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                              Caring Nurses, Inc., DAB CR5413 (2019)
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Caring Nurses, Inc., DAB CR5413 (2019)








  
  
    

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





Caring Nurses, Inc.,
(NPI:  1619113198),
Petitioner,
v.
Centers for Medicare & Medicaid Services
Docket No. C-17-1015Decision No. CR5413September 4, 2019

        
              
    

      DECISION
Palmetto GBA (Palmetto), an administrative contractor acting on behalf of the Centers for Medicare & Medicaid Services (CMS), revoked the Medicare enrollment and billing privileges of Petitioner, Caring Nurses, Inc., because Petitioner failed to produce to CMS complete medical records for several Medicare beneficiaries to whom Petitioner had provided home health services. CMS upheld the revocation in a reconsidered determination, and Petitioner requested a hearing. For the reasons explained in this decision, I affirm CMS’s determination revoking Petitioner’s Medicare enrollment and billing privileges.
I. Background and Procedural History
Petitioner is a home health agency which was enrolled as a Medicare provider in the state of Illinois. *See, e.g.*, CMS Exhibit (Ex.) 1 at 1, CMS Ex. 16 at 1.
On October 5, 2016, representatives of CMS’s Division of Field Operations North conducted an unannounced onsite inspection at Petitioner’s facility. *See*CMS Ex. 1; *see also*CMS Ex. 14 at 1. At that time, CMS requested that Petitioner produce the patient
**Page 2**
records of fifteen of Petitioner’s patients. CMS Ex. 1 at 1. In response to the request, Petitioner provided CMS with some documentation; however, CMS determined that Petitioner failed to provide complete documentation for seven patients. *See*CMS Ex. 13 at 2.
By letter dated February 17, 2017, Palmetto issued an initial determination revoking Petitioner’s Medicare billing privileges, effective March 19, 2017, citing 42 C.F.R. § 424.535(a)(10). CMS Ex. 14 at 1. The initial determination included a spreadsheet listing the documentation CMS asserted was missing from the records of the seven beneficiaries. *Id.*at 3. Pursuant to 42 C.F.R. § 424.535(c), Palmetto established a one‐year re-enrollment bar. *Id.* at 2.
In a memorandum dated March 7, 2017, Petitioner requested reconsideration, stating that CMS took many of the records during the onsite inspection, and stating Petitioner faxed the remainder of the records to CMS on October 13, 2016. CMS Ex. 15 at 1-2. With its request for reconsideration, Petitioner submitted additional records for the seven beneficiaries. CMS Ex. 15 at 37-166.
By letter dated June 7, 2017, CMS’s Provider Enrollment & Oversight Group1
 issued an unfavorable reconsidered determination citing 42 C.F.R. § 424.535(a)(10) and 42 C.F.R. § 424.516(f). CMS Ex. 16 at 1-6. CMS concluded that Palmetto made no error in the initial determination, and upheld the revocation, citing specific missing documentation for the seven beneficiaries. *Id.* at 6.
Petitioner timely requested a hearing before an administrative law judge and the case was assigned to me. I issued an Acknowledgment and Pre-Hearing Order dated August 16, 2017 (Pre-Hearing Order). Pursuant to the Pre-Hearing Order, CMS filed a Combined Motion and Memorandum of Law in Support of Summary Disposition and Prehearing Brief (CMS Br.), along with 18 proposed exhibits (CMS Exs. 1-18). CMS’s proposed exhibits included attestations from two of Petitioner’s employees (CMS Exs. 9 and 10), but did not include a witness list or proposed written direct testimony of any witnesses. Petitioner did not object to CMS’s proposed exhibits. Therefore, in the absence of objection, I admit into evidence CMS Exs. 1-18. On November 8, 2017, Petitioner filed an exchange consisting of a Memorandum of Law and Prehearing Brief (P. Br.), along with two proposed exhibits (P. Exs. 1-2) and two files labeled as “Medical Records.”
Neither Petitioner’s proposed exhibits nor the medical records it submitted were in the form required by my Pre-Hearing Order. I therefore issued an Order to Show Cause in which I explained to Petitioner the corrections required to conform its submissions to my Pre-Hearing Order. The Order to Show Cause further informed Petitioner that if
**Page 3**
Petitioner failed to make the required corrections, I would impose sanctions on Petitioner. Petitioner did not respond to the Order to Show Cause.2
 I therefore exclude from evidence P. Exs. 1 and 2, as well as the unlabeled medical records because the documents are not marked or paginated as required by my orders, nor has Petitioner offered any argument explaining their relevance to the issues for decision.3
Neither party offered the written direct testimony of a witness or requested to cross-examine a witness. As I informed the parties in my Pre-Hearing Order, a hearing is only necessary if a party requests to cross-examine a witness for whom the opposing party offered written direct testimony. Pre-Hearing Order ¶ 10. Because an in-person hearing to cross-examine witnesses is not necessary, I decide this case based on the written record, without considering whether the standards for summary judgment are satisfied.
II. Issue
The issue is whether CMS had a legal basis to revoke Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. §§ 424.535(a)(10) and 424.516(f) because Petitioner did not maintain and provide CMS access to requested documentation.
III. Jurisdiction
I have jurisdiction to hear and decide this case. 42 C.F.R. §§ 498.3(b)(17), 498.5(*l*)(2); *see also* Social Security Act (Act) § 1866(j)(8) (codified at 42 U.S.C. § 1395cc(j)(8)).
IV. Discussion
**A. Statutory and Regulatory Background**
The Social Security Act (Act) authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations governing the enrollment process for providers and suppliers. Act §§ 1102, 1866(j) (42 U.S.C. §§ 1302, 1395cc(j)). A “provider” is “a hospital, critical access hospital, skilled nursing facility, comprehensive outpatient rehabilitation facility, home health agency, hospice program, or, for purposes of section 1814(g) and section 1835(e), a fund” under the Medicare provisions of the Act. Act
**Page 4**
§ 1861(u) (42 U.S.C. § 1395x(u)); *see also* Act § 1861(d) (42 U.S.C. § 1395x(d)). The Secretary has delegated the authority to revoke enrollment and billing privileges to CMS. 42 C.F.R. § 424.535.
CMS or its Medicare contractor may revoke an enrolled provider’s Medicare enrollment and billing privileges for any of the reasons listed in 42 C.F.R. § 424.535. Pursuant to 42 C.F.R. § 424.535(a)(10), CMS may revoke a provider’s or supplier’s billing privileges and any corresponding provider agreement if:
(i) The provider or supplier did not comply with the documentation or CMS access requirements specified in § 424.516(f) of this subpart.
(ii) A provider or supplier that meets the revocation criteria specified in paragraph (a)(10)(i) of this section, is subject to revocation for a period of not more than 1 year for each act of noncompliance.
Section 424.516(f), cross-referenced in 42 C.F.R. § 424.535(a)(10), additionally requires providers and suppliers to maintain records and provide CMS access to such records, among other things. As relevant here, the regulation provides:
(f) *Maintaining and providing access to documentation*. (1)(i) A provider or a supplier that furnishes covered ordered items of DMEPOS, clinical laboratory, imaging services, or covered ordered/certified home health services is required to—
(A) Maintain documentation (as described in paragraph (f)(1)(ii) of this section) for 7 years from the date of service; and
(B) Upon the request of CMS or a Medicare contractor, to provide access to that documentation (as described in paragraph (f)(1)(ii) of this section).
(ii) The documentation includes written and electronic documents (including the NPI of the physician who ordered/certified the home health services and the NPI of the physician or, when permitted, other eligible professional who ordered items of DMEPOS or clinical laboratory or imaging services) relating to written orders and certifications and requests
**Page 5**
for payments for items of DMEPOS and clinical laboratory, imaging, and home health services.
If CMS revokes a provider’s Medicare billing privileges, the revocation becomes effective 30 days after CMS or one of its contractors mails the revocation notice to the provider, subject to some exceptions not applicable in this case. After a provider’s Medicare enrollment and billing privileges are revoked, the provider is barred from reenrolling in the Medicare program for one to three years. 42 C.F.R. § 424.535(c).
**B. Findings of Fact, Conclusions of Law, and Analysis**
***1.******Petitioner did not maintain all required documents, including physician certifications for home health care, or provide CMS with access to those records upon request.***
***2.******CMS had a basis to revoke Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. §§ 424.535(a)(10) and 424.516(f).***
Pursuant to 42 C.F.R. § 424.535(a)(10), CMS may revoke a provider’s enrollment and billing privileges if the provider did not maintain documents or did not provide CMS access to such documents as required by 42 C.F.R. § 424.516(f). Section 424.516(f) specifies that the provider must maintain certain kinds of documents, including “written and electronic documents . . . relating to written orders and certifications and requests for payments for . . . home health services.” 42 C.F.R. § 424.516(f)(1)(ii). As an appellate panel of the Departmental Appeals Board (DAB) has explained, the plain meaning of 42 C.F.R. § 424.516(f) requires a provider or supplier to do two things: 1) the provider or supplier must maintain documents, written and electronic, related to written orders or certifications or requests for payments for specified Medicare items and services for a period of seven years; 2) the provider or supplier must provide CMS or its contractor access to those documents upon request. *George M. Young, M.D.*, DAB No. 2750 at 8 (2016).4
 In the present case, Petitioner did not maintain or provide CMS access to all of the required documents. Accordingly, CMS had a basis to revoke Petitioner’s Medicare enrollment.
**Page 6**
Petitioner is required to maintain and provide access to documents related to certifications for home health services. 42 C.F.R. § 424.516(f)(1)(ii). As CMS correctly points out, Medicare only pays for home health services that are properly certified by a physician. CMS Br. at 3 (citing 42 C.F.R. § 424.22). Section 424.22(a)(1)(v) provides that, as part of a home health certification, a physician must document that a face‐to‐face encounter occurred no more than 90 days prior to the start of home health care or within 30 days of the start of the home health care. CMS has provided additional guidance via the Medicare Benefit Policy Manual, CMS Pub. 100-02 (MBPM). Using language unchanged since the relevant time period, the MBPM states: “The patient must be under the care of a physician who is qualified to sign the physician certification and plan of care in accordance with 42 [C.F.R. §] 424.22.” CMS Ex. 18 at 17 (MBPM, Ch. 7, § 30.3 (Rev. 208, eff. Jan. 1, 2015)). Moreover, the MBPM states: “HHAs that maintain patient records by computer rather than hard copy may use electronic signatures. However, all such entries must be appropriately authenticated and dated.” CMS Ex. 18 at 16 (MBPM, Ch. 7, § 30.2.8 (Rev. 1, eff. Oct. 1, 2003)). The MBPM requirements for authentication state: “[a]uthentication must include signatures, written initials, or computer secure entry by a unique identifier of a primary author who has reviewed and approved the entry.” *Id*.
CMS offered evidence that Petitioner failed to maintain and provide access to records, or provided unsigned records, for at least four patients. Petitioner produced no admissible evidence that contradicts the evidence offered by CMS. I therefore find that Petitioner failed to maintain or provide access to the following documents:
**Missing Documentation for Patient 2:5**
home health certification and plan of care for the certification period dated January 15, 2016, to March 14, 2016;
	face‐to‐face encounter for the certification period dated January 15, 2016, to March 14, 2016;
	physician-signed home health certification and plan of care for the certification period dated March 15, 2016, to May 13, 2016 (CMS Ex. 15 at 52-54);
	face‐to‐face encounter for the certification period dated March 15, 2016, to May 13, 2016 with authenticated digital signature of a physician (CMS Ex. 15 at 57).6**Page 7**
**Missing Documentation for Patient 4:**
physician-signed home health certification and plan of care for the certification period dated March 8, 2016, to May 6, 2016 (CMS Ex. 15 at 95-99);
	physician-signed face‐to‐face encounter for the certification period dated March 8, 2016, to May 6, 2016 (CMS Ex. 15 at 100-102);
	face‐to‐face encounter for the certification period dated May 7, 2016, to July 1, 2016.**Missing Documentation for Patient 5:**
physician-signed home health certification and plan of care for the certification period dated March 10, 2016, to May 8, 2016 (CMS Ex. 15 at 124‐127).**Missing Documentation for Patient 6**:
physician-signed home health certification and plan of care for the certification period dated May 3, 2016, to June 27, 2016 (CMS Ex. 15 at 153-155);
	face‐to‐face encounter for the certification period dated May 3, 2016, to June 27, 2016 with authenticated digital signature of a physician (CMS Ex. 15 at 156-158).7*See*CMS Br. at 7 (citing CMS Ex. 14).
Petitioner admits that it did not fully comply with CMS’s policies on document retention and access. Petitioner argues, instead, that it was in “substantial compliance with all Medicare Conditions of Participation” and that “[v]irtually all of the relevant documents . . . were signed.” P. Br. at 2. Nevertheless, Petitioner acknowledges that some of its records of face‐to‐face encounters between physicians and patients were not signed by the physician. *Id.* at 6. Petitioner characterizes its admitted failure to comply as “a technical violation of the many convoluted and cumbersome regulations.” *Id*. at 2. Petitioner suggests that its noncompliance should be overlooked because its records demonstrate that a face‐to‐face was done, and that its other records would show the accuracy of those face‐to‐face documents. *Id.*at 6. In a similar vein, Petitioner argues that “[t]here was no evidence presented that (i) any of the patients were not homebound or (ii) that skilled care was not ‘reasonable and necessary.’” *Id.*at 2. Petitioner states
**Page 8**
that the patients’ multiple conditions made it clear the patients were homebound and that skilled nursing was required. *Id*. at 4.
These arguments are unavailing. The issue before me is not whether the home health services at issue were reasonable and necessary for the patients, but whether Petitioner complied with the document retention and access requirements of section 424.516(f). The regulation does not include an exception for “substantial compliance.” Rather, the regulation requires Petitioner to maintain and provide access to all required documents in the proper form (i.e. signed by the treating physician). For the reasons explained above, I conclude that Petitioner did not do so. Accordingly, CMS had a basis to revoke Petitioner’s Medicare enrollment pursuant to 42 C.F.R. §§ 424.535(a)(10) and 424.516(f). Further, as discussed in the following section, Petitioner’s equitable arguments do not lead to a different conclusion.
***3.******Petitioner’s equitable and Constitutional arguments do not provide a basis to overturn the revocation of its Medicare enrollment and billing privileges.***
Petitioner argues that it submitted all requested documents, and Petitioner “was specifically told by the visiting auditor . . . in an October 13, 2016 telephone conversation that all of the necessary records had been received.” P. Br. at 1-2. Based on this reported conversation, Petitioner argues that it relied on the statements of CMS’s representative. *Id.* In effect, Petitioner is arguing that CMS should be estopped from enforcing the regulations. Whether the government can ever be estopped from enforcing valid regulations based on the misrepresentations of government employees or their agents is highly questionable. *See Heckler v. Cmty. Health Servs. of Crawford Cnty.*, 467 U.S. 51, 63 (1984); *Schweiker v. Hansen*, 450 U.S. 785 (1981). In any event, on the present facts, I would find that Petitioner could not reasonably rely on the alleged advice. As a Medicare provider, Petitioner is “presumed to have constructive notice of the statutes and regulations that govern [its] participation as a matter of law.” *Pepper Hill Nursing & Rehab. Ctr.*, DAB No. 2395 at 8 (2011). Given that presumed knowledge, Petitioner could not then reasonably rely on any purported advice of a CMS representative that would have the effect of waiving a requirement spelled out in the regulations.8
Furthermore, to the extent Petitioner’s arguments raise equitable considerations beyond estoppel, those arguments are likewise unavailing. I do not have authority to grant equitable relief based on Petitioner’s general contentions that the actions of CMS and its
**Page 9**
administrative contractor inflicted a punishment that did not “fit the crime” or that CMS did not consider additional potentially mitigating factors. P. Br. at 5-8; *see US Ultrasound*, DAB No. 2302 at 8 (2010) (“[n]either the [administrative law judge] nor the Board is authorized to provide equitable relief by reimbursing or enrolling a [provider] who does not meet statutory or regulatory requirements”). My review is limited to determining whether CMS had a lawful basis for its action. I am not authorized to overturn CMS’s exercise of discretion, even if I would not have chosen to revoke had the decision been mine in the first instance.9
 *See, e.g.*, *Abdul Razzaque Ahmed, M.D.*, DAB No. 2261 at 19 (2009), *aff’d*,*Ahmed v. Sebelius*, 710 F. Supp. 2d 167 (D. Mass. 2010) (if CMS establishes the regulatory elements necessary for revocation, an administrative law judge may not substitute his or her “discretion for that of CMS in determining whether revocation is appropriate under all the circumstances”); *see also Letantia Bussell, M.D.*, DAB No. 2196 at 13 (2008) (administrative law judge review addresses only “whether CMS had the authority to revoke”).
Petitioner also argues that CMS’s revocation action is an excessive fine in violation of the Eighth Amendment to the US Constitution. P. Br. at 5-6. As authority for this argument, Petitioner cites *United States v. Bajakajian*, 524 U.S. 321 (1998). P. Br. at 5. However, Petitioner’s reliance on this case, or on the Eighth Amendment generally, is misplaced. The Eighth Amendment sets limits on punishments for criminal offenses.
Revocation of Petitioner’s Medicare enrollment and billing privileges is an administrative remedy for Petitioner’s failure to comply with Medicare participation requirements, not a sanction for a criminal offense. CMS’s revocation action does not involve imposing a fine. Instead, by revoking Petitioner’s Medicare enrollment and billing privileges, CMS has exercised its discretion to decline to do business with Petitioner. While that decision undoubtedly has financial consequences, it is not a fine, nor even a civil money penalty. Moreover, Congress authorized this precise administrative remedy by statute, based on its determination that home health services were at high risk of fraud and abuse:
The Secretary may revoke enrollment, for a period of not more than one year for each act, for a physician or supplier under section 1866(j) of the [Act] if such physician or supplier fails to maintain and, upon request of the Secretary, provide access to documentation relating to written orders or requests for payment for [DMEPOS], certifications for homehealth services, or referrals for other items or services written or ordered by such physician or supplier . . . .
**Page 10**
Patient Protection and Affordable Care Act, Pub. L. No. 111-148, § 6406, 124 Stat. 769 (2010). CMS’s revocation action, based upon Petitioner’s multiple admitted violations of Medicare document retention and access requirements, is entirely consistent with Congress’ intent as expressed in the Affordable Care Act and its implementing regulations. For all these reasons, Petitioner’s Constitutional argument is without merit.
V. Conclusion
For the foregoing reasons, I affirm that CMS had a basis to revoke Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10) and 42 C.F.R. § 424.516(f).


          /s/
        Leslie A. Weyn

                      Administrative Law Judge
      1. The Provider Enrollment & Oversight Group is a component of CMS itself, not an administrative contractor. back to note 1
                      2. It would not be surprising for an unrepresented party to have difficulty complying fully with all procedural requirements. Had that been the case, I might have been inclined to be more lenient. However, Petitioner is represented by an attorney in this matter. I expect an attorney to be capable of reading and implementing my orders. Yet, even after I issued the Order to Show Cause, counsel did not submit conforming documents or otherwise respond to the order. back to note 2
                      3. I note also that the unlabeled medical records appear to be duplicates of at least some documents offered by CMS. back to note 3
                      4. The Young decision concerned a physician’s obligation to maintain and provide access to documents related to orders, certifications, or requests for payments for items of durable medical equipment, prosthetics, and orthotics that he or she ordered, pursuant to 42 C.F.R. § 424.516(f)(2). However, the requirement for a provider to maintain and provide access to documents relating to orders, certifications, or requests for payments for home health services furnished by the provider, pursuant to 42 C.F.R. § 424.516(f)(1), uses parallel language. I therefore find the analysis in Young persuasive in this case. back to note 4
                      5. CMS assigned numerical identifiers to the patients to protect their privacy. See CMS Patient Identification Key (Item #7 in DAB E-File). I refer to the patients by these numerical identifiers. back to note 5
                      6. An encounter note for an April 7, 2016 visit indicates that the patient was seen by “John Olivieri, M.D.” but the electronic signature is by “Thalia Cervantes.” CMS Ex. 15 at 56-57. The record does not reveal the professional qualifications of Ms. Cervantes or what her relationship is, if any, to Dr. Olivieri or his practice. back to note 6
                      7. An encounter note for a May 9, 2016 visit indicates that the patient was seen by “Maria Perez, MD” but the electronic signature is by “Loreta Morochin.” CMS Ex. 15 at 156, 158. The record does not reveal the professional qualifications of Ms. Morochin or what her relationship is, if any, to Dr. Perez or her practice. back to note 7
                      8. In addition, no alleged misrepresentation by CMS’s auditor explains why, if Petitioner had additional documents that would demonstrate its compliance, it did not submit them in these proceedings and argue that it had good cause to do so based on the alleged comments of the auditor. back to note 8
                      9. This is not to suggest that I disagree with CMS that revocation was warranted in the present case. back to note 9 Back to top
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