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FDA gives green light to remote monitoring in clinical trial
The Federal Drug Administration has approved a clinical drug trial that is unique for two reasons. It used crowd-sourcing, including physicians, for the design of the trial. And it’s using tele-monitoring to track patient data. The FDA granted new drug status to a proposal by drug development company Transparency Life Sciences to conduct a phase II study of the effect of a widely used hypertension drug, lisinopril, in patients with multiple sclerosis. The trial was designed using feedback from an online crowd-sourcing system, the first clinical drug trial of its kind to use crowd-sourcing in its design. “What we aim to do is get physicians involved with the design of these trials more systematically,” said Marc Foster, co-founder and chief operating officer of TLS. The company wants a broader set of ideas when it comes to clinical trial design. It is opening up the process through an online system where both physicians and patients can submit ideas. The company will use [Read more]
Stem cell research center needs overhaul, IOM panel says
An Institute of Medicine review of California’s prominent center for stem cell research found organizational flaws and called for sweeping changes to reduce potential conflicts of interest. The report praised the taxpayer-funded California Institute for Regenerative Medicine for its aggressive pace in awarding grants totaling $1.3 billion to 59 institutions, saying, “CIRM and those it has funded have set in motion a significant scientific enterprise.” However, the IOM found the center’s practices generate concerns about transparency and potential bias that could undermine support for the CIRM. Reviewers found “far too many” CIRM board members represent organizations that were awarded grants or benefited from the grants. The majority of board members should be independent with no conflicting personal or professional interests, the committee said. The CIRM definition of conflict of interest should be retooled to “include non-financial interests, such as the potenti [Read more]
Medicare pay struggle a familiar year-end cliffhanger
Physician organizations are working toward a permanent plan to bring payment stability and higher quality to Medicare, but they have run into a familiar roadblock on Capitol Hill — impending deep payment cuts and no immediate relief in sight. Doctors participating in Medicare again found themselves just days away from a large decrease in pay rates, with Congress working against the clock to craft another temporary solution. At this article’s deadline, no deal had been reached to stop a 26.5% cut under the sustainable growth rate formula even as lawmakers pledged to prevent the decrease before it hits on Jan. 1, 2013. Congress has enacted stopgap legislation to prevent statutory reductions since the last cut took place in 2002. Some pay patches lasting a matter of weeks or a few months have been enacted — and applied retroactively — days or weeks after the cuts technically had taken effect. Virtually no one believes Congress will allow the SGR to lower pay in 2013, but doc [Read more]
CMS innovation center faulted for wasteful duplication
Government investigators report that there appears to be overlap between agencies overseeing health programs and the relatively new Center for Medicare & Medicaid Innovation. The Government Accountability Office found instances in which similar multimillion-dollar programs exist in the Obama administration and urged in a report published on Dec. 21, 2012, that they be coordinated better. The Dept. of Health and Human Services, which oversees the innovation center, has championed the testing of new health care payment and delivery models that could lower federal health spending in the Medicare and Medicaid programs. GAO reviewed the innovation center’s funding and organization as of March 31, 2012. The report detailed the center’s plans for evaluating new models and examined whether there is overlap with activities by the Centers for Medicare & Medicaid Services. The innovation center had hired 184 employees to work in four groups overseeing the testing of 17 models designe [Read more]
Medicaid primary care pay at risk in lame-duck talks
Organized medicine reacted with strong opposition to indications that Congress might eliminate a temporary Medicaid pay increase to primary care physicians as lawmakers deliberate in year-end negotiations on outstanding fiscal issues. In a series of letters to House and Senate leaders on Dec. 5, more than 250 physician associations and state medical societies urged lawmakers to oppose any proposals to eliminate the Affordable Care Act provision that boosts Medicaid primary care rates to Medicare levels in 2013 and 2014. Doing away with the primary care parity policy “further burdens the already challenged Medicaid system of today,” the physician organizations wrote. The letters don’t specify the rationale behind the possible elimination of the pay bump. But some of the signatories said Republican lawmakers were eyeing the move as a way to help pay for preventing a 26.5% Medicare doctor pay cut under the sustainable growth rate formula, or as a general offset for avoiding el [Read more]
Incentive pay prevalence echoes boom in employed physicians
As more physicians opt for employment, annual incentive plans have been on the rise for the last five years, and employment contracts are increasing, according to the Hay Group, a global management consulting firm in Philadelphia. The number of hospitals that use incentive plans increased 23% since 2008, and integrated health care systems jumped from 43% to 61% in the same period. Physician practices went up from 70% to 80%, according to Hay’s 2012 Physician Compensation Survey, which was released in December. The boost in incentive plans is related to more doctors selecting employment with hospitals and groups, said C.J. Bolster, vice president of specialized industry for the Hay Group. Ninety-five percent of the largest health systems use incentive plans, he said. Growth in employment contracts also reflected physicians’ move away from independent practice. Seventy percent of hospital-based physicians had employment contracts in 2012, compared with 64% in 2011, while 67% [Read more]
Scope-of-practice challenge from chiropractors heads back to trial
Texas physicians will have to convince a trial court that a diagnostic procedure called Technological Instrumented Vestibular-Ocular-Nystagmus Testing — or VONT — is beyond chiropractors’ scope of practice. A district court, through summary judgment, earlier had ruled that chiropractors could not perform VONT because it expands their practice beyond what Texas law allows. But the Texas Court of Appeals, 3rd District in Austin reversed that decision in late November, saying it was unclear how VONT is defined. The court said that without that clarity, a trial needs to be held to determine those facts in the case that the Texas Medical Assn. filed against the Texas Board of Chiropractic Examiners. “What procedures are covered by the term, what are the purposes for performing those procedures and what do those procedures reveal about the patient, specifically about the biomechanical condition of the spine or musculoskeletal system?” the court asked in its opinion. The TM [Read more]
Universal EHR to streamline care for active military and vets
The Dept. of Defense and the Dept. of Veterans Affairs are accelerating efforts to link their health information technology systems to coordinate care better for service members as they transition out of the military and into civilian life. Leaders of the departments announced that they are moving toward using a single electronic health record system, for which the technology will be open-sourced and made available for use by other software developers. The integrated EHR will streamline administrative processes and encourage information sharing between the two departments, said VA Secretary Eric Shinseki during a Dec. 6 news conference. “The new program provides a warm handoff from service member to veteran status to ensure all who served are prepared to transition into civilian life and that they have access to VA benefits and services they’ve earned,” Shinseki said. Sharing between the departments with budgets the size of those for some small countries has not been eas [Read more]
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