The End of COVID Waivers and Exceptions: What Now?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
Prohibitions on Use of Chinese Telecommunications Equipment and Services, Complying with the NDAA
COVID-19: Where are we now?
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Value-based health care: fraud & abuse laws
What patients misunderstand about their right of informed consent
Bill on Bankruptcy: ResCap Report, a Bargain at $83 Million
Most healthcare providers understand that routinely waiving patient cost-sharing obligations creates compliance issues under the Anti-Kickback Statute, the Civil Monetary Penalties Law, and third-party payor agreements which...more
Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...more
Examine the Evolving Challenges That Lie Ahead for Healthcare Stakeholders and State Regulators—and What You Can Do Now to Prepare and Protect Your Organization—at a New Manatt Webinar. Effective health insurance...more
On March 17, 2020, OIG issued a policy statement titled, “Policy Statement Regarding Physicians and Other Practitioners That Reduce or Waive Amounts Owed by Federal Healthcare Program Beneficiaries for Telehealth Services...more
On March 24, 2020, the US Department of Health and Humans Services Office of Inspector General (OIG) issued guidance regarding OIG’s March 17, 2020, policy statement on reductions or waivers of cost-sharing obligations owed...more
On March 25, 2020, the Office of Inspector General, Health and Human Services (OIG) issued two frequently asked questions (FAQs), clarifying its March 17th Policy Statement Regarding Physicians and Other Practitioners That...more
On March 17, 2020, the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) issued a Policy Statement addressing the ability of physicians and other practitioners to reduce or waive patient...more
Over the past week, the Centers for Medicare & Medicaid Services (CMS) has made a number of announcements related to Medicare coverage in connection with the Coronavirus (COVID-19) outbreak. Several of those announcements...more
On March 17, the New York State Department of Financial Services (DFS) announced the issuance of a new emergency regulation requiring insurance companies in the state to waive cost-sharing, including deductibles, copayments,...more
While the COVID-19 emergency continues, Medicare will pay health care professionals to provide care by telehealth for Medicare beneficiaries in their homes, and HIPAA restrictions affecting the use of non-compliant video chat...more
On March 2, New York Gov. Andrew Cuomo announced new regulations on New York health insurers regarding coverage for coronavirus testing and related matters. The State Department of Financial Services (DFS) directive requires...more
On January 9, in its first Advisory Opinion of 2019 (OIG Advisory Opinion 19-01), the U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable opinion regarding an arrangement...more
In an Advisory Opinion posted earlier this week, the OIG gave the green light to a charitable pediatric clinic’s routine waiver of patient cost-sharing amounts. The OIG’s analysis hinged on several factors that, taken...more
On January 14, 2019, the Health and Human Services Office of Inspector General (OIG) published a favorable Advisory Opinion allowing a charitable pediatric clinic (Clinic) to routinely waive cost-sharing amounts for patients...more
August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more
A group of six government-operated fire departments has received a green light from the Office of Inspector General (OIG) to enter into a mutual aid agreement to provide backup emergency ambulance services and to bill for...more
Massachusetts Waiver Amendment Requests Partial Expansion and Closed Formulary - On September 8, 2017, Massachusetts submitted a waiver amendment request to the Centers for Medicare & Medicaid Services (CMS) to modify its...more
Recently, the U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) issued an Advisory Opinion (17-02) that allows for waivers or reductions of cost-sharing amounts owed by financially needy...more
Next Steps on Healthcare Reform - Though President Trump has continued to call for action on repeal and replace in the wake of the Senate’s failed vote at the end of July, congressional Republicans have been fairly muted...more
Below is a summary of recent U.S. Senate action on healthcare legislation and our outlook regarding coming issues and possible actions. Holland & Knight's Healthcare & Life Sciences Team will follow up as developments...more
The Office of Inspector General (OIG) recently issued Advisory Opinion 17-02, allowing waivers or reductions of cost-sharing amounts owed by financially needy Medicare beneficiaries in connection with certain clinical...more
After weeks of secrecy, the Senate has released a discussion draft of legislation that is the counterpart of the American Health Care Act (AHCA) previously passed by the House. The Senate legislation, entitled the Better Care...more
Just in time for the New Year, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued final regulations (Final Regulations) that revised two existing Anti-Kickback Statute safe...more
On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule creating additional “safe harbors” for the Federal Anti-Kickback Statute (42 USC § 1320a-7b(b) et...more
On December 17, 2015, the Centers for Medicare and Medicaid Services (CMS) approved Michigan’s request to amend its Healthy Michigan Section 1115 demonstration, through which the State provides coverage for more than 594,000...more