Quality Standards

One of the biggest issues connected with CMS’ implementation of competitive bidding is development of quality standards. At a meeting last month of the Program Advisory and Oversight Committee (PAOC), which is advising CMS on the program, CMS and its contractor, Research Triangle Institute (RTI), unveiled a preliminary draft outline of quality standards for DMEPOS suppliers. The draft provides an overview of the approach CMS plans to take in establishing eight “quality standards domains,” with a series of requirements in each of those domains as follows.

Organizational Structure — Compliance with federal, state and local laws; disclosure of ownership and financial interest; status and location of business/access to care and services; contracts/agreements; policies/procedures on scope and provision of services, coordination of care, disaster plan, replacement and rental of equipment; Medicare supplier enrollment process; normal and emergency operating business hours and services provided.

Financial Management — Financial management plan that includes an annual operating budget and capital expenditure plan prepared according to generally accepted accounting principles; projected and actual income, expenses and balances; acquisition and improvement of land, buildings and equipment; expansion of buildings and equipment; and invoices and receipts of each beneficiary’s equipment and supplies.

Human Resources — Licensure, registration, certification, qualifications of staff; competency of staff; criminal background checks.

Patient/Client Management — Physician orders, CMN, assessment; equipment/supplies delivery, set-up, safety, monitoring replacement, pick-up; beneficiary education, training, monitoring, follow-up, emergency response, participation in plan of care; self-administration, beneficiary requires assistance; coordination of care with physician and other providers; infection control practices; product-specific requirements (e.g., oxygen, hospital beds, orthotics, wheelchairs, pressure reduction devices, adaptive equipment); provision of care and services with respect and maintenance of beneficiary’s dignity; confidentiality; discharge form services.

Assessment and Evaluation of Quality — Tracking trends and patterns related to quality and outcomes of equipment and supplies staff performance, beneficiary satisfaction, financial stability, strategic/business plan; identifying, monitoring and evaluating problems to determine root cause(s) and effect of equipment and supplies on the maximization of beneficiaries’ health; responding to identified problems by developing, implementing and monitoring of strategies to improve quality of services and products; evaluating the effects of quality improvement interventions and taking corrective actions.

Facility and Patient Environment, Safety Management — System for tracking and monitoring equipment functions, failures, recalls, repairs, preventive maintenance, labeling, inspection, testing, calibration; safety of beneficiary’s home environment, emergency power; equipment and environmental hazards; maintenance of manufacturers’ information for all equipment and supplies.

Ethics/Rights — System for identifying, responding to and resolving grievance with written follow-up; informing each beneficiary in advance of furnishing or discontinuing equipment, supplies, services; personal privacy; beneficiary notification of rights.

Information/Management (Patient Records) — Medical records, complete, accurately documented, retained; safeguards against loss of destruction; confidentiality.

CMS plans to issue the final quality standards this summer, and would then issue a regulation explaining how accreditation organizations apply for “deemed status,” that is, apply to obtain approval that the organization’s standards meet or exceed CMS’ quality standards.

CMS would publish a list by the end of 2005 identifying which accreditation organizations received deemed status. Suppliers accredited by any of the CMS-approved organizations in turn would be deemed to meet CMS’ quality standards.

A specialist in health care legislation, regulations and government relations, Cara C. Bachenheimer is vice president, government relations, for Invacare Corp., Elyria, Ohio. Bachenheimer previously worked at the law firm of Epstein, Becker & Green in Washington, D.C., and at the American Association for Homecare and the Health Industry Distributors Association. You can reach her by phone at 440/329-6226 or by e-mail at [email protected].