Christopher Chen, M.D., DAB CR5599 (2020)

DECISION

I affirm the Centers for Medicare & Medicaid Services’ (CMS’s) revocation of the Medicare enrollment and billing privileges of Christopher Chen, M.D. (Dr. Chen or Petitioner) under 42 C.F.R. § 424.535(a)(14)(ii) because he engaged in a pattern or practice of prescribing drugs under Medicare Part D in a manner that failed to meet Medicare requirements.  42 C.F.R. § 424.535(a)(14)(ii)(C).  Petitioner prescribed drugs, including Subsys, a sublingual spray formulation of fentanyl (a highly regulated synthetic opioid pain reliever), to patients without a medically accepted indication (MAI), as that term is used in Social Security Act (Act) §§ 1860D-2(e)(4) and 1927(g)(1)(B)(i), (k)(6) (i.e., a use approved by the Food and Drug Administration (FDA) or supported by a statutorily accepted drug compendium), and did so in reckless disregard for the health and safety of his patients.  42 U.S.C. §§ 1395w-102(e)(4)), 1396r-8(g)(1)(B)(i), (k)(6).

I.  Background and Procedural History

Dr. Chen, a physician, was enrolled in the Medicare program as a supplier.  CVS Caremark identified Dr. Chen to CMS “as inappropriately obtaining prior authorizations for Subsys, as well as failing to provide appropriate diagnoses to support the use of Subsys.”  CMS Ex. 15 at 1.  As a result, a CMS Medicare Drug Integrity Contractor

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(MEDIC) reviewed Dr. Chen’s prescribing practices in relation to Subsys and Medicare Part D.  CMS Ex. 15 at 1; CMS Ex. 22; see also CMS Ex. 54 ¶ 6; CMS Exhibit List, n.1 (explaining that CMS Ex. 22 is a PDF reduction of an Excel spreadsheet of Dr. Chen’s Medicare data, and that the original Excel spreadsheet was identified as Exhibit 22 in the November 9, 2018 Reconsidered Determination); CMS Ex. 31 at 5 (Reconsidered Determination identifying Exhibit 22 as “PDE [Prescription Drug Event] Records for Christopher Chen, M.D. from January 2, 2012 through January 31, 2018 with a report run date of February 6, 2018.”).  A MEDIC pharmacist concluded that “the combination of multiple factors creates an overall impression of off-label use of Subsys . . . by this prescriber, which would not be covered under Medicare Part D.  In addition, patterns of long term authorization of short acting opioids without long acting opioids were found, which is indicative of poor practice habits and/or [fraud, waste, and abuse].”  CMS Ex. 15 at 10.  MEDIC’s Medical Director determined, based on review of the records, that they indicated “patterns that were found to demonstrate improper prescribing practices” by Dr. Chen.  CMS Ex. 30 at 1.

In a June 11, 2018 initial determination, a CMS contractor revoked Dr. Chen’s Medicare enrollment and billing privileges, effective July 11, 2018, based on improper prescribing practices under 42 C.F.R. § 424.535(a)(14)(i) and/or (ii).  CMS Ex. 1.  The CMS contractor also barred Dr. Chen from re-enrollment in the Medicare program for three years.  The CMS contractor concluded that Dr. Chen had engaged in improper prescription practices when he prescribed Subsys to nine Medicare beneficiaries without the proper diagnosis of breakthrough pain resulting from cancer.  The CMS contractor also found that one of the beneficiaries under Dr. Chen’s care died of an overdose from acute fentanyl intoxication.  Further, the CMS contractor found that for seven beneficiaries, Dr. Chen prescribed Subsys at a dosage strength in excess of the permissible initial dose.  CMS Ex. 1 at 2.

In an August 6, 2018 reconsideration request of the revocation, Petitioner argued that he had acted within the standard of medical care when he prescribed Subsys, but had not prescribed Subsys since 2015.  CMS Ex. 2.  Dr. Chen claimed that each beneficiary had been on increasing doses of narcotics, but their pain had been insufficiently controlled, resulting in the loss of ability to engage in activities of daily living (ADL).  Dr. Chen asserted that off-label use of an approved drug is not illegal.  CMS Ex. 2 at 1-3.  Petitioner submitted 12 exhibits with his reconsideration request.  CMS Exs. 3-14.

In the reconsidered determination, a CMS hearing officer upheld the revocation under 42 C.F.R. § 424.535(a)(14)(i) and (ii).  CMS Ex. 31.  The hearing officer found that three of the eight factors in § 424.535(a)(14)(i) supported revocation as follows:  there was no cancer diagnosis for any of the nine beneficiaries identified in the initial determination (§ 424.535(a)(14)(i)(A)); one of the beneficiaries died from fentanyl intoxication (§ 424.535(a)(14)(i)(C)); and Petitioner often did not start the beneficiaries at the lowest Subsys dose, increased dose amounts rapidly, maintained high dose amounts, and failed

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to achieve sustained improvement in pain scores (§ 424.535(a)(14)(i)(H)).  CMS Ex. 31 at 9-12.  As to § 424.535(a)(14)(ii), the hearing officer found that Petitioner engaged in a pattern or practice of prescribing drugs when there was no MAI (i.e., Petitioner prescribed the drugs for uses that were neither approved by the FDA nor supported by Medicare-approved drug compendia under section 1860D-2(e)(4) of the Act) and that Petitioner acted in reckless disregard for the health and safety of the patients.  42 C.F.R. § 424.535(a)(14)(ii)(C).  CMS Ex. 31 at 12-14.

On December 3, 2018, Petitioner electronically filed a request for hearing before an administrative law judge (ALJ) that was dated November 27, 2018.  The hearing request did not indicate the findings or conclusions in the reconsidered determination with which Petitioner disagreed or the basis for such disagreement.

On December 6, 2018, I issued an Acknowledgment and Prehearing Order (Order) establishing a prehearing submission schedule.  CMS promptly moved for a more definite statement from Petitioner due to the brevity of Petitioner’s hearing request.  On December 19, 2018, I ordered Petitioner to file an amended hearing request that complied with the requirements of 42 C.F.R. § 498.40.

On January 25, 2019, Petitioner filed a Statement of Issues and, on January 30, 2019, Petitioner filed an amended hearing request.  After two extensions of the pre-hearing exchange deadlines, on May 8, 2019, CMS filed its prehearing brief (CMS Br.) along with 59 proposed exhibits (CMS Exs. 1-59).  Included with these proposed exhibits were two declarations made under penalty of perjury from Jonathan K. Haag, Pharm. D., J.D. (CMS Ex. 54) and Kay Rankin, M.D., M.B.A., C.F.E. (CMS Ex. 56).  Petitioner, after receiving two extensions, on September 2, 2019, filed his brief (P. Br.) and two exhibits (P. Exs. 1-2).  The first exhibit was a report from Rick Chavez, M.D., and the second a curriculum vitae from Petitioner.  Petitioner’s witness list included Dr. Chavez and Petitioner.

II.  Evidentiary Rulings

Petitioner did not object to CMS’s proposed exhibits; therefore, I admit CMS Exs. 1-59 into the record.  Order ¶ 7; Civil Remedies Division Procedures (CRDP) § 14(e).

CMS objected to P. Ex. 1 on the grounds that, if it is a report, then Petitioner did not provide good cause for failing to submit it at the reconsideration level of appeal.  In the alternative, CMS argued, if it is written testimony, Dr. Chavez did not sign it under penalty of perjury.

In response, Petitioner submitted Amended P. Ex. 1.  Petitioner said that CMS correctly pointed out that “[i]n Dr. Chavez’s report P Ex. 1, Dr. Chavez forgot to add . . . that his report was written in a declaration or under penalty of perjury. . . . [W]e are asking leave

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of the court to amend Dr. Chavez’s report to include this language.  The substantive nature of the report is unchanged, it just includes a declaration that the report is written under penalty of perjury.”  November 3, 2019 Request to Amend Petitioner’s Prehearing Exchange Brief.  CMS objected to Amended P. Ex. 1 because it was untimely and Petitioner made numerous revisions and additions to P. Ex. 1.  CMS also submitted a document, confusingly marked as CMS Ex. 1, which clearly highlighted new text added in Amended P. Ex. 1.  Petitioner did not respond to CMS’s objection.

Petitioner appears to have withdrawn P. Ex. 1 due to CMS’s objection that it had not been signed.  However, if this is not the case, I exclude P. Ex. 1 from the record because it is a report and Petitioner never affirmatively stated good cause for the submission of that new evidence, even though advised to do so.  Order ¶ 6; see CMS Ex. 1 at 3; 42 C.F.R. §§ 405.803(e), 498.56(e).  If P. Ex. 1 was intended to be a declaration, as Petitioner later asserted, then the lack of a signature made it defective and inadmissible.1

I exclude Amended P. Ex. 1 from the record.  Petitioner filed Amended P. Ex. 1 as a written declaration, i.e., written direct testimony.  However, as CMS pointed out, Petitioner misleadingly indicated that the only substantive change made to P. Ex. 1 in Amended P. Ex. 1 was for Dr. Chavez to declare P. Ex. 1 was written under penalty of perjury.  A comparison of P. Ex. 1 and Amended P. Ex. 1 reveals that Dr. Chavez added approximately three pages of text.  Compare P. Ex. 1 at 6 with Amended P. Ex. 1 at 7; compare P. Ex. 1 at 7 with Amended P. Ex. 1 at 8-9; compare P. Ex. 1 at 15 with Amended P. Ex. 1 at 18; compare P. Ex. 1 at 17 with Amended P. Ex. 1 at 20-21; compare P. Ex. 1 at 18 with Amended P. Ex. 1 at 22, 23;  compare P. Ex. 1 at 36-37 with Amended P. Ex. 1 at 39; compare P. Ex. 1 at 37 with Amended P. Ex. 1 at 40.

I deny Petitioner’s request to file Amended P. Ex. 1 out of time.  Order ¶ 12; CRDP § 16(c) (“The ALJ . . .  might reject written direct testimony if the offering party has not timely served and submitted . . . relevant testimony.”).  If Petitioner wanted to amend P. Ex. 1 to include additional testimony, Petitioner needed to disclose that and request leave to do so.  Instead, Petitioner indicated the opposite, which provides another basis to exclude Amended P. Ex. 1.  CRDP § 23 (“The ALJ may sanction a . . . party . . . for . . . misconduct that interferes with the speedy, orderly or fair conduct of the hearing.”)

I exclude P. Ex. 2 as duplicative to CMS Ex. 3.  CRDP § 14(a); see 5 U.S.C. § 556(d).

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III.  Decision on the Record

CMS moved for a decision based on the written record and Petitioner did not respond to the motion.  The Order stated that an in-person hearing would only be necessary if a party submitted the written direct testimony for a witness and the opposing party requested to cross-examine the witness.  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 two expert witnesses (CMS Exs. 54, 56); however, Petitioner did not request to cross-examine them.  Although Petitioner submitted written direct testimony for an expert witness, I excluded that testimony.  Further, Petitioner did not submit written direct testimony for himself.  Therefore, I do not need to hold an oral hearing and I decide this case based on the written record.   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)(ii).2

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 Fact3

1. Subsys is a fentanyl sublingual spray that is indicated for the management of breakthrough pain due to cancer in adults who are already tolerant to opioid therapy.  With one exception, prescribers are to limit the initial prescription to 100 mcg and allow the patient to use all dosage units before increasing the strength to 200 mcg, with further increases in dosage to 400 mcg, then to 600 mcg, 800 mcg, 1,200 mcg, and 1,600 mcg.  Use of Subsys with benzodiazepines may result in profound sedation, respiratory depression, coma, and death.

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Subsys is a fentanyl sublingual spray.  CMS Ex. 34 at 1.  Fentanyl is a powerful synthetic opioid analgesic that is similar to morphine but 50 to 100 times more potent.  CMS Ex. 13 at 3; CMS Ex. 50 at 5; CMS Ex. 54 ¶ 7.  Subsys is a Schedule II controlled substance that “exposes users to the risks of addiction, abuse, and misuse.”  CMS Ex. 34 at 12.  Therefore, prescribers must monitor for signs of abuse and addiction.  CMS Ex. 34 at 23.

According to the manufacturer’s “FULL PRESCRIBING INFORMATION” document, “SUBSYS is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.”  CMS Ex. 34 at 4.  Indeed, the Subsys clinical trials “were designed to evaluate safety and efficacy in treating breakthrough cancer pain” (CMS Ex. 34 at 16), and the FDA approved it for that use.  CMS Ex. 13 at 6.  With the exception of patients already taking Actiq, prescribers are to initiate Subsys “for all patients . . . using ONE 100 mcg spray sublingually.”  CMS Ex. 34 at 5 (emphasis omitted); see CMS Ex. 15 at 2.  Further, prescribers are to limit the initial titration supply to 100 mcg Subsys units and prescribers should “[a]void prescribing a higher dose until patients have used up all units to prevent confusion and possible overdose.”  CMS Ex. 34 at 6.  Further, “[f]rom the 100 mcg initial dose, [prescribers should] closely follow patients and change dosage level until the patient reaches a dose that provides adequate analgesia using a single SUBSYS dose per breakthrough cancer pain episode with tolerable side effects.”  CMS Ex. 34 at 6.  Dosage adjustments should be made after the patient records his or her Subsys use “over several episodes of breakthrough cancer pain.”  CMS Ex. 34 at 6-7.  Titration steps to follow in order are 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,200 mcg, and 1,600 mcg.  CMS Ex. 34 at 7; see CMS Ex. 15 at 3.

Even when used as recommended, Subsys can result in life-threatening respiratory depression.  “While serious, life-threatening, or fatal respiratory depression can occur at any time during use of SUBSYS, the risk is greatest during the initiation of therapy or following a dosage increase.  Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with and following dosage increases of SUBSYS.”  CMS Ex. 34 at 10.  Correct and careful dosing is essential because overestimating a Subsys dosage can be fatal with the first dose.  CMS Ex. 34 at 10.  Further, “[c]oncomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.”  CMS Ex. 34 at 3; CMS Ex. 35 at 36.  Because of this risk for misuse, abuse, addiction, and overdose, the FDA only allows distribution of Subsys through a restricted program.  CMS Ex. 15 at 3.

2. Calculating the morphine milligram equivalent (MME) is a method of quantifying the cumulative intake of all opioid classified drugs during a 24-hour period and is used to help reduce the chance of overdosing.  The Centers for

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Disease Control and Prevention (CDC) has found that prescribing drugs at 90 or more MME per day should be avoided or carefully justified due to the risk of death from overdosing.

A primary side effect of opioid overdose is respiratory depression, which frequently leads to serious medical complications and death.  CMS Ex. 41 at 2.  MME is a value assigned to opioids to represent their relative potencies, and the daily MME is “the sum of the MME of all opioids a patient is likely to take within 24 hours, and that total is used to determine if the patient is nearing a potentially dangerous threshold.”  CMS Ex. 41 at 3; see CMS Ex. 39.

The CDC has determined that a low MME of 20 to 50 per day increases the risk for overdose, and that statistics obtained from the Veterans Health Administration indicated that patients who died from overdosing were prescribed an average dosage of 98 MME/day.  CMS Ex. 35 at 16; CMS Ex. 39 at 1.  As a result, the CDC stated that practitioners should:  use caution when prescribing any opioids; prescribe the lowest effective dose of opioids; use extra precaution when increasing to 50 or more MME per day; and avoid or carefully justify dosages of 90 or more MME per day.  CMS Ex. 35 at 25-26; CMS Ex. 39 at 2.  CMS uses an MME of 120 per day as a threshold to evaluate potential misuse of opioid controlled substances.  CMS Ex. 30 at 1; CMS Ex. 41 at 3.

3. Dr. Chen is a physician who has been licensed in the state of California since 1988 and has a specialization in pain management.  CMS Ex. 3.

4. Dr. Chen was enrolled in the FDA’s Transmucosal Immediate Release Fentanyl Risk Evaluation and Mitigation Strategy (TIRF REMS) Access Program from at least 2011 through 2017.  The rules of that program restricted Dr. Chen to prescribing Subsys at the lowest available dose and solely for management of “breakthrough” pain in adult cancer patients.

The TIRF REMS Access Program is an FDA “restricted distribution program” that seeks “to ensure appropriate use of TIRF medicines” due to “the risk of misuse, abuse, addiction, overdose, and serious complications due to medication errors.”  CMS Ex. 52 at 1; see also CMS Ex. 16.  TIRFs “are highly potent opioids, carrying significant risks of overdose and addiction.”  CMS Ex. 14 at 2.  Subsys, known generically as Oral Transmucosal Fentanyl sublingual spray, is covered by the TIRF REMS Access Program.  CMS Ex. 24 at 9; CMS Ex. 34 at 4, 13; CMS Ex. 53; see also CMS Ex. 16; CMS Ex. 25 at 3.  Insys Therapeutics, Inc. manufactures Subsys.  CMS Ex. 53 at 1.  Prescribers of TIRF REMS-covered drugs must enroll in the TIRF REMS Access program, which includes completion of an “Education Program.”  CMS Ex. 52 at 1, 3.

The TIRF REMS Access Program stated that “TIRF medicines are indicated only for the management of breakthrough pain in adult cancer patients 18 years of age and older . . .

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who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.”  CMS Ex. 24 at 2, 6; see CMS Ex. 14 at 3; CMS Ex. 16.  Further, “[p]atients beginning treatment with TIRF medicines must begin with titration from the lowest available dose for that specific medicine.”  CMS Ex. 24 at 3, 6.

Dr. Chen was enrolled in the TIRF REMS Access Program by, at the latest, 2011, and was enrolled until at least 2017.  See CMS Ex. 24 at 5, 14, 31.  From 2013 through 2015, Dr. Chen received over $55,000 from Insys Therapeutics, Inc., the manufacturer of Subsys.  CMS Ex. 36 at 2, 6, 12.

5. Dr. Chen prescribed Subsys for M.P. from March 2013 until April 2014, even though M.P. did not have a cancer diagnosis, twice tested positive for cocaine, lied about using crack cocaine and later admitted to using crack cocaine, and obtained a fentanyl prescription from another physician while also receiving fentanyl prescriptions from Dr. Chen.  Further, under Dr. Chen’s care, M.P. was prescribed medications in excess of the maximum MME of 90 per day that the CDC has identified as being at an elevated risk level for an overdose.  Dr. Chen only stopped prescribing Subsys after local police and Drug Enforcement Administration (DEA) personnel informed M.P. that they would confiscate Subsys when he received it because M.P. did not have a diagnosis of cancer.  Dr. Chen’s actions threatened M.P.’s health and safety.4

M.P. has been a Medicare Part A and Part B beneficiary since 2011 and 2012, respectively.  CMS Ex. 28 at 428.  On January 9, 2013, Dr. Chen began to treat M.P.  CMS Ex. 28 at 432.  M.P. entered into a Pain Management Agreement with Dr. Chen in which M.P. agreed, among other things, not to use any illegally-obtained controlled substance “including marijuana, cocaine, etc.,” to “not attempt to obtain any controlled medicines . . . from any other doctor,” and to “submit to a blood or urine test [that] is requested by my doctor.”  CMS Ex. 28 at 432, 506.  From his examination of M.P., Dr. Chen recorded M.P.’s chief complaint to be lower back pain, and Dr. Chen assessed M.P. as having lumbar disk disease.  CMS Ex. 28 at 505.  In M.P.’s care plan, Dr. Chen stated:  “Consider subsys 100 m[c]g spray qid #60, need prior auth.”  CMS Ex. 28 at 506.  The drug screening report of the sample taken on January 9, 2013, showed positive results for cocaine and benzodiazepines.  CMS Ex. 28 at 413.  By the January 23, 2013 examination, Dr. Chen noted he checked the Controlled Substance Utilization Review and Evaluation System (CURES) regarding M.P.  CMS Ex. 28 at 504.

By March 6, 2013, Dr. Chen added Lumbar Radiculopathy as part of his assessment for M.P., and Dr. Chen decided to “[s]tart Subsys 100 mcg spray sl tid prn breakthrough pain #90, patient is opioid tolerant, was registered in REMS, and risks, benefits, and potential

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side effects discussed, patient understands and accepts these risks.”  CMS Ex. 28 at 499; see CMS Ex. 22 at 1.  Dr. Chen also noted that a “Tox screen swab” of M.P. was positive for “cocaine and Benzos.”  Dr. Chen wrote that M.P. denied use of either substance, only admitting that he had been “in a car with people who were smoking crack.”  M.P. admitted “to taking benzos” from a previous prescription he had for anxiety.  CMS Ex. 28 at 499.  Despite this, Dr. Chen stated that “there is no evidence of diversion or abuse.”  CMS Ex. 28 at 498.

On April 12, 2013, Dr. Chen increased the strength of the Subsys to 200 mcg, and again to 400 mcg on May 21, 2013.  CMS Ex. 22 at 2; CMS Ex. 28 at 496, 490.  On June 12, 2013, Dr. Chen recorded that M.P. now admitted that he used “coke on New Years.”  CMS Ex. 28 at 488.  Dr. Chen also learned that an April drug screening showed M.P. was positive for “amp and coke.”  CMS Ex. 28 at 488.  Dr. Chen’s notes and Medicare records show an increased dose of Subsys to 600 mcg.  CMS Ex. 22 at 2; CMS Ex. 28 at 487.  On July 5, 2013, Dr. Chen recorded that M.P. had a cannabis card and smoked medical marijuana.  CMS Ex. 28 at 483.  From July 2013 through March 2014, Dr. Chen prescribed Subsys for M.P.  CMS Ex. 22 at 2-6; CMS Ex. 28 at 424-427, 457, 463, 466, 469, 472, 475, 481, 484; but see CMS Ex. 28 at 448, 451, 454, 460 (Dr. Chen’s notes indicating encounters where Subsys was not refilled).

On February 10, 2014, Dr. Chen recorded that he had discovered that M.P. received fentanyl from another physician and reminded M.P. of their agreement.  CMS Ex. 28 at 459.  Although Dr. Chen indicated that he would not refill the Subsys, Dr. Chen’s notes indicate that he did refill Subsys just two days later and again in March 2014.  CMS Ex. 28 at 419, 457, 459-60; see CMS Ex. 22 at 6.

On April 18, 2014, M.P. told Dr. Chen that, on March 14, 2014, local “police and DEA informed [M.P.] that subsys is only for cancer and that they will confiscate subsys when he gets it.”  CMS Ex. 28 at 439.  Dr. Chen reacted by discharging M.P. as a patient “[d]ue to aberrant behavior” in relation to Dr. Chen’s pain agreement.  CMS Ex. 28 at 440; see CMS Ex. 28 at 434.  Dr. Chen “[i]nstructed [M.P.] to see Kaiser doctor . . . she wants [M.P.] to come to detox program.”  CMS Ex. 28 at 440.  Despite this letter, Dr. Chen saw M.P. on April 21 and 28, 2014.  CMS Ex. 28 at 435-39.

Dr. Rankin, a physician and one of CMS’s expert witnesses, testified that Dr. Chen’s medical records regarding M.P. show unclear treatment goals, which were simply listed as improving functionality, decreasing pain, improving the quality of life and performing ADL with minimal supervision and assistance.  CMS Ex. 56 ¶ 15.  Dr. Rankin testified that goals for treatment should be specific and measurable, so that progress toward those goals can be evaluated on each visit.  CMS Ex. 56 ¶ 13.  Dr. Rankin opined that “Dr. Chen jeopardizes the health and safety of his patients by prescribing his patients Subsys, and then renewing those prescriptions, without sufficiently documenting that Subsys was

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helping his patients improve their daily functioning or pain management.”  CMS Ex. 56 ¶ 16.

Dr. Haag, a pharmacist and CMS’s other expert witness, testified as to his impressions and opinions about Dr. Chen’s prescription practices related to M.P. 

Despite patient MP testing positive for cocaine in January of 2013, on March 6, 2013, Dr. Chen prescribed him 100 mcg of Subsys, which as described above, is an extremely potent opioid.  Dr. Chen also renewed patient MP’s prescription of a fentanyl skin patch on March 6, 2013.  Although Dr. Chen noted that patient MP had a positive urine test for cocaine in his notes for March 6, 2013, Dr. Chen also wrote that, “patient denies history of or present substance abuse, there is no evidence of diversion or abuse.”

* * * * *

On September 16, 2013, Dr. Chen increased patient MP’s Subsys to 600 mcg.  Dr. Chen prescribed further refills for Subsys on October 14, 2013, November 11, 2013, December 30, 2013, February 12, 2014, March 14, 2014, and April 18, 2014, despite the fact that patient MP tested positive for amphetamines and cocaine on April 26, 2013.  There was also no indication in patient MP’s records that Dr. Chen determined the source of the positive test result of amphetamines, or that this test result was addressed with patient MP. . . .  Given the evidence that patient MP used illegal drugs, like amphetamines and cocaine, Dr. Chen’s decision to keep prescribing patient MP Subsys, and for Dr. Chen to increase patient MP’s Subsys dosage from 200 mcg to 600 mcg was improper, and was a threat to the health and safety of patient MP.

According to Dr. Chen’s notes for February 10, 2014, patient MP was prescribed fentanyl skin patches by another physician, in violation of the pain management agreement that he signed with Dr. Chen. . . .  Dr. Chen stated that he would not prescribe patient MP fentanyl skin patches or Subsys on February 10, 2014.  On February 12, 2014, March 14, 2014, and April 18, 2014, Dr. Chen prescribed patient MP Subsys again, despite the evidence that patient MP was also seeking and obtaining fentanyl elsewhere.  When a patient

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seeks opioid prescriptions from multiple physicians simultaneously, it is a sign of drug-seeking behavior and an indication of an opioid addiction, particularly when efforts to obtain opioids from multiple sources are not disclosed to the potential prescribers.

On February 24, 2014, Dr. Chen prescribed patient MP Suboxone, which is a medication prescribed to treat opioid addiction.  Although Dr. Chen prescribed patient MP Suboxone, Dr. Chen stopped prescribing patient MP Suboxone on March 14, 2014, and started prescribing patient MP Subsys again on March 14, 2014 and April 18, 2014.  It is unclear based on a review of patient MP’s medical record why Dr. Chen discontinued Suboxone and started patient MP on Subsys again.  Furthermore, Dr. Chen also put patient MP at high risk for an overdose since the MME/day for patient MP was 480 on April 18, 2014, which is over four times higher than the CDC has identified as having elevated risk of an overdose.

Dr. Chen’s notes for MP for March 14, 2014 stated that one of MP’s physicians was concerned that MP “will die from the fentanyl.”  Despite this concern, Dr. Chen prescribed patient MP 600 mcg of Subsys on March 14, 2014, and 600 mcg of Subsys again on April 18, 2014. . . .  Dr. Chen’s prescriptions of Subsys to patient MP were improper and threatened patient MP’s health and safety, since patient MP had tested positive for cocaine and amphetamines, had admitted to recent cocaine usage, had a history of being prescribed Methadone, and had simultaneously seen another physician for opioids.  A patient who has used cocaine and amphetamines recently is at high risk for a deadly overdose if they are prescribed Subsys.  In 2016, two out of five cocaine-related overdose deaths also involved fentanyl.  Cocaine and amphetamines are stimulants, and fentanyl is a depressant.  Stimulants and fentanyl are dangerous when taken together because they can mask the effect of the other drug, which could cause the user to continue taking the drugs without realizing the effect, or not realize that they are overdosing.  Furthermore, a patient who has a recent history of taking illegal drugs like cocaine is not a good candidate for taking a potent opioid like Subsys, since Subsys is very strong, and has a high potential for abuse.

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* * * * *

Given the signs of patient MP drug-seeking behavior and illegal drug use and possible addiction, Dr. Chen should not have prescribed him Subsys and a fentanyl skin patch.  Furthermore, given these signs Dr. Chen should also not have increased patient MP’s Subsys prescribed dosage.  When there are signs that a patient has an opioid abuse problem and has been prescribed opioids, a physician should take steps to address this problem by, for example, tapering the patient’s opioid prescriptions and referring the patient to drug treatment programs.  In light of patient MPs drug use and drug-seeking behaviors, Dr. Chen’s prescriptions of Subsys to patient MP threatened MP’s health and safety.

CMS Ex. 54 ¶¶ 29, 31-35 (citations omitted) (emphasis added).

Based on the evidence of record, I find that Dr. Chen prescribed Subsys for M.P. for approximately a year despite a lack of a cancer diagnosis with breakthrough pain.  Further, I find that Dr. Chen risked M.P.’s health and safety by prescribing medications, including Subsys, that exceeded the MME level that the CDC has found to be safe.  In addition, I find that Dr. Chen did not properly set or monitor goals to be achieved when prescribing Subsys.  Finally, Dr. Chen was aware that M.P. used illegal drugs and obtained opioid prescriptions from at least one additional physician in violation of the agreement that M.P. had with Dr. Chen.  I accept the uncontroverted testimony of Drs. Rankin and Haag that Dr. Chen’s actions placed M.P.’s health and safety at significant risk.  That testimony is consistent with the rest of the record.  See, e.g.,CMS Ex. 34.

6. Dr. Chen prescribed Subsys for M.F. starting in April 2013, at a strength of 200 mcg, and continuing through January 2015, at which time he was prescribing Subsys at 800 mcg strength.  M.F. did not have a cancer diagnosis.  In addition, Dr. Chen failed to prescribe Subsys initially at 100 mcg strength, as required by the manufacturer’s instructions.  Further, under Dr. Chen’s care, M.F. was prescribed medications with an MME in excess of the maximum amount that the CDC has identified as being at an elevated risk level for an overdose.  Dr. Chen’s prescription of Subsys was a threat to the health and safety of M.F.

M.F. was involved in a motor vehicle accident in 1993 and had a mental/emotional breakdown in 2008.  CMS Ex. 9 at 2; CMS Ex. 28 at 91.  Dr. Chen treated M.F. from at least June 27, 2012 through January 28, 2015.  CMS Ex. 9; CMS Ex. 28 at 1-92.  According to Dr. Chen’s notes, he examined M.F. on June 27, 2012, made a Care Plan based on a fibromyalgia diagnosis, prescribed morphine sulfate, checked CURES, and 

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noted that M.F. was taking numerous medications and signed a Pain Agreement.  CMS Ex. 9 at 2-3; CMS Ex. 28 at 91-92.  Based on an August 10, 2012 examination, Dr. Chen added a prescription for Norco to be used for breakthrough pain.  CMS Ex. 28 at 88.  In an October 3, 2012 note, Dr. Chen indicated that M.F. had a lumbar disk herniation and a moderate to severe bilateral foraminal stenosis.  CMS Ex. 28 at 84.  Following a December 28, 2012 examination, Dr. Chen noted that “[w]ith medications, [M.F.] is able to move around the house and do his ADLs.  Without the medications, [h]e cannot get out of bed.”  CMS Ex. 28 at 77.  On February 22, 2013, Dr. Chen increased the morphine sulfate prescription.  CMS Ex. 28 at 71-72.

In a note regarding a March 22, 2013 examination, Dr. Chen stated that the current medications were not controlling M.F.’s pain and that he “will try subsyx.  Subyx would be better choice as faster onset so prevent increases afterload to the heart.”  CMS Ex. 28 at 67.  Dr. Chen also stated that a “Goal specific treatment plan” related to the lumbar and cervical spine was to “improve functionality, decrease pain, improve quality of life, and perform ADL with minimal supervision or assistance.”  CMS Ex. 28 at 69.  In an April 3, 2013 note, Dr. Chen indicated his assessments of M.F. were intractable chronic neck and back pain as well as cervical and lumbar disk disease.  CMS Ex. 28 at 65.  Dr. Chen also indicated that he was stopping Norco and would “start subsyx 200 ug qid #120.”  CMS Ex. 28 at 65-66; see also CMS Ex. 22 at 2, 6-8, 13 (Medicare records showing an April 11, 2013 prescription for fentanyl sublingual spray (i.e., Subsys) for M.F. for 30 units of Subsys at 200 mcg).

On May 3, 2013, Dr. Chen increased M.F.’s Subsys prescription to 400 mcg and 90 units.  CMS Ex. 22 at 2, 6-8, 13; CMS Ex. 28 at 63.  According to Dr. Chen’s June 5, 2013 and July 8, 2013 notes, he refilled the Subsys prescription again at the 400 mcg strength level.  CMS Ex. 28 at 56, 59.  Dr. Chen again prescribed a refill of Subsys at that strength on August 16, 2013, but noted that an increase to 600 mcg would require prior insurance authorization.  CMS Ex. 22 at 3, 13, 15-17, 20; CMS Ex. 28 at 53.

In a September 18, 2013 note, Dr. Chen indicated that he would increase the Subsys prescription to a strength of 600 mcg, but continue providing 90 units.  CMS Ex. 28 at 50.  According to Medicare records, this prescription was filled on October 7, 2013.  CMS Ex. 22 at 4, 13, 15-17, 20.  On December 20, 2013, January 20, 2014, February 21, 2014, and March 18, 2014, Dr. Chen again prescribed 600 mcg of Subsys, but increased the quantity to 150 units.  CMS Ex. 22 at 4, 10, 13, 15-17, 20, 22; see CMS Ex. 28 at 35, 39, 42, 44.  On April 28, 2014, May 30, 2014, and July 2, 2014, , Dr. Chen prescribed Subsys at an increased strength of 800 mcg and a quantity of 150 units, and these prescriptions were filled on April 28, 2014, June 4, 2014, and July 11, 2014.  CMS Ex. 22 at 9, 11-12, 14-26; CMS Ex. 28 at 26, 29, 32.   Dr. Chen’s notes from July 2, 2014 and July 18, 2014, indicate that M.F. was having difficulty with his insurance covering Subsys.  CMS Ex. 28 at 23, 26.  However, a July 23, 2014 note indicates that M.F. was able to return to using Subsys.  CMS Ex. 28 at 22.

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On August 3 and August 11, 2014, Dr. Chen prescribed Subsys again at the strength of 800 mcg, but reduced the quantity to 120 units.  CMS Ex. 22 at 13, 15-26; see CMS Ex. 28 at 21.  On September 3, 2014, October 1, 2014, October 31, 2014, December 1, 2014, and January 5, 2015, Dr. Chen again prescribed Subsys at the strength of 800 mcg but increased the quantity to 150 units.  CMS Ex. 22 at 14-26; CMS Ex. 28 at 6, 9, 12, 15, 18.  In a January 28, 2015 note, Dr. Chen stopped prescribing Subsys for M.F.  CMS Ex. 9 at 6; CMS Ex. 28 at 3.

Dr. Rankin testified that Dr. Chen jeopardized M.F.’s health and safety because he never evaluated whether M.F. was attaining the goals Dr. Chen set for M.F. in relation to treatment.  Dr. Rankin testified that goals for treatment should be specific, and measurable, with progress toward the goals evaluated with each visit.  CMS Ex. 56 ¶ 13.  In regard to M.F., Dr. Rankin testified that: 

The goals listed for this patient were unchanged (copied and pasted) between March 22, 2013 and January 5, 2015.  (CMS Ex. 28 at 6-69).  Dr. Chen did not note any progress that patient MF made towards reaching these goals, and Dr. Chen did not revise the goals.  Id. . . . Dr. Chen jeopardized the health and safety of his patients by prescribing his patients Subsys, and then renewing those prescriptions, without sufficiently documenting that Subsys was helping his patients improve their daily functioning or pain management.

CMS Ex. 56 ¶ 16.

Dr. Haag testified that M.F. did not have a cancer diagnosis and opined that without the proper cancer diagnosis, the Subsys prescriptions placed M.F. “at risk of an overdose and opioid dependency.”  CMS Ex. 54 ¶¶ 14-15.

Further, Dr. Haag testified that “Dr. Chen put his patients at risk for overdose by not starting his patients at the lowest dose for SUBSYS of 100 mcg.  He started Subsys therapy at a dose greater than 100 mcg for . . . MF.”  CMS Ex. 54 ¶ 17.  Dr. Haag noted that when Dr. Chen enrolled in the TIRF REMS program, he signed an agreement that he would start patients on the lowest possible dose of 100 mcg.  As Dr. Haag testified:  “Since Subsys is such a potent opioid medication, it is important that patients do not start out on too high a dosage, in order to reduce the risk of an overdose.”  CMS Ex. 54 ¶ 16.  Dr. Haag’s opinion is supported by the record.  CMS Ex. 34 at 6.

In addition, Dr. Haag concluded from the review of M.F.’s records that Dr. Chen was prescribing medications with an MME exceeding 100, which Dr. Haag testified is an amount that “the CDC has identified as being at an elevated risk for overdose.”  CMS Ex.

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54 ¶ 22.  Dr. Haag testified that prescribing a high dosage of opioids to M.F. when he did not have a cancer diagnosis represented a threat to the health and safety of M.F.  CMS Ex. 54 ¶ 23.

Dr. Haag also testified that “Dr. Chen put his patients at risk for an overdose and opioid dependency by failing to regularly check CURES to make sure that they were not receiving any other opioids from other providers.”  CMS Ex. 54 ¶ 25.  Dr. Haag’s review of the records related to M.F. showed that “Dr. Chen checked CURES for him on October 1, 2014, and then did not check again until January 2015, despite [MF] being seen regularly by Dr. Chen during that time.  CMS Ex. 28 at 3-14.  Patient MF was receiving multiple controlled substances from other providers during this time.  CMS Ex. 22.”  CMS Ex. 54 ¶ 25.

Based on the evidence of record, I find that Dr. Chen prescribed Subsys for M.F. for more than a year and a half despite a lack of a cancer diagnosis with breakthrough pain.  Further, I find that Dr. Chen did not properly monitor goals to be achieved when prescribing Subsys.  In addition, Dr. Chen did not comply with the requirement that he start patients like M.F. at 100 mcg of Subsys and prescribed drugs such that M.F. had a MME in excess of 100, against CDC guidelines.  Finally, Dr. Chen failed to check CURES to monitor for all controlled substances that practitioners were prescribing for M.F.  I accept the uncontroverted testimony of Drs. Rankin and Haag that Dr. Chen’s actions placed M.F.’s health and safety at risk.

7. Dr. Chen prescribed Subsys for B.C. in April and May 2013.  When he did this, the medications Dr. Chen prescribed had an MME per day which was more than seven times higher than the maximum amount identified by the CDC as an elevated risk level for overdose.  Although B.C. previously had a cancer diagnosis in 2007, he did not have cancer with breakthrough pain in 2013.  Dr. Chen’s prescription of Subsys was a threat to the health and safety of B.C.

Dr. Chen commenced treating B.C. in September 2012.  A September 2012 note indicated that the chief complaint was colorectal pain and that B.C. had a “[history of] colorect[al] tumor and resection.”  CMS Ex. 7 at 5; CMS Ex. 26 at 6, 65.  The resection took place in 2007.  CMS Ex. 26 at 57.  In a note following a November 26, 2012 examination, Dr. Chen assessed B.C. as having colorectal pain and colorectal stricture.  CMS Ex. 26 at 59.  From September 2012 to April 2013, Dr. Chen tried a variety of pain medications to alleviate B.C.’s pain.  CMS Ex. 26 at 41-65.  In an April 19, 2013 note,  Dr. Chen indicated that he was prescribing for B.C. 10 units of Subsys at 100 mcg.  CMS Ex. 22 at 3; CMS Ex. 26 at 39.  Dr. Chen did this “so [B.C.] can come off norco as norco not controlling sx [symptoms].”  CMS Ex. 26 at 39.  In an April 26, 2013 note, Dr. Chen indicated he would increase the Subsys strength to 200 mcg.  CMS Ex. 26 at 35-37.  However, in a May 10, 2013 note, Dr. Chen stated that B.C. indicated that Subsys was too expensive and he could not afford the co-pay.  CMS Ex. 26 at 32, 34.  Dr. Chen

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further stated that:  “Tried subsys 100 mcg which helped but not strong enough, was given an Rx for 200 mcg but unable to fill due to cost.”  CMS Ex. 26 at 32.

Dr. Haag, CMS’s expert witness who is a pharmacist, testified that, while B.C. had colorectal cancer in 2007, B.C. was prescribed Subsys six years after surgical resection of the tumor.  Dr. Haag stated that B.C’s prescription for Subsys was not appropriate because “he did not have an active cancer diagnosis.”  CMS Ex. 54 ¶ 14.  Dr. Haag opined that such a high dose as given to B.C. without an active cancer diagnosis represented a threat to the health and safety of B.C.  See CMS Ex. 54 ¶ 15.  Further, Dr. Haag testified that “B.C. was prescribed 720 MME, which is over seven times higher than the 100 MME that the CDC has identified as being at an elevated risk for overdose.  CMS Ex. 26 at 18; CMS Ex. 35 at 25-26.”  CMS Ex. 54 ¶ 22.

Based on the evidence of record, I find that Dr. Chen prescribed Subsys for B.C. in April and May 2013 despite a lack of an active cancer diagnosis with breakthrough pain.  Further, I find that Dr. Chen prescribed Subsys while B.C. was taking medications that had a combined MME of more than seven times the safe limit for patients.  CMS Ex. 26 at 17-47 (indicating B.C. took medications in addition to Subsys, including MS Contin, Oxycodone, Opana [oxymorphone], Norco, MS IR [morphine], and Fentanyl patches).  I accept the uncontroverted testimony of Dr. Haag that Dr. Chen’s actions placed B.C.’s health and safety at risk.  See, e.g.,CMS Ex. 34.

8. Dr. Chen prescribed Subsys for J.F. in September 2013 at a strength of 200 mcg, and only ceased prescribing Subsys to J.F. because J.F.’s insurance stopped approving coverage for it.  J.F. did not have a cancer diagnosis.  In addition, Dr. Chen failed to prescribe Subsys initially at 100 mcg strength, as required by the manufacturer’s instructions.  Further, under Dr. Chen’s care, M.F. was prescribed medications with an MME per day in excess of the maximum amount that the CDC has identified as being at an elevated risk level for an overdose.  Dr. Chen’s prescription of Subsys was a threat to the health and safety of J.F.

J.F. has been a Medicare Part A beneficiary since 2001 and a Medicare Part B beneficiary since 2002.  CMS Ex. 28 at 95.  Dr. Chen started to treat J.F. in 2012.  In a note following a January 4, 2012 examination, Dr. Chen assessed J.F. as having a failed back surgery syndrome and chronic pain syndrome.  CMS Ex. 5 at 3.

In a note regarding a September 11, 2013 examination, Dr. Chen stated that he discussed Subsys with J.F. because J.F. was becoming tolerant to Norco.  Dr. Chen prescribed Subsys at a strength of 200 mcg.  Dr. Chen indicated the same assessment (failed back surgery syndrome and chronic pain syndrome) for J.F. as in the January 4, 2012 note.  CMS Ex. 28 at 239.  Dr. Chen refilled the Subsys prescription in October 2013, but with an increase in strength to 400 mcg.  CMS Ex. 28 at 236.  In November 2013, Dr. Chen increased the dosage strength for Subsys to 600 mcg.  CMS Ex. 28 at 230, 233.  Dr. Chen

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again prescribed Subsys at 600 mcg strength in December 2013.  CMS Ex. 22 at 4; CMS Ex. 28 at 227.  On January 3, 2014, Dr. Chen prescribed Subsys at 600 mcg strength, but at the end of January 2014, and in February and March 2014, Dr. Chen prescribed Subsys at 800 mcg strength.  CMS Ex. 22 at 4-6; CMS Ex. 28 at 212, 215, 218, 221, 224.  According to a note from an April 2014 examination, Dr. Chen was not refilling the Subsys prescription because J.F.’s insurance did not approve it.  CMS Ex. 28 at 209.

Dr. Rankin, CMS’s expert witness who is a physician, testified that Dr. Chen jeopardized J.F.’s health and safety because he never evaluated whether J.F. was attaining the goals Dr. Chen set for J.F. in relation to treatment.  Dr. Rankin testified that goals for treatment should be specific, and measurable, with progress toward the goals evaluated with each visit.  CMS Ex. 56 ¶ 13.  In regard to J.F., Dr. Rankin testified that:

Dr. Chen prescribed patient JF Subsys on September 11, 2013.  CMS Ex. 28 at 239.  Dr. Chen listed generic treatment goals for this patient, such as the goal that he would “improve functionality, decrease pain, improve quality of life, perform ADLs with minimal supervision or assistance.”  CMS Ex. 28 at 239.  ADLs means activities of daily living.  These were the identical goals for patient MP when patient MP began taking Subsys on March 6, 2013.  CMS Ex 28 at 499.  Goals should be individualized to the patient, and also [sic] should also be measurable, with progress documented.

CMS Ex. 56 ¶ 14.  Dr. Rankin testified that Dr. Chen jeopardized the health and safety of his patients, including J.F., by prescribing Subsys for his patients, and renewing those prescriptions, without sufficiently documenting that Subsys was helping to improve their daily functioning or pain management.  CMS Ex. 56 ¶ 16.

Dr. Haag, CMS’s expert witness who is a pharmacist, testified that J.F. did not have a cancer diagnosis and opined that without the proper cancer diagnosis, the Subsys prescriptions placed J.F. “at risk of an overdose and opioid dependency.”  CMS Ex. 54 ¶¶ 14-15.  Further, Dr. Haag concluded from the review of J.F.’s records that Dr. Chen was prescribing medications with an MME exceeding 100, which Dr. Haag testified is an amount that “the CDC has identified as being at an elevated risk for overdose.”  CMS Ex. 54 ¶ 22.  Dr. Haag testified prescribing a high dosage of opioids to J.F. when he did not have a cancer diagnosis represented a threat to the health and safety of J.F.  CMS Ex. 54 ¶ 23.  Finally, Dr. Haag testified that “Dr. Chen put his patients at risk for overdose by not starting his patients at the lowest dose for Subsys of 100 mcg.  He started Subsys therapy at a dose greater than 100 mcg for . . . JF.”  CMS Ex. 54 ¶ 17.  Dr. Haag noted that when Dr. Chen enrolled in the TIRF REMS program, he signed an agreement that he would start patients on the lowest possible dose of 100 mcg.  As Dr. Haag testified:  “Since Subsys is such a potent opioid medication, it is important that patients

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do not start out on too high a dosage, in order to reduce the risk of an overdose.”  CMS Ex. 54 ¶ 16.  Dr. Haag’s opinion is supported by the record.  CMS Ex. 34 at 6.

Based on the evidence of record, I find that Dr. Chen prescribed Subsys for J.F. despite a lack of a cancer diagnosis with breakthrough pain.  Further, I find that Dr. Chen risked J.F.’s health and safety by prescribing medications, including Subsys, which exceeded the MME level that the CDC has found to be safe.  In addition, I find that Dr. Chen violated the proper dosing guidelines for Subsys and initially prescribed J.F. Subsys at 200 mcg strength instead of at the required 100 mcg.  Finally, I find that Dr. Chen failed to set goals for J.F. to achieve and then failed to document whether Subsys was helping to achieve those goals.  I accept the uncontroverted testimony of Drs. Rankin and Haag that Dr. Chen’s actions placed J.F.’s health and safety at risk.

9. Dr. Chen prescribed Subsys for A.H. at 200 mcg strength and increased the strength to 400 mcg, and again to 1,200 mcg, in February 2014.  Dr. Chen ceased prescribing Subsys to A.H. based on her request.  A.H. did not have a cancer diagnosis.  Dr. Chen’s prescription of Subsys was a threat to the health and safety of A.H.

A.H. was a Medicare Part A and Part B beneficiary starting in 2013.  CMS Ex. 29 at 309.  Dr. Chen began treating A.H. in November 2013.  CMS Ex. 29 at 310-318.  In a note following an examination on November 27, 2013, Dr. Chen assessed A.H as having Ehler Danlos syndrome and chronic pain.  CMS Ex. 6 at 3; CMS Ex. 29 at 390.  Dr. Chen also decided to “start subsys 200m[c]g” because “Subsys will avoid GI problem.”  CMS Ex. 6 at 3; CMS Ex. 29 at 390.

In early December 2013, Dr. Chen prescribed for A.H. 120 units of Subsys at 200 mcg.  CMS Ex. 22 at 4, 6; CMS Ex. 29 at 405.  In early February 2014, Dr. Chen stopped the Subsys.  CMS Ex. 29 at 343.  However, in mid-February, Dr. Chen increased the strength of the Subsys prescription to 400 mcg and provided two prescriptions during that time: one for 30 units and the other for 120 units.  CMS Ex. 22 at 6-7; CMS Ex. 29 at 382, 400, 402.  Just a short time later, on February 24, 2014, Dr. Chen wrote another prescription for Subsys with a significantly increased dosage strength of 1,200 mcg (i.e., two 600 mcg doses at a time) and a quantity of 240 units.  CMS Ex. 22 at 6; CMS Ex. 29 at 378, 397-398.  In an April 7, 2014 note, Dr. Chen stopped Subsys again at A.H.’s request.  CMS Ex. 29 at 375-376.

Dr. Haag testified that A.H. did not have a cancer diagnosis and opined that without the proper cancer diagnosis, the Subsys prescriptions placed A.H. “at risk of an overdose and opioid dependency.”  CMS Ex. 54 ¶¶ 14-15.  Dr. Haag’s review of A.H.’s medical records shows that Dr. Chen did not explain why A.H. could not continue to take Dilaudid or morphine sulphate, or why other less potent opioid options, such as fentanyl patches or suppositories, could not be taken.  Dr. Haag opined:  “By switching patient

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AH to a more potent opioid [Subsys], Dr. Chen increased patient AH’s risk of an overdose, but Dr. Chen’s justification for switching patient AH to Subsys is not supported by the patient’s medical record.”  CMS Ex. 54 ¶ 45.    

Further, Dr. Haag concluded from the review of A.H.’s records that Dr. Chen was prescribing medications with an MME exceeding 100, which Dr. Haag testified is an amount that “the CDC has identified as being at an elevated risk for overdose.”  CMS Ex. 54 ¶ 22.  Dr. Haag testified that prescribing a high dosage of opioids to A.H. when she did not have a cancer diagnosis represented a threat to the health and safety of A.H.  CMS Ex. 54 ¶ 23. 

In addition, Dr. Haag testified that “Dr. Chen put his patients at risk for overdose by not starting his patients at the lowest dose for Subsys of 100 mcg.  He started Subsys therapy at a dose greater than 100 mcg for . . . AH.”  CMS Ex. 54 ¶ 17.  Dr. Haag noted that when Dr. Chen enrolled in the TIRF REMS program, he signed an agreement that he would start patients on the lowest possible dose of 100 mcg.  As Dr. Haag testified:  “Since Subsys is such a potent opioid medication, it is important that patients do not start out on too high a dosage, in order to reduce the risk of an overdose.  CMS Ex. 54 ¶ 16.  Dr. Haag’s opinion is supported by the record.  CMS Ex. 34 at 6.

Finally, Dr. Haag also testified that Dr. Chen failed to follow the manufacturer’s instructions to increase the strength of Subsys first to 200 mcg, then 400 mcg, then 600 mcg, then 800 mcg, and finally 1,200 mcg.  As Dr. Haag stated: 

Patient AH’s dose was increased from 400 mcg four times daily, to 1,200 mcg four times daily.  CMS Ex. 29 at 333.  If an increase in patient AH’s dosage for Subsys was necessary, the dosage should have increased from 400 mcg four times daily to 600 mcg four times daily, rather than 1,200 mcg four times daily.  CMS Ex. 34 at 6-7.  The manufacturer’s prescription instructions for Subsys states that to “reduce the risk of respiratory depression, proper dosing and titration of SUBSYS are essential.”  CMS Ex. 34 at 10.  In other words, if a physician increases a patient’s Subsys dosage too much, too quickly, the patient may overdose.  By failing to follow the manufacturer’s prescription instructions for Subsys, and by not complying with the requirements of the TIRF REMS program, Dr. Chen put his patients at a high risk of an overdose.

CMS Ex. 54 ¶ 18.

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Based on the evidence of record, I find that Dr. Chen prescribed Subsys for A.H. despite a lack of a cancer diagnosis with breakthrough pain and otherwise failed to provide clinical justification for prescribing Subsys.  Further, I find that Dr. Chen risked A.H.’s health and safety by prescribing medications, including Subsys, that exceeded the MME level that the CDC has found to be safe.  Finally, I find that Dr. Chen violated the proper dosing guidelines for Subsys and initially prescribed A.H. Subsys at 200 mcg strength instead of at the required 100 mcg, and increased the strength of prescriptions from 200 mcg to 400 mcg, and then to 1,200 mcg, in violation of the manufacturer’s instructions.  I accept the uncontroverted testimony of Dr. Haag that Dr. Chen’s actions placed A.H.’s health and safety at risk.

10. Dr. Chen prescribed Subsys for A.S. from January 2014 until her death in October 2015 from Acute Fentanyl Intoxication.  A.S. did not have a cancer diagnosis.  Dr. Chen also prescribed medications for A.S. that exceeded the maximum safe MME as determined by the CDC.  Finally, Dr. Chen concurrently prescribed alprazolam (Xanax) and diazepam (Valium) with the Subsys, resulting in an increased risk of significant harm to A.S. and possibly her death.

In 1992, A.S. had a lumbar fusion involving the L5-S1 vertebrae.  CMS Ex. 4 at 2.  Dr. Chen treated A.S. from at least January 2012 through October 5, 2015.  CMS Ex. 4; CMS Ex. 22 at 1-31; CMS Ex. 37.  On January 11, 2012, Dr. Chen examined A.S. and noted that A.S. was still having low back and leg pain, which was 6 out of 10 on the pain scale, despite use of a fentanyl patch.  CMS Ex. 4 at 2.  Dr. Chen diagnosed A.S. with Cervical and Lumbar Radiculopathy and assessed her with post-laminectomy syndrome in the lumbar region and “[c]hronic intractable low back pain.”  CMS Ex. 4 at 3.  Until that visit, A.S. was taking opioid pain relievers Kadian and Norco, but Dr. Chen discontinued the Kadian and the fentanyl patch, prescribed a refill for the Norco, and started MS Contin as a different opioid pain medication.  CMS Ex. 4 at 2-3.

According to Medicare records, on January 15, 2014, Dr. Chen prescribed Subsys for the first time for A.S.  Dr. Chen prescribed 90 units at 400 mcg.  CMS Ex. 22 at 5; CMS Ex. 29 at 473.  On February 11, 2014, Dr. Chen prescribed another 90 units of Subsys, but at an increased strength of 600 mcg.  CMS Ex. 22 at 5.  On March 7, 2014, and March 25, 2014, Dr. Chen prescribed another 90 units and 120 units of Subsys, respectively, at the strength of 600 mcg.  CMS Ex. 22 at 7, 15.  On April 18, 2014, Dr. Chen prescribed 120 units of Subsys for A.S. at the increased strength of 800 mcg.  CMS Ex. 22 at 9.  On May 13, 2014, and June 9, 2014, Dr. Chen prescribed another 120 units of Subsys, but at a decreased strength of 600 mcg.  CMS Ex. 22 at 10.  On July 6, 2014, and August 6, 2014, Dr. Chen prescribed 120 more units of Subsys, but increased the strength to 800 mcg.  CMS Ex. 22 at 10, 13.  On September 2, 2014, Dr. Chen prescribed 240 units of Subsys and increased the strength to 1,200 mcg (i.e., A.S. was to take two units of 600 mcg).  CMS Ex. 22 at 13; see also CMS Ex. 29 at 431, 620; CMS Ex. 37 at 41, 45.

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On October 1, 2014, October 29, 2014, November 26, 2014, December 23, 2014, January 20, 2015, February 17, 2015, March 17, 2015, April 14, 2015, April 29, 2015, May 12, 2015, June 17, 2015, July 15, 2015, August 12, 2015, September 9, 2015, and October 5, 2015, Dr. Chen again prescribed (or A.S. filled a prescription written by Dr. Chen) 240 units of Subsys to be taken at the 1,200 mcg level of strength.  CMS Ex. 22 at 14, 16, 17, 19, 21, 23, 25, 27, 28, 29, 31, 32; see also CMS Ex. 4 at 7; CMS Ex. 29 at 589, 593, 595, 600, 601, 604, 605, 609, 613, 614, 616-618; CMS Ex. 37 at 17, 18, 20.  But see CMS Ex. 37 at 28, 32, 37 (Dr. Chen’s examination records indicating that he temporarily stopped prescribing Subsys for late March, April, and May 2015).

Dr. Chen examined A.S. a number of times while he was prescribing Subsys at the 1,200 mcg strength level.  The records from those visits show that Dr. Chen’s diagnoses remained Cervical and Lumbar Radiculopathy, and his assessments still included post-laminectomy syndrome in the lumbar region and chronic intractable low back pain.  CMS Ex. 37 at 4, 8, 12, 16, 20, 24, 28, 32, 37, 41, 45.

Dr. Chen saw A.S. on September 9, 2015.  CMS Ex. 4 at 5.  At that time, A.S.’s medications included morphine and Norco.  CMS Ex. 4 at 5.  In the plan of care, Dr. Chen noted that he was discontinuing MS IR (morphine) for A.S.’s breakthrough pain because “her insurance is covering the Subsys 1200mcg QID 240 units.”  CMS Ex. 4 at 7.  Dr. Chen noted at an October 5, 2015 visit with A.S. that Subsys decreased A.S.’s pain by 50% and allowed her to be more functional.  Dr. Chen also discussed with A.S. that Subsys may no longer be authorized after 2015.  CMS Ex. 37 at 2.  Dr. Chen indicated in the care plan for A.S. that he was refilling a MS Contin prescription, but would not do so for the rest of the year and prescribed “Subsys 1,200 mcg QID 240 units.”  CMS Ex. 29 at 589; CMS Ex. 37 at 5.

On October 10, 2015, family members discovered A.S. to be unresponsive at her residence.  A.S.’s husband called 911 and paramedics ultimately determined A.S. had died.  A.S.’s husband indicated that A.S. took pain medication for degenerative disc disease, but “has often abused her pain medications.”  Her husband later stated that A.S. was not an intentional abuser of drugs, but would forget when she had taken medications and then accidentally take two doses.  CMS Ex. 18 at 3, 7.  A toxicology report indicated the presence of various drugs in her system, including 22 ng/mL of fentanyl.  CMS Ex. 18 at 11.  Based on a toxicology report, a pathologist with the Coroner’s office determined that the cause of death was Acute Fentanyl Intoxication.  CMS Ex. 18 at 7, 19.

A licensed pharmacist with the MEDIC reviewed the Medicare prescribing documentation related to A.S.  That pharmacist concluded that:

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• Dr. Chen authorized PDE records, including Subsys, which resulted in major drug interactions and duplicative sedative effects that could have caused significant harm to [A.S.]. .  . .
• Dr. Chen authorized opioid PDE records for [A.S.] which resulted in daily [MMEs] greater than 120 mg, which is a risk factor for over-utilization and an increase in mortality rate.

CMS Ex. 15 at 10.  In arriving at those conclusions, the pharmacist made a number of findings:  A.S. did not have a cancer diagnosis; Dr. Chen first prescribed Subsys at 400 mcg strength, but that A.S. had previously been taking the 200 mcg strength from another prescriber; Dr. Chen eventually not only prescribed Subsys to A.S. at 1,200 mcg strength, but increased the number of doses; Dr. Chen prescribed other drugs concurrently with Subsys, including morphine sulfate extended release, ondansetron, gabapentin, cyclobenzaprine, alprazolam, and diazepam, which resulted in major drug interactions through duplicative sedation side effects, including the concomitant use of Subsys and benzodiazepines (i.e., alprazolam and diazepam); and the latest prescription regimen for A.S. included two Schedule II drugs (morphine ER and Subsys) which resulted in a combined daily MME of 1,848 mg indicative of overutilization and a risk for an increased mortality rate; A.S. appeared to have had drug-seeking behavior as was evident by doctor and pharmacy shopping, which included the use of eight pharmacies and 12 prescribers.  CMS Ex. 15 at 6-8. 

A physician with MEDIC reviewed documentation related to A.S. and agreed with the pharmacist’s conclusions.  Further, the physician concluded the following:  Dr. Chen appeared to fall outside the standard of practice involving pain management, particularly in terms of “dosing and off-label use of sublingual fentanyl [Subsys]”; the FDA only approved Subsys for breakthrough cancer pain; there is likely a direct correlation between A.S.’s death from acute fentanyl intoxication and Dr. Chen’s prescribing because the only form of fentanyl that A.S. was using, from January 15, 2014, was Subsys, which Dr. Chen had prescribed; starting September 2, 2014, Dr. Chen prescribed 1,200 mcg of Subsys four times daily and had last prescribed that amount on October 7, 2015; Dr. Chen also prescribed hydrocodone for A.S.; Dr. Chen also prescribed a monthly supply of morphine sulfate CR 60 mg for A.S., “which added to the large morphine equivalent dose”; Dr. Chen twice prescribed benzodiazepines with opioids for A.S. before her death; and “there is a high likelihood of a direct correlation between the medications prescribed by Dr. Chen and the demise of [A.S.], particularly the sub-lingual fentanyl.”  CMS Ex. 19.

Dr. Haag testified that:  Dr. Chen prescribed Subsys for A.S. even though A.S. did not have a cancer diagnosis; Dr. Chen did not start A.S. at the lowest titration amount of 100 mcg; Dr. Chen prescribed multiple drugs to reduce A.S.’s pain that, at the time of her overdose, was 864 MME per day, or eight times the dosage, that the CDC has identified as being at elevated risk for overdose; Dr. Chen failed to check the CURES database for

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A.S., even though A.S. had been a long-time patient with a drug-seeking history, having received prescriptions from 12 different prescribers; Dr. Chen prescribed extremely high doses of opioids to A.S. and the prescription of Subsys, Valium, and Xanax to A.S. was improper and threatened A.S.’s health and safety.  Dr. Haag testified that Valium and Xanax are benzodiazepines.  CMS Ex. 54 ¶¶ 13, 22, 24-25, 36, 38, 40.  Dr. Haag explained how Dr. Chen risked A.S.’s health and safety:

In my professional opinion, Dr. Chen threatened patient AS’s health and safety by prescribing patient AS Subsys, morphine sulfate, Valium, and Xanax at the same time.  In the black box warning label for Subsys it states that, “Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.”  CMS Ex. 34 at 1.  A black box warning is the strictest warning put in the labeling of prescription drugs or drug products by the FDA when there is reasonable evidence of an association of a serious hazard with the drug.  Furthermore, it has long been recognized that benzodiazepines put patients at risk for respiratory depression and death when prescribed with opiates.  See CMS Ex[s]. 42, 43, 44.  Benzodiazepines and opioids, when taken together, are a frequent cause of fatal overdoses.  In 2010, 30% of patients in the United States who died of a fatal overdose from opioids were also taking benzodiazepines, according to the CDC.

Furthermore, Dr. Chen’s prescription of Valium and Xanax to patient AS also represented a threat to patient AS’s health and safety since Dr. Chen noted in the records for patient AS on January 15, 2014 that patient AS had a history of “Xanax dependency,” and that her Valium should be stopped.  CMS Ex. 29 at 473.  Despite Dr. Chen’s statement on January 15, 2014 that patient AS had a Xanax dependency, Dr. Chen started prescribing patient AS Xanax again in December of 2014.  CMS Ex. 29 at 616.  Dr. Chen was not specific about whether the dependency was psychological or physiologic.  CMS Ex. 29.  Psychologic dependency is associated with misuse/abuse of the drugs, where physiologic dependence with these drugs can develop to the point where the person can exhibit side effects (some being severe such as seizures) without abrupt discontinuation.  Patients who are abusing opioids often take prescriptions like

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Xanax because they feel an increased “high.”  CMS Ex. 43 at 1.  Dr. Chen did not specify in his notes why he thought it was clinically appropriate to prescribe patient AS Xanax again after he stopped prescribing her Xanax in January of 2014 due to patient AS’s dependence on the drug.  CMS Ex. 29.  Whether patient AS had a psychological or physiological dependence on Xanax, it was improper for Dr. Chen to prescribe patient AS Xanax again given her history of dependency.  Further, Dr. Chen seems to have made no attempt to place patient AS on a long term medication for her anxiety.  Benzodiazepines are used as bridge for anxiety until another medication (such as an antidepressant) starts to work, and are not meant to be prescribed on a long term basis.  CMS Ex. 43 at 3.

CMS Ex. 54 ¶¶ 41-42 (emphasis added).

Based on the evidence of record, I find that Dr. Chen prescribed Subsys for A.S. for a sustained period of time at a high strength level, despite a lack of a cancer diagnosis with breakthrough pain.  Further, I find that Dr. Chen risked A.S.’s health and safety by prescribing medications, including Subsys, which exceeded the MME level that the CDC has found to be safe.  However, I find that Dr. Chen did not violate the proper dosing guidelines for Subsys by initially prescribing A.S. Subsys at 400 mcg strength instead of at the required 100 mcg.  The MEDIC pharmacist indicated that A.S. had received Subsys from another physician previously at the 200 mcg level; therefore, it appears that Dr. Chen could increase the strength to 400 mcg based on the manufacturer’s instructions.  CMS Ex. 15 at 6; CMS Ex. 34 at 6-7.  Finally, I find that Dr. Chen concurrently prescribed Subsys and benzodiazepines for A.S., and accept the uncontroverted testimony of Dr. Haag that Dr. Chen’s actions therefore placed A.S.’s health and safety at significant risk.  Dr. Haag’s testimony is consistent with the written assessments by the MEDIC’s physician and pharmacist.  CMS Exs. 15, 19.

11. Dr. Chen first prescribed Subsys for S.A. in March 2014 at the 400 mcg strength level, but stopped prescribing Subsys in April 2014, when S.A. requested to stop all opioids.  S.A. did not have a cancer diagnosis.  Further, under Dr. Chen’s care, S.A. was prescribed medications with an MME in excess of the maximum amount that the CDC has identified as being at an elevated risk level for an overdose.  Dr. Chen’s prescription of Subsys was a threat to the health and safety of S.A.

S.A. has been a Medicare Part A and Part B beneficiary since 2009.  CMS Ex. 27 at 1.  Dr. Chen started to treat S.A. in July 2013.  CMS Ex. 27 at 3-13.  A note related to a July

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12, 2013 examination indicated that Dr. Chen assessed S.A. as having fibromyalgia.  CMS Ex. 8 at 5; CMS Ex. 27 at 102.

Dr. Chen prescribed for S.A. 120 units of Subsys at 400 mcg on March 18, 2014.  CMS Ex. 22 at 6.  In a March 21, 2014 note, Dr. Chen assessed S.A. as having fibromyalgia, lumbar radiculopathy, spasm of muscle, cervicalgia, long-term use of medications, and therapeutic drug monitoring.  CMS Ex. 27 at 50.  Dr. Chen also indicated that S.A. had not yet received Subsys.  CMS Ex. 27 at 49.  In notes from April 11 and 16, 2014 examinations of S.A., Dr. Chen stated that S.A. “is happy with the subsys” and indicated that he would continue to prescribe Subsys at 400 mcg.  CMS Ex. 27 at 43-44, 46-47.  In a note from an April 23, 2014 examination, Dr. Chen indicated that he would stop the Subsys prescription because S.A. requested to stop all opioids.  CMS Ex. 27 at 40-42.

Dr. Haag, CMS’s expert witness who is a pharmacist, testified that S.A. did not have a cancer diagnosis and opined that without the proper cancer diagnosis, the Subsys prescriptions placed S.A. “at risk of an overdose and opioid dependency.”  CMS Ex. 54 ¶¶ 14-15.  Further, Dr. Haag concluded from the review of S.A.’s records that Dr. Chen was prescribing medications with an MME exceeding 100, which Dr. Haag testified is an amount that “the CDC has identified as being at an elevated risk for overdose.”  CMS Ex. 54 ¶ 22.  Dr. Haag testified prescribing a high dosage of opioids to S.A. when she did not have a cancer diagnosis represented a threat to the health and safety of S.A.  CMS Ex. 54 ¶ 23.  Finally, Dr. Haag testified that “Dr. Chen put his patients at risk for overdose by not starting his patients at the lowest dose for Subsys of 100 mcg.  He started Subsys therapy at a dose greater than 100 mcg for . . . SA.”  CMS Ex. 54 ¶ 17.  Dr. Haag noted that when Dr. Chen enrolled in the TIRF REMS program, he signed an agreement that he would start patients on the lowest possible dose of 100 mcg.  As Dr. Haag testified:  “Since Subsys is such a potent opioid medication, it is important that patients do not start out on too high a dosage, in order to reduce the risk of an overdose.  CMS Ex. 54 ¶ 16.  Dr. Haag’s opinion is supported by the record.  CMS Ex. 34 at 6.

Based on the evidence of record, I find that Dr. Chen prescribed Subsys for S.A. despite a lack of a cancer diagnosis with breakthrough pain.  Further, I find that Dr. Chen risked S.A’s health and safety by prescribing medications, including Subsys, which exceeded the MME level that the CDC has found to be safe.  Finally, I find that Dr. Chen violated the proper dosing guidelines for Subsys and initially prescribed S.A. Subsys at 400 mcg strength instead of at the required 100 mcg.  I accept the uncontroverted testimony of Dr. Haag that Dr. Chen’s actions placed S.A.’s health and safety at risk.

12. Dr. Chen prescribed Subsys for B.B. in March 2014 at 400 mcg strength, and only ceased prescribing it because B.B. did not receive sufficient relief and B.B.’s insurance would not cover it.  B.B. did not have a cancer diagnosis.  Further, under Dr. Chen’s care, B.B. was prescribed medications with an MME per day in excess of the maximum amount that the CDC has identified as being

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at an elevated risk level for an overdose.  Dr. Chen’s prescription of Subsys was a threat to the health and safety of B.B.

B.B. has been a Medicare Part A and Part B beneficiary since 2007.  CMS Ex. 29 at 2.  Dr. Chen began to treat B.B. in March 2013.  In a note following a March 11, 2013 examination, Dr. Chen assessed B.B. as having stroke-related pain, neuropathic facial and right lower and upper extremity pain, and hemiparesis.  CMS Ex. 29 at 204.

In a note of a March 24, 2014 evaluation, Dr. Chen indicated that he assessed B.B. with:  a history of CVA with residual symptoms, pain, and paresis; neuropathic facial and right lower and upper extremity pain; hemiparesis; long-term use of medications; and therapeutic drug monitoring.  CMS Ex. 29 at 145.  Dr. Chen also stated that B.B. had been authorized for Subsys and he prescribed for B.B. 120 units of Subsys at 400 mcg.  CMS Ex. 22 at 7; CMS Ex. 29 at 144, 146, 295.  In an April 7, 2014 note, Dr. Chen stated that B.B.’s Part D Plan informed B.B. that it mistakenly authorized Subsys, and Dr. Chen noted B.B. would “appeal to get authorization” from the Plan.  CMS Ex. 29 at 141, 143.

Dr. Haag testified that B.B. did not have a cancer diagnosis and opined that without the proper cancer diagnosis, the Subsys prescriptions placed B.B. “at risk of an overdose and opioid dependency.”  CMS Ex. 54 ¶¶ 14-15.  Further, Dr. Haag concluded from the review of B.B.’s records that Dr. Chen was prescribing medications with an MME exceeding 100, which Dr. Haag testified is an amount that “the CDC has identified as being at an elevated risk for overdose.”  CMS Ex. 54 ¶ 22.  Dr. Haag testified that prescribing a high dosage of opioids to B.B. when he did not have a cancer diagnosis represented a threat to the health and safety of B.B.  CMS Ex. 54 ¶ 23.  Finally, Dr. Haag testified that “Dr. Chen put his patients at risk for overdose by not starting his patients at the lowest dose for Subsys of 100 mcg.  He started Subsys therapy at a dose greater than 100 mcg . . . [f]or example, Dr. Chen prescribed patient BB an initial starting dosage of Subsys of 400 mcg, even though patient BB had not been prescribed Actiq in the past.”  CMS Ex. 54 ¶ 17.  Dr. Haag noted that when Dr. Chen enrolled in the TIRF REMS program, he signed an agreement that he would start patients on the lowest possible dose of 100 mcg.  As Dr. Haag testified:  “Since Subsys is such a potent opioid medication, it is important that patients do not start out on too high a dosage, in order to reduce the risk of an overdose.  CMS Ex. 54 ¶ 16.  Dr. Haag’s opinion is supported by the record.   CMS Ex. 34 at 6.

Based on the evidence of record, I find that Dr. Chen prescribed Subsys for B.B. despite a lack of a cancer diagnosis with breakthrough pain.  Further, I find that Dr. Chen risked B.B.’s health and safety by prescribing medications, including Subsys, which exceeded the MME level that the CDC has found to be safe.  Finally, I find that Dr. Chen violated the proper dosing guidelines for Subsys and initially prescribed B.B. Subsys at 400 mcg

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strength instead of at the required 100 mcg.  I accept the uncontroverted testimony of Dr. Haag that Dr. Chen’s actions placed B.B.’s health and safety at risk.

13. Dr. Chen prescribed Subsys for B.S. starting in March 2014, at a strength of 400 mcg, and continuing through June 2015, at which time he was prescribing Subsys at 600 mcg strength.  B.S. did not have a cancer diagnosis.  Further, under Dr. Chen’s care, B.S. was prescribed medications with an MME per day in excess of the maximum amount that the CDC has identified as being at an elevated risk level for an overdose.  Dr. Chen’s prescription of Subsys was a threat to the health and safety of B.S.

B.S. was a Medicare Part A and Part B beneficiary since 1995 and 1997, respectively.  CMS Ex. 26 at 151.  B.S. had been in a vehicular accident involving a head-on collision, and was on permanent disability.  CMS Ex. 26 at 154, 155, 158.  The earliest note of an examination of B.S. by Dr. Chen is February 3, 2011, in which the chief complaint that B.S. had was neck and back pain.   CMS Ex. 11 at 2; CMS Ex. 26 at 155, 245.  On February 3, 2011, B.S. entered into a Pain Management Agreement with Dr. Chen in which B.S. agreed, among other things, not to use any illegally controlled substance “including marijuana, cocaine, etc.,” to “not attempt to obtain any controlled medicines . . . from any other doctor,” and to “submit to a blood or urine test [that] is requested by my doctor.”  CMS Ex. 26 at 163.  Dr. Chen noted, following an April 7, 2011 examination, that B.S. was seeing a certain physician, but that physician “will no longer be prescribing narcotics.”  CMS Ex. 26 at 242.

B.S. apparently stopped seeing Dr. Chen in 2011; however, B.S. again signed the Pain Management Agreement in March 2014 when he returned to Dr. Chen’s care.  CMS Ex. 26 at 147.  In a March 13, 2014 note, Dr. Chen diagnosed B.S. with Lumbar and Cervical Radiculopathy and decided to prescribe Subsys at 400 mcg.  CMS Ex. 26 at 241.  Dr. Chen replaced a prescription of Dilaudid with Subsys, asserting that Subsys had no street value and had a reduced potential for abuse, but also acknowledging that it is a stronger medication.  CMS Ex. 26 at 241.  In an April 8, 2014 note, Dr. Chen noted that B.S. was “very happy with subsys.”  CMS Ex. 26 at 237.

Dr. Chen prescribed Subsys for B.S., or B.S. filled Dr. Chen’s Subsys prescriptions, as follows:  120 units at the 400 mcg strength level in March, April, and May 2014; and 120 units at the 600 mcg strength level in July 2014, August 2014, September 2014, October 2014, January 2015, February 2015, March 2015, April 2015, May 2015, June 2015, July 2015, and August 2015.  CMS Ex. 22 at 7-9, 11, 13, 15, 16, 18, 21, 23, 26, 27, 29, 31, 39-41; CMS Ex. 26 at 208, 210, 212, 215, 217, 219, 221, 223, 225, 226, 228, 230, 234-236, 241, 266-267, 269, 271, 273, 275-277,  279, 282, 285, 288.  In a June 25, 2015 note, Dr. Chen indicated that B.S. wanted to stop Subsys and had admitted to taking MS Contin along with the Subsys; however, B.S. agreed to continue with that combination.  CMS Ex. 26 at 213.  In a September 3, 2015 note, Dr. Chen indicated “Stop subsys as pt

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[patient] does not want it due to uncertainty of delivery and authorizations.  But was helpful when it was delivered.”  CMS Ex. 26 at 205.

In a June 17, 2014 note, Dr. Chen recorded that B.S. went to another physician for Dilaudid and Dr. Chen reviewed the Pain Agreement with B.S., presumably the provision that deals with not obtaining controlled substances from other physicians.  CMS Ex. 26 at 236.  In August 2014, Dr. Chen noted that a tumor had been found in B.S.’s neck and removed by surgery; however, the note did not indicate that the tumor was cancerous and Dr. Chen did not include cancer as a diagnosis.  CMS Ex. 26 at 230.  In an August 4, 2015 note, Dr. Chen indicated that B.S. reported that his MS Contin had been stolen.  CMS Ex. 26 at 207.  Dr. Chen’s last examination of B.S. was on October 5, 2016, at which time Dr. Chen recorded that he was being discharged from Dr. Chen’s care due to a positive urine drug test.  CMS Ex. 11 at 4; CMS Ex. 26 at 167.

Dr. Haag testified that “Dr. Chen put his patients at risk for overdose by not starting his patients at the lowest dose for Subsys of 100 mcg.  He started Subsys therapy at a dose greater than 100 mcg for . . . BS.”  CMS Ex. 54 ¶ 17.  Dr. Haag noted that when Dr. Chen enrolled in the TIRF REMS program, he signed an agreement that he would start patients on the lowest possible dose of 100 mcg.  As Dr. Haag testified:  “Since Subsys is such a potent opioid medication, it is important that patients do not start out on too high a dosage, in order to reduce the risk of an overdose.  CMS Ex. 54 ¶ 16.  Dr. Haag’s opinion is supported by the record.   CMS Ex. 34 at 6.

Dr. Haag also testified that “Dr. Chen put his patients at risk for an overdose and opioid dependency by failing to regularly check CURES to make sure that they were not receiving any other opioids from other providers.”  CMS Ex. 54 ¶ 25.  Dr. Haag’s review of the records related to B.S. showed that “Dr. Chen documented that he checked CURES for patient BS on October 7, 2014, but according to Dr. Chen’s notes he did not check CURES for patient BS again until May 17, 2016.  CMS Ex. 26 at 182-226.”  CMS Ex. 54 ¶ 25.

Dr. Haag further testified that Dr. Chen threatened B.S.’s health and safety by prescribing Subsys without a medically supported reason.  For B.S., Dr. Chen’s purported reason for discontinuing Dilaudid and replacing it with Subsys was that, unlike Dilaudid, Subsys had no street value.  However, Dr. Haag testified that such a consideration is not a valid reason because both drugs have a street value, Subsys is a substantially more potent pain reliever, and drugs with higher potency typically have a higher street value.  CMS Ex. 54 ¶ 44.  

Finally, Dr. Haag testified that Dr. Chen threatened B.S.’s health and safety by failing to adequately assess and document B.S.’s risk for substance abuse.  Dr. Haag noted that Dr. Chen knew that another physician had refused to prescribe narcotics to B.S., but Dr. Chen did not address that issue.  Dr. Haag stated that Dr. Chen needed to find out

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why the other physician took that action because Dr. Chen had to consider potential substance abuse problems when prescribing to ensure B.S. would not overdose.  Further, Dr. Haag said that Dr. Chen’s notes indicate a check with the sheriff’s office concerning a DUI, but there is no other information.  Dr. Haag testified that alcohol use with Subsys can result in grave consequences for a patient:  “In other words, taking Subsys with alcohol can cause a patient to overdose.”  Dr. Haag noted further that Dr. Chen discharged B.S. after B.S. tested positive for methadone and methamphetamine in his urine.  CMS Ex. 54 ¶ 46-47.

Based on the evidence of record, I find that Dr. Chen prescribed Subsys for B.S. for more than a year despite a lack of a cancer diagnosis with breakthrough pain.  Further, I find that Dr. Chen did not comply with the requirement that he start patients like B.S. at 100 mcg of Subsys, and instead, started B.S. at the significantly higher strength of 400 mcg.  In addition, I find that Dr. Chen failed to check CURES to monitor for all controlled substances that practitioners were prescribing for B.S.  I also find that Dr. Chen did not have a medically acceptable reason for substituting Dilaudid with Subsys.  Finally, I find that Dr. Chen did not adequately inquire into or document issues related to B.S.’s potential substance abuse problems.  I accept the uncontroverted testimony of Dr. Haag that Dr. Chen’s actions placed B.S.’s health and safety at risk.

14. Dr. Chen prescribed Subsys for R.S. from October 2014 through January 2016, and only ceased because R.S. had difficulty obtaining insurance authorization for further prescriptions.  R.S. did not have a cancer diagnosis.  Further, under Dr. Chen’s care, R.S. was prescribed medications with an MME in excess of the maximum amount that the CDC has identified as being at an elevated risk level for an overdose.  Dr. Chen’s prescription of Subsys was a threat to the health and safety of R.S.

Dr. Chen began treating R.S. in July 2014.  See CMS Ex. 27 at 155-162.  In a July 21, 2014 note, Dr. Chen made the following assessments for R.S.:  Systemic Lupus Erythematous; chronic pain syndrome; generalized body ache; obesity; anxiety; and depression.  CMS Ex. 12 at 3; CMS Ex. 27 at 219.

Dr. Chen first prescribed Subsys for R.S. on October 17, 2014, at the 100 mcg strength level.  CMS Ex. 27 at 307.  Dr. Chen prescribed for R.S. 120 units of Subsys at 100 mcg in November 2014, December 2014, and January 2015.  CMS Ex. 22 at 18-20; CMS Ex. 27 at 205, 207, 211, 300-302, 304.  Starting in February 2015, and continuing in March 2015, April 2015, May 2015, June 2015, July 2015, August 2015, September 2015, October 2015, November 2015, December 2015, and January 2016, Dr. Chen prescribed Subsys at the 200 mcg strength level.  CMS Ex. 22 at 22, 24, 26-29, 31-33; CMS Ex. 27 at 173, 176, 179, 182, 185, 187, 191, 193, 195, 197, 199, 201.  In a February 1, 2016 note, Dr. Chen wanted to continue to prescribe Subsys for R.S.; however, R.S. was “[u]nable to get subsys due to auth issues.”  CMS Ex. 27 at 168, 170.

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Dr. Haag testified that R.S. did not have a cancer diagnosis and opined that without the proper cancer diagnosis, the Subsys prescriptions placed R.S. “at risk of an overdose and opioid dependency.”  CMS Ex. 54 ¶¶ 14-15.  Further, Dr. Haag concluded from the review of R.S.’s records that Dr. Chen was prescribing medications with an MME exceeding 100, which Dr. Haag testified is an amount that “the CDC has identified as being at an elevated risk for overdose.”  CMS Ex. 54 ¶ 22.  Dr. Haag testified prescribing a high dosage of opioids to R.S. when R.S. did not have a cancer diagnosis represented a threat to the health and safety of R.S.  CMS Ex. 54 ¶ 23.

Based on the evidence of record, I find that Dr. Chen prescribed Subsys for R.S. for nearly a year and a half despite a lack of a cancer diagnosis with breakthrough pain.  Further, I find that Dr. Chen risked R.S.’s health and safety by prescribing medications, including Subsys, which exceeded the MME level that the CDC has found to be safe.  I accept the uncontroverted testimony of Dr. Haag that Dr. Chen’s actions placed R.S.’s health and safety at risk.

VII.  Conclusions of Law and Analysis

The Act authorizes the Secretary of Health and Human Services (Secretary) 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 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 Secretary delegated 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 supplier from re-enrolling 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)(ii).  In making a determination to revoke the enrollment and billing privileges of a physician under that provision, CMS considers factors including whether the physician has a pattern or practice of prescribing drugs under Medicare Part D that:

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1) fail to meet Medicare requirements such as “prescribing drugs for indications that were not medically accepted–that is, for indications neither approved by the FDA nor medically accepted under section 1860D-2(e)(4) of the Act”; and

2) “whether there is evidence that the physician . . . acted in reckless disregard for the health and safety of the patient.”

42 C.F.R. § 424.535(a)(14)(ii)(C).

1. Dr. Chen failed to meet Medicare requirements because he prescribed Subsys to Medicare beneficiaries without an MAI as defined in section 1860D-2(e)(4) of the Act.  42 U.S.C. § 1395w-102(e)(4).

Relevant to this case, Medicare Part D covers “a drug that may be dispensed only upon a prescription . . . and [for] any use . . . for a medically accepted indication.”  42 U.S.C. § 1395w-102(e)(1).  An MAI for Medicare Part D has the same meaning for that term as in the Medicaid statute.  42 U.S.C. § 1395w-102(e)(4).  Therefore, for drugs not used in an anti-cancer regimen, an MAI is any use for an otherwise-covered outpatient drug that is either:  1) approved by the FDA under specified sections of the Federal Food, Drug, and Cosmetic Act; or 2) supported by one or more citations approved for inclusion in one or more drug compendia listed in the statute.  42 U.S.C. § 1396r-8(g)(1)(B)(i), (k)(6).  The Medicare-approved compendia are the American Hospital Formulary Service – Drug Information, the Micromedex Drugdex Information System, and the United States Pharmacopeia-Drug Information (USPDI) or its successor.  42 U.S.C. § 1927(g)(1)(B)(i).  Neither the USPDI nor a successor is currently in publication.

The FDA’s only approved use for Subsys is the same as the only use supported in the Medicare-approved compendia.  Subsys is for breakthrough cancer pain for an individual who is already tolerant to around-the-clock opioid therapy.  CMS Ex. 54 ¶ 11; see CMS Ex. 15 at 2; CMS Ex. 16; CMS Ex. 32 at 113.

Petitioner does not directly dispute CMS’s position and evidence that Subsys has only been approved by the FDA and supported by the drug compendia for use by individuals with breakthrough pain from cancer when already tolerant to around-the-clock opioid therapy.  See P. Br. 5-11 (indicating that, while the beneficiaries involved in this case were opioid tolerant, they had diagnoses other than cancer).  Rather, Petitioner argues that off-label prescribing of Subsys is within the standard of care for physicians and that the FDA does not regulate how physicians use approved drugs.  P. Br. at 17.  Petitioner also cited cases in which federal courts had ordered Medicare coverage for certain procedures as being medically necessary.  P. Br. at 18.

Petitioner’s arguments do not address the statutory requirement in Medicare Part D that, for drugs not used in an anti-cancer regimen, an MAI is limited to those uses approved by

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the FDA or for those uses approved for inclusion in a Medicare-approved compendium.  The term MAI is defined by statute and, therefore, it controls in this case.  As stated by the Medicare Appeals Council (MAC), when addressing this issue in the Medicare Part D coverage context: 

There is no question that the enrollee’s use of Geodon in this case is not FDA approved (i.e., not “on label”).  Therefore, the enrollee’s “off-label” use of Geodon must be supported by a statutorily recognized compendium.  The Council has determined, as explained earlier, that this requirement has not been met.

R.S., MAC Docket No. M-11-1799 at 9 (September 8, 2011) available at https://www.hhs.gov/sites/default/files/static/dab/decisions/council-decisions/m-11-1799.pdf (last visited April 20, 2020).  Therefore, I conclude that for the ten Medicare beneficiaries discussed in this decision, Petitioner did not prescribe Subsys for an MAI cognizable under the definition of that term in section 1860D-2(e)(4) of the Act.  42 U.S.C. § 1395w-102(e)(4).

2. Dr. Chen acted with reckless disregard to the health and safety of his patients when he prescribed Subsys to Medicare beneficiaries in violation of the terms of his TIRF REMS agreement and the manufacturer’s dosing instructions, and to Medicare beneficiaries who had an MME that was higher than a safe level as determined by the CDC and who were potential and actual drug abusers.

Under 42 C.F.R. § 424.535(a)(14)(ii)(C), revocation cannot be solely based on a physician failing to prescribe in a manner that meets Medicare requirements.  Rather, there must be evidence that the physician prescribed drugs in reckless disregard of the health and safety of his patients.  Neither the regulation nor the preamble to the final rule explains what “reckless disregard” means.  Therefore, I look to the first and third definitions below:

1.  Conscious indifference to the consequences of an act.
2.  Defamation.  Serious indifference to truth or accuracy of a publication.  “Reckless disregard for the truth” is the standard in proving the defendant’s actual malice toward the plaintiff in a libel action.
3.  The intentional commission of a harmful act or failure to do a required act when the actor knows or has reason to know of facts that would lead a reasonable person to realize that the actor’s conduct both creates an unreasonable risk of harm to someone and involves a high degree of probability that substantial harm will result.

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Black’s Law Dictionary (11th ed. 2019) (emphasis in original).  Consistent with the third definition, to avoid a finding of reckless disregard, the individual’s belief that his conduct was appropriate “had to be objectively reasonable.”  Karim Maghareh, Ph.D. & BestCare Lab. Servs., LLC, DAB No. 2919 at 22 (2018) (emphasis in original).

Petitioner argues that studies and medical literature show Subsys is used for breakthrough pain in non-cancer patients and that almost 40% of physicians already prescribe Subsys to non-cancer patients.  P. Br. at 16.  However, as found earlier in this decision, I have accepted the testimony of CMS’s expert witnesses that Petitioner’s actions endangered the health and safety of each of the ten Medicare beneficiaries involved in this case.  These findings are based on the specific facts related to each beneficiary. 

I also conclude that, as already discussed in detail above, Petitioner acted in reckless disregard for his patients’ health and safety.  Petitioner, time and time again, prescribed Subsys, a fentanyl drug, to those Medicare beneficiaries even though, under the terms of the FDA’s TIRF REMS program, Petitioner was prohibited from doing so.  The TIRF REMS programs was created to control extremely potent drugs like Subsys because Subsys is very addictive and poses a real danger for overdosing.  Petitioner, in nearly cavalier fashion, disregarded the manufacturer’s instructions that the initial prescription for Subsys was to be at 100 mcg strength.  Petitioner also completely disregarded the fact that his prescriptions to the Medicare beneficiaries were at MME danger levels.  Petitioner did not regularly check CURES to see if the beneficiaries were obtaining drugs from other practitioners, which may affect the MME.  He also failed to actively care whether the beneficiaries, such as M.P., abused drugs.  Amazingly, even after M.P. informed Petitioner in 2013 that the police and the DEA told M.P. that he could not legally possess Subsys without a cancer diagnosis, Petitioner simply disassociated himself from M.P., but continued his off-label prescriptions of Subsys to other patients.

Finally, Petitioner’s clinical decisions with respect to A.S. clearly show Petitioner’s indifference to his patient’s health and safety.  His decision to prescribe significant amounts of benzodiazepines along with Subsys was extremely risky.  Petitioner is a specialist in the field of pain management and has extensive training and knowledge in that field.  CMS Ex. 3.  It is inconceivable that he did not fully understand the jeopardy in which he placed A.S.

The regulation used to revoke Petitioner’s Medicare enrollment and billing privileges had its origins in an effort to help protect Medicare beneficiaries from the scourge of prescription drug addiction and the deaths associated with it.  As stated in the preamble to the final rule:

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The OIG [Office of Inspector General] has expressed particular concern over the potential for beneficiaries to become addicted to or otherwise be seriously harmed by certain drugs if they are inappropriately prescribed in dangerously excessive amounts.  We share this concern, particularly as we continue to receive reports of improper prescribing practices.  The difficulty, as we explained in the proposed rule, is that CMS does not possess the legal authority to take administrative action against the prescriber.  This means, in many cases, that the individual can continue prescribing drugs that will be covered under Part D and, if he or she is enrolled in Medicare, remain so enrolled to furnish medical services.  We believe this is inconsistent with:  (1) The OIG’s recommendations in its various Part D reports; and (2) our goals of protecting and promoting the health and safety of Medicare beneficiaries and of safeguarding the Medicare Trust Funds.

79 Fed. Reg. 29,844, 29,895 (May 23, 2014).  Physicians should be the first line of defense against prescription drug abuse.  However, in this matter, it fell to CMS to protect Medicare beneficiaries from Petitioner’s practices.

3. Petitioner engaged in a pattern or practice of improper prescribing; therefore, CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(14)(ii).

The facts in this case show Petitioner engaged in a pattern or practice of prescribing Subsys to Medicare beneficiaries who did not have an MAI for that prescription.  The record shows prescriptions to ten beneficiaries from March 2013 to January 2016.  For some beneficiaries, Petitioner prescribed Subsys only a few times (e.g., A.H., B.B., B.C., S.A.).  However, Petitioner also prescribed Subsys for more than a year for many beneficiaries as well (e.g., A.S., B.S, M.F. M.P., R.S.).  For each of these beneficiaries, Petitioner wrote multiple, if not many, prescriptions for Subsys.

Petitioner argues that CMS is retroactively applying § 424.535(a)(14) for conduct occurring before the regulation’s effective date in July 2014.  P. Br. at 14.  Further, Petitioner asserts that § 424.535(a)(14) only authorizes revocation if Petitioner presently “has” a pattern or practice, but, at the time of the revocation, Petitioner had not been prescribing Subsys for two and a half years.  P. Br. at 15; see also Amended Request for Hearing at 4.

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The Secretary addressed both of Petitioner’s arguments in response to public comments in the final rule:

Comment:  Several commenters requested clarification regarding whether CMS intends to implement § 424.535(a)(14) retrospectively.  They supported a strictly prospective application.

Response:  We reserve the right to revoke the billing privileges of a physician or eligible professional enrolled as of the effective date of this rule who has engaged or is engaging in abusive prescribing as described in § 424.535(a)(14).  However, the effective date of the revocation would not be earlier than the effective date of this final rule.

79 Fed. Reg. at 29,901.  Therefore, the Secretary’s position is that CMS may revoke under § 424.535(a)(14) for conduct occurring before the regulation’s effective date so long as the revocation itself does not occur before that date.  Further, the Secretary interprets this regulation to apply to conduct that occurred in the past but is no longer occurring in the present.

In regard to Petitioner’s retroactivity concern, the position taken by the Secretary is similar to that taken by the Departmental Appeals Board.  See e.g., Michael Scott Edwards, OD, & M. Scott Edwards, OD, PA, DAB No. 2975 at 15 (2019) (“The [Departmental Appeals] Board applies the effective date regulation in place at the time of revocation.”); Pa. Physicians, P.C., DAB No. 2980 at 10-11 (2019).

Even if there were an issue of impermissible retroactivity in this case, it is not as straightforward as Petitioner argues.  Section 424.535(a)(14) took effect on July 22, 2014.  79 Fed. Reg. at 29,844.  Petitioner’s conduct in this case occurred before and after that effective date.  Petitioner did not stop prescribing Subsys in violation of Medicare requirements after the regulation became effective, despite a 60-day notice period published in the Federal Register.  79 Fed. Reg. at 29,844.  Therefore, Petitioner’s conduct after the effective date forms the basis for CMS’s action, and the conduct before the effective date may be considered in order to discern whether Petitioner engaged in a pattern or practice that continued after the regulation became effective.  However, even if it were impermissible to consider any of Petitioner’s actions before July 22, 2014, the record is sufficient to show that Petitioner engaged in a pattern or practice of improper prescribing practices simply by looking at the substantial number of Subsys prescriptions he wrote after that date for beneficiaries A.S., B.S., M.F., and R.S.  Indeed, Petitioner did not start prescribing Subsys for R.S. until shortly after § 424.535(a)(14) took effect, and

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he continued until January 2016.  In addition, it was in 2015 that A.S. died of acute fentanyl intoxication while under Petitioner’s care.

Finally, as indicated in the response to the public comment in the final rule quoted above, Petitioner’s interpretation of the word “has” in § 424.535(a)(14)(ii) is far too limiting.  Petitioner would read the word “has” to mean that revocation under § 424.535(a)(14) could not occur unless Petitioner was engaging in a pattern or practice of improper prescribing at the time of the revocation.  However, it is possible for an individual to have a pattern or practice of improper prescribing for some time after stopping that practice.  Stopping the conduct does not erase the existence of it in the past, at least not in the recent past.  In this matter, as indicated at the beginning of this decision, CVS Caremark informed CMS that Petitioner was engaging in questionable prescribing practices.  The MEDIC promptly conducted an extensive investigation and CMS needed to review all of that evidence before revoking Petitioner’s enrollment and billing privileges.  It is to the benefit of enrolled suppliers that CMS does not take precipitous action when dealing with a complicated matter, such as discerning whether a practitioner has a pattern and practice of improper prescribing.  Two and a half years is not an unreasonable amount of time to thoroughly investigate this matter and conclude that revocation is necessary.

VIII.  Conclusion

I affirm CMS’s revocation of Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(14)(ii).

• 1. I directed the parties to submit written direct testimony and specified that “[y]ou must submit each witness statement 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.”  Order ¶ 8; CRDP § 19(b); see also 28 U.S.C. § 1746.  This is meant to ensure compliance with the requirement that “[w]itnesses at the hearing testify under oath or affirmation.”  42 C.F.R. § 498.62; see 42 U.S.C. §§ 405(b)(1), 1395cc(j)(8) (providing for the administration of oaths and affirmations, and the examining of witnesses at hearings).
• 2. For the reasons stated below, I uphold CMS’s revocation based on 42 C.F.R. § 424.535(a)(14)(ii).  Therefore, I do not rule on whether there is a basis for me to uphold the revocation under 42 C.F.R. § 424.535(a)(14)(i).
• 3. My Findings of Fact in this section of the decision, as well as my Conclusions of Law in the next section, appear in bold and italics.
• 4. I refer to Dr. Chen’s patients by their initials to protect their privacy.