Research, Operations & Compliance Solutions, Inc. - ROCS

31/01/2019

Tanya Green

Exercise is still important though!

18/10/2018

Come visit my sessions next Tuesday at the MAGI Clinical Research Conference 2018 West: (B341)-Fair Market Value in Clinical Research, and (B259)-Medicare Coverage Analysis Out of the Ordinary. Also Chairing Tuesday's (C708)-The FDA/CMS Parallel Review Process for Devices. Hope to see you there!

https://magiworld.org/forms/EventInfo.aspx?PK=16

Ambra Cerri, PhD, MBA, is Managing Director - Scientific Research IRCCS at Policlinico San Donato. Vani Nilakantan, PhD, is Vice President, Research of Allina Health System. Kent Thoelke is Chief Scientific Officer of PRA Health Sciences.Norman M. Goldfarb is Chairman of MAGI (moderator).

11/09/2018

Summary judgment issued Sept 7, 2018 by U.S. District Judge Rosemary Collyer in Washington, DC, in favor of UHC re their challenges to CMS 2014 Overpayment Final Rule as violating requirements for actuarial equivalence in payments between Medicare FFS and Medicare Advantage, and as unlawfully creating a negligence standard for FCA liability not supported by FCA statutory requirement of "knowingly" submitting false claims:
"Having recognized that actuarial equivalence, mandated by statute, required an FFS Adjuster for purposes of defining overpayments because of dissimilar data for RADV audits, CMS provides no legitimate reason for abandoning that statutory mandate in the context of the 2014 Overpayment Rule. The Court finds that CMS was arbitrary and capricious in adopting the 2014 Overpayment Rule without explaining its departure from prior policy. ***** ...the 2014 Overpayment Rule extends far beyond the False Claims Act and, by extension, the Affordable Care Act. Not being Congress, CMS has no legislative authority to apply more stringent standards to impose FCA consequences through regulation."
(Full opinion: https://www.scribd.com/document/388071196/UnitedHealth-Wins-Medicare-Overpayment-Rule-Case )

Federal judge sides with UnitedHealth in dispute over Medicare Overpayment Rule, rejecting the federal government’s view.

31/08/2018

Spoke about clinical research billing rules, risks and audits and the related revenue cycle integrity challenges, and exhibited, at the Annual Association of Healthcare Internal Auditors conference this last week in San Diego. FABULOUS group of people doing really important work!

07/08/2018

CMS Final IPPS Rule issued Aug 2nd - Some items I think are of interest for new technology/clinical research:
1 - Payments: CMS approved a new technology add‑on payment for FY 2019 for 10 of the 11 applications discussed in the proposed rule in which the technology received FDA approval by July 1, 2018. Included among the 10 approved applications for new technology add-on payment for FY 2019 are Chimeric Antigen Receptor (CAR) T‑cell therapy. Separately, CMS finalized its proposal to assign CAR T-cell therapy to a MS-DRG and rename this MS-DRG “Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy.
2 - Facility Pricing Transparency - Online posting of standard charges
Now hospitals are required to publicly post a list of their standard charges via the Internet in a machine readable format, and to update this information at least annually, or more often as appropriate.

https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2018-Fact-sheets-items/2018-08-02.html

03/08/2018

My company, ROCS, is thrilled to now offer end-to-end clinical research site management services. Site management services round out and compliment our existing service lines for process review and improvement engagements, research-related revenue cycle integrity/reimbursement support, and research/research billing compliance services, with the option to use convenient and efficient cloud-based solutions for efficient enterprise-wide stakeholder engagement and intelligent evidence-based assessment, decisions, and resource allocation.

Our service lines are arranged to follow our name:
R: research site management (site initiation, study pipeline, contract/budget negotiations, Medicare coverage analysis and budgets, coordination, financial management, revenue cycle support, policies/procedures, quality monitoring
O: operational process review and improvement engagements for research and related programs
C: compliance services for research and research billing compliance programs
S: solutions for efficient, effective enterprise stakeholder engagement to reach intelligent, evidence-based assessment and decisions

ROCS is committed to supporting quality clinical trial sites close to the patients for best patient options and outcomes.

BIG shout out to our webpage designer, Cassidy Harrison, Spectrum Internet Design. She is working on our webpage updates coming soon. What makes her and her business unique is she lives with autism. 80% of adults in America that live with disabilities are unemployed, so she started her own business so she won't have to depend on others to make a living. Check "Cassidy's Corner" on our webpage - http://rocs-hci.com/cassidys-corner/

My name is Cassidy Harrison. My business, Spectrum Internet Design, built this website for Research, Operations and Compliance Solutions, Inc. I have built websites for many other businesses, including a Building Supply Chain, an American Girl retailer, and a Martial Arts school, plus others. You ca...

22/03/2018

of interest for homeopaths and their clients about FDA enforcement and regulatory oversight regarding marketing of homeopathic drug products:

12/03/2018

Consequences of incivility in the workplace. Excellent TED Talk. ROCS approaches to creating solutions are designed to support full candor among stakeholders in spite of existing incivility, peer pressure, stress, fear, skepticism, etc. We want to create meaningful and sustainable solutions even where there are serious current state barriers to getting there. Failure is often related to culture and style. Worth listening:

Do you lift people up or hold them down? Based on research, Christine Porath shares the costs of incivility and how civility pays. She explains how incivilit...

08/03/2018

BRAVO - MyHealthEData Initiative. 2018.03.06: Speech: Partial Remarks by CMS Administrator Seema Verma at the HIMSS18 Conference,
"At a time when healthcare data is being generated from so many sources, too often that data runs into the hard walls of closed systems that hold patients, and their information, hostage. Our doctors run scans and other tests on us, but the results often sit dormant in distant databases where sometimes we can't even access the records without overcoming multiple barriers. We are told this lack of access is for our own security. Nod your heads if you've been in this situation.
So let's be clear. We cannot effectively transition to a value-based system unless we provide to both the doctor and the patient all of the clinical and payment data required at the point of care, to help them mutually make a different and better decision than they could have today.
To this end, the administration is launching the MyHealthEData Initiative. MyHealthEData is a government-wide initiative that will break down the barriers that contribute to preventing patients from being able to access and control their medical records. MyHealthEData makes it clear that patients should have access and control to share their data with whomever they want, making the patient the center of our health care system. Patients need to be able to control their information and know that it's secure and private. Having access to their medical information will help them make decisions about their care, and have a better understanding of their health.
MyHealthEData will unleash data to trigger innovation, and advance research to cure diseases and provide more evidence-based treatment guidelines that ultimately will drive down costs and improve health outcomes.
Steve Jobs shared his vision of empowering people with technology when he declared,
'Technology is nothing. What's important is that you have faith in people, and if you give them the tools, they'll do wonderful things with them.'"

21/09/2017

ROCS President/CEO, Shanley Curran, will be a session speaker again at the next MAGI conference in San Francisco, Nov. 12-15, 2017. http://www.magiworld.org/events/2017W/program.html

24/10/2016

At the West conference - great discussions about the need to overcome remaining barriers to Six Sigma. See my recent blog article on this... http://bit.ly/2cyxvHY. Great that has incorporated yellow belt cert sessions!

Process Improvement efforts are not getting healthcare and clinical research organizations the results they seek. This is also true for complex operations across businesses of all kinds. As far back as 2010, the Wall Street Journal reported studies suggesting nearly 60% of all corporate Six Sigma in...