Opinion
C.A. No. PC-2017-1282
02-15-2018
MARION STRESE v. RHODE ISLAND EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES
ATTORNEYS: For Plaintiff: Gretchen M. Bath, Esq. For Defendant: Gregory Hazian, Esq.
DECISION STERN , J. Marion Strese (Appellant or Ms. Strese) appeals a decision of the Rhode Island Executive Office of Health and Human Services (OHHS) finding that she is ineligible for coverage for a medication—Harvoni—to treat her hepatitis C virus. Ms. Strese argues that the decision was arbitrary and in violation of federal law requiring states that accept prescription drug reimbursement as part of Medicaid provide access to all medically necessary medications. Jurisdiction is pursuant to G.L. 1956 § 42-35-15. For the reasons set forth in this Decision, this Court sustains Ms. Strese's appeal, vacates the hearing officer's decision, and remands this case to OHHS for further proceedings consistent with this Decision.
I
Facts and Travel
Appellant is a sixty-three-year-old female who was diagnosed with hepatitis C in her late thirties or early forties. (SAR at 151-52.) Appellant receives Supplemental Security Income, and is therefore a "categorically needy" Medicaid recipient. Id. at 160; 42 U.S.C. § 1396a(a)(10)(A)(i). For about the past twenty years, she has been treated primarily by her gastroenterologist, Dr. Raymond Mis (Dr. Mis). Id. at 152-53.
The parties stipulated to a shortened administrative record (SAR), and this Court will refer to its pagination.
During that time, Appellant underwent three separate courses of treatment for hepatitis C. Id. at 154-55. Dr. Mis first prescribed Appellant a course of interferon, which involved three injections and four pills daily for a period of eight months. Id. at 154. Regrettably, the treatment failed, and the viral infection persisted. Id. Appellant then saw another doctor who prescribed Intron, but that too failed. Id. Appellant returned to Dr. Mis thereafter, and he prescribed Pegasys, another injectable medication, to treat Appellant's hepatitis C. Id. After nearly completing the treatment regimen, Appellant experienced an adverse reaction to the drug, which required Dr. Mis to discontinue its use. Id. at 154-55. Like the previous two attempts, this too was ineffective. Id.
The precise timeline for Appellant's original diagnosis and previous treatments are not in the record before the Court. Appellant testified at the OHHS hearing about the various treatments and her approximate age when she was diagnosed.
These three treatment attempts took place over a period of years as treatment options for hepatitis C developed. Id. at 153-54. In 2015, Appellant returned to Dr. Mis. Id. at 155. It was then that Dr. Mis prescribed Harvoni for Appellant's hepatitis C. Id.
Harvoni, which received FDA approval in 2014, is a direct-action antiviral that has proved effective as a treatment for hepatitis C. Diana Gritsenko & Gregory Hughes, Ledipasvir/Sofosbuvir (Harvoni): Improving Options for Hepatitis C Virus Infection, 40 Pharm. and Therapeutics 256, 256 (2015) (hereinafter Gritsenko & Hughes). Unlike the previous treatment options prescribed to Appellant, Harvoni has a substantially higher success rate—approaching 99% effectiveness. Id. at 256-58. With higher efficacy comes a higher price tag, however—the course of treatment Appellant seeks would cost in excess of $100,000. Id. at 259.
As a result of the drug's price, OHHS established a policy limiting coverage for Harvoni to patients with advanced liver damage (the Policy). (SAR at 15-19.) To qualify for Harvoni, Medicaid recipients must have severe liver scarring; specifically, stage 3 or 4 hepatic fibrosis or cirrhosis. Id. at 16. The Policy provides for several diagnostic criteria that can demonstrate this level of liver damage:
"Documentation may be by any of the following:It is undisputed that Appellant's liver disease is not this advanced. Id. at 139.
"i. AST to Platelet Ratio Index (APRI) greater than or equal to 1.0
"ii. Current liver biopsy is not required, however previous liver biopsy indicating METAVIR score of 3 or 4 may be used
"iii. Fibroscan score greater than or equal to 9.5kPa
"iv. Fibrotest score greater than or equal to 0.58
"v. Imaging study consistent with cirrhosis" Id. at 16.
As a result of the Policy, on May 25, 2016, the UnitedHealthcare Community Plan (UHCCP) denied Appellant's preauthorization request for Harvoni coverage. Id. at 54. Dr. Mis personally appealed UHCCP's initial decision to deny Appellant coverage for Harvoni. Id. at 57. Dr. Mis argued that Appellant and the healthcare system as a whole would be better served by allowing treatment before Appellant's hepatitis C caused more serious liver scarring. Id. Despite his request, on August 5, 2016, UHCCP again denied preauthorization citing the Policy as determinative of the issue. Id. at 74.
UHCCP is a Medicaid managed care organization contracted by OHHS to provide services to some Medicaid recipients in Rhode Island. (SAR at 137-38.)
On August 30, 2016, through counsel, Appellant filed a Level 2 appeal of UHCCP's decision to deny coverage for Harvoni. Id. at 76. On September 14, 2016, this appeal too was denied based upon application of the Policy. Id. at 85. On September 24, 2016, Appellant filed a request for a hearing with OHHS. Id. at 1.
At the December 15, 2016 hearing before the OHHS hearing officer (the Hearing Officer), Appellant, through counsel, argued that the Policy was in violation of federal Medicaid law because it failed to consider her medical need for Harvoni. Id. at 7, 115, 141. Appellant cited to a United States District Court case from the district of Washington, in which the court certified a class and granted a preliminary injunction requiring Medicaid coverage for Harvoni for hepatitis C patients where the state had a similar policy to the one at issue here. Id. at 160.
See B.E. v. Teeter, No. C16-0227-JCC, 2016 WL 3939674, at *1 (W.D. Wash. July 21, 2016) (certifying class); B.E. v. Teeter, No. C16-0227-JCC, 2016 WL 3033500, at *1 (W.D. Wash. May 27, 2016) (granting preliminary injunction).
UHCCP maintained, however, that the Policy governed the dispute, and that the Hearing Officer lacked jurisdiction to invalidate the Policy as violative of federal law. Id. at 156. UHCCP suggested at the hearing that Appellant seek a declaration, either from OHHS pursuant to § 42-35-8 or the Superior Court pursuant to § 42-35-7, if she sought to invalidate or override the Policy. Id. at 156-57.
Section 42-35-8(a) provides in pertinent part: "A person may petition an agency for a declaratory order that interprets or applies a statute administered by the agency or states whether, or in what manner, a rule, guidance document, or order issued by the agency applies to the petitioner."
Section 42-35-7 provides in pertinent part:
"The validity or applicability of any rule may be determined in an action for declaratory judgment in the superior court of Providence County, when it is alleged that the rule, or its threatened application, interferes with or impairs, or threatens to interfere with or impair, the legal rights or privileges of the plaintiff. The agency shall be made a party to the action. A declaratory judgment may be rendered whether or not the plaintiff has requested the agency to pass upon the validity or applicability of the rule in question."
UHCCP's Chief Medical Officer for the Rhode Island Medicaid plan, Dr. Renee Rulin, testified at the hearing that she was familiar with the Policy, and that the documentation provided by Appellant in her preauthorization request did not establish stage 3 or 4 hepatic fibrosis or cirrhosis as required by the Policy. Id. at 142-45. Dr. Rulin did not indicate consideration of any factors other than the stage of Appellant's fibrosis in determining her ineligibility for Harvoni coverage. Id.
Appellant also testified at the hearing. Id. at 151. She chronicled her history with hepatitis C and her past failed treatment regimens. Id. at 151-55. She also detailed the symptoms she experiences regularly, including lack of appetite and fatigue, and their impact on her ability to care for her son who has cerebral palsy:
"It's like I, I, I never feel well. My stomach, you know, I force myself to eat. I'm tired. I, I, I just don't have, you know, my life that I used to. I, my son has cerebral palsy. I always did everything with him and now my age, with my age and everything it's become difficult and it's a progressive disease and I've noticed over the years, every year it gets slower and harder and tireder until, you know, I'm just about dysfunctional of what I used to be." Id. at 155.
On February 27, 2017, the Hearing Officer issued a final written decision denying Appellant's appeal. Id. at 115. The Hearing Officer found that Appellant's fibrosis score was below that required by the Policy, and that, as a result, Harvoni was not a covered medication under the plan. Id. at 132, 134. Finally, the Hearing Officer found that she lacked the authority to invalidate the Policy if it violated federal law. Id. at 131-32. Appellant filed this timely appeal pursuant to § 42-35-15 on March 22, 2017.
Curiously, in addition to her other findings, the Hearing Officer found that OHHS was not a party to the appeal. (SAR at 132.) OHHS now avers that it is not a party to this action, and that it would only be a party if Appellant had instead brought a declaratory judgment action. (OHHS Memo at 5.) The Hearing Officer's finding on this issue is clearly erroneous. Federal law requires that "[a] State plan for medical assistance must . . . provide for granting an opportunity for a fair hearing before the State agency to any individual whose claim for medical assistance under the plan is denied or is not acted upon with reasonable promptness." 42 U.S.C. § 1396a(a)(3). OHHS was on notice of this appeal throughout its pendency below and in this Court and has been given every opportunity to be heard on the issues presented on appeal.
II
Standard of Review
Superior Court review of administrative agency decisions is governed by the Rhode Island Administrative Procedures Act (the APA), §§ 42-35-1 et seq. See Rossi v. Emps' Ret. Sys. of R.I., 895 A.2d 106, 109 (R.I. 2006). Section 42-35-15(g) provides this Court's standard of review:
"The court shall not substitute its judgment for that of the agency as to the weight of the evidence on questions of fact. The court may affirm the decision of the agency or remand the case for further proceedings, or it may reverse or modify the decision if substantial rights of the appellant have been prejudiced because the administrative findings, inferences, conclusions, or decisions are:Pursuant to the APA, this Court is limited to an examination of the record in determining whether the agency's decision is supported by substantial evidence. Johnston Ambulatory Surgical Assocs. v. Nolan, 755 A.2d 799, 804-05 (R.I. 2000) (citing Barrington Sch. Comm. v. R.I. State Labor Relations Bd., 608 A.2d 1126, 1138 (R.I. 1992)). Substantial evidence is such "relevant evidence that a reasonable mind might accept as adequate to support a conclusion [and] means an amount more than a scintilla but less than a preponderance." Town of Burrillville v. R.I. State Labor Relations Bd., 921 A.2d 113, 118 (R.I. 2007). This Court may not substitute its judgment for that of the agency as to the weight of the evidence on questions of fact. Interstate Navigation Co. v. Div. of Pub. Utils. & Carriers of R.I., 824 A.2d 1282, 1286 (R.I. 2003) (citations omitted).
"(1) In violation of constitutional or statutory provisions;
"(2) In excess of the statutory authority of the agency;
"(3) Made upon unlawful procedure;
"(4) Affected by other error or law;
"(5) Clearly erroneous in view of the reliable, probative, and substantial evidence on the whole record; or
"(6) Arbitrary or capricious or characterized by abuse of discretion or clearly unwarranted exercise of discretion."
Agency determinations of law are reviewed de novo. Iselin v. Ret. Bd. of Emps' Ret. Sys. of R.I., 943 A.2d 1045, 1049 (R.I. 2008). This Court accords great "weight and deference" to an administrative agency's interpretations of a statute it is empowered to enforce, "as long as that construction is not clearly erroneous or unauthorized." Labor Ready Ne., Inc. v. McConaghy, 849 A.2d 340, 344 (R.I. 2004). This is true "even when other reasonable constructions of the statute are possible." Id. at 345; see Town of Burrillville v. Pascoag Apartment Assocs., LLC, 950 A.2d 435, 445-46 (R.I. 2008). The reviewing court will also defer to an agency's "reasonable" interpretation of the regulations it promulgates pursuant to a statute it is authorized to enforce. See State v. Swindell, 895 A.2d 100, 105 (R.I. 2006); State v. Cluley, 808 A.2d 1098, 1104-06 (R.I. 2002); Pawtucket Power Assocs. Ltd. P'ship v. City of Pawtucket, 622 A.2d 452, 456-57 (R.I. 1993).
Finally, this Court may "reverse, modify, or remand the agency's decision" if the decision is "clearly erroneous in view of the reliable, probative, and substantial evidence on the whole record, or is arbitrary or capricious and is therefore characterized by an abuse of discretion." Johnston Ambulatory Surgical Assocs., 755 A.2d at 805. The Superior Court's authority to remand an administrative appeal for further proceedings is a broad grant of power calculated to correct deficiencies in the record and thus afford the litigants a meaningful review. Lemoine v. Dep't of Mental Health, Retardation and Hosps., 113 R.I. 285, 290, 320 A.2d 611, 614 (1974); see Ferrelli v. Dep't of Emp't Sec., 106 R.I. 588, 261 A.2d 906 (1970). This Court will "'reverse factual conclusions of administrative agencies only when they are totally devoid of competent evidentiary support in the record.'" Baker v. Dep't of Emp't & Training Bd. of Review, 637 A.2d 360, 363 (R.I. 1994) (quoting Milardo v. Coastal Res. Mgmt. Council, 434 A.2d 266, 272 (R.I. 1981)).
III
Analysis
OHHS is an agency within the executive branch of our state government and is responsible for the management, supervision, and control of numerous social service programs, including Medicaid. See §§ 42-12-1 et seq. Medicaid is a federal assistance program designed to help participating states provide medical coverage to individuals who do not possess the financial means to pay for necessary medical costs. 42 U.S.C. § 1396; Harris v. McRae, 448 U.S. 297, 301 (1980). Rhode Island willingly participates in the Medicaid program. See G.L. 1956 § 40-8-1.
While state participation in the federal Medicaid program is optional, once a state elects to participate, federal law dictates certain standards by which the program must be administered. Harris, 448 U.S. at 301. Under federal law, all Supplemental Security Income recipients are "categorically needy" and automatically qualify for Medicaid benefits if their state participates in the program. 42 U.S.C. § 1396a(a)(10)(A)(i).
All participating states must provide Medicaid recipients with certain "mandatory services," which include hospital and physician coverage. 42 U.S.C. § 1396a(a)(10)(A), 1396d(a)(1)-(5), (17), (21), (28). Participating states may elect to offer other "optional categories of service." See 42 U.S.C. § 1396d(a)(6)-(16), (18)-(20), (22)-(27), (29). Specifically relevant to this dispute, Rhode Island offers, and receives partial federal reimbursement, for prescription drug coverage. See 42 U.S.C. § 1396d(a)(12); § 40-21-1. By electing to offer prescription drug coverage, Rhode Island has "bound itself to act in compliance with [the Medicaid Act] and the applicable regulations in the implementation of [this service]." Meyers v. Reagan, 776 F.2d 241, 243-44 (8th Cir. 1985) (citing Eder v. Beal, 609 F.2d 695, 702 (3d Cir. 1979) ("[O]nce a state elects to participate in an 'optional' program, it becomes bound by the federal regulations [that] govern it.")). Therefore, Rhode Island's Medicaid prescription drug coverage "must be sufficient in amount, duration, and scope to reasonably achieve [the program's] purpose." 42 C.F.R. § 440.230(b). Moreover, "[a state] may not arbitrarily deny or reduce the amount, duration, or scope of a required service . . . to an otherwise eligible recipient solely because of the diagnosis, type of illness or condition." Weaver v. Reagen, 886 F.2d 194, 197-98 (8th Cir. 1989) (citing 42 C.F.R. § 440.230(c)).
OHHS has contracted with UHCCP to administer the state's Medicaid program. (SAR at 9.) UHCCP is charged with applying OHHS's policies, including the Policy, when determining eligibility for a given service. Id.
The Policy restricts coverage for Harvoni and several other similarly expensive direct-action antivirals based on specific criteria. Id. at 16. The individual Rhode Island Medicaid recipient must meet one of the five criteria listed in the Policy in order for any of the drugs referenced in the Policy to be covered by Medicaid. Id. Specifically, the Policy requires the recipient meet one or more of the following diagnostic criteria:
"Documentation may be by any of the following:
"i. AST to Platelet Ratio Index (APRI) greater than or equal to 1.0
"ii. Current liver biopsy is not required, however previous liver biopsy indicating METAVIR score of 3 or 4 may be used
"iii. Fibroscan score greater than or equal to 9.5kPa
"iv. Fibrotest score greater than or equal to 0.58
"v. Imaging study consistent with cirrhosis" Id.
The Policy leaves no room for discretion on the part of UHCCP or OHHS, or their consideration of other relevant factors. Id. It also ignores the medical opinion of the treating physician. Id. OHHS generally states that the Policy is valid.
This Court notes that the Policy is not a "rule" promulgated by OHHS after a notice and comment period or pursuant to any specified statutory authority. OHHS devised the Policy in response to the expense of new direct-action antivirals, and prior to enacting the Policy, OHHS sent a memorandum to UHCCP instructing it to deny all requests for direct-action antivirals. (SAR at 29.) Mandatory language, like that in the Policy, generally denotes a rule with the force of law, whereas "policies" are only advisory in nature and cannot eliminate agency discretion. See, e.g., Chen Zhou Chai v. Carroll, 48 F.3d 1331, 1341 (4th Cir. 1995) (holding that a rule is a general statement of policy not subject to the notice and comment requirement of the Administrative Procedures Act only when "it does not establish a binding norm and leaves agency officials free to exercise their discretion").
"The issue of the [sic] whether the policies violate federal law was not before the [Hearing Officer] nor did she have the authority to strike down the policies and guidelines. The administrative record is clear on that issue." (OHHS Mem. at 5.)
The United States Supreme Court has held that the fact that "a State's decision to curtail Medicaid benefits may have been motivated by a state policy unrelated to the Medicaid Act does not limit the scope of its broad discretion to define the package of benefits it will finance." Pharm. Research & Mfrs. of Am. v. Walsh, 538 U.S. 644, 666 (2003). While the State does have broad discretion to "choose the proper mix of amount, scope, and duration limitations on coverage," that discretion is not unlimited. Alexander v. Choate, 469 U.S. 287, 303 (1985). The care and services must still be provided in "the best interests of the recipients." Id. (quoting 42 U.S.C. § 1396a(a)(19)). The State may therefore only adopt standards that are "reasonable" and "consistent with the objectives of the [Social Security] Act," to help individuals in need "attain or retain capability for independence or self-care." 42 U.S.C. § 1396-1, 1396a(a)(17).
In Beal v. Doe, 432 U.S. 438, 444-45 (1977), the United States Supreme Court held that "[a]lthough serious statutory questions might be presented if a state Medicaid plan excluded necessary medical treatment from its coverage, it is hardly inconsistent with the objectives of the Act for a State to refuse to fund unnecessary though perhaps desirable medical services." State Medicaid standards that are not reasonably related to medical necessity are arbitrary because they do not bear a "rational relationship to the underlying federal purpose of providing the service to those in greatest need of it." White v. Beal, 555 F.2d 1146, 1151 (3d Cir. 1977).
Medical necessity is the primary consideration in the assessment of restrictions within Medicaid plans. See, e.g., Bontrager v. Indiana Family & Soc. Servs. Admin., 697 F.3d 604, 609 (7th Cir. 2012) (holding that a $1000 cap on certain dental procedures was arbitrary because it ignored medical necessity); Hern v. Beye, 57 F.3d 906, 910 (10th Cir. 1995) (invalidating state prohibition on Medicaid funding for abortions in circumstances other than where the life of the mother was in danger as arbitrary because it did not consider medical necessity in other circumstances); Pinneke v. Preisser, 623 F.2d 546, 548 n.2 (8th Cir. 1980) ("This standard of medical necessity is not explicit in the statute, but has become judicially accepted as implicit to the legislative scheme and is apparently endorsed by the [U.S.] Supreme Court."). Similarly, "state budgetary concerns cannot . . . be the conclusive factor in decisions regarding Medicaid." Pashby v. Delia, 709 F.3d 307, 331 (4th Cir. 2013) (internal quotations and brackets omitted) (quoting Indep. Living Ctr. of S. Cal., Inc. v. Maxwell-Jolly, 572 F.3d 644, 659 (9th Cir. 2009), vacated and remanded on other grounds 565 U.S. 606, (2012)).
This Court notes that in previous cases before the Rhode Island Superior Court, medical necessity has universally been considered the overarching consideration with respect to Medicaid coverage for a particular service. See Jasset v. R.I. Dep't of Human Servs., No. C.A. PC-2005-3815, 2006 WL 2169891, at *5 (R.I. Super. July 31, 2006) ("The concept of 'medical necessity' is the set measure—the touchstone—for evaluating the reasonableness of a participating state's Medicaid standards."); Bristol v. R.I. Dep't of Human Servs., No. PC-1995-6605, 1997 WL 839884, at *5 (R.I. Super. Jan. 30, 1997) ("An agency policy which does not and cannot respond to medical need is arbitrary and capricious."); see also Conti v. Ferguson, No. C.A. PC-1999-5109, 2001 WL 770898, at *6 (R.I. Super. July 5, 2001) (holding that Medicaid cannot categorically exclude ambulatory individuals from non-emergency transportation services to medically necessary appointments).
Appellant also introduced a memorandum from the Centers for Medicare & Medicaid Services (CMS), a division of the U.S. Department of Health and Human Services, at the hearing, which indicated CMS's opinion that state regulations that limit access to hepatitis C medications to Medicaid participants with a metavir score of F3 or F4 may violate federal law by restricting access to effective, medically necessary, clinically appropriate treatments, that are not subject to restriction by federal law. (SAR at 112-13.) The memorandum provided that restrictions like the Policy, which have apparently been enacted in several states as cost saving measures, violate federal law by unreasonably restricting access to direct-action antivirals without consideration of medical necessity. Id. at 112. While not binding, the CMS guidance memorandum is persuasive and helps identify the problems associated with limiting access to effective direct-acting antivirals to patients with severe liver scarring. See Christensen v. Harris Cty., 529 U.S. 576, 587 (2000) ("[I]nterpretations contained in formats such as opinion letters are 'entitled to respect' under [the United States Supreme Court's] decision in Skidmore v. Swift & Co., 323 U.S. 134, 140, 65 S.Ct. 161, 89 L.Ed. 124 (1944), but only to the extent that those interpretations have the 'power to persuade.'").
The legislative history of the Medicaid Act also reflects the importance of the physician's medical necessity determination:
"3(a) Conditions and limitations on payment for services.
"(1) Physicians' role
"The committee's bill provides that the physician is to be the key figure in determining utilization of health services and provides that it is a physician who is to decide upon admission to a hospital, order tests, drugs and treatments, and determine the length of stay. For this reason the bill would require that payment could be made only if a physician certifies to the medical necessity of the services furnished." S. Rep. No. 89-404, at 128 (1965), reprinted in 1965 U.S.C.C.A.N. 1943, 1986; see also Pinneke, 623 F.2d at 549 n.3.
OHHS's RI Medicaid Provider Reference Manual (the Manual) states that "[t]he term 'medical necessity' or 'medically necessary service' means medical, surgical, or other services required for the prevention, diagnosis, cure or treatment of a health related condition including such services necessary to prevent a decremental change in either medical or mental health status." (Manual at 10.) The Manual also states that "[t]he RI Medicaid program and its designees determine which services are medically necessary on a case-by-case basis, both in pre-payment and post-payment reviews, and via prior authorizations." Id.
While not raised by the parties, the Court notes that the General Assembly has provided some guidance for an analogous situation to the one at bar within the legislation authorizing portions of Rhode Island's Medicaid prescription drug program. Secs. 40-21-1 to -3. The General Assembly instructed the Department of Human Services to establish a Preferred Drug List, and provided a specific process for Medicaid recipients to receive drugs not on the Preferred Drug List if their physician deemed it necessary. Id. Specifically, the statute mandates that "[i]f, after consultation with the program, the prescriber, in his or her reasonable professional judgment, determines that the use of a prescription drug that is not on the preferred drug list is warranted, the prescriber's determination shall be final." Sec. 40-21-3(b) (emphasis added). The General Assembly's deference to the prescriber's medical opinion is in harmony with at least one line of federal cases discussing medical necessity for Medicaid coverage. See Smith v. Rasmussen, 249 F.3d 755, 759 (8th Cir. 2001) ("The Medicaid statute and regulatory scheme create a presumption in favor of the medical judgment of the attending physician in determining the medical necessity of treatment."); Pinneke, 623 F.2d at 549 ("[Strict adherence to a policy that limits coverage] reflects inadequate solicitude for the applicant's diagnosed condition, the treatment prescribed by the applicant's physicians, and the accumulated knowledge of the medical community.").
Despite the Manual providing for a case-by-case determination about medical necessity, neither UHCCP nor OHHS undertook such an evaluation with respect to Ms. Strese. See id. The Hearing Officer merely substituted the Policy for an evaluation of Ms. Strese's individual medical need for Harvoni: "[UHCCP]'s responsibility is to implement the Policies. In this instant matter UHCCP properly applied the Policies to the facts as presented to 'the letter.'" (SAR at 128.)
This case exemplifies a circumstance in which "necessary medical treatment," not merely "unnecessary though perhaps desirable medical services," is at issue. See Beal, 432 U.S. at 444-45. Hepatitis C is a life-threatening virus that causes long-term, life-altering health problems. See Gritsenko & Hughes, supra at 256. Direct-action antivirals like Harvoni are effective treatments for hepatitis C, regardless of the patient's current liver damage. Id.
Here, OHHS developed a rigid policy that fails to respond in any meaningful way to an individual Medicaid recipient's medical need for Harvoni or other direct-action antivirals. (SAR at 15-18.) The record reflects that Appellant has attempted virtually every other medication available to treat her hepatitis C virus—including complicated and onerous regimens involving multiple daily injections—and each of them has failed. Id. at 151-55. She is essentially without options other than to remain ill and allow her condition to continue to deteriorate until her liver damage is so severe that she qualifies for treatment.
Statements of policy can be useful in expediting approval for individuals whose condition OHHS has determined fulfills the medical necessity requirement. They cannot, however, be used as a mechanism to deny individuals coverage for services without consideration of their individual medical need for those services. See Pinneke, 623 F.2d at 550 ("[t]he decision of whether or not certain treatment . . . is 'medically necessary' rests with the individual recipient's physician and not with clerical personnel or government officials").
The Hearing Officer's decision is clear: neither UHCCP nor OHHS determined whether Harvoni was medically necessary to treat Appellant's hepatitis C. As medical necessity is at the core of the state's obligation to provide services to Medicaid recipients under the Medicaid Act, this Court finds that the Hearing Officer's decision denying Appellant Medicaid coverage for Harvoni was arbitrary and capricious.
IV
Conclusion
After reviewing the entire record, this Court finds that the Hearing Officer's decision was arbitrary and capricious in that it failed to evaluate or respond meaningfully to Ms. Strese's medical need for Harvoni. Consequently, as substantial rights of the Appellant were prejudiced, this Court sustains Ms. Strese's appeal, vacates the Hearing Officer's decision, and remands this case to OHHS for a new hearing limited to the issue of whether Harvoni is medically necessary for Ms. Strese. On remand, OHHS should consider, among other relevant factors, Ms. Strese's unique treatment experience, lack of other available treatment options, and her treating physician's medical opinion.
Counsel shall submit the appropriate order for entry.
ATTORNEYS:
For Plaintiff: Gretchen M. Bath, Esq.
For Defendant: Gregory Hazian, Esq.