Washington Week: Senate Passes SGR Fix; FDA Panel Backs One Drug, Nixes Another

WASHINGTON -- During a busy week in the nation's capital, the U.S. Senate voted to delay a steep pay cut for doctors, but not before CMS began processing claims at the lower rate; an FDA panel approved a new morning-after pill and voted against "female Viagra", and the agency fined the Red Cross for blood safety violations.

On Friday, the U.S. Senate passed a bill to push back the 21% cut for physicians who treat Medicare patients until Nov. 30.

The bill -- which also gives doctors a 2.2% increase in reimbursements -- was approved by voice vote early in the afternoon. But in the morning the Centers for Medicare and Medicaid Services (CMS) announced it would begin processing Medicare claims at the 21% lower rate, its grace period for delay of the June 1 cut having expired.

The Senate bill then went to the House, but members had already left for the weekend, so a vote will have to wait until Monday at the earliest. That means CMS will process claims at the lower rate until then, unless the agency announces otherwise.

Democratic senators had been unsuccessful in gaining enough votes to pass the so-called "doc-fix" as part of a larger $118 billion bill that would have extended a number of expired federal programs. But the doc-fix passed easily once it was removed from the broader bill.

The 21% cut is mandated by Medicare's sustainable growth rate (SGR) payment formula, which links physician reimbursement rates to increases in the gross domestic product (GDP). Because spending on physician services has outpaced increases in the GDP, the formula has called for cuts in reimbursements each year over most of the past decade, and Congress has always voted to push those cuts down the road, granting small rate increases instead.

New Morning-After Pill One Step Closer to Approval

An FDA advisory committee voted unanimously that the investigational emergency contraceptive pill ulipristal (ella) is both safe and effective at preventing pregnancy when taken up to five days after unprotected sex or contraception failure.

The two 11 to 0 votes of the Advisory Committee for Reproductive Health Drugs -- a panel of outside medical experts amount to a recommendation that the FDA should approve the drug. The FDA does not have to follow the advice of its advisory committees, but it usually does.

If approved, ulipristal -- which works by blocking or delaying ovulation -- would be the first selective progesterone receptor modulator (SPRM) available in the U.S for emergency contraception.

It also would be the first emergency contraception indicated for use up to 120 hours after unprotected sexual intercourse. Levonorgestrel (Plan B One-Step) must be taken within 72 hours after intercourse.

Although Plan B is available over the counter, HRA Pharma applied for approval for ulipristal only as a prescription product.

Libido-Boosting Drug for Women Not Ready for Prime Time

The day after the ulipristal vote, the same FDA advisory committee turned thumbs down on another investigational drug for women, voting that the maker of flibanserin (Girosa) -- often dubbed the female Viagra -- hadn't proved that the pill treats hypoactive sexual-desire disorder (HSDD) any better than placebo.

The panel voted 9 to 2 that Boehringer Ingelheim failed to prove efficacy of flibanserin, and 11-0 that the company failed to demonstrate that the benefits of flibanserin outweigh the risks, which include fainting, accidental injury, insomnia, and fatigue.

Although the committee felt the drug isn't ready for prime time, it agreed that HSDD -- the existence of which has itself been called into question -- is a legitimate medical disorder that deserves an FDA-approved treatment.

FDA Fines Red Cross

On Thursday, the FDA fined the American Red Cross more than $16 million for prior failures in complying with blood supply safety regulations.

Despite the fines, the agency said in a statement that it "found no evidence that the Red Cross violations endangered any patients, and the blood supply is believed to be safe," and noted that multiple layers of safeguards are in place to protect blood products.

However, the agency added, "these types of violations decrease the assurance that blood products manufactured by [the] American Red Cross will continue to be safe and have the potential to compromise the safety of the blood supply."

The Red Cross did not respond to a request for comment.

IDC-10 Start Date Set

The Centers for Medicare and Medicaid Services (CMS) announced that Oct. 1, 2013 is the "firm" start day for implementation of the new ICD-10 coding system for medical diagnoses.

The ICD-10 is the 10th edition of the International Classification of Diseases, the manual most commonly used for coding medical diagnoses. ICD-10 has two parts: ICD-10-CM contains diagnosis codes, and ICD-10-PCS contains inpatient procedure codes.

Physicians who see only outpatients will not have to deal with ICD-10-PCS; they can continue using Current Procedural Terminology (CPT) codes for outpatient procedures. However, for diagnosis codes, they still will need to transition to ICD-10-CM from the ICD-9 codes currently in use.

The biggest difference between the two sets is the number of codes involved. Because they are more complex and detailed, ICD-10 includes 69,099 diagnosis codes compared with only 14,315 ICD-9 codes.

Although the new codes will not be implemented for another three years, CMS has been updating both the ICD-9 and ICD-10 codes each year to add new diagnoses and procedures and to make other changes.

Physicians thinking about training staff members in using the new codes should plan to start their training anywhere from six to nine months ahead of the 2013 implementation date, said Pat Brooks, senior technical adviser with CMS' Hospital and Ambulatory Policy Group, said during a conference call with providers on Tuesday.