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 www.health-law.com.

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 www.WoltersKluwerLR.com, follow us on Facebook, Twitter and LinkedIn.

Annual report shows Health IT dramatically improving quality of care

Since the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act, the health information technology (health IT) landscape has dramatically evolved, with hospitals and health care providers using health IT more than ever. In 2015, 96 percent of hospitals and 78 percent of physician offices used certified EHR technology. The Office of the National Coordinator for Health Information Technology (ONC) details the advancements made in the health IT landscape in its 2016 Report to Congress on Health IT Progress.

Reporting requirements

Section 13113(a) of the American Recovery and Reinvestment Act of 2009 (ARRA) (P.L. 111-5), under the HITECH Act, requires HHS to submit to the appropriate committees of the House of Representatives and the Senate a report (1) describing the specific actions that have been taken by the federal government and private entities to facilitate the adoption of a nationwide system for the electronic use and exchange of health information; (2) describing barriers to the adoption of such a nationwide system; and (3) containing recommendations to achieve full implementation of such a nationwide system. This is the annual update to the previous submissions, which were released on January 17, 2012, June 21, 2013, October 9, 2014, and February 29, 2016.

HHS priorities

The progress of health IT allowed for a transition in focus for HHS to the seamless and secure flow of health information, or interoperability. The advancements set the foundation for delivery system reform, the Cancer Moonshot, combating the opioid epidemic, the Precision Medicine Initiative, clinical innovation, and protecting and advancing public health. HHS has focused on three priority areas:

  • promoting common standards to facilitate the seamless and secure exchange of data, including through the use of standardized, open application programming interfaces (APIs);
  • building the business case for interoperability, particularly through delivery system reform efforts that change the way CMS pays for care to reward quality over quantity of services; and
  • changing the culture around access to information through combating information blocking; ensuring that individuals know they have a right to access and transmit their health information and that health care providers know they must provide access to the individuals; and reminding health care providers that they are legally allowed to exchange information in the course of treatment or coordinating care.

Health IT changing the provision of care

The rapid adoption of health IT has facilitated increased use of functionalities that have real-world clinical impacts. These include clinical decision support, which can point health care providers to evidence-based clinical guidelines at the point of care, facilitate an enhanced diagnosis or treatment path, and alert providers to potentially harmful drug interactions. Hospitals and physicians have also gained the ability to exchange more electronic health information than ever, with 82 percent of non-federal acute care hospitals electronically exchanging laboratory reports, radiology reports, clinical summaries, or medication lists. Approximately 90 percent of hospitals reported that they routinely had clinical information needed from outside sources or health care providers available at the point of care. Notably, EHR systems have transformed the prescribing and dispensing of medications, with e-prescribing systems lowering costs, improving care, and saving lives by reducing medication errors and checking for drug interactions.

Increased access to health information

Digitizing the U.S. health system has empowered individuals to be more in control of their own health decisions. Those with electronic access to their health information can monitor chronic conditions, better adhere to treatment plans, find and fix errors in their records, and directly contribute their information to research. Today, 95 percent of hospitals have the capability to allow patients this type of access.

FDA, CMS facilitate continuity between approval of, payment for medical products

Fragmentation in the process of approving and clearing drugs for marketing by the FDA and then clearing drugs for coverage by CMS has led to questions regarding whether FDA approval necessarily results in approval for coverage and payment under Medicare and Medicaid. In a Journal of the American Medical Association (JAMA) perspective written by CMS Acting Administrator Andy Slavitt, FDA Commissioner Robert Califf, and FDA Deputy Commissioner for Medical Products and Tobacco Rachel Sherman, the authors posit that, despite such challenges, changes in the organization of health care and the larger technology landscape should allow the FDA and CMS to move toward the use of shared sources of evidence while still applying the most appropriate criteria to decision making.

In product approval and clearance for marketing by the FDA and in coverage and payment determinations by CMS, the agencies use scientific evidence to make determinations. The use of shared sources of evidence would help to reduce gaps in information that could lead to uncertainty in the approval or clearance of new therapies, as well as their subsequent use in medical treatment. Shared information would also increase efficiency in medical product development and ensure the use of high-quality evidence.

It is standard practice to use in the approval and clearance for marketing process research examining the effects of therapeutics in narrow, strictly delineated populations that may not reflect the clinical practice settings in which the products will be used. The authors stressed that when a product demonstrates promise in this narrow setting, developers should pivot quickly toward evaluating the product, using “evidence about the risks and benefits of tangible health outcomes in clinical settings and among patients representative of those who will actually use these products.” The expansion of the scope of research used in the approval and clearance process will help show how a product is likely to perform and how to utilize the product in treatment.  Garnering early involvement of health systems and payers will help the agencies to determine what kinds of evidence are needed to incorporate the product in practice, where the product fits in formularies and device inventories, and whether or how much to pay for its use.

The FDA and CMS are focusing on the following to ensure that adequate evidence is available to guide patients, clinicians, and payers in their choices:

  • clarifying the need for including diverse populations and measuring relevant clinical outcomes within the trials conducted for regulatory approval and to inform labeling;
  • collaborating with other federal agencies to build functional links across a range of systems to make the best use of existing digital information captured in the course of health care delivery, such as electronic health records, insurance claims, and data within clinical registries; and
  • ensuring broad collaboration across public and private sectors.

Annual report shows Health IT dramatically improving quality of care

Since the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act, the health information technology (health IT) landscape has dramatically evolved, with hospitals and health care providers using health IT more than ever. In 2015, 96 percent of hospitals and 78 percent of physician offices used certified EHR technology. The Office of the National Coordinator for Health Information Technology (ONC) details the advancements made in the health IT landscape in its 2016 Report to Congress on Health IT Progress.

Reporting requirements

Section 13113(a) of the American Recovery and Reinvestment Act of 2009 (ARRA) (P.L. 111-5), under the HITECH Act, requires HHS to submit to the appropriate committees of the House of Representatives and the Senate a report (1) describing the specific actions that have been taken by the federal government and private entities to facilitate the adoption of a nationwide system for the electronic use and exchange of health information; (2) describing barriers to the adoption of such a nationwide system; and (3) containing recommendations to achieve full implementation of such a nationwide system. This is the annual update to the previous submissions, which were released on January 17, 2012, June 21, 2013, October 9, 2014, and February 29, 2016.

HHS priorities

The progress of health IT allowed for a transition in focus for HHS to the seamless and secure flow of health information, or interoperability. The advancements set the foundation for delivery system reform, the Cancer Moonshot, combating the opioid epidemic, the Precision Medicine Initiative, clinical innovation, and protecting and advancing public health. HHS has focused on three priority areas:

  • promoting common standards to facilitate the seamless and secure exchange of data, including through the use of standardized, open application programming interfaces (APIs);
  • building the business case for interoperability, particularly through delivery system reform efforts that change the way CMS pays for care to reward quality over quantity of services; and
  • changing the culture around access to information through combatting information blocking; ensuring that individuals know they have a right to access and transmit their health information and that health care providers know they must provide access to the individuals; and reminding health care providers that they are legally allowed to exchange information in the course of treatment or coordinating care.

Health IT changing the provision of care

The rapid adoption of health IT has facilitated increased use of functionalities that have real-world clinical impacts. These include clinical decision support, which can point health care providers to evidence-based clinical guidelines at the point of care, facilitate an enhanced diagnosis or treatment path, and alert providers to potentially harmful drug interactions. Hospitals and physicians have also gained the ability to exchange more electronic health information than ever, with 82 percent of non-federal acute care hospitals electronically exchanging laboratory reports, radiology reports, clinical summaries, or medication lists. Approximately 90 percent of hospitals reported that they routinely had clinical information needed from outside sources or health care providers available at the point of care. Notably, EHR systems have transformed the prescribing and dispensing of medications, with e-prescribing systems lowering costs, improving care, and saving lives by reducing medication errors and checking for drug interactions.

Increased access to health information

Digitizing the U.S. health system has empowered individuals to be more in control of their own health decisions. Those with electronic access to their health information can monitor chronic conditions, better adhere to treatment plans, find and fix errors in their records, and directly contribute their information to research. Today, 95 percent of hospitals have the capability to allow patients this type of access.