A Medical Device Daily

Stryker (Kalamazoo, Michigan) reported that its Biotech division has received a warning letter from FDA related to quality systems and compliance issues at its Hopkinton, Massachusetts, location.

The warning letter concerns observations made during an inspection that was initiated in September 2007. The letter primarily cites issues relating to Stryker Biotech's handling of a past clinical study, its quality system including medical device reporting procedures, and the integrity of hospital Institutional Review Board (IRB) documentation used to approve implantation of Humanitarian Use Devices.

Several corrective actions and changes to processes put in place by Stryker Biotech were noted in the letter, the company said, adding that future improvements are forthcoming as the division continues to work with FDA.

The company said that no products have been recalled as a result of this warning letter. In addition, it said there were no observations related to any ongoing clinical trials or clinical trial IRBs.

"We take this matter very seriously, will continue to cooperate fully with FDA, and have initiated significant measures to address FDA's concerns," said Stephen MacMillan, president/CEO of Stryker.

In addition to specific corrective actions implemented at the Biotech division, Stryker noted it recently launched a company-wide quality action plan aimed at strengthening corporate-level oversight and at institutionalizing a more consistent implementation of best practices for meeting FDA requirements.

As part of its quality plan, Stryker said it has:

Strengthened roles and responsibilities to increase accountability for quality.

Established new company-wide standard operating procedures for quality processes that will be implemented consistently at each division.

Reorganized quality functions at the plant, division and corporate levels and increased third-party monitoring at all levels.

Tied a significant portion of senior management's compensation to meeting quality improvement measures

"We are committed to strengthening our quality systems to fully meet all FDA requirements. While we have made progress in fulfilling this commitment, we still have more work to do," MacMillan said.

House joins Senate in passing GINA Act

The House of Representatives passed a measure by a whopping 414-to-1 margin that would prohibit health insurers from canceling or denying coverage or hiking premiums based on a genetic predisposition to a specific disease.

Rep. Ron Paul (R-Texas) was the lone dissenter.

The legislation, the Genetic Information Nondiscrimination Act (GINA), also bars employers from using genetic information to hire, fire, promote or make any other employment-related decisions.

Last week, the Senate passed the same measure by a unanimous 95-0 vote and the measure now goes to President George Bush, who is expected to sign it into law (Medical Device Daily, April 28, 2008).

"Since no one is born with perfect genes, we are all potential victims of genetic discrimination. This legislation marks the beginning of a new era in health care where a person's genetic information can no longer be used against them,'" said bill sponsor Rep. Louise Slaughter (D-New York) after the legislation sailed through the House. "By prohibiting the improper use of genetic information, Americans will be encouraged to take advantage of the tremendous life-altering potential of genetic research.''

Slaughter, a microbiologist with a master's degree in public health, introduced the first genetic antidiscrimination legislation 13 years ago.

The House approved the bill last year on a 420-3 vote, but had to reconcile its version with that of the Senate, which inserted changes that attempt to make the bill easier on insurers. The changes were a concession to Sen. Tom Coburn (R-Oklahoma), who had blocked the bill, arguing that it could impose unintended liability risks.

The Senate compromise, worked out last week tightens language to ensure that there is a "firewall" between the part dealing with health plans and the section regarding employment, so as to discourage inappropriate claims.

CMS publishes 2009 payment rates for LTCHs

The Centers for Medicare & Medicaid Services (CMS) published the final regulation establishing rate year (RY) 2009 federal payment rates and policies for long-term care hospitals (LTCHs), a step that it said "ensures that some of the most vulnerable Medicare beneficiaries continue to receive high-quality care from their long-term care hospitals, while helping to ensure the solvency of the Medicare Trust Fund."

The nearly 400 LTCHs across the nation are acute-care hospitals that treat some of Medicare's most severely ill or medically complex patients, CMS noted.

"The policies we are announcing today will help to ensure access to high quality services in an inpatient setting for people with Medicare who are severely ill and who need long-term hospital-level treatment," CMS Acting Administrator Kerry Weems said.

CMS issued a final payment rule for rate year 2009 that increases the standard federal rate for LTCHs by 2.7% from the 2008 rate established by Congress in the Medicare, Medicaid and SCHIP Extension Act of 2007 (MMSEA). That increase establishes a standard federal rate for RY09 of $39,114.36 and is applicable to discharges during the 15-month period from July 1, 2008, through Sept. 30, 2009. Aggregate LTCH PPS payments for RY09 are estimated at about $4.47 billion, under the final rule, an increase of about $110 million over estimated payments in RY08.

LTCHs are generally defined as hospitals with an average Medicare inpatient length of stay greater than 25 days. These hospitals provide extended medical and rehabilitative care for patients with clinically complex conditions, including such services as weaning from ventilators so they can breathe without this assistance, pain management and rehabilitation. The final rule will be posted on the web at www.cms.hhs.gov/LongTermCareHospitalPPS/LTCHPPSRN/list.asp.