In a report released on March 9, 2017, a National Academies of Sciences, Engineering, and Medicine committee concluded that the bioeconomy is growing rapidly and the US regulatory system needs to provide a balanced approach to the many competing interests that will arise in the face of the expansion.
Compliance Program Development & Counseling
Internal compliance programs are health care companies’ first line of defense in preventing misconduct. Government enforcement actions, revisions to the US Sentencing Guidelines, a series of compliance program guidelines issued by OIG, and mandatory compliance programs issued by some state Medicaid programs should prompt providers to review and update their current compliance programs. Arent Fox assists health care providers and manufacturers in navigating this complex, ever-changing world of government regulation and enforcement.
Our services include:
- Compliance Program Development
- Ongoing Compliance Counseling and Program Assessment
- Compliance Training
- Internal Reviews and Audits
- Investigation Defense
- Corporate Integrity Agreements
- Voluntary Disclosures
In early February, the Department of Justice’s Criminal Division, Fraud Section, published a document titled, Evaluation of Corporate Compliance Programs. A must-read for any person responsible for a compliance program, regardless of industry, the document identifies common questions that DOJ may ask when making individualized determinations about a compliance program’s effectiveness.
For the first time in nearly three decades, the Substance Abuse and Mental Health Services Administration (SAMHSA) has updated the regulations on the confidentiality of substance abuse treatment records found in 42 C.F.R. Part 2 (the Part 2 Regulations).
As previously discussed on this blog (see here and here), the Office for Civil Rights (OCR) recently began its second round of audits of covered entities and business associates for compliance with the HIPAA Privacy Rule, Security Rule, and Breach Notification Rule (the “Phase 2” audits). Notably absent from the launch of Phase 2 was the release of the updated audit protoc
On May 6, 2016, CMS published in the Federal Register a request for comments on proposed revisions to the information to be collected pursuant to the CMS Voluntary Self-Referral (Stark) Disclosure Protocol (SRDP). The proposed revisions introduce a new SRDP submission form and update the requirements of the SRDP to reflect recent regulations that require providers to self-disclose overpayments going back up to six years, when appropriate.
On Friday, February 12, 2016, the Centers for Medicare and Medicaid Services (CMS) released the long-awaited Final Rule and regulations, providing much needed guidance to providers and suppliers on how to meet the Affordable Care Act’s (ACA’s) 60-day overpayment mandate. Specifically, a provision enacted as part of the ACA in 2010 requires that all Medicare and Medicaid overp
As part of the federal government’s multi-front attack on opioid abuse, the Department of Justice announced on Friday, February 12 that CVS Pharmacy, Inc. has agreed to pay $8 million to settle allegations that it violated the Controlled Substances Act (CSA).
We want to make all our clients and friends aware of this upcoming complimentary webinar featuring Arent Fox partner Linda Baumann and associate Hillary Stemple. The webinar’s subject, self-disclosures to the government, is so important to health care providers that we are alerting our subscribers to it.
Last month, we analyzed the draft guidance regarding Institutional Review Board (IRB) minutes (Draft Guidance) proposed by the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA).
ABOUT ARENT FOX LLP
Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.