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                              Saba F. Osmani, M.D., CR6290 (2023)
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Saba F. Osmani, M.D., CR6290 (2023)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





Saba F. Osmani, M.D.
(NPI No.: 1447539622 / PTANs: F400325251, F400609624)
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-22-93Decision No. CR6290May 23, 2023

        
              
    

      DECISION

This decision AFFIRMS the revocation of Dr. Saba F. Osmani’s Medicare enrollment and billing privileges by an administrative contractor for the Centers for Medicare & Medicaid Services (CMS).

I.    Background and Procedural History

Dr. Saba F. Osmani (Petitioner) is a physician who was enrolled as a supplier in the Medicare program.  P. Br. at 2.  CMS uses Unified Program Integrity Contractors (UPIC) to perform program integrity activities aimed to reduce fraud, waste, and abuse in the Medicare and Medicaid programs.  CMS Ex. 2 at 1.  On January 24, 2020, CoventBridge Group (CoventBridge), a UPIC, sent a letter to Petitioner requesting that she provide medical documentation for claims associated with referrals made for durable medical equipment (DME) items for 20 Medicare beneficiaries.  CMS Ex. 2.

On July 15, 2020, CoventBridge sent a follow-up letter, again requesting documentation.  CMS Ex. 3.  Petitioner did not respond to the letters.  By letter dated September 2, 2020, National Government Services (NGS), a CMS Medicare administrative contractor,

**Page 2**

informed Petitioner that her Medicare billing privileges were being revoked for failure to document or provide CMS access to documentation, and that she would be barred from reenrolling in Medicare for ten years.  CMS Ex. 4.

Petitioner requested reconsideration on September 7, 2021.  CMS Ex. 5.  In a reconsidered determination dated September 27, 2021, CMS informed Petitioner that the reconsideration upheld the revocation of her Medicare enrollment and billing privileges, and the 10-year reenrollment bar established in the initial determination.  CMS Ex. 1 at 4.

On November 12, 2021, Petitioner, through counsel, timely requested a hearing before an Administrative Law Judge (ALJ) to contest the revocation of her Medicare enrollment and billing privileges.  On November 17, 2021, at my direction, the Civil Remedies Division (CRD) issued an acknowledgment letter and my standing prehearing order (Standing Order), which set forth a schedule for briefing and submitting supporting evidence and other procedural requirements.

On December 22, 2021, CMS filed a Motion for Summary Judgment and supporting memorandum and brief (CMS Br.), along with 7 exhibits (CMS Exs. 1-7).  CMS did not offer any witnesses.

On January 24, 2022, Petitioner filed an unopposed Motion for Extension of Time.  Petitioner’s request was granted, and Petitioner’s pre-hearing exchange deadline was extended to February 25, 2022.  On February 24, 2022, Petitioner filed a second unopposed Motion for Extension of Time, which was granted.

On March 28, 2022, Petitioner filed a Response in Opposition to CMS’s Motion for Summary Judgment and supporting memorandum (P. Br.) and four exhibits (P. Exs. 1-4a, 4b), including affidavits from Kathy Ragusa (P. Ex. 3) and Dr. Sarah N. Siddiqui (P. Ex. 4b).1  Petitioner also filed a witness list indicating that Kathy Ragusa and Dr. Siddiqui would be called as witnesses should this case proceed to a hearing.

Neither party filed objections to the other party’s exhibits.  Absent objection, CMS Exs. 1-7 and P. Exs. 1-4a, 4b are admitted into evidence.  I will give the proper weight and consideration to the admitted evidence.  CMS did not request to cross-examine Petitioner’s witnesses.  Because CMS did not request cross-examination of Petitioner’s witnesses, for whom written testimony has been submitted, no hearing is necessary, and

**Page 3**

this matter will be decided based upon the written record.  *George Yaplee Med. Ctr.*, DAB No. 3003 at 5 (2020); Standing Order ¶¶ 7, 9, 10; Civil Remedies Division Procedures ¶ 19(d).  Because the matter will be resolved based on the written record, CMS’s motion for summary judgment is moot.

II.    Jurisdiction

This tribunal has the authority to hear and decide this matter.  42 C.F.R. §§ 498.3(b)(17), 498.5(1)(2); *Conchita Jackson, M.D.,*DAB No. 2495 at 2 (2013) (“While the language of [section 1866(j)(8) of the Social Security Act (Act)] does not specifically refer to hearing rights for enrolled providers and suppliers whose billing privileges are revoked, CMS has interpreted it as providing hearing rights in such cases.”); *See also*Act § 1866(j)(8) (codified at 42 U.S.C. § 1395cc(j)(8)).

III.  Issue

The issue to be decided is whether CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(10).

IV.   Findings of Fact

The following facts are undisputed.

Petitioner, a licensed physician, was employed by Presence Healthcare Services, Inc. (PHS) from October 6, 2014 through July 6, 2018.  P. Br. at 9; CMS Ex. 5 at 3.  PHS is part of Alexian Brothers-AHS Midwest Region Health Co. d/b/a AMITA Health (AMITA), an Illinois not-for-profit health system composed of Alexian Brothers Health System, Presence Health, and Adventist Midwest Health.  CMS Ex. 5 at 3.  Approximately seventeen months after ending her employment relationship with PHS, Petitioner began employment with Adventist Health Partners, Inc. (Adventist Health) on December 1, 2019.  Adventist Health is part of AMITA, where Petitioner is currently employed.  CMS Ex. 5 at 3.

From October 4, 2018 through April 10, 2019, Petitioner worked part-time for MD Staffing, where she performed work for Integrated Support Plus (ISP), a telemedicine service provider.  P. Br. at 8-9; CMS Br. at 3.  During her relatively brief time working for ISP, Petitioner evaluated and treated several patients, made referrals, and submitted orders for DME for Medicare beneficiaries.  P. Br. at 3, 9; CMS Ex. 4 at 1, 4.  Petitioner severed her professional relationship with ISP once she discovered that ISP was under investigation by law enforcement authorities.  P. Br. at 7; CMS Ex. 5 at 5-6; CMS Ex. 7 at 5.

**Page 4**

By letter dated January 24, 2020, CoventBridge informed Petitioner that one of its functions as the UPIC is to perform “program integrity activities aimed to reduce fraud, waste, and abuse in the Medicare and Medicaid programs.”  CMS Ex. 2 at 1.  In accordance with that function, CoventBridge reviewed claims associated with 20 Medicare beneficiaries serviced by Petitioner.  CoventBridge requested that Petitioner provide copies of medical documentation associated with orders and referrals for DME items for 20 beneficiaries.  CMS Ex. 2 at 1, 5.  The letter explained that Petitioner had until March 7, 2020 to submit the requested documents and that failure to comply with the request could result in penalties taken against Petitioner, including revocation of Petitioner’s Medicare billing privileges pursuant to 42 C.F.R. § 424.535(a)(10).  CMS Ex. 2 at 2.  The letter was sent by certified mail to Petitioner’s address on file.  CMS Ex. 2 at 6; CMS Ex. 5 at 12 ¶ 2.

The documents were not submitted by the imposed deadline.  CoventBridge sent another letter, dated July 15, 2020, informing Petitioner that the documents had not been received.  CMS Ex. 3 at 1.  CoventBridge provided Petitioner another opportunity to submit the documents and extended the submission deadline to July 30, 2020.  CMS Ex. 3 at 1.  The letter contained an express warning that failure to submit the documents would result in administrative actions taken against Petitioner, including revocation pursuant to 42 C.F.R. § 424.535(a)(10).  The follow-up letter was also sent via certified mail to Petitioner’s address on file.  CMS Ex. 3 at 7.

On September 2, 2020, NGS sent Petitioner a letter stating that her billing privileges were being revoked effective October 2, 2020, for failing to submit the documents requested by CoventBridge.  CMS Ex. 4 at 1.  The letter also stated that Petitioner was subject to a ten-year reenrollment bar.  CMS Ex. 4 at 3.  The letter was mailed to Petitioner’s address on file, the same address used by CoventBridge.  CMS Ex. 4 at 1; CMS Exs. 1 and 2.  NGS cited 42 C.F.R. § 424.535(a)(10) as the basis for the revocation.  CMS Ex. 4 at 1.

On September 7, 2021, Petitioner, through counsel, submitted a request for reconsideration of NGS’s initial determination, which revoked her billing privileges.  CMS Ex. 5 at 2-6.  She reported that she received neither CoventBridge’s records request nor the NGS revocation letter.  Once Petitioner learned of the imposed revocation, she searched for the records requested by CoventBridge.  CMS Ex. 5 at 4-6.  However, Petitioner was unable to obtain the requested records because ISP was no longer in existence.  CMS Ex. 5 at 6.

On September 15, 2021, Petitioner and her counsel received an email from CMS Provider Enrollment Appeals.  CMS Ex. 6.  The email contained copies of the records request, a copy of the revocation notice, and a link “to upload the requested medical records no later than the close of business on Wednesday, September 29, 2021.”  CMS Ex. 6.  In a reply email, Petitioner’s counsel communicated to CMS that Petitioner, “through her employer, AMITA Health, does not have any records requested by CoventBridge for the dates of

**Page 5**

service at issue.  Additionally, [Petitioner] is unable to provide any records from her limited work with [ISP] as she terminated her relationship with [ISP] when the placement agency . . . informed her the company became the subject of [a] government investigation.  [Petitioner] is unable to access . . . the records as the company is no longer in operation.”  CMS Ex. 6 at 2.

In the reconsidered determination dated September 27, 2021, CMS explained that although Petitioner’s request for reconsideration was untimely, it found that a good cause waiver was warranted and granted reconsideration.  CMS Ex. 1.  In the reconsidered determination, CMS upheld both the revocation of Petitioner’s Medicare enrollment and billing privileges and the ten-year reenrollment bar.  CMS Ex. 1 at 4.  CMS explained that Petitioner had failed to maintain and provide access to medical records as required by 42 C.F.R. § 424.516(f).  As a result, Petitioner’s billing privileges were revoked pursuant to section 424.535(a)(10).  CMS also upheld the ten-year reenrollment bar because “[e]ach failure constitute[d] an individual act of noncompliance for each beneficiary.”  CMS Ex. 1 at 4.  Lastly, CMS noted that there was “no Medicare claims data evidencing [Petitioner’s] interaction with any Medicare beneficiary to establish medical necessity.”  CMS Ex. 1; CMS Ex. 4 (listing the 20 patients with Petitioner as the ordering supplier for DMEPOS).

V.   Legal Authorities

The Secretary of Health and Human Services (Secretary) is authorized to establish regulations related to “a process for the enrollment of providers of services and suppliers.”  Act § 1866(j)(1)(A) (42 U.S.C. § 1395cc(j)(1)(A)).  A “supplier” is a “physician . . . [who] furnishes items or services under” the Act’s Medicare provisions.  Act § 1861(d) (42 U.S.C. § 1395x(d)).  It is undisputed that Petitioner is a supplier in the Medicare program.  P. Br. at 2, 3.  A supplier must be enrolled in the Medicare program to receive payment for covered Medicare items or services.  42 C.F.R. § 424.505.  Enroll means “the process that Medicare uses to establish eligibility to submit claims for Medicare-covered items and services.”  42 C.F.R. § 424.502.  To enroll and maintain active enrollment status in the Medicare program, a physician who “orders items of DMEPOS . . . is required to”:

(A)   Maintain documentation (as described in paragraph (f)(2)(ii) of this section) for 7 years from the date of the service; and

(B)  Upon the request of CMS or a Medicare contractor, to provide access to that documentation (as described in paragraph (f)(2)(ii) of this section).

**Page 6**

42 C.F.R. § 424.516(f)(2)(i) (2012).2  The regulation states that the documentation that must be maintained and provided “includes written and electronic documents . . . relating to written orders or certifications or requests for payments for items of DMEPOS and clinical laboratory, imaging, and home health services.”  42 C.F.R. § 424.516(f)(2)(ii) (2012).  CMS requires the maintenance and production of that type of documentation because, among other things, it allows CMS to determine whether a supplier, who has written an order for DMEPOS, has complied with the requirements of the regulations related to DMEPOS.  *See*42 C.F.R. § 424.507; 84 Fed. Reg. at 47,835.

CMS has the authority to revoke “a . . . supplier’s Medicare enrollment” when, inter alia, a supplier fails to “comply with the documentation or CMS access requirements specified in [section] 424.516(f).”  42 C.F.R. § 424.535(a)(10).  “A provider or supplier that meets the revocation criteria specified in paragraph (a)(10)(i) of [section 424.535], is subject to revocation for a period of not more than 1 year for each act of noncompliance.”  42 C.F.R. § 424.535(a)(10)(ii).  Unless otherwise specified, revocations become effective 30 days after CMS, or the CMS contractor, mails notice of its determination to the provider or supplier.  42 C.F.R. § 424.535(g).  Revocation bars the affected supplier from participating in the Medicare program from the effective date of the revocation until the end of the reenrollment bar.  42 C.F.R. § 424.535(c).  When CMS revokes a supplier’s Medicare enrollment and billing privileges, CMS must impose a reenrollment bar “for a minimum of [one] year, but not [more than ten] years . . . , depending on the severity of the basis for revocation.”  42 C.F.R. § 424.535(c)(1)(i).

Only an action that is an initial determination by CMS is subject to administrative review by an ALJ.  42 C.F.R. § 498.3(a).  “While the language of § 1866(j)(8) of the Act does not specifically refer to hearing rights for enrolled providers and suppliers whose billing privileges are revoked, CMS has interpreted it as providing hearing rights in such cases.”  *Conchita Jackson, M.D.,*DAB No. 2495 at 2 (2013).  Thus, a supplier whose enrollment and billing privileges have been revoked is entitled, once reconsideration of the initial determination by CMS has taken place, to an administrative hearing and judicial review.  *See*42 U.S.C. § 1395cc(j)(8).

During the review of the revocation, an ALJ will look to determine whether the parties satisfied their respective burdens of proof.  “CMS has the burden of coming forward with

**Page 7**

evidence that establishes a prima facie case that the cited basis for the revocation exists.  If CMS meets this burden, a petitioning provider then has the burden to prove its case, that is, to rebut the basis for the revocation, by a preponderance of the evidence.”  *Adora Healthcare Servs., Inc.*, DAB No. 2714 at 5 (2016).

VI.   Analysis and Conclusions of Law3

*****CMS made a prima facie showing that Petitioner ordered DMEPOS for 20 Medicare beneficiaries but failed to******maintain the required records and provide those records to CMS and its contractor as required by 42 C.F.R. § 424.516(f)(2)******.  Petitioner failed to overcome CMS’s prima facie showing by a preponderance of the evidence.*****CoventBridge requested that Petitioner submit medical documentation associated with orders and referrals for DME items for 20 Medicare beneficiaries, who were identified in the request letters submitted by CoventBridge.  CMS Exs. 2-3.  In support of its request, CoventBridge provided a list of 20 Medicare beneficiaries which included names, dates of birth, dates of service, and ordering provider’s name and NPI.  CMS Ex. 2 at 5.  Petitioner does not dispute that she ordered DMEPOS for the identified beneficiaries.  Petitioner states that she “prepared medical records for her telemedicine visits with each of the twenty (20) patients” and that she does not possess those records in any form.  P. Br. at 8-9; CMS Ex. 6.

Petitioner argues that it is unreasonable for CMS to require her to “keep separate records given that she was already required to submit records to ISP via its [electronic health record (EHR)] portal.”  P. Br. at 9.  Petitioner explains that she sent the prepared documents to ISP through ISP’s EHR, DMERX, but does not have access to ISP’s EHR because “it was no longer operational.”  P. Br. at 8-9.  Petitioner speculates that the government, because of its criminal investigation of ISP, made the requested records “unavailable[,] as they were seized by the government as part of its investigation.”  P. Br. at 8.  Petitioner claims, and I do not have a reason to doubt her, to have made every effort to access ISP’s EHR, DMERX, to retrieve those medical records  P. Br. at 9.  Petitioner argues that CMS or a government agency has custody of the requested documents because they were seized by the government during the investigation of ISP, and that it is unreasonable for her to keep separate records because she submitted the same records to ISP through a portal.  P. Br. at 9.  Petitioner implies that since the government has custody of the records, she should be relieved from the maintenance and production burden imposed by 42 C.F.R. § 424.516(f)(2).  *See* P. Br. at 9.  However, even if the government has access to the records, it does not exempt Petitioner from her duty to maintain and produce records, as imposed by 42 C.F.R. § 424.516(f)(2)(i)-(ii).

**Page 8**

The plain language of the regulation requires suppliers to maintain documentation relating to orders for items of DMEPOS for seven years from the date of service.  42 C.F.R. § 424.516(f)(2)(i)(A); 77 Fed. Reg. 25,284, 25,310 (Apr. 27, 2012) (“This final rule places the responsibility for the maintenance of records on both the ordering and certifying physician and the provider and supplier.”).  Additionally, Petitioner was required to produce that documentation to CMS and to CoventBridge once it was requested by those entities.  42 C.F.R. § 424.516(f)(2)(i)(B).  In this case, Petitioner failed to maintain the medical documentation related to the DME items ordered for the 20 Medicare beneficiaries and she was unable to provide the documentation to CMS when requested.  P. Br. at 8-9; CMS Ex. 6.

The Departmental Appeals Board (Board) has previously addressed arguments similar to those put forth by Petitioner.  The Board has concluded that it is the responsibility of the physician to maintain and disclose the documentation even if the physician’s employer maintained a copy of the records.  *George M. Young, M.D.*, DAB No. 2750 at 10 (2016).  The Board explained that:

[T]he regulatory preamble expressly provides that, even in instances of “referral to home health care or for DMEPOS at a hospital or nursing home discharge,” in which records “would typically be retained in that hospital’s or nursing home’s records, not by the physician in his/her records,” “[t]he physician or other eligible professional who signed the order or certification is responsible for maintaining and disclosing the documentation.”  77 Fed. Reg. at 25,310.  Thus, CMS contemplated that even physicians who may not have immediate, ready access to and direct control over medical documents (as, for example, a doctor who owns his or her own practice and keeps the medical documents within his or her medical office might) would be expected to adhere to the record retention and disclosure requirements.

*Id*. (internal citation omitted).  Therefore, even if Petitioner previously submitted the documentation to ISP, she was required to maintain a copy of those records and disclose them to CMS or its Medicare contractor upon request.  The email exchange between CMS and Petitioner’s counsel demonstrates that CMS granted Petitioner the opportunity, during the reconsideration process, to submit the documents previously requested by CoventBridge, but Petitioner failed to provide them.  CMS Ex. 6 at 1-4.

I find that CMS has met its burden to make a prima facie showing that Petitioner failed to maintain and produce records for DMEPOS ordered for 20 Medicare beneficiaries.  As a result, CMS had a basis to revoke Petitioner’s Medicare enrollment and billing privileges.

**Page 9**

42 C.F.R. § 424.535(a)(10).  I also find that Petitioner failed to rebut the existence of the basis of the revocation by a preponderance of the evidence.

*****An ALJ does not have the authority to review the length of the reenrollment bar.*****In the initial determination, NGS imposed a ten-year reenrollment bar on Petitioner, and CMS upheld the ten-year reenrollment bar in its reconsidered determination.  CMS Ex. 4 at 3; CMS Ex. 1 at 4.  Petitioner argues that the reenrollment bar should be “reduced to one (1) year to reflect the single [one-time] audit.”  P. Br. at 15.  Petitioner puts forth two arguments to challenge the length of the reenrollment bar:  1) CMS’s decision to uphold a ten-year reenrollment bar was arbitrary, capricious, and an abuse of discretion and 2) the length of the reenrollment bar is unreasonable because CMS failed to consider “aggravating and mitigating circumstances, the trustworthiness of [Petitioner], and the remedial nature of the exclusion laws.”  P. Br. at 4-5.  Regardless of the merits of Petitioner’s arguments, the Board has ruled that ALJs do not have the authority to review the length of the reenrollment bar imposed by CMS.  *Lilia Gorovits, M.D., P.C*., DAB No. 2985 at 15 (2020).

An ALJ is authorized to review CMS’s initial determination to “revoke a . . . supplier’s Medicare enrollment.”  42 C.F.R § 498.3(b)(17).  However, the determination of the reenrollment bar is not considered an initial determination and is not subject to review by an ALJ.  42 C.F.R. § 498.3(d).  “An appealable determination to revoke a supplier’s enrollment, and a decision about how long the revoked supplier must wait before being allowed to apply for reentry to the program, are factually distinct matters governed by different legal requirements.”  *Vijendra Dave, M.D.*, DAB No. 2672 at 10 (2016).  Unlike a determination to revoke, the determination of the duration of the reenrollment bar is an action not listed as an initial determination, which means that it is not subject to review by an ALJ.  42 C.F.R. § 498.3(b); *Vijendra Dave, M.D.*, DAB No. 2672 at 10.  Nonetheless, Petitioner’s arguments are addressed below.

As to Petitioner’s first argument, an ALJ has no authority to consider whether CMS’s actions were arbitrary and capricious because  “the arbitrary and capricious standard . . . is an Administrative Procedure Act (APA) standard for court review of final agency actions.”  *NMS Healthcare of Hagerstown*, DAB No. 2603 at 6 (2014).  “Neither CMS’s determination nor the [ALJ’s] Decision is a final agency action . . . .”  *Id.*; *see*42 C.F.R. § 498.90.  Thus, whether CMS’s decision to exercise its discretion was arbitrary and capricious is not an issue before this tribunal.

As to Petitioner’s second argument, Petitioner claims that CMS “did not have a reasonable basis to revoke Petitioner’s Medicare billing privileges for ten (10) years without consideration of aggravating and mitigating circumstances, the trustworthiness of [Petitioner], and the remedial nature of the exclusion laws.”  P. Br. at 5.  Although CMS

**Page 10**

did not revoke Petitioner’s billing privileges for ten years, CMS did impose a ten-year reenrollment bar.  Thus, I take Petitioner’s argument to mean that the imposition of the ten-year reenrollment bar without consideration of the factors mentioned by Petitioner is unreasonable.

Here, Petitioner seeks to apply the regulations and case law that apply only in exclusion cases brought by the Inspector General (IG) of the United States Department of Health and Human Services, pursuant to 42 C.F.R. § 1001.1.  P. Br. at 5-14.  However, those regulations are “applicable to and binding on [the IG] in imposing and proposing **exclusions**, as well as to [ALJs], the [Board], and federal courts **in reviewing the imposition of exclusions by the** **[IG]**.”  42 C.F.R. § 1001.1(b) (emphasis added).  In this case, none of the regulations or case law related to exclusions referred to—directly or indirectly—by Petitioner are relevant to this case.  Not only does Petitioner seek to apply inapplicable regulations to her case, but she also confuses the imposition of a reenrollment bar by CMS with the imposition of an exclusion by the IG.  P. Br. at 6.  Those actions are independent from each other and governed by different regulations.  Furthermore, as previously mentioned, I do not have the authority to review the length of the imposed reenrollment bar.

*****An ALJ does not have the authority to grant equitable relief.*****To the extent that Petitioner is arguing that her Medicare enrollment and billing privileges should be reinstated on equitable grounds, “[t]he Board has consistently held that it [and ALJs] lack the authority to restore a supplier’s billing privileges on equitable grounds.”  *Neb Grp. of Ariz. LLC*, DAB No. 2573 at 6 (2014) (citations omitted).  “[O]nce CMS has shown that one of the regulatory bases for revocation exists, the ALJ and the Board may not refuse to apply the regulation and must uphold the revocation.”  *Donald W. Hayes, D.P.M.*, DAB No. 2862 at 15 (2018).  While I am incapable of granting equitable relief and I do not have jurisdiction to review the duration of the reenrollment bar, I recognize that the imposed reenrollment bar is likely to have an unduly adverse impact on Petitioner’s professional and personal life.  P. Br. at 9-10.  Nonetheless, because Petitioner failed to comply with section 424.516(f)(2), CMS has a legal basis, pursuant to 42 C.F.R. § 424.535(a)(10), to revoke Petitioner’s Medicare enrollment and billing privileges.

VII.    Conclusion

Based on the foregoing reasons, I affirm CMS’s revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10).

Endnotes

1  Petitioner filed two exhibits labeled as Exhibit 4.  The first exhibit is a letter of recommendation from Dr. Sarah N. Siddiqui.  The second exhibit, also marked as Petitioner’s Exhibit 4, is an affidavit from Dr. Sarah N. Siddiqui.  A review of the documents shows that the content is the same for each document labeled P. Ex. 4.  Therefore, for purposes of this decision, the letter of recommendation will be referred to as P. Ex. 4a and the affidavit will be referred to as P. Ex. 4b.

2  The quoted language reflects the regulation in effect when Petitioner treated the 20 Medicare beneficiaries in this case.  CMS Ex. 4 at 4 (listing the date of service for each Medicare beneficiary).  Nonetheless, CMS subsequently broadened the scope of the requirement for physicians to maintain documentation.  84 Fed. Reg. 47,793, 47,835 (Sept. 10, 2019).  CMS now requires a physician “who orders, certifies, refers, or prescribes Part A or B services, items or drugs” to comply with the requirements imposed by 42 C.F.R. § 424.516(f)(2)(i).  The change in language does not alter a physician’s duty to maintain documentation associated with orders for DMEPOS.

3  My conclusions of law are set forth in bold and italicized headings below.
  
          /s/
        Tannisha D. Bell

                      Administrative Law Judge Back to top
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