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M ARCH 2008


Skin & Allergy News The Leading Independent Newspaper for Medical, Surgical, and Aesthetic Dermatology

Newspaper for Medical, Surgical, and Aesthetic Dermatology V O L . 39, N O . 3

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Surgical, and Aesthetic Dermatology V O L . 39, N O . 3 About 75% of

About 75% of patients in the 90-mg group had psoriasis rated as “cleared or minimal,” according to Dr. Kenneth B. Gordon.

Ustekinumab’s Next Psoriasis Stop: FDA


Southeast Bureau

S A N A NTONIO — Long-term, continuous use of ustekinumab for maintenance therapy in pa- tients with moderate to severe plaque psoriasis is efficacious and generally well tolerated, ac- cording to phase III study find- ings reported at the annual meeting of the American Acad- emy of Dermatology. The results of the PHOENIX I trial—a randomized, double-blind, placebo-controlled crossover trial of the human monoclonal anti- body against interleukins 12 and 23—showed that treatment re- sponse was better maintained at 76 weeks in responders who re- ceived 45 mg or 90 mg of ustek- inumab every 12 weeks, compared with those who discontinued treatment at 40 weeks, Dr. Ken- neth B. Gordon of Northwestern University, Chicago, reported dur- ing a poster session. Just days after the data were presented, the drug’s manufac- turer (Centocor Inc.) announced that its Biologics License Appli- cation for ustekinumab (CNTO 1275) had been accepted for re- view by the Food and Drug Ad- ministration. The results of another phase III study (PHOENIX II) of ustek- inumab, which were reported in October at the World Congress

of Dermatology in Buenos Aires, showed that ustekinumab was effective and safe in more than two-thirds of 1,230 patients with moderate to severe disease who received two subcutaneous doses of the drug. A 75% improvement in the psoriasis severity area index score (PASI 75) was achieved in 67% of patients randomized to receive 45-mg doses, 76% of those randomized to receive 90- mg doses, and 4% of those in the placebo group, the investigators reported. For the current study, 766 pa- tients were randomized to re-

I I N N S S I I D D E E Mohs Nose Tissue-sparing


I I N N S S I I D D E E Mohs Nose Tissue-sparing technique
I I N N S S I I D D E E Mohs Nose Tissue-sparing technique
Mohs Nose

Mohs Nose

Tissue-sparing technique may be best for critical anatomic sites.

Tissue-sparing technique may be best for critical anatomic sites.







FDA issues warning; injections show promise as Raynaud’s treatment.

FDA issues warning; injections show promise as Raynaud’s treatment.



injections show promise as Raynaud’s treatment. PAGE 13 Hands Off Even after diarrhea resolves, C. difficile
injections show promise as Raynaud’s treatment. PAGE 13 Hands Off Even after diarrhea resolves, C. difficile
Hands Off

Hands Off

Even after diarrhea resolves, C. difficile spores remain on patient’s body.

Even after diarrhea resolves, C. difficile spores remain on patient’s body.



See Ustekinumab page 7

A 66-year-old fisherman with a history of chronic sun expo-
sure presents with a 2-month history of a slowly growing
plaque that began as a bump and grew into a ring. The lesion
was completely asymptomatic. He has no known allergies or any
other pertinent history, except for hypertension. Physical exam
reveals a nontender, nonscaling annular plaque on his right fore-
arm. No other similar lesion is observed. The lesion is KOH neg-
ative. What’s your diagnosis? See Case of the Month, page 75.

Melanoma Quality Measures Dropped From Medicare P4P

Emphasis is placed on EMRs, e-prescribing.


San Francisco Bureau

T hree melanoma measures

that were added to the

Physician Quality Report-

ing Initiative in mid-2007 have been eliminated, leaving derma- tologists with limited opportuni- ties to qualify for bonus pay- ments from the Center for Medicare and Medicaid Services that could have totaled up to 1.5% of Medicare billings. Like physicians in other spe- cialties, dermatologists can still qualify by using certain electron- ic medical record (EMR) and e- prescribing systems. The e-pre- scribing measure can be reported alone and appears to be the most

suitable for dermatology prac- tices, according to Dr. Mark D. Kaufmann. A smoking cessation measure

also exists, but reporting it makes dermatologists subject to report- ing a cluster of preventive care measures. Many dermatologists are not satisfied with these limit- ed opportunities. “It’s clear to me, and it has been for several years now, that the government has convinced itself that we are going to save billions

of dollars by going electronic, and

I think that’s where the push is go-

ing to be from now on,” Dr. Kauf- mann said in an interview. And, at

a talk during the 2008 American Academy of Dermatology meet- See P4P page 61

Controversy Lingers Over Sunscreen Seal Program


Associate Editor

S A N A NTONIO — The Amer- ican Academy of Dermatology’s Seal of Recognition program continued to raise concerns among some dermatologists at the Academy’s annual meeting. Since the program was ap- proved in July 2006, two prod- ucts have been selected to carry the seal: Aveeno Continuous Protection Sunblock Lotion SPF 55 and Aveeno Baby Continu- ous Protection Sunblock Lotion SPF 5, according to the AAD. The Seal of Recognition is also

available for cosmetics/moistur-

izers, clothing, hats, laundry ad- ditives, shade structures, and window films/tints that meet ev- idence-based criteria for reducing sun exposure. At the AAD’s annual meeting, Dr. A. Bernard Ackerman sub- mitted to academy officials a pe- tition signed by 80 members op- posed to the program; that action caused a special meeting of members to be held on Feb. 4. The meeting was open to all AAD members; 97 voting mem- bers were present and 80 voted in

a closed ballot straw poll, ac-

See Controversy page 10


March 2008

w w w. s k i n a n d a l l e r g y n ew s . c o m

Practice Trends


Bush Proposes Medicare, Medicaid Cuts for 2009


Ne w York Bureau

I n the final budget proposal of his presidency, President Bush is planning substantial

cuts to hospitals, skilled nursing facilities, and graduate medical education. Leaders in the Democrat-con- trolled Congress immediately declared the proposal dead on arrival. Under the plan, the Bush ad- ministration has put forth leg- islative and administrative pro- posals that would cut $12.8 billion from the Medicare pro- gram in fiscal year 2009 and about $183 billion over the next 5 years, largely from hospital and other provider payments. The idea is to slow down the growth rate of the program from 7.2% to 5% over 5 years. But critics say the cuts would harm hospitals that care for low-income patients and train physicians. The FY 2009 budget proposal calls for freezing payments to in- patient hospitals, long-term care hospitals, skilled nursing facili- ties, hospices, outpatient hospi- tals, and ambulance services from 2009 through 2011. Pay- ments would then drop 0.65% annually under the proposal. The proposal also outlines a payment freeze for inpatient re- habilitation facilities and ambu- latory surgical centers in 2010 and 2011, followed by annual cuts. And home health agencies would also see a 0% update from 2009 through 2013 followed by annual payment cuts.

The proposal would reduce in- direct medical education add-on payments from 5.5% to 2.2% over the next 3 years, and would eliminate the duplicate hospital indirect medical education pay- ment for Medicare Advantage beneficiaries. Hospitals would also face ad- ditional cuts under the plan. For example, the proposed budget would reduce hospital capital payments by 5% in 2009, and hospital disproportionate share payments would drop 30% over the next 2 years. The FY 2009 budget plan also includes proposed legislative and administrative changes aimed at cutting nearly $18 billion from Medicaid over the next 5 years. The administration’s budget would reauthorize the State Chil- dren’s Health Insurance Program (SCHIP) through 2013. The plan calls for a $19.7 billion increase to the program over 5 years, in- cluding $450 million in outreach grants to states and other orga- nizations to help enroll uninsured children in the program. One area that the administra- tion’s budget proposal does not address is the 10.6% physician pay cut scheduled to take place this July. The administration’s budget “falls short” by not including a proposal to fix the Medicare physician payment formula, the American College of Cardiology said in a statement. “Physicians are willing to do their part, but quality cannot be achieved under a zero-sum sce- nario,” according to the state- ment. “Continued deep payment

cuts make it impossible for physi- cians to continue to invest in a health care infrastructure that fa- cilitates data collection and qual- ity improvement while ensuring that patients have access to high quality care.” In total, the administration is requesting $711.2 billion for the Centers for Medicare and Medic- aid Services to cover mandatory and discretionary outlays for the Medicare, Medicaid, and SCHIP programs. The request is a $32.7 billion increase over the FY 2008 funding level. Federal research agencies are also facing funding cuts or freezes under the FY 2009 budget proposal. The administration is propos- ing no increase for the National Institutes of Health, keeping the agency’s budget at approximate- ly $29.5 billion. Health advocates say the failure to expand NIH funding will hurt research efforts in several critical areas. For example, the National In- stitute of Diabetes and Digestive and Kidney Diseases would re- ceive an increase under the ad- ministration’s proposal, but the $2.6 million bump amounts to a 0.15% increase over FY 2008. The American Diabetes Association is urging Congress to disregard the president’s proposal and pro- vide $112.5 million in additional funding, a 6.6% increase. “We cannot afford not to invest in diabetes research, treatment, and prevention—the conse- quences for our health care sys- tem and our society will be too se- vere,” Dr. John B. Buse, president of medicine and science for the

American Diabetes Association, said in a statement. “The Ameri- can Diabetes Association calls on Congress to align their priorities and provide funds to remedy this growing health crisis.” The administration’s budget proposal also calls for $8.8 billion in funding for the Centers for Dis- ease Control and Prevention, a $412 million drop from FY 2008. The Agency for Healthcare Re- search and Quality would also face a cut under the proposal. The president is calling for $326 mil- lion in funding for the agency, a $9 million decrease from FY 2008. The Food and Drug Adminis- tration would receive a $130 mil- lion increase over FY 2008, bring- ing the total funding to 2.4 billion in FY 2009. The FDA budget pro- posal includes increases in the human drugs and devices pro- grams at FDA.

Under the plan, the human drugs program would receive $984 million in FY 2009, an in- crease of $68 million. The in- crease includes estimated user fees coming into the agency. The increases are slated to fund im- provements in drug safety and regulation of biologic therapies. The budget includes a funding

commitment of $389.5 million for drug safety, an increase of $36 million in FY 2008. In addition, the budget includes a proposal to grant the FDA new authority to approve follow-on biologic pro- teins through a new regulatory pathway. The administration also is seeking user fees to cover the costs of the new activity. Under the administration’s budget request, the medical de- vices program at FDA would re- ceive $291 million, an increase of

$7 million.

DD AA TT AA WW AA TT CC HH Adults Who Did Not Receive Needed
Adults Who Did Not Receive Needed Health Care
Because They Could Not Afford It
Age (years)
Note: Based on 2005 data from the previous 12 months.
Source: Centers for Disease Control and Prevention

NQF Failed to Endorse Measures

P4P from page 1

ing, he said, “It appears the government be- lieves that they will save a lot more money having [physicians] use EMR systems than saving melanoma patients’ lives.” Dr. Kaufmann of Mount Sinai Medical Center, New York, has a special expertise in EMRs. He serves as a juror for the Cer- tification Commission for Healthcare In- formation Technology (CCHIT), the non- profit organization formed to develop standards on the functionality and inter- operability of EMR systems. According to the 2008 list of eligible measures from the Physician Quality Re- porting Initiative (PQRI), qualifying EMR systems must either be CCHIT certified or capable of producing a medication list, generating a problem list, and enter- ing laboratory tests as discrete searchable data elements. During the last half of 2007, the PQRI list of eligible measures included three re- lated to melanoma. Dermatologists would be eligible for bonus payments from CMS

if they could demonstrate that they asked

about new or changing moles, performed

a complete skin exam, and counseled the

patient to perform self-examination for new or changing moles. The melanoma measures were added af- ter being endorsed by the AQA Alliance (formerly the Ambulatory Care Quality Alliance), but they were later removed because they failed to be endorsed by the National Quality Forum (NQF). “If it’s an AQA-endorsed measure, the federal government may recognize it,” said Dr. Dirk Elston, director of the de- partment of dermatology at the Geisinger Medical Center, Danville, Pa. “If it’s an NQF-endorsed measure, the federal gov- ernment must recognize it as a national standard other than by act of Congress.” There were several reasons for the NQF’s failure to endorse the melanoma items, Dr. Elston said. First, “they were specific to dermatology and would be dif- ficult to report for any other type of physi-

cian who was seeing patients with skin disease. And second, both AQA and NQF considered them low-bar measures.” But other items in the 134-item list for 2008 appear to be specific to certain spe- cialties. For example, item 14 calls for pa- tients with age-related macular degenera- tion to receive a dilated macular examination, item 43 calls for surgeons to use the internal mammary artery during coronary artery bypass grafting, and item 100 calls for colorectal cancer patients to receive a certain type of histologic staging. The full list of reported measures is avail- able through the PQRI Web site at Dr. Elston emphasized that complying with PQRI measures is voluntary, with the payments reaching at most 1.5% of the Medicare Physician Fee Schedule allowed charges for covered services. To receive payments, physicians must report mea- sures for at least 80% of eligible patients. While the benefits of participating in the PQRI program are modest and there are no penalties for noncompliance, Dr. El- ston noted that private payers are likely to adopt similar quality measures, and their

quality platforms are likely to include both bigger carrots and bigger sticks. “Not participating in private-payer pro- grams carries the risk of having a lower quality rating on the Web site where the carrier lists their participating physicians,” Dr. Elston said. “It also carries the risk of higher patient copays when they come to visit you.” Some states are even discussing the possibility of making physician reli- censure dependent on participation in a performance improvement plan, he said. In late 2007, the White House proposed that physicians who meet quality bench- marks would have their Medicare reim- bursements frozen at current levels, while those who did not would be subject to a 10% cut in payments. Meanwhile, the PQRI, the AQA alliance, and the NQF are working on new lists of quality measures, from which Dr. Elston hopes that dermatologists will have a menu of items from which they can choose relevant quality reporting mea- sures. Among them may be measures re- lated to glucocorticoid-induced osteo- porosis, proper antibiotic use, and other areas of patient safety.