Michael W. Lawrence, DPM, DAB CR5420 (2019)

DECISION

“[A]ny individual or entity that is excluded [from participation in all federal health care programs] . . . under this section is entitled to reasonable notice and opportunity for a hearing thereon by the Secretary . . . .” 42 U.S.C. § 1320a-7(f)(1).

In this case, Michael W. Lawrence, DPM (Dr. Lawrence or Petitioner) only received notice earlier this year that the Inspector General (IG) of the United States Department of Health and Human Services excluded him in early 2015, for five years, from participation in all federal health care programs. As a result, Dr. Lawrence has only now received his opportunity for a hearing by an administrative law judge (ALJ). Despite this lack of notice, neither the Social Security Act (Act) nor the regulations provide redress for the IG’s actions, except to permit this proceeding to review the IG’s imposition of the exclusion.   

Based on the record in this matter, the IG correctly concluded that the Act mandates Dr. Lawrence’s exclusion for a minimum of five years based on Dr. Lawrence’s criminal conviction. Consequently, I must affirm the IG’s determination to exclude Dr. Lawrence. 42 U.S.C. § 1320a-7(a)(4), (c)(3)(B).

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I. Background and Procedural History

On April 23, 2019, Dr. Lawrence requested a hearing to dispute an exclusion that the IG imposed on Dr. Lawrence in a notice dated January 30, 2015. The notice stated that the exclusion would take effect 20 days after the date on the notice. IG Exhibit (Ex.) 5.   

I was assigned to hear and decide this case. Therefore, I issued an Acknowledgment, Prehearing Order, and Notice of Prehearing Conference (Prehearing Order) to govern the prehearing process in this case. I also indicated that I would hold a prehearing conference and noted that “there is an issue as to whether Petitioner timely filed his hearing request under the applicable regulations.”

On May 22, 2019, I held the telephone prehearing conference. During the conference call, I confirmed that Dr. Lawrence did not have counsel and intended to represent himself. Further, I asked Dr. Lawrence when he received the IG’s January 30, 2015 exclusion notice. Dr. Lawrence responded that he probably received it in February 2015. I asked Dr. Lawrence why he did not request a hearing in 2015. Dr. Lawrence indicated that he was bewildered by the correspondence that he had received from the IG leading up to the January 30 exclusion letter. In particular, the IG had previously sent a notice dated May 28, 2014, stating an intent to exclude him based on 42 U.S.C. § 1320a-7(b)(4). Petitioner responded to the May 28 notice. Later that year he received another notice from the IG stating an intent to exclude him under 42 U.S.C. § 1320a-7(a)(4). Petitioner thought this notice was an exclusion notice, even though it was only a second notice indicating an intent to exclude. Dr. Lawrence was particularly displeased that the IG did not consider his response to the May 28 notice. Dr. Lawrence stated that he filed a hearing request after discussing the matter with IG staff. 

I told Dr. Lawrence at the prehearing conference that a hearing request had to be filed within 60 days of receipt of the exclusion notice. I informed Dr. Lawrence that the regulations did not permit me to accept a late-filed hearing request. Further, I said that I did not have jurisdiction to review an exclusion where there was an untimely hearing request and that the regulations required me to dismiss an untimely filed hearing request. 

On May 23, 2019, I issued an order that summarized the prehearing conference and dismissed Dr. Lawrence’s hearing request as untimely.   

On June 19, 2019, Dr. Lawrence requested that I reconsider the dismissal of his hearing request. Petitioner submitted five exhibits in support of reconsideration (P. Mot. Recon. Exs. 1-5). Departmental Appeals Board (DAB) E-File Document # 7. Petitioner asserted that he reviewed his file after the prehearing conference and realized that he had not received the January 30, 2015 exclusion notice until he made a document request to the IG. Specifically, Petitioner said that the IG sent a July 2014 notice of intent to exclude to his former work address of 6918 Shallowford Road, Suite 111, Chattanooga, Tennessee

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(Shallowford Road address), and that the IG received that notice back from the United States Postal Service (USPS) as undeliverable. P. Mot. Recon. Exs. 1, 2. The USPS also indicated that it could not forward the notice. P. Mot. Recon. Ex. 1. The IG later sent the January 30, 2015 exclusion notice to Petitioner’s Shallowford Road address. P. Mot Recon. Ex. 3. 

On June 28, 2019, the IG responded to Petitioner’s reconsideration request. In her response, the IG agreed with the basic facts asserted by Petitioner, but stated that the IG never received the January 30, 2015 exclusion notice back from the USPS. DAB E-File # 8. Further, the IG indicated that her office confirmed through a commercial database that Dr. Lawrence’s Shallowford Road address was his current address in May 2014. The IG also submitted six exhibits (IG Exs. 1-6), five of which were the same as Petitioner’s exhibits. The additional exhibit is a copy of the IG’s LexisNexis search result on May 19, 2014, showing that Dr. Lawrence’s Shallowford Road address was then his current address. IG Ex. 6.         

On July 1, 2019, without seeking leave, Petitioner replied to the IG’s response. DAB E-File Document # 9. Also on July 1, 2019, I ordered the parties to submit additional information (i.e., affidavits/declarations/other documents) related to the date on which Petitioner vacated the Shallowford Road address and Petitioner’s receipt of the January 30, 2015 exclusion notice.

On July 5, 2019, Petitioner submitted a declaration in which he stated that he first received the January 30, 2015 exclusion notice on April 8 or 9, 2019. Along with the declaration, Petitioner enclosed an April 2, 2019 letter from the IG responding to Petitioner’s Freedom of Information Act (FOIA) request for a copy of his exclusion file and also, the April 4, 2019 email from the IG to which that letter and the responsive documents were attached. DAB E-File Document # 14.    

Also on July 5, 2019, Petitioner submitted letters from the owner of the office building at the Shallowford Road address stating that Petitioner vacated that location in July 2013, and from the owner of a building at 6074 East Brainerd Road confirming that Petitioner began renting an office there in June 2013, which Petitioner kept until July 2017. DAB E-File Document # 15. 

The IG filed a statement on July 10, 2019, in which she indicated that she had no response to my July 1, 2019 order to submit additional information.   

On July 15, 2019, I issued an order vacating my earlier dismissal of Dr. Lawrence’s hearing request because I concluded that Dr. Lawrence made a reasonable showing that he did not receive the January 30, 2015 exclusion notice until April 2019. I considered the following undisputed facts as central to my conclusion:

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1. 1. The IG mailed the May 2014 notice of intent to exclude to Petitioner at the Shallowford Road address, and Petitioner received and responded to that notice. IG Exs. 1, 2.
2. 2. The IG mailed the July 2014 notice of intent to exclude to Petitioner at the Shallowford Road address, and the USPS returned the notice to the IG with the following stamped information on the envelope (IG Exs. 3, 4):

Return to Sender

Not Deliverable as Addressed

Unable to Forward

1. 3. The IG mailed the January 30, 2015 exclusion notice to Petitioner at the Shallowford Road address. IG Ex. 5.
2. 4. Petitioner did not request a hearing within 65 days of January 30, 2015.1
3. 5. Petitioner submitted a FOIA request to the IG on March 14, 2019, for a complete copy of his exclusion file, and the IG provided 50 of the 51 pages in the file to Petitioner on April 4, 2019. DAB E-file Document # 14.      

I provided the following analysis in the July 15, 2019 order:

The IG’s position that it was sufficient to send the January 30, 2015 exclusion notice to the Shallowford Road address was dealt a fatal blow when the USPS notified the IG that the July 2014 notice of intent to exclude was not deliverable and could not be forwarded to Petitioner. At that point, the IG was on actual notice that Petitioner did not receive the July 2014 notice of intent to exclude and would not receive future correspondence sent to the Shallowford Road address. Although IG counsel asserts that the IG never received the exclusion notice back from the USPS, IG counsel did not provide a declaration or affidavit from an IG employee to that effect. Rather, the IG’s position is that it had checked the viability of the Shallowford Road address in May 2014, and that is the only time the IG did so.

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The regulations state that the IG “will send written notice of this decision [to exclude] to the affected individual or entity.” 42 C.F.R. § 1001.2002(a). Implicit in that regulation is a requirement that the IG will send the exclusion notice to a current address for the affected individual. Excluded individuals have a statutory right to notice of the exclusion, and the IG must not send exclusion notices to addresses that the IG has reason to believe are no longer current for an excluded individual. It was not reasonable for the IG to rely on sending the January 30, 2015 exclusion notice to the Shallowford Road address without investigating further following the return of the July 2014 notice of intent to exclude. 

Although not undisputable, there are other reasons to conclude that Petitioner did not receive notice of the exclusion until April 2019. Petitioner’s response to the May 2014 notice of intent to exclude was made within weeks of the date on the notice and provides a spirited objection to exclusion. IG Ex. 2. It would be inconsistent for Petitioner to simply fail to respond to the January 30, 2015 exclusion notice. 

Further, the IG argues that Petitioner said in an email that the address on his response to the May 2014 notice of intent to exclude was his correct address. Although the Shallowford Road address is written by hand on the Petitioner’s response to the May 2014 notice of intent to exclude, Petitioner disputes he wrote that. Further, what Petitioner actually said in the email is that “[m]y new address would have shown on the envelope from my letter of explanations of June 22, 2014 . . . .” DAB E-file Document # 6 (emphasis added). Petitioner was clearly not referencing the hand written address on the letter itself. Unhelpfully, the IG did not provide a copy of the envelope to Petitioner’s June 22, 2014 letter. 

Finally, Petitioner provides letters from property owners to support his contention that he had leased office space at the Shallowford Road address until July 2013, but leased a smaller office in June 2013. DAB E-file Document #15. Because the USPS only forwards mail for a maximum of one year following a change of address, this information provides

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a chronology as to why the USPS forwarded the May 2014 notice of intent to exclude to Petitioner, but did not forward the second notice of intent to exclude sent near the end of July of 2014. See U.S. Postal Service, Forward Mail,     https://www.usps.com/manage/forward.htm (last visited on July 11, 2019).

Also in the July 15, 2019 order, I established a prehearing submission schedule. 

Petitioner submitted a Motion for Summary Judgment (P. MSJ). The IG then filed a short-form brief (IG Br.) and four exhibits (IG Exs. 7-10). Petitioner later submitted a short-form brief (P. Br.), a supplemental brief responding to the IG’s brief (P. Supp. Br.) and five exhibits (P. Exs. 1-5). The IG filed a reply brief (IG Reply).

II. Decision on the Record

Neither party objected to any of the proposed exhibits; therefore, I admit them all into the record. Prehearing Order ¶ 11; 42 C.F.R. § 1005.8(c); Civil Remedies Division Procedures (CRDP) § 14(e).  

Petitioner moves for summary judgment, arguing that the IG has no material facts that support Petitioner’s exclusion and that the IG’s errors prevented Petitioner from receiving due process. P. MSJ at 1. Petitioner asserts that the IG did not follow her procedures to provide him with a notice of intent to exclude. P. Supp. Br. at 1. Further, Petitioner argues that the IG “knowingly and intentionally sent [the January 30, 2015 exclusion notice] to an invalid, undeliverable address, therefore petitioner never received said document.” P. Supp. Br. at 2. As a result, Petitioner believes that the exclusion notice is defective and “should be invalidated and expunged.” P. Supp. Br. at 4. In response, the IG argues that the Act requires Petitioner’s exclusion and Petitioner is receiving due process through the current proceeding. IG Br. at 8-9. 

I deny Petitioner’s summary judgment motion. Despite the IG’s failure to properly serve Petitioner with the exclusion notice, Petitioner’s exclusion became effective 20 days following the date on the exclusion notice. 42 C.F.R. § 1001.2002(b). I do not have authority to disregard this regulation. 42 C.F.R. § 1005.4(c)(1).2 Further, the IG was not

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required to provide Petitioner with a notice of intent to exclude because the IG imposed a mandatory five-year exclusion and the IG is only required to send such notices when the IG imposes a mandatory exclusion that will last longer than five years or imposes a permissive exclusion. 42 C.F.R. § 1001.2001(a). As the IG argued, Petitioner is receiving his opportunity for a hearing in this proceeding.  

In their briefs, both parties indicated that neither had any witness testimony to offer and both thought that an in-person hearing was unnecessary to decide this case. IG Br. at 8; P. Br. at 2. Therefore, I issue this decision based on the written record. Prehearing Order ¶¶ 10, 15; CRDP § 19(d).     

III. Issue

Whether the IG had a basis to exclude Petitioner for five years from participation in Medicare, Medicaid, and all other healthcare programs. 42 C.F.R. § 1001.2007(a)(1)-(2). 

IV. Jurisdiction

I have jurisdiction to adjudicate this case. 42 U.S.C. § 1320a-7(f)(1); 42 C.F.R. § 1005.2. 

V. Findings of Fact, Conclusions of Law, and Analysis

My findings of fact and conclusions of law are set forth in italics and bold font.

The Secretary of Health and Human Services (Secretary) must exclude an individual from participation in Medicare, Medicaid, and all other federally-funded health care programs if that individual:

has been convicted for an offense which occurred after August 21, 1996, under Federal or State law, of a criminal offense consisting of a felony relating to the unlawful manufacture, distribution, prescription, or dispensing of a controlled substance.

42 U.S.C. § 1320a-7(a)(4). Further, the regulations implementing this statute state that this exclusion provision applies to, among others, health care practitioners. 42 C.F.R. § 1001.101(d)(1). Therefore, the five essential elements necessary to support the IG’s exclusion are: (1) the individual to be excluded must have been convicted of a criminal

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offense; (2) the criminal offense must have been a felony; (3) the felony conviction must have been for conduct relating to the unlawful manufacture, distribution, prescription, or dispensing of a controlled substance; (4) the felonious conduct must have occurred after August 21, 1996; and (5) the individual to be excluded is or was a health care practitioner. 42 U.S.C. § 1320a-7(a)(4); 42 C.F.R. § 1001.101(d)(1).

1. 1. Petitioner pleaded guilty in the United States District Court, Eastern District of Tennessee (District Court), to failing to maintain records according to the Controlled Substance Act in violation of 21 U.S.C. §§ 827(a)(3) and 843(a)(4)(A), and the District Court entered a Judgment in a Criminal Case adjudging Petitioner guilty and sentencing him to home detention for three months. 

On April 26, 2011, a Grand Jury impaneled by the District Court issued a 13-Count Indictment charging Petitioner with violating 21 U.S.C. §§ 827(a)(3) and 843(a)(4)(A) by failing to maintain records of Hydrocodone, a controlled substance, “which were received, delivered, and otherwise disposed of by” Petitioner. IG Ex. 7. Petitioner and the United States Attorney filed a Plea Agreement in which Petitioner agreed to plead guilty to one of the 13 counts in the Indictment. IG Ex. 8. Petitioner stipulated to the following facts:

In June of 2009, the Drug Enforcement Administration (DEA) began an investigation of Michael W. Lawrence, D.P.M. predicated upon his excessive purchases of Hydrocodone, a Schedule 3 controlled substance, ascertained from DEA records. On June 24, 2009, Dr. Lawrence admitted that he had purchased and distributed the Hydrocodone to unidentified recipients who were neither patients nor DEA registrants. An inspection of Dr. Lawrence’s office on June 24, 2009, revealed that he had neither the drugs nor any accountability records of their distributions as required by law.

On September 18, 2009, a representative of Moore Medical in Farmington, Connecticut, revealed that their records reflected that Dr. Lawrence had represented to them that he purchased the Hydrocodone to donate it to “medical missions.” During the time period of the indictment, Dr. Lawrence purchased considerable dosage units of Hydrocodone from Moore Medical according to their records. DEA’s records revealed that during this period Dr. Lawrence purchased Hydrocodone from other sources as well. One such instance is that charged in Count 13 of the Indictment, where Hydrocodone was

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ordered and received by Dr. Lawrence, and no record of same was made of this material fact by Dr. Lawrence as required by law.

IG Ex. 8 at 1-2.

On January 26, 2012, the District Court entered a Judgment in a Criminal Case in which it acknowledged Petitioner pleaded guilty to Count 13 in the Indictment, adjudged Petitioner guilty of that charge, and sentenced Petitioner to three months of home detention. IG Ex. 9 at 1, 3. 

1. 2. Petitioner was convicted of a criminal offense under 42 U.S.C. § 1320a-7(a)(4) because he pleaded guilty to violating 21 U.S.C. §§ 827(a)(3) and 843(a)(4)(A), and the District Court accepted that plea and entered judgment against him.    

For exclusion purposes, an individual is “convicted” of a criminal offense “when a judgment of conviction has been entered against the individual . . . by a Federal, State, or local court . . . .” 42 U.S.C. § 1320a-7(i)(1). Further, an individual is also “convicted” of a criminal offense when “a plea of guilty . . . by the individual . . . has been accepted by a Federal, State, or local court.” 42 U.S.C. § 1320a-7(i)(3). As previously discussed, Petitioner pleaded guilty to violating 21 U.S.C. §§ 827(a)(3) and 843(a)(4)(A), and the District Court accepted his plea and issued a judgment of conviction. IG Exs. 7-9. Petitioner concedes that he was convicted of a criminal offense. P. Br. at 1. Accordingly, for purposes of exclusion, Petitioner was “convicted” of a criminal offense.

1. 3. Petitioner was convicted of a felony.      

Petitioner was convicted of violating 21 U.S.C. §§ 827(a)(3) and 843(a)(4)(A), which is punishable by up to four years of imprisonment. 21 U.S.C. § 843(d)(1); IG Ex. 8 at 1.   Therefore, Petitioner was convicted of a class E felony because the maximum term of imprisonment for his offense was less than five years, but more than 1 year. 18 U.S.C. § 3559(a)(5). 

1. 4. Petitioner was convicted of a felony criminal offense relating to the unlawful manufacture, distribution, prescription, or dispensing of a controlled substance.

In order for a felony conviction to serve as a basis to exclude under 42 U.S.C. § 1320a-7(a)(4), that conviction must have been for conduct relating to the unlawful manufacture, distribution, prescription, or dispensing of a controlled substance. The terms “related to” and “relating to” in 42 U.S.C. § 1320a-7(a) simply mean that there must be a nexus or common sense connection. See James Randall Benham, DAB No. 2042 at 5 (2006) (internal citations omitted); see also Friedman v. Sebelius, 686 F.3d 813, 820 (D.C. Cir. 2012) (describing the phrase “related to” in another part of section 1320a-7 as

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“deliberately expansive words,” “the ordinary meaning of [which] is a broad one,” and one that is not subject to “crabbed and formalistic interpretation”) (internal quotation marks omitted). As discussed below, such a nexus exists between Petitioner’s criminal offense and the distribution or dispensing of a controlled substance.

The primary statutory obligation that Petitioner violated was that:

every registrant under this subchapter manufacturing, distributing, or dispensing a controlled substance or substances shall maintain, on a current basis, a complete and accurate record of each such substance manufactured, received, sold, delivered, or otherwise disposed of by him, except that this paragraph shall not require the maintenance of a perpetual inventory.

21 U.S.C. § 827(a)(3). Therefore, this provision directly discusses the duty to record controlled substances that a DEA registrant distributes or dispenses. In the Plea Agreement, Petitioner admitted that “he had purchased and distributed the Hydrocodone to unidentified recipients who were neither patients nor DEA registrants.” IG Ex. 8 at 2. 

In a disciplinary proceeding before the Tennessee Board of Podiatric Medical Examiners, Petitioner admitted additional facts related to his purchase and distribution of Hydrocodone. 

[Petitioner] has not maintained the required documentation regarding the 169,000 doses of Hydrocodone, such as purchase invoices, inventory logs or dispensing logs.

[Petitioner] claims he sent the 169,000 doses of Hydrocodone to overseas medical mission operations but will not reveal the names or locations of these operations.

[Petitioner] admits that sending controlled substances to overseas medical mission operations by improper means is unlawful.

IG Ex. 10 at 3. 

Therefore, while Petitioner’s crime was primarily an offense involving improper record keeping (42 U.S.C. § 843(a)(4)(A)), the specific facts and law of the case show that it was related to a failure to properly record and document the distribution or dispensing of a controlled substance.

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1. 5. The conduct for which Petitioner was convicted occurred after August 21, 1996.

Count 13 of the Indictment charged Petitioner with violating 21 U.S.C. §§ 827(a)(3) and 843(a)(4)(A) on May 12, 2008. IG Ex. 7 at 2. Petitioner pleaded guilty to Count 13 of the Indictment. IG Ex. 8 at 1. The District Court noted in its Judgment in a Criminal Case that Petitioner’s offense concluded on May 12, 2008. IG Ex. 9 at 1. Therefore, Petitioner’s criminal conduct occurred after August 21, 1996.        

1. 6. Petitioner is or has been a health care practitioner. 

The state of Tennessee licensed Petitioner as a doctor of podiatric medicine on May 15, 1986. The Tennessee Board of Podiatric Medical Examiners assigned Petitioner license number 297. IG Ex. 10 at 2. Therefore, Petitioner is or has been a health care practitioner for the purposes of the regulations implementing 42 U.S.C. § 1320a-7(a)(4). 42 C.F.R. § 1001.101(d)(1).        

1. 7. Under 42 U.S.C. § 1320a-7(a)(4), Petitioner must be excluded from participation in all federal health care programs for five years under 42 U.S.C. § 1320a-7(c)(3)(B). 

Petitioner argues that his conviction did not involve illegal distribution of controlled substances for monetary profit or for recreational/habitual use. Rather, Petitioner states that he simply failed to acquire a “Medical Mission Waiver Letter” from the DEA. P. Br. at 3. Petitioner asserts that even though the DEA conducted a two-year investigation, the DEA could not prove the criminal conduct that the DEA originally believed that Petitioner had committed. Therefore, the DEA “had to grab at straws” to charge him with criminal offenses. P. Supp. Br. at 2. Petitioner attributes the DEA’s inability to prove worse offenses to his record of working for and with medical missions to help the poor in other countries. P. Supp. Br. at 2; P. Exs. 2, 3. Petitioner asserts that he did not know of the DEA Medical Mission Waiver Letter requirement. Petitioner only pleaded guilty because the criminal matter “had broke him financially” and the DEA would have taken the case to trial. P. Supp. Br. at 3-4.        

Despite Petitioner’s arguments, neither the IG nor I have any authority to remove the exclusion or reduce the length of the exclusion. See 42 C.F.R. §§ 1001.1(b), 1001.101(d), 1001.102(a). Petitioner’s explanation that he only pleaded guilty to a crime due to a lack of resources to go to trial is not something that I can consider in this case. 42 C.F.R. § 1001.2007(d). My role in this proceeding is not to determine Petitioner’s guilt or innocence to the criminal charge that was brought against him. Further, I cannot consider equities or the fact that Petitioner’s actions may have involved helping the poor. 

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The United States Court of Appeals for the Ninth Circuit explained the mandatory nature of a five-year exclusion (albeit in a case involving a program-related crime rather than one involving controlled substances) in the following manner: 

However, the Inspector General was not engaging in a fact-finding or discretionary function when he excluded Travers.

Conviction of a program-related offense as defined by § 1320a–7(i) is the triggering event that mandates the Secretary to impose a minimum five-year exclusion. The language—“[t]he Secretary shall exclude”—is mandatory, not discretionary. 42 U.S.C. § 1320a–7(a). To determine whether Travers was convicted of a program-related offense, the Inspector General looked to the substance of the state proceedings and the nature of Travers’ crime as charged by the State of Utah. As noted by the district court, “[i]t is not necessary or proper for the Inspector General to delve into the facts surrounding the conviction.” Travers v. Sullivan, 801 F. Supp. 394, 403 (E.D. Wash. 1992). Once he found that the Utah state court’s disposition of the charge amounted to a conviction of a program-related offense, the Inspector General had no choice but to impose the mandatory 5–year exclusion under § 1320a–7(a)(1).

Travers v. Shalala, 20 F.3d 993, 998 (9th Cir. 1994). As indicated above, the record conclusively shows that Petitioner’s conviction meets all of the elements under 42 U.S.C. § 1320a-7(a)(4) for a mandatory exclusion. Therefore, the law required the IG to exclude Petitioner and requires me to affirm that exclusion. 

VI. Conclusion

I affirm the IG’s determination to exclude Petitioner for five years from participating in Medicare, Medicaid, and all federal health care programs under 42 U.S.C. § 1320a-7(a)(4).

• 1. Sixty-five days represents the 60-day time limit to file a hearing request and the presumption that an individual will receive an exclusion notice within five days of the date on the exclusion notice.  42 C.F.R. § 1005.2(c).
• 2. There is statutory support for the proposition that the exclusion was not effective until Petitioner received the exclusion notice.  See 42 U.S.C. § 1320a-7(c)(1).  However, such a conclusion would be at odds with the regulations, which I must follow.  Further, Petitioner does not identify any harm he has suffered by the substantial delay in learning about the exclusion.  He declares that he was unaware of the exclusion imposed on January 30, 2015, until April 2019, over four years since it went into effect.  However, the consequence of concluding that the five-year exclusion was not effective until Petitioner received a copy of the exclusion notice in April 2019, is that Petitioner would not be eligible for reinstatement until 2024.  Such a  result would cause Petitioner significant harm, in that he would be banned from participating in health care programs at a time when he now seeks employment requiring him to be able to so participate.