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Federal Register

2020

11-20-2020
Final Rule: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements
11-20-2020
Final Rule: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees
  • On March 22, 2021, OIG issued a notification of the court-ordered delay of the effective date of this final rule. That notification stated that the effective date of the amendments to 42 C.F.R. § 1001.952(h)(6) through (9), (cc), and (dd) is delayed until January 1, 2023. The notification also stated that the effective date of the corrections published at 86 Fed. Reg. 7815 (Feb. 2, 2021), is delayed from March 22, 2021, to January 1, 2023. See 86 Fed. Reg. 15,132 (Mar. 22, 2021).
  • On November 15, 2021, Public Law 117-58 became law. Section 90006 of Public Law 117-58 states that:

    Notwithstanding any other provision of law, the Secretary of Health and Human Services shall not, prior to January 1, 2026, implement, administer, or enforce the provisions of the final rule published by the Office of the Inspector General of the Department of Health and Human Services on November 30, 2020, and titled ''Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees'' (85 Fed. Reg. 76666).

    Consequently, there is a three-year moratorium on implementation of the amendments to 42 C.F.R. § 1001.952(h)(5) and 42 C.F.R. § 1001.952(h)(6) through (9), (cc), and (dd).
04-21-2020
Grants, Contracts, and Other Agreements: Fraud and Abuse; Information Blocking; Office of Inspector General's Civil Money Penalty Rules

2019

10-09-2019
Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements
01-31-2019
Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees

2018

08-27-2018
Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti- Kickback Statute and Beneficiary Inducements CMP

2017

12-27-2017
Notice: Solicitation of New Safe Harbors and Special Fraud Alerts
01-11-2017
Final Rule: Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities

2016

12-28-2016
Notice: Solicitation of New Safe Harbors and Special Fraud Alerts
12-06-2016
Final Rule: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Civil Monetary Penalty Rules
Final Rule: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements
09-19-2016
Proposed Rule: State Medicaid Fraud Control Units
03-17-2016
Notice: Statement of Organization, Functions, and Delegations of Authority

2015

12-23-2015
Notice: Solicitation of New Safe Harbors and Special Fraud Alerts
10-28-2015
Medicare Program: Final Waivers in Connection with the Shared Savings Program

2014

12-31-2014
Notice: Solicitation of New Safe Harbors and Special Fraud Alerts
10-02-2014
Proposed Rule: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements and Gainsharing
07-11-2014
Notice: Solicitation of Information and Recommendations for Revising OIG's Non-Binding Criteria for Implementing Permissive Exclusion Authority Under Section 1128(b)(7) of the Social Security Act
Special Fraud Alert: Laboratory Payments to Referring Physicians
05-13-2014
Proposed Rule: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Civil Monetary Penalty Rules
05-09-2014
Proposed Rule: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities

2013

12-27-2013
Final Rule: Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute
Notice: Solicitation of New Safe Harbors and Special Fraud Alerts
12-20-2013
Notice: Delegation of Authority
05-17-2013
Final Rule: State Medicaid Fraud Control Units; Data Mining
04-08-2013
Proposed Rule: Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute

2012

12-28-2012
Notice: Solicitation of New Safe Harbors and Special Fraud Alerts
06-18-2012
Notice: Solicitation of Information and Recommendations for Revising OIG's Provider Self-Disclosure Protocol
06-01-2012
Notice: Revision of Performance Standards for State Medicaid Fraud Control Units

2011

Notice: Privacy Act; System of Records
12-29-2011
Notice: Solicitation of New Safe Harbors and Special Fraud Alerts
10-12-2011
Proposed Revision of Performance Standards for State Medicaid Fraud Control Units
04-07-2011
Notice: Medicare Program; Waiver Designs in Connection With the Medicare Shared Savings Program and the Innovation Center
03-17-2011
Proposed Rule: State Medicaid Fraud Control Units; Data Mining

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