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

[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

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

Temporal Proximity Is Not Enough: Third Circuit Nixes FCA/Anti-Kickback Suit For Failure To Link Alleged Scheme to Claims

On January 19, 2018, the United States Court of Appeals for the Third Circuit affirmed a district court’s ruling granting summary judgment to a specialty pharmacy that was accused of violating the Anti-Kickback Statute and the federal False Claims Act (United States ex rel. Greenfield v. Medco Health Solutions, Inc. et al., No. 17-1152.). The court held that the relator, a former vice president of the specialty pharmacy, failed to link the pharmacy’s alleged kickback scheme to the actual submission of claims to Medicare. The decision is important because it stands for the proposition that to be liable under the False Claims Act a relator must allege more than the defendant was submitting claims for federal health care program beneficiaries while engaging in kickbacks. Rather, it must allege that at least one claim was submitted for services that were provided in violation of the Anti-Kickback Statute. Continue Reading

Escobar’s Demanding Materiality Standard Nixes $350 Million Verdict Against Florida Nursing Facility

A Florida federal court threw out a $350 million jury verdict against a nursing facility, citing the Supreme Court’s landmark decision in Universal Health Services, Inc. v. United States ex rel. Escobar. The court explained that the relators had failed to establish that the alleged violations were material to the federal Medicare and state Medicaid programs’ decision pay claims.

The ruling is another piece of welcome news to the healthcare community, which is historically the primary target of the government’s False Claims Act enforcement efforts. The ruling demonstrates that under Escobar, it is one thing to proclaim that a violation was material to the government’s decision to pay, but it is another thing to prove it. Continue Reading

The Department of Justice Delivers Some Good News to the Healthcare Industry: New False Claims Act Guidance Predicts More Challenges to Qui Tam Plaintiffs

The DOJ is empowered under the FCA to seek dismissal of unmeritorious qui tam suits brought in its name. The DOJ has historically used this power sparingly. We are happy to report, however, that more dismissals may be on the horizon.

On January 10, 2018, Michael Granston, Director of the Commercial Litigation Branch of the Fraud Section of the U.S. Department of Justice circulated an internal memorandum that was published last week in the legal press. The memorandum collects cases in which the Department sought dismissal of unmeritorious qui tams. It categorizes these cases into seven factors that DOJ attorneys should consider when evaluating whether the government should seek to dismiss a qui tam.

Nearly all FCA recoveries against healthcare entities in the last three years came from cases filed by qui tam relators. In other words, of $7.3 billion recovered from healthcare entities in 2015-17, $6.9 billion of that originated from qui tam suits. The Department of Justice’s guidance is welcome news for healthcare entities as it will likely further stymie unmeritorious qui tam litigation.

The following article, “DOJ Formalizes Guidance for Government Dismissal of Unmeritorious Qui Tam Suits,” by Michael Paddock, David T. Fischer and Matthew Turetzky was previously posted on January 25, 2018, on the Sheppard Mullin False Claims Act Defense Blog. Continue Reading

Life in the Slow Lane? What the Net Neutrality Repeal May Mean for Telehealth Services

Will the repeal of the net neutrality rules negatively impact the provision of TELEHEALTH SERVICES, which require robust and reliable internet connectivity?

Net neutrality is the principle that Internet Service Providers (ISPs) must treat all internet data equally and not discriminate or charge differently based on content, user, website, platform, application, or method of communication. Following this principle, the Obama-era Federal Communications Commission (FCC) adopted net neutrality rules in 2015, classifying high-speed broadband service as a public utility under Title II of the Telecommunications Act and prohibiting ISPs from intentionally speeding up, slowing down, or blocking any content, applications, or websites.[1] On December 14, 2017, however, the FCC voted 3-2 to repeal the net neutrality rules, creating considerable uncertainty about how this policy change will affect the healthcare industry, particularly with respect to telemedicine.[2]    Continue Reading

The 2017 Department of Justice False Claims Act Recovery Statistics:

In a year when the Department of Justice recovers $2.5 billion from the healthcare industry in False Claim Act judgements and settlements, can there really be a silver lining?

Every December, the Department of Justice (DOJ) releases its annual False Claims Act (FCA) recovery statistics for the preceding fiscal year. The recovery statistics, as they have for the past several years, indicate the DOJ considers the healthcare industry to be the number one target for FCA enforcement activity. Of the $3.7 billion in judgments and settlements recovered by the DOJ in 2017, $2.5 billion of that came from the healthcare industry. That is a tremendous number and indicates that the DOJ’s enforcement priority continues to be healthcare—as it has been for the last several years. In 2016, the DOJ recovered $2.6 billion from the healthcare industry. And in 2015, the DOJ recovered $2.2 billion from the healthcare industry. Healthcare has been a focus of DOJ’s FCA enforcement strategy for several years—and it shows no signs of changing any time soon.  Continue Reading

Day 4 Notes on the 2018 JP Morgan Healthcare Conference

San Francisco (January 11, 2018) – The final day of the 2018 JP Morgan Healthcare Conference gave us food for thought about the topic of healthcare navigation, as well as updates on the home health sector. Post-acute has become the focus of more attention, especially with the recently announced purchase by Humana of Kindred’s home health business. Genesis Healthcare’s presentation today also shared that they (the largest skilled nursing facility (SNF) operator in the U.S.) were at 84.6% occupancy and, given the growth in senior citizens, expected the SNF industry to run out of beds somewhere between 2020 and 2025. That’s a daunting forecast and clearly also emphasizes the importance of home health. But first, let’s look at the interesting topic of patient engagement and healthcare navigation. Continue Reading

Day 3 Notes on the 2018 JP Morgan Healthcare Conference

San Francisco (Wednesday, January 10, 2018) – The third afternoon of the conference was a deep dive into data and analytics, with successive presentations by IBM Watson Health, Inovalon and AthenaHealth and an earlier morning presentation by Chinese genomics company BGI. Significant progress was reported and, interestingly, the more these companies (and others like them) can do, the more that the market expands with new requests and newly discovered needs (a la “what can you really use a tablet for anyway?”). Inovalon reported that the total addressable market has grown in their estimation from $84 billion (as calculated back in 2014) to $142 billion as of 2018. Breaking that down, they believe that there currently is about $40 billion of demand from the provider sector, $51 billion from pharma/life sciences, $17 billion from payors and $33 billion from consumers. Continue Reading

Notes on Day 2 of the JP Morgan Healthcare Conference

San Francisco (Tuesday, January 9, 2018): Day 2 of the 2018 JP Morgan Healthcare Conference provided concrete examples of the trends that have been discussed in recent years – the impact of shifting healthcare delivery modalities on hospitals, the opportunity for retail medicine, the need for more effective management of chronic conditions and the increasing relevance of the Chinese markets. While some attendees complained about a lack of blockbuster announcements, today’s presentations were intriguing as an example of how the consulting and conference recommendations of the 2010 – 2014 period now are being played out in the real world of healthcare today. As the CEO of Advocate Health Care said, with tongue in cheek and quoting Game of Thrones, “Winter is coming….” and healthcare delivery will become even more difficult. There also was cause for optimism as well, as we saw multiple vibrant strategies for growth, including a continuing shift to value-based and risk-based reimbursement structures. Continue Reading

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