NGE IP Focus Life Sciences issue now available

As intellectual property practitioners working in the life sciences industry, we are positioned to engage with innovative scientific advances as well as emerging legal issues impacting the ability to secure and maintain patent protection for these advances. The legal issues encountered run the gamut from niche issues specific to the life sciences industry to intellectual property issues of general applicability across industries. In this issue of NGE IP Focus, we highlight some recent legal decisions in the life sciences industry that illustrate the depth and breadth of legal issues encountered in the field.

Wolters Kluwer Opens Registration for 2019 Healthcare Regulatory Update Quarterly Webinars

The webinars will feature attorneys and advisors from Hooper, Lundy and Bookman, P.C. who will review quarterly healthcare changes and preview legislative and regulatory issues on the horizon

Wolters Kluwer Legal & Regulatory U.S. today announced that registration is open for a quarterly webinar series in partnership with Hooper, Lundy and Bookman, P.C. focusing on significant health regulatory, legislative, litigation, and transactional developments throughout the year, analyzing each issue and forecasting what may be in store. This educational activity has been submitted for Continuing Legal Education (CLE) and is currently pending their review.

Each of the four webinars will be moderated by Kelly J. Rooney, JD, MPH, Managing Editor for Health Law at Wolters Kluwer Legal & Regulatory U.S., and will feature Robert L. Roth, managing partner of Hooper, Lundy and Bookman’s Washington, DC office, in addition to other experts from the firm and special guests.

“The healthcare industry is ever-changing, so it’s difficult for attorneys and compliance professionals to keep ahead of the curve,” said Rooney. “Wolters Kluwer is proud to provide customers and colleagues with discussions on timely topics that will help them better advise their clients. These webinars will focus on high-impact issues affecting health law today.”

“It’s extremely important for attorneys and others working in health care to keep up-to-date on regulatory, litigation, transactional, and legislative changes as they happen, as well as continuously assess how they will affect future decisions,” said Roth. “We are delighted to partner with Wolters Kluwer to provide updates on significant developments throughout the course of 2019. The year ahead will bring more challenges for industry professionals to navigate, and this webinar series will help them meet those challenges head-on.”

The first webinar in the series, “A New Year and a New Congress — Overview of Health Care Issues in 2019,” will uncover issues to watch in 2019 related to the new Congress, the CY 2019 Medicare Physician Fee Schedule and OPPS Final Rules, GME and IME issues, the outlook for health care provider mergers and acquisitions, and a look ahead to the January 15, 2019 oral argument in Azar v. Allina Health Services. To register, visit the link below:
A New Year and a New Congress — Overview of Health Care Issues in 2019

Tuesday, January 8, 2019 1 PM – 2 PM EST

Featured speakers: Robert L. Roth; Marty Corry, chair of government relations and public policy; Lisa Layman, principal of government relations and public policy; Robert Miller, associate; David Vernon, associate at Hooper, Lundy and Bookman.

The second webinar, “The First Quarter is in the Books — What’s in Store for the Rest of 2019,” will provide a status update on the 2019 health care issues and present new issues that have arisen since January, with a focus on trends in the False Claims Act enforcement, the latest on Azar v. Allina Health Services, Site Neutral payments, a telehealth update, and other timely topics. To register, visit the link below:

The First Quarter is in the Books — What’s in Store for the Rest of 2019

Tuesday, April 9, 2019 1 PM – 2 PM EST

Featured speakers: Robert L. Roth; Katrina Pagonis, partner; David Schumacher, partner, and Jeremy Sherer, associate; at Hooper, Lundy and Bookman.

The third webinar is titled “The First Half is in the Books — What’s in Store for the Rest of 2019.” Featured experts will survey the health care landscape and address emerging issues in health information technology and artificial intelligence, ACA and Medicare litigation, including the expected decision of the Supreme Court in Azar v. Allina Health Services, Update on the Federal policy for the Protection of Human Subjects in research (the “Common Rule”), and other timely topics. To register, visit the link below:

The First Half is in the Books — What’s in Store for the Rest of 2019

Tuesday, July 9, 2019 1 PM – 2 PM EST

Featured speakers: Robert L. Roth; Joe LaMagna, partner; Amy Joseph, senior counsel, Andrea Frey, associate; Jeremy Sherer, associate at Hooper, Lundy and Bookman with special guest presenter René Quashie, VP, Policy & Regulatory Affairs, Digital Health at Consumer Technology Association.

The fourth webinar is titled “Looking Back and Looking Ahead — What’s in Store for the Rest of 2019” will present special reports on the big three CMS rulemakings: the FFY 2020 Inpatient Prospective Payment System Final Rule, the CY 2020 Outpatient Prospective Payment Proposed Rule, and the CY 2020 Physician Fee Schedule Proposed Rule, a Medicaid DSH litigation update, a report on the Implementation of SUPPORT for Patients and Communities Act, including enforcement of the new Drug Anti-Kickback Law,  and other timely topics. To register, visit the link below:

Looking Back and Looking Ahead — What’s in Store for the Rest of 2019

Tuesday, October 8, 2019 1PM – 2 PM EST

Featured speakers: Robert L. Roth; Tracy Hale, associate; Kelly Carroll, associate; and Alicia Macklin, associate and Monica Massaro, manager of government relations and public policy; at Hooper Lundy and Bookman.

About Hooper, Lundy & Bookman

Founded in 1987, Hooper, Lundy & Bookman is the largest law firm in the country dedicated solely to the representation of health care providers and suppliers.  With offices in Los Angeles, San Francisco, San Diego, Boston, and Washington, D.C., and clients in all 50 states, we meet the business, litigation, regulatory, and government relations needs of a broad array of health care providers―ranging from the largest national health care organizations to community hospitals and individual physician practices.  We are pleased to be ranked by Chambers as Tier One: Healthcare, California.  For more information, please visit our website at

About Wolters Kluwer Legal & Regulatory U.S.

Wolters Kluwer Legal & Regulatory U.S. is part of Wolters Kluwer N.V. (AEX: WKL), a global leader in information, software solutions and services for professionals in the health, tax and accounting, risk and compliance, finance and legal sectors. We help our customers make critical decisions every day by providing expert solutions that combine deep domain knowledge with specialized technology and services.

Wolters Kluwer reported 2017 annual revenues of €4.4 billion. The group serves customers in over 180 countries, maintains operations in over 40 countries, and employs approximately 19,000 people worldwide. The company is headquartered in Alphen aan den Rijn, the Netherlands.

For more information about Wolters Kluwer Legal & Regulatory U.S., visit, follow us on Facebook, Twitter and LinkedIn.

Kusserow on Compliance: OIG Work Plan items for May 2018

The OIG regularly updates its Work Plan as it continues to assess relative risks in HHS programs and operations that may lead to new projects. The most recent changes involved adding six new projects. In making these additions, the OIG considered a number of factors, including mandates set forth in laws, regulations, or other directives; requests by Congress, HHS management, or the Office of Management and Budget; top management and performance challenges facing HHS; work performed by other oversight organizations (e.g., GAO); management’s actions to implement OIG recommendations from previous reviews; and potential for positive impact.

New Projects Added

  1. The Impact of Authorized Generics on Medicaid Drug Rebates. Under final rules implementing the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), CMS directed primary manufacturers to include in their calculation of average manufacturer price (AMP) the sale of authorized generic drugs to secondary manufacturers in some circumstances (42 C.F.R. Sec. 447.506(b)). OIG plans to examine selected drugs with authorized generics and determine how including the sales of authorized generic drugs to secondary manufacturers affects Medicaid drug rebates.


  1. Noninvasive Home Ventilators – Compliance with Medicare Requirements. For items such as noninvasive home ventilators (NHVs) and respiratory assist devices (RADs) to be covered by Medicare, they must be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Depending on the severity of the beneficiary’s condition, an NHV or RAD may be reasonable and necessary. NHVs can operate in several modes, i.e., traditional ventilator mode, RAD mode, and basic continuous positive airway pressure (CPAP) mode. The higher cost of the NHVs’ combination of noninvasive interface and multimodal capability creates a greater risk that a beneficiary will be provided an NHV when a less expensive device such as a RAD or CPAP device is warranted for the patient’s medical condition. The OIG will determine whether claims for NHVs were medically necessary for the treatment of beneficiaries’ diagnosed illnesses and whether the claims complied with Medicare payment and documentation requirements.


  1. States’ Procurement of Private Contracting Services for the Medicaid Management Information System (MMIS). MMIS is an integrated group of procedures and computer processing operations designed to meet principal objectives such as processing medical claims. Medicaid reimburses states’ MMIS administrative costs at enhanced rates of 90 and 75 percent. Many states use private contractors to design, develop, and operate their MMIS. When procuring MMIS contracting services, states are required to follow the same policies and procedures used for procurements paid with non-federal funds. Additionally, states must receive CMS’s prior approval to receive enhanced federal matching funds for MMIS administrative costs related to private contractors. OIG plans to determine if selected states followed applicable federal and state requirements related to procuring private MMIS contracting services and claiming federal Medicaid reimbursement.


  1. Monitoring Medicare Payments for Clinical Diagnostic Laboratory Tests – Mandatory Review. Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA) requires CMS to replace its current system of determining payment rates for Medicare Part B clinical diagnostic laboratory tests with a new market-based system that will use rates paid to laboratories by private payers. Pursuant to PAMA, OIG is required to conduct an annual analysis of the top 25 laboratory tests by Medicare payments and analyze the implementation and effect of the new payment system. The OIG plans to analyze Medicare payments for clinical diagnostic laboratory tests performed in 2016 and monitor CMS implementation of the new Medicare payment system for these tests.


  1. Ensuring Dual-Eligible Beneficiaries’ Access to Drugs Under Part D: Mandatory Review. Dual-eligible beneficiaries are enrolled in Medicaid but qualify for prescription drug coverage under Medicare Part D. As long as Part D plans meet certain limitations outlined in 42 C.F.R. Sec. 423.120, plan sponsors have the discretion to include different Part D drugs and drug utilization tools in their formularies. The OIG is required to review annually the extent to which drug formularies developed by Part D sponsors include drugs commonly used by dual-eligible beneficiaries as required.


Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2017 Strategic Management Services, LLC. Published with permission.

Expiration of federal funding threatens state CHIP programs

In light of the fact that federal funding for the Children’s Health Insurance Program (CHIP) expired on September 30, 2017, the Kaiser Family Foundation (KFF) analyzed the impact upon states and potential outcomes. Without an extension of federal funding for CHIP, KFF reported that states have or will run out of federal CHIP funding and may face budget shortfalls for CHIP, which covered 8.9 million children in 2016.

According to KFF under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) the enhanced federal funding matching rate was further increased by 23 percent. With this, the CHIP federal matching rate ranged from 88 percent to 100 percent. Because nearly all the states included federal funding for CHIP when creating their FY 2018 state budgets, nearly all the states will face a budget shortfall if the federal funding is not extended.

In the absence of an extension of federal funding for CHIP, some states will have to reduce CHIP coverage. States that have CHIP-funded Medicaid expansions must maintain the underage under the ACA “maintenance of effort” requirement, leaving state costs to increase in the face of lower federal Medicaid match rate. However, states with separate CHIP coverage are not required to maintain it, and states may freeze enrollment or discontinue CHIP coverage altogether.

In the short run, states can continue to use federal funding accrued through the September 30 expiration. Eleven states reported that they would run out of federal funding for CHIP by the end of FY 2017, and at least one state reported that their funding would be depleted at the expiration date. By redistribution of unspent CHIP funds, the Centers for Medicare and Medicaid Services (CMS) was able to provide enough additional funding to allow that state to maintain coverage without a budget shortfall through October. CMS was also able to provide redistributed funds to several other states that were close to running out of funds.

In order to address the expected states’ budget shortfalls, Congress is working on legislation for continued funding. Both the Senate and the House have reported bills out of committee to provide an extension of federal funding for CHIP. The bills from the House and Senate contain many of the same provisions, including a five-year extension for federal funding of CHIP and a transition down from the enhanced 23 percent match provided by the ACA. However, the House bill includes some additional provisions not included in the Senate bill. Both bills still need to be debated and voted upon by the full House and Senate, and if both are passed, Congress will have to reconcile the difference between the two bills.