that have been, and continue to be, issued for his monthly IVIG treatments. The district court‘s order reversing the denial of the December 16, 2014 claim has done nothing to stop the repetitive denials underlying Porzecanski‘s claim for declaratory and injunctive relief. Nor has the revised Novitas LCD given Porzecanski the full relief he requested.
Novitas’ September 2018 revisions expanded coverage of IVIG for SCLS “on a trial basis when associated with monoclonal gammopathy and used for prophylaxis,” although “prophylaxis should be tapered to the lowest dose obtainable.” Appellee‘s Addendum at 13-14. HHS argues the case is moot because coverage is no longer “categorically unavailable.” Appellee‘s Br. at 11-12. But Novitas has continued to deny Porzecanski‘s claims after Novitas’ revised LCD‘s effective date and he maintains that the “lowest dose obtainable” limitation is arbitrary and dangerous.5 Appellant‘s Reply Br. at 12-13. Shortly before oral argument in this case, Novitas again revised its LCD, replacing “lowest dose obtainable” with “lowest effective dose.” Local Coverage Determination (LCD): Intravenous Immune Globulin (IVIG) (L35093), CTRS. FOR MEDICARE & MEDICAID SERVS., https://www.cms.gov/medicare-coverage-datаbase/details/lcd-details.aspx?LCDId=35093 (last updated Aug. 22, 2019).6
Although the impact of this most recent change remains to be seen, it appears to support, if anything, coverage for Porzecanski. In any event, neither LCD revision has mooted this case.
Assuming, arguendo, that the current Novitas LCD manifests that Porzecanski‘s IVIG treatments are covered under Medicare Part B, he still would not have “obtained all the relief [he] sought.” Conservation Force, 733 F.3d at 1204 (quotation marks omitted). An LCD binds only the issuing contractor. See
In sum, other initial contractors, qualified independent contractors, ALJs and the Council are not bound by the Novitas LCD when deciding whether Porzecanski‘s IVIG treatments are covered under Medicare Part B. They would, however, be bound by the equitable relief he seeks. Accordingly, Porzecanski‘s appeal is not moot.
III. PORZECANSKI‘S REQUESTED RELIEF
Porzecanski contends the district court had authority to issue equitable relief because the December 16, 2014 claim was properly before it. We note as a preliminary matter that Porzecanski has narrowed the scope of his proposed remedy on аppeal. In district court, his proposed order requested, in part, “that [HHS], its contractors, and its administrative review officials will not deny Medicare Part B coverage for . . . future IVIG treatments furnished to [Porzecanski].” Proposed Order at 2, Porzecanski, 316 F. Supp. 3d 11 (No. 16-2064), ECF No. 15-6. Before us, however, he contends the requested injunction would not in fact require HHS to approve his future claims. Tr. of Oral Arg. 10:13-10:17. Instead, it would merely effectuate the district court‘s ruling that his December 16, 2014 claim was a covered Medicare Part B benefit by precluding the Secretary—and any HHS adjudicators and contractors—from denying future claims on the same rejected grounds. However Porzecanski frames his request, we believe the district court correctly declined to grant equitable relief.
A
Federal jurisdiction is extremely limited for claims arising under the Medicare Act. Generally, a beneficiary must first channel his claim “into the administrative process which Congress has provided for the determination of claims for benefits” before obtaining judicial review. Heckler v. Ringer, 466 U.S. 602, 614 (1984).
Three statutory provisions elucidate this channeling requirement.
First,
the exception ‘herein provided.‘” Id. Although
In relevant part,
Accordingly,
or revise policies, regulations, or statutes without possibly premature interference by different individual courts.” Id. at 12-13 (quotation marks omitted). That said, the preconditions do not apply “where application of
B
We review de novo the district court‘s conclusion that it was precluded by
A beneficiary seeking to establish a right to future benefit payments must be considered to have brought a claim that “arises under” the Medicare statute. Ringer, 466 U.S. at 615. Judicial review is therefore limited by the interplay between
not shown that judicial review will be “foreclose[d]” or “praсtically cut off” if he is forced to channel future claims through the HHS administrative process. See Am. Chiropractic Ass‘n, 431 F.3d at 816. To the contrary, he can obtain judicial review of any future claim denial just as he has done in this case. And to the extent he desires broader relief outside the case-by-case adjudicatory model, he has a clear administrative path to challenge an LCD or to request an NCD, see
Porzecanski cannot satisfy
conclusions that the treatments for his rare condition are not a Medicare-covered benefit and not medically necessary.” Appellant‘s Br. at 32.
Porzecanski‘s strained position is at odds with Supreme Court precedent. In Ringer, the Court held that
Ringer and Illinois Council directly foreclose Porzecanski‘s attempt to recast the requested relief as anything other than a claim for future benefits. An order requiring HHS to conclude that future IVIG treatments are
both a “Medicare-covered benefit” and “medically necessary” runs headlong into the Supreme Court‘s instruction that ”all aspects” of a claim be first channeled through the agency. Illinois Council, 529 U.S. at 12 (emphasis added). Moreover, the issues Porzecanski attempts to resolve through judicial decree are not merely related to his claim; they are his claim. Granted, Porzecanski would still need to provide appropriate documentation in connection with his claims but the ultimate issue of whether his treatments are covered under Medicare Part B would be predetermined by the relief he seeks. In other words, “only essentially ministerial details [would] remain before [he] would receive reimbursement” in the future. Ringer, 466 U.S. at 615. Porzecanski “is clearly seeking to establish a right to future payments” outside the appropriate channels and we therefore must reject his request for prospective relief. Ringer, 466 U.S. at 621. We believe the district court correctly rejected Porzecanski‘s attempt to circumvent the Medicare Act‘s channeling requirement.10 Because we hold that Porzecanski runs afoul of
We note that Porzecanski construes his case as one implicating the сourt‘s authority to issue equitable relief, not its jurisdiction of the underlying claim. There is no dispute that the December 16, 2014 claim was properly channeled through HHS before reaching the district court. Understandably, then, Porzecanski frames the equitable relief he seeks as
Porzecanski cites Califano v. Yamasaki, 442 U.S. 682 (1979), where the Supreme Court recognized that
relief in some circumstances does not mean equitable relief is appropriate in all cases. We recognize there may be situations where equitable relief is appropriate and necessary to carry out a decision. But when prospective relief would functionally determine future claims, we cannot ignore the restrictive mandate of the Medicare Act‘s channeling requirement.
Porzecanski‘s reliance on Lion Health Services, Inc. v. Sebelius, 635 F.3d 693 (5th Cir. 2011), and Los Angeles Haven Hospice, Inc. v. Sebelius, 638 F.3d 644 (9th Cir. 2011), is similarly misplaced. In both cases, hospice care providers challenged the so-called “hospice cap regulation,”
require HHS to cover claims that have neither been presented to the Secretary nor administratively exhausted.
Finally, we consider the practical effects of his requested relief. In district court, Porzecanski challenged no generally applicable regulation or policy. Instead, his complaint challenged only a single ALJ decision. The district cоurt reversed the claim denial because the ALJ, despite determining that Porzecanski‘s IVIG treatment was “reasonable and necessary,” nevertheless denied coverage due to multiple interpretative missteps. Porzecanski, 316 F. Supp. 3d at 19. And because the ALJ‘s “reasonable and necessary” decision was conclusive, see
found that Porzecanski‘s IVIG
Second, the injunction is not limited to ensuring coverage for the single claim that was properly before the district court. Rather, it attempts to stretch the outcome of a single claim dispute to foreclose a contrary decision in any future determination. This is at odds with the Medicare regime. Porzecanski wants a declaration that his treatments are “medically necessary” in all future cases but Medicare policy provides that for off-label uses—such as IVIG for the treatment of SCLS—a determination that the treatment is “medically accepted” is to be made on a “case-by-case basis.” Medicare Benefit Policy Manual § 50.4.2 (Rev. 1, Oct. 1, 2003) https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf. Medical science changes. An accepted practice may be obsolete in a few years. Ordering HHS to cover Porzecanski‘s treatments indefinitely can hardly be necessary to effectuate the district court‘s judgment regarding one treatment at a particular point in time. If Porzecanski disputes a future adverse determination, he has agency review—and, eventually, federal court—to vindicate his position.
Porzecanski‘s real problem seems to be with Novitas. To the extent he wants the Secretary to instruct Novitas to cover his treatments pursuant to its LCD, he cannot do so through the claim appeals process. There is a distinct path provided for beneficiaries to secure broader coverage determinations and Porzecanski cannot circumvent those procedures by obtaining an injunction as part of a single claim appeal.12
For the foregoing reasons, the district court‘s partial grant of summary judgment to HHS is affirmed.
So ordered.
a claim appeal is an improper mechanism by which to “set aside or review the validity of an . . . LCD.”