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Keeping you afloat amidst the rising sea of regulations

Future of Biotech: National Academies Committee Report Scans the Horizon

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.

What the Department of Justice Expects in a Compliance Program

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.

Substance Abuse Medical Record Privacy Rules Updated For The First Time in Nearly 30 Years

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).

New OCR HIPAA Audit Protocol Can Assist Providers with Preparing for Phase 2 Audits

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 protocol th

CMS Proposes New Requirements for Stark Self-Disclosures

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.

CMS’s Long-Awaited Final 60-Day Repayment Rule Provides Guidance and Eases Some Requirements for Health Care Providers and Suppliers

On Friday, February 12, 2016, the Centers for Medicare and Medicaid Services (CMS) released the long-awaited Final Rule and regulations,[1] providing much needed guidance to providers and suppliers on how to meet the Affordable Care Act’s (ACA’s) 60-day overpayment mandate.[2] Specifically, a provision enacted as part of the ACA in 2010 requires that all Medicare and Medicaid overpayments be reported and returned by the later of (i) 60 days after the date on which the overp

CVS Settles Controlled Substances Act Claim for $8 Million

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).

Webinar: The Decision to Disclose

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.

CMS Finalizes Quality Assessment and Performance Improvement (QAPI) Worksheets

* The following alert was originally published in California Healthcare News (CHN). To read it on the CHN website, click here.

A Holiday Break – Agencies Give Additional Time to Comment on Draft Guidance on IRB Minutes

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).