In the News for the Week of 5-2-06
Clinical news in the headlines
- Annals: gastric banding; patient care ratings; EMS do-not-resuscitate guidelines
- Studies prompt more calls for defibrillator monitoring
Medicare Part D
- Policy protects beneficiaries from formulary changes
- New one-time Part D enrollment for low-income beneficiaries
- Aetna and Cigna to pay physicians for Web visits
- CCHIT publishes certification criteria for electronic health records
Access to care
- Middle-class patients swell ranks of uninsured
- CMS releases electronic version of "E/M Services Guide"
- Pretest MKSAP 14 questions and qualify for free products
- College adopts new policy on personal health records
Clinical news in the headlines
The following articles appear in the May 2 issue of Annals of Internal Medicine. Full text is available to College members and subscribers online.
Gastric banding effective for mild to moderate obesity. Researchers randomly assigned 80 moderately obese patients to laparoscopic gastric banding or to a nonsurgical program involving very low-calorie diets, weight loss drugs and counseling.
At six months, both groups lost 13.8% of initial weight. At 24 months, patients with gastric banding had lost an average of 21.6% of initial body weight, compared to 5.5% in the nonsurgical group.
The Australian authors, who had financial ties to the adjustable gastric bands manufacturer, noted that the surgeons in the study had performed several hundred procedures and were experienced in providing follow-up and adjustment. They also pointed out that neither primary care providers nor patients should overlook the positive benefits of a 5% to 10% weight loss that can be achieved with lifestyle modifications.
An accompanying editorial noted that the surgery was performed on mild to moderately obese people for whom current weight-loss recommendations do not include surgery.
Patient ratings not good markers of technical health care quality. Many health systems conduct patient satisfaction surveys or care ratings to assess the care patients receive. But a new study of 236 frail and elderly adults living independently found that their ratings of global care quality were not significantly associated with the technical quality of their care.
Researchers found that for these elderly patients, the overall high rating of care directly correlated with high ratings for interpersonal communication with health care providers. However, the ratings did not correlate with 207 technical quality of care indicators for 22 clinical conditions. Those indicators were established by the Assessing Care of Vulnerable Elders (ACOVE) project (a collaboration between RAND Corp. and Pfizer to create a quality-of-care assessment system for older persons) and by Regenstrief Institute, a health care research organization based in Indianapolis.
Study examines EMS resuscitation guidelines. Researchers studied 35 emergency medical service (EMS) agencies in which 16 volunteered to implement new guidelines to withhold resuscitation if patients were terminally ill and if the patient, family or a caregiver said in writing or verbally that no resuscitation was desired.
Previous guidelines did not permit EMS personnel to withhold resuscitation at the end of life, particularly if there was no written do-not- resuscitate order.
During the two-year study period, personnel from the 16 agencies withheld resuscitation in 11.8% of patients having cardiac arrests, compared with an average of 5.3% of patients in control groups. Most—53%—of the withheld resuscitations came from honoring verbal requests.
An editorial noted that guidelines such as those in the study provide a “welcome alternative” to current guidelines to always resuscitate, which can lead to unnecessary and unwanted suffering at the end of life. However, the editorial pointed out that the study raises practical concerns, such as whether EMS personnel run the risk of agreeing to duplicitous family requests, or whether on-the-spot decisions have legal protection.
A study released last week highlights the difficulties physicians and patients face in deciding whether and when to replace recalled implantable cardioverter defibrillators (ICDs) and the need for timely, unbiased safety information.
The study, published in the April 26 Journal of the American Medical Association (JAMA), assessed complication rates as a result of generator replacements due to ICD advisories at 17 Canadian sites between October 2004 and October 2005.
Among the almost 3,000 patients who had recalled devices, 533 had replacements implanted and 43 (8.1%) experienced complications. Of those, 31 (5.8%) were major complications including two deaths from infection, 12 (2.3%) were minor complications and three (0.1%) had technical device malfunctions with no clinical consequences.
The study illustrates the complexities surrounding whether to conduct surgery in the event of a recall, an accompanying editorial pointed out. The authors noted that replacement in response to an advisory may not always be the best option, especially in cases where the risk of device failure is less than the risks associated with replacement.
This study, along with two related studies in the same JAMA issue, also found that device malfunction is not rare, the editorial continued. Data show that the average rate of ICD device malfunction severe enough to require replacement was almost 21 per 1,000 new implants between 1990 and 2002.
In response to the ICD controversy, the Heart Rhythm Society (HRS), a professional group representing cardiac pacing and electrophysiology specialists, released a set of proposed recommendations on performance issues and advisories, according to an April 26 HRS news release.
The recommendations urge manufacturers to expand wireless and remote monitoring technologies to identify abnormal devices earlier; establish independent committees of outside experts to analyze performance and recommend action; and communicate directly with patients regarding malfunctions.
The recommendations also ask the FDA to enhance existing databases to more readily identify potentially unsafe devices and to establish a post-marketing surveillance advisory panel of independent expert advisors, the HRS release said. The group also advised physicians to consider the risks of re-implantation when deciding whether to respond to an ICD advisory notice.
The New York Times is online.
The Heart Rhythm Society news release is online.
Medicare Part D
The CMS last week announced a new policy aimed at protecting Medicare beneficiaries from losing coverage when their medications are removed from their insurer’s formulary.
Under the ruling, when an insurer drops any drug from its formulary or imposes new restrictions, it must exempt beneficiaries currently taking those medications, said the April 27 New York Times. The policy allows beneficiaries to continue with the same medication for the remainder of the plan year, at which time they can switch plans during the open enrollment period.
The decision addresses criticisms that the Medicare drug benefit allowed insurers to unfairly change formularies at any time even though beneficiaries are locked into one plan for a full year, said the New York Times. The CMS now says that no beneficiary will lose coverage during the plan year except under certain circumstances, such as if a drug is removed due to safety concerns or when a cheaper generic equivalent comes on the market.
The ruling was made just three weeks before the May 15 sign-up deadline for Medicare Part D, the article said. Those who do not sign up by the deadline will have to wait until open enrollment in November and face higher premiums. About 40 drug plans offering different premiums, co-payments and deductibles are available in most states.
The recently released formulary policy guidelines continue to require CMS approval and at least 60 days notice to “affected enrollees” for any formulary change implemented by the drug plan.
The New York Times is online.
For more on Part D, see "Part D hopes and hassles begin to play out" in the May ACP Observer.
New one-time Part D enrollment for low-income beneficiaries
The CMS has announced the creation of a new one-time Part D enrollment opportunity for Medicare beneficiaries who qualify for the limited-income subsidy.
This new opportunity—which will extend beyond the current May 15, 2006, enrollment deadline—will allow current Medicare beneficiaries who miss that deadline to subsequently apply for the low-income subsidy and, if eligible, enroll in a Part D drug plan without accruing a premium penalty.
This one-time enrollment opportunity requires qualified individuals to enroll in a Medicare prescription drug plan right after they find they are eligible for the limited-income subsidy. Beneficiaries can qualify for the limited-income subsidy with incomes at or below 150% of the federal poverty level ($14,355 for an individual, $19,245 for a married couple) and with limited assets.
While this does not extend the initial enrollment period, it does allow beneficiaries who are newly qualified for the limited-income subsidy a one-time opportunity to enroll when they qualify.
Beneficiaries can apply for the subsidy through Social Security at 800-772-1213 or online . Applications can also be obtained at local state Medicaid offices.
Two major health insurers announced separately last month that they will begin paying physicians to conduct online consultations on non-urgent problems.
According to an April 4 Aetna news release, Aetna Inc., based in Hartford, Conn., will begin reimbursing physicians in California and Florida this week for physician-patient “webVisits.” Those webVisits will be conducted via software provided by the Emeryville, Calif.-based RelayHealth, a provider of online health care communication services. The benefit will apply to all primary care physicians of fully insured members as well as to Aetna members employed by self-insured companies in the participating states.
The service provided by RelayHealth is more secure than e-mail, the Aetna release noted, because RelayHealth uses a single, centrally-managed database for physician-patient communications.
Bloomfield, Conn.-based Cigna HealthCare, which has also partnered with RelayHealth, plans to offer a similar benefit starting in July for California members employed by Silicon Valley companies Cisco Systems Inc. and Intel Corp., said an April 4 company news release. The service, slated to be rolled out to all California members as well as members in Arizona, Florida and New York in 2007, will include online doctor visits, prescription refills and renewals, laboratory results and review, and appointment scheduling.
According to the May 1 AMNews, physicians will be reimbursed between $25 and $35 per online visit. Participating physicians must also pay a monthly fee to use the RelayHealth software.
The Aetna news release is online.
The Cigna news release is online.
AMNews is online (subscription required).
A national information technology certifying group has posted its certification criteria to certify ambulatory electronic health record (EHR) products and will start taking applications from EHR vendors this week.
Vendors can apply May 3-12 for certification to the Certification Commission for Healthcare Information Technology (CCHIT), according to an April 26 CCHIT news release. Product tests will be observed by a panel of jurors, including a physician and IT security expert. CCHIT is expected to announce the first list of certified products in early July.
"This is an important development for physicians practicing in ambulatory settings," said John Tooker, FACP, the College's CEO and Executive Vice President, who serves on the Commission. "It will assist physicians considering an electronic health record system in making an informed purchasing decision, and will ultimately contribute to the provision of quality, efficient patient care."
Applicants can access the final approved certification criteria, test scripts, handbook and sample contract on the CCHIT Web site.
A copy of the CCHIT press release is also available online.
Access to care
A survey released last week found that middle-income earners make up an increasing proportion of the nation’s uninsured population.
Of the estimated 48 million uninsured over the past year, 67% were in families with one working adult, according to the Commonwealth Fund’s Biennial Health Insurance Survey. The survey, conducted between August 2005 and January 2006, also found that one in five adults under age 65 were paying off debt from medical bills and that many chronically ill people were skipping medications due to cost.
Other survey highlights include:
- 41% of adults with incomes between $20,000 and $40,000 were uninsured for all or part of last year, compared with 28% in 2001.
- Adults with incomes under $20,000 made up 53% of the uninsured.
- More than half of uninsured adults reported problems with medical debt and many of those adults either used up their savings to pay off the debt or were unable to pay for necessities such as rent and food.
- Almost 60% of uninsured adults with chronic illnesses such as diabetes did not fill a prescription or skipped medications due to cost.
- Only 18% of uninsured adults age 50-64 had a colon cancer screening in the past five years while 48% of uninsured women age 50-64 had a mammogram in the past two years.
An executive summary of the Commonwealth Fund survey is online.
The CMS last week released an electronic version of its "Evaluation and Management Services Guide."
Most of the 32-page document is devoted to a tool to assist physicians in selecting the appropriate level of evaluation and management (E/M) code. There is also information on selecting the appropriate diagnosis code and guidelines for teaching physicians. The guide includes information on medical record documentation, E/M service guidelines for residents, and ICD-9 codes and AMA CPT codes.
The complete guide is online.
The CMS offers other tools on its online medical learning network.
ACP is looking for physicians willing to complete tests related to the new 14th edition of the Medical Knowledge Self-Assessment Program (MKSAP) by May 24, 2006. Participants may submit up to four pretests to receive up to four selected MKSAP products at no charge (one product per pretest).
The results of the pretests will provide data that MKSAP 14 subscribers can use to compare their performance to that of their peers. The advance test results will be published in MKSAP 14’s performance interpretation guidelines with norm tables in December 2008.
A limited number of physicians will be enrolled in this time-limited pretest program. Test takers can choose rewards including MKSAP 14 Online, MKSAP 14 Self-Assessment Updates, Prep for Boards 2 and MKSAP 13 Update.
More information and the free pretesting kit are available on ACP Online.
MKSAP 14 is also available at a special pre-publication discount. Between now and July 31, 2006, pre-order MKSAP 14 and save 10%.
At its April meeting, the Board of Regents approved a new policy statement regarding the use of personal health records (PHRs).
PHRs allow patients to partner with their health care providers to maintain a record of important health-related information. A PHR can include any information related to a patient’s health, including traditional health records information, as well as information a physician may not normally know, such as a patient's exercise routines or dietary habits.
According to the new policy, ACP supports the use of PHRs as a mechanism to create patient-centric repositories of clinical information—as long as the information contained in the PHRs remains secure and adheres to current privacy and security standards. The policy recommends features that should be included in PHRs and spells out physician responsibilities. It also states that physicians should be paid for time spent creating, updating and reviewing a PHR.
The policy statement can be found online.
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Copyright 2006 by the American College of Physicians.
A 30-year-old woman is evaluated for difficult-to-treat migraine. She has had severe headaches, usually on the first day of menses, since menarche. The pain is hemicranial, pulsatile, and associated with severe nausea and vomiting but no aura. She frequently awakens with the attack already in progress. A series of drug regimens have become ineffective in controlling pain. Following physical and neurological exams, what is the most appropriate next step in treatment?
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