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OIG Advisory Opinion Allows Routine Waiver of Federal Cost-Sharing Obligations
January 18, 2019 | Blog | By Karen Lovitch, Cassandra Paolillo
In an Advisory Opinion posted earlier this week, the OIG gave the green light to a charitable pediatric clinic’s routine waiver of patient cost-sharing amounts on the basis. The OIG’s analysis hinged on several factors that, taken together, led the OIG to refrain from exercising its enforcement discretion.
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In Case You Missed It: A List of Our Health Care Year in Review Posts
January 17, 2019 | Blog
Over the last few weeks, we published a number of posts examining important developments and trends in 2018 as well as what we expect to see in 2019. Our posts cover a range of topics, including enforcement and litigation, HIPAA and the FDA. In case you missed one, below are links to all of our Year In Review posts.
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The Buzz About Block Grants
January 16, 2019 | Blog
With the recent scoop from Politico that the Trump Administration is considering giving states the ability to implement Medicaid block grants, there has been considerable speculation on what the Administration is planning. Although we don’t know exactly what the Administration has in mind, there increasing skepticism on the legality of this move. So we are laying out the fundamentals and past history as we await the final guidance.
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ML Strategies Health Care Preview - January 14, 2019
January 15, 2019 | Blog
While Congress and the Administration are dug in entering the third week of a partial government shutdown, both branches of government are looking to shape other policy areas in 2019. The Administration is reportedly looking at reforming the Medicaid program and Congress is ramping up its oversight of prescription drug prices.
We cover this and what it will mean for this Congress in this week's preview.
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We cover this and what it will mean for this Congress in this week's preview.
Supreme Court to Decide Critical Case on When CMS Must Use Formal Rulemaking when Instructing Medicare Contractors
January 14, 2019 | Blog | By Laurence Freedman, Daryl Berke
On January 15, 2019, the U.S. Supreme Court will hear arguments in a hotly-contested case involving a challenge by hospitals over when Medicare’s instructions to its contractors impact a “substantive legal standard” and thus must be issued through formal rulemaking. In Azar v. Allina Health Services, the Court will review the U.S. Court of Appeals for the D.C. Circuit’s decision that threw out a new Medicare rate calculation methodology for Disproportionate Share Payments (DSH) to hospitals adopted by the U.S. Department of Health and Human Services (HHS) because the agency promulgated it through “interpretative guidance” but failed to undergo notice-and-comment rulemaking. The Supreme Court is now tasked with answering a broader question: what is the legal standard for when HHS must use formal rulemaking and not “interpretative” instructions to its contractors in the administration of the Medicare program?
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Health Care Enforcement Year in Review and 2019 Outlook: Civil Litigation Developments and Settlements
January 11, 2019 | Blog | By Brian Dunphy, Laurence Freedman, Karen Lovitch
As in years past, the False Claims Act (FCA) remained a powerful health care enforcement tool in 2018, and FCA investigations and litigation persisted, fueled mainly by hundreds of lawsuits filed annually by relators, including 645 new qui tam actions initiated in FY 2018.
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Health Care Enforcement Year in Review & 2019 Outlook: New DOJ Policies Applicable to FCA Litigation
January 10, 2019 | Blog | By Brian Dunphy, Laurence Freedman
Last year, as we previously discussed, there were two significant Department of Justice (DOJ) policy developments that are applicable to False Claims Act (FCA) litigation: (1) the “Granston Memo” (issued by DOJ Civil Fraud Director Michael Granston), which set forth direction for DOJ’s exercise of its authority to dismiss declined qui tam FCA cases; and (2) the “Brand Memo” (issued by Associate Attorney General Rachel Brand), which instructed DOJ’s FCA litigators not to use any sub-regulatory guidance to create legal obligations.
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Health Care Enforcement Year in Review & 2019 Outlook: Criminal Enforcement Trends
January 9, 2019 | Blog | By Eoin Beirne
Criminal healthcare enforcement in 2018 once again focused heavily on opioids, targeting manufacturers, prescribers, dispensers and those who contribute to the addiction epidemic, and on prosecution of individuals for a variety of offenses. In addition, the DOJ announced some expected policy changes related to the way it investigates and prosecutes corporations as well as the restrictions placed on corporations after resolution of government charges. We will address each of these issues in this post and will attempt to forecast what we expect to occur in the coming year.
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Health Care Enforcement Year in Review & 2019 Outlook: Analysis of Health Care FCA Litigation Trends
January 8, 2019 | Blog | By Kevin McGinty
In 2018, the volume of False Claims Act (FCA) litigation remained high, and health care-related qui tam (i.e., whistleblower) cases continued to lead the way. Using data compiled in the Mintz Health Care Qui Tam Database (which is described further below), this post analyzes the trends in cases unsealed in 2018. To evaluate long-term trends, we examined the annual Department of Justice (DOJ) compilation of FCA cases. Together these data sets show that health care cases continue to make up a large majority of all whistleblower cases brought under the FCA, and almost two-thirds of those cases were brought by current or former employees, mostly against large pharmaceutical companies, physicians, and hospitals.
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DOJ Updates its Justice Manual to Include Section Limiting Use of Guidance Documents in Litigation
January 7, 2019 | Blog | By Samantha Kingsbury
Nearly one year ago, on January 25, 2018, the Department of Justice’s (DOJ) Regulatory Reform Task Force issued a memorandum entitled “Limiting Use of Agency Guidance Documents In Affirmative Civil Enforcement Cases.” Many refer to this memorandum as the “Brand Memo” because it was authored by Associate Attorney General Rachel Brand. The Brand Memo implemented the prohibition previously issued by U.S. Attorney General Jeff Sessions in November 2017 against, in part, DOJ using guidance documents issued by other agencies “to create binding standards by which [DOJ] will determine compliance with existing statutory or regulatory requirements” (the “Sessions Memo”).
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ML Strategies Health Care Preview - Week of January 7, 2019
January 7, 2019 | Blog
The partial government shutdown is on its 17th day with no end in sight. In this week's preview, we discuss how reaching a solution is challenging for both sides and implications for legislating going forward. We also cover some of the latest polling on health care issues, which may offer a preview into messaging in this space over the next two years.
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HIPAA and Health Care Data Privacy - 2018 Year-in-Review
January 4, 2019 | Blog
Today, we’re looking back at HIPAA and other privacy and security developments in 2018. This past year saw continued HIPAA enforcement (including the largest ever fine for a HIPAA breach), reminders from the OCR on best practices for HIPAA compliance, and updates to state and international privacy and security laws. We’ll also look ahead to 2019, which could bring several significant changes to HIPAA, such as reducing the burdens for sharing patient information in order to promote care coordination and better patient outcomes.
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340B, When a Price Adjustment is Not Really an Adjustment, and the Implications for CMS Efforts to Attack Drug Prices
January 2, 2019 | Blog
The Federal Courts gave the America Hospital Association and 340B covered entities a late Christmas present and in doing so may have dealt a blow to the Trump Administration’s initiatives aimed at controlling or reducing drug prices.
On December 27, 2018, Judge Rudolph Contreras granted the American Hospital Association’s Motion for a Permanent Injunction over CMS’ Medicare Part B reimbursement cut for 340B hospitals. As I have previously written, the vehicle for that reimbursement cut was the 2018 Outpatient Prospective Payment System (OPPS) rule, and CMS’ existing authority to adjust OPPS drug reimbursement.
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On December 27, 2018, Judge Rudolph Contreras granted the American Hospital Association’s Motion for a Permanent Injunction over CMS’ Medicare Part B reimbursement cut for 340B hospitals. As I have previously written, the vehicle for that reimbursement cut was the 2018 Outpatient Prospective Payment System (OPPS) rule, and CMS’ existing authority to adjust OPPS drug reimbursement.
FDA 2018 Year in Review (and a Few Thoughts on 2019)
December 27, 2018 | Blog | By Joanne Hawana, Benjamin Zegarelli
As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs point to yes” that everything on the list below will continue to be major areas of focus for both FDA and the U.S. Congress next year and into the foreseeable future.
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As 2019 Approaches, Private Equity Investment in Health Care Shows No Signs of Slowing Down
December 26, 2018 | Blog | By Cassandra Paolillo
As the year draws to a close, it’s clear that 2018 was another record year for private equity investment in health care. In its report on the top health industry issues of 2019, PWC’s Healthcare Research Institute recently highlighted the continued prevalence of private equity in health care transactions, and predicted even more private equity investment in the coming year. Below is an overview of the current and expected trends, as well as a few key considerations for private equity deals in the health care space.
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DOJ Follows Through on a 2018 New Years’ Resolution: Rein In Qui Tam Actions
December 20, 2018 | Blog | By Laurence Freedman, Bridgette Keller
Along with most of us, last January DOJ set its own goals for 2018: new policies related to False Claims Act (“FCA”) enforcement. One such “resolution” for 2018 was the DOJ Civil Fraud section’s instruction to its attorneys and all AUSAs handling FCA cases to routinely consider whether declined qui tam actions should be dismissed under the Department’s authority in Section 3730(c)(2)(A) of the FCA, which it had rarely used from 1986 through 2017. Known as the “Granston Memo” (which we discuss here) and now codified in the Justice Manual, the central theme of the instruction is that seeking dismissal of qui tam actions may be in the government’s interest to “preserve limited resources and avoid adverse precedent.” We are now seeing the first evidence of DOJ following through on that resolution.
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Observations from FDA’s Public Workshop on Medical Device Servicing and Remanufacturing
December 19, 2018 | Blog | By Benjamin Zegarelli
On December 10-11, 2018, FDA hosted a public workshop, Medical Device Servicing and Remanufacturing Activities, as part of its effort to develop a draft guidance that will distinguish servicing activities from remanufacturing. FDA expressed intent to develop a draft guidance on this topic as part of its May 15, 2018 report to Congress on the quality, safety, and effectiveness of medical device servicing. This post provides some observations about areas of agreement among stakeholders and FDA’s perspective on servicing versus remanufacturing.
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Paradigm Shift: Regulating Software as a Medical Device in the U.S.
December 19, 2018 | Blog
The U.S. Food and Drug Administration (FDA) is exploring the development of a new regulatory approach for software as a medical device (SaMD) that the agency believes will promote innovation while still assuring device safety and effectiveness. SaMD is software used for a medical purpose that is not part of a hardware medical device. The new approach is known familiarly as Pre-Cert and relies on a company being certified by FDA as having a culture of quality and organizational excellence.
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ML Strategies Weekly Preview - December 17, 2018
December 17, 2018 | Blog
This week, Congress is in session for what should be the last week of the 115th Congress. However, the spending fight that has been raging since the last continuing resolution is no closer to being wrapped up than it was a month ago. Additionally, we watch to see if the IMPROVE Act can be finalized this week.
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What's Next After the Texas vs. Azar Ruling?
December 17, 2018 | Blog
On Friday, December 14th, Judge O’Connor, a Texas Federal District Court Judge, ruled on the case Texas vs. Azar. As background, Texas vs. Azar was filed by 20 Republican state attorneys general and governors. The plaintiffs challenge the constitutionality of the individual mandate in the Affordable Care Act (ACA) and argue that since the individual mandate has been repealed, or more technically zeroed out, the rest of the ACA must be struck down. They argue that the individual mandate cannot be severed from the ACA given its key structural role in the law. The Department of Justice agreed with some, but not all parts, of this argument, and sixteen states and DC are defending the ACA.
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Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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