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Common use of Exclusion Review Clause in Contracts

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. whether the Provider was in material breach of this CIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-day period, but that: (i) the Provider had begun to take action to cure the material breach within that period; (ii) the Provider has pursued and is pursuing such action with due diligence; and (iii) the Provider provided to OIG within that period a reasonable timetable for curing the material breach and the Provider has followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for the Provider, only after a DAB decision in favor of OIG. The Provider’s election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the Provider upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that the Provider may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. The Provider shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of the Provider, the Provider shall be reinstated effective on the date of the original exclusion.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. whether J&J and/or the Provider was J&J Pharmaceutical Affiliate(s) were in material breach of this CIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-day period, but that: (i) J&J and/or the Provider J&J Pharmaceutical Affiliate(s) had begun to take action to cure the material breach within that period; (ii) J&J and/or the Provider J&J Pharmaceutical Affiliate(s) has pursued and is pursuing such action with due diligence; and (iii) J&J and/or the Provider J&J Pharmaceutical Affiliate(s) provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the Provider J&J Pharmaceutical Affiliate(s) has followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the ProviderJ&J Pharmaceutical Affiliate(s), only after a DAB decision in favor of OIG. The ProviderJ&J’s and/or a J&J Pharmaceutical Affiliate(s)’ election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the Provider J&J Pharmaceutical Affiliate(s) upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the Provider J&J Pharmaceutical Affiliate(s) may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. The Provider J&J and/or the J&J Pharmaceutical Affiliate(s) shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the ProviderJ&J Pharmaceutical Affiliate(s), the Provider J&J Pharmaceutical Affiliate(s) shall be reinstated effective on the date of the original exclusion.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title Chapter 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA IA shall be: a. whether the Provider was Providers were in material breach of this CIAIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-30 day period, but that: (i) the Provider Providers had begun to take action to cure the material breach within that period; (ii) the Provider has Providers have pursued and is are pursuing such action with due diligence; and (iii) the Provider Providers provided to OIG within that period a reasonable timetable for curing the material breach and the Provider has Providers have followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for the ProviderProviders, only after a DAB decision in favor of OIG. The Provider’s Providers’ election of its their contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the Provider Providers upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that the Provider Providers may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. The Provider Providers shall waive its their right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of the ProviderProviders, the Provider Providers shall be reinstated effective on the date of the original exclusion.

Appears in 1 contract

Samples: Integrity Agreement

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. be whether the Provider Prime was in material breach of this CIA;CIA and, if so, whether:‌ a. Prime cured such breach within 30 days of its receipt of the Notice of Material Breach; or‌ b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-30 day period, but that: , during the 30 day period following Xxxxx’s receipt of the Notice of Material Breach:‌ (i) the Provider Prime had begun to take action to cure the material breach within that period; breach;‌ (ii) the Provider has Prime pursued and is pursuing such action with due diligence; and (iii) the Provider Prime provided to OIG within that period a reasonable timetable for curing the material breach and the Provider has followed the timetable. breach.‌ For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for the ProviderPrime, only after a DAB decision in favor of OIG. The ProviderPrime’s election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the Provider Prime upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that the Provider Prime may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. The Provider Prime shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of the ProviderPrime, the Provider Prime shall be reinstated effective on the date of the original exclusion.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. whether the Provider Novartis was in material breach of this CIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-day period, but that: (i) the Provider Novartis had begun to take action to cure the material breach within that period; (ii) the Provider Novartis has pursued and is pursuing such action with due diligence; and (iii) the Provider Novartis provided to OIG within that period a reasonable timetable for curing the material breach and the Provider Novartis has followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for the ProviderNovartis, only after a DAB decision in favor of OIG. The Provider’s Novartis’ election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the Provider Novartis upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that the Provider Novartis may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. The Provider Novartis shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of the ProviderNovartis, the Provider Novartis shall be reinstated effective on the date of the original exclusion.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Corporate Integrity Agreement King Pharmaceuticals, Inc. Xxxxxx Xxxxxx Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. whether the Provider King was in material breach of this CIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-day period, but that: (i) the Provider King had begun to take action to cure the material breach within that period; (ii) the Provider King has pursued and is pursuing such action with due diligence; and (iii) the Provider King provided to OIG within that period a reasonable timetable for curing the material breach and the Provider King has followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for the ProviderKing, only after a DAB decision in favor of OIG. The ProviderKing’s election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the Provider King upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that the Provider King may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. The Provider King shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of the ProviderKing, the Provider King shall be reinstated effective on the date of the original exclusion.

Appears in 1 contract

Samples: Corporate Integrity Agreement (King Pharmaceuticals Inc)

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title Chapter 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. whether the Provider Rotech was in material breach of this CIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-30 day period, but that: : (i) the Provider Rotech had begun to take action to cure the material breach within that period; ; (ii) the Provider Rotech has pursued and is pursuing such action with due diligence; and and (iii) the Provider Rotech provided to OIG within that period a reasonable timetable for curing the material breach and the Provider Rotech has followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for the ProviderRotech, only after a DAB decision in favor of OIG. The Provider’s Rotech's election of its contractual right to appeal to the DAB shall not abrogate the OIG’s 's authority to exclude the Provider Rotech upon the issuance of an ALJ’s 's decision in favor of the OIG. If the ALJ sustains the determination of the OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that the Provider Rotech may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. The Provider shall Rotech agrees to waive its its/his/her right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of the Provider, the Provider shall be reinstated effective on the date of the original exclusion.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Rotech Healthcare Inc)

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title Chapter 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA IA shall be: a. whether the Provider Ho Medical was in material breach of this CIAIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-30 day period, but that: (i) the Provider Ho Medical had begun to take action to cure the material breach within that period; (ii) the Provider Ho Medical has pursued and is pursuing such action with due diligence; and (iii) the Provider Ho Medical provided to OIG within that period a reasonable timetable for curing the material breach and the Provider Ho Medical has followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for the ProviderHo Medical, only after a DAB decision in favor of OIG. The ProviderHo Medical’s election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the Provider Ho Medical upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that the Provider Ho Medical may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. The Provider Ho Medical shall waive its [his, her or its] right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of the ProviderHo Medical, the Provider Ho Medical shall be reinstated effective on the date of the original exclusion.

Appears in 1 contract

Samples: Integrity Agreement

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. whether the Provider HealthSouth was in material breach of this CIA; b. whether such breach was continuing on the date of the Exclusion Letter; andand Corporate Integrity Agreement HealthSouth Corporation c. whether the alleged material breach could not have been cured within the 30-day period, but that: (i) the Provider HealthSouth had begun to take action to cure the material breach within that period; (ii) the Provider HealthSouth has pursued and is pursuing such action with due diligence; and (iii) the Provider HealthSouth provided to OIG within that period a reasonable timetable for curing the material breach and the Provider HealthSouth has followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for the ProviderHealthSouth, only after a DAB decision in favor of OIG. The ProviderHealthSouth’s election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the Provider HealthSouth upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that the Provider HealthSouth may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. The Provider HealthSouth shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of the ProviderHealthSouth, the Provider HealthSouth shall be reinstated effective on the date of the original exclusion.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Healthsouth Corp)

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. whether the Provider was Xxxx and EHS were in material breach of this CIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-day period, but that: (i) the Provider EPI had begun to take action to cure the material breach within that period; (ii) the Provider EPI has pursued and is pursuing such action with due diligence; and (iii) the Provider EPI provided to OIG within that period a reasonable timetable for curing the material breach and the Provider Endo has followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for the ProviderEndo, only after a DAB decision in favor of OIG. The ProviderEPI’s election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the Provider EPI upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that the Provider EPI may request review of the ALJ decision by the DAB. If the DAB Endo Pharmaceuticals Inc. Corporate Integrity Agreement XXX finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. The Provider EPI shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of the ProviderXxxx, the Provider EPI shall be reinstated effective on the date of the original exclusion.

Appears in 1 contract

Samples: Corporate Integrity Agreement