Doctors Nationwide Call For Reduction Of Regulations to Help Reduce Drug Shortages, Increase Patient Access and Save Billions of Dollars Without Affecting Quality Care

Dec 13, 2011, 15:55 ET from American Society of Interventional Pain Physicians

NEW YORK, Dec.13, 2011 /PRNewswire-USNewswire/ -- The American Society of Interventional Pain Physicians (ASIPP), the Society of Interventional Pain Management Surgery Centers (SIPMS), and 50 ASIPP-affiliated state societies are in agreement with President Obama's efforts to reduce the regulatory burden on the health care industry. However, the associations believe that the government must address additional regulations that are adding financial burdens to independent medical practices without improving patient access or care. To this end, the societies have sent a letter to Kathleen Sebelius, Secretary of Health and Human Services stating their positions.

Three areas of immediate interest to the medical societies are: single dose vials for infection control, ICD-10 implementation, and electronic medical records (EMR) implementation.

Dr. Laxmaiah Manchikanti, Chairman of the Board and CEO of ASIPP, stated "None of these guidelines, recommendations or regulations are based on evidence-based medicine. There is no proof that their implementation will improve quality of care or reduce patient harm. However, they will increase costs significantly, create shortages in medicine, and may even reduce patient access to services by causing physicians to close their practices."

ASIPP and SIPMS represent approximately 4,500 interventional pain management (IPM) physicians, other practitioners, and more than 100 surgery centers—all dedicated to ensuring safe, appropriate, and equal access to essential pain management services for patients across the country suffering from chronic and acute pain. These three issues impact medical professionals, patients, the entire medical community and health care industry. Brief descriptions of the issues follow:

Single Dose Vials for Infection Control

While the associations are strong supporters of appropriate infection control measures they are opposed to inappropriate ones. There is no evidence thus far that single dose vials are responsible for any infections if proper infection control measures are applied. The guidelines for injection practices for single-dose and multi-dose vials, universally applied since January 2010, may be overreaching, expensive and burdensome to the practice of medicine, and may ultimately result in reduced patient access to certain drugs and procedures.

Following current guidelines, if a doctor uses any portion of a vial of liquid medication, the remaining vial and medication must be discarded. To implement the full guidelines is extremely expensive and difficult with increases in personnel and stress thus reducing the quality of care and in some cases total elimination of access as practices go out of business. 

The societies believe that eliminating this regulation could bring a savings of approximately $750 million per year- a conservative estimate- to the healthcare industry.  

ICD-10 Implementation

The International Classification of Disease (ICD) is a coding system for medical providers to support diagnoses and procedures in electronic administration transactions for insurance coverage. The newest version, ICD-10 is to be implemented October 1, 2013, replacing the ICD-9 code set created in 2003 by the Health Insurance Portability and Accountability Act (HIPAA). 

Concerns exist that ICD-10 has been created without establishing necessity or thinking through the far-reaching consequences. ICD-10 is much more complex than ICD-9 and could cost each physician in the range of $25,000 to $50,000 to implement. Opponents also argue that beyond the financial expenses, which include new software and hardware, it is also costly in administrative and medical staff training and has the potential to delay reimbursement.

This new system, which is federally mandated and based on a weak interpretation of the 2003 HIPAA, contains over 141,000 codes—a 712% increase over approximately 20,000 ICD-9 codes. These numerous codes could hinder a physician's ability to properly review and select treatments specific to the needs of each patient, thereby hindering proper care.

The societies would like to continue with ICD-9 which could save the 300,000 practicing physicians in the United States $15 billion every 2 to 3 years ($50,000 x 300,000 = $15 billion, a conservative estimate).

Electronic Medical Records Implementation

While the societies are strong supporters of electronic medical records (EMR) the expanding regulations of meaningful use have greatly inflated the costs to implement. The $1.2 billion funds provided by the federal government under the stimulus act are not only insufficient but may also soon be running out.

It is estimated that EMRs will cost around $25,000 per physician to meet federal regulations, which translates to $7.5 billion every 2 to 3 years. Physicians will need to replace their EMR system every few years due to changing documentation regulations ($25,000 x 300,000 practicing physicians = $7.5 billon – a conservative estimate). 

The Congressional Budget Office (CBO) concluded that cost savings may occur only in large integrated offices and not in small physicians' offices. And many health care providers feel EMRs compromise privacy. In 2007, the Government Accountability Office (GAO) reported that there was "no overall strategy to ensure that privacy protections would be built into computer networks linking insurers, doctors, hospitals and other health care providers." 

Most Medicare directors do not trust the documentation provided by EMRs. It may be useful for fraud and abuse but it inhibits personalized record keeping which is paramount to effective medical care. In the end, EMRs actually reduce office productivity.

The societies believe that removal of federal regulation with meaningful use will save upwards of $7.5 billion to the public and approximately $3 billion to the government. 

According to Dr. Manchikanti, "These three regulations not only increase costs, but reduce efficiency and severely hinder patient access. Elimination of these could save hundreds or thousands of dollars for certain practices and provide better patient care." 

About the American Society of Interventional Pain Physicians

ASIPP's mission statement is to promote the development and practice of safe, high-quality, cost-effective interventional pain management techniques for the diagnosis and treatment of pain and related disorders, and to ensure patient access to these interventions. 

Founded in 1998 by Chairman of the Board and CEO Laxmaiah Manchikanti, MD, ASIPP is a rapidly growing not-for-profit organization that supports access to interventional techniques and the needs of physicians who practice Interventional Pain Management across the country.

Since its inception, the organization has had a substantial impact on the practice of interventional pain management, resulting in an impressive list of major achievements.  In 2005, ASIPP succeeded in passing The National All Schedules Prescription Electronic Reporting Act (NASPER), which provides and improves patient access to quality care, and protects patients and physicians from the deleterious effects of controlled substance misuse, abuse and trafficking.  ASIPP is headquartered in Paducah, KY and currently has 4,500 members.  For more information, visit or call 270.554.9412. Ext. 215

About the Society of Interventional Pain Management Surgery Centers

SIPMS was organized in response to an urgent need for a national organization devoted exclusively to the issues related to providing Interventional Pain Management procedures in an Ambulatory Surgery Center (ASC) setting. By being solely devoted to ASC issues, SIPMS effectuates a new level of involvement and a specificity that creates an image of increased experience and credibility. SIPMS focuses all of its resources on challenges unique to the ASC setting, including the growing list of legislative and administrative attempts to increase regulation of surgery centers.

SOURCE American Society of Interventional Pain Physicians