K&l Gates Health Care Triage

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 considerations, and the role of the OIG work plan.

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 opportunities that these transactions can bring for the health care industry.

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 audit issues.

In this week's episode, Myla Reizen interviews Bruce Spurlock, quality expert and President and CEO of Cynosure Health, about long-term care facilities focusing on lessons learned over the past year with COVID-19, with a deep-dive into a recent survey of California nursing homes and key take-aways. The presenters also address current issues facing the industry including top-of-mind concerns with vaccine hesitancy, potential litigation, and patient concerns when entering long-term care moving forward.

In this week’s episode, Josh Skora interviews Rick Giovannelli and Ken Marlow about current trends in health care transactions, with a particular focus on how COVID-19 has affected pricing considerations and the appetite for mergers, acquisitions, and joint ventures for traditional health care providers and private equity firms alike. The presenters also discuss how changes in the political landscape, funding, and other trends in the provision of health care may affect deal structures moving forward.

In this episode, Richard Church and Andrew Ruskin discuss recent developments in the landscape of the 340B Drug Pricing Program in 2020, and forecast some of the major areas of focus and potential change for 340B covered entities under the new administration in 2021 and beyond.

In this episode, Jackie Hoffman interviews Spencer Hamer about recent developments in employment law that have impacted the health care industry. This episode touches on various topics, including COVID-19 screening at the workplace, vaccination requirements, family member and whistleblower claims, physician non-competes, and racism as a public health threat. This episode of Triage is recorded in collaboration with our Working Wise podcast. For more information on this topic, please read our related client alert, “Employment Law Developments That Will Impact the Health Care Industry in 2021,” authored by members of our Labor, Employment, and Workplace Safety practice.

In this week’s episode, Richard Church and Mary Beth Johnston discuss a number of critical issues in the health care industry that are likely to be points of focus in the coming year, including the COVID-19 pandemic, False Claims Act cases, the Affordable Care Act, health care consolidation, and more.

In this episode, Health Care partner Rebecca Schaefer interviews Karishma Page, partner of the firm’s Public Policy and Law practice group, on what is likely to be coming down the pike in the health care policy landscape of particular interest to academic medical centers vis-à-vis regulatory and legislative action in 2021. 

 In this week’s episode, Gina Bertolini discusses two important aspects of the CMS Interoperability and Patient Access Final Rule that directly relate to health care providers, and how those aspects of the Final Rule will intersect with health care providers’ obligations under the ONC Information Blocking Rule. Specifically, Gina discusses CMS’ public reporting requirements for clinicians and hospitals who make attestations under the CMS Promoting Interoperability Program related to information blocking, and the new Medicare Condition of Participation which will require hospitals to send electronic patient event notifications in certain instances.

On this week’s episode, Carla DewBerry and Sarah Carlins discuss a recent California Federal District Court decision in David Wit v. United Behavioral Health, in which the court found that the defendant insurer violated ERISA by improperly denying behavioral health claims submitted by over fifty thousand beneficiaries. The presenters discuss the ways in which the insurer’s inadequate internal guidelines for the processing of behavioral health treatment claims led to the decision, and what this might mean for the design of behavioral health claims processing guidelines under ERISA regulated health plans in the future.

In this episode of Triage, Andrew Ruskin and Victoria Hamscho provide an update on recent developments in the 340B Program and, in particular, on two recent legal challenges covered entities brought in response to drug manufacturer contract pharmacy actions where they are requesting, among other things, for the Health Resources and Services Administration (HRSA) to promulgate 340B administrative dispute resolution regulations, which HRSA recently sent to the Office of Management and Budget for review.

In this episode, Rebecca Schaefer and Victoria Hamscho discuss the impact of the ongoing COVID-19 pandemic on university research programs and public policy projections for a potential federal response. The presenters are joined by Robin Cyr, Vice Provost for Research Administration at Northeastern University, who shares her frontline perspective and insights on the impact of COVID-19 on research programs at the institution and the types of relief that would help mitigate.

On this week’s episode, John Lawrence, Leah Richardson, and John Rothermich discuss compliance requirements associated with federal funding provided to health care providers through the CARES Act Provider Relief Fund, as well as the potential for forthcoming enforcement actions under the Federal False Claims Act (FCA). In particular, the presenters discuss the general confusion surrounding the gradual release of information regarding CARES Act funding compliance, and ways in which providers can prepare for potential government or private party actions alleging the misuse of CARES Act funds.

In this week’s episode, Kenneth Kennedy discusses FDA’s ongoing focus on the issuance of warning letters to firms marketing fraudulent COVID-19 products, and to manufacturers who have failed to meet certain requirements under applicable FDA Emergency Use Authorizations (EUAs), as well as what manufacturers and health care providers alike can learn from this trend.

In this episode, Jackie Hoffman addresses the challenges of providers, and those who advise providers, to identify available resources and maximize reimbursement in the face of the costs of care of uninsured and underinsured patients with COVID-19, or where providers generally face reimbursement challenges due to the pandemic environment.

In this episode, Rebecca Schaefer and Victoria Hamscho provide an update on next month’s Supreme Court oral arguments in California v. Texas, a case in which the Court will be reviewing the constitutionality of key parts of the Affordable Care Act (ACA). The presenters discuss the potential impact of the Supreme Court’s decision on health care providers and other stakeholders as well as the current Republican and Democratic plans to address its impact in case the entire ACA or major parts of the law are overturned. Presenters: Rebecca Schaefer, Victoria Hamscho

In this episode, Stephen Bittinger discusses the recent announcement that cease and desist letters from the Centers for Medicare & Medicaid Services (CMS) have been sent to 171 facilities testing for COVID-19 without proper CLIA certifications. Stephen outlines the impact of these cease and desist letters to the facilities, including potential implications for reimbursement of COVID-19 testing. Presenter: Stephen Bittinger

In this week’s episode, Myla Reizen and Jackie Hoffman discuss recent developments on the state and federal level related to the operation of long-term care facilities in light of the ongoing COVID-19 public health emergency. In particular, the presenters discuss recent federal regulatory and executive actions, as well as important state developments in Florida and Texas. Presenters: Myla Reizen and Jackie Hoffman

In this week’s episode, Limo Cherian, Steve Pine, and Macy Flinchum discuss some of the key changes for Accountable Care Organizations (ACOs) in the recent Medicare Physician Fee Schedule proposed rule. In particular, the presenters discuss the implications and potential challenges for ACOs if the proposed changes to quality reporting and the metrics on which ACOs are scored are finalized for 2021.