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                              Paul Sender, M.D., DAB CR5395 (2019)
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Paul Sender, M.D., DAB CR5395 (2019)








  
  
    

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





Paul Sender, M.D.
(NPI:  1124321286 / PTAN:  267507),
Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-18-114Decision No. CR5395August 14, 2019

        
              
    

      DECISION
The Centers for Medicare & Medicaid Services (CMS) revoked the Medicare enrollment and billing privileges of Paul Sender, M.D. (Dr. Sender or Petitioner) because Dr. Sender allegedly engaged in improper prescribing practices involving ten prescriptions provided to four Medicare Part D enrollees in late 2015 to early 2016. Dr. Sender requested a hearing to dispute the revocation. For the reasons stated below, I affirm CMS’s determination to revoke Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(14)(i) (i.e., a pattern or practice of prescribing Medicare Part D drugs that is abusive or represents a threat to the health and safety of Medicare beneficiaries, or both).
I. Background and Procedural History
Dr. Sender, a physician, was enrolled in the Medicare program as a supplier. In a July 6, 2017 initial determination, CMS revoked Petitioner’s Medicare enrollment and billing privileges, effective August 5, 2017, for the following reason:
**Page 2**
**42 CFR § 424.535(a)(14) – Improper Prescribing Practices**
****
Data analysis conducted on [Medicare] Part D drugs prescribed by Dr. Paul Sender from October 7, 2015 through November 9, 2015 revealed claims submitted for prescriptions purportedly written for beneficiaries by Dr. Paul Sender, as demonstrated on the enclosure which includes ten (10) claims for four (4) Medicare beneficiaries. *See Enclosure A.*
However, the said Medicare beneficiaries attested they never received treatment from Dr. Paul Sender.  Therefore, Paul Sender, M.D.’s aforementioned prescribing behavior constitutes a violation of 42 CFR 424.535(a)(14)(i) because CMS has determined that the provider “has engaged in a pattern or practice of prescribing part D drugs that do not have diagnoses to support the indications for which the drugs were prescribed” and “prescribing part D drugs in which the necessary evaluation of the patient for whom the drug was prescribed could not have occurred”.
CMS Exhibit (Ex.) 1 at 1. The initials for the four beneficiaries listed in Enclosure A to the initial determination were T.R., S.B., E.W., and W.M.1
 CMS Ex. 1 at 3. In the initial determination, CMS barred Petitioner from re-enrollment in the Medicare program for three years. CMS Ex. 1 at 2.
Petitioner timely requested reconsideration. CMS Ex. 17. Petitioner submitted the patient chart for one of the beneficiaries referenced in Enclosure A to the initial determination, who has the initials of T.R. CMS Exs. 15, 17. Petitioner indicated that he needed CMS to provide all of the documents on which it based its initial determination and did not substantively respond to CMS’s basis for revocation. CMS Ex. 17.
Petitioner later filed a supplement to the reconsideration request. CMS Ex. 4. In the supplement, Petitioner asserted that he treated the beneficiaries identified in Enclosure A to the initial determination “after evaluating them by phone as to their symptoms and diagnoses and performed a mental status examination, which is the appropriate and
**Page 3**
indicated evaluation for the purposes of prescribing the metabolic vitamin supplements and pain creams they requested and which I prescribed.” CMS Ex. 4 at 1. Petitioner also stated that the initial determination’s Enclosure A was incorrect because Petitioner did not prescribe “Gelatin Capsule (empty)” for a beneficiary with the initials T.R., but did prescribe for T.R. a metabolic supplement with three renewals.  CMS Ex. 4 at 1. Further, Petitioner argued:
The vitamin metabolic supplements that I prescribed to beneficiaries who requested them were likely helpful, posed no health risk and their equivalents could have been obtained over the counter. And the pain creams that I prescribed were likely to be helpful to their recipients, posed no health risk and were also prescribed only to those requesting them.
CMS Ex. 4 at 1-2.
Finally, Petitioner noted that CMS did not respond to his request to “send me all documentation that you used regarding the patients in Enclosure A to revoke my [Medicare billing] privileges.” CMS Ex. 4 at 1.
In the reconsidered determination, a CMS hearing officer upheld the revocation. CMS Ex. 18. The hearing officer concluded that the record supported four of the eight factors listed under 42 C.F.R. § 424.535(a)(14)(i) and, therefore, CMS properly revoked Petitioner under that regulation.
The first factor the hearing officer considered was whether there was a diagnosis present to support the indications for which the drugs were prescribed. 42 C.F.R. § 424.535(a)(14)(i)(A).  The hearing officer found:
In each of the attestations from S. B[.], T. R[.], E. W[.], and [W]. M[.], each Medicare beneficiary indicated that they received a telephone call from Dr. Sender and were asked general questions, told that they would not have to pay anything out of pocket, and that their insurance would cover the prescriptions.  While Dr. Sender provided a patient chart for beneficiary T. R[.] only, there was no indication in that chart or in his reconsideration request to prove that any of the four unique Medicare beneficiaries had a diagnosis present to support the medical necessity of the prescribed gelatin capsules, alpha-lipoic acid powder, and scar cream.
CMS Ex. 18 at 8.
**Page 4**
The next factor considered by the hearing officer was the number, type, and reason for disciplinary actions taken against Petitioner by the licensing body or medical board for the state or states in which Petitioner practices. 42 C.F.R. § 424.535(a)(14)(i)(D).  The hearing officer found that in 2005 Petitioner’s medical license in New Jersey was suspended for five years and, on October 17, 2017, Petitioner’s medical license in New York was revoked. CMS Ex. 18 at 9.
The hearing officer also considered whether Petitioner had any history of final adverse actions as defined in the regulations to include license suspensions, or exclusion or debarment from participating in a federal or state health care program.  42 C.F.R. § 424.535(a)(14)(i)(E). The hearing officer found that the New Jersey Medicaid program suspended Petitioner from 2006 to 2014, and the New York Medicaid program excluded Petitioner from 2005 until at least 2016. The hearing officer reiterated Petitioner’s medical license suspension in New Jersey and revocation in New York. CMS Ex. 18 at 9.
Finally, the hearing officer considered whether any state Medicaid program or public or private health insurance program has restricted, suspended, revoked, or terminated Petitioner’s ability to prescribe medications. 42 C.F.R. § 424.535(a)(14)(i)(G). The hearing officer reiterated Petitioner’s suspension from the New Jersey Medicaid program and New York’s exclusion of Petitioner from its Medicaid program. CMS Ex. 18 at 9.
Petitioner filed a timely request for hearing (Hearing Req.) before an administrative law judge (ALJ), asserting:
All the beneficiaries for whom I prescribed were evaluated by me by phone, received a mental status exam by phone and had diagnoses of pain and /or fatigue to justify the pain creams and metabolic vitamin supplements which were requested by the beneficiaries and which I prescribed. Contrary to the CMS report, the diagnosis of pain (of lower L leg and L buttock) is clearly documented in the chart of T R[.] which I previously submitted, as well as my mental status exam[.]
****
The CMS does not allege harm or potential harm to any beneficiary as a result of my prescribing, and in truth no harm occurred and no potential harm could have been reasonably expected to occur as a result of my prescribing.  As it is impossible to abuse or threaten the health and safety of Medicare beneficiaries without harming or potentially
**Page 5**
harming them, the conclusion by the CMS that I did this is clearly false, defies reason and [is] without legitimate basis.
Hearing Req. at 2.
On November 3, 2017, Judge Bill Thomas issued an Acknowledgment and Pre-hearing Order (Pre-hearing Order). In compliance with the Pre-hearing Order, CMS filed a pre-hearing brief (CMS Br.) along with 20 exhibits (CMS Exs. 1-20). Petitioner filed a pre-hearing brief (P. Br.) along with 15 exhibits (P. Exs. A-O). CMS filed a reply brief in which CMS objected to many of Petitioner’s proposed exhibits, requested a decision on the written record or, in the alternative, summary judgment.
On November 20, 2018, I was assigned to hear and decide this case.
II. Evidentiary Rulings
Petitioner did not object to any of CMS’s proposed exhibits. Pre-hearing Order ¶ 7; Civil Remedies Division Procedures (CRDP) § 14(e). Therefore, I admit CMS Exs. 1 through 20 into the record.
CMS objected to a number of Petitioner’s proposed exhibits. Below I provide an analysis of each objection and my ruling. However, in summary, I admit P. Exs. C, D, F, and K into the record and exclude Petitioner’s other proposed exhibits.
CMS objected to the admission of the declaration that Petitioner submitted in this proceeding as his written direct testimony. P. Ex. A. CMS asserted that Petitioner did not sign the declaration under oath or under penalty of perjury. Petitioner did not respond to this objection or submit a corrected version of his declaration, even though Petitioner has had over a year to do so.
The statutory provision applicable to the hearing in this case provides for the administration of oaths and affirmations, and the examining of witnesses. 42 U.S.C. §§ 405(b)(1), 1395cc(j)(8). The regulations implementing that statute require that “[w]itnesses at the hearing testify under oath or affirmation.” 42 C.F.R. § 498.62. The CRDP recognizes that a presiding ALJ may direct the parties to submit written direct testimony for witnesses in lieu of obtaining direct testimony during an oral hearing. However, the CRDP requires that “[a]ny written direct testimony must be in the form of a sworn affidavit or declaration under penalty of perjury.” CRDP § 19(b); *see also* 28 U.S.C. § 1746 (allowing, in certain circumstances, an unsworn declaration made under penalty of perjury to substitute for a sworn declaration).
**Page 6**
The ALJ originally assigned to this case ordered the parties to submit written direct testimony and specified that “[a] witness statement must be submitted in the form of an affidavit made under oath or as a written declaration that the witness signs under penalty of perjury for false testimony.” Pre-hearing Order ¶ 8. Petitioner’s written direct testimony is not sworn, under affirmation, or signed under penalty of perjury. Therefore, I sustain CMS’s objection and exclude P. Ex. A.
CMS objected to letters of support that Petitioner submitted from former patients (P. Ex. B) because 1) Petitioner did not offer good cause for failing to submit these documents earlier in the administrative appeals process, 2) they are irrelevant, and, 3) they are unreliable.
There are several letters marked as P. Ex. B, which appear to be from Petitioner’s former patients expressing gratitude for his services as a physician upon the closure of his practice when his New Jersey medical license was suspended. As CMS argues, the initial determination notified Petitioner that he must submit evidence to be considered by an ALJ with the reconsideration request:
You may submit additional information with the reconsideration that you believe may have a bearing on the decision.  However, if you have additional information that you would like a hearing officer to consider during the reconsideration or, if necessary, an administrative law judge to consider during a hearing, you must submit that information with your request for reconsideration.  This is your only opportunity to submit information during the administrative appeals process; you will not have another opportunity to do so unless an administrative law judge specifically allows you to do so under 42 CFR § 498.56(e).
CMS Ex. 1 at 2. Petitioner did not submit the documents in P. Ex. B with the reconsideration request.
In this proceeding, the Pre-hearing Order stated the following in regard to the submission of evidence:
Petitioner may not offer new documentary evidence in this case absent a showing of good cause for failing to present that evidence previously to CMS. If Petitioner offers such evidence, the evidence must be specifically identified as new, and Petitioner’s brief must explain why good cause exists for me to receive it. I must exclude any new evidence for which
**Page 7**
a showing of good cause has not been made pursuant to 42 C.F.R. § 498.56(e).
Pre-hearing Order ¶ 6.
I agree with CMS that Petitioner did not state good cause under 42 C.F.R. § 498.56(e) as to why this exhibit was not submitted at the reconsideration stage in this process. Therefore, I sustain CMS’s objection and exclude P. Ex. B. *See* 42 C.F.R. § 405.803(c).
CMS objected to an evaluation in support of Petitioner’s New Jersey medical reinstatement (P. Ex. C) because 1) Petitioner did not offer good cause for not submitting this document earlier in the proceeding, 2) it is irrelevant, and 3) it is unreliable.
The May 31, 2013 letter is from a physician who appears to have been monitoring/evaluating Petitioner’s work as a physician as part of the November 30, 2010 consent order related to Petitioner’s reinstatement to partial practice in New Jersey (CMS Ex. 10 at 3-4). I conclude that Petitioner has good cause for submitting this letter during this proceeding because CMS only raised the issue of his New Jersey medical license suspension in the reconsidered determination. Further, since it relates to a CMS exhibit and an issue CMS has raised, it has relevance to this case. Finally, CMS points out that this letter is only a cover letter to a quarterly evaluation, but the quarterly evaluation itself was not submitted. I do not exclude this exhibit on that basis, but note CMS’s concern in relation to the weight to be afforded this letter. Therefore, I overrule CMS’s objection and admit P. Ex. C.
CMS also objected to P. Exs. D through J as redundant to CMS’s exhibits or the hearing request. The CRDP informs parties not to submit proposed exhibits that are already in the record, such as the hearing request, or file an exhibit that has already been submitted by the opposing party. CRDP § 14(a); *see also* 5 U.S.C. § 556(d) (agencies must, as a matter of policy, provide for the exclusion of unduly repetitious evidence.). P. Exs. E, G, H, I, and J include Petitioner’s hearing request (P. Ex. J) and procedural documents that CMS has already filed in this case as CMS Exs. 1, 9, 17, and 18. Therefore, I sustain CMS’s objection and exclude P. Exs. E, G, H, I, and J.
However, I overrule CMS’s objections to P. Exs. D and F. These exhibits relate to Petitioner’s licensure issues in New York State, which CMS raised for the first time in its reconsidered determination. These documents are not duplicative of exhibits submitted by CMS, but do relate to CMS Ex. 9. Therefore, I find good cause under 42 C.F.R. § 498.56(e) to admit these documents into the record, which are relevant to the issues CMS has raised in this case.
**Page 8**
CMS objected to letters of support that Petitioner submitted (P. Exs. K, L, M, N, and O) because Petitioner did not provide good cause for their submission at this stage in the appeal process and they are irrelevant.
The document marked as P. Ex. K is a Supporting Affidavit in support of restoration of Petitioner’s medical license in New York State. Thus, this document relates to a matter CMS first raised in its reconsidered determination. Therefore, I overrule CMS’s objection and admit P. Ex. K because there is good cause for its submission during this proceeding and the document has at least some relevance to this case.
The documents marked as P. Exs. L, M, N, and O are letters generally supportive of Petitioner, but do not provide a context for why they were written or if they played a role in any of Petitioner’s medical licensure matters. Petitioner did not provide good cause for submitting these documents at this stage in the process. Therefore, I sustain CMS’s objection and exclude P. Exs. L, M, N, and O.
III. Decision on the Record
CMS moves for a decision based on the written record because Petitioner’s only written direct testimony for a witness is defective and should be excluded, and Petitioner did not request to cross-examine CMS’s witness. Petitioner neither responded nor objected to CMS’s motion.
The Pre-hearing Order advised the parties that an in-person hearing would only be necessary if a party submitted the written direct testimony of a proposed witness and the opposing party requested an opportunity to cross-examine the witness. Pre-hearing Order ¶¶ 8-10; CRDP §§ 16(b), 19(b); *see* *Vandalia Park*, DAB No. 1940 (2004); *Pac. Regency Arvin*, DAB No. 1823 at 8 (2002) (holding that the use of written direct testimony for witnesses is permissible so long as the opposing party has the opportunity to cross-examine those witnesses). CMS submitted written direct testimony for one expert witness (CMS Ex. 14). However, Petitioner did not request to cross-examine this witness. Further, as discussed above with regard to P. Ex. A, Petitioner submitted his own written direct testimony, but I excluded that exhibit because Petitioner failed to meet the requirement of signing that document under oath or affirmation, or under penalty of perjury. Since I excluded that testimony, there is no witness for CMS to cross-examine. Therefore, I do not need to hold an oral hearing in this case and I decide this case based on the written record. Pre‐hearing Order ¶ 11; CRDP § 19(d).
IV. Issue
Whether CMS had a legitimate basis for revoking Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(14)(i).
**Page 9**
V. Jurisdiction
I have jurisdiction to decide this case. 42 C.F.R. §§ 498.1(g); 498.3(b)(17), 498.5(*l*)(2);*see also* 42 U.S.C. § 1395cc(j)(8).
VI. Findings of Fact
My findings of fact appear in bold and italics.
***1.******The New Jersey State Board of Medical Examiners (NJ Board) suspended Petitioner in 2005 from the practice of medicine in New Jersey for five years, reinstated Petitioner’s license with conditions and monitoring in 2010, and restored Petitioner’s unrestricted medical license in 2013.***
In 1984, Petitioner was licensed to practice medicine in New Jersey. CMS Ex. 11. In 2004, the New Jersey Attorney General initiated an action before the NJ Board seeking Petitioner’s suspension from the practice of medicine for engaging in repeated acts of gross and/or simple negligence in his treatment of seven patients, which the Attorney General believed was a clear and imminent danger to the public. CMS Ex. 5 at 1. In response, Petitioner voluntarily agreed to a temporary suspension of his medical license. CMS Ex. 5 at 2. Petitioner ultimately did not litigate the merits of the case at a hearing and, on September 14, 2005, the NJ Board entered a Consent Order suspending Petitioner’s medical license for five years, of which two years were in active suspension and three years were in a stayed suspension/probation. CMS Ex. 5 at 5. The Consent Order conditioned restoration of Petitioner’s medical license on an affirmative showing of fitness to practice medicine. CMS Ex. 5 at 6. The Consent Order also indicated that Petitioner had to pay $50,000 in costs and civil penalties. CMS Ex. 5 at 7.
After five years, Petitioner sought reinstatement of his medical license in New Jersey. On November 30, 2010, the NJ Board found that Petitioner had complied with all of its previous requirements, with the exception of payment of most of the $50,000 costs/civil penalties, and reinstated Petitioner’s medical license under a variety of conditions, including monitoring by another licensed physician. CMS Ex. 10.
On May 31, 2013, Samuel Preschel, M.D., submitted an evaluation of Petitioner as required under the NJ Board’s November 30, 2010 reinstatement order. In the cover letter to the evaluation, Dr. Preschel recommended that the NJ Board fully restore Petitioner’s medical license. P. Ex. C.
On November 8, 2013, based heavily on Dr Preschel’s recommendation, the NJ Board reinstated Petitioner’s unrestricted license to practice medicine in New Jersey. P. Ex. D. As of December 8, 2017, Petitioner was still licensed to practice in New Jersey. CMS Ex. 11.
**Page 10**
***2.******The New York State Board for Professional Medical Conduct (NY Board) revoked Petitioner’s license to practice medicine in New York in 2005 based in part on improper prescribing practices. Although Petitioner sought restoration of his license in New York, the NY Board denied restoration.***
In 1982, Petitioner was licensed to practice medicine in New York State. CMS Ex. 3 at 4; CMS Ex. 8. In March 2006, the New York Bureau of Professional Medical Conduct filed a Statement of Charges with the NY Board, asserting that Petitioner’s conduct that resulted in the suspension of Petitioner’s New Jersey medical license would constitute misconduct had the conduct occurred in New York State. CMS Ex. 3 at 13-15. On May 17, 2006, a NY Board hearing committee held a hearing. CMS Ex. 3 at 3. The hearing committee concluded that Petitioner’s conduct, had it been committed in New York State, would have constituted the following misconduct under New York law: 1) practicing the medical profession with negligence on more than one occasion; 2) practicing the medical profession with gross negligence on a particular occasion; 3) practicing the medical profession with incompetence on more than one occasion; 4) practicing the medical profession with gross incompetence; 5) having a psychiatric condition that impairs the ability to practice; and 6) failing to maintain a record for each patient which accurately reflects the evaluation and treatment of the patient. CMS Ex. 3 at 5. The hearing committee’s determination stated the following:
The New Jersey Order . . . was based on charges of professional misconduct in New Jersey that were both serious and numerous. For patient N.T., the [Petitioner] repeatedly prescribed controlled substances without adequately determining the need for the prescriptions. He continued to prescribe controlled substances to N.T. even after he had learned that the patient had altered one of the controlled substance prescriptions. The [Petitioner] should have recognized that N.T. was an addict and taken steps to deal with this problem effectively. For patient A.F., the [Petitioner’s] initial impression was acute appendicitis. Nonetheless, the [Petitioner] did not obtain a surgical consultation for three days, a step that should have been taken within hours. Although imminent surgery was a distinct possibility, he allowed the patient to drink clear liquids and take oral antibiotics, a dangerous choice for a patient who may soon have surgery. Furthermore, the [Petitioner] chose an outdated antibiotic. When confronted by the New Jersey Board with information concerning this antibiotic, he responded that he would continue to use it. For patient C.B., the [Petitioner] failed to evaluate properly the patient’s respiratory distress and calf pain and overlooked abnormal
**Page 11**
liver function and white blood cell test results. On a later visit, the [Petitioner] failed to evaluate adequately the patient’s chest pain and dyspnea, simply attributing them to anxiety with no adequate exploration of other possible causes. In general, for the seven patients described in the New Jersey charges, the [Petitioner] made inadequate efforts to determine the cause of symptoms, provided inadequate treatment or contraindicated treatment, and failed to obtain the services of specialists in a timely manner.
CMS Ex. 3 at 6-7. The hearing committee revoked Petitioner’s medical license, concluding that it “has no confidence in [Petitioner’s] ability to practice medicine safely and must protect the people of New York State from him.” CMS Ex. 3 at 9.
In 2014, Petitioner sought restoration of his medical license in New York State. CMS Ex. 9 at 2; *Cf*. P. Ex. K. In February 2015, a Report of Peer Committee (Report) was issued in which two members of the committee recommended denying the restoration of Petitioner’s license and one member recommended restoration. CMS Ex. 9 at 24.
The Report provided additional details regarding Petitioner’s previous misconduct. In regard to patient C.B., C.B. died three days after his last visit with Petitioner of a massive pulmonary embolism. C.B. was 32 years old. CMS Ex. 9 at 5.
Petitioner saw patient B.S. at the hospital and diagnosed B.S. as septic with out-of-control diabetes. It was not until the sixth day B.S. was in the hospital that Petitioner ordered an infectious disease consultation, which resulted in a change in antibiotics and improvement in B.S.’s condition. CMS Ex. 9 at 5-6.
Petitioner treated patient W.G. in a hospital’s intensive care unit for a gastrointestinal bleed and congestive heart failure. Petitioner placed W.G. on an oral diet despite W.G.’s inability to swallow, thus creating a risk of aspiration. CMS Ex. 9 at 6-7.
Petitioner also treated patient V.D. in the hospital. “[Petitioner] inappropriately prescribed beta-blockers over an extended period of time for a patient who had a history of asthma with active bronchospasm . . . . The [Petitioner’s] action(s) was a gross deviation from the standard of care and defied universally recognized caveats about the use of beta-blockers.” CMS Ex. 9 at 7.
Petitioner treated R.J. as an outpatient, although R.J. was ultimately admitted to the hospital. Petitioner discharged R.J. from the hospital before a consultation with a specialist had been completed, resulting in readmission to the hospital two weeks later. CMS Ex. 9 at 8.
**Page 12**
The Report also evaluated Petitioner’s application for restoration of his license. An investigation noted that Petitioner and his family had limited income and received food stamps and public medical assistance. CMS Ex. 9 at 11. It also showed that despite the restoration of his medical license in New Jersey in 2013, Petitioner had not resumed practice in that state. CMS Ex. 9 at 13. Finally, the Report indicated that a majority of the Peer Committee was troubled by Petitioner’s lack of understanding of his mistakes, standing by his past mistakes, and refusing to yield. CMS Ex. 9 at 22-24.
Petitioner appealed the Peer Committee findings, but as of December 8, 2017, Petitioner’s license in New York State was still revoked. CMS Ex. 8; P. Ex. F.
***3.******Petitioner was suspended from participating in the New Jersey Medicaid program from November 20, 2006 to December 22, 2014. CMS Ex. 6.***
***4.******Petitioner was excluded from participating in the New York Medicaid program in March 2005 and, as of May 2016, was still excluded. CMS Ex. 7.***
***5.******Petitioner prescribed compounded substances for four Medicare Part D beneficiaries; however, these beneficiaries either dispute that Petitioner communicated with them before providing the prescription or indicated that he simply spoke briefly with them on the telephone before providing the prescription.***
A Medicare Part D beneficiary located in New Jersey with the initials S.B. reported to Express Scripts Medicare PDP (Express Scripts) for the State of New Jersey that there was possible fraud because “prescriptions from RX Pro of Alabama were not requested by her and that she is not familiar with the prescriber associated with these claims.” CMS Ex. 12 at 6. Express Scripts reviewed S.B.’s records and found that between June 25, 2015 and September 15, 2015, there were four compounded drug claims on S.B.’s prescription benefit and all had been prescribed by Petitioner. An inquiry by Express Scripts showed that S.B. “is not familiar with and has never seen or spoken with Dr. Sender” and has never used RX Pro of Alabama (RX Pro). CMS Ex. 12 at 6. S.B. received the compounded drugs billed in June, August, and September 2015, but not the one billed in July 2015. S.B. tried to contact RX Pro and Dr. Sender multiple times but was unsuccessful. S.B. indicated that she is a transplant recipient and would never take any medications that her own physician did not prescribe for fear of a medication interfering with the anti-rejection medication. S.B. also indicated that she had received a phone call from a man who tried to convince her that she needed the medication sent from RX Pro. CMS Ex. 12 at 7. Express Scripts attempted to obtain information about this matter from RX Pro and Dr. Sender, but met with limited success. Express Scripts confirmed through Federal Express the delivery of the compounded drugs on June 25, 2015, August 25, 2015, and September 17, 2015. CMS Ex. 12 at 13-15. Express Scripts
**Page 13**
also obtained the prescription Petitioner signed. CMS Ex. 12 at 11. The total amount billed for the compounded drugs sent to S.B. was over $24,000. CMS Ex. 12 at 9.
On April 26, 2016, Express Scripts sent a letter to a Medicare Part D beneficiary with the initials W.M. asking W.M. to review a list of prescriptions to verify whether W.M. received them. CMS Ex. 13 at 22. W.M. returned a form in which he identified Petitioner as the prescriber of creams for the pain he has. CMS Ex. 13 at 23. W.M. specified that he obtained the prescription by phone and described it as follows: “I get phone calls from people offering scar meds cream & pain cream. They [f]orce these medications. Sometimes a Doctor will call & confirm my conditions.” CMS Ex. 13 at 23. W.M. stated that he never met Dr. Sender, but that he might have spoken with him on the phone. CMS Ex. 13 at 24. Express Scripts confirmed that in late 2015 and early 2016 Dr. Sender prescribed and W.M. received several compounded drugs. CMS Ex. 16 at 33-63. The total amount billed for W.M.’s prescriptions was approximately $115,000. CMS Ex. 13 at 23.
E.W. is another Medicare Part D beneficiary who received a patient verification questionnaire from Express Scripts. E.W. completed and signed the questionnaire on April 22, 2016. CMS Ex. 13 at 32.  E.W. confirmed that from November 2015 to January 2016, E.W. received compounded drugs that Petitioner prescribed, although she indicated that she had not received treatment from Petitioner. CMS Ex. 13 at 31-32. E.W. indicated that she only had phone contact in order to obtain the medication: “This was a telephone transaction!  I was asked the question did I have any pain.  The answer was yes.  Then I was told about the compound product, and that my insurance would pay.  I stated yes!”  CMS Ex. 13 at 32.  Express Scripts confirmed that Dr. Sender prescribed and E.W. was provided with compounded drugs in 2015. CMS Ex. 16 at 1-25. The total billed amount for E.W.’s prescriptions was over $89,000. *See* CMS Ex. 13 at 23.
T.R. also returned a completed patient verification questionnaire, which he signed on April 24, 2016.  CMS Ex. 13 at 30. T.R. confirmed that he received compounded drugs from October 2015 to January 2016. CMS Ex 13 at 29. T.R. answered that he never received treatment from Petitioner, but indicated that he had spoken to Petitioner: “This Dr. Sender stated that my insurance company either advised him to call me or authorized him to call me and I listened to what he has to due to having severe symptoms of neuropathy Up receiving the last bottle of his compound I told them send me a return address envelope because I do not want anymore[.]” CMS Ex. 13 at 30. Express Scripts confirmed that Dr. Sender prescribed compounded drugs for T.R. in 2015. CMS Ex. 16 at 26-31. The total billed amount for T.R.’s prescriptions was $57,754.62. CMS Ex. 13  at 29.
Petitioner’s chart for T.R. shows that he prescribed 360 grams of a compound pain cream (to be applied two to four times a day) and 180 capsules of a compound for “General Wellness” (taken two to three times a day). CMS Ex. 15 at 1. The patient details show
**Page 14**
check marks next to the words “Cholesterol,” “Pain,” “Metabolic,” and “Scar,” and the word “Yes” next to “Diabetes.” CMS Ex. 15 at 3. The form also includes several other basic questions. CMS Ex. 15 at 4-5.
VII. Conclusions of Law and Analysis
My conclusions of law appear in bold and italics.
The Social Security Act (Act) authorizes the Secretary of Health and Human Services to establish regulations for enrolling providers and suppliers in the Medicare program.  42 U.S.C. § 1395cc(j)(1)(A). Suppliers must enroll in the Medicare program and receive a billing number in order to obtain payment for services rendered to Medicare beneficiaries. 42 C.F.R. § 424.505. For Medicare purposes, a physician is considered a supplier. 42 U.S.C. § 1395x(d).
The regulations delegate to CMS the authority to revoke the enrollment and billing privileges of suppliers. 42 C.F.R. § 424.535.  CMS or a CMS contractor may revoke a supplier’s Medicare enrollment and billing privileges for any of the reasons listed in 42 C.F.R. § 424.535(a). 42 C.F.R. §§ 405.800(b)(1), 424.535(a).  If CMS revokes a supplier’s Medicare enrollment and billing privileges, the revocation becomes effective 30 days after CMS or one of its contractors mails the revocation notice to the supplier, subject to exceptions not applicable in this case. 42 C.F.R. §§ 405.800(b)(2), 424.535(g). After CMS revokes a supplier’s enrollment and billing privileges, CMS bars the provider from reenrolling in the Medicare program for a minimum of one year, but no more than three years. 42 C.F.R. § 424.535(c).
CMS revoked Petitioner’s Medicare enrollment and billing privileges based on 42 C.F.R. § 424.535(a)(14)(i). That provision allows CMS to revoke a physician who has a pattern or practice of prescribing Medicare Part D drugs that is abusive or represents a threat to the health and safety of Medicare beneficiaries or both. In making the determination as to whether a physician should be revoked under this regulation, CMS considers eight factors: 1) whether there are diagnoses to support the indications for which the drugs were prescribed; 2) whether the necessary evaluation of the patient for whom the drugs were prescribed could not have occurred; 3) whether the physician has prescribed controlled substances in excess dosages that are linked to patient overdoses; 4) the number and type of disciplinary actions taken against the physician by state licensing boards and the reasons for the action(s); 5) whether the physician has a history of final adverse actions as that term is defined in 42 C.F.R. § 424.502; 6) the number and types of malpractice suits filed against the physician related to prescribing; 7) whether any state Medicaid program, or any other public or private health insurance program has restricted, suspended, revoked, or terminated the physician’s ability to prescribe medications; and 8) any other relevant evidence provided to CMS. 42 C.F.R. § 424.535(a)(14)(i)(A)‐(H).
**Page 15**
In its initial determination, reconsidered determination, and brief in this case, CMS does not assert that all eight of the factors above apply to this case. I conclude that the record directly implicates four of the specific factors enumerated in § 424.535(a)(14)(i) as well as the final factor, which is any other relevant evidence provided to CMS.
***1.******The record does not contain evidence that there were diagnoses to support the prescribing of compounded drugs to the beneficiaries identified by CMS. Therefore, the factor at 42 C.F.R. § 424.535(a)(14)(i)(A) provides significant support for CMS’s determination to revoke Petitioner’s Medicare enrollment for improper prescribing practices.***
The first factor listed in § 424.535(a)(14)(i) is whether there are diagnoses to support the indications for which the drugs were prescribed.
In the reconsideration request, Petitioner asserted that he evaluated the diagnoses for each beneficiary before prescribing the compounded drugs. CMS Ex. 4 at 1. In his hearing request, Petitioner stated that the beneficiaries had diagnoses of pain and/or fatigue that justified the prescriptions he wrote. Hearing Req. at 2. CMS argues that Petitioner only provided documentation for one of the beneficiaries at issue, T.R., but otherwise failed to provide any documentation concerning diagnoses for the other three beneficiaries. CMS Br. at 16. In regard to the chart for T.R., CMS asserts that this documentation does not support a diagnosis for prescribing the compounded drugs. CMS Br. at 17-18.
CMS submitted the expert testimony of Kathryn A. Rankin, M.D., M.P.H., M.B.A, in order to substantiate its position. I accept, without objection from Petitioner, that Dr. Rankin is an expert who can testify about physician evaluations of patients and diagnoses, as well as the standard of care for prescribing controlled substances to patients. Dr. Rankin not only is a licensed physician with many years of experience treating patients, but has served as medical director or deputy medical director for a large private health insurance company and CMS contractors. CMS Ex. 14 at 2-3 ¶¶ 5-11; CMS Ex. 19.
Dr. Rankin evaluated the substantive exhibits in this case relating to the prescriptions Petitioner wrote, the Express Scripts investigation, as well as Petitioner’s supplement to his reconsideration request, Petitioner’s hearing request, and Petitioner’s file related to beneficiary T.R. CMS Ex. 14 at 3-4 ¶ 12.  Based on this review, Dr. Rankin testified that “there was no proper evaluation or diagnosis for any of the four beneficiaries upon whose prescriptions CMS bases its revocation.” CMS Ex. 14 at 4 ¶ 13. Given that Petitioner did not provide any documentation for three of the beneficiaries at issue in this case, Dr. Rankin noted that Petitioner did not meet “any possible documentation or diagnosis standard” for prescribing medications. CMS Ex. 14 at 4 ¶ 17.
**Page 16**
With regard to beneficiary T.R., Dr. Rankin stated that a prescription for a metabolic vitamin supplement would generally be for fatigue. As she testified, no diagnoses related to fatigue were documented. CMS Ex. 14 at 6 ¶ 21. As she further stated in regard to T.R.: “[T]here was no documentation of medical decision-making because the record did not have a diagnosis. As explained above, there was no documented examination of the area of pain to determine a cause. So, [T.R.’s] medical record describes a symptom but not a diagnosis.” CMS Ex. 14 at 5 ¶ 17. A review of T.R.’s medical record bears out Dr. Rankin’s observation. CMS Ex. 15. I accord Dr. Rankin’s opinions significant weight, due to her training, knowledge, and experience, and because her assessment is clearly explained and supported by the record. Therefore, I conclude that CMS properly considered this factor when deciding to revoke Petitioner.
***2.******The record does not contain evidence that Petitioner conducted a medical evaluation of each of the beneficiaries before prescribing compounded drugs to the beneficiaries identified by CMS.  Therefore, the factor at 42 C.F.R. § 424.535(a)(14)(i)(B) provides significant support for CMS’s determination to revoke Petitioner’s Medicare enrollment for improper prescribing practices.***
The second factor listed in § 424.535(a)(14)(i) is whether there are instances when the necessary evaluation of the patient for whom the drug was prescribed could not have occurred. Although this factor appears aimed at instances where an evaluation could not have taken place, I consider this factor also to implicate situations where there is no evidence that an evaluation took place.
Petitioner has asserted in this matter that “I did treat [the four beneficiaries], after evaluating them by phone as to their symptoms and diagnoses and performed a mental status examination, which is the appropriate and indicated evaluation for the purposes of prescribing the metabolic vitamins supplements and pain creams they requested and which I prescribed.”  CMS Ex. 4 at 1; *see also* Hearing Req. at 2. Petitioner states in his brief that he was working for Locum Tenens USA, Inc, a national telemedicine corporation at the time he prescribed for the four beneficiaries in this case. P. Br. at 3. Further, Petitioner admits that when he engaged in telemedicine, it was not legal to do so in New Jersey, which was the only state where Petitioner was licensed to practice medicine. P. Br. at 1. However, Petitioner argues that his prescriptions were medically appropriate based on each of the beneficiaries’ medical conditions, which he determined after having performed an individual evaluation by telephone. P. Br. at 4.
CMS argues that Petitioner’s evaluations were cursory and could not fulfill the regulatory requirement of a “necessary evaluation” given that Petitioner had no prior or post-prescription relationship with the beneficiaries. CMS Br. at 13. CMS also argues that the term “necessary evaluation” is not defined in the regulations, but it would be appropriate to apply the standard in New Jersey given that Petitioner was licensed in New Jersey and all of the beneficiaries resided in New Jersey. CMS Br. at 14; CMS Exs. 12-13, 16. As
**Page 17**
Petitioner has conceded, CMS points out that New Jersey law applicable during the relevant time period did not permit telemedicine, but rather required a properly documented physical examination of the patient with diagnoses, a therapeutic plan, and appropriate follow-up care when prescribing drugs. CMS Br. at 14, quoting New Jersey Annotated Code § 13:35-7.1A(a). CMS relies on Dr. Rankin’s opinion to show that Petitioner failed to meet the evaluation criteria under New Jersey law to prescribe drugs.
When the prescriptions at issue were written in 2015 and 2016, the governing regulations in New Jersey required prescribers to, among other things, conduct and document an appropriate history and physical examination in the medical record prior to issuing a prescription. [footnote omitted]   There was no documentation in the medical record for [T.R.] of a medical history, appropriate physical examination or medical decision making.  For instance, the “triage” section of the medical record noted pain in the lower right leg and left buttock; however, there was no documented examination of the area of pain to determine a cause and justify the prescription pain cream.  The other three beneficiaries certainly did not meet the New Jersey standard because there was no documented medical history or physical examination for those beneficiaries.  Therefore, New Jersey prescribing regulations were not met.
CMS Ex. 14 at 4 ¶ 15. Dr. Rankin also testified that under the American Medical Association’s Current Procedural Terminology 2015 (CPT), which has been adopted as CMS’s coding standard under 42 C.F.R. § 162.1002, Petitioner failed to conduct a necessary evaluation.
The CPT requires three key components for new patient encounters:  history, examination, and medical decision-making. The three beneficiaries without any medical record documentation other than the prescriptions, [E.W.], [S.B.] and [W.M.], certainly do not meet this standard, or any possible documentation or diagnosis standard for that matter.  According to the CPT, the history must include the chief complaint and a brief history of the problem.  In the medical record for [T.R.], there was no documentation of a chief complaint or history of the problem.  Medical decision-making refers to the complexity of establishing a diagnosis and/or selecting a management option.  Even for [T.R.], there was no documentation of medical decision-making because the record did not have a diagnosis.  As explained above,
**Page 18**
there was no documented examination of the area of pain to determine a cause.  So, [T.R.]’s medical record describes a symptom but not a diagnosis.  Although a brief mental status exam was documented, there was no exam documented to support the prescription for pain cream.
CMS Ex. 14 at 5 ¶ 17. Dr. Rankin also considered Petitioner to have failed to conduct evaluations under “usual medical standards for prescribing,” resulting in a conclusion that “there was no proper evaluation . . . for any of the four beneficiaries upon whose prescriptions CMS bases its revocation.” CMS Ex. 14 at 4, 6 ¶¶ 14, 19-20.
I again accord Dr. Rankin’s uncontested opinion significant weight due to its thoroughness and consistency with the record. Petitioner admits to having engaged in telemedicine outside the scope of his license and only conducted cursory telephonic evaluations. Petitioner has not supplied documentation to support that he conducted a “necessary evaluation” for each of the four beneficiaries. Therefore, I conclude that CMS properly considered this factor when deciding to revoke Petitioner.
***3.******Petitioner was suspended for five years from the practice of medicine in New Jersey and Petitioner’s medical license was revoked in New York, and the basis for the discipline involved improper prescribing of medications as well as other malfeasance. Therefore, the factor at 42 C.F.R. § 424.535(a)(14)(i)(D) provides significant support for CMS’s determination to revoke Petitioner’s Medicare enrollment for improper prescribing practices.***
As discussed above, the NJ Board suspended Petitioner’s medical license for five years and subjected Petitioner to another three years of practice while under a monitor. The NJ Board took this action based on Petitioner’s misconduct as it related to seven patients. Petitioner consented to his suspension in New Jersey; therefore, the records from that matter do not provide much information related to Petitioner’s conduct.
Petitioner, however, had a license revocation hearing before the NY Board, resulting in a hearing committee decision, and a Peer Review Committee’s Report regarding his license restoration request. These documents provide a detailed review of Petitioner’s conduct that resulted in the lengthy suspension in New Jersey and revocation of Petitioner’s New York license. Although all of Petitioner’s missteps regarding the seven patients discussed by the NY Board’s documents illuminate Petitioner’s weaknesses as a physician, for purposes of this proceeding, it is most significant that Petitioner was disciplined for matters involving the prescribing of drugs. In regard to Patient N.T., Petitioner “repeatedly prescribed controlled substances without adequately determining the need for the prescriptions” even after Petitioner “should have recognized that N.T. was an addict.” CMS Ex. 3 at 6. Further, for Patient A.F., Petitioner “chose an outdated antibiotic” and, when confronted with this fact, “responded that he would continue to use
**Page 19**
it.” CMS Ex. 3 at 6. For patient B.S., Petitioner prescribed an ineffective antibiotic and failed to involve a specialist for days. After a consult with an infectious disease specialist, the antibiotic was changed, leading to B.S.’s improvement and discharge from the hospital. CMS Ex. 9 at 5. For Patient V.D., Petitioner “inappropriately prescribed beta-blockers over an extended period of time for a patient who had a history of asthmas with bronchospasm, just to treat that patient’s anxiety and hypertension. [Petitioner’s] action(s) was a gross deviation from the standard of care . . . .” CMS Ex. 9 at 7.
These instances resulted in the NY Board concluding that Petitioner’s medical license had to be revoked to protect the people of New York State. CMS Ex. 3 at 9. The NY Board still has not restored Petitioner’s medical license, even after an in-depth consideration of Petitioner’s competence to practice medicine. CMS Ex. 9. Therefore, I conclude that CMS properly considered this factor when deciding to revoke Petitioner.
***4.******Petitioner was subject to four “final adverse actions” as that term is defined in 42 C.F.R. § 424.502.  Therefore, the factor at 42 C.F.R. § 424.535(a)(14)(i)(E) provides support for CMS’s determination to revoke Petitioner’s Medicare enrollment for improper prescribing practices.***
The term “final adverse action” is defined in the regulations to include a suspension or revocation of a license to provide health care by a state licensing authority or an exclusion or debarment from participation in a federal or state health care program. 42 C.F.R. § 424.502. The respective suspension and revocation of Petitioner’s New Jersey and New York medical licenses have already been considered under the previous factor. For purposes of this factor, CMS properly considered that Petitioner was suspended for eight years from the New Jersey Medicaid program and has been excluded from participating in the New York Medicaid program since 2005. CMS Ex. 7.
***5.******Other relevant information provided to CMS supports revocation of Petitioner’s Medicare enrollment for improper prescribing practices under the factor at 42 C.F.R. § 424.535(a)(14)(i)(H).***
This matter began due to an investigation conducted by Express Scripts based on a report from beneficiary S.B.  S.B. reported that unsolicited prescription drugs she received pursuant to one of Petitioner’s prescriptions might involve Medicare fraud. Express Scripts conducted a detailed investigation and summarized its findings and conclusions as follows:
After reviewing the prescribing profile of [Petitioner], Express Scripts found a high number of compounds attributed to his NPI number. Express Scripts found that Dr. Sender prescribed 2,340 non-controlled and controlled substance
**Page 20**
medications across the Express Scripts’ network between May 2013 and May 2016. Of the 2,340 claims, 1,743 are compounds . . . .
Between June 2015 and May 2016, *State of New Jersey EGWP* had 122 members that have received prescriptions from Dr. Paul Sender. Express Scripts identified that this physician prescribed 573 non-controlled and controlled substance medications to these members. Of the 573 claims Dr. Sender prescribed 112 *State of New Jersey EGWP* members a total of 552 compounds during the review period. This means 96% of the *State of New Jersey EGWP* combined claims prescribed by Dr. Sender were for compounds. The potential exposure amount for 552 compounds totaled to $5,737,136.45.
CMS Ex. 13 at 4.
Expert witness Dr. Rankin provided an explanation of how unusual this prescribing pattern is for a physician. Dr. Rankin based her opinion on Medicare Part D records associated with Dr. Sender from August 1, 2013 to May 3, 2016, but her concerns regarding Dr. Sender’s prescribing practices involving compound drugs are applicable, even though she was considering a smaller universe of prescriptions.
Per the U.S. Food & Drug Administration (“FDA”), compounding is generally a practice in which a medication is tailored to the needs of an individual patient.  The FDA advises that compounds are sometimes needed when the health needs of a patient cannot be met by an FDA-approved medication.  For example: if a patient has an allergy and needs a medication to be made without a certain dye; or if an elderly patient cannot swallow a pill and needs a medicine in a liquid form that is not otherwise available. [footnote omitted]  It is not consistent with usual practice patterns of care that a prescriber would be associated with such a large portion of their PDE records as compounded medications.  In the appeal submitted by Dr. Sender, he advised the metabolic supplements that were prescribed to beneficiaries “could have been obtained over the counter.”  This statement indicates that Dr. Sender was not individualizing these compounded treatments for unique beneficiary needs.
****
**Page 21**
The compounded prescriptions submitted by Dr. Sender are template prescriptions which are not tailored to the needs of individual patients.  They consist mainly of three types of compounds across multiple pharmacies:  vitamin capsules, topical pain creams, and topical scar treatments.  The prescriptions are templates with the same directions, quantities, and drug ingredients/strengths for each patient.  This type of prescribing is inconsistent with legitimate prescribing of compounded medications and to treating individual patient diagnoses.
CMS Ex. 14 at 7-8 ¶¶ 23, 25.
While consideration of this additional information that had been provided to CMS supports the revocation, I do not consider the information stated under this factor as necessary to uphold the revocation. I include discussion of it because it clarifies the legitimate concerns that CMS has with regard to Petitioner’s prescribing practices.
***6.******The three remaining factors in the regulations at 42 C.F.R. § 424.535(a)(14)(i)(C), (F), and (G) are not implicated by the record.***
CMS does not suggest nor does the record show that Petitioner has prescribed controlled substances in excess dosages that are linked to patient overdoses or had medical malpractice lawsuits filed against him related to prescribing drugs. 42 C.F.R. § 424.535(a)(14)(i)(C), (F).
Further, while the reconsidered determination indicated that the factor at 42 C.F.R. § 424.535(a)(14)(i)(G) was implicated because Petitioner was suspended from the New Jersey Medicaid Program and revoked from the New York Medicaid program, the reconsidered determination is incorrect. Although Petitioner was prohibited from participating in those Medicaid programs generally, Petitioner’s “ability to prescribe medications” was not “restricted, suspended, revoked, or terminated.” As discussed above, the factor at 42 C.F.R. § 424.535(a)(14)(i)(E) specifically covers adverse actions, which include suspensions or revocations from a state Medicaid program.
***7.******There is a legitimate basis to revoke Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(14)(i).***
In consideration of the factors above, CMS was justified in determining that Petitioner has a pattern or practice of prescribing Medicare Part D drugs that is abusive and/or a threat to the health and safety of Medicare beneficiaries. It is clear that Petitioner had a history of dubious prescription practices as evidenced by the conduct that formed the
**Page 22**
basis for suspension of his New Jersey license and revocation of his New York license. Importantly, more than a decade after that conduct, the New York licensing authorities still viewed Petitioner as unfit to practice medicine again. While the NJ Board was more optimistic and reinstated Petitioner’s unrestricted medical license, the facts in this case show that the NY Board was correct.
In the present matter, Express Scripts obtained information showing that Petitioner was engaged in prescribing expensive compounded drugs with little or no medical evaluation on template prescriptions not individually tailored to the beneficiaries. Further, the beneficiaries involved in this case indicated that they were contacted concerning the drugs, rather than the beneficiaries first receiving a prescription from a physician with the beneficiary then seeking to fill the prescription. As Dr. Rankin testified, “[t]his type of prescribing is inconsistent with legitimate prescribing of compound medications and to treating individual patient diagnoses.” CMS Ex. 14 at 8 ¶ 25. Therefore, Petitioner’s prescribing was abusive.
Petitioner’s prescribing also represents a threat to beneficiary health and safety. Dr. Rankin testified to this point in detail:
Before prescribing a medication, the usual medical practice for a physician is to obtain and document a full medication history.  This would include a full medication regimen, not just current medications being taken, including over-the-counter and vitamin products for each patient.  When prescribing pain medication it is necessary to determine what a patient may have used with benefit or adverse effects in the past.  The medication history of a patient is relevant to whether a specific form of a drug or a type of drug is appropriate for a given patient, including preventing any adverse reactions.
[T.R.] was prescribed a metabolic vitamin supplement.  Such a prescription would generally be for fatigue.  “Metabolic” is checked as a condition.  But no medical evaluation, questions, or diagnoses related to fatigue were documented.  There are many causes of fatigue and a vitamin supplement prescribed without an appropriate medical assessment could result in patient harm if a treatable condition was not properly diagnosed and treated in a timely fashion.  Further, the patient was prescribed a topical pain cream for pain in the lower right leg and left buttock.  The patient stated he had open sores and was diabetic, but was seemingly not asked about previous pain medications, or the location or severity of the open sores.
**Page 23**
In addition, there is no documentation of an assessment of the type of pain the patient was having to ascertain what treatments might be helpful.  A topical pain cream could potentially be harmful in a diabetic with open sores if applied to those areas.  No discussion or individualization of prescribing was noted in regards to these issues.
CMS Ex. 14 at 6 ¶¶ 20-21. Further, CMS argues that beneficiary S.B. received unsolicited drugs prescribed by Petitioner and she refused to use them because she had received a transplant and was concerned that the drugs could interfere with her anti-rejection medication. CMS Ex. 12 at 6-7. S.B. was astute, but was certainly placed at risk by Petitioner’s prescribing practices.
The situations with both S.B. and T.R. make it clear that Petitioner does not practice medicine safely.
VIII. Conclusion
I affirm CMS’s revocation of Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(14)(i).


          /s/
        Scott Anderson

                      Administrative Law Judge
      1. The beneficiary identified with the initials W.M. is shown as having a first initial of “J” in Enclosure A to the initial determination.  However, with the exception of the initial and reconsidered determinations, this beneficiary has the first initial of “W” in the rest of the record.  Therefore, I will refer to this beneficiary throughout this decision as W.M. back to note 1 Back to top
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