The Granston Memo in 2019: Recent Cases Highlight the Granston Memo’s Effectiveness as a Tool to Dismiss False Claims Act Cases

The “Granston Memo” has proven to be a boon again in 2019 for False Claims Act (“FCA”) defendants.  In a January 15, 2019 Sheppard Mullin FCA Defense Blog article, we highlighted a growing movement by the Department of Justice (“DOJ”) to utilize its dismissal power on meritless and burdensome qui tam FCA cases following an internal policy memorandum issued in early 2018, now dubbed the “Granston Memo.”  The Granston Memo encouraged DOJ attorneys to seek dismissal of such cases where it served one or more important policy objectives.  The DOJ has met with almost uniform success in its continued focus on this effort: since the Memo issued, the DOJ has sought dismissal in 36 cases and been unsuccessful only twice.  Continue Reading

Global and Professional Options Direct Contracting Model RFA and LOI Now Active

On April 21, 2019, the Center for Medicare and Medicaid Innovation (“CMMI”) announced the CMS Primary Cares Initiative – a voluntary, risk-based initiative to transform the Medicare program’s reimbursement of primary care services from a fee-for-service payment system to a value-based system that rewards physicians who keep patients healthy and out of the hospital. The CMS Primary Cares Initiative creates five payment models under two paths: the Primary Care First Model (“PCF Model”) and the Direct Contracting Model (“DC Model”).   All five models focus on care for chronically and seriously ill patients. Continue Reading

The California Consumer Privacy Act of 2018: Why the Healthcare Sector Needs to Pay Attention (and Not Just in California)

Background

On June 28, 2018, California’s new privacy bill A.B-375 was signed into law as the California Consumer Privacy Act of 2018 (“CCPA”). On October 10, 2019, the California Attorney General issued proposed regulations for implementing and interpreting the CCPA.[1] Effective on January 1, 2020, the CCPA will apply to all for-profit entities and businesses that:

  • Do business in California;
  • Collect the personal information (“PI”) of California residents, and
  • (a) Annually have gross revenues of $25 million or more; (b) derive half or more of their annual revenue from selling PI; or (c) transact in the PI of 50,000 or more consumers, households, or devices per year.[2]

Continue Reading

2019 Moss Adams Health Care Conference – Vision 2020: The Future of Health Care

Attendees of the annual Moss Adams Health Care Conference held in Las Vegas on November 7th and 8th, were treated to a heated exchange between political all-stars Karl Rove and James Carville over a variety of topics including the likely impeachment proceedings against President Trump, US policy in Syria and the upcoming elections (and the recently announced entry of yet another Democratic presidential candidate—Michael Bloomberg).  But at the top of everyone’s minds in the audience were questions over healthcare policy and specifically Elizabeth Warren’s Medicare-for-All plan, with an estimated price tag of $34 trillion.  It turned out that Karl and James were in lockstep agreement on the issue— “It makes no sense.  She is just completely insane!” Carville screamed.  The audience laughed.  But earlier, several conference speakers opined that some form of government mandated universal healthcare program could very well happen.  Continue Reading

Adventist – St. Joseph Merger: AG Concludes Merger is Not in the Public Interest

As we noted in our November 1, 2019 Healthcare Law Blog post, California Attorney General Xavier Becerra rejected the proposed merger between Adventist Health System/West and St. Joseph Health System (the “Proposed Merger”) in a denial letter issued on October 31, 2019. The Proposed Merger would have created a joint operating company to manage each health system’s facilities in Humboldt, Lake, Mendocino, Napa, Solano, and Sonoma Counties. In this blog post we will be discussing the Attorney General’s review process of hospital transactions and the reasons why this particular transaction may have been rejected. Moreover, we will assess what lessons can be learned going forward for other California healthcare systems and entities undergoing mergers and acquisitions in the future. Continue Reading

Adapting To FDA’s Proposal For Diagnosis Support Software

*This article was originally posted in Law360 on November 4, 2019

With the rise of artificial intelligence and machine learning, clinical decision support, or CDS, software presents a novel opportunity to analyze immensely large amounts of data for patterns or other information that may be relevant to a particular patient’s diagnosis or health care options. Continue Reading

Legislation Re-Introduced to Expand Access to Telehealth Under Medicare

A bipartisan group of senators introduced legislation on October 30th designed to expand Medicare beneficiaries’ access to telehealth services. The bill is called the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2019 (hereinafter, the “CONNECT Act” or the “Act”). In order to understand what the Act seeks to accomplish, it is important to have a working understanding of Medicare’s current policies governing telehealth. A brief overview is provided below followed by a section by section summary of the Act. Continue Reading

Merger of Adventist-St. Joseph Rejected by the California Attorney General

On October 31, 2019, the California Department of Justice (“DOJ”) issued a denial letter rejecting a proposed merger between Adventist Health System/West and St. Joseph Health System. The parties had submitted notices to the DOJ requesting approval to form a joint operating company to manage the health systems’ nine health facilities in Northern California. According to the denial letter, the proposed transaction was rejected because the Attorney General concluded that it was not in the public interest due to concerns related to the potential for higher health costs and for reduced access and availability of health care services. Continue Reading

CMS’s Mandatory Radiation Oncology Payment Model: Negative Reactions in the Radiation Oncology Treatment Community

On July 10 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a Notice of Proposed Rulemaking (“NPR”) entitled, “Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures.” In the NPR, CMS proposes to implement two new mandatory specialty care payment models – one of which, the Radiation Oncology Model (“RO Model”), applies to selected radiation therapy (“RT”) services[1] as provided by physician group practices, hospital outpatient departments, and freestanding radiation therapy centers, all located within randomly selected geographic areas throughout the country.

Although the proposed RO Model is consistent with broader trends in the healthcare industry to cut healthcare costs and increase quality through the use of bundled and other alternative (i.e., not fee-for-service) payment methodologies, the RO Model has garnered its fair share of detractors within the RT community.

In this article, we will focus on the concerns of such detractors, including those voiced by proton therapy providers who consider the RO Model’s payment reductions – which apply to all RT providers regardless of the treatment modality at issue – as a CMS-intended financial hit against proton beam therapy. Proton beam therapy is a form of radiation treatment that the Medicare Payment Advisory Commission (“MedPAC”), in its “June 2018 Report to the Congress: Medicare and the Health Care Delivery System,” (the “MedPac Report”) once referred to as a “potentially low value” treatment modality and an example of why CMS should consider the development and implementation of new RT payment models to create, “incentives for organizations to reduce low-value services.” Continue Reading

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