Battle Creek Health System v. Leavitt ( 2007 )


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  •                            RECOMMENDED FOR FULL-TEXT PUBLICATION
    Pursuant to Sixth Circuit Rule 206
    File Name: 07a0314p.06
    UNITED STATES COURT OF APPEALS
    FOR THE SIXTH CIRCUIT
    _________________
    BATTLE CREEK HEALTH SYSTEM; TRINITY HEALTH- X
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    Plaintiffs-Appellants, -
    MICHIGAN,
    -
    -
    No. 06-1775
    ,
    v.                                            >
    -
    -
    -
    MICHAEL LEAVITT, Secretary of the United States
    Defendant-Appellee. -
    Department Of Health and Human Services,
    -
    -
    -
    N
    Appeal from the United States District Court
    for the Western District of Michigan at Lansing.
    No. 05-00014—Wendell A. Miles, District Judge.
    Argued: March 9, 2007
    Decided and Filed: August 14, 2007
    Before: BOGGS, Chief Judge; BATCHELDER and GRIFFIN, Circuit Judges.
    _________________
    COUNSEL
    ARGUED: John R. Trentacosta, FOLEY & LARDNER, Detroit, Michigan, for Appellants.
    Jacqueline M. Zydeck, OFFICE OF THE GENERAL COUNSEL, Chicago, Illinois, for Appellee.
    ON BRIEF: John R. Trentacosta, H. William Burdett, Jr., FOLEY & LARDNER, Detroit,
    Michigan, for Appellants. Jacqueline M. Zydeck, OFFICE OF THE GENERAL COUNSEL,
    Chicago, Illinois, J. Joseph Rossi, ASSISTANT UNITED STATES ATTORNEY, Grand Rapids,
    Michigan, for Appellee. Michael J. Philbrick, Joan L. Lowes, HALL, RENDER, KILLIAN,
    HEATH, & LYMAN, Troy, Michigan, for Amicus Curiae.
    _________________
    OPINION
    _________________
    GRIFFIN, Circuit Judge. Plaintiffs-appellants Battle Creek Health System (“Battle Creek”)
    and Trinity Health-Michigan (“Trinity Health”), doing business as Mercy General Health Partners,
    are acute-care hospitals and participating Medicare providers located in southwestern Michigan.
    Plaintiffs brought the present action against defendant-appellee Michael Leavitt, Secretary of the
    United States Department of Health and Human Services (“defendant” or “the Secretary”), pursuant
    1
    No. 06-1775              Battle Creek Health System, et al. v. Leavitt                                       Page 2
    to Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395ggg (the “Medicare Act”) and the
    Administrative Procedure Act, 5 U.S.C. § 551 et seq. (the “APA”), challenging the final
    administrative decision of defendant denying Medicare reimbursement for certain bad debts incurred
    by plaintiffs during the fiscal year 1999. The district court affirmed the Secretary’s decision,
    granting summary judgment in favor of defendant and denying plaintiffs’ similar motion. See Battle
    Creek Health Sys. v. Thompson, 
    423 F. Supp. 2d 755
    (W.D. Mich. 2006). Plaintiffs now appeal.
    For the reasons set forth below, we affirm.
    I.
    A.
    Plaintiffs are non-profit, tax-exempt, acute-care hospitals located in southwestern Michigan
    that provide services to persons covered by Medicare (“Medicare beneficiaries”). The Medicare Act
    provides a system for payment of health services to eligible elderly and disabled persons. Medicare
    providers participate in Medicare by entering into an agreement with the Secretary and the
    Department of Health and Human Services Center for Medicare and Medicaid Services (“CMS”),
    formerly the Health Care Financing Administration (“HCFA”), which administers the program for
    the Secretary. Both plaintiffs are parties to a Medicare participation agreement with defendant.
    The present case implicates only Medicare Part A reimbursement for hospital services. Part
    A authorizes payments primarily for institutional care, including hospital inpatient services and
    skilled nursing facility services. See 42 U.S.C. §§ 1395c-1395i-4. Medicare beneficiaries are
    responsible for paying a portion of the cost of hospital services in the form of deductibles and
    coinsurance. 42 C.F.R. §§ 409.80 - 409.83.
    Before 1983, the Medicare Act based hospital reimbursement upon a retrospective
    determination of “reasonable cost” as defined in the Secretary’s regulations and identified in a
    provider’s annual cost report. 42 U.S.C. § 1395x(v); 42 C.F.R. § 413.1 et seq. In 1983, Congress
    established a Prospective Payment System (“PPS”), whereby hospital operating costs are reimbursed
    on a per discharge basis through prospectively fixed rates that are based upon the “diagnostic related
    group” assigned to the discharge. 42 U.S.C. § 1395ww(d); 42 C.F.R. § 412.1 et seq. Certain
    Medicare payments to hospitals,  however, continue to be determined retrospectively and reimbursed
    on a reasonable cost basis.1 Included in this latter category are the unpaid deductible and
    coinsurance obligations of Medicare beneficiaries (Medicare “bad debts”) at issue herein. 42 C.F.R.
    § 412.115(a).
    The regulations pertaining to Medicare declare that amounts due to providers from other
    parties that providers cannot recover are generally not reimbursable under the Medicare program
    because these bad debts are deemed “deductions       from revenue and are not to be included in
    allowable cost.” 42 C.F.R. § 413.89(a).2 The Secretary will nonetheless reimburse a provider for
    certain bad debts attributable to deductible and coinsurance amounts related to covered services
    received from beneficiaries. 42 C.F.R. § 412.115(a). Such reimbursable bad debts are defined at
    42 C.F.R. § 413.89(b):
    1
    The Medicare Act defines “reasonable cost” as “the cost actually incurred, excluding therefrom any part of
    incurred cost found to be unnecessary in the efficient delivery of needed health services. . . .” 42 U.S.C.
    § 1395x(v)(1)(A). The statute further provides that “reasonable cost” “shall be determined in accordance with
    regulations [promulgated by the Secretary] establishing the method or methods to be used, and the items to be included
    in determining such costs . . . .” 
    Id. 2 Before
    October 1, 2004, this same regulatory provision was found at 42 C.F.R. § 413.80. Fed. Reg. 48916
    (Aug. 11, 2004, effective Oct. 1, 2004).
    No. 06-1775                 Battle Creek Health System, et al. v. Leavitt                                      Page 3
    Bad debts are amounts considered to be uncollectible from accounts and notes
    receivable that were created or acquired in providing services. “Accounts
    receivable” and “notes receivable” are designations for claims arising from the
    furnishing of services, and are collectible in money in the relatively near future.
    Bad debts are reimbursed in order to prevent the costs of Medicare-covered services from
    being shifted to non-Medicare patients or their payors. 42 C.F.R. § 413.89(d). Consequently, a
    provider may receive reimbursement for Medicare bad debt if it meets all of the criteria set forth in
    42 C.F.R. § 413.89(e):
    (e) Criteria for allowable bad debt. A bad debt must meet the following criteria to
    be allowable:
    (1) The debt must be related to covered services and derived from deductible and
    coinsurance amounts.
    (2) The provider must be able to establish that reasonable collection efforts were
    made.
    (3) The debt was actually uncollectible when claimed as worthless.
    (4) Sound business judgment established that there was no likelihood of recovery
    at any time in the future.
    42 C.F.R. § 413.89(e).3 See also Provider Reimbursement Manual § 308 (reiterating these four
    criteria).
    The Secretary’s Provider Reimbursement Manual (“PRM”) contains non-binding guidelines
    and interpretative rules to assist providers and intermediaries in the implementation of the Medicare
    regulations.4 Relevant to the present case, PRM § 310 addresses the “reasonable collection
    effort[s]” that must be undertaken by providers when seeking to recoup bad debts:
    To be considered a reasonable collection effort, a provider’s effort to collect
    Medicare deductible and coinsurance amounts must be similar to the effort the
    provider puts forth to collect comparable amounts from non-Medicare patients. It
    must involve the issuance of a bill on or shortly after discharge or death of the
    beneficiary to the party responsible for the patient’s personal financial obligations.
    It also includes other actions such as subsequent billings, collection letters and
    telephone calls or personal contacts with this party which constitute a genuine, rather
    than a token, collection effort. The provider’s collection effort may include using
    or threatening to use court action to obtain payment. (See § 312 for indigent or
    medically indigent patients.)
    PRM § 310.A further explains:
    A provider’s collection effort may include the use of a collection agency in addition
    to or in lieu of subsequent billings, follow-up letters, telephone and personal
    3
    When plaintiffs first sought recovery of the bad debts, this provision was found at 42 C.F.R. § 413.80. Section
    413.80 was redesignated as § 413.89 at 69 Fed. Reg. 48916 (Aug. 11, 2004, effective Oct. 1, 2004). The text of the 1998
    and 2004 regulations is identical, and we will, throughout this opinion, refer to the newest regulation.
    4
    See TEXT, infra, Section II.
    No. 06-1775                Battle Creek Health System, et al. v. Leavitt                                 Page 4
    contacts. Where a collection agency is used, Medicare expects the provider to refer
    all uncollected patient charges of like amount to the agency without regard to class
    of patient. The “like amount” requirement may include uncollected charges above
    a specified minimum amount. Therefore, if a provider refers to a collection agency
    its uncollected non-Medicare patient charges which in amount are comparable to the
    individual Medicare deductible and coinsurance amounts due the provider from its
    Medicare patient, Medicare requires the provider to also refer its uncollected
    Medicare deductible and coinsurance amounts to the collection agency. Where a
    collection agency is used, the agency’s practices may include using or threatening
    to use court action to obtain payment.
    In addition, PRM § 310.2 provides for a “Presumption of Noncollectibility”:
    If after reasonable and customary attempts to collect a bill, the debt remains unpaid
    more than 120 days from the date the first bill is mailed to the beneficiary, the debt
    may be deemed uncollectible.
    “The amounts uncollectible from specific beneficiaries are to be charged off as bad debts in
    the accounting period in which the accounts are deemed to be worthless.” 42 C.F.R. § 413.89(f).
    Consistent with this regulation, PRM § 314 provides that uncollectible debts and coinsurance
    amounts “are recognized as allowable bad debts in the reporting period in which the debts are
    determined to be worthless.” PRM § 314 also requires the provider to document its claimed bad
    debts (“the provider should have the usual accounts receivable records – ledger cards and source
    documents – to support its claim for a bad debt for each account included.”). See also PRM § 310.B
    (“[t]he provider’s collection effort should be documented in the patient’s file by copies of the bill(s),
    follow-up letters, reports of telephone and personal contact, etc.”). These guidelines are in keeping
    with regulations that require documentation. See 42 C.F.R. §§ 413.9, 413.24, and 413.20(a) (“[t]he
    principles of cost reimbursement require that providers maintain sufficient financial records and
    statistical data for proper determination of costs payable under the program.”).
    PRM § 316 further addresses the recovery of bad debts and provides in pertinent part:
    Amounts included in allowable bad debts in a prior period might be recovered in a
    later reporting period. Treatment of such recoveries under the program is designed
    to achieve the same effect upon reimbursement as in the case where the amount was
    uncollectible.
    Where the provider was reimbursed by the program for bad debts for the reporting
    period in which the amount recovered was included in allowable bad debts,
    reimbursable costs in the period of recovery are reduced by the amounts recovered.
    However, such reductions in reimbursable costs should not exceed the bad debts
    reimbursed for the applicable prior period.
    Fiscal intermediaries under contract to the Secretary5 serve as claims managers for the
    Medicare program and make the initial determination regarding the amount of reimbursement to be
    paid to the health care provider. At the close of a fiscal year, a Medicare provider submits a cost
    report to its fiscal intermediary setting forth its incurred costs and the proportion of the costs to be
    allocated to Medicare. 42 C.F.R. § 413.20. The fiscal intermediary audits the report and ascertains
    the final amount of Medicare reimbursement owed to the provider. 42 U.S.C. § 1395g. The fiscal
    intermediary then issues a Notice of Program Reimbursement (“NPR”). 42 C.F.R. § 405.1803.
    5
    In this case, plaintiffs’ fiscal intermediary is United Government Services, Inc. (“UGS”).
    No. 06-1775           Battle Creek Health System, et al. v. Leavitt                              Page 5
    The Secretary has issued guidelines for fiscal intermediaries to follow when auditing cost
    reports. The Intermediary Manual instructs in part:
    If the bad debt is written-off on the provider’s books 121 days after the date of the
    bill and then turned over to a collection agency, the amount cannot be claimed as a
    Medicare bad debt on the date of the write-off. It can be claimed as a Medicare bad
    debt only after the collection agency completes its collection effort.
    Intermediary Manual, Part 1B, 13-2.
    An HCFA policy memorandum dated June 11, 1990, further elaborates on the bad debt
    policy. The memorandum states in pertinent part:
    [U]ntil a provider’s reasonable collection effort has been completed, including both
    in-house efforts and the use of a collection agency, a Medicare bad debt may not be
    reimbursed as uncollectible. This is in accord with the fourth criterion in section 308
    which provides that an uncollected Medicare account cannot be considered an
    allowable Medicare bad debt unless sound business judgment established that [there]
    is no likelihood of recovery at any time in the future. We have always believed that,
    clearly, there is a likelihood of recovery for an account sent to a collection agency
    and that claiming a Medicare bad debt at the point of sending the account to the
    collection agency would be contrary to the bad debt policy in sections 308 and 310
    ....
    If a Medicare provider is dissatisfied with the fiscal intermediary’s determination of
    reimbursement and otherwise satisfies applicable criteria, it is entitled to a hearing before the
    Secretary’s Provider Reimbursement Review Board (“PRRB”), within 180 days of receipt of the
    NPR. 42 U.S.C. § 1395oo(a), (b); 42 C.F.R. §§ 405.1835, 405.1837. The PRRB’s decision is
    subject to review, upon written request by one of the parties, by the Deputy Administrator of CMS
    (the “Administrator”), pursuant to 42 C.F.R. § 405.1875. The Administrator’s decision, which
    constitutes the final decision of the Secretary, is in turn subject to review by the appropriate federal
    district court. 42 U.S.C. § 1395oo(f)(1).
    B.
    In this case, the fiscal intermediary audited plaintiffs’ fiscal year (“FY”) 1999 cost reports
    for the period ending June 30, 1999, and disallowed $155,822 and $327,829 in bad debts claimed
    by plaintiffs Battle Creek and Trinity Health, respectively. The intermediary determined that
    plaintiffs had included and written off as bad debts on their cost reports any Medicare accounts that
    were at least 120 days old by the end of the cost reporting period, including debts that had been
    referred to the collection agency. The intermediary concluded that the debts that were sent to the
    collection agency, but not returned to plaintiffs as uncollectible, did not meet the requirements of
    42 C.F.R. § 413.89(e)(3) and (4), because these debts had never been determined to be uncollectible
    and collection efforts could be expected to continue after the accounts were written off. According
    to the fiscal intermediary, the fact that the bad debts remained at a collection agency constituted
    evidence that plaintiffs did not consider the accounts to be worthless or that there was no likelihood
    of recovery at any time in the future.
    Plaintiffs appealed these disallowances to the PRRB which, following a hearing on the
    matter, concluded that the intermediary’s determination was erroneous and held that plaintiffs were
    No. 06-1775               Battle Creek Health System, et al. v. Leavitt                                        Page 6
    entitled to reimbursement for the bad debts invalidated by the fiscal intermediary.6 The PRRB
    found that the evidence at the hearing established that plaintiffs undertook reasonable collection
    efforts in accordance with 42 C.F.R. § 413.89(e). The PRRB was “unable to reconcile” the
    intermediary’s position with either the presumption of noncollectibility set forth in PRM § 310.2 or
    with PRM § 310.A, which states that a provider’s use of a collection agency may be “in addition to
    or in lieu of” collection efforts undertaken by the provider itself. Thus, according to the PRRB, “the
    Intermediary’s argument that the Provider’s use of an outside collection agency obligated the
    Provider to engage in its collection efforts for a period greater than the 120 days set forth in [PRM]
    § 310.2 is not supported by the applicable Medicare regulations or manual instructions.” The PRRB
    further concluded that
    [PRM] § 316 indicates that when a provider, in a later period, recovers amounts
    previously included in allowable bad debts, the provider’s reimbursable costs in the
    period of recovery are reduced by the amounts so recovered. Thus, it is reasonable
    to infer that the Medicare program expects that providers will continue to pursue
    collection activities with respect to debts that have been deemed uncollectible for
    Medicare reimbursement purposes.
    The PRRB therefore held that plaintiffs were entitled to Medicare reimbursement for the bad debts
    at issue.
    Upon further review by the Administrator, the PRRB’s decision was reversed. In a final
    Decision of the Administrator issued on November 12, 2004, the Administrator held that the
    language of PRM § 310.2 “implies discretionary rather than mandatory application of the
    presumption, i.e., the debt ‘may’ rather than ‘shall’ be deemed uncollectible” if it remains unpaid
    for more than 120 days. Consequently, the Administrator found that the presumption of
    noncollectibility does not relieve a provider from meeting the regulatory documentation
    requirements for ascertaining bad debts and “only applies where a provider has otherwise
    demonstrated through appropriate documentation that it engaged in reasonable collection efforts.”
    Relying upon the Intermediary Manual, Part IB, 13-2 and the June 11, 1990, policy memorandum,
    as well as the relevant regulations and PRM sections, the Administrator concluded that if a provider
    continues to attempt collection of a debt either through in-house efforts or a collection agency,
    it is reasonable to conclude that the provider still considers the debt to have value
    and not worthless. Thus, contrary to the Provider’s argument, the Administrator
    finds it reasonable to expect a provider to demonstrate that it has completed its
    collection effort, including outside collection, before claiming debts as worthless.
    Under the circumstances, the Administrator found the requisite documentation had not been
    provided:
    The Administrator notes that the Provider’s testimony suggested that the collection
    agency furnished a report telling the Provider which of its accounts were
    uncollectible and worthless, and which ones the collection agency still pursued.
    However, the Provider admitted that it did not request such reports and indicated that
    it had not attempted to compare what it had written off as bad debt and what the
    6
    Plaintiffs also appealed another unrelated disallowance pertaining to the Secretary’s adjustment to plaintiff
    Battle Creek’s report. The Tax Equity and Fiscal Responsibility Act (“TEFRA”) established a ceiling on the allowable
    rate-of-increase for hospital inpatient operating costs. The TEFRA Target Amount for a provider is updated for each
    hospital cost reporting period by an annual rate-of-increase percentage. Plaintiffs’ complaint included a claim
    challenging the adjustment to Battle Creek’s TEFRA rate. However, the parties resolved and stipulated to dismissal of
    this claim, which was dismissed by order of the court entered on March 6, 2006.
    No. 06-1775               Battle Creek Health System, et al. v. Leavitt                                            Page 7
    collection agency was actually still collecting on. In addition, the record contains no
    evidence reflecting the point in time when the debts were actually uncollectible.
    There is no documentation of when, or if, the collection agency returned the debts
    to the provider, or otherwise informed the provider that collection efforts were
    terminated.
    In light of these documentation deficiencies, the Administrator concluded that the
    presumption of noncollectibility did not apply because plaintiffs had failed to establish that the
    accounts were “actually uncollectible” when claimed as worthless or that “sound business judgment”
    established that there was no likelihood of recovery at any time in the future, pursuant to 42 C.F.R.
    § 413.80(e)(3) and (4). The Administrator therefore disallowed reimbursement for the FY 1999 bad
    debts.7
    On January 20, 2005, plaintiffs filed the present suit in federal district court, challenging the
    Administrator’s final decision. In response to cross-motions for summary judgment, the district
    court denied plaintiffs’ motion and granted defendant’s summary judgment motion, affirming the
    Secretary’s final decision denying Medicare reimbursement for the FY 1999 bad debts claimed by
    each plaintiff. The district court found that the Secretary’s interpretation of § 310.2 of the PRM
    gave effect to each of the four requirements of 42 C.F.R. § 413.89(e), and therefore was not arbitrary
    and capricious nor inconsistent with Medicare policy. Battle Creek Health 
    Sys., 423 F. Supp. 2d at 761-62
    . This appeal followed.
    II.
    When reviewing an administrative agency’s final decision under the APA, we review the
    district court’s summary judgment decision de novo, while applying the “appropriate standard of
    review” to the agency’s decision. Fligiel v. Samson, 
    440 F.3d 747
    , 750 (6th Cir. 2006). In the
    context of Medicare reimbursement, the scope of judicial review is narrow:
    The Supreme Court has established a two-step process for reviewing an agency’s
    interpretation of a statute that it administers. Chevron U.S.A., Inc. v. Nat. Resources
    Defense Council, Inc., 
    467 U.S. 837
    (1984). “First, always, is the question whether
    Congress has directly spoken to the precise question at issue. If the intent of
    Congress is clear, that is the end of the matter; for the court, as well as the agency,
    must give effect to the unambiguously expressed intent of Congress.” Jewish Hosp.,
    Inc. v. Sec’y of Health & Human Servs., 
    19 F.3d 270
    , 273 (6th Cir. 1994) (emphasis
    in original) (citing CenTra, Inc. v. United States, 
    953 F.2d 1051
    (6th Cir. 1992)).
    The Supreme Court has explained that “[t]he judiciary is the final authority on issues
    of statutory construction and must reject administrative constructions which are
    contrary to clear legislative intent.” 
    Chevron, 467 U.S. at 843
    n.9.
    7
    The Administrator further disagreed with the PRRB’s conclusion that the language of PRM § 316, pertaining
    to the subsequent payment of a previously reimbursed bad debt, supported an inference that the Medicare program
    expects that providers will continue to pursue bad debt collection activities after being reimbursed:
    [T]his PRM section provides only an instruction, in the event that a Medicare bad debt is subsequently
    recovered, for reporting such revenue and its reimbursement effect. This is a provision to prevent
    double dipping by the Provider at the expense of the Program. The Administrator finds that the
    language of the manual section in no way infers that the Medicare program expects, or even
    anticipates, providers to continue to pursue collection activities after claiming Medicare bad debts on
    their cost reports.
    (Emphasis in original.)
    No. 06-1775                Battle Creek Health System, et al. v. Leavitt                                           Page 8
    Second, if we determine that Congress has not directly addressed the precise
    question at issue, that is, that the statute is silent or ambiguous on the specific issue,
    we must determine “whether the agency’s answer is based on a permissible
    construction of the statute.” Jewish Hosp., 
    Inc., 19 F.3d at 273
    . In assessing whether
    the agency’s construction is permissible, we “need not conclude that the agency
    construction was the only one it permissibly could have adopted to uphold the
    construction, or even the reading [we] would have reached if the question initially
    had arisen in a judicial proceeding.” 
    Id. at 273-74
    (citing 
    Chevron, 467 U.S. at 843
             n.11). In fact, the agency’s construction is entitled to deference unless “arbitrary,
    capricious, or manifestly contrary to the statute.” 
    Chevron, 467 U.S. at 844
    .
    Our review of an agency’s interpretation of its own regulations is highly deferential.
    Pursuant to 42 U.S.C. § 1396oo(f)(1), a decision by the [CMS] is subject to review
    under the [APA], 5 U.S.C. § 706(2)(A). Under the APA, we review an agency
    decision to see whether it is “arbitrary, capricious, an abuse of discretion, or
    otherwise not in accord with law.” Thomas Jefferson Univ. v. Shalala, 
    512 U.S. 504
    ,
    512 (1994). Under the APA, an agency’s interpretation of a regulation must be given
    controlling weight unless it is “plainly erroneous or inconsistent with the regulation.”
    
    Id. Clark Reg’l
    Med. Ctr. v. U.S. Dept. of Health & Human Servs., 
    314 F.3d 241
    , 244-45 (6th Cir.
    2002). See also Med. Rehab. Servs., P.C. v. Shalala, 
    17 F.3d 828
    , 831 (6th Cir. 1994) (agency’s
    interpretation of its own regulations accorded considerable deference, “especially in areas like
    Medicare reimbursements.”).
    However, “[i]nterpretations such as those in opinion letters – like interpretations contained
    in policy statements, agency manuals, and enforcement guidelines, all of which lack the force of law
    – do not warrant Chevron-style deference.” Christensen v. Harris County, 
    529 U.S. 576
    , 587
    (2000). Thus, “[i]nterpretative guidance from administrative agencies that is not the product of
    formal, notice-and-comment rulemaking is entitled to respect ‘to the extent that the interpretations
    have the power to persuade.’” Bank of New York v. Janowick, 
    470 F.3d 264
    , 2698 (6th Cir. 2006)
    (quoting 
    Christensen, 529 U.S. at 587
    ) (internal quotations and citations omitted). See also Clark
    Reg’l Med. 
    Ctr., 314 F.3d at 248
    (“The PRM is ‘the prototypical example of an interpretive rule
    issued by an agency to advise the public of the agency’s construction of the statutes and rules which
    it administers.’”) (quoting Shalala v. Guernsey Mem’l Hosp., 
    514 U.S. 87
    , 99 (1995)); St. Mary’s
    Hosp. of Troy v. Blue Cross & Blue Shield Ass’n, 
    788 F.2d 888
    , 890 (2d Cir. 1986) (PRM is an
    “interpretive” source entitled to persuasive weight).
    III.
    Battle Creek and Trinity Health, with the support of amicus curiae Michigan Health and
    Hospital Association, a membership organization representing 145 Michigan acute-care hospitals,
    argue that the Secretary’s determination that plaintiffs failed to satisfy regulatory requirements for
    reimbursement of the bad debts at issue is arbitrary and capricious, not only because plaintiffs had
    no notice of the new standard, but also because the decision purportedly has no basis in, and
    conflicts with, the Secretary’s current published regulations and reimbursement guidelines issued
    to Medicare providers. Specifically, plaintiffs complain that “[t]he Secretary’s newly-imposed
    8
    As we have noted, “[w]here an administrative agency creates manual provisions that are inconsistent with the
    governing regulations, it creates for itself a kind of open-ended discretion in its administrative investigations, and opens
    the door to disparate treatment of interested parties.” Maximum Home Health Care, Inc. v. Shalala, 
    272 F.3d 318
    , 321
    (6th Cir. 2001). “It undermines the clear congressional purpose underlying the requirement that significant rules be
    established by regulations.” 
    Id. No. 06-1775
                   Battle Creek Health System, et al. v. Leavitt                                           Page 9
    requirement that providers discontinue collection agency efforts before seeking reimbursement of
    debts outstanding for more than 120 days is inconsistent with the § 310.2 presumption and with
    Medicare’s requirement that its beneficiaries bear the costs of deductibles and co-insurance [set forth
    in] 42 U.S.C. § 1395x(v)(1)(A).”
    Plaintiffs, however, have failed to persuade us that the Secretary’s action in denying
    reimbursement to plaintiffs for the FY 1999 bad debts in question, based upon his interpretation of
    the germane Medicare-related regulations, is “arbitrary, capricious, an abuse of discretion, or
    otherwise not in accord with law.” Clark Reg’l Med. 
    Ctr., 314 F.3d at 245
    . In affirming the
    Secretary’s decision, we have carefully considered the following arguments advanced by plaintiffs
    and amicus curiae regarding the significant regulatory issue raised in this case.
    Battle Creek and Trinity Health first maintain that they are entitled to rely upon the
    presumption of noncollectibility set forth in PRM § 310.2. According to plaintiffs, this presumption
    establishes a mandatory, bright-line rule that a provider may deem bad debts uncollectible and
    worthless after at least 120 days of reasonable collection efforts and, so interpreted, eliminates the
    administrative costs that otherwise would be incurred by having to demonstrate noncollectibility on
    a debt-by-debt basis. They argue that the Secretary’s mandate – that providers discontinue
    collection agency efforts before seeking reimbursement of debts outstanding for more than 120 days
    – essentially abolishes the presumption and renders PRM § 310.2 meaningless.
    Plaintiffs further posit that to the extent that the presumption in PRM § 310.2 is
    discretionary, the presumption only has significance if it is the provider, not the fiscal intermediary,
    that has the discretion to apply the presumption, because the fiscal intermediary does not audit cost
    reports until a year after the close of the cost reporting year. Consequently, a provider would not
    know if the presumption would be applied until it was too late to rely upon it. As a result, a provider
    purportedly would have no option but to ignore the presumption and make a debt-by-debt
    determination of noncollectibility, precisely the time-consuming task that the presumption was
    meant to obviate.
    In rejecting plaintiffs’ argument, we initially note that the Medicare Act grants the Secretary
    broad discretion to determine which “reasonable costs” may be reimbursed to Medicare providers,
    42 U.S.C. § 1395x(v)(1)(A), and what information is required from providers as a condition of
    reimbursement, 42 U.S.C. § 1395g(a). Pursuant to this broad statutory authority, the Secretary
    promulgated the various regulations implicated herein pertaining to bad debt reimbursement and the
    documentation required to substantiate reimbursement requests. 42 C.F.R. § 413.20(a) requires
    providers “to maintain sufficient financial records and statistical data for proper determination of
    costs payable under the program.” Related to this requirement, 42 C.F.R. § 413.89(e), the focal
    point of this litigation, provides that bad debts may be reimbursed as “reasonable costs” only if four
    criteria are met, including the two criteria at issue in this case – “the debt was actually uncollectible
    when claimed as worthless” and “[s]ound business judgment established that 9there was no likelihood
    of recovery at any time in the future.” 42 C.F.R. § 413.89(e)(3) and (4). The presumption of
    noncollectibility set forth in PRM § 310.2 states that, “[i]f after reasonable and customary attempts
    to collect a bill, the debt remains unpaid more than 120 days from the date the first bill is mailed to
    the beneficiary, the debt may be deemed uncollectible.” (Emphasis added). This interpretive
    guideline must be read in such a way that it is consistent with the plain language of the regulation.
    See Guernsey Mem’l 
    Hosp., 514 U.S. at 99-100
    (Interpretive rules do not have force and effect of
    law and do not effect a “substantive change” that is inconsistent with existing regulations.).
    9
    It is undisputed that with regard to the FY 1999 bad debts in controversy, plaintiffs complied with the first two
    criteria of 42 C.F.R. § 413.89(e) and adequately demonstrated that the debts were incurred for covered services and
    reasonable collection efforts were undertaken. 42 C.F.R. § 413.89(e)(1) and (2).
    No. 06-1775           Battle Creek Health System, et al. v. Leavitt                           Page 10
    The Secretary opined that the presumption of noncollectibility is discretionary in nature and
    was not to be applied automatically for the benefit of plaintiffs in this case despite the passage of
    120 days, because the accounts in question had been referred to a collection agency and not yet
    returned to the provider as uncollectible. Thus, according to the Secretary, plaintiffs failed to show
    that the “debt was actually uncollectible when claimed as worthless” and that “[s]ound business
    judgment established that there was no likelihood of recovery at any time in the future,” as called
    for by 42 C.F.R. § 413.89(e)(3) & (4).
    We find the Secretary’s interpretation of § 413.89(e) to be eminently reasonable. First, it
    conforms to the plain language of the regulation and PRM § 310.2. Plaintiffs’ debts did not meet
    the criteria for reimbursement because the debts at issue were being serviced by a collection agency
    when claimed as worthless. The very fact that a collection agency was still attempting to collect the
    bad debts at issue indicates that these debts had not yet been determined to be “actually uncollectible
    when claimed as worthless” and certainly contraindicates that “[s]ound business judgment
    established that there was no likelihood of recovery at any time in the future.” 42 C.F.R.
    § 413.89(e)(3) and (4). These criteria cannot be met until the collection agency completes its
    collection effort and returns the debts to plaintiffs as uncollectible. Moreover, as the Secretary
    determined properly, the language in PRM § 310.2 is discretionary in nature (“may be deemed”),
    rather than mandatory. See Matovski v. Gonzales, — F.3d —, 
    2007 WL 1713306
    , *16 (6th Cir.
    June 15, 2007) (“[T]he regulation employs the term ‘may’ not ‘shall,’ implying that the grant of
    authority [bestowed by the regulation] is permissive not mandatory.”). Thus, application of the
    presumption is not inevitable in every instance due to the mere passage of 120 days following a
    provider’s use of reasonable collection efforts.
    Second, from a practical standpoint, if the presumption of noncollectibility is characterized
    as mandatory, as plaintiffs argue, then the third and fourth criteria of 42 C.F.R. § 413.89(e) would
    be rendered nugatory. We agree with the district court’s assessment that
    [t]o permit a provider to deem a debt uncollectible after 120 days for Medicare
    reimbursement purposes, but to continue its efforts to collect the debt would be
    inconsistent with the requirements that the debt was actually uncollectible and there
    was no likelihood of future collection. Such an interpretation would transform the
    four-requirement statute [42 C.F.R. § 413.89(e)] into a two-requirement statute: (1)
    The debt must be related to covered services and derived from deductible and
    coinsurance amounts, and (2) the provider must be able to establish that reasonable
    collection efforts were made for 120 days. The Court cannot conclude that it was
    arbitrary or capricious, or inconsistent with Medicare policy for the Secretary to
    interpret section 310.2 of the PRM in a manner that gave effect to each of the four
    requirements.
    Battle Creek Health 
    Systems, 423 F. Supp. 2d at 761
    .
    PRM § 310.2 neither expressly nor implicitly excuses a provider from satisfying the specific
    criteria of § 413.89(e). Indeed, when read in tandem with the regulation, we agree with the district
    court that the Secretary has interpreted the presumption of noncollectibility in a manner that is
    consistent with, and most effectively enforces, all of the criteria of 42 C.F.R. § 413.89(e).
    Likewise, the presumption of noncollectibility does not relieve a provider from fulfilling the
    specific documentation requirements of PRM §§ 310 and 314. Plaintiffs argue that the Secretary’s
    reliance upon PRM §§ 310 and 314 as a basis for his decision is misplaced, because neither
    guideline imposes any requirement that providers cease collection efforts before deeming the debts
    uncollectible pursuant to the presumption of noncollectibility. Battle Creek and Trinity Health
    contend that PRM § 310.A, which states that a provider’s use of a collection agency may be “in
    No. 06-1775           Battle Creek Health System, et al. v. Leavitt                            Page 11
    addition to or in lieu of” its own collection efforts, actually encourages providers to use collection
    agencies to recoup Medicare bad debts and thus reinforces their argument that there is no regulatory
    basis for requiring a Medicare provider to recall a bad debt from a collection agency before the debt
    can be deemed worthless pursuant to 42 C.F.R. § 413.89(e). Again, we disagree.
    These PRM provisions are part of the overall framework of the Medicare reimbursement
    scheme, implemented by the Secretary to provide guidance regarding specific methods of collection
    and documentation. PRM § 310 addresses the “reasonable collection effort” that must be undertaken
    by providers when seeking to recoup bad debts, PRM § 310.A states that a provider’s collection
    efforts may include the use of a collection agency, PRM § 310.B provides that the provider’s
    collection effort “should be documented in the patient’s file by copies of the bill(s)and [other letters
    or reports],” and PRM § 314 states that a provider “should have the usual accounts receivable
    records-ledger cards and source documents to support its claim for a bad debt for each account
    included.” While these sections of the PRM do not address explicitly the issue of finality of
    collection efforts, conversely, nothing in the text of these manual provisions contradicts or precludes
    the Secretary’s mandate that, for documentation purposes, a provider must show concretely, when
    a collection agency is used by the provider, that those debts in the hands of the collection agency
    are truly uncollectible before the presumption will apply. As the Secretary properly held, PRM
    § 310.2 “does not suggest that this ‘presumption’ relieves the Provider from meeting the general
    regulatory documentation requirements or the specific documentation requirements in sections
    310.B and 314 of the PRM.”
    Battle Creek and Trinity Health further argue that the Secretary’s decision is contrary to
    PRM § 316, which, according to plaintiffs, encourages providers to continue collection efforts after
    the provider has been reimbursed by the Medicare program for a bad debt. Plaintiffs maintain that
    the Secretary’s decision appears to be grounded in part in a concern that providers would be able
    to obtain double recovery for bad debts that are paid after reimbursement. Plaintiffs note, however,
    that this concern is addressed expressly in PRM § 316, which requires a provider to reimburse
    Medicare for bad debts that are collected in a later reporting period after CMS has reimbursed the
    provider for the same. Section 316 therefore supports “the obvious inference . . . that seeking
    reimbursement for bad debts does not require discontinuation of on-going collection efforts. . . .”
    However, this common-sense provision merely recognizes that if a provider recovers
    amounts previously included in allowable bad debts, it must reduce reimbursable costs in the period
    during which the debt was recovered by the same amount. As the district court found, “Section 316
    is not incompatible with the Secretary’s decision that debts are not reimbursable until collection
    efforts have ceased” and “it is not unreasonable for the Secretary to include guidelines to govern that
    situation.” Battle Creek Health 
    Systems, 423 F. Supp. 2d at 762
    .
    Plaintiffs also challenge the sources underlying the Secretary’s decision, claiming that the
    Intermediary Manual should be disregarded because it is issued only to fiscal intermediaries, not
    providers, and, from a substantive standpoint, Part IB, 13-2 of the Intermediary Manual allegedly
    conflicts with PRM § 310.2 and deprives a provider of the discretion to use its sound business
    judgment in determining which accounts are worthless and uncollectible. Plaintiffs likewise assert
    that the Secretary’s reliance upon the June 11,1990, HFCA policy memorandum is arbitrary and
    capricious because the memorandum actually imposes more stringent requirements than called for
    in 42 C.F.R. § 413.89(e)(3) and (4).
    To the contrary, the Intermediary Manual and the HFCA policy memorandum serve to
    bolster the Secretary’s interpretation of 42 C.F.R. § 413.89(e). The Intermediary Manual advises
    that a Medicare bad debt cannot be claimed as reimbursable until “after the collection agency
    completes its collection effort.” Intermediary Manual, Part IB, 13-2. The policy memorandum
    No. 06-1775              Battle Creek Health System, et al. v. Leavitt                           Page 12
    similarly provides, “in accord with the fourth criterion in section 308,” that “until a provider’s
    reasonable collection effort has been completed, including both in-house efforts and the use of a
    collection agency, a Medicare bad debt may not be reimbursed as uncollectible.” As noted
    previously, these interpretive tools are entitled to respect to the extent that those interpretations have
    the power to persuade and, so long as these interpretive sources are not inconsistent with
    promulgated regulations or outside of coverage of the Act, they are valid. Clark Reg’l Med. 
    Ctr., 314 F.3d at 245
    . In this case, the provisions of the Intermediary Manual and policy memorandum
    are persuasive, consistent with the regulatory provisions, and thus valid sources upon which the
    Secretary can legitimately rely.
    Plaintiffs’ contention that the Intermediary Manual is not a usable interpretive source
    because providers are not given notice of its provisions is without merit. Although it is directed to
    fiscal intermediaries for auditing purposes, the Intermediary Manual is often referenced by the courts
    as an authoritative source. See Mercy Catholic Med. Ctr. v. Thompson, 
    380 F.3d 142
    , 161-62 (3d
    Cir. 2004); Fanning v. United States, 
    346 F.3d 386
    , 400-01 (3d Cir. 2003); Tenet Health Sys.
    HealthCorp. v. Thompson, 
    254 F.3d 238
    , 249 (D.C. Cir. 2001); Keefe on Behalf of Keefe v. Shalala,
    
    71 F.3d 1060
    , 1066-67    (2d Cir. 1995). The Intermediary Manual is also available for public perusal
    on the CMS website.10
    Next, Battle Creek and Trinity Health suggest that the Secretary’s decision will deprive
    providers of the discretion and the ability to exercise their “sound business judgment” in deeming
    a bad debt uncollectible, and places this discretion in the hands of the fiscal intermediary or the
    collection agency. This fear, however, is unfounded for the reasons explained by the district court:
    [T]he Secretary’s interpretation does not wrest discretion from service providers.
    After 120 days of reasonable and customary collection efforts, it is within the
    discretion of the service provider to either continue collection efforts or cease
    collection efforts and deem the debt uncollectible. The Secretary merely requires
    that a service provider take one course or the other in order to satisfy the four criteria
    entitling a provider to reimbursement. Moreover, the Secretary’s interpretation does
    not preclude, nor necessarily discourage, service providers from using collection
    agencies, as Plaintiffs argue. If a service provider has determined that, in general,
    turning its receivables over to a collection agency at a given point in the collection
    process is beneficial, it may still do so.
    Battle Creek Health 
    Systems, 423 F. Supp. 2d at 761
    -62.
    Finally, we conclude that the dire public policy concerns cited by plaintiffs and amicus curiae
    will not come to fruition. Battle Creek and Trinity Health claim that as a result of the Secretary’s
    decision, it will be cost-prohibitive for providers, annually faced with thousands of bad debts, to
    document decisions regarding each account on a case-by-case basis; the Secretary’s documentation
    requirement will shift costs and burdens of Medicare to “individuals not covered by the Medicare
    program. . . .” 42 C.F.R. § 413.89(d). Plaintiffs note that there is no additional cost to providers or
    ultimately to the Medicare program by allowing bad debts to remain at the collection agency beyond
    120 days; in practical terms, collection agencies are often the only cost-effective avenue to pursue
    stale accounts in a cost-efficient manner. Plaintiffs argue that the purpose of PRM § 310.2 is to
    simplify, not increase, providers’ administrative burdens and costs.
    The testimony taken at the PRRB hearing in this case established that it would not have been
    unduly burdensome for plaintiffs to determine the date that the collection agency found that the
    10
    See http://www.cms.hhs.gov/Manuals.
    No. 06-1775           Battle Creek Health System, et al. v. Leavitt                            Page 13
    debts were uncollectible. Battle Creek’s Regional Director of Accounts Receivable, Robert
    Hammond, testified that the providers received a monthly report from the collection agency listing,
    on a case-by-case basis, which accounts were considered worthless and active or inactive. Plaintiffs,
    however, were not using the information contained in these reports to determine the date that the
    debts were uncollectible and did not reconcile these reports with their own records because they had
    already written off the debts as reimbursable. Thus, there was no attempt to compare what plaintiffs
    had written off as bad debt with those accounts the collection agency was still actively pursuing.
    Battle Creek and Trinity Health could have determined, with minimal increased cost and effort, the
    date that the debts were determined to be uncollectible.
    This evidence also belies plaintiffs’ claim that both the Medicare program and the hospitals
    will lose revenue if they are forced to comply with the Secretary’s decision. Plaintiffs anticipate that
    the policies advocated by the Secretary will act as a disincentive for providers to continue collection
    efforts beyond 120 days, which will ultimately have a negative fiscal impact on both the Medicare
    program as well as providers. Further, because the requirements of § 310 require that all patients
    be treated the same, plaintiffs anticipate that the cessation of collection efforts will apply to all
    patients, not just Medicare beneficiaries.
    The Secretary’s decision, however, does not deprive plaintiffs or other providers of
    reimbursement for Medicare bad debts; rather, it merely requires them to engage in the same sound
    business practices that they use when pursuing non-Medicare debt. It is not unreasonable for the
    Secretary to require providers to exhaust every available method of collection before receiving
    reimbursement for uncollectible debts. Providers using collection agencies will still receive
    reimbursement, after the collection agency completes its collection efforts and the debt is determined
    to be uncollectible. Moreover, because, as noted above, precise information on individual bad-debt
    accounts is readily obtainable from collection agencies (but was not utilized by the present
    plaintiffs), the documentation requirements now levied by the Secretary should not deter providers
    from using such agencies as a resource. In sum, through his decision, the Secretary, as the steward
    of the Medicare system, has reasonably reinforced providers’ accountability to him.
    IV.
    We hold that the Secretary’s final decision disallowing Medicare reimbursement for the bad
    debts at issue incurred by plaintiffs Battle Creek and Trinity Health during the fiscal year 1999 is
    neither arbitrary nor inconsistent with the governing Medicare regulations and is supported by
    substantial evidence. Therefore, we defer to the Secretary’s reasonable interpretation of the
    Medicare Act and accompanying regulations that he administers. For the foregoing reasons, we
    affirm the judgment of the district court.