K&L Gates Healthcare Triage

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 cultu...

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 t...

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...

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...

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 digit...

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 r...

In the recent Medicare Physician Fee Schedule proposed rule for CY 2022, CMS has proposed adding a new category of reimbursable digital health services with new CPT codes classified as remote therapeutic monitoring (RTM). In this episode, Leah D'Aurora Richardson and Sarah Staples explain what RTM is, how it is different from remote physiologic monitoring (RPM), and the uncertainty regarding which...

In this week's episode, Andrea Cunha outlines some of the key considerations directors and officers should assess when their company is approaching insolvency, including how to evaluate financial distress of the company, the fiduciary duties they owe to the company, considerations for avoiding personal liability, and the maintenance of adequate insurance coverage.

As health care providers are increasingly relying on complex and integrated electronic medical record systems, the health care industry has rapidly become one of the most frequent and often vulnerable targets for cybersecurity threat actors.  In this week's episode, partners Gina Bertolini, John Lawrence, and David Rybicki discuss why health care providers in particular are being targeted by threa...

In this week's episode, Richard Church interviews Rebecca Schaefer about the intersection and blurred line between clinical research and quality initiatives. The presenters discuss what factors to consider when defining research, the regulatory requirements for research, and HIPAA exemptions to the Common Rule.

Health Care partners Sarah Carlins and Jackie Hoffman interview Labor, Employment, and Workplace Safety partner Craig Leen in this episode of Triage, recorded in collaboration with our Working Wise podcast. As the former director of the Office of Federal Contract Compliance Programs (OFCCP) at the U.S. Department of Labor, Craig shares engaging insights about OFCCP enforcement in the health care i...

Richard Church interviews Stephen Bittinger about the scope and authority of OIG and CMS audits, outlining the similarities and differences between the two from a provider perspective. The presenters discuss the key distinctions in the mechanics of the different types of audits that providers should be aware of, as well as strategies for preparing for and managing an audit, reporting consideration...

Businesses across all industries are experiencing a drive toward sustainability. Companies want to be at the forefront of this movement, not only out of ethical considerations, but also because it is in their financial interests to do so. In this episode, Richard Church interviews Teresa Hill, a partner in our energy practice, about the history and structure of power purchase agreements and the op...

In this week's episode, Richard Church interviews Stephen Bittinger about current trends and points of concern in the areas of health care reimbursement and integrity audit activity. The presenters discuss increases in provider audits, the potential for collaboration between the government and private payors, changes in the extrapolation process, and how providers can be proactive to avoid major a...