Showing posts with label About FDA. Show all posts
Showing posts with label About FDA. Show all posts

Sunday, January 29, 2012

Maryland’s Multi-payer Patients Centered Medical Home Program

As the result of legislation, insurance carriers required to participate are the following Aetna, CareFirst, BlueCross, BlueShield, CIGNA, United Healthcare, and Coventry. Carriers who gross more than 90 billion are required participators

The Centers for Medicare and Medicaid Services announced a pilot project so that any state-sponsored programs may participate.

The program requires that all participating practices apply for NCQA’s recognition program for level 1+ or higher within 6 months. By December 2011 and level 2+ within 18 months of implementation. The practices must pass categories within each of the nine NCQA domains. The elements are strongly linked to potential cost savings to purchasers, and patients. 
  
Selection criteria including primary care physicians, and nurse practitioners. Geographic diversity, practice size, and ownership type are a part of the criteria selection too.
According to the NCQA recognition requirement nurse practitioners are not recognized however, NCQA will review applications and forward the details to the MHCC, if they meet level 1+ and level 2+ requirements. The caveat is they will not be recognized by NCQA.

Practices may participate in Maryland’s MHCC program and single payer programs, such as CareFirst if the program is site specific, using NCQA requirements; CareFirst is enrolling practices at the organization level. Participation with both programs requires following patient participation rules, payment methodologies, and quality reporting according to both programs. In other words not combining information into one report if variances between the reporting requirements differ.  CareFirst may supplement MHCC payment system consistent with Care First’s for the practice using both payment systems. Other practice locations not in the MMPP will follow the CareFirst conventions.

In order for cost-effectiveness for the practice, the practice needs to participate with 2-5 of the required carriers.

Patient participation includes an op-out option. The payment for those patients opting out who opt-out are excluded from the payment and quality measures.
Every six months patients joining and leaving the practice will be added to the payment program. The quality measure includes providing a list of patients and their insurer to MHCC. The information is matched against enrollment records and claims histories. The patient according to where most primary services received using E&M codes for the prior two years are matched to the primary provider. If the patient has not received services within the window, the patients are evaluated with pharmacy claims. Those patients who have changed carriers within the window are in the process of determining verification.
Do I want the government knowing what I am being treated for and how is that information used? What other entities have access to the information.
It is irrelevant the number of locations within the practice, all locations is included in the payment system.

Practices performance measures for monitoring are at least one disease including diabetes, heart/stroke management, and asthma control. These measures align with Medicare and Medicaid’s EHR meaningful use definition for bonus payments and Medicare’s PQRI standards. Incentive payment guidelines including meeting thresholds in reduction.

The payment structure is different from managed care capitation. PCMH offers a fixed and incentive payment in addition to the fee-for-service payment. The fixed and incentive payments differ for treatment services.

Payment includes two types of reimbursement. Practices will receive per patient monthly payment for those patients participating with the program. This is to cover the cost related to the program. This payment is semiannual. Adjustments include the number of patients, payer category, and NCQA recognition standards. Practices that decrease emergency department visits and hospital utilization are included in payment as well. Fixed payments begin April 1, 2011. The semiannual payment is retrospective and depends upon meeting quality thresholds.
How much is per patient, is the carrier required to report this information to MHCC? How does it benefit the carriers who pay the fixed payment?  If the practice receives bonuses for decreasing hospital services and ER services then how is that a savings for the state? What is the projected savings with and without using this incentive?
  
If the practice receives subsidy from a private carrier for house bill 706 and participate in the program the subsidy payment will be a countable cost in shared savings computation.  The example provided is if a practice location receives $15,000.00 in HER subsidies in 2011, those payments will be counted as expenses to the practice when the shared savings are calculated. The treatment of the subsidy is identical to the fixed payments are considered in the share savings computation.

Friday, January 27, 2012

Reducing Readmission Rates Part III
            Starting October 2012 Medicare begins penalties for facilities for readmissions within 30 days of discharge. Late last year Dartmouth Institute for Health Policy and Clinical Practice and Robert Wood Johnson Foundation announced little progress was made during a study from 2003-2009. The report found 1 in 6 Medicare patients were readmitted within 1 month of discharge. A staggering 60% Medicare patients did not follow-up after discharge as a factor.
            Hospitals have until October to make systemic changes to coordinate care across the health care continuum. Systemic changes will include ancillary service coordination. 
Medicare will start a 1% reduction in payments to facilities not reducing the readmission rate for patients with specific diagnoses including pneumonia, heart attack, or heart failure.
The National Committee for Quality Assurance implemented 9 practice standards that align with the Joint Principles of Patient Centered Medical Home including Access and Communication, Patient Tracking and Registry Functions, Care Management, Patient Self-Management Support, Electronic Prescribing, Test Tracking, Referral Tracking,
Performance Reporting and Improvement, and Advanced Electronic Communications.
             Group Health Cooperative published a study after one year of using the model emergency room visits saw a 29% reduction rate. Hospitalizations decreased 11%. The medical home visits decreased 6%. The caveat is the model administrative cost increased $ 53 per patient. The emergency room savings saw a decrease of $ 54 per patient.
           CMS Partnership for Patients initiatives is to improve the quality, safety, and affordability of health care not exclusive for the Medicare population, rather for all. The partnership has nine core areas to improve hospital readmission rates by 20% by 2013. The elements include adverse drug events, catheter-associated Urinary Tract Infection, Central Line-associated bloodstream infection, Injuries from Falls, and Immobility, Obstetrical adverse events, pressure ulcers, surgical site infections, Venous thromboembolism, Ventilator-associated Pneumonia, preventable readmissions.
            Higher Volume of Post-acute Care Patients Associated With a Lower Rehospitalizations Rate in Skilled Nursing Facilities by Li Y (at el,) says yes. The study found a 15% reduction in readmission rates within 30 days of discharge. Patients that transfer to step down care requiring skilled nursing care supports the need for improved care coordination.

Tuesday, January 17, 2012

A Regulatory: The Food and Drug Administration


The core of the Food and Drug Administration is to uphold consumer protection, of public health. The first law created by King John of England, in 1202 called the Assize of Bread, prohibited adulteration of bread with ingredients from ground peas, and beans (FDA Basics, 2010). Federal control allowed inspecting drug supply of imported medications in 1848 (FDA Basics, 2010). Since the evolution of the administration, science continues to improve the health of the consumer. The FDA keeps abreast of developments, by regulation products. The regulations have to keep up with social, cultural, and economical change for the developments related to food and drugs. 
History and Health Care Influence 
The origins of the FDA begin with Lewis Caleb Beck in the mid-1800s performing a chemical analysis of agricultural products prior to the Department of Agriculture inception (FDA Basics, 2010). The title of the department changed in 1930 to the Food and Drug Administration. 
The Food and Drug Administration responsibility is, “protect human, and veterinary drugs, biological products, and medical devices, nations food supply, cosmetics, and products that emit radiation” (FDA Basics, 2010). The FDA evaluates innovations of medicines and foods for effectiveness, safety, and. The FDA provides the consumer, science-based information they need to use medicines and foods to improve their health (FDA Basics, 2010). 
Source and Scope of Authority 
In 1906, congressional legislation implemented the Pure Food and Drug’s Act (FDA Basics, 2010). This act currently incorporated in to the Food Drug and Cosmetic Act prohibiting interstate commerce of adulterated and misbranded food and drugs. 
The Food Drug and Cosmetic Act (FD&CA) is a federally enacted law on which the department operates. The FDA follows the Administrative Procedure Act to issue regulations. The Act gives the FDA rulemaking functions. FDA regulations are not part of the FD&CA. The FDA follows Good Guidance Practice Regulations that describes the stance of the regulatory issue (FDA Basics, 2010). 
Structure and Responsibilities 
The Center for Toxicological Research Organization supports the product centers by providing scientific technology, training, and technical expertise. 
Office of Regulatory Affairs Organization provides leadership and direction of product centers, research center, and office of Regulatory Affairs. 
The Center for Biologics Evaluation and Research Organizations regulates products for vaccines, blood, and gene therapy. This center monitors allergenic, tissue, and tissue products like bone, skin, and sperm. The department also works with transplantation of non-human cells, and tissues organs into humans. 
Center for Devices and Radiological Health Organization regulates medical devices from thermometers to dialysis machines. This center approves devices such as implants, and prosthetics. Monitoring includes radiation safety. 
Center for Drug Evaluation and Research Organization regulates over-the-counter and prescription medications. This department is responsible for items like toothpaste, and sunscreen. The products have pharmaceutical properties. 
The FDA approval process has specific steps for medication. The process begins with laboratory and animal testing. Next, testing on human subjects for safety and effectiveness evaluation. Following this, the manufacturer submits a New Drug Application. A biologic requires a Biologic License Application. The application includes, the test results, manufacturing information to ensure proper manufacturing, and the proposed label. If after review shows the benefits outweigh the risk, and manufacturing a quality product the medication meets the approval guidelines. The department is responsible for counteracting bio-terrorism, drug preparedness’, and natural disaster response. 
Center for Food Safety and Applied Nutrition Organization regulates most foods and additives, excluding meat, infant formulas, dietary supplements, and cosmetics. The FDA inspects food facilities along with the state agencies. This department regulates cosmetics to ensure safe and proper labeling. FDA approves cosmetic dyes. In 1994, The Dietary Supplement Health and Education Act amended the (FD&CA) to regulate the safety and labeling of dietary supplements (FDA Basics, 2010). The definition of a dietary supplement is a product taken by mouth intended to add dietary ingredients. 
Center for Tobacco Products Organization regulates tobacco cigarettes, rolling, and smokeless tobacco. This center is responsible for Regulatory issues and policy issues with the Family Smoking Prevention and Tobacco Control Act of 2009 (FDA Basics, 2010). 
Center for Veterinary Medicine regulates feed, drugs, and devices for animals. The FDA monitors the manufacturing and distribution of food additives and drugs given to animals. This includes meat used for human consumption. 
Example 
The Center for Drug Evaluation and Research Organization, wrote to General Mills, the manufacturer of Cheerios warning the manufacture that Cheerios statement regarding the cereal helps lower cholesterol. The FDA told General Mills to remove the statement, “diets rich in whole grain foods can reduce the risk of heart disease” (FDA calls cheerios and “unapproved drug,” 2009). The FDA warned the statements were violations of the FD&CA. The FDA informed General Mills that Cheerios is an unapproved drug that must go through the drug approval process (FDA calls cheerios and “unapproved drug”, 2009). 
Conclusion 
The Unites States Food and Drug Administration a department of the United States Department of Health & Human Services protects and promotes health by regulating more than just food, drugs, and cosmetics. The FDA works in more than an advisory capacity. The FDA works in conjunction with international programs to promote the safety and welfare of the consumer. The FDA conducts criminal investigations and institute sanctions. The department ensures emergency preparedness, and response to bio-terrorism. 


References 
FDA Basics (2010) Retrieved on February 12, 2010 from The Food and Drug Administration http://www.fda.gov/AboutFDA/Basics/default.htm 

FDA calls cheerios and “unapproved drug” (2009) Retrieved on February 12, 2010 from USA Today Magazine (138): p14-15. Retrieved from http://search.ebscohost.com/login.aspx?direct=true&db=f5h&AN=43741553&site=ehost-live