|For Immediate Release:||Monday, August 17, 2009|
|CMS Office of Public Affairs|
MEDICARE DEMONSTRATIONS SHOW PAYING FOR QUALITY HEALTH CARE PAYS OFF
Demonstrations being conducted by the Centers for Medicare & Medicaid Services (CMS) continue to provide strong evidence that offering financial incentives for improving or delivering high quality care increases quality and can reduce the growth in Medicare expenditures.
Today CMS is announcing new results from three of these demonstrations, one for large physician practices, one for small and solo physician practices, and one for hospitals. CMS is also announcing the start of three additional value based purchasing demonstrations.
“We continue to be encouraged by the progress of our ongoing programs that test value based-purchasing across a variety of health care services,” said Charlene Frizzera, Acting Administrator of CMS; “Building on those efforts, we are pleased to announce the start of our Nursing Home Value-Based Purchasing Demonstration and two gainsharing demonstrations.”
“What we learn from the various Medicare demonstrations help to achieve the Administration’s goals of paying for high quality and efficient health care in America,” said Jonathan Blum, director of the CMS’ Center for Medicare Management and acting director of the Center for Health Plan Choices. “Building on these findings, we will aggressively test new demonstration concepts to continue to meet these goals.”
The CMS value-based purchasing (VBP) initiative is designed to tie Medicare payments to performance on quality and efficiency and is part of CMS’ effort to transform Medicare from a passive payer to an active purchaser of higher quality, more efficient health care.
Entering its fifth year, the Hospital Quality Incentive Demonstration (HQID) shows continued quality improvement among participating hospitals. In addition, physician practices participating in the Physician Group Practice (PGP) Demonstration continue to improve quality for patients with chronic illnesses or requiring preventive care.
And more than 560 small and solo physician practices participating in the Medicare Care Management Performance (MCMP) Demonstration are being rewarded for providing high quality care in the delivery of preventive care and care for patients with chronic illnesses.
New demonstration programs include the Nursing Home Value-Based Purchasing Demonstration, the Medicare Hospital Gainsharing Demonstration, and the Physician Hospital Collaboration Demonstration.
The nursing home demonstration program will reward facilities that can improve or deliver high quality care in four specific areas: staffing, resident outcomes, avoidable hospitalizations and reductions in deficiency citations.
The gainsharing and physician hospital collaboration programs will evaluate whether gainsharing leads to improvements in quality and efficiency. The demonstrations provide a promising opportunity for hospitals and physicians to join forces to improve quality and efficiency of care, establish effective means to govern use of inpatient resources, reduce costs, and share the rewards.
Overall, demonstrations give CMS the opportunity to work closely with providers to improve quality and efficiency and serve as a vehicle to test various VBP methodologies.
Hospitals Continue to Improve Quality
The HQID is sponsored by Medicare in partnership with Premier, Inc., a national hospital quality measurement organization. The demonstration, which began in 2003 with hospitals in 38 states, was designed to test payment incentives under Medicare to see if they would improve the safety, quality and efficiency of inpatient services by linking incentives to improved quality.
Participants raised overall quality by an average of 17 percentage points over four years, based on their performance on more than 30 nationally standardized and widely accepted care measures for patients in five clinical areas – heart attack, coronary bypass graft, heart failure, pneumonia, and hip and knee replacements.
CMS is awarding incentive payments totaling $12 million in year four to 225 hospitals for top performance, top improvements and overall attainment in the five clinical areas. Through the first four years, CMS awarded more than $36.6 million to top performers. After the initial three years of the demonstration, CMS extended the project for three additional years to test new incentive models and ways to improve patient care.
Physician Groups Improve Quality and Share Savings
All ten of the physician groups participating in the PGP Demonstration achieved benchmark performance on at least 28 of the 32 measures reported in year three of the demonstration. Two groups – Geisinger Clinic in Danville , Penn. and Park Nicollet Health Services in St. Louis Park , Minn. – achieved benchmark performance on all 32 performance measures.
Over the first three years of the demonstration, the physician groups increased their quality scores an average of 10 percentage points on ten diabetes measures, 11 points on ten congestive heart failure (CHF) measures, 6 points on seven coronary artery disease (CAD) measures, 10 points on two cancer screening measures, and 1 percentage point on three hypertension measures.
Under the PGP demonstration, physician groups earn incentive payments based on the quality of care they provide and the estimated savings they generate in Medicare expenditures for the patient population they serve. As a result of their efforts to reduce the growth rate in Medicare expenditures, five physician groups will receive performance payments totaling $25.3 million as part of their share of $32.3 million of savings generated for the Medicare Trust Funds in performance year 3.
Over 560 Small Physician Practices Earn Incentive Payments for Quality Performance
In the first year of the MCMP demonstration, almost all of the 610 participating small and solo physician practices are being rewarded for performance on 26 quality measures. CMS is awarding approximately $7.5 million dollars in incentive payments to over 560 practices in California , Arkansas , Massachusetts and Utah . The average payment per practice is $14,000 but some practices earned as much as $62,500. Last year, CMS paid out over $1.5 million in incentives for reporting baseline quality measures.
The goal of the MCMP Demonstration is to promote the use of health information technology to improve the quality of care for beneficiaries with chronic conditions.
Doctors in small to medium sized practices who meet clinical performance standards on each measure are eligible to receive financial rewards under the MCMP Demonstration. The demonstration also provides an additional bonus to practices that report the data using an electronic health record (EHR) certified by the Certification Commission for Health Information Technology. Twenty-three percent of practices were able to submit at least some of the measures from a certified EHR.
Nearly 200 Nursing Homes in Three States Testing Value-Based Purchasing
Nearly 200 nursing homes in three states will participate in a Medicare demonstration to determine if financial incentives will improve the quality of the care they provide.
The Nursing Home Value-Based Purchasing demonstration will reward those facilities that improve or deliver quality care in four areas: nurse staffing, resident outcomes, avoidable hospitalizations and reduction of the scope and severity of deficiency citations the home may have received during inspections. Nursing homes will be awarded points in each of these areas; homes with the highest scores or greatest improvement will become eligible for a performance payment.
Savings that result from improved quality and efficiency will be used to fund incentive pools in each state.
CMS will conduct the demonstration in 79 homes in New York , 62 in Wisconsin and 41 in Arizona . Each of these states assisted in the recruitment process by encouraging facilities to apply to CMS. Participating homes were then selected from the applicant pool.
The demonstration will run from July 2009 through June 2012, at which time its effectiveness will be evaluated to inform Medicare value-based purchasing policies.
14 Hospitals Collaborating with over 1,000 Physicians in Gainsharing Demonstrations
CMS also announced today it will operate two demonstrations to evaluate gainsharing as a means of aligning incentives between hospitals and physicians to improve quality of care and overall hospital efficiency.
Gainsharing occurs when a hospital pays incentives to a physician who assists in saving internal hospital costs while improving quality and efficiency and is normally restricted in Medicare’s fee-for-service program.
The Medicare Hospital Gainsharing Demonstration began in October 2008. This demonstration consists currently of two sites, Beth Israel Medical Center in New York City and Charleston Area Medical Center in West Virginia. Under this demonstration, CMS will evaluate whether gainsharing leads to short-term improvements in quality and efficiency during the inpatient stay and immediately following discharge.
The Physician Hospital Collaboration Demonstration, comprised of a consortium of twelve hospitals administered by the New Jersey Hospital Association, began in July. This demonstration is designed to track patients beyond a hospital episode to determine the impact of hospital-physician collaborations on preventing short- and longer-term complications and duplication of services.
These demonstrations will allow physicians to share in the savings generated by the adoption of structural and procedural changes made to improve the quality of inpatient hospital care.
For additional information on value based purchasing demonstrations, visit the demonstrations webpage at http://www.cms.hhs.gov/DemoProjectsEvalRpts/MD/list.asp.
The Newsletter, ON TARGET, and the BLOG, Target Health Global are on vacation, in the US Southwest and will be back in September.
Upon returning, we will feature a new section called Molecular Medicine, which will focus on the cutting edge technologies in stem cell biology, nanotechnology, regenerative medicine, and molecular biology.
For more information about Target Health and our software tools for paperless clinical trials, please contact Dr. Jules T. Mitchel (212-681-2100 ext 0) or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com
TARGET HEALTH ACCOMPLISHMENTS LAST 12 MONTHS
Update From Target Health – August 2009
Several times a year we are asked what Target Health does and what are our accomplishments. The following summarizes what has happened over the last 12 months.
We are very pleased to announce that there are now over 25 products with FDA marketing approval and 17 unique products (NDA-4; PMA-10; BLA-1; MAA-1; and 510k-1) that used Target e*CRF® for their pivotal trials. Of these 17 products, three were approved in 2009 (MAA in Women’s Health; NDA in Dermatology; and PMA in Cardiology
In 2009, Target Health celebrated its 16th year as a New York City-based, full-service e*CRO with full-time staff dedicated to all aspects of Drug and Device Regulatory Affairs, Clinical Research, Biostatistics, Data Management, Internet-based clinical trials (Target e*CRF®), Medical Writing, and Strategic Planning. We also provide fully validated software for clinical trials.
A. Regulatory Affairs
1. Regulatory Representation
Represent over 30 companies at FDA from all over the world including England, France, Germany, Israel, Korea, Switzerland and the US.
2. 2009: MAA ellaONE (HRA Pharma)
May 2009: – HRA Pharma was granted marketing authorization by the European Commission for ellaOne® (ulipristal acetate), the next generation emergency contraceptive. For this program, Target Health provided monitoring, data management, biostatistics and medical writing services. Target e*CRF® was used for the Phase 3 studies.
3. 2009: NDA Ulesfia (Sciele Pharma Inc.)
April 2009: Sciele Pharma Inc. received FDA approval of Ulesfia for the treatment of head lice (Pediculosis capitis) infestation for use in patients 6 months of age and older. For this program, Target Health provided full turn-key CRO services including regulatory consultations and submissions, toxicology, monitoring, data management, biostatistics and medical writing services. Target Health prepared the NDA and Target e*CRF® was used for all Phase 2 and Phase 3 studies.
4. 2009: PMA REPEL-CV (SyntheMed Inc.)
March 2009: Synthemed Inc. received FDA approval of REPEL-CV Adhesion Barrier for use in pediatric cardiac surgery patients. For this program, Target Health provided regulatory consultations, monitoring, data management, biostatistics and medical writing services. Target Health prepared the PMA and Target e*CRF® was used for the pivotal trial.
5. 2008: NDA Degarelix (Ferring Pharmaceuticals)
December 2008: Ferring Pharmaceuticals received both FDA and EMEA approvals for the marketing of its prostate cancer treatment, degarelix, a new GnRH receptor blocker intended for patients in whom androgen deprivation is warranted. Target e*CRF® was used for all Phase 2 and Phase 3 studies. In addition to Degarelix, Target Health has collaborated with Ferring on 3 marketed NDAs for products sold in the US, Canada and Europe. Two of these programs also used Target e*CRF®.
6. 2008: 510(k) PD2i Analyzer (Vicor Technologies Inc.)
December 2008: The Vicor PD2i Analyzer is a device for measuring heart rate variability (HRV). The device can use any ECG acquisition System that can digitize raw signals, in order to perform proprietary calculations from HRV and then display the results utilizing a display unit. The objective of the PD2i Algorithm is to make the PD2i Correlation Integrals (CI’s) from the input data, and then find the accepted and convergent slopes of the linear scaling regions for each embedding dimension (i.e., the PD2i values).
7. FDA Inspection of Target Health
In May 2008, FDA completed a 4 day, unannounced though not unexpected, inspection of Target Health for an NDA under review. For this program Target Health performed all of the clinical and regulatory strategic planning, toxicology, regulatory, study designs, monitoring of the clinical trials (Phase 1, 2 and 3), data management, including Target e*CRF® (EDC), statistics, medical writing and preparation of the NDA. There were 2 pivotal trials and a rescue protocol for treatment failures. The FDA audit also included a detailed review of Target e*CRF® and data management. The outcome of the inspection was that from evaluation of the establishment inspection report and the documents submitted with that report, we conclude that you adhered to the applicable statutory requirements and FDA regulations governing the monitoring practices of clinical investigations and the protection of human subjects.
8. NDA Submission
Digestive Care Inc. submitted an NDA for Pancrecarb for the treatment of digestive systems associated with pancreatic insufficiency. Target Health prepared all submission data sets for the studies and the ISS, wrote the ISS and ISE and wrote most of the study reports submitted as part of the NDA.
9. INDs / CTAs
a. Cushing’s syndrome
c. Gaucher disease (USA and Canada)
d. Ulcerative colitis (n=2)
10. Orphan Drug
a. Scleroderma (US and EU)
11. FDA Meetings
a. Adhesion prevention
b. Cushing’s syndrome
c. Emergency contraception
d. Gaucher disease
e. Growth disorders
f. Hereditary angioedema
g. Herpes simplex
h. Hormone replacement therapy
i. Ulcerative colitis
j. Uterine myoma
12. Other Major Approvals Prior to 2008
a. NDAs for Repronex, Bravelle and Menopur. Target e*CRF used in the 2 latter programs.
b. 8 PMAs approved in the diagnostic area which used Target e*CRF for data management. “PMAs submitted within 30 days of LPLV. Flawless FDA BIMO (Bioresearch Monitoring) audits.”
c. PMA approved in the area of periodontal disease for a combination drug/device. Target e*CRF® was used for the pivotal trial and Target Health monitored the study and performed statistical analyses and medical writing.
13. Electronic Submissions
Target Health has expertise in preparation and publishing of electronic submissions and is an FDA approved vendor for electronic submissions through the Electronic Submissions Gateway (ESG). In 2009, it is expected that an NDA will be submitted in the area of Women’s Health as well as an NDA for an Orphan Metabolic Disease.
B. Clinical Trial Software Packages
Target e*CRF®: Target e*CRF has now been used in over 200 clinical trial since 1999. Largest trial to date is over 7,000 patients. There are now 17 Approved Products in the US that used Target e*CRF® for their clinical trial programs (3-NDAs, 1-BLA, 1-MAA, 10-PMAs and 1-510(k)). This coming year, an NDA will be submitted in the area of Women’s Health as well as an NDA for an Orphan Metabolic Disease.
Target Document®: Target Document is a USER-FRIENDLY, INEXPENSIVE; HIGHLY SOPHISTICATED, Web-based, document management system that allows authorized users to view, download, and manage any document for their organization. – No More paper – Target Document features include: 1) 21 CFR Part 11 compliance; 2) routing for electronic signatures; 3) email alerts; 5) communication tools.
Target Encoder®: Target Encoder is a USER-FRIENDLY, INEXPENSIVE; HIGHLY SOPHISTICATED, Web-based, coding system that allows authorized users to automatically code MedDRA and WHO Drug and other types of dictionaries. Target Encoder is fully integrated with Target e*CRF.
Target e*CTMSTM: Target e*CTMS is a USER-FRIENDLY, INEXPENSIVE; HIGHLY SOPHISTICATED, Web-based, clinical trial management system. A new clinical trial starts with identification of the sponsor and project name. Investigators, IRBs and users are maintained within the CTMS and can be easily assigned to a project. All staff within a clinical site can be identified with their title and contact information, as well as shipping addresses which could be different from the head office. As the site commits to participate in the clinical trial, a site number can be assigned. Once IRB approval is obtained, and all regulatory documents have been identified as received, an alert can be sent out via email to allow for drug shipment. Target e*CTMS provides many additional features such as: 1) Decision Logs, 2) Meeting Logs with uploading of the meeting minutes, 3) Questions and Answers, 4) status of Regulatory Submissions and Deliverables, and 5) Monitor Site Visit Tracking with document upload.
Target Batch Edit Checks: With Target e*CRF®, batch edit checks are now integrated with the electronic query system within the study. Target e*CRF® runs the edits and displays the results of those edits through a discrepancy review screen integrated with the query system.
Target e*PharmacovigilanceTM: Target e*CRF integrates EDC with a pharmacovigilance module by 1) allowing the principle investigators to enter a narrative, 2) allowing the medical monitor to enter a narrative and then have the EDC system generate an FDA-approved version of Form 3500A or CIOMS for regulatory submission with the ability to control the original and followup submissions.
Target eClinical Trial Record (Target e*CTRTM; Patent Pending): Target e*CTR allows the clinical study sites to perform direct data entry into any EDC system, and at the same time generates a read-only electronic document, which can be designated as the primary source data (eSource). These data, maintained in a secure, read-only trusted 3rd party environment, are available to the clinical study sites, monitors and regulatory agencies in a human readable format. An accelerated patent review has been granted.
C. Academic Collaborations
EDC vendor for 2 NIH grants in Juvenile Rheumatoid Arthritis at the Cleveland Clinic and University of Washington. EDC project completed in the newborn under an HHS grant at Stanford University. Collaboration with the Biotechnology Center at SUNY Stony Brook and UMDNJ (the Medical School of New Jersey).
D. Current Indications
3rd degree burns; Emergency contraception; Menopausal symptoms;
Adhesion prevention; Gaucher’s disease; Nocturia;
Atopic dermatitis; Growth Impairment; Osteoporosis;
Bone fractures; Hereditary angioedema; Pre-eclampsia; diagnostic
Brain Imaging; Head lice; Prostate cancer;
Cardiac implant device; Hemostasis; Scleroderma;
Cardiology diagnostic; HIV diagnostic; Ulcerative colitis;
Cushing’s disease; Infertility; Wound Healing;
Cystic fibrosis; Juvenile rheumatoid arthritis
Abstract: A Complex Protocol Design To Accelerate Clinical Trial: How To Implement Multiple Database Lock In An Electronic Data Capture System (Bio-IT World, 2008).
Mitchel J., Ghilezan I., Kim, Y.J., et al., The End of the Paper Trail, European Pharmaceutical Contractor Winter 2008; 72-75.
Mitchel J, Park G, Lynch S., Pagano R. and Citron M. Phase 1 Clinical Trials and Exploratory Phase 2 Clinical Trials. Book Chapter in Principles in Clinical Oral Health Research, Edited by: William Giannobile (University of Michigan Clinical Center), Brian Burt and Robert Genco (State University of New York at Buffalo) 2009 In Press.
Dye BA and Mitchel J. Data Management in Oral Health Research. Book Chapter in Principles in Clinical Oral Health Research, Edited by: William Giannobile (University of Michigan Clinical Center), Brian Burt and Robert Genco (State University of New York at Buffalo) 2009 In Press.