Do Sung Uhm v. Humana, Inc.Do Sung Uhm v. Humana, Inc.
Opinion by Judge PAEZ; Concurrence by Judge B. FLETCHER.
OPINION
Plaintiffs-Appellants Do Sung Uhm and Eun Sook Uhm (“the Uhms”) appeal the district court’s order dismissing their complaint against Defendants-Appellees Humana Health Plan, Inc., and Humana, Inc., (collectively, “Humana”) on the ground that their claims are preempted by the express preemption provision of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (“MMA” or “the
1. FACTS
The Act established Medicare Part D (“Part D”), a voluntary prescription drug benefit program for seniors.
See
In late 2005, the Uhms — Medicare beneficiaries — chose Humana as their Part D provider based in part on the representations Humana made in its marketing materials. 5 In particular, the Uhms relied on Humana’s representation that they would be enrolled in the benefits plan and accordingly receive coverage for their prescription drugs beginning January 1, 2006, the first day Part D sponsors could provide benefits under the Act.
Intending to enroll in Humana’s program, the Uhms submitted the Humana Prescription Drug Plan Enrollment Form. The Uhms chose “Social Security Check Deduction” as their method of premium payment. Accordingly, the $6.90 plan premium was deducted from their January 2006 and February 2006 social security checks.
January 1, 2006, came and passed, and the Uhms did not receive the materials necessary for obtaining their drug benefits. The Uhms were forced to buy their prescription medications out-of-pocket at costs higher than those provided by Humana’s plan, despite the fact that the PDP premium was deducted from their social security checks in both January and February of that year.
On February 6, 2006, the Uhms filed a complaint against Humana Health Plan, Inc., and Humana, Inc.,
6
in the U.S. District Court for the Western District of Washington, claiming breach of contract, violation of several state consumer protection statutes, unjust enrichment, fraud, and fraud in the inducement. The Uhms filed the complaint on behalf of themselves and a putative class consisting of “all persons who paid and/or were billed by Humana, for enrollment in the Humana Part D PDP and (a) did not rеceive benefits under the Humana Part D PDP, and/or (b) whom Humana failed to actually enroll in the Humana Part D PDP, and/or (c) whom Humana enrolled in the Humana Part D PDP on a date or dates later than the date or dates promised by Humana.” They invoked federal subject matter jurisdiction over the suit under the Class Action Fairness Act of 2005 and
Humana responded with a motion to dismiss under
The Uhms filed a motion for partial reconsideration, arguing that their claims were not preempted with respect to Humana, Inc., because Humana, Inc., is not a CMS-approved PDP provider. The district court denied that motion. The Uhms timely appealed both orders.
II. ANALYSIS
A. Standard of Review
We review de novo the district court’s dismissal of a case under
B. Exhaustion of Administrative Remedies
Humana argues that the Uhms’ claims must be exhausted through the Act’s administrative remedial scheme before a federal court may exercise jurisdiction under the Medicare Act. The issue of exhaustion bears on the district court’s jurisdiction,
see Kaiser v. Blue Cross of Cal.,
The Act’s exhaustion requirement,
Humana contends that the Uhms’ claims are subject to these provisions and that the Uhms have failed to exhaust those claims. The Uhms admit they have not pursued any of their claims through the Act’s administrative processes, but argue that they need not exhaust their administrative remedies because their claims do not “arise under” the Medicare Act. They further contend that because their claims arose before they were enrolled in the program, they did not have access to the Act’s remedial mechanisms and therefore cannot be subject to the exhaustion requirements. We address these arguments in turn.
(1) “Arising Under” the Medicare Act
The key inquiry in determining whether
The Supreme Court has identified two circumstances in which a claim “arises under” the Medicare Act: (1) where the “standing and the substantive basis for the presentation of the claims” is the Medicare Act,
Heckler,
In
Kaiser,
we held that even a state law claim may “arise under” the Medicare Act.
Kaiser
also forecloses the Uhms’ argument that, because they are not seeking reimbursement of lost benefits, their claims do not “arise under” the Act. We held in
Kaiser
that whether or not plaintiffs seek reimbursement of benefits is not “strоngly probative” of whether a claim “arises under” the Medicare Act.
Id.
at 1112. The plaintiffs there argued that their claims did not “arise under” the Medicare Act because they were seeking damages beyond the reimbursement of benefits.
Id.
We disagreed, pointing to a number of cases in which the Supreme Court had refused to treat the remedy sought as dispositive of the “arising under” question.
Id.; see also Shalala v. III. Council on Long Term Care, Inc.,
Our opinion in
Ardary,
In sum, contrary to the Uhms’ argument, our case law establishes that where, at bottom, a plaintiff is complaining about the denial of Medicare benefits— here, drug benefits under Part D — the
(a) Breach of Contract and Unjust Enrichment
The Uhms’ primary complaint, and the basis of their breach of contract and unjust enrichment claims, is that, despite having paid their monthly premiums and having filed the appropriate enrollment documents, Humana failed to provide them with drug benefits. See, e.g., Compl. ¶4.12 (“Plaintiffs Uhm bring this action against Defendants on behalf of themselves and all persons who paid and/or were billed by Humana, for enrollment in the Humana Part D PDP and (a) did not receive benefits under the Humana Part D PDP....”); ¶6.4 (“Defendants breached each contract with Plaintiffs and with each Class member when they failed to provide prescription drug benefits as promised.”); ¶ 8.2 (“Defendants received monies as a result of payments made by Plaintiffs and Class members for prescription drug benefits that Defendants failed to provide to Plaintiffs and Class members.”). More specifically, the Uhms’ breach of contract claim is premised on the fact that Humana “failed to provide prescription drug benefits as promised.” Likewise, the Uhms’ unjust enrichment claim alleges that “[Humana] received monies as a result of payments made by [the Uhms] and Class members for prescription drug benefits that [Humana] failed to provide.”
After a careful review of these claims, we conclude that they are, at bottom, merely creatively disguised claims for benefits. While the Uhms assert that they are not seeking to remedy a denial of benefits due under the Act, we find this argument unconvincing. Indeed, the Uhms have not alleged that Humana promised anything more than to abide by the requirements of the Act. Nor did they identify or describe in their complaint any provision creating obligations above and beyond Humana’s obligations under the Act. Thus, there is no claim that the alleged contract imposed upon Humana any duties above and beyond compliance with the Act itself. Instead, the Uhms’ breach of contract claim is a backdoor attempt to enforce the Act’s requirements and to secure a remedy for Humana’s alleged failure to provide benefits. For example, the Uhms claim that Humana promised to provide them with benefits beginning January 1, 2006 — the date that the Act’s implementing regulations set. See 42 C.F.K. § 423.40(a) (2005) 12 (setting effective dates of enrollment which would have required the Uhms’ coverаge to begin January 1, 2006). The Uhms’ unjust enrichment claim fares no better, as it seeks to vindicate the same alleged injury, based upon the same alleged promises, and thereby to enforce the benefit requirements of the Act via an implied contract, rather than an express one. 13
Furthermore, the Uhms’ claim for benefits could have been remedied through the Act’s administrative review process.
Cf. Ardary,
In sum, because the Uhms’ contract and unjust enrichment claims arise under the Medicare Act, they should have exhausted their claims for benefits through the coverage determination or grievance process and then sought judicial review under
The Uhms, however, argue that, even if the exhaustion requirements apply to them, they should be excused from- those requirements because pursuit of administrative remedies would be futile.
See S.E.C. v. G.C. George Sec., Inc.,
Exhaustion is generally required as a matter of preventing premature interference with agency processes, so that the agency may function efficiently and so that it may have an opportunity to correct its own errors, to afford the parties and the courts the benefit of its experience and expertise, and to compile a record which is adequate for judicial review. If a court were to prematurely tackle a question inextricably intertwined with an issue properly resolved by an agency, the court would defeat the purposes of§ 405(g) and (h) even if the question was not one that the agency has the authority to answer fully.
Id.
(internal citation and quotation omitted). Despite the fact that administrative remedies may not be available against Humana, Inc., claims “arising under” the Act must be brought before the Secretary before judicial review can be sought. Thus, we hold that the Uhms cannot circumvent
We thus conclude that the district court lacked jurisdiction over the Uhms’ breach of contract and unjust enrichment claims.
(b) Fraud and Consumer Protection Act Claims
The Uhms’ consumer protection act and fraud claims allege that Humana made material misrepresentations and engaged in other systematic deceptive acts in the marketing and advertising of their Part D plan to induce the Uhms and putative class members to enroll. Specifically, the Uhms allege that Humana misrepresented that their prescription drug coverage would begin on January 1, 2006, and that Humana is committed to providing “reliable customer service” and “has been a trusted Medicare insurer for more than 20 years, helping the Medicare population with their health insurance needs.” We hold that these claims do not “arise under” the Act and therefore are not subject to its exhaustion requirements. The basis of these claims is an injury collateral to any claim for benefits; it is the misrepresentations themselves which the Uhms seek to remedy. The Uhms may be able to prove the elements of these causes of action without regard to any provisions of the Act relating to provision of benefits. To the extent that is the case, the Uhms claims are not subject to the Act’s exhaustion provisions.
See Heckler,
(2) The Uhms’Enrollment Status When the Claims Arose
The Uhms argue that, even assuming our analysis of exhaustion is correct, the Act’s exhaustion provisions do not apply to them because they were not enrolled in the program at the time their claims arose. We find that the pertinent question is not whether the Uhms were “enrolled,” but rather whether they were “enrollees” within the meaning of the Act and its regulations. We conclude that they are properly classified as “enrоllees.”
The Uhms allege that Humana “failed to actually enroll” them in the PDP, and
The relevant section of the implementing regulations in force at the time of the alleged injury, titled “Enrollment process,” provides:
A Part D eligible individual who wishes to enroll in a PDP may enroll during the enrollment periods specified in § 423.38, by filing the appropriate enrollment form with the PDP or through other mechanisms CMS determines are appropriate.
“Enroll,” therefore has two distinct (if related) usages. An eligible individual “enrolls” by filing the enrollment form with the PDP sponsor.
See
Although the Uhms allege, and we accept, that a Humana customer service representative told the Uhms that they were “not recognized as members of the Humana Part D PDP,” the Uhms do not allege that Humana issued them a “notice of ... denial of [their] enrollment request, in a format and manner specified by CMS.”
See
Fortunately, this case does not require us to discern the exact moment at which a
According to the regulation, “[ejnrollee means a Part D eligible individual who has elected or has been enrolled in a Part D plan.”
C. Preemption
(1) The Preemption Provision
Humana contends, and the district court ruled, that each of the Uhms’ state law claims is preempted by the Act’s express preemption provision. As we have concluded that the Uhms’ breach of contract and unjust enrichment claims fall within the Act’s exhaustion requirements and have yet to be exhausted, we turn to the Uhms’ fraud, fraud in the inducement, and consumer protection act claims.
The Supreme Court has made clear that Congress may displace state law through express preemption provisions.
Altria Group, Inc. v. Good,
— U.S. -,
Medicare Part D incorporates the express preemption provision contained in Part C, the Medicare Advantage (“MA”) program, which provides medical benefits to seniors through managed care. 19 The Part D preemption provision states:
The provisions of sections 1395w-24(g) [ (prohibition of premium taxes) ] and 1395w-26(b)(3) [ (preemption) ] of this title shall apply with respect to PDP sponsors and prescription drug plans under this part in the same manner as such sections apply to MA organizations and MA plans under part C of this subchapter.
The Part C preemption provision in turn provides:
The standards established undеr this part shall supersede any State law or regulation (other than State licensing laws or State laws relating to plan solvency) with respect to MA plans which are offered by MA organizations under this part.
The issue here is precisely
which
claims fall within the ambit of this provision. In other words, what qualifies as a state law or regulation “with respect to” a PDP? The phrase “with respect to” is not defined in the Act, but the Act’s legislative history provides guidance as to its meaning. Pri- or to the 2003 amendments, the preemption clause provided that federal standards would supersede state law and regulations “with respect to” MA plans only “to the extent such law or regulation is inconsistent with such standards” and specified several “[s]tandards specifically superseded.”
The conference agreement clarifies that the MA program is a federal program operated under Federal rules. State laws, do not, and should not apply, with the exception of state licensing laws or state laws related to plan solvency. There has been some confusion in recent court cases.
H.R.Rep. No. 108-391, at 557 (2003) (Conf. Rep.).
23
That passage indicates that Con
For present purposes, however, the precise degree to which the 2003 amendment expanded the preemption provision beyond state laws and regulations “inconsistent” with the enumerated standards does not matter. Rather, it is sufficient for our purposes that, at the very least, any state law or regulation falling within the specified categories and “inconsistent” with a standard established under the Act remains preempted. 24 That limited scope, it turns out, is sufficient to decide this appeal. 25 To explain why, we turn to evaluating the Uhms’ claims.
(2) State Consumer Protection Statutes
To recall, the Uhms’ consumer protection act claims allege that Humana violated the consumer protection statutes of various states in which Humana operates by “systematically representing] ... that prescription drug coverage would begin January 1, 2006 for those Class members who enrolled by December 31, 2005, when in fact [Humana] knew, or should have known, that Defеndants would not be providing prescription drug coverage” beginning on that date. According to the Uhms’ complaint, these misrepresentations were both written and oral: written in the Humana Prescription Drug Plan Enrollment Form and orally stated by Humana’s employees in the course of marketing the plan. We hold that the Uhms’ claims are preempted by the extensive CMS regulations governing PDP marketing materials.
The Act provides that CMS must approve all PDP marketing materials before they are made available to Medicare beneficiaries.
See
The regulations define marketing materials as “any informational materials targeted to Medicare beneficiaries which — (1) Promote the Part D plan. (2) Inform Medicare beneficiaries that they may enroll, or remain enrolled in a Part D plan. (3) Explain the benefits of enrollment in a Part D plan, or rules that apply to enrollees. (4) Explain how Medicare services are covered under a Part D plan, including conditions that apply to such coverage.”
The Humana Prescription Drug Plan Enrollment Form on which the Uhms base their misrepresentation claim is “marketing material” as defined by the regulations. The vague oral misrepresentation that the Uhms allege as the basis for their state consumer protection act claim — that Humana’s representаtives “systematically represented” to them that they would receive Medicare Part D prescription drug plan coverage and benefits beginning January 1, 2006 — is also preempted. Those representations appear to have been made pursuant to “marketing representative materials such as scripts or outlines for telemarketing,” and, in any event, were identi
Standards relating to these materials therefore fall within a category — “Requirements relating to marketing materials”— specified under the 2000 preemption clause as “superseded.”
Thus, allowing a suit to proceed based on a state statute such as New York’s consumer protection law risks the possibility that materials CMS has deemed not misleading — and therefore allowed to be distributed — will later be determined “likely to mislead” by a state court. In other words, application of these state laws could potentially undermine the Act’s standards as to what constitutes non-misleading marketing.
30
That is precisely the situation that both the current version of the Act’s preemption provision as well as its previous incarnations contemplated and sought to avoid. As noted, in enacting Title VI of the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), Pub.L. No. 106-554,114 Stat. 2763, Congress amended
Therefore, we hold that the Uhms’ cause of action premised on these state consumer protection statutes is inconsistent with the standards established under the Act and therefore is expressly preempted.
(3) Fraud, and Fraud in the Inducement
As to the Uhms’ common law claims for fraud and fraud in the inducement, the parties dispute whether the phrase “any State law or regulation” in the preemption provision also refers to common law actions. At first blush, the scope of that phrase would appear to be controlled by the Supreme Court’s interpretation of a similar phrase — “a law or regulation” — in
Sprietsma v. Mercury Marine,
In reaching that conclusion, however, the Court relied on three statutory features of the FBSA, two of which the Act does not share. First, the Court reasoned that “the article ‘a’ before ‘law or regulation’ implies a discreteness — which is embodied in statutes and regulations — that is not present in the common law.”
Id.
Medicare Part D, by contrast, uses the phrase
“any
State law or regulation.”
Second, and critically, the Court noted that the FBSA contains a savings clause which states that “[c]ompliance with this chapter or standards, regulations, or orders prescribed under this chapter does not relieve a person from liability at common law or under State law.”
Sprietsma,
Third, the Sprietsma Court reasoned that: .
[B]ecause “a word is known by the company it keeps,” Gustafson v. Alloyd Co.,513 U.S. 561 , 575,115 S.Ct. 1061 ,131 L.Ed.2d 1 (1995), the terms “law” and “regulation” used together in the preemption clause indicate that Congresspre-empted only positive enactments. If “law” were read broadly so as to includе the common law, it might also be interpreted to include regulations, which would render the express reference to “regulation” in the pre-emption clause superfluous.
Id.
at 63,
If
Sprietsma
does not control, we are still left to determine whether the Act’s preemption clause encompasses common law claims. Having found no clear congressional intent on the face of the statute, we turn to the legislative history of the Act.
Medtronic,
(a) General preemption. Except as provided in paragraph (b) of this section, the rules, contract requirements, and standards established under this part supersede any State laws, regulations, contract requirements, or other standards that would otherwise apply to M + C organizations and their M + C plans only to the extent that such State laws are inconsistent with the standards established under this part.
Comment: A commenter asked that we revisit our position that State tort or contract remedies may be available tobeneficiaries whose coverage determination dispute goes through the Medicare appeals process. This commenter believes that coverage determination cases are contract disputes, and therefore should be the sole province of the Medicare appeals process.
65 Fed.Reg. 40170, 40261 (June 29, 2000).
In response, CMS retreated from its former position that “tort claims or contract claims under State law are not preempted”:
Response: In some cases, a case that is cast as a State contract claim may amount to a claim that services are covered under an organization’s M + C contract. We agree with the commenter that in that case, the claim would be preempted. However, there are other tort or State contract law, or consumer protection-based claims that would be entirely independent of the issue of whether services are required under M + C provisions.
Id.
Obviously, CMS’s revised interpretation of the preemption clause admits that some common law claims may be preempted. While we emphasize that the Secretary’s interpretation of the statute does not speak to congressional intent, it is important in helping to divine Congress’s subsequent intent when it amended the Part C preemption clause in December 2000
32
and again in 2003 when it passed the Medicare Modernization Act. Because, as early as June 2000, the Secretary had interpreted the phrase “any State law or regulation” to include some common law claims, we may reasonably presume that Congress was aware of that interpretation while crafting the two subsequent amendments to the Part C preemption provision.
See Abebe v. Gonzales,
CMS’s interpretations of the Part D preemption provision, while requiring no deference, further bolster our conclusion. See
Wyeth v. Levine,
— U.S. -,
Having concluded that some common law claims fall within the ambit of the Act’s preemption clause, the remaining question is whether the Uhms’ fraud and fraud in the inducement claims do. The Uhms allege that Humana made misrepresentations “that were material to the subject transactions” and that Humana “knew of the false representations of fact and intentionally entered into contracts with Plaintiffs and Class members with knowledge of these misrеpresentations.” For substantially similar reasons as those discussed in reference to the Uhms’ state consumer protection claims, these common law claims are preempted.
In the same way that an action brought under the auspices of a state consumer protection statute would be inconsistent with those standards established under the Act, so too could these tort actions pose such a problem. Indeed, the Supreme Court has indicated, and we agree, that both positive state enactments and liability under state common law may be inconsistent with standards imposed by federal statutes.
See Geier,
Here, in order to determine whether Humana committed a fraud or fraud in the inducement, a court would necessarily need to determine whether the written and oral statements were misleading.
See W. Coast, Inc. v. Snohomish Cnty.,
(I) Preemption of Claims Against Humana, Inc.
The Uhms argued in their motion for reconsideration that regardless of whether the Act preempts their claims against Humana Health Plan, Inc., their claims against Humana, Inc., are not preempted because Humana, Inc., is not a CMS-approved PDP sponsor, and the Act’s preemption provision applies only to PDP sponsors. Humana, Inc., argues that preemption under the statute is determined by whether federal standards exist with respect to the prescription drug plan, not by the identity of the defendant. We assess this argument with respect to the claims against Humana Health Plan, Inc., that we have found preempted — the fraud and consumеr protection claims — and conclude that the Uhms’ claims against Humana, Inc., are also preempted.
To recall, the Act’s preemption provision provides:
The standards established under this part shall supersede any State law or regulation (other than State licensing laws or State laws relating to plan solvency) with respect to [PDPs] which are offered by [Part D sponsors] under this part.
III. CONCLUSION
Because the Uhms’ state consumer protection claims and fraud claims fall within the ambit of the federal standards provided for in the Act and its implementing regulations, those claims are preempted. Because the breach of contract and unjust enrichment claims fall squarely within the Act’s exhaustion provision, the district court lacked jurisdiction over those claims. Accordingly, the judgment of the district court is AFFIRMED.
B. FLETCHER, Circuit Judge, concurring.
I concur in the opinion, which carefully and painstakingly analyzes the claims. I add this concurrence simply to vent my frustration. What have Uhms’ counsel accomplished for the Uhms, for justice, or for the law?
The Uhms suffered a frustrating and bureaucratic “snafu” that temporarily cost them two months’ prescription costs. They filled out the forms to receive Part D prescription drug benefits from Humana. The process obviously enrolled them to the point where automatic deductions were made from their social security checks. But the other half of the process failed— them status as beneficiaries was denied and, as a consequence, the Uhms had to pay for their prescriptions. Frustrating indeed. But what to do? Make a federal case of it — start a class action where simply following the administrative appeal process would suffice? A class action all for the recovery of two months’ prescriptions?
Today the Uhms receive the prescription drug benefits to which they are entitled. But not as a result of this lawsuit. The cost to the court system and to the Uhms is unconscionable. A bit of common sense and attention to the available administrative remedies should have beеn applied. Instead we have an opinion with endless pages of legal analysis, months of study and delay, and a determination that no benefit can be awarded to the Uhms. Counsel particularly should take heed.
Notes
. We revisit this appeal after having granted the Uhms’ Petition for Rehearing and withdrawing our original opinion in this matter.
See Uhm v. Humana, Inc.,
. Prior to 2001, CMS was known as the Health Care Financing Administration.
. The Uhms allege that Humana, Inc., was involved in marketing and administering Humana Health Plan, Inc.'s PDP. Because the Uhms do not distinguish between Humana Health Plan, Inc., and Humana, Inc., with respect to any specific factual allegations, we refer to them collectively as “Humana.” In Parts 11(B)(1)(a) and 11(C)(4), infra, which address the Uhms’ claim that the Act does not apply to Humana, Inc., we address the two entities separately.
. Becausе this appeal is from an order granting a motion to dismiss, we take the material facts alleged in the Uhms’ complaint as true and construe them in the light most favorable to the Uhms.
Sprewell v. Golden State Warriors,
. The Uhms initially sued Humana Medical Plan, Inc., as well, but later voluntarily dismissed the complaint against that entity.
.
The findings and decision of the Commissioner of Social Security after a hearing shall be binding upon all individuals who were parties to such hearing. No findings of fact or decision of the Commissioner of Social Security shall be reviewed by any person, tribunal, or governmental agency except as herein provided. No action against the United States, the Commissioner of Social Security, or any officer or employee thereof shall be brought under section 1331 or 1346 of Title 28 to recover on any claim arising under this subchapter.
.
Any individual, after any final decision of the Commissioner of Social Security made after a hearing to which he was a party, irrespective of the amount in controversy, may obtain a review of such decision by a civil action commenced within sixty days after the mailing to him of notice of such decision or within such further time as the Commissioner of Social Security may allow. Such action shall be brought in the district court of the United States for the judicial district in which the plaintiff resides. ... The court shall have power to enter ... a judgment affirming, modifying, or reversing the decision of the Commissioner of Soсial Security, with or without remanding the cause for a rehearing.
. Although codified elsewhere in the Social Security Act,
. A narrow exception to these requirements, not applicable here, exists where a plaintiff challenges the validity of the Act’s provisions or the Secretary’s implementation of regulations pursuant to those provisions.
See Bowen v. Mich. Acad, of Family Physicians,
. We note that, at first blush,
Kaiser’s
rule might seem to conflict with our prior holding that: “[s]ection 405(h) only bars actions under
. Since CMS initially promulgated the Act's implementing regulations in 2005, they have been amended on a number of occasions. See, e.g., 75 FR 19825 (Apr. 15, 2010); 73 FR 54208-01 (Sept. 18, 2008). In this opinion, we refer to the regulations in place at the time of the Uhms’ alleged injury. Where the regulations have been subsequently amended or redesignated, we will so note for ease of reference. As discussed below, however, none of the amendments or redesignations affect our analysis.
. Assuming that there was a valid express contract between the Uhms and Humana, we further note thаt under Washington state law, "[a] party to a valid express contract is bound by the provisions of that contract, and may not disregard the same and bring an action on an implied contract relating to the same matter, in contravention of the express contract.”
Chandler v. Wash. Toll Bridge Auth.,
. The regulations also required that "[t]he PDP sponsor must provide the individual with prompt notice of acceptance or denial of the individual’s enrollment request, in a format and manner specified by CMS,”
. We note that reading
.
An enrollee with a Medicare + Choice plan of a Medicare + Choice organization under this part who is dissatisfied by reason of the enrollee’s failure to receive any health service to which the enrollee believes the enrollee is entitled and at no greater charge than the enrollee believes the enrollee is required to pay is entitled, if the amount in controversy is $100 or more, to a hearing before the Secretary to the same extent as is provided insection 405(b) of this title, and in any such hearing the Secretary shall make the organization a party. If the amount in controversy is $1,000 or more, the individual or organization shall, upon notifying the other parly, be entitled to judicial review of the Secretary’s final decision as provided insection 405(g) of this title, and both the individual and the organization shall be entitled to be parties to that judicial review.
.The Uhms argue that the term "elected” means someone who is automatically enrolled in a PDP (i.e., dual-benefit individuals who are entitled to both Medicare and Medicaid coverage). In support of this argument, they point to a passage in the Act’s implementing regulations, which provides:
Comment: We received one comment requesting that the definition of enrollee be revised to include people who are automatically enrolled in a PDP or MA-PD. Response: We agree with the commenter and have revised the definition of enrollee in this final rule to mean a Part D eligible individual who has elected or has been enrolled in a Part D plan.
70 Fed.Reg. 4194, 4344 (Jan. 28, 2005). The Uhms' reading of the term “elected” is not persuasive. The plain text of the regulation permits only one reading — that a person who has “elected ... a Part plan” is one who has chosen or selected it; a person who has “been enrolled” is one who has been automatically enrolled. The proposed regulation provides further suppоrt for this reading. Before it was amended to clarify the inclusion of dual-benefit individuals, it read: “Enrollee means a Part D eligible individual, or his or her authorized representative, who has elect
.The Uhms also argue that the Act’s preemption provisions do not apply to them because they were not enrolled in the program at the time their claims arose. For precisely the same reasons that this argument fails as applied to the exhaustion provision, it also fails as applied to the preemption provisions.
. Prior to the Act, Medicare Advantage was called "Medicare + Choice.”
See
. Although the term "standard” is not defined in the Act, at the narrowest cut, a "standard” within the meaning of the preemption provision is a statutory provision or a regulation promulgated under the Act and published in the Code of Federal Regulations. Humana points to a broad definition of the term "stan
.CMS replaced the phrase “PDP sponsor” in its implementing regulations with “Part D sponsor,” because it "believe[d] that the preemption of State law ... should operate uniformly for all Part D sponsors.” 70 Fed.Reg. 4194, 4319 (Jan. 28, 2005). A PDP provides "prescription drug coverage that is offered under a policy, contract, or plan that has been approved ... and that is offered by a PDP sponsor that has a contract with CMS
. In full, that prior preemption clause read:
(A) In general
The standards established under this subsection shall supersede any State law or regulation (including standards described in subparagraph (B)) with respect to Medicare + Choice plans which are offered by Medicare + Choice organizations under this part to the extent such law or regulation is inconsistent with such standards.
(B) Standards specifically superseded Stаte standards relating to the following are superseded under this paragraph:
(i) Benefit requirements (including cost-sharing requirements).
(ii) Requirements relating to inclusion or treatment of providers.
(iii) Coverage determinations (including related appeals and grievance processes).
(iv) Requirements relating to marketing materials and summaries and schedules of benefits regarding a Medicare + Choice plan.
. The Secretary adopted the same reading of the Conference Report in promulgating the final rules: "We believe that the Conference Report was clear that the Congress intended
. We stress that, in using the term ''inconsistent,” we do not mean to be incorporating the same standards used in implied preemption cases.
Cf. Gade v. Nat'l Solid Wastes Mgmt. Assoc.,
. Amicus American Association of Justice argues that because consumer protection laws are laws of general applicability, they should not be considered laws "with respect to” Part D plans. That same argument was specifically rejected in
Riegel v. Medtronic, Inc.,
. These regulations have since been amended and renumbered. See 73 FR 54208-01 (Sept. 18, 2008). These amendments added a number of new regulatory provisions regarding the marketing process of PDP plans, none of which affect our analysis.
. As amended in 2008, these regulations mandate a slightly different process for apprоval of Part D marketing materials. Part D sponsors must now submit materials to CMS for review at least 45 days prior to distribution (or 10 days, in certain cases), and are allowed to distribute those materials if CMS does not object.
See
.Under the 2005 version of the regulations, "marketing materials” also included "membership or claims processing activities,”
id..,
although the current version of the regulations has revised that category to include only “membership activities (for example, materials on rules involving non-payment of premiums, confirmation of enrollment or disenrollment, or nonclaim-specific notification information),"
. We note, however, that in the most recently amended version of the implementing regulations, the term "marketing materials” excludes "ad hoc enrollee communications materials, meaning informational materials that ... (iv) Apply to a specific situation or cover member-specific claims processing or other operational issues.”
. The same result is possible under the other state consumer protection statutes on which the Uhms rely. For example, Washington’s consumer protection law prohibits “[ujnfair mеthods of competition and unfair or deceptive acts or practices in the conduct of any trade or commerce.”
. The Medicare Part C preemption provision created in 1997 read:
In general
The standards established under this subsection shall supersede any State law or regulation (including standards described in subparagraph (B)) with respect to Medicare-)-Choice plans which are offered by Medicare + Choice organizations under this part to the extent such law or regulation is inconsistent with such standards.
(B) Standards specifically superseded State standards relating to the following are superseded under this paragraph:
(i) Benefit requirements.
(ii) Requirements relating to inclusion or treatment of providers.
(iii) Coverage determinations (including related appeals and grievance processes).
. Again, in enacting Title VI of the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), Pub.L. No. 106-554, 114 Stat. 2763, Congress amended subsection (B) of
(B) Standards specifically superseded State standards relating to the following are superseded under this paragraph:
(i) Benefit requirements (including cost-sharing requirements).
(ii) Requirements relating to inclusion or treatment of providers.
(iii) Coverage determinations (including related appeals and grievance processes).
(iv) Requirements relating to marketing materials and summaries and schedules of benefits regarding a Medicare + Choice plan.
. For example, "[a] commenter expressed concern that while State contract and tort law principals [sic] may have general application, State standards developed through case law based on interpretations of State contract and tort law may be specific to health plans, and may apply State standards that would otherwise be preempted under Section 232(a) of the [Act].” 70 Fed.Reg. 4588, 4665 (Jan. 28, 2005).
. In its amicus brief to this court, CMS took the position that, under
Sprietsma,
the Act’s express preemption provision does not contemplate common law claims (although such claims can, argued CMS, be impliedly preempted). We accord that position no deference here.
See United States v. Trident Seafoods Corp.,
. We emphasize that this holding does not mean that all common law fraud and fraud in the inducement claims would be preempted under the Act. The preemption inquiry turns on the specific allegations forming the basis of those claims, not their labels.
.
See