by Denise M. Retcher, JD
All Medicare suppliers will have to eventually be accredited, and CMS will do its own validation surveys to check up on the accreditation organizations.
CMS says it has attempted to minimize the mandatory accreditation burden by selecting several accreditation organizations. In doing this, CMS hopes to induce competition that will decrease accreditation costs.
Second, during the application process, CMS has asked accreditation organizations to include a plan that outlines their methodology to reduce accreditation fees for small/specialty suppliers and suppliers that have multiple locations. Third, CMS encourages accreditation organizations not to expand on streamlined quality standards.
CMS has stated that the role of the accreditation organizations is to ensure compliance with quality standards, and that accreditation should not be contingent on using consultation services or purchasing manuals. Finally, according to CMS, using an unannounced survey process reduces "ramp-up" costs and survey preparation time.
CMS released the final quality standards for HME suppliers on August 15, 2006. Suppliers must meet these quality standards to furnish any HME item for which Medicare Part B makes payment, as well as to receive or retain a supplier number.
Based on more than 5,600 comments received pertaining to the September 2005 draft quality standards, CMS made substantial revisions to the final quality standards. According to CMS, examples of key revisions included:
- eliminating unnecessary specificity and redundant information, and reducing the standards from 104 pages to 14 pages;
- modifying overly prescriptive requirements to focus more clearly on providing reliable quality service to beneficiaries (for example, eliminating the requirement to be open for 40 hours per week and replacing it with a requirement to maintain posted business hours);
- clarifying requirements for performance management to allow suppliers flexibility in determining indicators related to their products and services;
- consolidating and incorporating certain product-specific standards into the general product-specific service standards, reducing the number of standards from 15 to three.
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| Denise M. Fletcher |
Currently, HME suppliers that are awarded competitive bid contracts in the first 10 competitive bidding areas (CBAs) must be accredited by August 21, 2007. Eventually, all HME suppliers that furnish items or services under Medicare, or receive or retain a supplier number, will be required to be accredited.
CMS may conduct validation surveys of suppliers to validate the accreditation organization's survey process. A supplier selected for a validation survey must authorize the survey to take place and allow a CMS survey team to monitor the correction of any deficiencies that are found. If a deficiency is discovered by the validation survey, CMS may revoke the supplier's number or require the accreditation organization to perform a full accreditation survey at the organization's expense.
If a validation survey results in a finding that the supplier is out of compliance with one or more of the Medicare quality standards, the supplier's number may be revoked. A supplier that fails to cooperate with the validation survey will be deemed as no longer meeting the Medicare quality standards and its supplier number may be revoked.
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Additional articles on accreditation can be found in previous 2007 issues (see Related Articles box below). Featured authors/interview subjects include: Sandra C. Canally; Mary Ellen Conway; Robert J. Floro; Wayne M. Link; Timothy L. Safley; and Vianna Zimbel. |
The supplier must be accredited for every product category in which the supplier furnishes products or services to patients. If a supplier chooses an accreditation organization that is not approved for all the product categories in which the supplier intends to furnish items, the supplier should request that the accreditation organization coordinate with another accreditation organization that is approved for the "missing" product categories.
Suppliers are encouraged to seek accreditation as soon as possible. Generally, accreditation involves submitting documentation and information regarding the supplier's entire business to the accreditation organization and preparing for an on-site survey by the organization.
Tools and Tactics - Preparing for Accreditation
Follow these steps to get the accreditation ball rolling.
- Display your current business license.
- Display current HME license.
- Display current pharmacy license (if applicable).
- File copies of applicable laws and rules (Board of Pharmacy, Respiratory Care Board, Board of Nursing, HME Board, and Department of Health) and make sure they are readily available to staff members.
- Make policy and procedure manuals readily available.
- Make sure the office is clean and organized.
- See to it that all fire extinguishers are checked and current.
- Clearly mark all exits (it is recommended that exit signs are illuminated).
- Display an exit plan in each office, hallway, warehouse, and storage area.
- Keep a file/log for storage of complaints.
- Post an organizational chart that shows all staff.
- Make brochures or other marketing materials readily available to staff and customers.
- Keep employee handbooks available to staff members.
- Check that your on-call system is effective.
- Clean and organize your warehouse.
- Keep maintenance logs readily available (inspection should reveal that records are being kept current on all rental equipment).
- Check expiration dates on all products with dates.
- Keep an appropriate first aid kit readily available.
- Keep an eyewash station available.
- Cover rental equipment with plastic.
- If oxygen concentrators are provided, be sure calibration records are present for oxygen analyzers (O2 calibration gas tanks with certificates of analysis are recommended).
- If oxygen tanks are being filled (liquid or gaseous), check for compliance with FDA requirements.
- Check for a tracking log for oxygen that indicates the customer, lot number, and expiration date.
- Keep a tracking log that includes any solutions with a lot number, expiration date, and client to whom they are dispensed.
- Material safety data sheets (MSDS) files are available with a sheet for all hazardous materials used by the facility.
- Make sure a safety inspection of the facility has been performed within the past 12 months (and any discrepancies have been corrected).
- Keep a file/log/notebook in which all recall notices are maintained.
- Post all required documents (Family Leave Act, Equal Employment Opportunity Act, and OSHA 300A).
- Stock proper personal protective equipment for delivery vehicles (eyewash, gloves, mask, HEPA mask, gowns, germicide, towels, hand sanitizer, and plastic bags).
- Make MSDS files available with a sheet for all hazardous materials carried in the delivery vehicles.
- Provide annual continuing education for staff members to improve safety, infection control, compliance, ethics, cultural awareness, and customer rights and responsibilities (document the education).
- See to it that all staff members are in compliance with all reporting requirements as requested by the Quality Improvement Coordinator.
Denise M. Fletcher, JD, is an attorney with the Health Care Group of Brown & Fortunato PC, an Amarillo, Tex-based law firm. Fletcher is Board Certified in Health Law by the Texas Board of Legal Specialization and represents HME companies, pharmacies, infusion companies, and other health care providers throughout the United States. She can be reached via e-mail: .
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