Healthcare science has moved rather far away from the “first, do no harm” standard for the delivery of therapy to patients. The newest science contends that there are no benefits without a certain number of risks. But the industry as a whole — and, perhaps, more importantly and significantly, the FDA — hasn’t done a very good job of communicating this to patients, many believe.
Such a statement is best supported by noting the need to attach “black box” warnings to many drugs that are considered safe — but only after careful patient selection and the close conformance to label directions; the recall of drugs often based on the broad ignoring of label guidance; and the general failure of patients to focus on potential risks. Additionally, recent recalls of devices have been accompanied by considerable confusion concerning how to “recall” implantable devices such as pacemakers and defibrillators. Other actions, such as simply warnings or highlighting of risks has resulted in broad confusion: What are the actual clinical implications of these warnings and how much, if any, of this information should be communicated patients?
Thus, the FDA in June said that it would form an advisory committee with the job of providing it counsel on, as it put it, “how to strengthen the communication of risks and benefits of FDA-regulated products to the public. Called the Risk Communication Advisory Committee, (interestingly, the word “benefits” not used in the committee’s name) the group has several goals:
• help the agency to better understand the communication needs and priorities of the general public;
• advise the agency on the development of strategic plans to communicate product risks and benefits;
• and make recommendations to the agency on what current research suggests about crafting risk and benefit messages, as well as how to most effectively communicate specific product information to vulnerable audiences.
The need to develop new messages and message channels concerning product defects is not mentioned here, but the sharpening of messages and means for communicating recall information is certainly embedded in the key needs and priorities for the general public/patients. But it is clear that drug information will be high-profile for the committee, given the recent spate of recalls of drugs and criticisms of the FDA either for approving these products or not puling them earlier (or both). More broadly is the issue of communicating more clearly the risks to some, when, overall, benefits are very large for very many.
Randall Lutter, PhD, FDA’s acting deputy commissioner for policy, said, “The Risk Communication Advisory Committee will bring together a broad range of experts and views to help improve FDA’s communication of the science-based information about product risks and benefits that the public needs to make informed decisions.”
The FDA said that the establishment of the advisory group “stems from the 2006 report of the Institute of Medicine (IOM; Washington), ‘The Future of Drug Safety: Promoting and Protecting the Health of the Public.’”
The IOM report recommended that Congress enact legislation establishing a new advisory committee to address how FDA communicates information about the efficacy, safety and use of drugs and other FDA-regulated medical products. FDA said that it “agreed with the value of such a committee and acted promptly to establish it through more speedy administrative procedures.”
Importantly, it said it also expanded the scope of the committee to cover “communication of risks and benefits of all products regulated by the agency.”
The committee will be made up of 15 voting members that include experts and public members who are not affiliated with the FDA. Experts will include authorities knowledgeable in the fields of risk communication, social marketing, health literacy, cultural competency, journalism, bioethics, and other relevant behavioral and social sciences. Public members will include those who can provide the perspective of users of FDA-regulated products, such as consumers, patients, caregivers and health professionals.
MedPAC suggests less rigid rules for rehab facility PPS
The Centers for Medicare & Medicaid Services published its proposed rule for prospective payment for inpatient rehabilitation facilities (IRFs) last month and is sorting through the feedback, including a letter from the Medicare Payment Advisory Commission (MedPAC). The CMS payment rule covers discharges from facilities for FY08, and would boost total payments by about $150 million to roughly $6.3 billion. According to CMS estimates, slightly more than 1,200 IRFs will receive payments next fiscal year.
CMS Administrator Leslie Norwalk said in a statement that the rule “continues Medicare’s commitment to support access to inpatient rehabilitation facility services while at the same time improving the appropriateness and consistency of payment for beneficiary care in all post acute settings.”
The rule would keep CMS on track for phase-in of the 75% rule, which requires that at least three-fourths of an IRF’s total inpatient population have one of the 13 medical conditions that CMS has designated for intensive inpatient rehabilitation services. This rule came into being in 1983 along with a rule that eliminated cost as a basis for payment, but according to the CMS press release, “the IRF PPS provides higher payment levels than would be paid for these cases under the [hospital] IPPS, thus the need to continue this important classification initiative.” In 2003, CMS suspended the 75% threshold for a 65% setting for three years.
One feature of the 75% rule that has industry most abuzz is a rule that deals with a set of co-morbidities that have qualified patients under the 75% rule for the past few years, even if that patient does not have one of the 13 conditions. This provision is scheduled to sunset Jan. 1, 2008, and CMS has expressed little interest in extending the exception.
As for payment numbers, the agency has reviewed data from FY 2005 and is proposing to sharply increase the high-cost threshold, from slightly more than $5,500 to roughly $7,500, but to tighten the numbers of patients whose care would qualify. CMS said this move “would maintain estimated payments at 3% of total payments under the IRF PPS.” A lower threshold would “require an across-the-board reduction in the base payment for an IRF stay” to achieve budget neutrality, according to the CMS statement.
In a June 11 letter to Norwalk, Glen Hackbarth, chairman of MedPAC, said commission members have “been supportive of CMS’s efforts to clinically distinguish IRFs from other Medicare providers” in part because of the high cost of operating an IRF, but he described the 75% rule as “a blunt instrument.” He saidd that MedPAC favors a less stringent approach to patients who do not qualify under the 13 conditions, but who nonetheless “may benefit from the level of rehabilitation that only an IRF can provide.” Hackbarth recommended that CMS “periodically revisit the list of diagnoses” with an eye toward “moving away from simple diagnosis-based criteria to more specific patient-based criteria.”
The health subcommittee of the House Ways and Means Committee hosted a hearing to assess strategies to boost comparative effectiveness data, drawing a list of witnesses that included Carolyn Clancy, MD, the director of the Agency for Healthcare Research and Quality (AHRQ), and Mark Miller, the executive director of MedPAC. As Clancy pointed out in her written testimony, the amazing amount of medical research in the modern world has made it difficult “to evaluate these innovations and determine which represent added value, which offer minimal enhancements to current choices, which fail to reach their potential, and which work for some patients and not for others.”
Miller was quicker to the point. “There is not enough comparative-effectiveness information available to patients, providers and payers to make informed treatment decisions,” he said. On behalf of MedPAC, Miller suggested that Congress form an independent entity to “sponsor credible research on the comparative effectiveness of healthcare services and disseminate this information.”
MedPAC also recommended an independent entity with a secure source of funding that would “sponsor studies that compare” treatments, which in some cases might consist of analysis of existing studies. Miller said that “the Commission prefers a public-private” partnership for staffing such a body, with funding at least in part by the public sector.
“We emphasize that the entity would not have a role in how payers apply this information,” Miller noted.
CMS suspends some PFFS marketing to weed out ‘bad actors’
The Centers for Medicare and Medicaid Services reported that because of concerns about marketing practices, seven healthcare sponsors have signed an agreement to suspend the marketing of Private-Fee-For-Service (PFFS) plans. CMS said that any suspension of a given plan will be lifted only until the systems and management controls in place meet all of the conditions in a call letter and guidance that it issued May 25.
The signatories are: United Healthcare, Humana, Wellcare, Universal American Financial Corporation (Pyramid), Coventry, Sterling, and Blue Cross/Blue Shield of Tennessee.
Leslie Norwalk, acting administrator of CMS, said that while most health insurance agents are helpful and responsible in describing and explaining choices to beneficiaries, there are a few bad actors that need to be removed from the system for good.”
She said that the agreement “demonstrates that CMS and the plans are stepping up to ensure that deceptive marketing practices end immediately, and that beneficiaries understand what they are purchasing. Through a variety of methods, including our ‘secret shopper’ program... CMS is proactive in protecting beneficiaries from rogue agents. Although the 2,700 agent complaints we logged from December 2006 to April 2007 represent less than one-half of 1% of the 1.3 million members enrolled in individual PFFS plans, we can always do better.”
The agreement will continue to apply to individual plans until they have demonstrated that they have systems and management controls in place to ensure that they can meet all the CMS requirements. CMS said that any such review will begin “as soon as plans indicate they are ready.”
Plans signing the agreement will be monitored and violations will be subject to penalties such as suspension of enrollment, suspension of payment for new enrollees, civil-monetary penalties and termination of a plan’s involvement in Medicare. The updated conditions will be in effect for all sponsors of PFFS plans beginning Oct. 1, and violations of those conditions will be subject to the same types of penalties.
FDA releases guidance to reclassify fusion devices
FDA has released its guidance for its reclassification of intervertebral body fusion devices with bone graft materials from class III, which requires a PMA, to Class II, a 510(k) category with special controls. However, FDA is keeping such devices that contain therapeutic biologics, such as morphogenic proteins, in the Class III bin. FDA published the draft in February 2006 and said it took in a dozen comments. Two of those comments were on the subject of device sterilization and testing, which the announcement in the Federal Register says prompted the agency to “update the guidance to clarify its recommendations about these two topics.”
On the topic of sterilization, the guidance recommends that the device “should be sterile with a sterility assurance level (SAL) of 1 x 10-6” that is validated per the Quality Systems Regulation. If the manufacturer intends to ship the device minus sterilization “for subsequent sterilization in a healthcare facility, you should provide clear and adequate instructions for sterilization,” and clearly indicate on the label that the device is not sterile.
As for testing, the agency suggests that “you test constructs comprised of components that are of the worst case (e.g., most likely to fail) final design version” and provide a rationale for selecting that construct. All components, metallic or otherwise, should be tested after sterilization if there is a chance those components would be affected by sterilization.
Test reports should include data on tests for static and dynamic torsion testing for cervical fusion devices, static and dynamic axial compression and compression shear testing for both lumbar and cervical devices, and subsidence testing for both types.
The agency cautions, however, that it might want to see additional tests for a design that makes use of polymer composites and for some designs and methods of attachment.
HHS to create advisory group to focus on agents used in bioterror
Mike Leavitt, secretary of U.S. Health and Services, has reported the establishment of a public health advisory panel concerned with chemical, biological, nuclear or radiological agents. The National Biodefense Science Board will give the Secretary guidance on preventing, preparing for, and responding to release of such agents, whether they are naturally occurring, accidental, or deliberate.
The board, which was authorized by the Pandemic and All-Hazards Preparedness Act, will advise the secretary about trends, challenges and opportunities in the field. At the secretary’s request, it will also provide recommendations for research and development.
“Planning responses to incidents involving chemical, biological, nuclear or radiological agents requires state of the art science,” Leavitt said. “This new advisory board will add a wide range of expertise and viewpoints from outside of government to help inform HHS decision-making processes.”
Board members are yet to be selected. There will be 13 members, appointed by the secretary, from among leading experts in science, public health and medicine. Four will be from the pharmaceutical, biotechnology and device industries. Four will be from academic institutions. Of the remaining five, one must be from an organization representing health care consumers and one must be a practicing health care professional. The Secretary also will appoint federal officials to support the board’s functions.