We are very pleased to introduce a new resource that has been added to our blog. On February 19, Cooley teamed up with New York City Health Business Leaders to sponsor “Health Exchanges: Passing the Torch to the Next Phase of Implementation,” a panel discussion led by Cooley Attorney, Wendy C. Goldstein, on the health exchanges established under the Affordable Care Act (ACA). Panel participants included: Mario Schlosser, Co-Founder and Co-CEO at Oscar Insurance Corporation; Debra Friedman, CEO of Health Republic Insurance of New York also participated from the plan perspective; and Dr. Amanda Parsons, Deputy Commissioner for the Division of Health Care Access and Improvement at the NYC Department of Health and Mental Hygiene provided insight into health exchange activities occurring at the state and local level. The discussion topics included a wide variety of issues including an assessment of the first phase of implementation and predictions for the next phase, as well as unique features of individual plans. There also was a discussion of provider responses to the exchange plans. Readers of our blog may access the presentation deck that accompanied this discussion, either by clicking on the link on the right-hand side of this page, or by clicking on the Resources link at the top of this page. Cooley would like to thank the NYC Department of Health and Mental Hygiene for assistance with the introductory slides.
In today’s Federal Register, the U.S. Food and Drug Administration (“FDA”) announced the availability of a revised draft guidance document titled: “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (the “Revised Draft Reprint Guidance”). This revises the FDA’s 2009 draft guidance document on the subject, which was titled: “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices” (the “2009 Draft Guidance”). Key changes in the Revised Draft Reprint Guidance as compared to the 2009 Draft Guidance include the provision of a number of “explanatory sections” as well as a new section addressing clinical practice guidelines (or “CPGs”). Comments on guidance documents may be submitted at any time; however, the FDA encourages stakeholders to submit comments by May 2, 2014, “to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance.” The FDA has not indicated when it would anticipate publication of a final guidance document. As with all FDA guidance documents, both draft and final, the Revised Draft Reprint Guidance is not binding on the FDA, but rather represents the Agency’s “current thinking.”
The Department of Health and Human Services (DHHS) and The Department of Justice (DOJ) Health Care Fraud and Abuse Control (HCRAC) Program Annual Report for Fiscal Year 2013 (Report) was released this week. The Report states that the DHHS and DOJ recovered $4.3 billion in health care fraud judgments and settlements in fiscal year 2013. Some interesting statistics from the Report include the following:
DOJ opened 1,013 new criminal health care fraud investigations involving 1,910 potential defendants and had 2,041 health care fraud criminal investigations pending
DOJ opened 1,083 new civil health care fraud investigations and had 1,079 civil health care fraud matters pending
DHHS’ Office of Inspector General (OIG) investigations resulted in 849 criminal actions and 458 civil actions
OIG excluded 3,214 individuals and entities for criminal convictions related to Medicare and Medicaid (1,132) or other health care programs (311); patient abuse or neglect (180); and as a result of licensure revocations (1,324)
- Over $324 million paid to False Claims Act whistleblowers
The Report also states that the return-on-investment (ROI) for the HCFAC Program for years 2011-2013 is $8.10 returned for every $1.00 expended by the government. This strong ROI further reinforces that the government will continue to expend resources to combat fraud, waste and abuse in the health care industry.
CMS Proposes Rate Adjustments and Policy Changes for Medicare Advantage and Medicare Part D Programs: Draft Rate Notice and “Call Letter” for 2015 Plan Year Released
On February 21, 2014, the Centers for Medicare & Medicaid Services (“CMS”) released its Advance Notice of Methodological Changes for Calendar Year 2015 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies (the “Draft Rate Notice”), as well as its draft “Call letter” for the 2015 Medicare Advantage and Medicare Part D plan year. (The draft Call Letter is set forth as Appendix VI – beginning on page 62 – of the Draft Rate Notice.) Medicare Advantage is Medicare’s “Part C” managed medical benefit, and the Part D benefit is the outpatient drug benefit that is offered as a stand-alone plan, or as an adjunct to a Medicare Advantage plan. CMS will accept public comments submitted by 6:00 PM EST on Friday, March 7, 2014.
The Centers for Medicare & Medicaid Services (CMS) issued this week additional resources for Phase I of registration and Sunshine data reporting. For more information regarding CMS’s two phased approach to registration and data reporting, see the blog posts here and here. Specifically, CMS released the following materials:
30 page PowerPoint titled “Step-by-Step: Industry Data Registration & Data Submission”
Sample template for Phase 1 aggregate data submission
Six new frequently asked questions related to the registration and data reporting process:
- 9722 When requesting access to Open Payments, which user role should I select from the dropdown?
- 9724 Do I need to provide my social security number to get an EIDM account?
- 9726 What if the automated identity verification function does not work for me?
- 9728 I am planning on submitting a consolidated report in Phase 2; how is this addressed in Phase 1?
- 9730 I do not see the yellow “Open Payments” button on the portal. Where is it?
- 9732 What is the difference between the “officer” and the “authorized official”?
This week at the Healthcare Information and Management Systems Society (“HIMSS”) Conference, Susan McAndrew, the Deputy Director for Information Privacy at the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”), announced that OCR is planning to resume its HIPAA compliance audit program in 2014. As a first step, OCR will soon launch a survey of 1,200 organizations – 800 Covered Entities and 400 Business Associates – in order to select audit targets. Organizations were selected to receive the OCR survey from a large database, and the survey itself will seek to determine whether each entity is an appropriate audit candidate by, for instance, verifying whether the organization is still in business. Not all surveyed entities will wind up being audited.
Important Dates for Coding and Reimbursement Announced: CMS Schedules Public HCPCS Meetings for Drugs, Biologics, DME and Various Other Products
In today’s Federal Register, the Centers for Medicare & Medicaid Services (“CMS”) announced the dates, time and location of the Healthcare Common Procedure Coding System (“HCPCS”) public meetings for calendar year 2014. CMS hosts these meetings to discuss the preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. Ensuring that appropriate HCPCS codes (for some drugs, these are referred to as “J-Codes”) are available for products can be critical to successful commercialization in the United States. These codes are used by government, as well as commercial payors, for classifying items and services and assigning reimbursement rates.