Cintron-Acevedo v. Department of Health Human Services

MOTION for Summary Judgment

D.P.R.April 28, 2017

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF PUERTO RICO FRANCISCO CINTRON ACEVEDO, Plaintiff v. DR. THOMAS E. PRICE, Secretary, United States Department of Health and Human Services, Defendant. CIVIL NO. 16-2364 (GAG)(SCC) MOTION FOR SUMMARY JUDGMENT TO THE HONORABLE COURT: COMES NOW, Defendant, the Secretary of the United States Department of Health and Human Services (HHS), Dr. Thomas E. Price, through the undersigned attorney, and very respectfully STATES and PRAYS as follows: 1. On April 30, 2015, the Inspector General sent a letter to Francisco Cintrón Acevedo (Cintrón) notifying that he was being excluded from participation in Medicare, Medicaid, and all other federal health care programs for five years pursuant to section 1128(a)(3) of the Act (42 U.S.C. § 1320a-7(a)). The Inspector General based its exclusion on Cintrón’s conviction in this Court of a felony criminal offense “related to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct in connection with the delivery of a health care item or service”, pursuant to 42 U.S.C. § 1320a-7(a)(3). 2. Cintrón went on to exhaust administrative remedies, requesting a hearing before an Administrative Law Judge (ALJ) of the Departmental Appeals Board, who decided that the exclusion under section 1128(a)(3) was authorized and that the five-year period was reasonable. Subsequently, Cintrón filed a notice of appeal with the Appellate Division, which declined to Case 3:16-cv-02364-SCC Document 17 Filed 04/28/17 Page 1 of 3 2 review the ALJ’s decision, summarily affirming the ALJ’s conclusions. This petition for judicial review of the Departmental Appeals Board’s Appellate Division determination followed. 3. It is undisputed that Cintrón’s petition for review before this Court was not timely filed. Additionally, the Departmental Appeals Board exclusion decision is supported by substantial evidence and is in accordance with the law. Therefore, summary judgment is appropriate and supported in this case. Defendant respectfully requests that this Honorable Court grant the foregoing motion for summary judgment, affirming Cintrón’s five-year exclusion and, dismiss the Complaint with prejudice. 4. Pursuant to Rule 56(c) of the Federal Rules of Civil Procedure, it is hereby requested that summary judgment is entered, dismissing the Complaint as there are no genuine issues as to any facts relevant to the allegations, and Defendant is entitled to a remedy as a matter of law. 5. Attached is a Memorandum of Law and a Statement of Material Uncontested Facts (SMUF), which supports this motion. The statements therein are based on documents included within the certified transcript of the record pertaining to the administrative proceedings that heralded the filing of the instant petition for review, which was filed in this Court along with Defendant’s answer to the complaint (ECF No. 7-1). WHEREFORE, Defendant respectfully request entry of summary judgment and dismissal of the complaint. RESPECTFULLY SUBMITTED in San Juan, Puerto Rico, this 28th day of April 2017. Case 3:16-cv-02364-SCC Document 17 Filed 04/28/17 Page 2 of 3 3 CERTIFICATE OF SERVICE I hereby certify that on this date, I electronically filed the foregoing document with the Clerk of the Court using CM/ECF system which will send notification of such filing to all counsel of record. ROSA EMILIA RODRIGUEZ VELEZ United States Attorney s/Rafael J. López-Rivera Assistant United States Attorney USDC-PR No. 221213 UNITED STATES ATTORNEY’S OFFICE Torre Chardón, Suite 1201 350 Carlos Chardón Street San Juan, Puerto Rico 00918 Phone Number: (787)766-5656 Facsimile: (787)766-6219 rafael.j.lopez@usdoj.gov Case 3:16-cv-02364-SCC Document 17 Filed 04/28/17 Page 3 of 3 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF PUERTO RICO FRANCISCO CINTRON ACEVEDO, Plaintiff v. DR. THOMAS E. PRICE, Secretary, United States Department of Health and Human Services, Defendant. CIVIL NO. 16-2364 (GAG)(SCC) STATEMENT OF MATERIAL UNCONTESTED FACTS IN SUPPORT OF MOTION FOR SUMMARY JUDGMENT TO THE HONORABLE COURT: COMES NOW, Defendant, the Secretary of the United States Department of Health and Human Services (HHS), Dr. Thomas E. Price, through the undersigned attorney, and very respectfully STATES and PRAYS as follows: 1. On February 26, 2014, Francisco Cintrón Acevedo (Cintrón), a licensed pharmacist in Puerto Rico, was indicted in this Court on counts of health care fraud in violation 18 U.S.C. §§ 1347 and 2; conspiracy to commit health care fraud in violation of 18 U.S.C. §§ and 1349; and misbranding and adulterating prescription medications with the intent to mislead and defraud in violation of 21 U.S.C. §§ 331(k), 333(a)(2), 351(a)(2)(A) and (B), and 352(a), (b), and (o) for facilitating and causing the adulteration and misbranding of Levalbuterol and Budesinide. See 3:14-cr-00139 (JAG) ECF No. 3; ECF No. 7-1, pgs. 186-187. 2. Cintrón pled guilty to Count Ten of the Indictment, which charged him with misbranding and adulterating prescription medications with the intent to mislead and defraud in Case 3:16-cv-02364-SCC Document 17-1 Filed 04/28/17 Page 1 of 4 violation of 21 U.S.C. §§ 331(k), 333(a)(2), 351(a)(2)(A) and (B), and 352(a), (b), and (o). See 3:14-cr-00139 (JAG) ECF No. 96 and 97. 3. Cintrón’s plea was accepted by this Court, which entered a judgment of conviction and sentenced him accordingly. See 3:14-cr-00139 (JAG) ECF No. 139, 143, and 142. 4. On April 30, 2015, the Inspector General sent a letter to Cintrón notifying him that he was being excluded from participation in Medicare, Medicaid, and all other federal health care programs for five years pursuant to section 1128(a)(3) of the Act (42 U.S.C. § 1320a-7(a)). See ECF No. 7-1, p. 22; see also item 4 of Complaint (ECF No. 1), and the corresponding response (ECF No. 7) 5. The Inspector General based its exclusion on Cintrón’s above-referenced conviction in this Court of a felony criminal offense “related to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct in connection with the delivery of a health care item or service”, pursuant to 42 U.S.C. § 1320a-7(a)(3). See ECF No. 7-1, p. 22. 6. After service of the notice, Cintrón filed a request for a hearing before an Administrative Law Judge (ALJ) of the Departmental Appeals Board, Civil Remedies Division. See ECF No. 7-1, p. 20. 7. The Inspector General moved for summary judgment, which was granted by the ALJ in a decision dated February 4, 2016. See ECF No. 7-1, p. 67 through 77, and p. 110 through 120. 8. The ALJ upheld Cintrón’s exclusion under section 1128(a)(3) of the Act and the reasonableness of the five (5) year exclusion period. See ECF No. 7-1, p. 16 through 17. 9. The ALJ determined that Cintrón pled guilty to and was convicted of a felony criminal offense under Federal law related to fraud in connection with the delivery of a health care Case 3:16-cv-02364-SCC Document 17-1 Filed 04/28/17 Page 2 of 4 item or service that occurred after August 21, 1996. Therefore, the ALJ concluded that all the elements for exclusion under section 1128(a)(3) of the Act were satisfied in this case. See ECF No. 7-1 p. 12; see also 3:14-cr-00139 (JAG) ECF No. 3, 96, and 97. 10. The ALJ determined that five years was the minimum authorized period of exclusion pursuant to section 1128(a)(3) of the Act, and that Cintrón’s five-year exclusion was not unreasonable as a matter of law. See ECF No. 7-1 p. 12. 11. Cintrón filed a notice of appeal of the ALJ’s decision with the Appellate Division of the Departmental Appeals Board. See ECF No. 7-1, p. 108. 12. After the filing of briefs by the parties (ECF No. 7-1, p. 125 through 146, and 152 through), the Appellate Division of the Departmental Appeals Board issued a determination on May 19, 2016, in which it: (1) declined to review the ALJ’s decision; and (2) summarily affirmed the ALJ’s conclusions that exclusion under section 1128(a)(3) was authorized and that the five- year exclusion period was reasonable. ECF No. 7-1, p. 18 through 19. 13. The Departmental Appeals Board’s Appellate Division decision advised the parties that the ALJ decision became final and binding 60 days from the date of service of this determination to decline review. See 42 C.F.R. § 1005.21(j). The decision further advised that judicial review is available in an appropriate United States district court if a civil action is filed within 60 days after service of this determination to decline review. Act §§ 1320a-7(f)(1) and 405(g); 42 C.F.R. § 1005.21(k)(1). ECF No. 7-1, p. 19. 14. Cintrón was served with the Departmental Appeals Board’s decision via email, by way of its electronic filing (e-File) system on May 19, 2016, the same day it was entered. See ECF No. 1, paragraph titled “Jurisdiction”, and the corresponding response at ECF No. 7. Case 3:16-cv-02364-SCC Document 17-1 Filed 04/28/17 Page 3 of 4 15. Cintrón filed his appeal of the May 19, 2016, Departmental Appeals Board, Appellate Division’s determination to decline review with this Court on July 19, 2016. See ECF No. 1. RESPECTFULLY SUBMITTED, in San Juan, Puerto Rico this 28th day of April 2017. CERTIFICATE OF SERVICE I hereby certify that on this date, I electronically filed the foregoing document with the Clerk of the Court using CM/ECF system which will send notification of such filing to all counsel of record. ROSA EMILIA RODRIGUEZ VELEZ United States Attorney s/Rafael J. López-Rivera Assistant United States Attorney USDC-PR No. 221213 UNITED STATES ATTORNEY’S OFFICE Torre Chardón, Suite 1201 350 Carlos Chardón Street San Juan, Puerto Rico 00918 Phone Number: (787)766-5656 Facsimile: (787)766-6219 rafael.j.lopez@usdoj.gov Case 3:16-cv-02364-SCC Document 17-1 Filed 04/28/17 Page 4 of 4 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF PUERTO RICO FRANCISCO CINTRON ACEVEDO, Plaintiff v. DR. THOMAS E. PRICE, Secretary, United States Department of Health and Human Services, Defendant. CIVIL NO. 16-2364 (GAG)(SCC) MEMORANDUM OF LAW IN SUPPORT OF MOTION FOR SUMMARY JUDGMENT TO THE HONORABLE COURT: COMES NOW, Defendant, the Secretary of the United States Department of Health and Human Services (HHS), Dr. Thomas E. Price, through the undersigned attorney, and very respectfully STATES and PRAYS as follows: I. INTRODUCTION On February 26, 2014, Francisco Cintrón Acevedo (Cintrón or Plaintiff) was indicted in this Court on counts of health care fraud in violation 18 U.S.C. §§ 1347 and 2; conspiracy to commit health care fraud in violation of 18 U.S.C. §§ and 1349; and misbranding and adulterating prescription medications with the intent to mislead and defraud in violation of 21 U.S.C. §§ 331(k), 333(a)(2), 351(a)(2)(A) and (B), and 352(a), (b), and (o). Specifically, Cintrón facilitated and caused the adulteration and misbranding of prescription drugs Levalbuterol and Budesinide, and subsequently billed Medicare. Cintrón pled guilty to one count of misbranding and adulterating prescription medications with the intent to mislead and defraud in violation of 21 U.S.C. §§ 331(k), 333(a)(2), 351(a)(2)(A) Case 3:16-cv-02364-SCC Document 17-2 Filed 04/28/17 Page 1 of 16 2 and (B), and 352(a), (b), and (o). The Court accepted Cintrón’s plea, entered a judgment of conviction and sentenced him accordingly. On April 30, 2015, the Inspector General (I.G.) sent a letter to Cintrón notifying him that he was being excluded from participation in Medicare, Medicaid, and all other federal health care programs for the minimum period of five years pursuant to section 1128(a)(3) of the Social Security Act (Act) (42 U.S.C. § 1320a-7(a)). The I.G. based its exclusion on Cintrón’s above- referenced conviction in this Court of a felony criminal offense “related to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct in connection with the delivery of a health care item or service”, pursuant to 42 U.S.C. § 1320a-7(a)(3). Cintrón appealed this action to the Departmental Appeals Board, Civil Remedies Division, and on February 4, 2016, the Administrative Law Judge (ALJ) upheld the I.G.’s determination to exclude Cintrón from participation in Medicare, Medicaid, and all federal health care programs pursuant to section 1128(a)(3) of the Act (42 U.S.C. §1320a-7(a)(3)) for the minimum period of five years, effective May 20, 2015. Specifically, the ALJ granted the I.G.’s motion for summary judgment and held that: (1) the I.G. had a legal basis to exclude Cintrón under section 1128(a)(3) of the Act, and (2) the length of Cintrón’s five-year exclusion was not unreasonable. Cintrón then appealed the ALJ’s February 4, 2016, decision to the Departmental Appeals Board, Appellate Division (Board). On May 19, 2016, the Board declined review of and summarily affirmed the ALJ’s conclusions that Cintrón’s exclusion from participation in Medicare, Medicaid, and all federal health care programs pursuant to section 1128(a)(3) of the Act was authorized and that the length of the five-year exclusion was reasonable. In neither his petition for review before this Court, nor in the administrative process before it, did Cintrón challenge that the I.G. had a basis to exclude him under section § 1320a-7(a), or the reasonableness of the mandatory minimum five-year exclusion period, as required by section Case 3:16-cv-02364-SCC Document 17-2 Filed 04/28/17 Page 2 of 16 3 1320a-7(c)(3)(B). Instead, Cintrón challenges his exclusion on the grounds that: (1) it prevents him from complying with the terms of this Court’s judgment of conviction to remain employed; (2) the I.G.’s April 30, 2015, exclusion letter violates his constitutional due process rights because the letter was vague and overbroad; and (3) the exclusion imposed by the I.G. violates his constitutional right against double jeopardy in that the exclusion subjects him to additional punishment for the same conduct and carries the potential for criminal penalties. These same grounds, which Cintrón raised before the ALJ and Board, were previously considered and rejected. As discussed below, it is undisputed that Cintrón’s petition for review before this Court was not timely filed. Additionally, the Departmental Appeals Board exclusion decision is supported by substantial evidence and is in accordance with the law. Therefore, summary judgment is appropriate and supported in this case. Defendant respectfully requests that this Honorable Court grant the foregoing motion for summary judgment, affirming Cintrón’s five-year exclusion and, dismiss the Complaint with prejudice. II. STANDARD OF REVIEW Under 42 U.S.C. § 1320-7(f), the standard of review applicable to exclusion matters is that prescribed in 42 U.S.C. § 405(g): “the findings of the [Secretary of the Department of Health and Human Services] as to any fact, if supported by substantial evidence, shall be conclusive, and where a claim has been denied. . . the court shall review only the question of conformity with such regulations and the validity of such regulations.”1 Under Fed.R.Civ.P. 56(c), summary judgment is proper where there are no genuine issues of material fact and the moving party is entitled to judgment as a matter of law, even after drawing all reasonable inferences in favor of the non-moving party. Thompson v. Coca-Cola Co., 522 F.3d 1 The Secretary has delegated to the I.G. the authority to determine and impose exclusions under section 1128 of the Act. See 53 Fed. Reg. 12,993 (Apr. 20, 1988). Case 3:16-cv-02364-SCC Document 17-2 Filed 04/28/17 Page 3 of 16 4 168, 175 (1st Cir. 2008); Dávila v. Corporación de Puerto Rico para la Difusión Pública, 498 F.3d 9, 12 (1st Cir. 2007). The party moving for summary judgment bears the initial responsibility of demonstrating the absence of a genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 325 (1986). A fact is "material" if it potentially affects the outcome of the case in light of applicable law. Calero Cerezo v. United States DOJ, 355 F.3d 6, 19 (1st Cir. 2004). A dispute is said to be “genuine” when it “could be resolved in favor of either party.” Ramírez Ortiz v. Corporación del Centro Cardiovascular de Puerto Rico, 32 F.Supp.3d 90, 93 (D.P.R. 2014). It is upon the moving party to identify “portions of ‘the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any’” that support its motion. Id. at 93 (citing Celotex Corp. v. Catrett, 477 U.S. at 323). Once a motion for summary judgment is filed, the non-moving party bears the burden of pointing to “competent evidence and specific facts to stave off summary judgment,” thus showing that there is a genuine issue for trial. Tropigas de P.R., Inc. v. Certain Underwriters at Lloyd’s of London, 637 F.3d 53, 56 (1st Cir. 2011). In order to fulfil this burden, the party opposing summary judgment may not rest on mere “conclusory allegations, empty rhetoric, unsupported speculation, or evidence which, in the aggregate, is less than significantly probative.” See Nieves Romero v. United States, 715 F.3d 375, 378 (1st Cir. 2013); Bennett v. Saint Gobain, Corp., 507 F.3d 23, 30 (1st Cir. 2007). III. DISCUSSION A. Cintrón’s petition for judicial review of the Departmental Appeals Board’s determination to decline review, is untimely. On May 19, 2016, the Board tendered its determination in which it declined review of the ALJ decision. See SMUF¶11. The determination, which summarily affirmed the ALJ’s decision, Case 3:16-cv-02364-SCC Document 17-2 Filed 04/28/17 Page 4 of 16 5 expressly advised that the ALJ decision would become final and binding 60 days from the date of service of the determination to decline review. See 42 C.F.R. § 1005.21(j). The decision further advised that judicial review was available in an appropriate United States district court, if a civil action was filed within 60 days after service of the determination to decline review. See Act §§ 1320a-7(f)(1) and 405(g); 42 C.F.R. § 1005.21(k)(1). See SMUF ¶11. The 60-day filing period set forth in 42 U.S.C. §405(g) is not jurisdictional, but rather constitutes a statute of limitations. See Bowen v. City of New York, 476 U.S. 467, 478, 106 S. Ct. 2022 (1986). Therefore, the limitation period constitutes a condition on the waiver of sovereign immunity that must be strictly construed. Id. at 479; McElrath v. Colvin, 2016 U.S. Dist. LEXIS 98728 (D.Mass. 2016). As asserted in the Complaint and admitted by Defendant, Cintrón was served with the Board’s determination via email, by way of its electronic filing (e-File) system on May 19, 2016, the same day it was entered. See SMUF ¶14. Accordingly, Cintrón had 60 days from that date- until July 18, 2016 - to file his petition seeking judicial review of the Board’s determination declining review of the ALJ’s decision. In his initial pleadings, and later while elaborating his claims in the Joint Initial Scheduling Conference Memorandum, Cintrón does not dispute that he had 60 days from May 19, 2016, the date on which he was served with the Board’s determination, to timely file an appeal to this Court. It is also undisputed that 60 days from May 19, 2016, is July 18, 2016. Further, Cintrón does not dispute that he filed his petition to this court on July 19, 2016, (as reflected on the PACER date stamp), thereby making it untimely. Because the complaint in the instant case was filed on July 19, 2016, the same is untimely, and must be dismissed with prejudice. Case 3:16-cv-02364-SCC Document 17-2 Filed 04/28/17 Page 5 of 16 6 B. The Departmental Appeals Board’s determination is supported by substantial evidence and legally correct In the alternative and as noted above, the Board declined review of and summarily affirmed the ALJ’s conclusions that Cintrón’s exclusion from participation in Medicare, Medicaid, and all federal health care programs pursuant to section 1128(a)(3) of the Act was authorized and that the length of the five-year exclusion was reasonable. The Board’s determination, as well as the ALJ decision underlying the Board’s determination, is supported by substantial evidence and is legally correct. Section 1128(a)(3) of the Act requires that the Secretary of the Department of Health and Human Services exclude from participation in Medicare, Medicaid, and all other federal health care programs, any individual or entity: (1) convicted of an offense under Federal or state law; (2) whose offense occurred after August 21, 1996; (3) whose offense was committed in connection with the delivery of a health care item or service; (4) whose criminal offense was a felony; and (5) whose offense was related to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct. See 42 U.S.C. § 1320a-7(a)(3); 42 C.F.R. § 1001.101(c). An individual or entity is considered to have been “convicted” of a criminal offense under section 1128(i) of the Act when: (1) a judgment of conviction has been entered against the individual or entity by a Federal, State, or local court, regardless of whether there is an appeal pending or whether the judgment of conviction or other record relating to criminal conduct has been expunged; (2) there has been a finding of guilt against the individual or entity by a Federal, State, or local court; (3) a plea of guilty or nolo contendere by the individual or entity has been accepted by a Federal, State, or local court; or (4) the individual or entity has entered into participation in a first offender, deferred adjudication, or other arrangement or program where judgment of conviction has been withheld. See 42 U.S.C. § 1320a-7(i)(1)-(4); 42 C.F.R. § 1001.2. Case 3:16-cv-02364-SCC Document 17-2 Filed 04/28/17 Page 6 of 16 7 The ALJ correctly determined that Cintron was “convicted” of a criminal offense within the meaning of the Act when the District Court accepted Petitioner’s guilty plea, adjudged him guilty, issued a judgment of conviction, and sentenced him for misbranding and adulterating prescription medications with the intent to mislead and defraud in violation of 21 U.S.C. §§ 331(k), 333(a)(2), 351(a)(2)(A) and (B), and 352(a), (b), and (o). See ECF No. 7-1 p. 14; SMUF ¶1, 2, and 3. The ALJ also correctly determined that Cintron’s criminal conduct, which resulted in his felony conviction, occurred after August 21, 1996. Id.; see also, 18 U.S.C. § 3559 (reflecting that Petitioner’s offense is classified as a Class E felony because the maximum imprisonment term is less than five years, but more than one year). The ALJ also correctly found that Cintron’s criminal offense involved fraud and was related to or committed in connection with the delivery of a health care item or service. ECF No. 7-1 p. 14. The ALJ specifically noted that Cintron’s offense involved fraud because the count to which Cintron pleaded guilty indicated that Cintron had ‘the intent to mislead and defraud.’ ECF No. 7-1 p. 14; SMUF ¶1, 2, and 3. The nexus between Cintron’s offense and the delivery of a health care item or service was “plain”, according to the ALJ, because the count to which he pleaded guilty indicated that the misbranded or adulterated prescription of Budesonide was dispensed to a Medicare beneficiary. ECF No. 7-1 pgs. 14, 195, and 198; SMUF ¶1, 2, and 3. Therefore, the ALJ properly determined (and the Board summarily affirmed) that the I.G. had a legal basis to exclude Petitioner under section 1128(a)(3) of the Act. Moreover, Cintron has not disputed and does not now dispute that the essential requirements for an 1128(a)(3) exclusion were met in this case. ECF No. 7-1 pgs. 17. Section 1128(c)(3)(B) of the Act provides that an exclusion imposed under section 1128(a) of the Act will be for a period of not less than five years. 42 C.F.R. § 1001.102(a). Where, as here, the I.G. imposes the minimum authorized five-year period of exclusion under section l 128(a) Case 3:16-cv-02364-SCC Document 17-2 Filed 04/28/17 Page 7 of 16 8 of the Act, there is no issue as to whether the period of exclusion is unreasonable. 42 C.F.R. § 1001.2007(a)(2). Neither an ALJ nor the I.G nor the Board has discretion to reduce the length of an exclusion below the minimum mandatory period of five years. 42 C.F.R. § 1005.4(c). Therefore, the ALJ properly determined (and the Board summarily affirmed) that Cintron’s exclusion for five years was not unreasonable as a matter of law since there was a basis to exclude Cintron pursuant to section 1128(a)(3) of the Act. ECF No. 7-1 p. 17. Cintron also has not disputed and does not now dispute the reasonableness of the length of the exclusion that the I.G. imposed in this case. In the instant case, Cintrón does not dispute that all elements for exclusion under section 1128(a)(3) are met, nor does he argue that the five-year exclusion period is unreasonable. The administrative record, which is comprised in part by the Court’s docket entries in Cintrón’s criminal case at 3:14-cr-00139 (JAG), substantially supports and proves that the Secretary’s decision is legally sound. Following the well-settled legal precepts referred to above, the Secretary’s findings of fact are supported by substantial evidence, and therefore, are conclusive. Rodríguez v. Sec’y of Health & Human Servs., 647 F.2d 218, 222 (1st Cir. 1981). Likewise, the Secretary’s conclusions of law, which the Board summarily affirmed, are legally correct. Accordingly, summary judgment is appropriate and supported. Cintron’s untimely petition for judicial review must be denied, and the Complaint dismissed with prejudice. C. Cintrón’s claims are nothing more than impermissible collateral attacks on his sentence, as his constitutional challenges are unavailing. In his untimely petition for judicial review, Cintrón does nothing more than restate those same arguments that he unsuccessfully brought before the ALJ, and then in his appeal before the Board. Cintrón contends: (1) that the I.G.’s exclusion prevents him from complying with the terms of this Court’s judgment of conviction to remain employed; (2) the I.G.’s April 30, 2015, exclusion letter violates his constitutional due process rights because the letter was vague and overbroad; Case 3:16-cv-02364-SCC Document 17-2 Filed 04/28/17 Page 8 of 16 9 and (3) the exclusion imposed by the I.G. violates his constitutional right against double jeopardy in that the exclusion subjects him to additional punishment for the same conduct and carries the potential for criminal penalties. Cintron’s arguments are without merit and the Secretary’s determination is supported by substantial evidence and legally correct. In his decision summarily dismissing Cintrón’s appeal, the ALJ delineated the limited regulatory scope of his review. See ECF No. 7-1 p. 10. Pursuant to 42 C.F.R. §1001.2007(a)(1), an ALJ can only consider issues of whether: “(i) The basis for the imposition of the sanction exists, and (ii) The length of exclusion is unreasonable.” Accordingly, the ALJ true to his delegated authority, as bounded by the limitations imposed by §1001.2007(a)(1) and 1005.4(c)(1), concluded that he was not allowed to decide whether the provisions of the Act or regulations were unconstitutional. See ECF No. 7-1 p. 16. Nevertheless, in summarily dismissing Cintrón’s appeal, the ALJ nevertheless specifically addressed Cintron’s legal arguments, before properly finding against him as a matter of law. (i) Employment Requirement Referring to the administrative record, the ALJ properly observed that the Judgment entered by this Court stated as a condition of Cintron’s supervised release on probation that “…4) the defendant shall support his or her dependents and meet other family responsibilities; 5) the defendant shall work regularly at a lawful occupation, unless excused by the probation officer for schooling, training, or other acceptable reasons”. See ECF No. 7-1 p. 168. Significantly, the judgment of conviction did not require Cintron to be employed as a pharmacist or by working in a pharmacy to support his family. As such, the ALJ correctly found that Cintrón’s exclusion did not prevent him from supporting his family by being gainfully employed in a lawful occupation, only that the exclusion prevented him from being employed in an occupation that would have him Case 3:16-cv-02364-SCC Document 17-2 Filed 04/28/17 Page 9 of 16 10 participating in Medicare, Medicaid, and all other federal health care program, while receiving payment. Cintrón’s conviction triggered the I.G.’s statutory duty to exclude him from participating in any federal health care program, but the I.G.’s exclusion does not impair Cintron from seeking lawful and gainful employment in a field unrelated to any federal health care program participation. In this regard, the ALJ’s decision and the Board’s summary affirmation of such is supported by substantial evidence and legally correct. Thus, his challenge to the ALJ’s decision, and by extension, the Board’s determination, on this basis is meritless. (ii) Due Process The ALJ then considered Cintrón’s constitutional challenge that the exclusion was vague and overbroad, thereby violating his due process rights. In rejecting this claim, the ALJ held that the notice of exclusion was consistent with and based on clear direction of Congress. A governmental directive may be void for vagueness in violation of due process if “in the circumstances it fails to provide a person of ordinary intelligence fair notice of what is prohibited.” F.C.C. v. Fox Television Stations, Inc., 132 S. Ct. 2307, 2317, 183 L. Ed. 2d 234 (2012) (internal quotation marks omitted). “Fair” notice, however, is understood as notice short of semantic certainty. Because “words are rough-hewn tools, not surgically precise instruments. Consequently, some degree of inexactitude is acceptable in statutory language.” URI Student Senate v. Town Of Narragansett, 631 F.3d 1, 14 (1st Cir. 2011). The fact that the language used “requires some interpretation” does not serve to invalidate on vagueness, since “reasonable breadth in terms employed” is allowed. See Id. at 14; see also Draper v. Healey, 827 F.3d 1, 4 (1st Cir. 2016). In his decision, the ALJ pointed out that from the Inspector General’s April 30, 2015 notice, Cintrón became readily cognizant of the reasons why he was being excluded, the scope of his Case 3:16-cv-02364-SCC Document 17-2 Filed 04/28/17 Page 10 of 16 11 exclusion, and the effect of his exclusion. See ECF No. 7-1 p. 15. Furthermore, in declaring that the Inspector General’s notice (ECF No. 7-1 p. 172-174) was not vague, the ALJ observed that the notice and its attachment were detailed and clear. The ALJ directed Cintrón’s attention to the updated online version of the “Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs”, even providing the hyperlink for the same: http://oig.hhs.gov/exclusions/files/sab-05092013.pdf.2 Direct reference to the updated “Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs” is made in the Inspector General’s notice in boldfaced and underlined terms. See ECF No. 7-1 p. 172. The principal objective of the Bulletin is to provide guidance as to the scope and effect of the legal prohibition on payment by federal health care programs for items or services furnished by an excluded person, among others. The Bulletin sums up over a decade of experience in describing the effect of an exclusion. Therein, Cintrón had guidance as to how all parties affected by an exclusion (excluded person, providers, employing or contracting third parties) can ensure compliance with the statutory and regulatory mandates. In light of all these resources at hand, Cintrón’s claims of vagueness fall within the brink of frivolousness. Accordingly, the ALJ’s rejection of Cintron’s claim is supported by substantial evidence and legally correct. Thus, this Court must affirm the Board’s decision. (iii) Double Jeopardy Finally, Cintrón contends that an exclusion under 42 U.S.C. § 1320a-7 is punitive in nature and effect, and thus unconstitutional in violation of the Double Jeopardy Clause, since the same is akin to additional criminal punishment. The ALJ decided, and the Board affirmed, that an 2 A hard copy of the updated “Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs” was hand delivered to Petitioner’s counsel during the Initial Scheduling Conference. Case 3:16-cv-02364-SCC Document 17-2 Filed 04/28/17 Page 11 of 16 12 exclusion under Section 1320a-7(a)(3) is a civil sanction, intended to be remedial and not punitive, so there is no exposure to double jeopardy (ECF No. 7-1 p. 16). To determine if a statute violates the Double Jeopardy Clause, the first step is to determine whether the penalty imposed is civil or criminal by inquiring what type of penalty Congress intended to impose. United States v. Ward, 448 U.S. 242, 248-249 (1980). If the evidence reflects that Congress intended a penalty to be civil, the analysis continues with a focus on “whether the statutory scheme was so punitive either in purpose or effect as to negate that intention.” Id. Whether 42 U.S.C. § 1320a-7 is civil or criminal is an issue of statutory construction. Id. By way of 42 U.S.C. § 1320a-7 Congress gave the Secretary of the U.S. Department of Health and Human Services the authority to exclude individuals from participating in federal health care program. The delegation of exclusion authority on an administrative agency is “prima facie evidence that Congress intended to provide for a Civil Sanction.” Hudson v. United States, 522 U.S. 93, 103 (1997). In Hudson, the Supreme Court further recognized that all civil penalties have some deterrent effect. Id. at 103. Along those lines and in the context of an exclusion under § 1320a-7, courts have repeatedly found that the deterrence sought is that of protecting federal health care programs and their beneficiaries, which is consistent with a remedial objective in creating a civil statute. Patel v. Thompson, 319 F.3d 1317, 1319 (11th Cir. 2008); Manocchio v. Kusserow, 961 F.2d 1539, 1542 (11th Cir. 1992); Erickson v. U.S. ex rel. Dep't of Health & Human Servs., 67 F.3d 858, 864 (9th Cir. 1995); Gupton v. Leavitt, 575 F. Supp. 2d 874, 882 (E.D. Tenn. 2008); Westin v. Shalala, 845 F.Supp. 1446, 1453 (D. Kan. 1994); Bickelhaupt v. Sebelius, 2014 U.S. Dist. LEXIS 72878 (N.D.Ill. 2014). Having determined that the penalty at 42 U.S.C. § 1320a-7 is civil, the next step is to look at whether the exclusion is so punitive in purpose or effect as to negate Congress’ intention to create a civil statute. See Ward, 448 U.S. 249-50. In making that determination, courts have Case 3:16-cv-02364-SCC Document 17-2 Filed 04/28/17 Page 12 of 16 13 traditionally considered the factors listed in Kennedy v. Mendoza-Martinez: “whether the sanction involves an affirmative disability or restraint, whether it has historically been regarded as a punishment, whether it comes into play only on a finding of scienter, whether its operation will promote the traditional aims of punishment—retribution and deterrence, whether the behavior to which it applies is already a crime, whether an alternative purpose to which it may be rationally connected is assignable for it, and whether it appears excessive in relation to the alternative purpose assigned.” Kennedy, 372 U.S. 144 at 168-169 (1963). These factors must show the “clearest proof” that the penalty here in question is punitive in either purpose or effect for it to be considered a criminal sanction. Ward, at 242, 251 (1980). As applied in this case, these factors demonstrate that the civil penalty under 42 U.S.C. § 1320a-7, does not implicate the Double Jeopardy Clause. First, the exclusion does not prevent Cintrón from supporting his family by being gainfully employed in a lawful occupation, nor does it bar him from his profession. Rather, it prohibits him from providing items or services that would be payable by federal health care programs. The government may constitutionally refuse to deal with people that it has found to be untrustworthy or potentially harmful to patients through exclusion. See Friedman v. Sebelius, 686 F.3d 813, 824 (D.C. Cir. 2012). In Hudson, the Supreme Court found that debarment from the banking industry by the Office of the Comptroller of the Currency was not an affirmative disability or restraint. 522 U.S. 93, 104. Likewise, exclusion, which is similar to debarment, is not an affirmative disability or restraint. Second, as noted above, courts have consistently held that the exclusion under § 1320a-7 is not considered punishment, but remedial in nature and purpose. See Patel, supra; Manocchio supra, and other cases previously cited in the foregoing motion. Case 3:16-cv-02364-SCC Document 17-2 Filed 04/28/17 Page 13 of 16 14 Third, exclusion under 42 U.S.C. § 1320a-7(a)(3) does not require a finding of scienter because exclusion is only applicable if there has been a conviction of a felony offense related to fraud (among other conduct) in the delivery of a health care item or service. For purposes of the exclusion statute, conviction is defined by 42 U.S.C. § 1320a-7(i), which does not require a finding of willfulness. Fourth, while exclusion may promote some deterrence, it is well-established that all civil penalties have some deterrent effect. Hudson, 522 U.S. at 103. Both exclusion and loss of licensure have been found not to violate the Double Jeopardy clause. Greene v. Sullivan, 731 F.Supp.838, 840 (E.D. Tenn. 1990). In fact, exclusion is a milder remedy than is loss of licensure, which multiple courts have found is not a punishment and does not violate the Double Jeopardy Clause despite its deterrent effect. See Schillerstrom v. State, 885 P.2d 156, 159 (Ariz. App. 1994); Loui v. Board of Medical Examiners, 889 P.2d 705, 711 (Haw. 1995). Fifth, even though the exclusion at issue in this case applies to individuals convicted of a felony, this fact alone is insufficient to render the exclusion criminally punitive. In LaCrosse v. Commodity Futures Trading Commission, 137 F.3d 925, 932 (7th Cir. 1998), the Seventh Circuit found that the imposition of a five-year commodities trading ban imposed on an individual based on his felony conviction did not violate the Double Jeopardy Clause, despite the fact that the sanction was dependent on a felony conviction. See also United States v. Dixon, 509 U.S. 688, 704 (1993)(rejecting ‘same-conduct’ test for double jeopardy purposes). Sixth, exclusion has a rational relationship to the purpose of protecting the federal health care programs and their beneficiaries because it protects both by prohibiting certain potentially untrustworthy or dangerous individuals from providing care paid for by the programs. In sum, Congress determined that exclusion was the most appropriate way to protect federal health care programs and their beneficiaries from individuals who could cause them harm, and that exclusion for five years was not excessive and, therefore, an appropriate remedy. Congress intended for all parts of 42 U.S.C. Case 3:16-cv-02364-SCC Document 17-2 Filed 04/28/17 Page 14 of 16 15 § 1320a-7 to be civil and remedial, and the factors analyzed above show that the statute is not punitive either in purpose or effect and so does not function as a criminal statute. See Ward, 448 U.S. at 248-249. Based on the foregoing, the ALJ rightfully held, and the Board summarily affirmed, that the exclusion under Section 1320a-7(a)(3) is not a criminal penalty, and therefore, it does not trigger the constitutional prohibition of exposure to double jeopardy. Furthermore, in the Statement of Fact attached to the Plea Agreement entered to by Cintrón and approved by the Court (ECF No. 7-1 p. 205), he admitted and assumed full responsibility for: aiding and abetting others to cause Levalbuterol and Budenoside to become misbranded and adulterated with the express intent to defraud; causing these prescription drugs to bear labels that were false and misleading; and aiding and abetting the illegal manufacturing, preparation, process propagation, and compounding of drugs in an establishment not registered with the Food and Drug Administration. These prescription drugs, which were intended for sale in interstate commerce, were prepared, packed and held under insanitary conditions, which represented a serious health risk, as the method of production did not conform to good manufacturing practices. In consideration of all these facts, as they emerge from the administrative record, the ALJ correctly concluded (and the Board correctly affirmed) that all elements of Section 1320a-7(a)(3) had been met, including the required nexus between the criminal offense and the delivery of health care item or service. Based on Cintrón’s pervasive misconduct, the exclusion order in this case, serves the prophylactic congressional purpose of defending the public, while deterring the repetition of the proscribed conduct. Accordingly, the ALJ did not err in rejecting Cintrón’s constitutional challenge, which warrants affirmation from this Court’s review. See United States v. Stoller, 78 F.3d 710, 720 (1st Cir. 2016)(finding that a debarment order imposed by the FDIC Case 3:16-cv-02364-SCC Document 17-2 Filed 04/28/17 Page 15 of 16 16 is predominantly remedial in nature, therefore it does not constitute a punishment under appropriate double jeopardy analysis) IV. CONCLUSION From the above, it must be concluded that summary judgment is appropriate and supported in this case because there are no material facts in dispute. Cintrón’s petition for review was untimely filed with this Court. Alternatively, the Board’s determination, which declined review and summarily affirmed the ALJ’s decision, is supported by substantial evidence and legally correct. Accordingly, this Court should grant Defendant’s Motion for Summary Judgment, affirm Cintrón’s five-year exclusion, and dismiss the Complaint with prejudice. RESPECTFULLY SUBMITTED, in San Juan, Puerto Rico this 28th day of April 2017. CERTIFICATE OF SERVICE I hereby certify that on this date, I electronically filed the foregoing document with the Clerk of the Court using CM/ECF system, which will send notification of such filing to all counsel of record. ROSA EMILIA RODRIGUEZ VELEZ United States Attorney s/Rafael J. López-Rivera Assistant United States Attorney USDC-PR No. 221213 UNITED STATES ATTORNEY’S OFFICE Torre Chardón, Suite 1201 350 Carlos Chardón Street San Juan, Puerto Rico 00918 Phone Number: (787)766-5656 Facsimile: (787)766-6219 rafael.j.lopez@usdoj.gov Case 3:16-cv-02364-SCC Document 17-2 Filed 04/28/17 Page 16 of 16