Case Information
*2 Before WOLLMAN, BEAM, and BENTON, Circuit Judges.
___________
BENTON, Circuit Judge.
Plaintiffs – disabled adult Medicaid recipients – seek a preliminary injunction prohibiting Missouri's Director of Social Services from enforcing a state regulation curtailing the provision of durable medical equipment ("DME") to most categorically- needy Medicaid recipients. See Mo. Code Regs. Ann. tit. 13, § 70-60.010 (2005) . Invoking 42 U.S.C. § 1983 and the Supremacy Clause, U.S. Const. Art. VI, cl. 2, they allege that the regulation violates Medicaid's comparability and reasonable-standards requirements. See 42 U.S.C. §§ 1396a(a)(10)(B), (a)(17) . The district court denied a preliminary injunction, finding the regulation consistent with the Medicaid Act. Plaintiffs appeal. Having jurisdiction under 28 U.S.C. § 1292(a)(1), this court vacates the order of the district court, and remands for further proceedings.
I.
Before the 2005 legislative session, Missouri provided DME as a stand-alone Medicaid benefit to all recipients. Under the DME program, plaintiffs received wheelchairs, wheelchair batteries and repairs, orthotics, orthopedic devices, parenteral nutrition, augmentative communication devices, hospital beds, bed rails, lifts, and other prosthetics. Mo. Rev. Stat. § 208.152.1(15) (repealed August 28, 2005). Citing budget constraints, the General Assembly passed a new statute eliminating the DME program as a covered Medicaid service, except for recipients who are blind, pregnant, or needy children, or for those who receive home health care services under the state plan. Mo. Rev. Stat. § 208.152.2 (Supp. 2005) (providing an exception for wheelchairs, prosthetics, and orthopedic devices to these individuals). Under the revised statute, Medicaid recipients may not receive DME as a stand-alone benefit, unless they fall within one of the statutory groups.
Plaintiffs have never challenged the statute's elimination of the DME program. Rather, plaintiffs contest a September 2005 emergency regulation, which reinstates coverage of certain DME items for all Medicaid recipients, while specifically defining the statutorily-provided DME items for the blind, pregnant, and needy children, and those receiving home health care. Mo. Code Regs. Ann. tit. 13, § 70-60.010 (2005) . [1]
Under the regulation, the blind, pregnant, needy children, and individuals who receive home health care may receive Medicaid coverage for DME items that include, but are not limited to:
Prosthetics; orthotics; oxygen and respiratory care equipment; parenteral nutrition; ostomy supplies; diabetic supplies and equipment; decubitus care equipment; wheelchairs; wheelchair accessories and scooters; augmentative communication devices; and hospital beds.
Id. § 70-60.010.6 . All other adult Medicaid recipients cannot receive Medicaid- funded DME, except for:
Prosthetics, excluding an artificial larynx; ostomy supplies; diabetic supplies and equipment; oxygen and respiratory equipment, excluding CPAPs, BiPAPs, nebulizers, IPPB machines, humidification items, suction pumps and apnea monitors; and wheelchairs, excluding wheelchair accessories and scooters.
Id.
The regulation further clarifies that, for all DME recipients, "DME is equipment that can withstand repeated use, is primarily and customarily used to serve a medical *4 purpose, generally is not useful to a person in the absence of an illness or injury, and is appropriate for use in the home." Id. § 70-60.010(4) . Even if an item is classified as DME, it is not covered unless it both meets the DME definition and "is reasonable and necessary for treatment of the illness or injury, or to improve the functioning of a malformed or permanently inoperative body part." Id. § 70-60.010(6) .
Plaintiffs, adult Medicaid recipients, have disabilities ranging from paralysis to cardiopulmonary disease. Before the new regulation, they received medically- prescribed DME from Medicaid. Under the new regulation, however, plaintiffs claim they are ineligible to receive DME items that are necessary for their medical care and independence (which they cannot afford). Compared to the repealed DME program, they argue, the new regulation excludes (for most recipients) orthotics, parenteral nutrition, catheters, augmentative communication devices, hospital beds, bed rails, lifts, and wheelchair batteries and repair items.
Rather than attack the revised statute, plaintiffs seek to enjoin the DME regulation. Plaintiffs agree that Missouri may lawfully provide additional benefits only to needy children and pregnant women. 42 U.S.C. § 1396a(a)(10)(G)(V), 42 C.F.R. § 440.250(p) (pregnant women); 42 U.S.C. §§ 1396a(a)(4)(B), 1396d(r) , 42 C.F.R. § 440.250(b) (needy children). Plaintiffs contend that Missouri may not provide additional DME benefits to blind recipients (unless Missouri provides those benefits to all adult recipients). Plaintiffs assert violations of federal comparability and reasonable-standards requirements that the State treat Medicaid recipients equally and with reasonable, non-discriminatory standards. See 42 U.S.C. §§ 1396a(a)(10)(B), (a)(17) . See also 42 C.F.R. § 440.230 . They also claim that the state regulation conflicts with these federal requirements, and is preempted by the Supremacy Clause. U.S. Const. Art. VI, cl. 2.
In the district court, the State defended the DME regulation primarily by arguing that it had applied to the Centers for Medicare and Medicaid Services *5 ("CMS") for a waiver of the federal comparability requirement, which would permit additional benefits for the blind. 42 U.S.C. § 1396n(b) . The State argued that the waiver application defeated plaintiffs' likelihood of success on the merits. The State also claimed that plaintiffs can still obtain necessary DME if they (1) qualify for home health care, or (2) seek an exception for non-covered DME items through the exceptions process. Due to these options, said the State, the DME regulation did not harm plaintiffs enough to justify an injunction.
The district court denied a preliminary injunction. The court focused entirely on plaintiffs' comparability claim, and did not discuss the reasonable-standards claim. Specifically, the court determined that, because plaintiffs had other options to receive necessary DME, they could not establish irreparable harm. Moreover, the court agreed that Missouri's pending waiver application precluded a likelihood of success on the merits. The court noted, however, that if the waiver were not obtained, Missouri could not provide additional items of DME to the blind (without providing them to all adult recipients). Plaintiffs appeal. [2]
II.
Before addressing the merits, this court must resolve the issue of mootness –
a jurisdictional issue raised in the State's supplemental brief and at oral argument.
See
Ali v. Cangemi
,
The State argues that its decision to fund the DME program for blind recipients
only with state dollars makes the amended plan comply with all Medicaid rules,
rendering this case moot. It is well-settled that "a defendant's voluntary cessation of
a challenged practice does not deprive a federal court of its power to determine the
legality of the practice."
City of Mesquite v. Aladdin's Castle, Inc.
,
The State does not meet the "heavy burden" to show mootness. Despite the
claim of voluntary cessation, the State may reinstate a Medicaid plan that uses federal
funding for additional assistance to the blind.
Charleston Hous. Auth. v. U.S.
Dep't of Ag.
,
III.
A motion for preliminary injunction requires the district court to consider four
factors: (1) the probability of success on the merits, (2) the threat of irreparable harm
to the movant, (3) the balance between the harm and the injury that granting the
injunction will inflict on other interested parties, and (4) the public interest.
See
Dataphase Sys. v. C L Sys., Inc.
,
The district court has broad discretion when ruling on preliminary injunctions.
See
Manion v. Nagin
,
IV.
The Medicaid Act is a federal aid program designed to help the states provide
medical assistance to financially-needy individuals, with the assistance of federal
funding.
See
Schweiker v. Hogan
, 457 U.S. 569, 572 (1982);
Hodson v. Bd. of
County Comm'rs
,
Participating states must furnish medical assistance to the "categorically needy,"
a group that includes financially-needy blind, aged, and disabled individuals, pregnant
women, and children.
See
42 U.S.C. § 1396a(a)(10)(A)
. A state may also choose to
provide medical assistance to the "medically needy" – those who do not qualify under
a federal program, but lack the resources to obtain adequate medical care.
See
id.
§
1396(a)(10)(C)
;
Gray Panthers
,
Once a state decides which groups will receive medical assistance under the plan, it then determines which services it will provide. 42 U.S.C. § 1396d(a) . To receive federal approval, the Medicaid Act mandates that a plan include only seven enumerated medical services. id. §§ 1396a(a)(10) , 1396d(a)(1)-(5), (17), (21) (including as mandatory: inpatient hospital, outpatient hospital, laboratory and x-ray, nursing facility, physician, nurse-midwife, and nurse-practitioner services).
A state may also elect to provide optional medical services, such as dental
services, prosthetics, and prescription drugs.
See
id.
§§ 1396(a)(10)(A)
,
1396(d)(a)
(listing 27 categories of medical assistance, only seven of which are mandatory).
Once the state offers an optional service, it must comply with all federal statutory and
regulatory mandates.
See
Ellis v. Patterson
,
DME is an optional service under the Medicaid Act, unless the recipient
qualifies for home health care.
See
42 U.S.C. § 1396a(a)(10)(D)
. The provision of
home health care is a mandatory requirement of the state plan, if the individual is
entitled to nursing facility services.
See
id.
;
42 C.F.R. § 440.210(a)(1)
. Under the
federal regulations, "home health services" are medically-prescribed services provided
to a Medicaid recipient at his or her place of residence.
42 C.F.R. § 440.70(a)
. If a
recipient receives home health services, the state also must provide "medical supplies,
equipment, and appliances suitable for use in the home" as part of the program.
See
id.
§§ 440.70(b)(3), 441.15(a)(3)
. Federal law does not define these terms for
purposes of Medicaid.
DeSario v. Thomas
,
Missouri funds home health care to Medicaid recipients who meet certain requirements. Mo. Rev. Stat. § 208.152.2(10) (Supp. 2005). Specifically, the recipient must (1) require intermittent nursing care or therapy, (2) be confined to the home, (3) have a prescription for home health services from a physician, and (4) receive the services in the home from a qualified provider. Mo. Code Regs. Ann. tit. 13, § 70-90.010(1) . "A recipient may be considered homebound even if s/he occasionally leaves home for non-medical purposes, as long as these absences are infrequent, or relatively short duration, and do not indicate that the recipient has the capacity to obtain the needed care on an outpatient basis." Id. § 70-90.010(3) . If the individual qualifies for home health care under Missouri's regulation, prescribed items of DME are covered. See id. § 70-90.010(4) . The State asserts that the provision of *10 DME items under Missouri's home health care program is not limited to the items prescribed under the new DME regulation. Compare id. § 70-60.010(6) (2005), with id. § 70-90.010(4) .
In this case, no plaintiff receives home health care under the state plan. As plaintiffs are not blind, pregnant, or children, the list of DME items that Missouri will reimburse is curtailed. See id. § 70-60.010(6) . As the State points out, if a DME item is prescribed that is not covered under the DME regulation, plaintiffs have two options. First, they can seek qualification for home health care under the state plan. See id. § 70-90.010 . Second, they can seek an exception for non-covered items through the exceptions procedure. See id. § 70-2.100 . As these options do not treat plaintiffs the same as blind recipients under the state plan, and do not afford an opportunity to obtain non-covered DME items, plaintiffs allege that the DME program does not meet federal Medicaid requirements.
A. Comparability
The new regulation eliminates coverage of most DME items for the
categorically-needy who are aged or disabled. The regulation maintains full DME
coverage for categorically-needy recipients who are blind. Plaintiffs claim this
violates Medicaid's comparability requirement that states provide an equal "amount,
duration, [and] scope" of medical assistance to all categorically-needy.
42 U.S.C.
§ 1396a(a)(10)(B)(i)
;
42 C.F.R. §§ 440.240(a)
,
(b)(1)
;
Hogan
,
The district court found that the DME regulation complies with Medicaid's comparability requirement, primarily because Missouri had a comparability waiver pending with CMS. The record has significantly changed. CMS denied the waiver. The Director of Social Services and the Missouri Attorney General represent to this court that Missouri has now deleted the part of its state plan that calls for federal funding of additional services to the blind. As the current state plan provides an equal amount, duration, and scope of DME services to all categorically-needy recipients, and Missouri uses only state funding to provide additional DME services to the blind, the State contends that its program is consistent with the comparability requirement.
While a state plan must comply with all federal statutory and regulatory
requirements, a state may give additional medical assistance under its own legislation,
independent of federal reimbursement.
Harris v. McRae
,
As Missouri represents to this court that it does not accept federal assistance, and uses only state funds, to provide additional DME benefits to blind Medicaid recipients, this court finds that the DME regulation (as currently funded) does not violate the federal comparability requirement.
B. Reasonable Standards
Plaintiffs next allege that the DME regulation violates Medicaid's requirement
that the state create reasonable standards for determining the extent of medical
assistance under the plan, which are consistent with Medicaid's objectives.
42 U.S.C.
§ 1396a(a)(17)
.
Wis. Dep't of Health & Family Servs. v. Blumer
,
While optional DME programs are not explicitly subject to these requirements,
CMS (the agency that administers Medicaid) maintains that the reasonable-standards
provisions apply to all forms of medical assistance, including a state's provision of
DME.
See
Slekis v. Thomas
, 525 U.S. 1098, 1099 (1999) (remanding based on
September 4, 1998, CMS letter to state Medicaid directors, which advised that DME
is subject to the federal reasonable-standards requirements).
See also
St. Mary's
Hosp. of Rochester v. Leavitt
,
Plaintiffs argue that the limited DME services in the Missouri regulation are inconsistent with these mandatory reasonableness requirements, because they discriminate on the basis of diagnosis, do not provide a sufficient amount of DME services to meet Medicaid's objectives, and fail to establish a procedure for recipients to obtain non-covered DME items. Citing conflicts between the Missouri regulation and the federal reasonable-standards requirements, they also contend that the state regulation is preempted under the Supremacy Clause. The district court did not address these arguments, focusing solely on comparability.
1.
Plaintiffs' discrimination argument is very similar to their comparability claim, as it is based on the provision of additional DME services to blind recipients. Specifically, they contend that the regulation is facially unreasonable, because it discriminates on the basis of a medical condition or diagnosis – blindness – in violation of 42 C.F.R. § 440.230(c).
Like plaintiffs' comparability claim, this argument is foreclosed by Missouri's
recent amendment to its plan. Because the State represents that it is independently
funding the provision of additional DME services to the blind, the amended plan
complies with the federal regulation.
See, e.g.,
Neb. Health Care Ass'n
,
2.
The State asserts that there is no individualized federal right to reasonable
Medicaid standards, enforceable under 42 U.S.C. § 1983.
See, e.g.,
Gonzaga Univ.
v. Doe
,
The State argues that, because this legal issue decreases the likelihood that
plaintiffs will succeed on the merits of their reasonable-standards claim, it is
reviewable by this court. As this issue directly affects plaintiffs' probability of success
– a critical factor in whether a preliminary injunction should issue – and the district
court did not discuss this claim in denying the injunction, this court agrees.
See, e.g.
,
S. Camden Citizens in Action v. N.J. Dep't of Envtl. Protection
,
For legislation enacted pursuant to Congress's spending power, like the
Medicaid Act, a state's non-compliance typically does not create a private right of
action for individual plaintiffs, but rather an action by the federal government to
terminate federal matching funds.
Pennhurst State Sch. & Hosp. v. Halderman
,
A three-part test determines whether Spending Clause legislation creates a right of action under 42 U.S.C. § 1983: (1) Congress intended the statutory provision to benefit the plaintiff; (2) the asserted right is not so "vague and amorphous" that its enforcement would strain judicial competence; and (3) the provision clearly imposes a mandatory obligation upon the states. Blessing , 520 U.S. at 340-41. If the legislation meets this test, there is a presumption it is enforceable under section 1983. Id. at 341. The presumption is rebutted if Congress explicitly or implicitly forecloses section 1983 enforcement. Id. (noting that implied foreclosure occurs if Congress creates "a comprehensive enforcement scheme that is incompatible with individual enforcement"). The availability of administrative mechanisms alone, however, cannot defeat the plaintiff's ability to invoke section 1983, so long as the other requirements of the three-part test are met. id. at 347.
In
Gonzaga University v. Doe
, the Supreme Court clarified the first prong,
holding that "anything short of an unambiguously conferred right" does not support
an individual right of action under section 1983.
Gonzaga
,
Medicaid's reasonable-standards requirement provides that a state Medicaid
plan must "include reasonable standards . . . for determining eligibility for and the
extent of medical assistance under this plan."
42 U.S.C. § 1396a(a)(17)
. Like the
Ninth Circuit – the only other circuit to address this issue – this court finds the
statutory language insufficient to evince a congressional intent to create individually-
enforceable federal rights.
See
Watson v. Weeks
, 436 F.3d 1152, 1162 (9th Cir.
2006). First, the statute is not phrased in terms of the individuals it intends to benefit,
as it lacks any reference to "individuals" or "persons."
Id.
(noting this omission is
"fatal under
Gonzaga
to the existence of a section 1983 right"),
citing
Gonzaga
U.S. at 284. Rather than focusing on an individual entitlement to medical services,
the reasonable-standards provision focuses on the aggregate practices of the states in
establishing reasonable Medicaid services.
See, e.g.
,
Gonzaga
,
Even if the statute referenced the individuals benefitted, "the right it would
create is too vague and amorphous for judicial enforcement."
Watson
,
3.
Plaintiffs claim that the Missouri DME regulation is preempted by the
Supremacy Clause, because it directly conflicts with Medicaid's reasonable-standards
requirements.
U.S. Const. Art. VI, cl. 2
. The Supremacy Clause is not the direct
source of any federal right, but "secures federal rights by according them priority
whenever they come in conflict with state law."
Golden State Transit Corp. v. City
of Los Angeles
,
Under the preemption doctrine, state laws that "interfere with, or are contrary
to the laws of congress, made in pursuance of the constitution" are preempted.
Wis.
Pub. Intervenor v. Mortier
,
In this case, plaintiffs claim that Missouri's DME regulation conflicts with the
federal regulations that implement Medicaid's reasonable-standards requirement.
See
42 C.F.R. § 440.230(b)
. "Federal regulations can preempt state laws . . . if the
agency, acting within the scope of its delegated authority, intends them to."
Wuebker
v. Wilbur-Ellis Co.
,
When a state receives federal matching funds, its medical assistance program
must comply with all federal statutory and regulatory requirements.
Meyers v.
*19
Reagan
,
Missouri's amended plan includes only three categories of "prosthetic devices" available to all adult Medicaid recipients: ostomy supplies, oxygen and respiratory equipment, and wheelchairs. [3] The DME regulation says that adult Medicaid recipients are also entitled to diabetic supplies and equipment, but not artificial larynxes, CPAPs, BiPAPs, IPPB machines, humidification items, suction pumps, apnea monitors, wheelchair accessories, or scooters. Mo. Code Regs. Ann. tit. 13, § 70-60.010(6) (2005). Plaintiffs argue that these limitations make Missouri's amended Medicaid plan unreasonable in light of the purposes of Medicaid. See 42 U.S.C. §§ 1396, 1396a(a)(17) ; 42 C.F.R. § 440.230(b) .
Plaintiffs contend that the limited DME items available to all adult Medicaid recipients are insufficient in amount and scope to reasonably achieve the purpose of the DME program. 42 C.F.R. § 440.230(b) . For example, the regulation covers wheelchairs, but excludes funding for the batteries, filters, accessories, repairs, and other types of replacement parts necessary to keep the equipment functioning. It *20 covers oxygen and other limited respiratory equipment, but not other equipment, such as suction pumps, apnea monitors, and humidification devices that is medically necessary to assist in breathing. Moreover, the regulation completely excludes items like augmentative communication devices, catheters, and parenteral nutrition supplies. Given these limits, plaintiffs claim that the regulation does not meet Medicaid's goals of providing medically-necessary services, rehabilitation, or the capability of independence and self-care. See 42 U.S.C. § 1396 .
While a state has discretion to determine the optional services in its Medicaid
plan, a state's failure to provide Medicaid coverage for non-experimental, medically-
necessary services within a covered Medicaid category is both per se unreasonable
and inconsistent with the stated goals of Medicaid.
See
Meusberger v. Palmer
F.2d 1280, 1282 (8th Cir. 1990) (organ transplants);
Weaver
,
The State responds that pre-approved lists of DME are acceptable under
Medicaid's reasonable-standards provisions.
42 C.F.R. § 440.230(d)
(allowing
utilization controls as a means of administrative convenience). While a state may use
a pre-approved list, CMS has directed that the state must include specific criteria for
the extent of DME coverage under the plan, and a mechanism for recipients to request
timely reimbursement for non-covered, medically-necessary items.
Letter from
Sally K. Richardson
, Director of the Center for Medicaid and State Operations, to
*21
State Medicaid Directors 1 (Sept. 1, 1998). According to CMS, a policy without a
meaningful procedure for requesting non-covered items is inconsistent with the
reasonable-standards requirement and the objectives of Medicaid.
Id.
While these
requirements are not explicit in the federal Medicaid regulations, CMS's interpretation
is entitled to considerable deference.
See
Slekis
,
The State contends that it meets these federal mandates, as all Medicaid recipients have two options for receiving non-covered DME items under the state Medicaid plan. First, recipients can qualify for home health care services, requiring necessary DME items to be provided. See Mo. Code Regs. Ann. tit. 13, § 70- 90.010(4) . Second, recipients can seek reimbursement for non-covered items through the established exceptions process. See id. § 70-2.100 . Plaintiffs respond that neither option is a meaningful procedure for requesting non-covered items.
Plaintiffs aver – although the state questions – that they do not qualify for home health care under Missouri's plan, because it is available only to individuals who both require skilled-nursing services and are confined to the home. See id. §§ 70- 90.010(1) . While the federal regulation requires that DME items be "suitable for use in the home," it does not mandate that an individual recipient be homebound or receive skilled-nursing services to receive DME as part of home health care. 42 C.F.R. § 440.70(b)(3) . In fact, CMS specifically instructs that a homebound requirement is an improper restriction for the provision of any home health care service. Letter from the Center for Medicaid and State Operations , to State Medicaid Directors 1 (July 25, 2000), Letter from James G. Scott , Associate *22 Regional Administrator for Medicaid and Children's Health, to Gary Sherman, Director of the Missouri Department of Social Services 2 (Nov. 21, 2005) (Missouri may not institute a homebound requirement or mandate that recipients receive skilled nursing services to receive home health services). See also Skubel v. Fuoroli F.3d 330, 337 (2d Cir. 1997) (home health care nursing services cannot be limited to the recipient's home).
As CMS recognizes, restricting home health care to the homebound "ignores
the consensus among health care professionals that community access is not only
possible, but desirable for individuals with disabilities."
Letter from the Center
for Medicaid and State Operations
, at 1.
See also
Olmstead v. L.C.
,
Plaintiffs also assert that Missouri's exceptions process does not provide them with an adequate mechanism to obtain non-covered DME items. To qualify for an exception, a Medicaid provider must demonstrate that: (1) the item is needed to sustain life; (2) the item will substantially improve the qualify of life for a terminally- *23 ill patient (3) the item is necessary as a replacement due to an act of nature; or (4) the item is necessary to prevent a higher level of care. Mo. Code Regs. Ann. tit. 13, § 70-2-100(2)(J) . Even if the provider makes this demonstration, "no exception can be made where requested items or services are restricted or specifically prohibited under state or federal law." Id. § 70-2.100(1) .
The State clarified the exceptions process for non-covered DME items in an August 29, 2005, notice to providers. The notice advises that the exceptions process is available to recipients with respiratory conditions who require use of pre-approved BiPAP, CPAP, or nebulizer machines, even though such items are technically prohibited under the revised DME regulation. id. § 70-60.010(6) (2005). The notice also identifies as "not covered" other DME items, such as hospital beds, wheelchair batteries and repairs, and leg braces, and makes no reference to an available exception for them. As the regulation allows no exception for items that are restricted under state law – and the DME regulation specifically restricts all non- covered DME items – the exceptions process does not appear to provide a reasonable opportunity to obtain non-covered items.
Because the DME regulation restricts available DME, and plaintiffs have no
other procedure to obtain it, the regulation – on the present record – appears
unreasonable under directives from both CMS and this court.
See, e.g.
,
Meusberger
,
V.
Likelihood of success on the merits is only one of the four factors determining
whether a preliminary injunction should issue.
Dataphase
,
______________________________
Notes
[1] The validity of the emergency regulation in light of the revised statute has not been raised in this litigation.
[2] The parties' motions to supplement the record are granted, and the exhibits are considered in this appeal. Dakota Indus., Inc. v. Dakota Sportswear, Inc. F.2d 61, 63 (8th Cir. 1993).
[3] The plan also provides that home parenteral nutrition services, electric wheelchairs, electric hospital beds, and back-up ventilators may be provided upon prior authorization. It is unclear whether these services are available to all Medicaid recipients, or only those who qualify for home health care. While neither party provides guidance on the implementation of this provision, the DME regulation appears to limit these services to home health care recipients. Mo. Code Regs. Ann. tit. 13, § 70-60.010(6) (2005).
