Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
King of Prussia Surgery Center, LLC
(NPI: 1740823848 / PTAN: 1I5824),
Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-21-614
Decision No. CR6398
DECISION
Petitioner, King of Prussia Surgery Center, LLC, an ambulatory surgical center (ASC), challenges the determination of the Centers for Medicare & Medicaid Services (CMS) that October 2, 2020, is the effective date for Petitioner’s Medicare agreement and Medicare billing privileges. As explained below, I affirm CMS’s determination.
I. Background and Procedural History
On October 29, 2020, a CMS contractor issued a notice of initial determination approving Petitioner’s application to enroll in the Medicare program as an ASC with October 2, 2020, as the effective date for Petitioner’s Medicare billing privileges. CMS Ex. 8 at 1.
In a November 3, 2020 letter, Petitioner requested that CMS reconsider the October 2, 2020 effective date and, instead, establish an effective date of July 1, 2020. The basis for this request was that the COVID-19 pandemic significantly delayed the state licensing process for Petitioner and Petitioner had provided excellent care to 87 patients from July through September 2020. CMS Ex. 9 at 1.
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On January 28, 2021, a CMS hearing officer issued a reconsidered determination affirming the October 2, 2020 effective date for Petitioner’s participation in the Medicare program. CMS Ex. 1. The CMS hearing officer stated that the effective date for an ASC’s billing privileges is the date on which the ASC is determined to have met all health and safety standards. CMS Ex. 1 at 3. The CMS hearing officer recounted that the Accrediting Association for Ambulatory Health Care, Inc. (AAAHC) determined, after an accreditation survey, that Petitioner had deficiencies requiring correction. Further, AAAHC accepted Petitioner’s plan of correction and accredited Petitioner on October 2, 2020. CMS Ex. 1 at 3. The CMS hearing officer concluded the following:
[Petitioner] asserts that it provided excellent services to patients from July 1, 2020, in anticipation of its certification, which was delayed due to [COVID-19]. This [Petitioner] claims that CMS should provide it a retroactive effective date of July 1, 2020. However, CMS is unable to grant it an earlier effective date prior to October 2, 2020, because [Petitioner] did not receive its successful accreditation from AAAHC until October 2, 2020. Therefore, its enrollment effective date cannot be modified to a date preceding October 2, 2020. Thus, even though [Petitioner] may have rendered services prior to October 2, 2020, the AAAHC was not able to confirm that [Petitioner] met the applicable health and safety standards until October 2, 2020. Therefore, [Petitioner] cannot receive an effective date earlier than the date on which the AAAHC deemed it accredited, which was October 2, 2020.
CMS Ex. 1 at 3.
On March 29, 2021, Petitioner requested a hearing before an administrative law judge (ALJ) to dispute the effective date for Petitioner’s billing privileges. In the hearing request, Petitioner presented the same argument as it had in the reconsideration request except that Petitioner also asserted that “[w]e take regulatory compliance and patient safety very seriously and proactively corrected every item on our survey in ten days (not the 30 that are allowed).”
The Civil Remedies Division acknowledged receipt of the hearing request and issued my Standing Prehearing Order (SPO), which provided prehearing procedures and submission dates for prehearing exchanges. In compliance with the SPO, CMS filed a prehearing brief, which included a motion for summary judgment, and nine proposed exhibits. Petitioner submitted a prehearing brief (P. Br.) and nine proposed exhibits (P. Exhibit 9 is composed of four parts designated as P. Ex. 9a-d). CMS filed a reply brief (CMS Reply).
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II. Evidentiary Rulings
Petitioner did not object to CMS’s proposed exhibits. SPO ¶ 10; Civil Remedies Division Procedures (CRDP) § 14(e). Therefore, I admit CMS Exhibits 1 through 9 into the record.
CMS objected to Petitioner’s proposed exhibits because Petitioner did not provide good cause for submitting the proposed exhibits for the first time at the ALJ level of appeal. CMS Reply at 1. Petitioner did not respond to CMS’s objection. For the reasons explained below, I sustain CMS’s objection and exclude Petitioner Exhibits 1 through 9 from the record.
The notice of initial determination approving Petitioner’s enrollment application and establishing an effective date for Medicare billing privileges expressly advised Petitioner of its right to request reconsideration of the initial determination. CMS Ex. 8 at 2-3. The notice also stated:
Providers and suppliers may: Submit additional information with the reconsideration that may have a bearing on the decision. However, if you have additional information that you would like a Hearing Officer to consider during the reconsideration or, if necessary, an Administrative Law Judge (ALJ) to consider during a hearing, you must submit that information with your request for reconsideration. This is your only opportunity to submit information during the administrative appeals process unless an ALJ allows additional information to be submitted.
CMS Ex. 8 at 2 (emphasis added).
My SPO provided the following instructions on how Petitioner could submit new evidence during this proceeding:
Offer of New Evidence by Petitioner – Good Cause Requirement
With respect to enrollment-related cases, Petitioner may not offer new documentary evidence absent a showing of good cause for failing to present that evidence previously to CMS. 42 C.F.R. §§ 405.803(e), 498.56(e). If Petitioner offers new evidence, the evidence must be specifically identified as new and Petitioner must explain, in a separate filing from its brief, why good cause exists for its submission.
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Petitioner must file the request when it files its prehearing exchange.
SPO ¶ 9 (emphasis in original).
Petitioner did not submit evidence with its reconsideration request. See CMS Ex. 9; see also CMS Ex. 1 at 1-2 (list of exhibits considered/submitted on reconsideration). However, Petitioner submitted nine proposed exhibits with its prehearing exchange. Despite being warned that 42 C.F.R. § 498.56(e) requires Petitioner to provide good cause for submitting new exhibits with its prehearing exchange, Petitioner did not explain why it had not previously submitted these exhibits.1
I must determine whether Petitioner “has good cause for submitting the evidence for the first time at the ALJ level,” and, if there is no good cause, I “must exclude the evidence from the proceedings and may not consider it in reaching a decision.” 42 C.F.R. § 424.56(e). Because Petitioner has not provided good cause for filing these exhibits for the first time at the ALJ level of appeal, I must exclude Petitioner Exhibits 1 through 9 from the record.
III. Decision on the Written Record
I directed the parties to submit the written direct testimony from witnesses who the parties wanted to present in this case, and that I would only convene a hearing if the opposing party requests to cross-examine one or more witnesses from whom written direct testimony had been submitted. SPO ¶¶ 11-13; see also CRDP §§ 16(b), 19(b); Vandalia Park, DAB No. 1940 (2004); Pacific Regency Arvin, DAB No. 1823 at 7-8 (2002) (holding that the use of written direct testimony for witnesses is permissible so long as the opposing party has the opportunity to cross-examine those witnesses). Because neither CMS nor Petitioner submitted written direct testimony for any witnesses, I issue this decision based on the written record. SPO ¶ 14; see also CRDP § 19(d); El Medico, Inc., DAB No. 3117 at 15 (2023). As a result, I deny CMS’s summary judgment motion as moot.
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IV. Issue
Whether CMS had a legitimate basis to assign October 2, 2020, as the effective date for Petitioner’s Medicare agreement and Medicare billing privileges.
V. Jurisdiction
I have jurisdiction to hear and decide the issue in this case. 42 C.F.R. §§ 498.3(b)(15), 498.5(l)(2); see also 42 U.S.C. § 1395cc(h)(1), (j)(8).
VI. Findings of Fact and Conclusions of Law
- On December 17, 2019, Petitioner filed a CMS-855B Medicare Enrollment Application seeking enrollment in the Medicare program as an ASC. CMS Ex. 2 at 6, 69.
- On December 18, 2019, a CMS contractor notified Petitioner that it had received Petitioner’s enrollment application, but that Petitioner needed to submit additional information to perfect the application. CMS Ex. 3 at 1-2.
- Petitioner provided the additional information requested by the CMS contractor. CMS Ex. 1 at 2.
- In a January 22, 2020 letter, the CMS contractor informed Petitioner that its enrollment application was referred to the relevant CMS regional office and that “[t]he next step will be a survey conducted by a State Survey Agency or a CMS approved deemed accrediting organization to ensure compliance with required conditions of participation.” CMS Ex. 5.
- On September 8 and 9, 2020, AAAHC conducted a Medicare Deemed Status Survey of Petitioner’s facility during which AAAHC found that there were deficiencies in Petitioner’s compliance with Medicare requirements. CMS Ex. 6.
- On October 2, 2020, AAAHC received Petitioner’s plan of correction, which AAAHC found to be acceptable. CMS Ex. 6 at 1.
- In an October 12, 2020 Accreditation Notification, AAAHC accredited Petitioner as of October 2, 2020, as having “demonstrated its compliance with the AAAHC Standards and all Medicare Conditions for Coverage. . . . The AAAHC Accreditation Committee recommends your ASC for participation in the Medicare Deemed Status program.” CMS Ex. 6 at 1.
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- In the October 12 Accreditation Notification, AAAHC advised that “[CMS] has the final authority to determine participation and effective dates in Medicare Deemed Status in accordance with the regulations at 42 CFR 489.13.” CMS Ex. 6 at 1.
- In the October 12 Accreditation Notification, AAAHC stated that “[s]ubsequent surveys by AAAHC will seek evidence that [the] deficiencies from this survey were addressed within the timeframes of your [plan of correction].” CMS Ex. 6 at 1.
- In an October 27, 2020 letter, CMS informed Petitioner that “[b]ased upon the approval for deemed status by AAAHC and compliance with the additional requirements for certification established by the Secretary, your request for participation [as a supplier of ASC services] has been approved. The effective date of participation is October 2, 2020.” CMS Ex. 7.
- On October 29, 2020, a CMS contractor issued a notice of initial determination approving Petitioner’s Medicare enrollment application and setting the effective date for billing privileges as October 2, 2020. CMS Ex. 8.
- Because AAAHC found Petitioner failed to meet applicable health and safety standards, the effective date for Medicare participation is the date “on which a . . . supplier is found to meet . . . all conditions of coverage, but has lower-level deficiencies, and . . . a CMS-approved accreditation decision issues a positive accreditation decision after it receives an acceptable plan of correction for the lower-level deficiencies.” 42 C.F.R. §§ 424.520(a), 489.13(c)(2)(ii)(A). AAAHC received Petitioner’s plan of correction on October 2, 2020, and found it acceptable. Therefore, the effective date for Petitioner’s Medicare agreement and Medicare billing privileges is October 2, 2020.
VII. Discussion
The Social Security Act (Act) authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations for enrolling providers and suppliers in the Medicare program. 42 U.S.C. § 1395cc(j). For purposes of the Medicare program, an ASC is considered to be a “supplier.” See 42 U.S.C. § 1395x(d) (defining a “supplier” to include “a facility or other entity (other than a provider of services) that furnishes items or services under [the Medicare program.]”), (u) (definition of “provider of services” does not include ASC); 42 C.F.R. §§ 488.1 (definition of “Supplier”), 498.2 (paragraph (10) under definition of “Supplier”).
Under the Secretary’s regulations, a supplier must enroll in the Medicare program to receive payment for covered Medicare items or services provided to beneficiaries.
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42 C.F.R. § 424.505. To enroll, a supplier must complete and file an enrollment application with CMS and meet all of the requirements to be a supplier. 42 C.F.R. §§ 424.510, 424.530.
In addition to general enrollment requirements for all suppliers, the Act places additional requirements on ASCs for participation in the Medicare program. In order for an ASC to receive Medicare payment,2 it must:
- “meet[] health, safety, and other standards specified by the Secretary in regulations”;
- “ha[ve] an agreement in effect with the Secretary by which the [ASC] agrees to accept the standard overhead amount determined . . . as full payment for such services”; and
- “accept an assignment . . . with respect to payment for all such services . . . furnished by the [ASC] to individuals enrolled under [Medicare Part B].”
42 U.S.C. § 1395k(a)(2)(F)(i).
The Secretary’s regulations require an ASC to comply with the requirements in 42 C.F.R. Part 416 to receive payment under Medicare Part B. 42 C.F.R. § 410.165(b)(1); see also 42 C.F.R. §§ 410.3(a)(2), 410.5(c), 410.150(b)(9). Broadly, an ASC must (1) meet the regulatory definition of an ASC and (2) have a qualifying agreement in effect with CMS. 42 C.F.R. § 416.25.
The regulations define an ASC as a distinct entity that operates exclusively to provide surgical services to patients not requiring hospitalization rendering services that are not expected to exceed 24 hours after admission. The definition reiterates that an ASC must have an agreement with CMS to participate in the Medicare program and must meet the conditions of coverage provided in the regulations. 42 C.F.R. § 416.2.
The conditions of coverage for ASCs include: state licensure; establishment of a governing body; compliance with standards for surgical services; a quality assessment and performance improvement (QAPI) program; a sanitary and safe environment for patients; medical staff that are accountable to the ASC governing body; nursing staff that
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provide nursing care within recognized standards of practice; a system for maintaining complete medical records; safe and effective administration of drugs; compliance with standards for laboratory or radiological services provided; posting of patient rights under the regulations; maintenance of an infection control program; appropriate pre-surgical and post-surgical assessments and discharge; and an emergency preparedness program that complies with regulatory requirements. 42 C.F.R. §§ 416.40-416.54.
The terms of an ASC agreement with CMS include: complying with the regulatory conditions of coverage; limiting fees charged to Medicare beneficiaries; refunding excess amounts charged to beneficiaries; furnishing information to CMS necessary to establish payment rates to the ASC; and accepting assignment from beneficiaries for all facility services furnished in connection with covered surgical procedures. 42 C.F.R. § 416.30.
In order for an ASC to qualify for an agreement with CMS, the ASC must either be surveyed by a state survey agency or accredited by a national accrediting body to ensure compliance with the conditions of coverage. 42 C.F.R. §§ 416.26(a)-(b), 488.3(a), 488.6, 488.7; see also 42 U.S.C. §§ 1395aa(a), 1395bb(a). Compliance with a condition of coverage is determined by the manner and degree to which the supplier satisfies the standards within the condition. 42 C.F.R. § 488.26(b). If deficiencies are of such character as to “substantially limit the . . . supplier’s capacity to furnish adequate care or which adversely affect the health and safety of patients,” the supplier is not in compliance with conditions of coverage. 42 C.F.R. § 488.24(b).
If a state survey agency conducts the survey and finds that a supplier is deficient in one or more standards in the conditions for coverage, the supplier will be given an opportunity to file an acceptable plan of correction in order to achieve compliance. 42 C.F.R. § 488.28. CMS may “refuse to enter into an agreement” with a provider that fails to meet even one condition of participation. 42 C.F.R. § 488.3(a); see also 42 U.S.C. § 1395cc(b)(2)(B).
If a national accrediting body provides reasonable assurance to CMS that an ASC meets the conditions of coverage, then the ASC may be deemed in compliance with those conditions. 42 C.F.R. §§ 416.26(a), 488.4, 488.6; see also 42 U.S.C. § 1395bb(a)(1). However, CMS may determine that a supplier does not meet the conditions for coverage based on the accreditation survey or other evidence. 42 C.F.R. § 488.7(a); see also 42 U.S.C. § 1395bb(c).
If CMS determines, after reviewing the survey agency recommendation that the ASC meets the requirements in the regulations, CMS will issue a determination and provide the ASC with an agreement. 42 C.F.R. § 416.26(c). The ASC must return the signed agreement to CMS. 42 C.F.R. § 416.26(c). If CMS accepts the agreement from the ASC, then CMS issues “a notice of acceptance specifying the effective date.” 42 C.F.R. § 416.26(e).
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Because ASCs must pass a survey and enter into an agreement with CMS, the effective date for a Medicare agreement and Medicare billing privileges is based on the successful completion of the survey and CMS approval of the agreement. 42 C.F.R. §§ 424.520(a), 489.13(a)(1).
In the present case, there is no question that Petitioner met the general Medicare requirements to enroll as a supplier in the Medicare program. After meeting those requirements, Petitioner needed to be surveyed to ensure that Petitioner met all of the conditions and standards of coverage for ASCs in the regulations. Petitioner sought accreditation (i.e., deemed compliance with Medicare requirements) through a survey conducted by AAAHC. However, during the survey, AAAHC concluded that Petitioner did not meet all of the Medicare standards for ASCs and required Petitioner to submit a plan of correction. AAAHC received the plan of correction on October 2, 2020, and found it acceptable. AAAHC must have considered the deficient standards to be lower level in nature because AAAHC was able to accredit Petitioner based on an acceptable plan of correction without a follow-up survey to confirm Petitioner was compliant with all standards for ASCs.
Therefore, the following rule concerning the effective date for participation in the Medicare program applies:
If, on the date the survey is completed, the provider or supplier has failed to meet any one of the applicable health and safety standards, the following rules apply for determining the effective date of the provider agreement or supplier approval, assuming that no other Federal requirements remain to be satisfied. . . .
* * * * *
(2) For an agreement with, or an approval of, any other provider or supplier, (except those specified in paragraph (a)(2) of this section), the effective date is the earlier of the following:
(i) The date on which the provider or supplier meets all applicable conditions of participation, conditions for coverage, or conditions for certification; or, if applicable, the date of a CMS-approved accreditation organization program's positive accreditation decision, issued after the accreditation organization has determined that the provider or supplier meets all applicable conditions.
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(ii) The date on which a provider or supplier is found to meet all conditions of participation, conditions for coverage, or conditions for certification, but has lower-level deficiencies, and—
(A) CMS or the State survey agency receives an acceptable plan of correction for the lower-level deficiencies (the date of receipt is the effective date regardless of when the plan of correction is approved); or, if applicable, a CMS-approved accreditation organization program issues a positive accreditation decision after it receives an acceptable plan of correction for the lower-level deficiencies; or
(B) CMS receives an approvable waiver request (the date of receipt is the effective date regardless of when CMS approves the waiver request).
42 C.F.R. § 489.13(c).
Based on the initial and reconsidered determinations, it is not entirely clear whether CMS applied the provision of section 489.13(c)(2)(i) or (ii) to this case. As explained in the following paragraphs, I conclude that section 489.13(c)(2)(ii) applies to this case.
“[S]ection 489.13(c)(2)(i) must be read to apply where a provider is found to meet all conditions of participation and to have no lower-level deficiencies.” Ridgeview Hosp., DAB No. 2593 at 8 (2014) (emphasis in original) (citing Oak Lawn Endoscopy, DAB No. 1952 (2004)). Moreover, for a prospective accredited provider, the second clause of 42 C.F.R. § 489.13(c)(2)(i) (i.e., “the date of a CMS-approved accreditation organization program’s positive accreditation decision, issued after the accreditation organization has determined that the provider or supplier meets all applicable conditions”) applies, not the first clause (i.e., “[t]he date on which the provider or supplier meets all applicable conditions of participation, conditions for coverage, or conditions for certification”). Ridgeview, DAB No. 2593 at 7. The record in this case does not clearly reflect the scenario required to apply section 489.13(c)(2)(i). Therefore, that regulation does not appear to be applicable to this case.
Rather, section 489.13(c)(2)(ii) appears to apply because AAAHC found Petitioner had filed an acceptable plan of correction for lower-level deficiencies in order to accredit Petitioner. See CMS Ex. 6 at 1; P. Br. at 2 (Petitioner describing the AAAHC survey as finding the need for “many minor corrections.”); Ridgeview, DAB No. 2593 at 10.
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Therefore, the effective date of the Medicare agreement for a prospective accredited provider or supplier that meets the conditions of participation but has lower-level deficiencies “is the date when . . . the provider is in compliance with all applicable conditions of participation but has lower-level deficiencies; the [accrediting organization] has received an acceptable plan of correction; and the [accrediting organization] has issued a positive accreditation decision.” Ridgeview, DAB No. 2593 at 10 (emphasis in original); see also 42 C.F.R. § 488.28(a) (“If a . . . supplier is found to be deficient in one or more of the standards in the . . . conditions of coverage . . . it may participate in, or be covered under, the Medicare program only if the . . . supplier has submitted an acceptable plan of correction for achieving compliance within a reasonable period of time acceptable to CMS.”); CMS Ex. 6 at 1 (noting that AAAHC would seek evidence in the future from Petitioner to confirm that Petitioner addressed the deficiencies found during the survey in the timeframe established in the plan of correction.).
Applying the facts in this case to section 489.13(c)(2)(ii), CMS correctly determined that October 2, 2020, is the effective date for Petitioner’s Medicare agreement and Medicare billing privileges because that is the date AAAHC received an acceptable plan of correction. CMS Ex. 6 at 1.
In its brief, Petitioner again requests July 1, 2020, as the effective date for Medicare billing privileges. P. Br. at 1. However, based on section 489.13(c)(2)(ii), there is no legal basis to modify the effective date to a date preceding the accreditation survey (i.e., there is no authority to provide a retroactive effective date). See 75 Fed. Reg. 50,042, 50,402-403 (Aug. 16, 2010) (deleting paragraph (d) from section 489.13, which provided limited authority to provide retroactive effective dates); see also 42 C.F.R. § 424.521(a)(2) (ASCs are omitted from the list of suppliers eligible for retrospective billing privileges).
Petitioner also asserts that it spent over six million dollars building its facility and received its certificate of occupancy late in 2019. However, due to the COVID-19 pandemic, the Pennsylvania Department of Health did not license Petitioner until June 15, 2020. Petitioner states that, from June 15 through September 9, 2020, Petitioner performed 87 surgeries while awaiting the AAAHC survey. Petitioner posits that its patients received excellent care. However, because of the delays caused by COVID-19, Petitioner has incurred significant debt and financial hardship. P. Br. at 2.
While Petitioner’s situation is extremely unfortunate and occasioned by a pandemic, it does not provide a legal basis for granting Petitioner a retroactive effective date for billing privileges. I am not authorized to provide Petitioner the relief it seeks based on equitable arguments. US Ultrasound, DAB No. 2302 at 8 (2010).
Finally, Petitioner argues, for the first time in its prehearing exchange, that AAAHC should not have found deficiencies with its electrical system during the accreditation
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survey (i.e., Life Safety Code violations). P. Br. at 1. Petitioner cited as support for its challenge to the electrical system deficiencies the proposed exhibits that it also filed for the first time with its prehearing exchange. P. Br. at 1-2; P. Exs. 1-9. Petitioner argues that the Pennsylvania Department of Safety Inspection approved the original electrical plans for Petitioner’s facility and that the electrical plans were drawn in accordance with the standards from the regulatory bodies that AAAHC cited as authority for the deficiency findings. P. Br. at 2. Therefore, those deficiencies were erroneous.
Petitioner cannot challenge the electrical system deficiencies at this juncture in the case. Although the regulations generally permit parties to add new issues in a case before an ALJ, this is not true for provider and supplier enrollment appeals.
Except for provider or supplier enrollment appeals which are addressed in § 498.56(e), the ALJ may consider new issues even if CMS or the OIG has not made initial or reconsidered determinations on them, and even if they arose after the request for hearing was filed or after the prehearing conference.
42 C.F.R. § 498.56(a)(2).
Petitioner admits that its Board of Managers “decided at great expense to make all electrical changes even though they believe they should not have been necessary for accreditation.” P. Br. at 1. Further, Petitioner stated that it “decided to make the electrical changes instead of appealing the finding. . . .” P. Br. at 2 (emphasis added).
As stated in the quoted regulation, the prohibition on new issues in supplier enrollment appeals relates to the exclusion of new evidence under section 498.56(e). As discussed above, I excluded Petitioner’s new evidence that relates to Petitioner’s new argument. Similarly, I cannot entertain Petitioner’s late challenge to the electrical deficiencies found by AAAHC. 73 Fed. Reg. 36,448, 36,450-51 (Jun 27, 2008) (“Accordingly, we proposed revising § 498.56 . . . to prohibit providers and suppliers from submitting new provider enrollment issues or evidence at the ALJ . . . level[] of review.”).
VIII. Conclusion
I conclude that October 2, 2020, is the effective date of Petitioner’s Medicare agreement and Medicare billing privileges.
Endnotes
1 While Petitioner did not explain why it failed to submit its proposed exhibits with its reconsideration request, Petitioner’s brief in this matter posits a new argument that Petitioner neither identified in the reconsideration request nor the hearing request. P. Br. at 1-2. It appears that Petitioner failed to submit this evidence previously because Petitioner only now raises a new issue. Below, I discuss my inability to entertain Petitioner’s new issue at this stage in the appeal process.
2 The Act provides the Secretary with significant authority to “specify those surgical procedures which are appropriately . . . performed on an inpatient basis in a hospital but which also can be performed on an ambulatory basis in as [ASC].” 42 U.S.C. § 1395k(a)(2)(F)(i). The Medicare program may pay for the surgical procedures authorized by the Secretary when provided to Medicare beneficiaries. 42 U.S.C. § 1395l(i)(1)(A).
Scott Anderson Administrative Law Judge