Life Science Compliance Update

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26 posts from June 2012

June 29, 2012

Affordable Care Act and Supreme Court: Full Speed Ahead

Full Steam Ahead
Many are wondering with the Supreme Court decision  where do we go from here.  The answer is, full steam ahead.  All those states who put off forming health insurance exchanges, the clock is ticking, 2014 is just around the corner.  For those states wondering what to do with the additional funds for Medicaid they have a choice, leave it alone, if the administrative cost is too large or go for it.   The Centers for Medicare and Medicaid Services (CMS) has hundreds of regulations to write and projects to get going. 

The court decided that the mandate was a tax, that being said, the President will have to figure out how to sell his tax to his constituents after promising “not to raise taxes on those making less than $250,000 per year.”  This is not the first stop in the road, but an important one.     

Healthcare insurance is expensive and we have to come up with ways to get the costs of care down.    This is where continuing medical education comes into play.  We need the best trained smartest healthcare force there is.   If we are going to have efficiencies in the system to take care of the estimated 32,000,000 patients (more people than Canada), then we will need to devote significant resources into to educating healthcare extenders, nurse practitioners, physician assistants, and nurses on the management of chronic diseases, hypertension, diabetes, asthma, COPD, depression…… 

All this will require significant resources in education.  In the coming days we will devote a significant article to the actual decision once the smoke clears, but in the mean time CMS, and the states have to get this train moving.  Move quickly, before the next political stop in the road.

CME Coalitions Comments to CMS on Long Term Care and Consultant Pharmacists CE

Longterm Care Pharmacy
Recently the CME Coalition submitted comments to the Centers for Medicare and Medicaid Services (CMS) regarding the proposed rule to require Long Term Care (LTC) Consultant Pharmacists, who review patients medication schedules, to be independent from the LTC Pharmacies that serve those facilities.  As the Department of Health and Human Services (HHS) looks to determine a comprehensive approach to improving the quality of patient care in LTC facilities, the Coalition urged the Department to recognize the potential to improve patient outcomes through an enhanced commitment to continuing medical education (CME).

Under current regulations, long term care (LTC) facilities must provide, either directly or under arrangements with others, for the provision of pharmaceutical services to meet the needs of each resident.  This requires LTC facilities to employ or obtain the services of a licensed pharmacist to provide consultation on all aspects of the provision of pharmacy services in the facility, including a drug regimen review at least once a month for each facility resident. 

Background on CME Coalition  

The CME Coalition represents a collection of CME provider companies, in addition to other supporters of CME and the vital role it plays in our health care system.  Member organizations manage and support the development of healthcare continuing education programs that impact more than 500,000 physicians, nurses and pharmacists annually. 

Independence of LTC Consultant Pharmacists  

The CME Coalition recognized that the over-prescription of psychotropic drugs and the use of chemical restraints in nursing homes presents direct health risks to patients in these settings, and believe there is an important role that CME can play in better educating health care providers as to the risks involved with these drugs.  Accordingly, the Coalition urged CMS to consider a role for CME as the agency finalizes rules in this area. As health care and educational professionals who value the importance of enhancing the continuing education of the country’s health care providers, the Coalition considers “it vital that the Department recognize the potential to improve patient outcomes through an enhanced commitment to CME.” 

To support its comments, the Coalition pointed to recent data, which suggests that health care providers who participate in additional educational programs are significantly more likely to provide appropriate diagnoses and prescriptions that those who do not attend such programs.   Specifically, a recent survey of physicians found that 94% said CME was very useful or somewhat useful to stay informed about medications to treat particular conditions.   With respect to the educational value of industry supported programs: 

  • 59% of attendees always or usually gain improved clinical knowledge
  • 63% of attendees always or usually learn about potential side effects of medicines
  • 54% of attendees always or usually gain knowledge of new uses for medicines
  • 58% of attendees always or usually improve knowledge of the range of treatment options
  • 54% of attendees always or usually add knowledge about emerging drug risks
  • 50% of attendees always or usually strengthen ability to care for patients 

The Coalition noted that today, “it would seem impossible for a consultant pharmacist to be competent in their review without the information, tools, data, and other resources provided through continuing education.”  In addition, they maintained that “greater educational requirements for physicians could be instrumental in reducing unnecessary prescriptions.”   The Coalition concluded its comments by recognizing how “CME serves an irreplaceable role in disseminating this information to health care professionals and should be a focus of the Department’s response to these concerns.”

June 28, 2012

Patient Centered Outcomes Research Institute Announces First Round of Grant Recieptents

Biotech Financing
After receiving more than 800 grant applications, the Patient-Centered Outcomes Research Institute (PCORI) recently announced $30 million over two years in funding awards for comparative-effectiveness research. 

PCORI was created to conduct research to provide information about the best available evidence to help patients and their health care providers make more informed decisions.  PCORI’s research is intended to give patients a better understanding of the prevention, treatment and care options available, and the science that supports those options.  Its mission is to fund research that offers patients and caregivers the information they need to make important healthcare decisions.  PCORI focuses on CER that compares options for preventing disease and providing treatment and care by:   

  1.  Identifying national priorities for research.
  2.  Creating a research agenda based on identified priorities.
  3. Funding research consistent with these priorities and agenda.
  4. Providing patients and their caregivers with useful research information.  

Fifty pilot projects “led by creative and innovative researchers” will focus on engaging patients in the health research and dissemination process, PCORI said.  The agency selected the recipients, in part, for their innovative ways to address challenges of improving patient-centered care and decision-making. 

Awards, approved for research institutions in 24 states and the District of Columbia, include those for projects designed to develop a range of tools and techniques aimed at 

  • improving patient-centered care and decision-making;
  • creating a new patient-centered care measures; and
  • improving the delivery of patient-centered counseling and care in various health care settings. 

The Pilot Projects were selected by PCORI‘s Board of Governors through a competitive, multi-stage review process. Proposals were evaluated for their scientific merit and rigor and fit within the eight areas of interest outlined in the pilot projects announcement. All awards have been approved pending completion of a business review and a formal award agreement with PCORI. 

“These projects will improve our understanding of how to conduct research and disseminate research findings in ways that are more responsive to the needs of patients and the health care community,” said PCORI Executive Director Joe Selby, MD, MPH.  “We are excited to have approved funding for 50 projects nationwide, led by creative and innovative researchers.  “Their work will help us establish a foundation for patient-centered research that will give patients, caregivers and clinicians the information and tools they need every day.” 

For instance, University of California, Los Angeles, won more than $300,000 to determine how providing transportation to appointments, conducting case management assessments or performing community outreach for low-income patients affects the delivery of medical care, according to the pilot project abstract.  Other examples of grants include: 

  • Addressing Mental Health Needs of Rural African Americans (University of Arkansas for Medical Sciences)
  • Promoting Patient-Centered Counseling to Reduce Inappropriate Diagnostic Tests (University of California, Davis)
  • Development and Pilot of Three Patient Decision Aids for Implanted Defibrillators (University of Colorado School of Medicine)
  • Integrating Patient-Centered Outcomes in Arthritis Clinical Care (Johns Hopkins University) 

The University of California, Davis, won almost $700,000 to enhance physicians' patient-centered counseling skills to reduce inappropriate or unnecessary care, while the Palo Alto (Calif.) Medical Foundation Research Institute collected roughly $675,000 to test interventions designed to improve patient-centered communication and make shared decision-making routine among providers. Last month, the research instate found that many patients surrender their authority to physicians because they fear being labeled "difficult." According to the study, 48 Bay Area patients said they held back from challenging their physicians or asking questions, worried that such actions would lead to inferior care or a damaged relationship. 

“The impressive volume of high-quality funding applications we received persuaded us to expand the program beyond its original scope to ensure we are capturing as much valuable information as possible to support our patient-centered research efforts,” said PCORI Board of Governors member Christine Goertz, DC, PhD, who led the Pilot Projects Program effort. “The Pilot Projects will allow PCORI to learn more about evidence-based methods and strategies, with an emphasis on effectively involving patients in the entire research process, from the selection of research topics to the dissemination of results.”


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