The Mid-term Elections

The Mid-term Elections

The mid-term elections results are in for the most part, and of course the Democrats will control the House of Representatives in the 110th Congress, and they may wind up controlling the Senate as well. Reporters at Govexec.com have begun to prognosticate about the impact that the new House leadership will have on federal employees.

There likely will be plenty of time for prognostication as the common wisdom is that the lame duck session of Congress will be very brief, e.g., simply extending the current continuing resolution funding the federal government into January. This would allow the new Congress to take up the appropriations issues as well as many other issues discussed in this blog == health information technology, Medicare, and the Food & Drug Administration’s drug review process. For example, likely House Speaker Nancy Pelosi (D Cal.) is a major advocate for CMS directly negotiating drug prices with the drug manufacturers in the Medicare Part D program. Also Rep. Nancy Johnson (D Conn.) who was a major force behind the push to accelerate implementation of the ICD 10 not only lost her Ways and Means Health Subcommittee chair, but she also lost her seat in Congress.

Health Care Policy Resources

On Monday, I gave a talk about U.S. healthcare to 25 Turkish government members. It was the first time that I ever gave a talk through a translator. A very enjoyable experience. In preparing for the talk, I ran across two very useful health care policy resources on the web:

Health United States 2005 by the U.S. Centers for Disease Control

Health Care Industry Report by the U.S. Bureau of Labor Statistics

Tidbits from the BLS report:

  • Health care is the largest U.S. industry providing 13.5 million jobs in 2004 out of a total labor force of 150 million
  • 40% of healthcare employees work at hospitals
  • Over 85% of nonhospital health services establishments employ fewer than 20 workers.

Medicare 2007 Fee Cut to Physicians Only 5.0%

On November 1, 2006, the Centers for Medicare and Medicaid Services announced its final 2007 Medicare Part B physician fee schedule rule. Medicare Part B reimburses physicians based on a resource based relative value schedule (RBRVS). In August CMS published a proposed rule calling for a 5.1% reduction in physician reimbursement levels based on a statutory formula. The final rule reduces that reduction slightly to 5.0%. That change will go into effect on January 1, 2007, unless Congress amends the Medicare law to reverse the reduction as it did earlier this year to reverse the 2006 reduction.

CMS made significant payment policy changes in order to increase payments for direct patient care and for expanded preventive care:

The hallmark of this rule is a stronger emphasis on the physician-patient relationship. The final rule increases significantly the work component for the [relative value units] RVUs for the face-to-face visits (evaluation and management or “E&M services”) during which the physician and patient discuss the patient’s health status and the steps that can be taken to maintain or improve the patient’s health. For example, the work component for RVUs associated with an intermediate office visit, the most frequently billed physician’s service, is increasing by 37 percent. The work component for RVUs for an office visit requiring moderately complex decision-making and for a hospital visit also requiring moderately complex decision-making are increasing by 29 percent and 31 percent respectively. Both of these services rank in the top 10 most frequently billed physicians’ services out of more than 7,000 types of services paid under the physician fee schedule. * * *
“We believe this increase in the work component will encourage physicians to spend more time with their patients, assessing their health status, and educating them about how to live longer, healthier lives,” said [CMS Acting Administrator] Ms. [Leslie] Norwalk. Beginning January 1, Medicare will expand its preventive services benefits, as provided for in the Deficit Reduction Act of 2005 (DRA). Medicare will pay for preventive ultrasound screening for abdominal aortic aneurysms (AAA) for at risk beneficiaries as part of the Welcome to Medicare physical. AAA refers to a weakening in the wall of the large artery that takes blood from the heart to the body. Caught early, there are a number of treatment options, but if the AAA ruptures, it can be fatal. AAA affects 6-9 percent of men over 65 and is the 10th leading cause of death for men over 55. The screening will be available to men aged 65 to 75 who have smoked at least 100 cigarettes in their lifetimes, individuals with a family history of AAAs and any other individuals recommended for screening by the United States Preventive Services Task Force. The rule expands the number of beneficiaries who qualify for bone mass measurement due to long term steroid therapy. For these beneficiaries, the rule reduces the dosage equivalent required for eligibility by one-third, from an average of 7.5 milligrams per day of prednisone for at least three months to 5.0 milligrams. The final rule also exempts the colorectal cancer screening benefit from the Part B deductible, eliminating a potential financial barrier to using this benefit. Colorectal cancer is the second leading cause of cancer deaths, and survival is closely related to the stage of the disease at diagnosis. The five-year survival rate when the cancer is detected early approaches 90 percent. Unfortunately, approximately 65 percent of patients present with advanced disease. Once the lymph nodes are involved, chances of survival drop to a range of 35 to 60 percent and with metastatic disease, less than 10 percent.

Also on November 1, CMS announced its final 2007 Medicare Part A outpatient hospital prospective payment system (OPPS) rule.

Hospitals would receive an estimated $32.5 billion in CY 2007 under the final rule that revises policies and payment rates under the OPPS for outpatient services provided to Medicare beneficiaries. The final rule affects outpatient services furnished by general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children’s hospitals, and cancer hospitals. As provided by statute, the rule includes a 3.4 percent market basket update to Medicare payment rates for services paid under the hospital OPPS for CY 2007. After taking into account other factors that affect the level of payments, CMS estimates that hospitals will receive an overall average increase of 3.0 percent in Medicare payments for outpatient department services in 2007 due to the changes in this final rule. While the market basket update accounts for increases in the costs of providing a service, much of the growth in outpatient spending results from increases in utilization and complexity (volume and intensity). CMS estimates that between 2005 and 2006, hospital outpatient expenditures increased by nearly 12 percent, mainly due to growth in the volume and intensity of services. CMS projects that the expenditures under the OPPS in CY 2007 will be approximately 9.2 percent higher than the estimated CY 2006 expenditures. That rate of growth in expenditures is of great concern to CMS, not only because of its impact on all taxpayers, but especially on beneficiaries whose monthly premiums cover 25 percent of Part B expenditures. In order to promote greater value in the purchase of hospital outpatient services for Medicare beneficiaries, the final rule ties OPPS rate increases to the reporting of quality measures beginning in 2009. The final rule announces CMS’ plans to develop additional quality measures that are specifically appropriate for hospital outpatient care, and will require hospitals to report the outpatient-specific measures beginning in CY 2009.

The final Medicare OPPS rule is scheduled to be published in the Federal Register on November 9, 2006, and the final PFS rule is scheduled to be published there on December 1, 2006.

Off label drug usage problem

The Food and Drug Administration approves a label for every drug marketed in the United States. “The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient. Labels are often found inside drug product packaging.” While physicians may prescribe FDA approved drugs for off-label uses, it is illegal for the manufacturer to market one of its drugs for an off-label use.

John Carreyrou writes in the November 3, 2006, Wall Street Journal that while off label prescriptions may not be illegal, they can be dangerous to the patient’s health. He uses the powerful painkiller Actiq, which he describes as a highly addictive “narcotic lollipop” with an active ingredient fentanyl that is 80 times more powerful than morphine. Cephalon markets Actiq. The San Francisco Chronicle features today a first person account of Actiq abuse.

Actiq was approved for marketing in 1998. Its sales volume climbed from $15 million in 1999 to $412 million in 2005.

The Wall Street Journal story explains that

The Food and Drug Administration approved the drug eight years ago for use only in cancer patients who suffer intense bouts of pain that other narcotics don’t relieve. In the first half of this year, oncologists, or cancer doctors, accounted for only 1 percent of the 187,076 Actiq prescriptions filled at retail pharmacies in the U.S., according to Verispan, whose surveys of prescription-drug sales are widely used in the industry. Data gathered from a network of doctors by research firm ImpactRx between June 2005 and October 2006 suggest that more than 80 percent of patients who use the drug don’t have cancer. Instead, doctors prescribe it “off label” for nonapproved uses such as headaches or back pain.Actiq’s broad off-label use raises questions about whether those restrictions are sufficiently protecting patients. “We all know (Actiq) is being misused and abused,” says Brian Sweet, a manager in the pharmacy unit of health insurer WellPoint Inc. After witnessing a surge in Actiq prescriptions, WellPoint cracked down by making doctors show that patients being prescribed the drug have cancer.

The U.S. Attorney for the Eastern District of Pennsylvania is investigating Cephalon’s marketing practices, according to the Journal.

CDC Recommendation on Meningitis Vaccine

The AP reports that the U.S. Centers for Disease Control have announced that there is no longer a shortage in the meningitis vaccine, Menactra, manufactured by Sanofi Pasteur. Last year, after the Food and Drug Administration approved Menactra for marketing, the CDC recommended that three age groups — college freshmen, teens entering high school and children aged 11-12 — receive the vaccine. In May 2006, the CDC delisted preteens due to a vaccine shortage. That shortage now has been resolved and the CDC has reinstated its recommendation that children aged 11 – 12 receive the vaccine.

CVS / Caremark merger

Steven Pearlstein assesses the CVS / Caremark merger in the Washington Post this morning. Analysts predict that the merger will survive government antitrust review. Both companies announced strong third quarter earnings yesterday. The merger is expected to close next year.

AHIC Meeting News

Joseph Conn reports in Modern Healthcare.com that the American Health Information Community (AHIP) at its October 31 meeting gratefully accepted the Health Information Technology Standards Panel’s work product: “22 standards and eight implementation specifications to support data transmissions in three areas selected by AHIC: to move lab data into electronic health-records systems; to populate personal health records with a patient’s medication history and basic information to facilitate registration; and to speed the transfer of healthcare information from providers to public-health authorities for biosurveillance.” He also reports controversy over the lab data transfer standards.

Pay for Performance

Dr. Elliot Fisher, a professor of medicine at Dartmouth, wrote an interesting opinion piece on Medicare’s pay for performance programs in the Nov. 2 issue of the New England Journal of Medicine. Dr. Fisher provides a medical community perspective on the long term goals for pay for performance inside and outside of Medicare.

Thirty Safe Hospital Practices

Laura Landro reports in the Wall Street Journal today that “a coalition of health-care purchasers, quality groups and government agencies working with the National Quality Forum, the leading government advisory body on health-care quality measurement and standards, have agreed for the first time to endorse a single set of 30 ‘safe practices’ that all hospitals should use to prevent death and injury to patients.” That’s progress.

CVS and Caremark Announce Merger

What was hinted at this morning became reality this afternoon when CVS, a major pharmacy chain which has a prescription benefit manager affiliate Pharmacare and a major PBM Caremark announced their merger. Caremark shareholders will receive 1.67 shares of CVS stock for each of their Caremark shares. The new company will be called CVS /Caremark and it will be headquartered in Woonsocket, Rhode Island (gateway to the Taunton). The stock swap deal is valued at $21 billion and the projected 2006 revenues for the combined company are $75 billion. The Wall Street Journal notes that CVS has been very acquisitive this year and that PBM stocks have been down since September when Walmart announced its $4 generic prescription price. The proposed settlement in the AWP price fixing litigation has added to the PBM stock woes as discussed in the blog last week.

The AP reports that

Glenn Garmont, an analyst with First Albany Corp., said before the announcement that the deal was likely spurred in part by the fear that Wal-Mart, “will emerge as a fierce new competitor following its introduction of selected $4 generic drugs.” Wal-Mart announced last week that it is extending its $4 for a one-month supply of 314 different generic prescriptions to make the program available at 1,008 stores in 27 states. However, [CVS CEO Tom] Ryan and [Caremark CEO Tom] Crawford said Wal-Mart’s action didn’t affect their decision to merge. “We’ve been working on all this for some time,” Crawford said. “This didn’t have anything to do with Wal-Mart.” Garmont said such a deal between Caremark and CVS “would spawn others, and we view all PBMs … as potential take-out targets.” Still, some analysts said the deal might face antitrust concerns. Barry Barnett, a health care consultant for PricewaterhouseCoopers, said regulators might be concerned that Caremark might unfairly funnel business to CVS pharmacies at the expense of other drug stores.

Several years ago Caremark acquired Advance PCS, one of the original PBMs. Earlier in its history, PCS had been owned by a drug manufacturer Eli Lilly, a drug wholesaler McKesson, and a pharmacy chain Rite Aid. None of those arrangements were profitable, as I recall. Another major PBM Medco recently split away from its drug manufacturer parent Merck a few years ago following considerable antitrust scrutiny. So the experience of this new combination will be worth following.