Health Law Hot Topics Webinar Series

Please Join Us

Complimentary 3-Part CLE-Approved Health Law Webinar Series

May 3, 10, and 17

In partnership with Goodwin Law, Wolters Kluwer is offering a three-part webinar series focusing on issues of high impact on health law today.

 

CLE credits are only offered for live attendance and are complimentary.

 

Session 1

Title: Healthcare Law for Digital Health, Telemedicine, and Health IT Companies

Date: Thursday, May 3, 2018

Time: 1:00 PM Eastern Daylight Time

Duration: 1 hour

Register for Session One: Healthcare Law for Digital Health, Telemedicine, and Health IT Companies

 

Session 2

Title: FDA Regulation of Digital Health and Health IT

Date: Thursday, May 10, 2018

Time: 1:00 PM Eastern Daylight Time

Duration: 1 hour

Register for Session Two: FDA Regulation of Digital Health and Health IT

 

Session 3

Title: Data Privacy and Security for Digital Health and Health IT

Date: May 17, 2018

Time: 1:00 PM Eastern Daylight Time

Duration: 1 hour

Register for Session Three: Data Privacy and Security for Digital Health and Health IT

 

FEATURED PRESENTER:

Roger A. Cohen is a partner in Goodwin’s nationally recognized Life Sciences Practice.
He counsels healthcare services, life sciences, and healthcare IT clients concerning compliance with the myriad laws and regulations governing the delivery of healthcare services such as the Anti-Kickback Statute, the Physician Self-Referral Law (the Stark Law), the False Claims Act, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Medicare and Medicaid rules and regulations, and laws governing reimbursement, licensure, and certification.

MODERATOR:

Kathryn Beard is the Associate Managing Editor in the Health Law editorial team of Wolters Kluwer Legal & Regulatory U.S.
Her areas of expertise include the Affordable Care Act, health care reform, Medicaid expansion, social media, and the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), including the merit-based incentive payment system (MIPS), advanced alternative payment models (APMs), and the Quality Payment Program (QPP).

 

Wolters Kluwer Legal & Regulatory U.S. is pleased to partner with Above the Law for CLE accreditation.*  Upon the conclusion of each webinar an informal certificate of completion will be issued by Wolters Kluwer Legal & Regulatory U.S. Attendees will also receive an official certificate via email from Above the Law’s third party CLE provider, Marino Law. 

*CLE available for NY, NJ and CA. A Uniform Certificate of Attendance for CLE credit will be issued for all other states.

Breakthrough cancer detection device gets parallel FDA, CMS review

A breakthrough cancer in vitro diagnostic (IVD) device that uses next generation sequencing (NGS) to detect genetic mutations in solid tumors took only six months from product application to FDA approval and a preliminary national coverage determination (NCD) from CMS, thanks to the Parallel Review program. Foundation Medicine’s FoundationOne® CDx™ (F1CDx) received simultaneous overlapping review by the FDA and CMS, which reduces the time necessary to marketing and coverage of innovative medical devices.

The Parallel Review program for medical devices was fully implemented in October 2016 following a pilot program (see Parallel Review program will be fully implemented and extended indefinitely, Health Law Daily, October 24, 2016). Ordinarily, CMS does not begin the NCD decision-making process until after a device has been approved or cleared for marketing by the FDA, which results in a longer wait before Medicare beneficiaries can access the device. Through Parallel Review, manufacturers receive feedback from both agencies through the clinical trial design stage, which helps them to design trials that fulfill evidentiary requirements for both steps of the process, potentially eliminating the need for additional trials.

Although the F1CDx device is a laboratory-developed test and therefore generally would not require premarket review from the FDA, Foundation Medicine requested Breakthrough Device designation for the test. The 21st Century Cures Act (P.L. 114-255) expanded the Expedited Access Pathways (EAP) program to breakthrough technologies that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions (see Will the Cures Act address what ails the FDA approval process?, Health Law Daily, March 9, 2017). The FDA granted that designation because the F1CDx test has “potential to consolidate multiple companion diagnostic claims for patients and health care providers into a single test.”

Happy Thanksgiving

The health law editorial team at Wolters Kluwer Legal & Regulatory U.S. is out of the office for the Thanksgiving holiday. We will resume our regular posting schedule on Monday, November 27th. In the interim, we invite you to check out the USDA’s Five Tips for a Food Safe Thanksgiving.

Two-year commitment needed for CSR stability

At least two years of continuous funding for cost-sharing reduction (CSR) benefits is necessary to stabilize and strengthen the individual health insurance marketplace, according to a coalition of health care and health insurance providers. In a letter to the chair and ranking member of the Senate Committee on Health, Education, Labor, and Pensions, a group including America’s Health Insurance Plans, the American Hospital Association, the American Academy of Family Physicians, the American Medical Association, BlueCross BlueShield Association, the American Benefits Council, and the U.S. Chamber of Commerce requested a firm commitment to CSR payments.

Under Section 1402 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), many individuals enrolling in qualified health plans through the marketplace are eligible for reduced cost sharing based on income. These reductions are guaranteed by the ACA; the federal government is supposed to make CSR payments to insurers offering plans in the marketplace to cover the reduced prices paid by plan enrollees, but the law does not guarantee those payments. The Trump Administration has not yet committed to continuing to make the payments.

In the letter, the providers and insurers explained that nearly 60 percent of enrollees in qualified health plans have CSR benefits, but noted their concern about uncertainty about CSR payment funding. They requested two full years’ funding for the CSR program, and warned that without that certainty, premiums will increase and fewer insurers will participate in the marketplace.