The Genetic Information Non-Discrimination Act (GINA, HR 493) will be considered on the Senate floor tomorrow according to the Associated Press after Sen. Tom Coburn (R. Okla.), who is an MD, agreed to lift his hold on the bill. The AP story explains that

The compromise tightens language to ensure there is a “firewall” between the part dealing with health plans and the section regarding employment so as to discourage inappropriate claims.It also makes clear that, while individuals are protected from discrimination based on genetic predisposition, insurance companies still have the right to base coverage and pricing on the actual presence of a disease

The House already has passed the bill, and presumably the compromise that lead Sen. Coburn to release his hold will satisfy the White House’s concerns about GINA as well.

The New York Times article accurately notes that federal law (HIPAA) already prohibits group health plans from discriminating in coverage based on genetic testing so this law primarily impacts individual health insurers and employers. Furthermore, as noted in genome.gov, “

President Clinton issued an executive order ( Executive Order 13145 to Prohibit Discrimination in Federal Employment Based on Genetic Information) in February 2000 prohibiting agencies of the federal government from obtaining genetic information about their employees or job applicants and from using genetic information in hiring and promotion decisions

But it is a complicated law. Privacy advocates already are criticizing its “limited” scope.

• The FEHBlog schedule has gotten offtrack because my wife and I enjoyed a weekend off in Connecticut.
• The Tier 4 controversy continues. Sen. Barack Obama (D Ill) sent OPM Director Linda Springer a letter last week requesting by April 30 a report on “skyrocketing copayment costs for prescription drugs.” USA Today followed the New York Times in opining against the growing practice of increasing cost sharing on biologic or specialty drugs. AHIP President Karen Ignani presented a counterpoint to the USA Today’s editorial — urging Congress to create a pathway to biogenerics and “a national institution to compare the effectiveness of new and existing therapies, and provide patients and doctors with data about which are safest, work the best and are most cost-effective.”
• I ran across two interesting articles in the AMA News. One discussed a healthcare marketplace website — www.carol.com — that according to the about us page on the siete allows Twin Cities (Minneapolis / St. Paul MN) consumers to compare health care services, practitioner credentials, quality dimensions, and costs—with or without insurance. Carol works with insurance companies to verify membership and provide cost estimates for care packages.” The AMA News provides this background information on Carol:
  

  Carol’s founders include Tony Miller, co-founder and former chief executive officer of Definity Health, one of the first companies to offer consumer-driven health plans such as health savings accounts. United bought Definity, its fellow Minneapolis-area company, in December 2004. Miller then formed Lemhi Ventures, which put $25 million into the startup of Carol. For now, Carol’s reach extends only to the Minneapolis-St. Paul vicinity, though the company says talks are under way with physicians and hospitals in Seattle and Cincinnati to offer services there.

  On a related note the Wall Street Journal reported managed care company earnings for the first quarter of 2008 appear to be unhealthy. However, according to the Journal’s report

  Health insurers have been cushioning problems in their core commercial health-insurance market by expanding into new areas, such as offering plans to Medicare beneficiaries and developing health-information tools and capabilities that might help employers and individuals better control their own costs.

  Some analysts say, for example, that Aetna’s successful packaging of medical-cost and disease-management tools in recent years is one reason it hasn’t seen the same enrollment shortfalls as its competitors. Last year, among the top four carriers — including WellPoint, UnitedHealth and Cigna Corp. — Aetna was the only one that didn’t see a decline in people it charges a premium to insure.

• The other AMA News article of note was an interview with the AMA’s President Ron Davis, MD, who recently has been diagnosed with pancreatic cancer. Dr. Davis, who clearly is a brave man, blogs about his illness at carepages.com, a Revolution Health social website that “connects family and friends during illness or injury.”

• The House passed a tax bill on April 15 that would impose a requirement on health savings account (HSA) trustees, e.g., banks, to substantiate the health care nature of expenses reimbursed out of HSAs. According to Workforce Management, “The 238-179 vote came after intense debate on the House floor in which opponents of the HSA provision—which is part of a broader tax bill, H.R. 5719—warned that such a requirement could cripple HSAs.” The White House issued a statement of administration policy that includes a veto warning over this provision.
  

  These new burdens on HSA administrators are unnecessary for efficient tax administration, inconsistent with the flexibility purposely afforded HSAs at their inception, and could undermine efforts by employers, individuals, and insurers to reduce health care costs and improve health outcomes by empowering consumers to take greater control of health care decision-making. If H.R. 5719 were presented to the President with these provisions, his senior advisors would recommend he would veto the bill.

  We shall have to wait and see what the Senate does with the bill.

• The Centers for Medicare and Medicaid Services published on April 14 a proposed rule concerning changes to the prospective payment system that compensates hospitals for Medicare Part A covered care in the next federal fiscal year that begins October 1, 2008. The CMS fact sheet on the rule is here. Modern Healthcare reports that
  

  Under the proposal, hospitals would receive the full inflation, or marketbasket, update, projected at 3%, but given all the changes in the rule, the CMS projects that on average, hospitals will see an increase in payments of 4.1%, according to the American Hospital Association.

  The proposed rule also expands the number of quality measures on which hospitals must report to CMS and expands the list of never events that Medicare will not cover.

• Healthcare IT News reports that AHIC’s Consumer Empowerment workgroup “considered recommendations on April 15 from the Centers for Disease Control and Prevention on how best to push personal health records.” Among other suggestions, CDC recommended market research on consumers.

• A Wellpoint subsidiary, Healthcore, Inc., is working with the Food and Drug Administration to mine claims data for the purpose of creating a Safety Sentinel System to promptly identify unanticipated health risks associated with prescription drug use. According to Wellpoint’s press release,
  

  Jerry Avorn, M.D., professor of medicine, Harvard Medical School and chief, division of pharmacoepidemiology and pharmacoeconomics, Brigham and Women’s Hospital, said, “The discovery of important risks of drugs like Vioxx(R) and Avandia(R) has demonstrated that the health care system currently has no reliable means of quickly measuring the safety of drugs once they’re in widespread use. I look forward to working with HealthCore and its partners on this project and bringing the value of WellPoint’s Safety Sentinel System to a large number of patients.”

  Ultimately, the system is expected to be capable of continually monitoring WellPoint’s 35-million member database and identifying increases in health problems among members taking a given drug, indicating a potential Serious Adverse Event (SAE). It is anticipated that the company’s Safety Sentinel System will also make it possible to examine whether particular combinations of treatments could cause serious medical problems, especially in patients with certain diseases or health conditions.

  Sam Nussbaum, M.D., chief medical officer for WellPoint, said, “This critical information will allow health care decision-makers including federal agencies, physicians, consumers and manufacturers to move far more quickly than in the past in addressing potential drug risks. “Our company’s Safety Sentinel System will draw upon the vast amount of data generated by WellPoint’s health plans, including the use of specific medications. It will enable us to identify potential hazards and allow faster, more informed decision making by health care professionals.”

  “Our initial developmental work on the system has clearly demonstrated its ability to detect adverse events rapidly,” Nussbaum said. “We were able to pick up a safety signal within a few months on certain drugs even though in some cases in the industry’s current system it can take more than 5 years.”

  “WellPoint’s investment in its Safety Sentinel System demonstrates the company’s commitment to providing the best possible care to its members,” said Marcus Wilson, Pharm.D., president of HealthCore. “What differentiates our system from other safety programs is not only our ability to access massive amounts of data to detect the presence of serious safety issues, but also our ability to work in collaboration with our vast network of health care providers across the country to quickly and effectively evaluate the validity of the signal.”

Most health plans offer their members three tiers of prescription drug benefits — generic, preferred brand, and non-preferred brand. The co-payments/co-insurance increase as you move from generic to non-preferred brand. The New York Times reported that health plans are beginning to add a fourth tier for specialty drugs.

Specialty drugs are high cost, typically injectable drugs used to treat complex conditions. AIS Health posts a library of articles on specialty drugs here. Specialty drugs are expensive because, among other reasons, there is no legal “pathway” at present for creating generic versions of biological drugs. The New York Times article is noteworthy because it describes the impact of a fourth tier for specialty drugs on a FEHB plan participant. The Times article illustrates the importance of finetuning benefit communications.

In Tuesday’s paper, the Times weighs in with an editorial on the issue:

There is little doubt that the so-called tiered formularies, in which co-payments rise along with the cost of the drugs, are a sensible approach for encouraging consumers to use the cheapest drug suitable for their condition. But the system seems to break down when it moves to Tier 4 drugs where co-payments can be huge and suitable alternatives don’t exist. The insurers say that forcing patients to pay more for unusually high-priced drugs allows them to keep down the premiums charged to everyone else. That turns the ordinary notion of insurance on its head. Instead of spreading the risks and costs across a wide pool of people to protect a smaller number of very sick patients from financial ruin, insurers are gouging the sickest patients to keep premiums down for healthier people.

The Times editorial oversimplifies the issue. Heavy utilizers of healthcare typically pay more than those who don’t through co-insurance. A person who undergoes heart surgery will pay more out of pocket than a person who only receives routine care. The more refined issue is whether the plan places a stop loss on the aggregate co-insurance for the specialty drugs as it would with co-insurance on surgical treatment and if so at what dollar amount is the stop loss threshold set.

• There’s reportedly efforts underway to harmonize the House and Senate mental health parity bills but no details have been released as yet. Meanwhile, Business Insurance reports that Rep. Robert Andrews (D N.J.) has introduced a bill to require prosthetic appliance parity with group health plan medical/surgical benefits (HR 5615). Many health plans, including FEHB plans, cap coverage of prosthetic appliances. OPM’s 2008 call letter provided the following guidance on the broader benefits category of durable medical equipment:
  

  Carriers should review their coverage for durable medical equipment (DME) in light of advances in technology for assistive devices designed for individuals with special needs; including vision, hearing, mobility and movement, and cognition. Examples include augmentative and alternative communication (AAC) products such as speech generating devices and audible prescription reading devices. Please provide a statement concerning your coverage for these types of benefits.

• Business Insurance also reports on a standard methodology for rating health care provider performance known as the “Patient Charter for Physician Performance Measurement, Reporting and Tiering Programs” that was released earlier this month by a multi-stakeholder group known as the Consumer-Purchaser Disclosure Project. The standards comply with last year’s settlement agreement between CIGNA and the New York State Attorney General. AHIP endorsed the Patient Charter. Health care quality transparency has become a standard requirement in OPM’s call letter as it is one of HHS Secretary Leavitt’s four cornerstones.

• While on the topic of disclosure, the AP reports that
  

  For years, the nation’s largest drug and medical device manufacturers have courted doctors with consulting fees, free trips to exotic locales and sponsoring the educational conferences that physicians attend. Those financial ties in most cases need not be disclosed and can lead to arrangements that some say improperly influence medical care. Now, under the threat of regulation from Congress, the two industries are promising to be more forthcoming about their spending. A dozen of the nation’s leading drug and device makers have told Sen. Charles Grassley, R-Iowa, that they have plans or are working on plans to publicly disclose grants to outside groups. The details will be provided on each company’s Web sites.

• The Las Vegas Review Journal reports today that

  Although Southern Nevada Health District officials maintain there is no evidence that the unsafe injection practices they believe led to six people contracting hepatitis C at a Las Vegas endoscopy clinic took place before March 2004, at least one health insurance provider isn’t taking any chances. Anthem Blue Cross Blue Shield plans to alert all members treated at the Endoscopy Center of Southern Nevada at 700 Shadow Lane to speak with their physicians about having tests for blood-borne diseases regardless of procedure date. Anthem spokeswoman Sally Vogler said Friday that the notification will appear in the form of an advertisement in the Review-Journal on Sunday and on April 20. She said the advertisement stems in large part from the possibility of patients who were treated at the clinic before March 2004 testing positive for hepatitis C or another blood-borne disease.

• Finally, Healthcare IT News reports that the Trizetto Group which sells claims payment and related software to health plans has been acquired for $1.4 billion by Apax Partners. Apax plans to take Trizetto private. Trizetto’s press release explains that “BlueCross BlueShield of Tennessee and The Regence Group, both customers of TriZetto, are providing a portion of the funding for the transaction and will be equity investors in the newly private company.”

• I think that this is really cool. A researcher has developed a drug that may allow radiation therapy to kill cancer cells without harming the healthy cells. According to MedHeadlines,
  

  The trick is apoptosis, or cellular suicide. When healthy cells are exposed to radiation, even at doses that produce damage than can be repaired, they instead do what seems to be suicide. The cells in the bone marrow and gastrointestinal (GI) tract are particularly vulnerable. Cancer cells, however, use various means of blocking apoptosis, enabling cancerous tumors to grow. One way they block cellular suicide is by activating a signaling pathway known as NFKB, or nuclear factor-KappaB. By imitating this tumor trick, Andrei Gudkov and his team of colleagues affiliated with the Roswell Park Cancer Institute ,were able to block apoptosis in healthy tissue by introducing flagellin, a protein made from bacteria in the GI tract, to activate the NFKB pathway. They then administered their flagellin-based experimental drug on rhesus monkeys and mice before exposing the animals to full-body, lethal doses of radiation, similar to what might be received during a widespread nuclear emergency. The drug was administered 15 minutes to one hour before radiation exposure. The remarkable result of this experimental trickery was protection of the animals’ bone marrow and GI tracts from destruction typically caused by radiation, and with no no observable side effects. What is even more exciting is that the cancerous tumors were killed, as desired, by the radiation treatment.

  I do believe that medical breakthroughs like this will be keep on coming due to the groundwork laid be basic research, such as the Human Genome Project.

• Speaking of cool, I visited Nationals Park this week. Great ballpark, great food, very easy to reach by Metro (similar to the Verizon Center). Hopefully, our team will achieve greatness in time.

• On April 2, OPM Director Linda Springer testified about her agency’s fiscal year 2009 budget before a House appropriations subcommittee. Director Springer had the following remarks about the FEHB Program:
  

  As the administrator of the FEHBP, OPM will continue to negotiate and contract with private insurance companies that offer a broad range of health insurance benefits, including high-deductible health plans with Health Savings Accounts and consumer-driven health plan options. As such, OPM will spend $26 million in FY 2009 to ensure the viability of the Program’s 283 health care plans covering over 8 million people. As usual, OPM will continue to carry out tough negotiations with health carriers to contain premium hikes. Over the years these negotiations have resulted in employee premiums that are substantially lower than those of the private sector while maintaining benefit levels, and continuing to provide, improve, and expand tools so customers can make informed health insurance decisions. In fact, the FEHBP increase for 2008 was 2.1 percent, compared to an average 8.7 percent increase for the private sector and a 6.3 percent increase for the California Public Employees’ Retirement System during that same year.

• The Chairman of the Senate Finance Committee, Sen. Max Baucus (D Mont) reportedly plans to send Medicare legislation directly to the Senate floor without a Committee markup. This is the bill that would avoid a 10% cut in Medicare reimbursement to physicians currently scheduled for July 1, 2008. The bill would not rely on Medicare Advantage payment cuts to cover bill’s costs according to ModernHealthcare.com.

• The Blue Cross Blue Shield Association has released its 2008 Medical Cost Reference Guide.

• The press has picked up on a debate over the level of charity care provided by non-profit hospitals here and here.

• The Burlington Free Press reports that the Vermont legislature is planning to tax health plan claim payments — 0.12 percent of the medical claims paid by a health insurer in a quarter — in order to provide electronic health record implementation grants to doctors. The FEHB Act, 5 USC § 8909(f), preempts the imposition of such taxes, fees, etc. on FEHB plans.

Vytorin a Schering Plough prescription drugs which combines the now generic Zocor with Schering Plough’s Zetia, has come under fire this week following the release of a study at the American College of Cariology’s annual conference this week concluding that Vytorin is no more effective in reducing plaque in neck arteries than Zocor alone. Indeed the Wall Street Journal reports today that “Schering-Plough Corp. announced a plan to cut costs by $1.5 billion by 2012, after a panel of cardiologists called for doctors to limit use of the company’s blockbuster cholesterol drugs and sent its stock down nearly 29%.”

The New Jersey Star Ledger reports that an FDA medical policy official warns that patients on cholesterol medication should be wary about abandoning treatment.

“(A)n aspect of the current discussion that troubles me greatly is the implication in some stories that we’re not so sure anymore that even lowering cholesterol with statins is all that clearly beneficial,” Robert Temple, medical policy director for the FDA’s Center for Drug Evaluation and Research, told the web site. [That’s what I took away from reading a recent BusinessWeek article on statins, but I’m not an MD.] “As the recent Crestor story reminds us (for people without known cardiac disease, by the way) we sure do know it is beneficial and people who need that treatment will pay with their lives if they’re encouraged to avoid treatment.” Temple also said he hasn’t drawn any conclusions about the purported ineffectiveness of Vytorin, also known as ezetimibe, and said the agency will likely take six months to review new data about the drug.

The New York Times reports that UnitedHealth Group is recommending — in line with the FDA official’s comments — that its members who have Vytorin prescriptions remain on the drug because it presents no safety issues. CNNMoney reports that Cigna adjusted its drug coverage in response to the study. “The Philadelphia health insurer said it was immediately suspending part of a program that notified members using certain other cholesterol drugs that Vytorin was an effective and less costly alternative. The program, known as ‘step therapy,’ is an effort to help health plans control drug costs.” Similar to UnitedHealthcare, “Cigna will continue to pay for Vytorin prescriptions, and the insurer stressed that no one should discontinue any therapy without first talking to a doctor.”

• Taking a page out of Medicare’s playbook, Wellpoint, the Nation’s largest health insurer by membership, has announced that it is rolling out an in-network claims policy to exclude coverage of expenses caused by eleven preventable medical errors designated by CMS and the National Quality Council. Wellpoint’s policy will prevent network providers from balancing billing patients for these expenses. (Several states hospital associations have agreed not to charge patients or insurers for never events.) Wellpoint plans to expand the never events over time. The Indianapolis Star quotes Debora Spano, spokeswoman for Minnesota-based UnitedHealthcare as follows: “We continue to evaluate the new Medicare policies and how they may be applied to best meet the needs of our members.”
• The Centers for Medicare and Medicaid Services (CMS) published a final rule setting standard for voluntary electronic prescribing by doctors serving Medicare patients. According to CMS’s press release, “The rule adopts four standards for use in e-prescribing effective April 1, 2009:
  

  Formulary and benefits: This standard will allow doctors and other prescribers to communicate with Part D sponsors about which drugs are covered by a Medicare eligible individual’s prescription drug benefit plan. Prescribers can also learn which generic prescription drugs might offer lower-cost options for the individual.

  Medication history: This standard will allow doctors and other providers, as well as dispensers and Part D sponsors, to communicate among themselves about prescribed medications a beneficiary has taken or is taking, including those prescribed by other providers. This information can help reduce the number of adverse drug events that result from drugs negatively interacting with other drugs a beneficiary is already taking, and can ensure that the doctor or other prescriber has the necessary information about a beneficiary’s current prescription medications.

  Fill status notification: This standard will allow doctors and other providers to receive an electronic notice from the pharmacy or other dispenser telling them that a patient’s prescription has been picked up, not picked up, or has been partially filled. These notifications can help health care providers monitor patients with chronic conditions, such as diabetes or hypertension, by providing an indicator as to whether they are taking their medicines.

  Provider identifier: The final rule requires providers, dispensers, and Part D sponsors to use the National Provider Identifier (NPI) to identify individual health care providers in Part D e‑prescribing transactions. Adoption of the NPI will speed workflows by eliminating call-backs by pharmacies to medical offices to verify the identity of individual prescribers.”

  The Chair of the AMA’s Board of Trustees encourages doctors in this week’s AMA News to take the lead in e-prescribing.

• Meanwhile, Cigna closed earlier this week on its acquisition of Great-West Healthcare. According to Cigna’s press release, “The transaction includes 1.9 million covered lives, including approximately 1.4 million medical members in its employer segment.”

The American Imaging Management (“AIM”), a Wellpoint subsidiary, has created an innovative web site that advises patients about the amount of radiation that they will receive from specific CT, PET scans and other nuclear medicine tests. For instance, I had a sinus CT last year. According to this site, that’s the equivalent of 100 chest x-rays or half a year of sunlight. This site also suggests alternatives, such as endoscopy in my case. The AMA News published an article critical of the website:

Some doctors said they suspect AIM could be trying to create doubt in patients’ minds about the safety of tests to save money for its health plan clients, and they aren’t comfortable with what they see as interference with the doctor-patient relationship.
Aimee isn’t giving accurate and complete data, the doctors said, because the Web site doesn’t allow for variance in equipment, or patient gender, age or weight. It doesn’t give users a full risk-benefit analysis of a diagnostic test. “This is not a service to anyone,” said Richard L. Morin, PhD, chair of the American College of Radiology Safety Committee.

The medical authorities quoted in the article would support an “unbiased” website. The Center for Studying Health System Change issued a brief on this issue titled Health Plans Target Advanced Imaging Services: Cost, Quality and Safety Concerns Prompt Renewed Oversight in February.