Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Theodore S. Wright, Jr., M.D.
(PTAN: 728700 / NPI: 1598830796),
Petitioner,
v.
Centers for Medicare & Medicaid Services
Docket No. C-16-176
Decision No. CR5235
DECISION
The Medicare enrollment and billing privileges of Petitioner, Theodore S. Wright, Jr., M.D., are revoked pursuant to 42 C.F.R. § 424.535(a)(10)1 for noncompliance with 42 C.F.R. § 424.516(f)(2)(i)(A) and (B). The effective date of Petitioner’s revocation is December 10, 2015, for a period of one year.
I. Procedural History and Jurisdiction
On November 10, 2015, National Government Services (NGS), a Medicare Administrative Contractor (MAC), notified Petitioner that his Medicare enrollment and billing privileges were revoked effective December 10, 2015. NGS cited 42 C.F.R. § 424.535(a)(10) as the basis for revocation on grounds that Petitioner failed to provide CMS access to medical records for 11 of 21 beneficiaries when requested by NGS. The MAC failed to cite in its initial determination the statutory or regulatory requirement for
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Petitioner to retain the records NGS requested that he produce. The MAC also notified Petitioner that he was subject to a one-year bar to reenrollment pursuant to 42 C.F.R. § 424.535(c). Centers for Medicare & Medicaid Services (CMS) Exhibit (Ex.) 1 at 4-5.
Petitioner requested reconsideration of the initial determination to revoke by letters dated November 13 and 25, 2015, stating that he did not have records for 11 of the beneficiaries for whom NGS requested records. CMS Ex. 1 at 6, 40-42. By letter dated December 9, 2015, NGS notified Petitioner that the revocation of his Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10) was upheld on reconsideration because Petitioner failed to provide CMS access to documents for 11 of 21 Medicare beneficiaries. The NGS employee who issued the reconsidered determination also failed to cite the statutory or regulatory requirement for Petitioner to retain the records NGS requested that he produce. CMS Ex. 1 at 1‑3.
Petitioner requested review by an administrative law judge (ALJ) on December 15, 2015. The case was assigned to me on December 31, 2015, and an Acknowledgment and Prehearing Order (Prehearing Order) was issued at my direction.
On January 29, 2016, CMS filed a prehearing brief and motion for summary judgment (CMS PHB) with CMS Exs. 1 through 6. On February 29, 2016, Petitioner filed a prehearing brief and response to the CMS motion for summary judgment (P. PHB), with Petitioner’s declaration marked Petitioner’s Exhibit (P. Ex.) 1. On March 10, 2016, CMS filed a reply brief and CMS Exs. 7 through 11. On July 14, 2016, I denied CMS’s motion for summary judgment and ordered the parties to file a joint status report advising me of their availability for hearing.
A hearing was convened by video teleconference on January 9, 2018. A transcript (Tr.) of the proceedings was prepared. CMS offered CMS Exs. 1 through 11. Petitioner did not object to my consideration of CMS Exs. 1 through 11 and all were admitted as evidence. Tr. 25-27. CMS did not call any witnesses but rested after counsel’s opening statement. Tr. 36, 121. Petitioner’s declaration (P. Ex. 1) was not admitted as evidence because it was cumulative of Petitioner’s testimony during the hearing. Tr. 28-31, 39-119.
On March 12, 2018, CMS filed its post-hearing brief (CMS Br.) and its Proposed Findings of Fact and Conclusions of Law. Petitioner filed a letter dated March 9, 2018, which I treat as Petitioner’s post-hearing brief (P. Br.). CMS filed a post-hearing reply brief on April 10, 2018 (CMS Reply). Petitioner did not file a post-hearing reply brief.
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II. Discussion
A. Applicable Law
Section 1831 of the Social Security Act (the Act) (42 U.S.C. § 1395j) establishes the supplementary medical insurance benefits program for the aged and disabled known as Medicare Part B. Payment under the program for services rendered to Medicare-eligible beneficiaries may only be made to eligible providers of services and suppliers.2 Act §§ 1835(a) (42 U.S.C. § 1395n(a)), 1842(h)(1) (42 U.S.C. § 1395(u)(h)(1)). Petitioner, a physician, is a supplier. Administration of the Part B program is through the MACs. Act § 1842(a) (42 U.S.C. § 1395u(a)).
The Act requires the Secretary of Health and Human Services (the Secretary) to issue regulations that establish a process for the enrollment of providers and suppliers, including the right to a hearing and judicial review of certain enrollment determinations. Act § 1866(j) (42 U.S.C. § 1395cc(j)). Pursuant to 42 C.F.R. § 424.505, a provider or supplier must be enrolled in the Medicare program and be issued a billing number to have billing privileges and to be eligible to receive payment for services rendered to a Medicare-eligible beneficiary.
The Secretary 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 supplier’s Medicare enrollment and billing privileges and supplier agreement for any of the reasons listed in 42 C.F.R. § 424.535, which provides in pertinent part:
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(10) Failure to document or provide CMS access to documentation.
(i) The provider or supplier did not comply with the documentation or CMS access requirements specified in § 424.516(f) of this subpart [42 C.F.R. § 424.516(f)].
(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.
42 C.F.R. § 424.535(a)(10) (italics in original). Revocation under authority of 42 C.F.R. § 424.535(a)(10)(i) is based on violation of the document retention and access requirements established by 42 C.F.R. § 424.516(f).
The Departmental Appeals Board (Board) has previously concluded that in provider and supplier enrollment cases, including revocations of enrollment such as this case, ALJ review is limited to the basis for the contractor or CMS action cited in the reconsidered determination. Neb Group of Ariz. LLC, DAB No. 2573 at 7 (2014); 42 C.F.R. § 498.5(l)(2). The Board’s rationale for its conclusion is persuasive in this case. The NGS employee who issued the reconsidered determination did not specifically cite the legal authority that required Petitioner to retain records for the 11 beneficiaries to which CMS and NGS wanted access. However, the citation of 42 C.F.R. § 424.535(a)(10) as the basis for revocation shows that the person who issued the reconsidered determination was enforcing the requirements of 42 C.F.R. § 424.516(f).
The requirement to maintain and provide CMS or its contractor access to documents established by 42 C.F.R. § 424.516(f) is as follows:
(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
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(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 for payments for items of DMEPOS and clinical laboratory, imaging, and home health services.
(2)(i) A physician who orders/certifies home health services and the physician or, when permitted, other eligible professional who orders items of DMEPOS or clinical laboratory or imaging services 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 request of CMS or a Medicare contractor, to provide access to that documentation (as described in paragraph (f)(2)(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 the items of DMEPOS or the clinical laboratory or imaging services) 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) (italics in original, emphasis added). The regulation distinguishes between providers and suppliers who furnish DMEPOS,3 laboratory testing, imaging, and
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home health services and physicians and other eligible professionals who order or certify the need for the DMEPOS, laboratory tests, imaging, and home health services. It should also be noted that the record retention requirements established by 42 C.F.R. § 424.516(f) are limited in their application to DMEPOS, laboratory tests, imaging, and home health services.
The NGS employee who issued the reconsidered determination in this case clearly refers to Petitioner as an ordering or certifying physician rather than a physician who delivered care and services. CMS Ex. 1 at 1. Therefore, I conclude that 42 C.F.R. § 424.516(f)(2) is applicable in this case and not 42 C.F.R. § 424.516(f)(1).
Pursuant to 42 C.F.R. § 424.516(f)(2)(i)(A), the period that records must be retained is seven years from the date of service. Pursuant to 42 C.F.R. § 424.516(f)(2)(i)(B), the ordering or certifying physician must give CMS or the Medicare contractor access to documentation required to be maintained under the regulation, including orders, certifications, and requests for payment, regardless of whether the records are physical documents or in electronic form.
Generally, when CMS revokes a supplier’s Medicare billing privileges for not complying with enrollment requirements, the revocation is effective 30 days after CMS or its contractor mails notice of its determination to the supplier. 42 C.F.R. § 424.535(g). After a supplier’s Medicare enrollment and billing privileges are revoked, the supplier is barred from re-enrolling in the Medicare program for one to three years. 42 C.F.R. § 424.535(c). However, when revocation is pursuant to 42 C.F.R. § 424.535(a)(10)(i), as in this case, the regulation specifies that revocation is for not more than one year for each act of noncompliance. 42 C.F.R. § 424.535(a)(10)(ii). It is not clear whether the period of revocation authorized to be imposed by 42 C.F.R. § 424.535(a)(10)(ii), i.e., one year for each of act of noncompliance, is limited to the period of a reenrollment bar, i.e., one to three years, under 42 C.F.R. § 424.535(c). It is not clear whether the period of revocation is intended to be the reenrollment bar. However, I need not resolve the issue in this case as the reenrollment bar imposed by the initial determination and upheld on reconsideration was only one year. CMS Ex. 1 at 1-5.
A supplier whose enrollment and billing privileges are revoked may request reconsideration and review as provided by 42 C.F.R. pt. 498. A supplier submits a written request for reconsideration to CMS or its contractor. 42 C.F.R. § 498.22(a). CMS or its contractor must give notice of the reconsidered determination to the supplier, giving the reasons for its determination and specifying the conditions or requirements the supplier failed to meet, and advising the supplier of its right to an ALJ hearing. 42 C.F.R. § 498.25. If the decision on reconsideration is unfavorable to the supplier, the supplier has the right to request a hearing by an ALJ and further review by the Board. Act § 1866(j)(8) (42 U.S.C. § 1395cc(j)(8)); 42 C.F.R. §§ 424.545, 498.3(b)(17), 498.5(l)(2). CMS is also granted the right to request ALJ review of a reconsidered determination with
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which it is dissatisfied. 42 C.F.R. § 498.5(l)(2). A hearing on the record, also known as an oral hearing, is required under the Act unless waived. Crestview Parke Care Ctr. v. Thompson, 373 F.3d 743, 748-51 (6th Cir. 2004). The supplier bears the burden to demonstrate that it meets enrollment requirements with documents and records. 42 C.F.R. § 424.545(c).
The Secretary’s regulations do not address the allocation of the burden of proof or the standard of proof. However, the Board has addressed the allocation of the burden of proof under 42 C.F.R. pt. 498 in many decisions. The standard of proof is a preponderance of the evidence. CMS has the burden of coming forward with the evidence and making a prima facie showing of a basis, in this case, for revocation of Petitioner’s enrollment. “Prima facie” means generally that the evidence is “[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted.” Black’s Law Dictionary 1228 (8th ed. 2004). CMS has the initial burden of coming forward with sufficient evidence to show that its decision to revoke Petitioner’s Medicare participation and billing privileges is legally sufficient under the Act and regulations. CMS makes a prima facie showing of a basis for revocation if the credible evidence CMS relies on is sufficient to support a decision in its favor absent an effective rebuttal by Petitioner. Petitioner bears the burden of persuasion to rebut the CMS prima facie showing by a preponderance of the evidence or to establish any affirmative defense. Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Ctr., DAB No. 1665 (1998); Hillman Rehab. Ctr., DAB No. 1611 (1997) (remand), DAB No. 1663 (1998) (aft. remand), aff’d, Hillman Rehab. Ctr. v. United States, No. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999).
B. Issues
The issue in this case is:
C. Findings of Fact, Conclusions of Law, and Analysis
My conclusions of law are set forth in bold text followed by the pertinent findings of fact and analysis. The findings of fact are based on the exhibits admitted and testimony at the hearing. I have carefully considered all the evidence and the arguments of both parties,
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though not all may be specifically discussed in this decision. I discuss in this decision the credible evidence given the greatest weight in my decision-making.4 I also discuss any evidence that I find is not credible or worthy of weight. The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ. There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so. Charles H. Koch, Jr., Admin. L. & Prac. § 5:64 (3d ed. 2013).
1. Petitioner violated 42 C.F.R. § 424.516(f)(2)(i)(A) by failing to maintain required documents for nine Medicare beneficiaries for seven years from the dates he ordered clinical laboratory services, imaging services, or certified home health services for those patients.5
2. Petitioner violated 42 C.F.R. § 424.516(f)(2)(i)(B) by failing to give CMS or the MAC access to documents for nine Medicare beneficiaries for whom he ordered clinical laboratory services, imaging services, or certified home health services during the preceding seven years.
3. There is a basis for revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10)(i) for noncompliance with the requirements of 42 C.F.R. § 424.516(f)(2)(i)(A) and (B) to retain and give access to required documents.
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a. Facts
Petitioner is a physician and solo practitioner in Chicago, Illinois. Tr. 39. Prior to his revocation, he was enrolled in Medicare. Tr. 43; CMS Ex. 7.
On August 26, 2015, two CMS employees from the Investigations and Audit Group, Center for Program Integrity of CMS, conducted an unannounced site visit at Petitioner’s office located at 4757 West Montrose Avenue, Chicago, Illinois. CMS Ex. 11 at 1; Tr. 39, 42, 55. One of the CMS employees was Elizabeth Lindner, Acting Director of Field Operations – North, Investigations and Audits Group, Center for Program Integrity. Ms. Lindner’s declaration was admitted as CMS Ex. 11. Ms. Lindner testified by her declaration that during the site visit, Petitioner stated that he was not currently reassigning his Medicare claims to other physician groups and had not done so for the past five or six years. Ms. Lindner states that after she showed Petitioner documents showing he reassigned his right to bill Medicare to Chicago Personal Care, Inc. (CPC), he backtracked on his denial, but she does not explain what that means. Ms. Lindner states that Dr. Wright did not deny knowledge of CPC or that he signed a document reassigning his right to bill Medicare to CPC. She also stated that Petitioner did not state or suggest that the reassignment to CPC was without his knowledge. CMS Ex. 11. CMS has presented no written statement received from Petitioner by Ms. Lindner and her co-investigator, and CMS has presented no transcript of a conversation or detailed investigator notes of what was asked and Petitioner’s responses, except the limited “Physician Questionnaire” admitted as CMS Ex. 8. CMS elected not to examine Ms. Lindner at hearing to clarify her declaration. Ms. Lindner’s declaration is entitled to little weight. Ms. Lindner could truthfully attest to the fact Petitioner “did not state” or “did not admit or deny” without ever asking Petitioner a question. Therefore, absent clearer evidence of the questions she asked and the response Petitioner gave, Ms. Lindner’s testimony is not weighty. Ms. Lindner does not state that Petitioner admitted that he assigned his right to bill Medicare to CPC to permit CPC to bill Medicare for services he purportedly delivered. At hearing, Petitioner admitted he signed papers, including a form reassigning his right to bill Medicare, but he denied knowing or understanding the effect of the documents he signed. Petitioner asserted that he understood that he was going through a credentialing process so that he could review patient charts and he emphasized that he never actually saw any of the nine patients in issue before me. Tr. 80-83. Ms. Lindner’s declaration does not rebut Petitioner’s testimony.
The evidence shows that on November 19, 2013, Petitioner signed a form CMS-855R that reassigned his right to bill Medicare to CPC. CMS placed in evidence an extract of the CMS-855R (and a subsequent amendment) with a copy of Petitioner’s controlled substances registration, driver’s license, and license to practice medicine. CMS Exs. 7, 9; Tr. 46, 49-50, 80. Petitioner identified his signature on the CMS-855R. Petitioner testified that that he did not know what he was signing at the time, he was asked to sign several documents, and he understood that the paperwork was being completed so he
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could review files. Petitioner also identified his controlled substance card and driver's license. Tr. 80-82. On December 11, 2013, because corrections had to be made to the CMS-855R, Petitioner signed a second CMS-855R certification statement. CMS Ex. 9 at 5. NGS notified CPC by letter dated January 3, 2014, that it approved the reassignment from Petitioner to CPC effective November 15, 2013. CMS Ex. 10. There is no evidence that NGS notified Petitioner of its approval of the reassignment.
During the visit at Petitioner’s office on August 26, 2015, the CMS investigators gave Petitioner a list of Medicare beneficiaries with specific dates of service. It is not clear from Ms. Lindner’s declaration whether the investigators gave Petitioner a copy of the letter in evidence as CMS Ex. 2, which is dated August 26, 2015, and has an attached list. The letter in CMS Ex. 2 is not annotated to indicate it was personally served upon Petitioner, and Ms. Lindner does not state more than Petitioner was given a list of beneficiaries for whom CMS sought documentation for services allegedly furnished by Petitioner on dates of service on the list. No copy of a list is attached as an exhibit to Ms. Lindner’s declaration. CMS Ex. 2; CMS Ex. 11 at 2-3. At hearing, Petitioner acknowledged that the August 26, 2015 letter in CMS Ex. 2 was vaguely familiar. Tr. 56. However, he identified the list attached (CMS Ex. 2 at 3) as the list the investigators gave him on August 26, 2015. Tr. 57-58. Ms. Lindner stated that Petitioner did not deny (but apparently, he also did not admit) that the individuals listed were his patients but Petitioner failed to produce any documents related to any of them during the site visit. CMS Ex. 11 at 3. Petitioner testified that he thought he provided records for those listed who were actually his patients. Tr. 58. Petitioner identified the letter dated September 15, 2015, which is in evidence as CMS Ex. 3. Petitioner testified that he agreed that the letter was probably sent because he did not provide records during the site visit. Petitioner identified the handwriting and signature on the list at CMS Ex. 3 page 3 as his, he testified that he highlighted the names of the patients that were actually his patients seen in his office, and he provided documents to CMS related to those 10 highlighted beneficiaries. Copies of the records provided for the 10 highlighted beneficiaries are in evidence at CMS Ex. 1 at 12-39. Tr. 59-65. There is no dispute that Petitioner did not provide CMS records for the 11 beneficiaries not highlighted on CMS Ex. 3 at 3. CMS elected to proceed only as to 10 of the 11 beneficiaries not highlighted. Initials of the beneficiaries are used in this decision to protect any potential privacy interests they may have. The 10 beneficiaries for whom records were not provided, i.e., the unaccounted for beneficiaries that CMS argues are the bases for revocation, are: LB, SB, LBu, JC, OF, RL, NM, BS, JS, and ST. CMS Ex. 3 at 3, Tr. 71.
CMS placed in evidence CMS Exs. 4 and 5 to show the medical care and services for which CPC submitted claims for care and services Petitioner ordered for the 10 unaccounted for beneficiaries for whom Petitioner failed to produce records.
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|
BENE. |
SUMMARY OF EVIDENCE |
|---|---|
| LB | CMS Ex. 4 at 1-5 is a Part B Medicare Summary Notice for LB that shows claims filed by CPC for services provided or ordered by Petitioner including a patient visit, ultrasound scans, EKG, an allergy injection, and nerve transmission studies, with date of service January 21, 2015. |
| SB | CMS Ex. 5 at 1-10 is a Part A Medicare Summary Notice for SB that shows Petitioner certified SB for home health care services for the period April 11 to June 9, 2015. CMS Ex. 5 at 3, 7, 10. |
| LBu | CMS Ex. 4 at 6-8 is a Part B Medicare Summary Notice for LBu that shows claims filed by CPC for services provided or ordered by Petitioner for a patient visit, ultrasounds, and nerve transmission studies with date of service January 19, 2015. |
| JC | CMS Ex. 5 at 11-20 is a Part A Medicare Summary Notice for JC that shows Petitioner certified JC for home health care services for the period April 1 to May 30, 2015. CMS Ex. 5 at 13, 17, 20. |
| OF | CMS Ex. 5 at 21-30 is a Part A Medicare Summary Notice for OF that shows Petitioner certified OF for home health care services for the period February 16 to April 16, 2015. CMS Ex. 5 at 23, 27, 30. |
| RL | CMS Ex. 4 at 9-10 is a Part B Medicare Summary Notice for RL that shows claims filed by CPC for services provided by Petitioner for a patient home visit with date of service January 9, 2015. No orders from home health, imaging, or clinical laboratory services are reflected in CMS Ex. 4 or 5 for RL. |
| NM | CMS Ex. 4 at 11-12 is a Part B Medicare Summary Notice for NM that shows claims filed by CPC for services provided by Petitioner for patient home visits with date of service January 5, 2015. CMS Ex. 5 at 31-36 are screens shots of a CMS computer system showing the Petitioner certified NM for home health care services for the period December 28, 2014 to February 25, 2015. CMS Ex. 5 at 34-37. |
| BS | CMS Ex. 4 at 13-17 is a Part B Medicare Summary Notice for BS that shows claims filed by CPC for services provided or ordered by Petitioner for a patient visit, ultrasounds of six different areas/systems, and an EKG all with date of service January 23, 2015. |
| JS | CMS Ex. 4 at 18-19 is a Part B Medicare Summary Notice for JS that shows claims filed by CPC for services provided by Petitioner for a patient visit with a date of service of January 20, 2015. CMS Ex. 5 at 39-47 is a Part A Medicare Summary Notice for JS that shows Petitioner certified JS for home health care services for the period January |
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|
BENE. |
SUMMARY OF EVIDENCE |
|---|---|
| 16 to March 16, 2015, including skilled nursing and home health aide visits. CMS Ex. 5 at 39, 43, 47. | |
| ST | CMS Ex. 4 at 20-23 is a Part B Medicare Summary Notice for ST that shows claims filed by American Diagnostic Lab, Inc. for laboratory testing with date of service January 14, 2015, based on referral by Petitioner; and a claim filed by CPC for services provided by Petitioner for a patient visit. |
Pursuant to 42 C.F.R. § 424.516(f)(1) and (2) a provider or supplier who provides or physician or other qualified professional who orders or certifies home health services, DMEPOS, clinical laboratory services, or imaging services must retain copies of the records reflecting that activity for seven years and produce them on request by CMS or a MAC. The regulations do not specifically define the term “imaging services.” However, 42 C.F.R. § 415.120(a) lists covered radiology services, including interpretation of x-rays, angiograms, myelograms, pyelograms, and ultrasound procedures. Pursuant to 42 C.F.R. § 414.68(b) advanced diagnostic imaging includes magnetic resonance imaging (MRI), computed tomography (CT scan), nuclear medicine, and positron emission tomography. Applying the foregoing regulations to the table summarizing the evidence produced by CMS related to the 10 unaccounted for beneficiaries, I find that the evidence shows CPC filed claims for the following services that CPC claimed were ordered or certified by Petitioner for which record retention is clearly required by 42 C.F.R. § 424.516(f)(2).
|
BENE |
SERVICE |
|---|---|
| LB | Ultrasound Services |
| SB | Home Health Services |
| LBu | Ultrasound Services |
| JC | Home Health Services |
| OF | Home Health Services |
| RL | No Services Claimed Subject to 42 C.F.R. § 424.516(f) |
| NM | Home Health Services |
| BS | Ultrasound |
| JS | Home Health Services |
| ST | Clinical Laboratory Services |
Petitioner has not challenged the authenticity of the documents in CMS Exs. 4 and 5 or that they accurately reflect information from CMS records. Petitioner does not deny that claims were filed listing him as physician. Tr. 108. I also find that Petitioner does not dispute that he does not have records for the nine unaccounted for beneficiaries for the services the evidence shows that he ordered or certified for nine beneficiaries that are subject to the record retention and production requirements of 42 C.F.R. § 424.516(f)(2)(i)(A) and (B). Petitioner admitted when requesting reconsideration that
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he did not have records for 11 of 21 beneficiaries requested by NGS, including the 9 beneficiaries for whom I have found records should have been retained based on claims filed by CPC. Petitioner explained that he did not have access to the records for the unaccounted for beneficiaries. He explained that records for patients of Grand Medical Offices and Affiliates (Grand Medical) were brought to his office for review. Petitioner asserts that he conducted chart reviews of the records and oversight management, and after reviewing records they were returned to Grand Medical. Petitioner told NGS that he believed the records were seized by the FBI. CMS Ex. 1 at 6, 40-42.
Petitioner testified at the hearing. He testified that he was approached multiple times by a representative of Grand Medical to do chart reviews and auditing of patients’ records, services for which he understood that he would be paid. He testified that he went through a credentialing process with Grand Medical. Pursuant to his arrangement with Grand Medical, they brought him patient charts, he reviewed the charts, he wrote comments as appropriate including suggestions and next appropriate steps, and then Grand Medical retrieved the records from him. He testified that he was not supposed to be the treating physician or have a physician-patient relationship with the Grand Medical patients whose records he reviewed. He believed he was only making recommendations to treating physicians. He participated with Grand Medical for approximately 11 months reviewing boxes of records. He was subsequently notified by a representative of Grand Medical that the FBI had shut their office and seized all records. Thereafter the CMS investigators visited his office. Tr. 40-44.
During my examination of Petitioner, he clarified that he reviewed files from both Grand Medical Clinic and Madison Health Care (Madison), both of which were part of the same organization, and that CPC was also part of the organization. Tr. 47-51. On cross-examination, Petitioner testified that in his own medical practice he ordered home health services, clinical laboratory tests, and ultrasounds and other imaging tests for his patients. He testified that he was aware of the importance of documenting care and services he ordered for his patients and the document retention and access requirements, although he did not recognize the reference of CMS’s counsel to 42 C.F.R. § 424.516(f). Tr. 52-55. According to Petitioner, Grand Medical brought him patient charts “from different hospitals, different emergency room notes, different laboratories, different physicians,” and “they were from all over the city of Chicago.” Tr. 85-86. Petitioner testified that when he reviewed the charts, he made notations on the records and initialed them. He sometimes recommended treatment or diagnostic tests for the patients, such as blood tests, X-rays, CAT scans, and ultrasounds. Tr. 86-87, 99-100. He testified that occasionally staff in other physicians’ offices called him directly, seeking his advice or clarification regarding treatment he had suggested in reviewing patient charts. Petitioner stated that when he made recommendations regarding patient treatment, he expected that the recommendations would be acted upon as if he had given an order. He testified that when he gave advice on the telephone he may have spoken to a physician assistant or medical assistant; he would recommend an x-ray or CT; he did not know whether they
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prepared a telephone order, but he stated that he would hope so. Tr. 86-87. When asked about documentation related to home health services, Petitioner stated that he reviewed and initialed plans of care and signed certification statements for homebound status. He testified that things he needed to sign were flagged for him. Tr. 87-88, 98-99, 112. Petitioner implied at hearing that he did not know CPC was filing claims with Medicare for services he rendered, and prior to hearing he asserted that he did not know. P. PHB at 3-4 (citing P. Ex. 1 (not admitted)); Tr. 103-104. Petitioner testified that his arrangement with Grand Medical was that he would be paid for reviewing charts, possibly “several thousand a month” in exchange for his “reviewing hundred, 200, 300 charts” a month. Tr. 106. In response to my question, Petitioner agreed that his position in this proceeding is that he was duped into participating in this scheme. Tr. 108.
I find by a preponderance of the evidence based on the testimony of Petitioner and other evidence discussed that:
(2) Petitioner did review records pursuant to the arrangement but whether or not he was ever paid is not clear from the evidence and not relevant to this decision;
(3) In the course of reviewing the medical records, Petitioner made notes on the medical records and also spoke with medical staff participating in the care and treatment of the nine unaccounted for Medicare beneficiaries to whom the records related, LB, SB, LBu, JC, OF, NM, BS, JS, and ST;
(4) Petitioner admits that his notes on the medical records and discussions with medical staff included recommendations for additional or alternative care and services for the nine Medicare beneficiaries;
(5) Petitioner admitted that he intended, at least in some instances, that his recommendations be treated as orders for the delivery of care and services;
(6) Petitioner also admitted that he signed documents required for ordering home health care services;
(7) Petitioner, not once but twice, executed a CMS-855R allowing CPC to submit claims to Medicare for services Petitioner delivered to Medicare beneficiaries and it is not credible that Petitioner did not understand the significance of his agreeing to the reassignment, particularly given that the agreement was that he was to be paid by CPC, Madison, or Grand Medical for his record reviews;
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(9) I infer, based on the preponderance of the evidence, that:
(a) Petitioner made notes on the files he reviewed for LB, SB, LBu, JC, OF, NM, BS, JS, and ST or he had discussions with medical staff in which he made recommendations for home health, imaging, or clinical laboratory services, or he signed certification documents necessary for home health services, and
(b) His recommendations were treated as orders for which CPC subsequently billed Medicare; and
(10) Petitioner did not retain for seven years and produce to CMS or NGS the records related to his orders for ultrasounds, home health services, and clinical laboratory services for the nine Medicare beneficiaries, LB, SB, LBu, JC, OF, NM, BS, JS, and ST.
b. Analysis
I conclude that CMS has made a prima facie showing of a basis for revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10) because Petitioner failed to retain for seven years and produce records related to his orders for ultrasounds, home health services, and clinical laboratory services for nine Medicare beneficiaries in violation of 42 C.F.R. § 424.516(f)(2)(i)(A) and (B). I further conclude that Petitioner failed to rebut the CMS prima facie case or establish any affirmative defense.
The regulation is clear that a physician who orders or certifies home health services, DMEPOS items, clinical laboratory services, or imaging services, must maintain written or electronic documents related to those orders or certifications, including requests for payment, for seven years. Furthermore, the physician must be able to produce the documents to CMS or the MAC upon request. 42 C.F.R. § 424.516(f)(2)(i)(B). Failure to maintain the documents required by 42 C.F.R. § 424.516(f) or to produce the documents when requested is a basis for revocation of Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10)(i).
CMS made a prima facie showing of a basis for revocation of Petitioner’s Medicare enrollment and billing privilege pursuant to 42 C.F.R. § 424.535(a)(10)(i) because:
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Petitioner admits that he wrote notes on the patient records and, in some cases, had telephone calls with medical staff responsible for the patients’ care and treatment, in which Petitioner suggested or recommended care and services;
Petitioner admitted that he intended that his suggestions and recommendations be implemented by medical staff;
In the case of the nine unaccounted for Medicare beneficiaries, LB, SB, LBu, JC, OF, NM, BS, JS, and ST described in the tables above, CPC filed claims with Medicare for home health services, ultrasound (imaging), and clinical laboratory services, and listed Petitioner as the ordering or certifying physician; and
Petitioner did not retain or grant CMS or the MAC access to the records related to the claims filed by CPC for LB, SB, LBu, JC, OF, NM, BS, JS, and ST, which included claims for home health service, imaging services, and clinical laboratory services.
The evidence presented by CMS establishes by a preponderance of the evidence, i.e., it is more likely than not, that Petitioner ordered home health service, imaging services, or clinical laboratory services for LB, SB, LBu, JC, OF, NM, BS, JS, and ST. Petitioner’s admissions are consistent with and support the CMS prima facie case.
Petitioner admits that he reviewed files for the 11 unaccounted for beneficiaries, including the 9 who are the focus of this decision, LB, SB, LBu, JC, OF, NM, BS, JS, and ST . P.Br. at 1. No document has been produced that shows that Petitioner actually ordered or certified home health services, imaging services, or clinical laboratory services for LB, SB, LBu, JC, OF, NM, BS, JS, and ST. However, the absence of a document reflecting the specific orders is not fatal to the CMS prima facie case. Once CMS makes a prima facie showing, as it has in this case, the burden is upon Petitioner to rebut the prima facie case by a preponderance of the evidence. Petitioner has failed to meet his burden to show by a preponderance of credible evidence that he did not, in fact, order home health services, imaging services, or clinical laboratory services for the nine unaccounted for beneficiaries, LB, SB, LBu, JC, OF, NM, BS, JS, and ST.
Petitioner asserts in his declaration, which was not admitted as evidence, that he never “knowingly” ordered or provided services to LB, SB, LBu, JC, OF, NM, BS, JS, and ST, and one other unaccounted for beneficiary or submitted bills to Medicare for those beneficiaries. P. Ex. 1. Even if the declaration was admitted and treated as evidence, it is insufficient to rebut the CMS prima facie case. Petitioner has admitted that he reviewed
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medical records for the 11 unaccounted for beneficiaries. P. Br. at 1. Petitioner admitted that, in the case of at least some of the patient files he reviewed, he wrote recommendations on files or gave recommendations during telephone conversations for additional care and treatment that he intended be carried out as he directed, that is, ordered. Tr. 86-88, 98-100, 112. There is no question Petitioner did not possess the files for the nine unaccounted for beneficiaries still at issue before me. I find not credible Petitioner’s declaration under penalty of perjury that he could recall that he did not order or certify services for any of the nine, particularly given the assertion in his prehearing brief that he had a “total lack of awareness related to services” provided to the unaccounted for beneficiaries. Further, Petitioner’s declaration is inconsistent with the evidence that shows that CPC submitted claims to Medicare listing Petitioner as the ordering or certifying physician for home health, imaging, or clinical laboratory services for the nine unaccounted for beneficiaries. CMS Exs. 4, 5; Tr. 108. Petitioner has presented no evidence, other than his denial of knowledge, that the CPC Medicare claims were actually false and not based on Petitioner’s notes on patient records or his directions to medical staff in telephone calls.
In his request for hearing, Petitioner’s counsel represented that “all records he maintained related to the eleven (11) Beneficiaries at issue were stored at the office of Grand Medical Services. . . .” RFH at 1. In the request for hearing, Petitioner’s counsel asserted that, despite his willingness to produce the records for the 11 unaccounted for beneficiaries, Petitioner could not do so because the FBI had seized those records from Grand Medical. RFH at 2. The allegations in the request for hearing are consistent with Petitioner’s allegations in the supplemental reconsideration request. CMS Ex. 1 at 40-41. I construe the argument to be that, if Petitioner reviewed the records and ordered services for the 11 unaccounted for beneficiaries, the FBI seized the documents that were stored at Grand Medical, depriving Petitioner of his ability to access the documents. However, Petitioner has presented no documentary evidence (such as a form CMS-855I or copies of any of the documents he argues he signed at the behest of CPC, Grand Medical, or Madison to establish his credentials) showing that he had a records storage arrangement with Grand Medical, Madison, or CPC, and he did not testify to that effect. Furthermore, the preamble to the April 27, 2012 CMS final rule promulgating 42 C.F.R. § 424.516(f) states that the “rule places the responsibility for the maintenance of records on both the ordering and certifying physician and the provider and supplier.” 77 Fed. Reg. 25,284, 25,310 (Apr. 27, 2012). The Secretary acknowledged in rulemaking that certain records, such as an order for durable medical equipment at a hospital or a nursing home discharge, would typically be retained by the hospital or nursing home, and not by the physician, but nevertheless stated “[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. The regulatory history is clear that when there are circumstances in which a physician may not have immediate access and control over medical documents, the physician must nevertheless comply with the documentation retention and access
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requirements of 42 C.F.R. § 424.516(f). George M. Young, M.D., DAB No. 2750 at 10 (2016).
CMS policy is consistent with the rulemaking:
CMS Pub. 100-08, Medicare Program Integrity Manual (MPIM), ch. 15, § 15.18(C) (rev. 587, eff. July 20, 2015). The CMS policy is clear that under 42 C.F.R. § 424.516(f), regardless of whether medical records are maintained by a physician in his own office or stored with another entity, it is the physician’s responsibility to maintain records and provide documentation upon CMS’s request. There is no question that CMS has the discretion to decide not to revoke pursuant to 42 C.F.R. § 424.535(a)(10) for noncompliance with 42 C.F.R. § 424.516(f). However, when I conclude that there was a basis for revocation, it is not for me or the Board to look behind CMS’s exercise of discretion to proceed with revocation. George M. Young, M.D., DAB No. 2750 at 11; Abdul Razzaque Ahmed, M.D., DAB No. 2261 at 19 (2009), aff’d, Ahmed v. Sebelius, 710 F. Supp. 2d 167 (D. Mass. 2010).
Petitioner’s argument may also be construed to be that CMS should be estopped from revocation because the FBI seizure caused Petitioner not to have the required documents and deprived him of a defense. Estoppel against the federal government, if available at all, is presumably unavailable absent “affirmative misconduct,” such as fraud. See, e.g., Pacific Islander Council of Leaders, DAB No. 2091 at 12 (2007); Office of Pers. Mgmt. v. Richmond, 496 U.S. 414, 421 (1990). Other than evidence that the FBI seized documents, which CMS does not appear to dispute, there is no evidence suggesting fraud or other intentional misconduct on the part of the MAC, CMS, or the FBI to, for example, prevent Petitioner from defending this case or to establish a basis for revocation. I conclude Petitioner has not met the heavy burden required for estoppel.
Petitioner took the approach at hearing and in post-hearing briefing that the 11 unaccounted for beneficiaries were not his patients and he was only a consulting physician. Petitioner reasons that because he was only reviewing files as a consultant, 42 C.F.R. § 424.516(f) should not apply to him. P. Br. Petitioner cites no authority to support his argument that a physician acting as a consultant should not be held to the
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requirements of 42 C.F.R. § 424.516(f), if he orders or certifies home health, imaging, clinical laboratory services or DMEPOS. Neither the Act nor the regulations draw any distinction between a physician who reviews or audits patient charts as a consultant and one who provides direct care to a beneficiary. Moreover, there is nothing in the regulatory history or CMS policy that suggests that any such distinction is to be made for purposes of applying the requirements of 42 C.F.R. § 424.516(f). 77 Fed. Reg. 25,284 et. seq. Petitioner ordered or certified home health, imaging, or clinical laboratory services for 9 of the 11 unaccounted for beneficiaries, and he did not retain and produce copies of the documents reflecting the orders. These are the facts that trigger violation of 42 C.F.R. § 424.516(f)(2) and provide a basis for revocation under 42 C.F.R. § 424.535(a)(10). Based upon Petitioner’s testimony and arguments post-hearing, it is clear that Petitioner failed to recognize and understand his duty under 42 C.F.R. § 424.516(f)(2)(i)(A) and (B) to retain for seven years and produce records related to his orders for home health, imaging, and clinical laboratory services for the nine patients for whom he ordered such services. The fact that Petitioner believed, incorrectly, that as a consulting physician he was not subject to the requirement for record retention and production under 42 C.F.R. § 424.516(f) is no defense, as ignorance of the law can be no excuse for physicians who apply for and are granted permission to participate in Medicare. 42 C.F.R. § 424.510(d)(3) (signature on CMS-855 application “attests that the information submitted is accurate and that the provider or supplier is aware of, and abides by, all applicable statutes, regulations, and program instructions.”); see Heckler v. Cmty. Health Servs. of Crawford Cnty., 467 U.S. 51, 63-64 (1984) (participant in the Medicare program had “duty to familiarize itself with the legal requirements for cost reimbursement”); Thomas M. Horras & Christine Richards, DAB No. 2015 at 23-24 (2006) (officer and principal of provider had responsibility to be aware of and adhere to applicable law and regulations), aff’d, Horras v. Leavitt, 495 F.3d 894 (8th Cir. 2007).
Petitioner asserts that he was tricked or duped by CPC, Madison, and Grand Medical because he believed he was only consulting and reviewing records of their patients or the patients of other physicians or practitioners. Petitioner’s argument is not credible. Petitioner admits he had an arrangement with CPC, Madison, and Grand Medical to review patient records. As part of his arrangement, Petitioner executed two CMS-855Rs granting CPC the right to bill Medicare for his services. Petitioner admits that CPC, Madison, or Grand Medical would be paying him for his services. I do not accept Petitioner’s suggestion that given his level of education and experience as a doctor, he was tricked. Even if Petitioner was tricked, he admits that he recommended and signed documents required for home health, imaging, and clinical laboratory services for some of the patients whose records he reviewed, orders he expected would be acted upon. The fact that triggers the application of 42 C.F.R. § 424.516(f)(2)(i) to Petitioner, is that he ordered or certified home health, imaging, or clinical laboratory services. Whether or not Petitioner was a primary treating physician or a consulting physician, whether or not he understood his role in the care and treatment of the beneficiaries, and whether or not he was aware that CPC was billing Medicare listing Petitioner as the ordering physician,
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Petitioner was obliged as a Medicare-enrolled supplier to comply with Medicare regulations, including 42 C.F.R. § 424.516(f)(2)(i)(A) and (B).
Petitioner states the concern in his post-hearing submission that the application of 42 C.F.R. § 424.516(f) in the manner advocated by CMS in this case would result in many physicians being required to maintain documents for thousands of patients for seven years even when they are only serving as consultants. P. Br. The regulation, however, is limited in its application to physicians, whether consultants or primary treating physicians, who order, certify, or deliver, DMEPOS, imaging services, home health services, or clinical laboratory services. 42 C.F.R. § 424.516(f). Further, CMS has discretion not to revoke, and I have no authority to review the exercise of discretion to revoke when I find there is a basis for revocation. 42 C.F.R. § 424.535(a) (CMS may revoke for any of the reasons listed); Young, DAB No. 2750 at 11; Ahmed, DAB No. 2261 at 19. I am required to follow the Act and regulations and have no authority to declare statutes or regulations invalid. 1866ICPayday.com, L.L.C., DAB No. 2289 at 14 (2009). To the extent Petitioner’s arguments may also be viewed as tantamount to requests for equitable relief, I have no authority to grant such relief. US Ultrasound, DAB No. 2302 at 8 (2010).
III. Conclusion
For the foregoing reasons, I conclude that Petitioner’s Medicare enrollment and billing privileges are revoked pursuant to 42 C.F.R. § 424.535(a)(10) for failure to comply with the documentation requirements of 42 C.F.R. § 424.516(f)(2)(i)(A) and (B) for one year.
Keith W. Sickendick Administrative Law Judge
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1. Citations are to the 2015 revision of the Code of Federal Regulations (C.F.R.), unless otherwise stated.
- back to note 1 2. A “supplier” furnishes services under Medicare and the term supplier applies to physicians or other practitioners and facilities that are not included within the definition of the phrase “provider of services.” Act § 1861(d) (42 U.S.C. § 1395x(d)). A “provider of services,” commonly shortened to “provider,” includes hospitals, critical access hospitals, skilled nursing facilities, comprehensive outpatient rehabilitation facilities, home health agencies, hospice programs, and a fund as described in sections 1814(g) and 1835(e) of the Act. Act § 1861(u) (42 U.S.C. § 1395x(u)). The distinction between providers and suppliers is important because they are treated differently under the Act for some purposes.
- back to note 2 3. DMEPOS is durable medical equipment, prosthetics, orthotics, and supplies. 42 C.F.R. § 414.402
- back to note 3 4. “Credible evidence” is evidence that is worthy of belief. Black’s Law Dictionary 596 (8th ed. 2004). The “weight of evidence” is the persuasiveness of some evidence compared to other evidence. Id. at 1625.
- back to note 4 5. The reconsidered determination found that that Petitioner failed to produce documents for 11 beneficiaries (the unaccounted for beneficiaries). However, CMS elected to proceed on only 10 of the 11 beneficiaries because CMS could not get necessary records related to one, a beneficiary with the initials LM. CMS PHB at 1 n.1; CMS Br. at 10 n.6; Tr. 94-96. As explained hereafter, the evidence only shows that home health, imaging, or laboratory services were ordered for 9 of the 10 unaccounted for beneficiaries.
- back to note 5
