OIG Issued Updated General Compliance Program Guidance for Healthcare Providers and Stakeholders

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By Allison (Ally) Kjellander

On Monday, November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released its General Compliance Program Guidance (“GCPG”) for the general healthcare compliance community and other healthcare stakeholders. The GCPG generally covers the following topics: Read more

Prepare for the End of the Public Health Emergency: Compliance Concerns

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By Kim Stanger

For nearly three years, federal and state agencies have waived or relaxed regulatory requirements and expanded reimbursement for services due to the COVID-19 public health emergency (PHE), but the signs indicate that the party is nearly over. Many states have already ended their emergency exceptions, and the federal PHE appears to be coming to an end. The current 90-day PHE extension issued by the Health and Human Services (HHS) will expire January 11, 2023. (See here.) The Biden Administration has informally promised that it would notify stakeholders at least 60 days in advance of ending the PHE; consequently, there is a good chance that the PHE will be extended an additional 90 days into April 2023, but no formal announcement has issued yet. In the meantime, HHS has warned providers that most of the PHE waivers will end upon termination of the PHE and that providers should prepare now for a return to normal standards. (See CMS, “Creating a Roadmap for the End of the COVID-19 Public Health Emergency” (8/18/22), available here.) Read more

No Surprise Billing Rules: Checklist for Providers

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By Kim Stanger

Many providers make the No Surprise Billing Rules more complicated and expansive than they are. To help healthcare providers and facilities understand, implement and monitor compliance with the new rules, Holland & Hart has prepared a short guide and checklist for compliance, available here.

CMS Vaccine Mandate for Healthcare Workers: Resources for Preparing Your Policies

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By Kim Stanger

Under the Centers for Medicare & Medicaid Services (CMS)’s new vaccine mandate for healthcare workers, facilities must draft and implement policies and procedures by December 6, 2021 to ensure covered personnel are fully vaccinated or exempted by January 4, 2022. (86 FR 61573). That does not give facilities much time, but here are some resources that may help with compliance. (This alert supplements our summary of the CMS and OSHA mandates.) Read more

Common Stark Concerns for Hospitals

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by Kim Stanger

Unless structured properly, a hospital’s financial relationship with referring physicians or other providers may violate the federal Ethics in Patient Referrals Act (“Stark”) and Anti-Kickback Statute (“AKS”), resulting in civil and criminal fines, penalties, and repayments. Under Stark, if a hospital has a financial relationship with a physician, the physician may not refer patients to the hospital for certain designated health services1 payable by Medicare or Medicaid unless the arrangement fits within a regulatory safe harbor. (42 USC § 1395dd; 42 CFR § 411.353). The AKS generally prohibits knowingly offering, paying, soliciting or receiving remuneration to induce referrals for items or services payable by federal healthcare programs unless the arrangement fits within a regulatory safe harbor. (42 USC § 1320a-7b(b); 42 CFR § 1001.952). Below are some of the top compliance concerns arising from relationships with referring providers:

1. No Written Agreement. Except for employment arrangements, Stark and the AKS generally require that financial arrangements are documented in writing and signed by the parties, including arrangements involving the payment for services, sale or lease of space or equipment, recruitment subsidies, etc. (See, e.g., 42 CFR §§ 411.357(a), (b), (d), (e), (l), (p), (y), and 1001.952(b)-(d)). CMS has confirmed that a single formal contract is not necessarily required; instead, “a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties, may satisfy the writing requirement…” (80 FR 71315).

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