On July 25, 2023, HHS, the Department of Labor, and the Department of the Treasury (the Departments) issued proposed rules (Proposed Rules) and other information regarding health plan and issuer compliance with mental health...more
8/7/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Consolidated Appropriations Act (CAA) ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Health Insurance ,
Mental Health ,
MHPAEA ,
NQTLs ,
Proposed Rules ,
Substance Abuse ,
U.S. Treasury
On April 5, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule (CMS-4201-F) regarding the Medicare Advantage (MA) and Part D programs. The Final Rule includes changes related to various aspects of...more
4/10/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Continuity of Care ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Care Providers ,
Medical Necessity ,
Medicare Advantage ,
Medicare Part D ,
OIG ,
Regulatory Agenda ,
Regulatory Requirements ,
Two-Midnight Rule
Hospitals that participate in the 340B program may be entitled to additional monies from Medicare Advantage plans in the wake of the Supreme Court’s decision in AHA v. Becerra.
In AHA v. Becerra, a unanimous Supreme Court...more
On October 3, 2022, the Attorneys General for California, New York, and Massachusetts, in collaboration with Attorneys General from 18 other states and the District of Columbia (State Attorneys General) submitted a comment...more
10/14/2022
/ Affordable Care Act ,
Algorithms ,
Anti-Discrimination Policies ,
Decision-Making Process ,
Department of Health and Human Services (HHS) ,
Healthcare ,
Medicaid ,
Medicare ,
Proposed Rules ,
Request For Information ,
Risk Mitigation ,
State Attorneys General
On August 23, 2022, Senate Finance Committee Chair Ron Wyden (D-Ore.) announced he was launching an inquiry into potentially deceptive marketing tactics by organizations offering Medicare Advantage benefits and Part D...more
OIG periodically makes updates to its Integrity Agreement (IA) and Corporate Integrity Agreement (CIA) model language. It is important for healthcare organizations – even those not subject to a CIA – to monitor changes to...more
On June 21, 2022, the United States Supreme Court granted certiorari in United States, ex rel. Polansky v. Executive Health Resources, Inc., et al. The Supreme Court will review the Third Circuit’s October 2021 opinion in...more
Last week, HHS withdrew the SUNSET rule, which, in general, would have caused HHS regulations to expire unless reviewed or assessed every 10 years. As previously reported (see here and here), the Biden administration twice...more
On September 22, 2021, OIG Principal Deputy Inspector General Christi Grimm delivered a keynote speech to the American Health Law Association (AHLA) Fraud and Compliance Forum. Consistent with her remarks this spring at the...more
10/11/2021
/ AHLA ,
Compliance ,
Coronavirus/COVID-19 ,
Enforcement ,
Fraud ,
List of Excluded Individuals/Entities (LEIE) ,
Medicaid ,
Medicare ,
Nursing Homes ,
OIG ,
Request For Information
On September 15, 2021, OIG posted Advisory Opinion 21-12, regarding a proposed arrangement involving a program to offer certain free items and services to patients who experience specific complications after undergoing...more
On July 7, 2021, OIG posted Advisory Opinion No. 21-07 relating to a proposed arrangement between a Medigap Plan and a Preferred Hospital Organization (PHO). The proposed arrangement involves (i) a discount on policyholder’s...more
Last week, OIG posted Advisory Opinions Nos. 21-03, 21-04, and 21-05 relating to three near-identical arrangements between Medigap plans and Preferred Hospital Organizations (PHOs). The arrangements involve (i) a discount on...more
On April 8, 2021, CMS issued proposed rules for the Fiscal Year (FY 2022) Skilled Nursing Facility (SNF) Prospective Payment System (PPS) and FY 2022 hospice payments. CMS estimates that the aggregate impact of the payment...more
4/16/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Conditions of Participation (CoP) ,
Consolidated Appropriations Act (CAA) ,
Hospice ,
Medicare Part A ,
Patient-Driven Payment Model (PDPM) ,
Payment Systems ,
Proposed Rules ,
Reporting Requirements ,
Request For Information ,
Skilled Nursing Facility ,
Value-Based Purchasing
On November 20, 2020, CMS issued a final rule (the Final Rule) strengthening the Organ Procurement Organization (OPO) Conditions for Coverage. The new Conditions of Coverage will subject OPOs to greater scrutiny with the...more
On October 21, 2020, CMS announced that it is pushing the implementation of its radiation oncology payment model (RO Model) back from January 1, 2021 to July 1, 2021 in response to industry concerns regarding the...more
On September 21, 2020, the HHS Office of Civil Rights (OCR) announced a $1.5 million settlement with Athens Orthopedic Clinic, a Georgia orthopedic clinic, to settle potential violations of the Health Insurance Portability...more
On August 24, 2020, CMS released a notice extending its timeline to publish its final rule with significant changes to the Stark regulations that was proposed in October 2019. Previously, CMS had indicated that it intended...more
On July 1, 2020, OIG published an advisory opinion regarding a discount medical plan organization (DMPO). A DMPO is not an insurer but contracts with providers who agree to reduce their fees for the DMPO’s members. Under...more
On June 1, 2020, the DOJ Criminal Division released an updated version of its guidance regarding the evaluation of corporate compliance programs (the 2020 DOJ Compliance Guidance). DOJ originally issued this guidance in...more
On May 18, 2020, CMS released guidelines for State and local officials for phased nursing home reopenings. The guidelines include recommendations for (1) the criteria for relaxing certain restrictions and mitigating the...more
On January 9, 2020, DOJ announced it recovered more than $3 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending September 30, 2019. DOJ...more
1/17/2020
/ Clinical Laboratories ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Qui Tam
On April 30, 2019, DOJ’s Criminal Division announced the release of an updated version of guidance previously issued in February 2017 regarding the evaluation of corporate compliance programs (Revised DOJ Compliance...more
In March, OIG released its annual Medicaid Fraud Control Units (MFCUs) report for Fiscal Year (FY) 2018. MFCUs investigate and prosecute Medicaid provider fraud and patient abuse and neglect and are jointly funded by the...more
On January 8, 2019, almost exactly a year after CMS removed total knee arthroplasties from the Medicare Inpatient-Only List, CMS released additional guidance regarding the application of the Two-Midnight Rule to these cases. ...more
On December 8, 2018, ProPublica and The New York Times published an article describing failures by several prominent physicians to disclose their financial relationships with drug companies in studies they published in...more