K&l Gates Health Care Triage

In this episode, Norman Acker, Nora Becerra, and Katherine Rippey discuss the False Claims Act as it relates to Stark Law and the Anti-Kickback Statute. They analyze the Wheeling Hospital case and the Catholic Medical Center case and discuss key takeaways from the cases as they relate to the False Claims Act.  

In this episode Victoria Hamscho, Andrew Ruskin, and Leah Richardson provide an update on key developments to the 340B Program. They discuss the effects of the Supreme Court’s decision earlier this year overturning 340B hospital reimbursement cuts, the agency’s proposed rule with respect to hospital outpatient reimbursement, and some considerations for hospitals when reviewing Medicare Advantage contracts.

In this episode, Gina Bertolini and Stephen Page discuss the most recent Information Blocking Rule compliance deadline. Using a recent letter from several health care providers and other stakeholders to the Office of the National Coordinator for Health IT (ONC) that outlines concerns related to the Information Blocking regulations, Gina and Stephen discuss the definition of electronic health information, the implication of technical changes to certified electronic health record technology, and application of some of the Information Blocking Rule’s exceptions as well as offer recommendations for compliance.

In this episode, Darlene Davis, Andrew Ruskin, and Lauren Norris Donahue review data that is now available in light of the hospital price transparency rule. They discuss the recent increase in compliance among hospitals, benefits of hospital price transparency data, antitrust considerations, and suggestions for hospitals to implement guidelines for clients when accessing data.

In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device clinical trials, sponsor obligations for investigator-initiated studies, and compliance for expanded access INDs and for GMPs in the case of hospital manufacturing of cell culture products and 3D printing.

In this episode, Rebecca Schaefer and J.D. Koesters review key components of the recent National Institute of Standards and Technology (NIST) revised publication regarding cybersecurity. They highlight how this resource incorporates NIST security lessons from other industries and maps the guidance to compliance requirements under the HIPAA Security Rule.

In this episode, Andrew Ruskin, Leah Richardson, and Victoria Hamscho analyze the U.S. Court of Appeals for the Fourth Circuit’s recent decision in Genesis Healthcare v. Becerra. They discuss its potential impact on the Health Resources and Services Administration’s definition of a 340B eligible patient in light of recent developments in the 340B Program and this year’s upcoming election.

In this episode, Stephen Bittinger and Nathan Huff discuss the growth of Medicare Part C (Medicare Advantage), new enforcements for Medicare Advantage Organization fraud, recent cases of False Claims Act liability, and key takeaways for Medicare Advantage Organizations and providers.

In this episode, Gabriel Scott and Darlene Davis analyze the private payor rates reporting requirements under the Protecting Access to Medicare Act. They discuss the type of entities required to report, potential penalties for failing to report, and provide some suggestions for how to initiate the reporting process.

Steve Pine and Alexa Sengupta address the Centers for Medicare and Medicaid Services’ emerging focus on ESG and health equity priorities, and how these priorities are impacting health data collection and Medicare value-based reimbursement models.

In this episode, Rebecca Schaefer and Gina Bertolini discuss the incredible value of health care data and how providers can harness the power of data transactions to drive innovation, discovery, and advancements in medical therapies.

In this episode, Myla Reizen, John Lawrence, and Bobby Higdon analyze the increase in governmental scrutiny around laboratory investigations and enforcement. They discuss the Eliminating Kickbacks Recovery Act (EKRA), trends in enforcement surrounding Operation Double Helix, guidance for medical labs, and the importance of outside counsel for compliance.

In this episode, Steven Pine and Gary Qualls discuss the arbitration provision under the federal No Surprises Act, controversy around the qualifying payment amount (QPA), a recent decision in a Texas federal court that impacts the QPA, and new developments around the independent dispute resolution process.

In this episode, Lou Patalano, Jacqueline Hoffman, and Spencer Hamer discuss employment law and the health care sector. They give a review of highlights from 2021, as well as developments that will impact employment law and the health care sector in 2022, including vaccine mandates, non-competes, and diversity, equity and inclusion.

Andrew Ruskin and Gabriel Scott discuss how Centers for Medicare & Medicaid Services (CMS) has recently promulgated rules implementing the provisions of the Consolidated Appropriations Act that affect a very large number of community hospitals. Specifically, due to CMS’s interpretation of Medicare graduate medical education reimbursement rules, many community hospitals are no longer eligible for these payments and don’t even know it. This episode discusses the dilemma that community hospitals might be facing and emphasizes the importance of meeting a 1 July 2022 deadline CMS has imposed that may allow these hospitals to press the reimbursement “reset button.”

Desiree Moore, Gina Bertolini, and Jackie Hoffman discuss the increasing impact of data security incidents and security breaches on the health care sector. They define what qualifies under HIPAA as a protected health information breach, discuss the importance of outside counsel in security incidents, review the timeline of reporting a breach to the Office for Civil Rights (OCR), and provide a road map on to how to manage a security incident from start to finish.

In this week’s episode, Richard Church interviews Michael Hinckle about FDA inspections of health care providers. They discuss why an inspection might come up, what providers should expect, the do’s and don’ts of inspection day, and the action items health care providers should implement post-inspection.

In this week’s episode, Darlene Davis interviews Andrew Ruskin about updates to the CMS Hospital Price Transparency rule now that it has been in effect for almost one year. The presenters discuss the expanded scope of pricing information that should be provided, the increased potential and severity of fines and enforcement actions CMS can take in cases of non-compliance, and steps hospitals should take if they are contacted by CMS.

In this episode, Rebecca Schaefer interviews Gina Bertolini and Desiree Moore about the recent Federal Trade Commission (FTC) policy statement regarding the FTC Health Breach Notification Rule and its applicability to vendors of personal health records. The presenters discuss the requirements of the FTC Rule, when it applies relative to HIPAA, and the implications of the policy statement for digital health companies and health IT developers. Gina and Desiree also provide practical takeaways for both health care providers and health app vendors.

In this week’s episode, Don Walker and Macy Flinchum discuss new regulations stemming from the No Surprises Act and the new parameters for health care providers around balance billing, including for example, requirements for adequate notice and consent. Our presenters explain when these requirements apply, who is responsible for providing notice and consent in various situations, and how the new regulations may impact reimbursement and arbitration moving forward.