California Sues Sutter Health Alleging Anti-Competitive Practices

By David Garcia, Matthew Goldman, Jordan Grushkin and Samuel Gilkeson on April 6, 2018 Posted in Antitrust

California Attorney General Xavier Becerra filed a civil antitrust lawsuit in San Francisco County Superior Court on March 29, 2018 (the “Complaint”), alleging that Sutter Health (“Sutter”), one of Northern California’s largest healthcare providers, engaged in unlawful conduct in violation of California’s Cartwright Act (the “Act”).[1] Sutter Health has a substantial healthcare network that includes: 24 hospitals, 35 outpatient centers, physician’s organizations with over 5,500 members, and over 12,000 other physicians who partner with Sutter. Continue Reading

Blockchain for Healthcare

By James Gatto on April 3, 2018 Posted in Blockchain, Healthcare Information Technology

Blockchain technology is finding its way into every industry. Healthcare is no exception. According to a recent report by Deloitte, “blockchain technology has the potential to transform health care, placing the patient at the center of the health care ecosystem and increasing the security, privacy, and interoperability of health data.” Some of the proposed applications include truly patient-centric health records, provider licensure and credentialing, supply chain management in conjunction with predictive analytics and more accurate tracking capabilities, among many others. A recent whitepaper addresses “Innovative Blockchain Uses in Health Care” and an overview of blockchain technology. Just recently, Humana, MultiPlan, Optum, Quest Diagnostics and UnitedHealthcare announced a pilot program that will apply blockchain technology to improve data quality and reduce administrative costs around provider data management. Continue Reading

Direct Primary Care Legislation Continues its Roll Across the Country: Florida Governor Rick Scott signs Florida House Bill 37, Direct Primary Care Agreements

By Kenneth Yood and Samuel Gilkeson on March 30, 2018 Posted in Direct Primary Care (DPC)

Direct Primary Care. Direct primary care (DPC) is a style of clinical practice in which a healthcare provider (usually a physician or a physician group) offers primary care services to patients who pay a monthly membership fee for the provision of primary care services at no additional charge to the patient/member. For its most ardent enthusiasts, DPC may best be described as it is on the Direct Primary Care Coalition’s home page:

Direct Primary Care (DPC) is an innovative alternative payment model improving access to high functioning healthcare with a simple, flat, affordable membership fee. No fee-for-service payments. No third party billing. The defining element of DPC is an enduring and trusting relationship between a patient and his or her primary care provider. Patients have extraordinary access to a physician of their choice, often for as little as $70 per month, and physicians are accountable first and foremost to their patients. DPC is embraced by health policymakers on the left and right and creates happy patients and happy doctors all over the country! Continue Reading

Take-Aways from CMS’ Recent Listening Session Regarding E/M Services: Documentation Guidelines and Burden Reduction

By Sheppard Mullin and Lynsey Mitchel on March 27, 2018 Posted in Centers for Medicare and Medicaid Services ("CMS")

On March 21, 2018, a representative from the Hospital and Ambulatory Policy Group at the CMS, held a listening session regarding proposed updates to documentation guidelines for Evaluation and Management (“E/M”) Services. The purpose of this listening session was for the agency to obtain stakeholder feedback in order to develop policy proposals for upcoming notice and comment rulemaking, which, according to the CMS, will require a multi-year, collaborative effort among the agency and providers. Despite the warning of a Sisyphean task ahead, the CMS seems focused on reducing the burdens associated with the documentation requirements, which date back to 1995. Perhaps the effort will be moot as documentation as the driver of reimbursement will be replaced with clinical and quality outcomes. While the industry is certainly on this path – moving from “if it is not documented, it has not been done” to “if there is no value, it has not been done,” coding remains key and the 20 year old guidelines must be re-visited in light of the current state of the practice of medicine, especially the wide-spread use of electronic health records (“EHRs”). Continue Reading

New York Settles EmblemHealth Breach for $575,000

By Kristi Kung on March 15, 2018 Posted in Privacy and Data Security

“New York Settles EmblemHealth Breach for $575,000,” is a reprint of an article first posted on the Sheppard Mullin Eye on Privacy blog on March 15, 2018. EmblemHealth is one of the United States’ largest nonprofit health plans. It is headquartered in New York City, New York.

New York Settles EmblemHealth Breach for $575,000

The recent $575,000 settlement with EmblemHealth signals a push from AG Schneiderman “for stronger security laws and hold[ing] businesses accountable for protecting their customers’ personal data.” Noting New York’s “weak and outdated” security laws, AG Scheiderman used the settlement to urge for the swift passage of the Stop Hacks and Improve Electronic Data Security Act (“SHIELD Act”) introduced by his office in November 2017, which would make New York one of the most protective states in terms of data privacy and security. Continue Reading

Healthcare Industry Beware: The Use of Statistical Sampling to Establish Damages and Liability Under the False Claims Act Remains a Viable Option for Plaintiffs

By Matthew Turetzky and Robert T. Rhoad on March 14, 2018 Posted in False Claims Act

The False Claims Act contains numerous requirements that are designed to prevent meritless cases from proceeding to discovery and trial. Among these provisions is the rule that, to establish liability, the government or a relator must show that an actual claim was submitted to federal Medicare or state Medicaid for reimbursement. In some Circuits, such as the Eleventh, the government or a relator must identify claims at the pleading stage. Failure to do so will result in dismissal. Continue Reading

Proposed CVS Health-Aetna Acquisition Holds Strong in Congressional Hearing

By Jeralin Cardoso on March 6, 2018 Posted in Antitrust, Healthcare

Last Tuesday, February 27, 2018, representatives of CVS Health and Aetna went before the House Judiciary Committee Subcommittee on Regulatory Reform, Commercial, and Antitrust Law (“Subcommittee”) to argue in favor of CVS Health’s recently proposed acquisition of Aetna.[1] The Hearing, “Competition in the Pharmaceutical Supply Chain: the Proposed Merger of CVS Health and Aetna,” has drawn significant attention from stakeholders in the healthcare marketplace who are looking at the testimony and questions as an indicator of the current Congressional mood regarding (i) the antitrust/anticompetitive concerns raised by the transaction’s detractors, and (ii) the pro-consumer benefits (e.g., reduction in healthcare care costs and the transformation of the CVS Pharmacy locations into community medical hubs for primary care and basic procedures) identified by the transaction’s supporters. Continue Reading

Lifting the Limits on Physician-Owned Hospitals: Can Regulators Prevail Where Legislators Have Stalled?

By Rachel Landauer on March 2, 2018 Posted in Hospitals

We reported, in early 2017, on what was then the latest legislative effort to repeal the Affordable Care Act’s amendment to the Stark Law’s whole hospital exception, which amendment has effectively prevented new physician-owned hospitals from participating in the Medicare program. (You can visit—or revisit—that post, which explores arguments in favor of and in opposition to the restriction, here.)

While the Patient Access to Higher Quality Health Care Act of 2017, introduced in the House in February 2017 and, in May 2017, the Senate, did not pass, recent rumblings suggest that repeal efforts are far from exhausted; rather, proponents of physician hospital ownership may be targeting a new tactic: regulation. Continue Reading

New DOJ Guidance Policy Limits Use of Guidance Documents in Federal Civil Actions

By Matthew Goldman, Jordan Grushkin and Cody Fierro on February 20, 2018 Posted in Fraud and Abuse

[1] On January 25, 2018, Associate Attorney General Rachel Brand issued a memorandum on behalf of the U.S. Department of Justice (DOJ) (the “Brand Memo”) which effectively limits the use and enforcement power of guidance documents for the purposes of affirmative civil enforcement cases, a development that could have a significant impact on how certain healthcare cases are handled at the federal level by federal departments, agencies, and administrations, including those that are fixtures of the healthcare marketplace – the Department of Health and Human Services (HHS) and its constituent agencies, including the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA) and the HHS Office of Inspector General (OIG). Continue Reading

The Bipartisan Budget Act Boosts Medicare: Flexibility and Financing for Healthcare Plans and Providers

By Matthew Goldman, Jordan Grushkin and Samuel Gilkeson on February 15, 2018 Posted in Medicare

On Friday, February 9, 2018, President Trump signed the Bipartisan Budget Act of 2018 (the “Budget”), a two-year budget which, in significant part, made substantial revisions to Medicare, including the Medicare Advantage (MA) program. Such revisions include:

i. the addition of non-medical services (e.g., home-delivered meals, transportation to and from a physician’s office, etc.) and telehealth services to the range of MA-covered services that an MA plan (Plan) can offer to its members;

ii. a significant increase in federal funding for services provided by federally qualified health centers (FQHCs);

iii. disbanding the Independent Payment Advisory Board (IPAB), a board comprised of presidential appointees whose sole authority and responsibility was to cut Medicare costs and expenses; and

iv. an increase in the discounts that pharmaceutical companies must give seniors enrolled in Medicare Part D drug plans by making the so-called “doughnut hole” disappear in 2019.

The above Medicare-related changes were part of the “Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017” (the “Act”) – a bipartisan bill that passed the Senate last October and was incorporated into the Budget during the final throes of Budget negotiations.

The following includes a more in-depth discussion of each of the Budget items described above. Continue Reading