ATLANTA — As the 36-month oxygen cap kicked in Jan. 1 and CMS' new post-cap payment rules took effect, beleaguered providers struggling to implement those rules said they still have unanswered questions about procedures, billing and the like. They also said they're not giving up on getting the cap repealed.

"What's going on with providers right now is a lot of confusion," said Sean Schwinghammer, senior advisor for the Accredited Medical Equipment Providers of America, Miami. "We are getting calls from providers, from billing agents. We have inquiries that have gone to CMS and we are not getting answers."

On Jan. 2, the day after the cap was implemented, Rob Brant of North Miami Beach-based City Medical Services and president of AMEPA, wrote the following letter to Joel Kaiser, deputy director of DMEPOS policy at CMS:

"Dear Mr. Kaiser,
As of yesterday, we have begun the era of capped oxygen equipment. My understanding is that patients who have been using prescribed oxygen for over 5 years, beyond the 'useful lifetime' of the equipment, are entitled to have their 5-year-old equipment replaced. I have the following questions regarding this rule.

For all of these examples, the patient had an oxygen concentrator initially delivered on March 15, 2003.
1) In this case, are we entitled to replace the patient's oxygen concentrator with a fresh, restart of the 36-month billing period as of Jan. 2, 2009?
2) Do we need a statement or documentation that the patient's equipment is not functioning properly?
3) Assuming the patient is entitled to a new oxygen concentrator, do we obtain a new CMN with an initial date of Jan. 2, 2009; or do we use a new CMN with an initial date of March 15, 2003, and a revised date of Jan. 2, 2009?
4) In order to qualify for the replacement oxygen concentrator is a new ABG or oximetry test required as well?
5) When billing the replacement oxygen concentrator, how are the new modifiers used with the E1390?

Thank you in advance for your time. Unfortunately, these questions are no longer hypothetical, as I have already received a call yesterday from a patient with a problem with their oxygen system. I needed clarification as soon as possible, if they were entitled to a new oxygen concentrator."

As of press time Friday, Brant said he had received no response.

Cara Bachenheimer, senior vice president of government relations for Invacare, Elyria, Ohio, said the biggest unanswered questions relate to specific documentation requirements at 60 months, when replacement equipment is provided.

"We understand CMS will soon issue instructions and [the DME MACs] will shortly follow with more details," she said, adding that she believes the documentation requirements will relate to both medical need and that delivery did occur.

Along with trying to get their questions answered, providers also are working on both legal and legislative fronts to get the cap repealed.

Brant said his association was in the process of evaluating a legal analysis it received last week from the Miami-based law firm Greenberg Traurig about the possibility of a lawsuit against Medicare over the oxygen cap.

In a contention supported by the Small Business Administration, AMEPA maintains that CMS violated Congress' Regulatory Flexibility Act, which requires a complete analysis of the benefit or harm of government mandates on small businesses. The law firm's analysis supports that contention, Brant said.

AMEPA, which received financial aid from VGM, The MED Group, Invacare, Respironics and AirSep to look into the possibility of a lawsuit, will have to assess the analysis to determine if it is in the industry's best interest to move forward with a suit, Brant said.

One of the critical questions is whether a lawsuit would be timely, he said, pointing out that the process could take a year or even longer. Also, he noted, "It would take an effort from providers if we decided to do a suit. Providers would have to step up with the funds — a quarter- to a half-million dollars."

If a lawsuit doesn't turn out to be plausible, Brant said, the only recourse is Congress.

"It would be wonderful to be able to say [to CMS], 'You violated the RegFlex rule, therefore you have to stop this.' Unfortunately, we've got to plead our case to Congress or get the violation of the RegFlex rule to go through a court of law," Brant said.

On another front, some stakeholders are pushing for legislative action to repeal the cap. The National Association of Independent Medical Equipment Suppliers last week called on providers to contact their legislators and urge them to include both a repeal of the oxygen cap and of competitive bidding in the economic stimulus bill.

"Provisions included in the stimulus package would likely be exempted from the pay/go rules," said Wayne Stanfield, president and CEO of NAIMES. "This means that Congress would not need to find offsets to pay for the repeals."

Stanfield said NAIMES supports reform of the oxygen benefit, but added, "We must pursue every avenue possible to stop the cap before it harms patients. We must achieve a repeal of the oxygen cap while we work toward achieving meaningful results."