AMA Morning Rounds: Genzyme expects Pompe drug determination

The AP (1/21) reported, "Genzyme Corp. said Thursday the Food and Drug Administration is scheduled to make a decision on its Pompe disease drug Lumizyme [alglucosidase alfa] by June 17." The agency "had refused to approve Lumizyme until Genzyme fixed manufacturing problems at a facility in Allston Landing, MA," where "some of the bioreactors...contained a virus that slowed down the production of the company's drugs." The drugmaker "is seeking FDA clearance to market the Lumizyme it produces in 4,000-liter bioreactor tanks at its facility in Belgium."

The Boston Business Journal (1/22, Donnelly) reports, "The company said in November it would address the FDA's concerns about the manufacturing processes at the Allston plant by adding internal controls, updating the filling and finishing capabilities and using contract manufacturers and Genzyme's own Ireland manufacturing plant." Since then, "Genzyme has...hired a new senior vice president of global product quality and entered into an agreement with" Hospira Worldwide Inc. "to provide fill and finish manufacturing services." Dow Jones Newswire (1/22, Gryta) also covers the story.

CMS expands Medicare Advantage payment dispute resolution process

Last year, CMS established a payment dispute resolution process for physicians who encountered problems in getting accurate compensation from Medicare Advantage (MA) private fee-for-service (PFFS) plans. Now, CMS has expanded the process to include non-contracted physicians and to include all MA organizations, including HMOs and PPOs, not just PFFS plans. The dispute resolution process can be used by non-contracted physicians to address problems of MA organizations paying less than regular Medicare rates as well as downcoding of claims, but not for denied claims. The contractor handling the disputed payments is First Coast Service Options, Inc. Information on how to initiate the dispute resolution process is available on the FSCO website.

Limited Study EMG: 95870

Parenthetical directions below code 95870 refer users to 95860-95864 when reporting a complete study of an extremity(s). It's not always clear what this means. I have heard from some members who want more information regarding what constitutes a complete study versus a limited study, and when to use the limited code in general.

First, the language of the code 95870 is helpful. "Needle electromyography; limited study of muscles in 1 extremity or non-limb (axial) muscles (unilateral or bilateral), other than thoracic paraspinal, cranial nerve supplied muscles, or sphincters." Study of thoracic paraspinal muscles T2-T11 is reported using 95869. Study of cranial nerve supplied muscle(s) is reported with 95867 (unilateral) or 95868 (bilateral). Study of sphincters is reported with 51785-51792. Additiaonlly, oculoelectromyography is reported with 92262. Finally, laryngeal and diaphragm muscles are also not reported using the limited code becasue they have separate codes, 95865 and 95866 respectively.

Second, five muscles have to be examined to report needle EMG study of a limb. CMS provided specific guidance for codes 95860-95864 in its Final Rule for 1998 on page 59090. “To bill these codes, extremity muscles innervated by three nerves (for example, radial ulnar, median, tibial, peroneal, femoral, not sub branches) or four spinal levels must be evaluated, with a minimum of five muscles studied.” Use this standard for all EMG coding as it is now universally accepted.

If EMG testing fails to meet the five muscle standard described above and cannot be reported using a code for other anatomic sites, report limited needle electromyography code 95870. When appropriate, multiple units of 95870 can be reported for limited study of two, three, or four extremities. It may be necessary to add modifier 59 to additional units of 95870 with some payers.

Needle Electrode Expense

Occasionally I am contacted by a member who wants to know if it is possible bill for the needle electrodes that are used to perform EMG. It is incorrect to report this supply separately becasue it is already included int he value of the procedure code.

Some of these people have tried reporting HCPCS supply code A4215: Needle, sterile, any size, each. I suspect that most of the communication I get on this topic comes after a denial when someone tries A4215 for the first time, because people usually ask if they can bill for the needle, then they ask, "What about A4215?" There may be providers who bill separately for needle electrodes without any problems, but it is technically incorrect and could raise issues in the future during an audit or chart review.

Medicare Consultation Coding: MLN Matters MM6740

Medicare released a Medicare Learning Network bulletin last month that provides additional guidance on billling patient visits instead of consultations. This change regulatory change was discussed in an earlier post when first finalized in November.

AAN Guideline: TENS Not Effective for Chronic Low-Back Pain

A new guideline issued by the AAN finds that transcutaneous electric nerve stimulation (TENS), a widely used pain therapy involving a portable device, is not recommended to treat chronic low-back pain pain that has persisted for 3 months or longer because research shows it is not effective. The guideline is published in the December 30 online issue of Neurology®.

The guideline also determined that TENS can be effective in treating diabetic nerve pain, also called diabetic neuropathy, but more and better research is needed to compare TENS to other treatments for this type of pain.

Senate Passes Health Reform Bill

In a 60-39 party line vote, the Senate passed the Patient Protection and Affordable Care Act in the morning on December 24.

Prior to the Senate vote, AMA President-elect Cecil B. Wilson, MD, announced the Association's backing during a Dec. 21 Capitol Hill appearance with Senate Majority Leader Harry Reid (D, Nev.) and other top Democrats. Dr. Wilson noted that the leaders had amended the bill to eliminate some earlier provisions that had prompted AMA concerns, such as a one-year Medicare pay patch that would have led to a projected 23% cut in 2011, an elective cosmetic surgery tax and a proposed Medicare enrollment fee.

But the AMA will continue to push for additional changes to the legislation during the conference negotiations. The Association, for instance, said it will not support a final House-Senate bill unless lawmakers make key revisions to: a proposed independent Medicare advisory board that could impose pay cuts on physicians, a plan to release Medicare data in the form of physician performance reports, and a requirement that doctors participate in Medicare quality reporting or face penalties.

In order to preserve AMA backing for the health system reform bill, the Association said Congress must also demonstrate that it is on track to approve separate legislation permanently repealing the Medicare physician payment formula before the current rate freeze expires at the end of February.

CMS Holds Claims and Extends Provider Enrollment

Last week Congress temporarily averted the 21.2% Medicare physician payment cut. On December 19, President Obama signed the bill which will stop the cuts until March 1, 2010. Other changes reflected in the 2010 Medicare Physician Fee Schedule final rule will still take effect on January 1, 2010 and may have a slight impact on the conversion factor used for the first two months of 2010. Similar to other years, since Congress acted so late in the year to avert the cut, CMS will hold claims for the first 10 business days of January (January 1 through January 15) for 2010 dates of service to allow its contractors time to update their systems and pay claims based on the updated rates CMS does not anticipate any cash flow problems for physicians since by law no claims are paid prior to 14 days after receipt anyway.

In addition, CMS has extended the 2010 Annual Participation Enrollment Program end date from January 31, 2010, to March 17, 2010. Physicians still have time to consider their participation options with the Medicare program. Additional information can be found on the AMA's web site. The effective date for any participation status change during this extension remains January 1, 2010, and will be in force for the entire year. Medicare contractors will accept and process any participation elections or withdrawals made during the extended enrollment period that are received or post-marked on or before March 17, 2010.