GESTIÓN EN SALUD PÚBLICA: FDA Law Blog: 21st Century Cures Act: Three Notable Health Care Provisions and a Reminder to Sign Up for HP&M’s Two Complimentary Webinars

viernes, 6 de enero de 2017

FDA Law Blog: 21st Century Cures Act: Three Notable Health Care Provisions and a Reminder to Sign Up for HP&M’s Two Complimentary Webinars

21st Century Cures Act: Three Notable Health Care Provisions and a Reminder to Sign Up for HP&M’s Two Complimentary Webinars

Posted: 05 Jan 2017 06:43 PM PST

By Michelle L. Butler & Serra J. Schlanger –
To complete our initial summaries (see here, here, and here) of the 21st Century Cures Act (Act), we want to highlight the three health care provisions included in Title IV – Delivery and Title V – Savings that we think are of most relevance to our readers.
Sec. 4010. Medicare pharmaceutical and technology ombudsman.
Section 4010 creates a new pharmaceutical and technology ombudsman within the Centers for Medicare & Medicaid Services (CMS). This will provide an avenue for drug and device manufacturers to communicate with CMS about coverage, coding, and payment issues under Medicare Parts A, B, and D. The new ombudsman must be in place no later than 12 months after the date of enactment of the Act.
Sec. 5004. Reducing overpayments of infusion drugs.
Section 5004 addresses findings from an OIG report that determined Medicare has overpaid for certain drugs and underpaid for others by applying a new pricing methodology to better reflect actual transaction prices. The payment amount for Part B infusion drugs furnished through durable medical equipment will be set to Average Sales Price (ASP) plus 6% beginning on January 1, 2017. These drugs were previously paid based on 95% of the Average Wholesale Price (AWP) in effect on October 1, 2003.
Sec. 5012. Medicare coverage of home infusion therapy.
Section 5012 updates the payment policy for home infusion therapy by implementing a single payment for items and services furnished by a qualified home infusion therapy supplier. The single payment unit is for each infusion drug administration calendar day in the patient’s home. In addition, this section requires the Secretary to designate organizations to accredit suppliers furnishing home infusion therapy by January 1, 2021. This section applies to items and services furnished on or after January 1, 2021.

We would also like to remind our readers that Hyman, Phelps & McNamara, P.C. ("HP&M") will hold complimentary webinars on Thursday, January 12, 2017 from 12:00-1:30 PM (Eastern) and Wednesday, January 18, 2017 from 12:00-1:30 PM (Eastern).
During the January 12 webinar, Frank Sasinowski, David Clissold, and James Valentine, with Michelle Butler moderating, will focus on the pharmaceutical and biologics provisions. Jeff Shapiro and Allyson Mullen will focus on the device and combination products provisions during the January 18 webinar. See our previous announcement for more details.
Both webinars will provide a question and answer period and attendees will have an opportunity to submit questions during the webinar. Responses to any questions that are not addressed will be available on the HP&M firm website after the webinar.
You can register for the first webinar here and the second webinar here
Please contact Lisa Harrington at lharrington@hpm.com with any registration questions.
If you have questions or need more information about the health care provisions in the Act, please contact: