Social media’s interplay with healthcare privacy presents a constantly evolving challenge. ICYMI (“in case you missed it”), there is an uptick in enforcement and scrutiny IRL (“in real life”) related to communications through social media and other public platforms by entities subject to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).
Regulatory enforcement and large litigation relating to the use of third party trackers on companies’ websites and applications have been on the rise. Tracking often occurs without the companies’ knowledge or consent. Third party tracking on hospital and provider websites has specifically garnered notable media attention. Recently, there has been significant activity by the Federal Trade Commission (“FTC”) under the Health Breach Notification Rule for unauthorized sharing of personal information. It has begun to penalize and impose steep corrective actions, including long-impacting future restrictions, for such violations.
Continue Reading Web Tracking Creates a Web of Data Privacy Risks
What Happened?
On Friday, February 3, the Department of Justice, Antitrust Division (the “DOJ”) announced its withdrawal of three policy statements on health care antitrust enforcement: (1) The Department of Justice and Federal Trade Commission Antitrust Enforcement Policy Statements in the Healthcare Area (Sept. 15, 1993); (2) The Department of Justice and Federal Trade Commission Statements of Antitrust Enforcement Policy in Healthcare (Aug. 1, 1996); and (3) The Department of Justice and Federal Trade Commission Statement of Antirust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program (Oct. 20, 2011) (together, the “Healthcare Statements”). It has been reported that the Federal Trade Commission (the “FTC”), which shares antitrust enforcement authority with the DOJ (together the “Agencies”), intends to withdraw the Healthcare Statements as well. Assuming the FTC follows the DOJ’s lead, the withdrawal of the Healthcare Statements may be the most significant antitrust enforcement development under the Biden Administration to date and is likely the most significant healthcare antitrust development in decades.
Continue Reading Department of Justice Withdraws Key Healthcare Antitrust Policy Statements
On January 31, 2023, the New York State Office of the Medicaid Inspector General (OMIG) released three guidance documents to assist Medicaid providers in meeting the requirements of recently adopted regulations governing (i) the implementation and maintenance of an effective compliance program for certain providers; (ii) Medicaid managed care fraud, waste and abuse prevention programs; and (iii) OMIG’s Self-Disclosure Program for overpayments.
Continue Reading Attention New York Medicaid Providers: It’s Time to Upgrade Your Compliance Program
A well-crafted letter of intent (“LOI”) adds value for the negotiating principals by helping to ensure the parties are in agreement on key deal terms before they spend significant time and money on diligence and definitive documents. It can also help the parties’ advisors understand the deal and prepare initial drafts of transaction documents that minimize the number of open issues to be resolved, thereby significantly reducing the time it might otherwise take to finalize the documents. Putting in the additional effort to flesh out details at the LOI-stage can thereby help reduce “deal fatigue” and frustration later on. Below are some often overlooked terms that can bolster your LOI to avoid time-consuming post-LOI disputes and increase the chances of a successful transaction.
On January 30, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released the long-delayed final rule on risk adjustment data validation (“RADV”) audits of Medicare Advantage (“MA”) organizations (the “Final Rule”). CMS promotes the Final Rule as improving program integrity and payment accuracy as well as transparency and certainty. One thing that is certain, CMS can expect further challenges to its RADV audit methodology.
Continue Reading CMS Issues Long-Awaited Medicare Advantage RADV Final Rule
As we approach the middle of the first quarter of 2023, private equity firms have continued to demonstrate their interest in investing in digital health. This does not come as a surprise, as most startups in the healthcare technology space have been active in developing attractive strategies. These companies strive to improve health outcomes and lower expenses by focusing on specific gaps, issues or illnesses, prioritizing technological innovation, and customizing individualized care plans.
Continue Reading Private Equity and Digital Health in 2023: Policy Updates and Trends to Watch
This blog is the second installment of our Digital Health Trends series.
Overview
Digital health services have exploded since the onset of the COVID-19 pandemic, and behavioral health services have seen large increases in utilization. Prior to the pandemic, telehealth visits for mental health or substance use disorder represented less than 1% of outpatient visits, but by mid-2020 nearly 40% of telehealth outpatient visits were for mental health or substance use.[i] Behavioral health is the highest-funded clinical indication within digital health, and digital behavioral health companies raised $1.7 billion in the first three quarters of 2022.[ii] Investments in behavioral digital health services have the potential to transform the healthcare system in several key areas.
Continue Reading The Transformation in Behavioral Digital Health Services
On January 5, 2023, the U.S. Department of Health and Human Services (“HHS”) published a notice of proposed rulemaking entitled “Safeguarding the Rights of Conscience as Protected by Federal Statutes” (the “Proposed Rule“). In this article we provide a brief summary of the Proposed Rule, while also examining the statutory amendments and previous rulemakings that create its foundation.
Continue Reading HHS Issues Proposed Rule to Provide Clarity on Rights of Conscience in Healthcare
Introduction: Defining Interprofessional Consultation
In a January 5, 2023, letter to state health officials, the Centers for Medicare & Medicaid Services (“CMS”) clarified a Medicaid and Children’s Health Insurance Program (“CHIP”) policy on the coverage and payment of interprofessional consultations (the “Guidance”). An interprofessional consultation occurs when the patient’s treating physician requests the opinion and/or advice from a specialist practitioner without the patient making face-to-face contact with the specialist practitioner. The new CMS guidance clarifies that it is permissible for Medicaid and CHIP to provide reimbursement for an interprofessional consultation when the consultation is for the direct benefit of the patient without the patient’s presence.[1]
Continue Reading CMS Issues Interprofessional Consultation Guidance