Confirming what insiders have been speculating for some time, the announcement that accreditation will be implemented in stages was made during a special CMS Open Door Forum on the newly released draft of quality standards for suppliers (see HomeCare Monday, Sept. 26). The forum, which included attendance of 65 and another 420 phone participants, was held last Monday as part of a scheduled meeting of the government's Program and Advisory Oversight Committee, a 22-member panel that is advising CMS on national competitive bidding.

Eventually all DMEPOS suppliers who want to participate in Medicare will have to meet the quality standards--including business and product-specific requirements--which will be applied by CMS-approved accrediting bodies as mandated under the Medicare Modernization Act.

But frustration and confusion with the proposed standards--and CMS--was apparent following release of the draft, developed by CMS contractor Abt Associates, Cambridge, Mass. Before the meeting started, stakeholders scrambled to make sense of the 104-page document, which was released on Sept. 23, the Friday before the Monday PAOC meeting.

"I appreciate the detail and the work that's gone into the document, but I was a little concerned that we only had in essence a business day to review a 100-page document to provide some comments," Don Clayback, senior vice president of networks for Lubbock, Texas-based The Med Group, told CMS during the forum.

CMS also announced a revised timeline for the process, raising new concerns that providers who want to take part in Medicare's DME bid may not have enough time to get accredited before 2007. According to Linda Smith, CMS project officer, the final quality standards now will likely be published in March or April of 2006, at the same time that the 10 MSAs where bidding is to begin will be announced. Only then, after the stardards are finalized, will the agency release information on how accreditation organizations can apply for "deemed status" to become official accrediting bodies.

Clayback estimated that, according to the CMS timeline, selection of the accreditors would occur in the summer or fall of 2006. Smith responded with few details: "When the rule is final and published, we will then provide the Federal Register notice to receive application from accreditation organizations. I cannot give you a specific date."

Previously, approved accreditors were expected to be named by the year's end or by early 2006 at the latest.

"It's not the progress we thought would be made by this time this year," said forum attendee Mary Ellen Conway, president of Capital Healthcare Group, a Bethesda, Md.-based health care consulting firm. "I think it's frustrating because it really doesn't move the process along in a timely manner."

Providers who are already accredited by one of several current HME accrediting bodies could be grandfathered in--but only if those organizations' standards meet the final CMS standards, according to Smith.

"How do they expect suppliers to go forward and prepare? CMS is not giving them the information they need," said PAOC member Seth Johnson, director of government affairs for Exeter, Pa.-based Pride Mobility. "There's a lot of apprehension out there to go forward with accreditation when [providers] are not confident the agency they're going with will be grandfathered."

About Those Quality Standards
Some industry stakeholders say that in their current form, the proposed supplier standards are both confusing and impractical. The draft document focuses on two areas: business standards and product-specific requirements for providers who specialize in particular categories, such as oxygen, support surfaces and power wheelchairs. Several proposed financial requirements were singled out by attendees as cause for concern.

"It was clear to me that, overall, the people who prepared the draft report had real gaps in understanding of HME operations and of health care," said Wallace Weeks, president of Weeks Group, a Melbourne, Fla.-based strategy consulting firm.

For example, he noted after the meeting, one of the financial requirements calls for an audited financial statement, something that he said is completely unrealistic for a small provider. Although the standards do not specify whether the audits need to be internal or external, it could cost a provider from $6,000 to $7,000 to have one completed by a CPA. "This is an asinine requirement," he said. "If providers are going to be required to have a CPA complete an audited financial statement on an annual basis, this will pose an insurmountable problem for the industry."

A requirement to notify CMS of "potential adverse financial operations" that could lead to delayed payments or bankruptcy disturbed Tim Pederson, president and CEO of WestMed Rehab, Rapid City, S.D. "That's very ambiguous, very vague, and it begs the question: Why is it included? All providers have financial issues like this," he told officials during the Open Door session. "Does this mean we'll be sanctioned or punished [or that] payments will be withheld, which would exacerbate the situation even more? I don't think there's a provider in this room that isn't behind in payments to one ... manufacturer or another."

CMS' Smith responded that the agency had found "by the time suppliers notify CMS usually they're in real trouble and almost out of the program, or they're so far behind that they can't get financially stable." She said the requirement "was not meant to be punitive but to enhance communications early on in an attempt ... to work together" to resolve such problems.

The business standards outline requirements in eight areas: administration, financial management, human resource management, beneficiary services, performance management, equipment and safety, beneficiary rights and ethics and information management. These comprise 11 pages of the proposal, while another 89 are devoted to product-specific requirements that outline service standards and requirements for inspection, delivery/set-up, beneficiary education/training and follow-up for suppliers specializing in 14 different categories. Requirements in another 18 categories are to be developed by CMS and Abt Associates as the project continues.

"It's overkill," Conway said of the product-specific requirements. "Products are going to change and requirements are going to change. Why wouldn't they just leave it to manufacturer's guidelines?"

Other attendees expressed concern that the standards would hinder access to care, especially in the case of rural providers who often serve large areas and have trouble hiring staff--such as wound care specialists or rehab technologists--with the specific qualifications the CMS standards require.

"Some things are just impossible to do," said Mike Hamilton, executive director of the Alabama Durable Medical Equipment Association (ADMEA) and Georgia Association of Medical Equipment Services (GAMES).

He cited a requirement that oxygen suppliers respond within 60 minutes of a telephone call. "Can you imagine a supplier in any place with traffic jams being able to respond?" he asked?

"Some of the standards are just so far-fetched and removed from reality that it would put 60 percent or more suppliers out of the business if they had to comply," said Hamilton. "They are appalling and have got to undergo a major overhaul."

Although Pride's Johnson said he also was disappointed the quality standards weren't "further along," he said he was heartened that CMS said it will be requesting volunteers to serve on product-specific workgroups for further feedback. "I think it's good they're forming these workgroups and CMS isn't just doing this in a vacuum without the industry's input."

To view a draft of the standards, click here.

CMS will accept public comment on the draft standards until Nov. 28. Comments can be e-mailed to dmepos_quality_standards_public_comments@cms.hhs.gov.

--Winning Strategies for Marketing Within Legal Parameters, Tuesday, Oct. 18. In this panel discussion, attorneys Cara Bachenheimer of Invacare Corp., Jeffery Baird of Brown & Fortunato and Asela Cuervo of the Law Offices of Asela Cuervo will focus on steps providers can take to grow their businesses, in addition to the legal parameters that govern marketing, joint ventures and other strategies.

--Winning Strategies for Benchmarking HME, Wednesday, Oct. 19. Compare your business costs, revenue and profitability with those of other providers at this must-attend session presented by Bruce Brothis of Alternative Billing Solutions, Jack Evans of Global Media Marketing and Wallace Weeks of Weeks Group.

--Winning Strategies for Referral Marketing, Thursday, Oct. 20. An expert panel of referral sources will share tips on how to become a preferred provider. Learn how to approach referral sources, educate and sell them.

--HME Makeover, Tuesday, Oct. 18. Back by popular demand, this hands-on workshop, led by retail and showroom design experts Evans and Ed Lemar of Gladson Store Design will help participants learn how to redesign their own HME showrooms. Bring your ideas and questions to this special session.

We also hope you'll join HomeCare to celebrate with friends and colleagues at the Medtrade Welcome Reception & Awards Ceremony, 5:30 p.m. on Tuesday, Oct. 18, in the Thomas Murphy Ballroom, where the magazine will present its 2005 HomeCaring Awards(TM), given in recognition of distinguished service to the home medical equipment industry. The $30 ticket price includes food and beverages, and proceeds will be donated to the Shepherd Spinal Center in Atlanta. For tickets and information, call (800) 933-8735 or visit www.medtrade.com.