In July of this year, UPMC got rid of more than half of its board of directors. The explanation was plausible enough: The board had grown unwieldy over time as UPMC took over new hospitals. A consultant advised that a smaller group would be more practical. Twenty-nine board members were invited out. Shortly before this happened, UPMC announced a unilateral divorce from the region's largest insurer, insisting that Highmark's rescue of a much smaller hospital system made it a direct competitor. Without a new contract, many Highmarkers will find UPMC services too expensive. They will have to pay substantially higher out-of-network rates, change insurance companies (as if that were as easy as changing their minds) or seek care elsewhere, and to hell with doctor-patient relationships. Is it a coincidence that the board was so dramatically downsized just as UPMC went to the mattresses? It's not unusual to reduce a board, but then again, if you're going to war, you only want your most trusted lieutenants in the tent.
The outcry among many physicians and patients over a government panel's recent announcement that healthy men should no longer receive P.S.A. blood testing to detect prostate cancer is rooted in a long and impassioned history among cancer screening advocates that early detection must always save lives. But as science has taught us, that?s not always the case. As early as 1913, physicians and laypeople formed the American Society for the Control of Cancer, which later became the American Cancer Society, bearing this hopeful message: ?With early recognition and prompt treatment, the patient?s life may often be saved.? The idea had some scientific basis. ?Delay kills!? posters bluntly warned. But research also emerged that questioned the cancer society?s original assumption that cancer was a local disease that spread in a gradual and orderly fashion. Scientists had found cancer cells in the blood of patients with seemingly tiny, localized cancers, suggesting that cancer cells could spread silently early in the course of disease. In that case, so-called early detection might not really be early, or of much value.
Two federal agencies that usually conduct separate reviews of medical devices, drugs, and biologic tests to determine safety, effectiveness, and whether they merit federal coverage have announced a parallel review for innovative concepts.
"It has come to our attention that innovators have generally focused solely on obtaining FDA [U.S. Food and Drug Administration] approval, only to later realize that Medicare payment may not automatically be forthcoming," says the announcement, published Friday in the Federal Register.
Over the years, regional coverage decisions on certain types of medical equipment – from breast cancer drugs like Avastin to surgical devices like the CyberKnife – have received FDA approval, yet have gained spotty or partial approval from regional Centers for Medicare & Medicaid Services contracting agencies, in a process known as local coverage decision-making. Some FDA-approved products wait years before CMS accumulates enough information to determine whether the technology will or won't be covered.
The pilot program is intended to assure safety and effectiveness while reducing the time between FDA approval or clearance decisions and Medicare's decision to cover the innovation at a national level, the joint announcement says.
"Patients are expected to gain quicker access to innovative medical technologies if they are covered," the agencies say.
Many companies and individuals have commented that they are opposed to the idea, out of concern for sufficient review and an expedient process. But CMS and FDA officials say they intend that the parallel review will "focus attention on health outcomes of importance to Medicare, and provide early awareness of any remaining evidence gaps." If there are gaps, the CMS may implement an evidence development policy, covering the device only within certain parameters of a post-approval study.
"The parallel review program has the potential to increase patient access to innovative devices that improve clinical outcomes," Patrick Conway, MD, CMS' chief medical officer, says in a statement. Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, adds that the program will make the process work "efficiently for expedient patient access to safe and effective medical devices."
The pilot program will last up to two years and will accept no more than three to five submissions per year. The emphasis will initially be on medical devices but the agencies say they will use the experience to develop similar pilots for drugs and biologics. Eventually, the agencies hope the program will "inform guidance for a broader program applicable to all medical products."
The announcement comes one year after the FDA and CMS announced their intention to implement the review process. But several individuals and companies have posted comments on Regulations.gov that the parallel review was necessary, and that changing the process in fact may slow down reviews.
For example, Genentech's vice president of government affairs, Evan L. Morris, wrote: "if CMS requires data for its review that are not required in the FDA clearance or approval process, the manufacturer might be required to submit additional data that could prolong the parallel review process as well as potentially requiring both the manufacturer and the Agencies to devote more resources to the review than was originally anticipated."
Officials for the Blue Cross and Blue Shield Association also worried about unintended consequences. "We urge that any change to FDA or CMS review of new technologies maintains meticulous attention to the scientific evidence supporting a product as well as the item’s impact on patient outcomes and clinical safety," wrote Allan M. Korn, MD, senior vice president and Justine Handelman, vice president of legislative and regulatory policy for BCBSA.
"Failure to do so would not only put individual patients at unnecessary risk, but also put the entire healthcare system at risk of continued, unsustainable cost increases that result in part from ineffective treatments or inadequate consideration of the comparative clinical effectiveness of new technologies."
Korn and Handelman added that they are aware of "numerous instances where the science supporting new devices cleared by the FDA did not also demonstrate improved clinical benefit or safety relative to existing covered products. In light of this, the establishment of parallel review must not allow a foregone conclusion that products evaluated through parallel review will be covered by Medicare if cleared for market by the FDA. Whether operating sequentially or in parallel, the two agencies must be able to draw independent conclusions based on their independent statutory authorities and the strength of the scientific evidence before them."
Raj D. Rao, professor of orthopedic surgery and neurosurgery and director of spine surgery at Medical College Physicians in Milwaukee, wrote, "The FDA looks at device safety and effectiveness with no consideration as to its cost, whereas CMS must take the financial element into account with its decisions. While this is somewhat of an obvious statement, it is difficult to harmonize in combining the different perspectives of FDA and CMS.
"It appears to me that the current process is working well as is," Rao wrote. The FDA should initially review and approve products for their scientific merit. After the product has been in use by the community for a couple of years, it is likely that more efficacy studies will be available, from users other than the industry-sponsored physicians."
Rhode Island Gov. Lincoln D. Chafee, other state politicians, education and hospital executives, and business and labor leaders were in Pittsburgh last week hoping to learn how they might transform the Ocean State?s faltering economy. They toured a downtown building where the University of Pittsburgh Medical Center leases about a third of the 2-million-square-feet of space. UPMC's President/CEO Jeffrey A. Romoff told the delegation at the start of a tour of the massive facility that when the nonprofit medical center relocated its headquarters into vacant space at the top of the building (and emblazoned its initials on the outside of the tower), the building's occupancy rate shot up to 95%, which Romoff said contributed to the turnaround of an "OK downtown" into a thriving area. When Chafee said he was particularly interested in learning how the nonprofit medical center overtook the for-profit industry. And, turning to Providence Mayor Angel Taveras, Chafee said he's particularly interested in how the host city has been compensated. "You're going right to the jugular," acknowledged G. Nicholas Beckwith III, chairman of the UPMC board of directors.
Independent hospitals—the local stalwarts that birth babies, handle heart attacks and support Little League teams, too—are facing hard times. The new healthcare law will demand more of every hospital, including expensive records systems and more attention to quality care, and meanwhile both the government and private insurers want hospitals to be more efficient. Those demands will make it difficult for many independent hospitals to remain independent. Statewide, about two in five hospitals are losing money. But quite the opposite holds true for hospitals that are part of a larger network, whether a for-profit chain or a local nonprofit system. Many turned in strong financial performances in 2010, according to a review by The Atlanta Journal-Constitution. Piedmont Hospital, for example, enjoyed its best profit margin of the decade in 2010. The five-hospital WellStar Health System's profit margin last year was double that of 2007. Smaller systems and standalone community hospitals, however, struggled to show a modest profit or just to break even.
Athol Memorial Hospital made headlines recently when it was ranked one of the best hospitals in the country by The Joint Commission, a nonprofit hospital accreditation organization, joining five other Massachusetts institutions. "I think we showed that, along with a lot of other small hospitals in the country, that we do really good quality care," said Athol Memorial President and CEO Steve Penka. The 25-bed hospital intends to remain small, but not independent. It's in the process of being acquired by Vanguard Health Systems, the owner of Saint Vincent Hospital in Worcester and MetroWest Medical Center in Framingham and Natick. That will mean becoming a for-profit hospital, assuming the change meets with state approval. But Penka said the acquisition won't hamper its ability to provide excellent care. Athol Memorial announced its intention to join Vanguard in March 2010. Penka said the two parties are now working under a letter of intent —which is being kept private—and going through a due diligence process.