Real Endpoints would like to congratulate our intern, Halleh Balch, on her graduation from Swarthmore College. We expect great things from Halleh in the years to come; she is one to watch!
PSA: To test – or not to test. The big news this week was the United States Preventative Services Task Force’s decision to downgrade the necessity prostate-specific antigen test. After reviewing two large studies, the task force’s working group decided the PSA test, which is designed to flag prostate cancers early, does more harm than good, leading to overdiagnosis and increased treatment risks rather than improved outcomes. According to the USPSTF’s findings, between 1986 and 2005 an estimated one million men received surgery, radiation therapy or both thanks to findings of the PSA test. Of these, at least 5000 died soon after surgery and between 10,000 and 70,000 had serious complications, while another 200,000 to 300,000 suffered impotence. And while the task force is officially recommending against the test, the group seems to have learned something from the mammogram debacle. If patients and doctors feel the test is necessary, it should be performed, as long as there is an “informed “ discussion about the possible benefits and harms. Many, including Matt Farber, the director of the economics and public policy at the Association of Community Cancer Centers and Otis Brawley, CMO of the American Cancer Society, are doubtful the new recommendation will alter clinical practice. That’s because most urologists have come out in full force against the recommendation and prominent prostate cancer survivors like baseball’s Joe Torre, financier Michael Milliken, and former NYC mayor Rudy Guiliani have also promised to fight the recommendation. What will payers do? Here many are looking to Medicare, which has an opportunity to lead by not covering PSA tests for patients who are 75 years or older, where there are considerable data showing PSA isn’t good enough to detect which prostate cancers are dangerous or not. But it’s unlikely CMS will come out that forcefully: the Obama administration has already said Medicare will continue to pay for PSA screenings. For more on the controversy, here’s a short list of sources. – Halleh Balch & Ellen Licking
- The Annals of Internal Medicine provides a summary for patients on the controversy.
- Dr. Kevin Pho argues that the USPSTF should use individual stories—not just statistics—to change medical practice.
- You can find NPR’s coverage of the decision and the potential impact on medical practice here and here.
- A write-up by Huffington Post is here.
- Matt Farber’s treatment of the subject is here.
ACOs: Emerging models and unusual bedfellows. The reports on accountable care organizations just keep coming. The consulting firm Milliman has published a white paper comparison of the Medicare Shared Savings Program programs and the Pioneer Accountable Care Organizations, which outlined both the principles behind the alternative payment models developed by the Center for Medicare and Medicaid Innovation and the Patient Protection and Affordable Care Act. The paper compares six main territories of reimbursement policy: payment arrangements, beneficiaries, interim payment methods, and a calculation of shared savings or losses. The MSSP was set up to encourage the development of ACOs and patient care will be monitored by CMS with respect to quality, data transfer, and coverage eligibility. The Pioneer ACO program, meantime, evaluates alternative payment models to test how well ACOs versus other cost-containment programs fare in providing coordinated, high quality care at a reduced cost. The Milliman report notes that the Pioneer program provides greater potential rewards while carrying more risk. Still, that risk has been enough to deter many physicians, who are skeptical of the ACO model, according to a Medscape survey released this month. Meantime the push to provide more cost-effective care has triggered a wave of mergers, particularly as payers buy up physician practices to gain expertise in care delivery.
This week’s merger between DaVita, one of the biggest US operators of dialysis clinics, and HealthCare Partners, which operates physician practices, highlighted the trend. It also shows how forward-thinking service providers are trying to get in on the ACO act. DaVita, of course, has already had to adapt its business model with the adoption by CMS of bundled programs to treat end-stage renal disease patients. It’s extending that knowledge via HealthCare Partners, which has more than 50 medical offices and 550,000 patients across Southern California and is recognized as a leader in coordinated patient care. As the WSJ points out HealthCare Partners gets much of its payment in so-called capitated flat fees, and as such, has learned to implement patient treatment practices that emphasize efficiency. Still for many, the deal was a jarring reminder that the pressures of health care reform can result in unexpected partnerships. Glenn Melnick, a Rand Corp. health economist and professor at USC told the LA Times DaVita’s participation “comes out of left field.” – HB & EL
- The CMO of DaVita weighs in on the importance of integrated care in kidney disease at his blog.
- The LA Times covers the DaVita/HealthCare Partners merger here.
- Reuters outlines DaVita’s new healthcare model here.
Using REMS to block generic drugs. News broke this week in the Washington Post that the FTC and Senate are investigating whether pharmaceutical companies are using a loophole tied to the use of Risk Evaluation Mitigation Strategies (REMS) to prevent generic drug makers from obtaining samples of brand name drugs. FTC chairman Jon Leibowitz described this type of practice as “particularly troubling.” What’s the link between REMS and anti-competitive behavior? To bring a generic to market, a generic company has to conduct bioequivalence studies of its product and the brand-name version, demonstrating that the two compounds are identical in efficacy and safety. And REMS, a drug safety program created by the FDAAA act of 2007, allows for the approval of riskier medicines—some come with significant side-effects, while others are prone to abuse—provided the drug manufacturer restricts their distribution via specific commercial channels. In other words, under the restricted distribution mandated by a REMS, a generic drug maker can’t purchase drugs via normal channels; so if a branded manufacturer refuses to provide the medicine, it can delay—or stop altogether—development of a generic version. The potential for drug makers to hide behind REMS to prevent generic competition has been a concern from the get-go; as this recent article in The RPM Report outlines (in addition to flagging the potential for an FTC probe), provisions in FDAA include a provision to prevent this behavior, but the language is vague and difficult to enforce. Buried within the new Prescription Drug User Fee Act passed this week by the Senate is a clause to close the loophole. That bill passed with wide bipartisan support; the House version of the bill does not, however, include this provision. –HB & EL
- Read the article from the Washington Post here.
- The RPM article on the potential anti-competitive use of REMS is here. (Sub req.)
- Senate bill aims to increase drug import safety (Huffington Post).
- Politico’s treatment of the PDUFA passage is here.
Wait, there’s an “app” for that? We give Pfizer a lot of credit for thinking outside the pharmaceutical marketing box and embracing mobile health marketing tools. The big pharma giant is launching a marketing tour-de-force that fits in the palm of your hand. In a partnership with Meredith Corp.’s Eating Well magazine, Pfizer is publishing a Lipitor For You Recipes 2 Go “app” that offers consumers resources to manage heart health via their smart phones. The app includes recipes, shopping lists, and tips on portion sizes and exercise. But here’s the good part: when consumers download the app, they also receive a $4 Lipitor co-pay card to help cut costs on their next prescription refill. Co-pay cards are a hot-button issue; in March, Community Catalyst filed suit against 8 drug companies seeking to ban the use of co-pay cards on behalf of unions that provide drug benefits for civilian and uniformed municipal workers in New York City, carpenters in New England, and plumbers in various states. Late last year, the Pharmaceutical Care Management Association, the leading trade group representing PBMs, published a white paper claiming co-pay card could increase prescription drug costs by more than $32 billion over the next decade. –HB
- MediaPost covered the Lipitor/EatingWell app here.
Think inside the “BUN”dle. You might remember our prior coverage on bundled payment systems for knee replacements and how studies show paying a fixed, predetermined fee for such an episode-of-care can result in lower healthcare costs. This week comes news that Blue Cross Blue Shield of Tennessee has joined forces with four of that state’s most highly regarded orthopedic practices to implement a bundled payment system for total knee and hip replacements, which average between $25,000 and $35,000. The new approach will focus on patient care, quality, and outcomes, and the set payment includes the costs associated with surgery, post-care, and physical therapy. In order to improve quality of care, Blue Cross Blue Shield of Tennessee will collect data to identify—and then work to standardize—variations in care. As a result, the episode-of-care pilots can be used to capture real-time comparative effectiveness information for different care regimens. Of course, costs associated with procedures (be they knee replacements or angioplasty) are relatively easy to capture and thus bundle together in an episode. It’s much harder to develop bundles that work in the chronic care setting, especially oncology. Still that hasn’t stopped executives from either United HealthCare or Priority Health from devising models that attempt to disrupt the linkage between drug selection and physician reimbursement that was an unintended consequence of the Medicare Modernization Act. In both cases, the two payers have created a system that pays drugs “at cost”, not the typical average sale price plus 6% fee owed under the current model. Since a case management fee replaces the income lost by the elimination of the drug margin, physicians aren’t taking a tremendous financial risk adopting the program. Six physican groups are participating in the United pilot, which got underway in 2010. Data are expected to be published later this year, while a recent HealthAffairs story explains how the model works. –EL
- Read Blue Cross Blue Shield’s announcement here.
- The Nashville Post’s treatment of the BCBS decision is here.
- For more on United Healthcare’s model read this recent Health Affairs piece (Sub required).
Image courtesy of the Scott Arboreteum at Swarthmore College (which also happens to be Ellen’s alma mater.)