New Acting Management Team at OPM

New Acting Management Team at OPM

The OPM senior staff web page, which had numerous vacancies yesterday, was filled up today. Kathie A. Whipple, former OPM Deputy General Counsel, is now Acting Director. Presumably, Ms. Whipple will be treated as a President Obama appointee for purposes of the order governing regulatory affairs discussed in the FEHBlog yesterday.  R. Alan Miller, who is a senior attorney in the OPM General Counsel’s office, is now Acting General Counsel. Richard B. Lowe is the Acting Chief of Staff and Director of External Affairs. Michael Orenstein is the Acting Director, Office of Communications & Public Liaison. Charlene Luskey is the Acting Director, Office of Congressional Relations. Sydney Smith-Heimbrock is the Acting Executive Director, CHCO Council. Good luck to them.

HITECH Act

Government Health IT News reports that the Ways and Means Committee has included an extensive health information technology bill called the Health IT for Economic and Clinical Health Act, or HITECH Act in the draft economic stimulus legislation now under consideration by Congress with the Obama Administration’s support. In addition to giving doctors as much as $65,000 apiece ($20 billion in total) via Medicare “for showing that they are meaningfully using health information technology,” the bill would add new privacy requirements

The privacy provisions include a requirement to notify patients and the federal government of security breaches that result in the release of protected health information. Privacy and security rules under the Health Insurance Portability and Accountability Act of 1996 would be extended to health information exchanges, health records banks and business partners of health care providers and insurers. HIPAA enforcement would be strengthened. The sale of identifiable health information without the patient’s authorization would be forbidden in most cases, and the HIPAA loophole that some have used to send advertising to patients would be closed.

The Ways and Means Committee draft must be reconciled with an Appropriations Committee draft so this is not a done deal. The Wall Street Journal reports today there’s still disagreement over how to handle privacy. I found the following quote from that report revealing

“In some ways I am thrilled, because IT will need federal help,” said John Glaser, chief information officer for Partners HealthCare, a large nonprofit hospital system in Boston. “But you can bring in too much money too fast and not only waste it, but set us back.”

Impact of the Obama transition on OPM

  • If you look at the OPM organization chart today, you’ll see a lot of vacancies, including Deputy Director, General Counsel, Chief of Staff and Office of Congressional Relations Director.
  • The new President, via his Chief of Staff, has ordered that federal agencies may not propose or finalize a regulation unless it has been approved by an Obama administration appointed agency head, according to Govexec.com.  OPM’s current director, Michael Hager, was appointed by former President Bush.  The order also asks “agency officials to consider extending for 60 days the implementation period of all final rules that appeared in the Federal Register but have yet to go into effect. The extension would include reopening the notice and comment period for 30 days.”
  • Govexec.com also reports that President Obama’s anticipated appointee for the OPM Directorship, John Berry, is a likely “champion” of extending FEHB Program coverage to domestic partners of federal and postal employees. This goal is shared by Sen. Joe Lieberman (I Conn.) who chairs the Senate committee with oversight responsibility for the FEHB Program.

Weekend update / Miscellany

  • The big news of the past week was the United Healthcare and Aetna settlements with the NY Attorney General and the American Medical Association to replace the Ingenix usual reasonable and customary databases with an “independent” database created by a “qualified university” to be appointed by the NY Attorney General. A copy of the NY Attorney General’s report is here. A copy of the Aetna settlement is here. The response by the managed care industry trade association is here. While this is a happy outcome for doctors who operate outside of health plan networks, it’s not a good deal for consumers or doctors who participate in health plan networks.
  • Last October, the Department of Health and Human Services’ Office of the National Coordinator of Health Information Technology held a conference on medical identity theft. Last week, Booz Allen issued a final report on that topic to the ONC. The New York Times reports today that privacy issues may interfere with the President elect’s plans to include electronic medical record funding in the next stimulus package.
  • Eli Lilly & Co. conceded that it violated federal law by encourage the off label use of its blockbuster drug Zyprexa. Forbes.com explains that

    Lilly admitted to promoting the drug to elderly patients for off-label use as a treatment for dementia. The drug caused increased risk of death in this patient group. Zyprexa was approved in 1996 and will lose patent protection in 2011. It had annual sales of $4.7 billion in 2007.

    According to a U.S. Justice Department press release,

  • The global resolution [with Eli Lilly] includes the following agreements: A plea agreement signed by Eli Lilly admitting guilt to the criminal charge of misbranding. Specifically, Eli Lilly admits that between Sept. 1999 and March 31, 2001, the company promoted Zyprexa in elderly populations as treatment for dementia, including Alzheimer’s dementia. Eli Lilly has agreed to pay a $515 million criminal fine and to forfeit an additional $100 million in assets.
  • A civil settlement between Eli Lilly, the United States and various States, in which Eli Lilly will pay up to $800 million to the federal government and the states to resolve False Claims Act claims and related state claims by Medicaid and other federal programs and agencies including TRICARE, the Federal Employees Health Benefits Program, Department of Veterans Affairs, Bureau of Prisons and the Public Health Service Entities. The federal government will receive $438,171,544 from the civil settlement. The state Medicaid programs and the District of Columbia will share up to $361,828,456 of the civil settlement, depending on the number of states that participate in the settlement.
  • The qui tam relators will receive $78,870,877 from the federal share of the settlement amount.
  • A Corporate Integrity Agreement (CIA) between Eli Lilly and the Office of Inspector General of the Department of Health and Human Services. The five-year CIA requires, among other things, that a Board of Directors committee annually review the company’s compliance program and certify its effectiveness; that certain managers annually certify that their departments or functional areas are compliant; that Eli Lilly send doctors a letter notifying them about the global settlement; and that the company post on its website information about payments to doctors, such as honoraria, travel or lodging. Eli Lilly is subject to exclusion from Federal health care programs, including Medicare and Medicaid, for a material breach of the CIA and subject to monetary penalties for less significant breaches.
  • CMS issued three Medicare national coverage determinations holding that

    Wrong surgical or other invasive procedures performed on a patient; Surgical or other invasive procedures performed on the wrong body part; and Surgical or other invasive procedures performed on the wrong patient.

    are “never events” for which no Medicare reimbursement will be made.

HHS announces HIPAA transaction and code set changes

HHS announced today that HIPAA covered entities (health plans, heath care providers who use electronic transactions, and health care clearinghouses) must adopt the ANSI X12 5010 electronic transaction standards by January 1, 2012, and the ICD-10 diagnosis and hospital procedure code sets by October 1, 2013. HHS adopted the health care industry’s recommended implementation schedule. This conversion is a huge undertaking.

More UCR News

  • United Healthcare and its Ingenix subsidiary raised the white flag again today by agreeing to settle the American Medical Association’s lawsuit over the validity of the Ingenix usual reasonable and customary (UCR) databases that insurers often use to set out-of-network provider rates. While not conceding liability, the defendants agreed to pay $350 million into a fund to be distributed to doctors and consumers. The lawsuit had been pending since 2000 in the federal district court in Manhattan. The AMA claims victory here.
  • The New York attorney general announced today that Aetna has agreed to contribute $20 million toward the cost of retaining a qualified university to create an independent UCR database. According to Aetna’s press release, Aetna

    will stop using the Ingenix databases for the purpose of determining “prevailing” or “usual, customary and reasonable” charges when members receive covered care from providers outside a health plan’s network. Aetna will instead help the Attorney General to create a new independent database for this purpose, and will use the new database when it is ready for use. Aetna is contributing $20 million to a nonprofit organization to help create the new database and to help educate members about reimbursement rates.

  • The New York AG’s press release provided more details:
  • Under Attorney General Cuomo’s agreement with Aetna:
  • Aetna will pay $20 million toward a new, independent database run by a qualified nonprofit organization;
  • The nonprofit will own and operate the new database, and will be the sole arbiter and decision-maker with respect to all data contribution protocols and all other methodologies used in connection with the database;
  • The nonprofit will develop a website where, for the first time, consumers around the country can find out in advance how much they may be reimbursed for common out-of-network medical services in their area;
  • The nonprofit will make rate information from the database available to health insurers;
  • The nonprofit will use the new database to conduct academic research to help improve the health care system;
  • The nonprofit will be selected and announced at a future date.
  • The AMA in another press release called upon insurers to follow Aetna’s lead. However, the Ingenix databases are not the only show in town. Many insurers use Medicare’s resource based relative value schedule (RVRBS) to set their out of network rates.

This Math Does Not Add Up

The Hartford Courant reports today that “Consumers nationwide are expected to save millions of dollars on medical care under an industry-changing settlement announced Tuesday
aimed at forcing insurers to pay fairer reimbursement to doctors and hospitals outside their networks.” Under this settlement discussed in yesterday’s Tuesday Tidbits, Ingenix is jettisoning its UCR schedule in favor of an independent database to be developed by a university designated New York’s attorney general, Andrew Cuomo.

The Courant article accurately, in my opinion, presumes that the university database will produce higher reimbursement rates for out-of-network providers than the Ingenix databases. However, all this means is more money in the doctors’ pockets. The consumers who use out of network providers will pay less out of pocket, but the vast majority of consumers who use in-network providers necessarily will pay more. What’s more the consumers who use out of network providers will not benefit dollar for dollar because insurers likely will be forced to raise premiums for everyone as a result of this change.

Remember that it was the American Medical Association that sued Ingenix over this database in 2000 and stood firmly behind Mr. Cuomo. The AMA is in the process of killing the golden goose.

Interesting Developments

The Walgreens pharmacy chain, in conjunction with its Take Care clinics, announced the launch of an “employer centric” pharmacy and health care service called Complete Care and Well Being. Walgreens describes the new service as “a new and unique approach to health care that brings together pharmacy, health and wellness services under a single program, with all prices transparent to the employer.”

HHS has unveiled a new version of its personal health record tool called My Family Health Portrait. The HHS press release explains that

Key features of the new version of the Surgeon General’s My Family Health Portrait include:

  • Convenience – Consumers can access the tool easily on the Web. Completing the family health history profile typically takes 15-20 minutes. Consumers should not have to keep filling out different health history forms for different practitioners. Information is easily updated or amended.
  • Consumer control and privacy – The family health history tool gives consumers access to software that builds a family health tree. But the personal information entered during the use of the tool is not kept by a government or other site. Consumers download their information to their own computer. From there, they have control over how the information is used.
  • Sharing – Because the information is in electronic form, it can be easily shared with relatives or with practitioners. Relatives can add to the information, and a special re-indexing feature helps relatives easily start their own history based on data in a history they received. Practitioners can help consumers understand and use their information.
  • EHR-ready, Decision support-ready – Because the new tool is based on commonly used standards, the information it generates is ready for use in electronic health records and personal health records. It can be used in developing clinical decision software, which helps the practitioner understand and make the most use of family health information.
  • Personalization of care – Family history information can help alert practitioners and patients to patient-specific susceptibilities.
  • Downloadable, customizable – The code for the new tool is openly available for others to adopt. Health organizations are invited to download and customize, using the tool under their own brand and adding features that serve their needs. Developers may also use the code to create new risk assessment software tools.

Finally, the AP reports that software glitches in the Veterans Affairs Department’s electronic medical records systems caused numerous treatment errors over the past four to five months. The VA has stated no patients were harmed. According to the AP report

“It’s very serious potentially,” said Dr. Jeffrey A. Linder, an assistant professor of medicine at Harvard Medical School who has studied electronic health systems. “There’s a lot of hype out there about electronic health records, that there is some unfettered good. It’s a big piece of the puzzle, but they’re not magic. There is also a potential for unintended consequences.”

Hey it’s my job as a lawyer to belabor the obvious!

Tuesday Tidbits (plus)

On Friday January 9, 2009, the Office of Management and Budget cleared the final HHS 5010 transaction
standards and ICD-10 code set rules for publication in the Federal Register.
I expect that the rules will be published on Thursday or Friday of this week (in other words before Inauguration Day as HHS has projected.) We won’t know whether the implementation deadlines have been extended until the rules are published. I’ll be keeping an eye out here

While the first point was a tidbit the next one is not. Today, Ingenix and United Healthcare announced a UCR rate settlement with New York attorney general Andrew Cuomo. (Health plans generally pay out of network providers based on usual reasonable and customary (UCR) rates.) Under this agreement, Ingenix and UHC will pay $50 million to a qualified university selected by Mr. Cuomo. According to Mr. Cuomo, the selected university will create a new database.”to help determine fair and accurate reimbursement rates. The university will also develop a website where for the first time consumers will be able to learn in advance how much they are likely to be reimbursed if they go out of network.” Replacement of the current widely used Ingenix databases with this “independent” database is bound to reduce the incentive for plan members to use in-network providers.Finally, Govexec.com confirms a Washington Post report that the chief Washington, D.C., zookeeper, John Berry, is expected to become the OPM Director in the Obama administration. (I couldn’t resist that sentence. Mr. Berry is a skilled executive who is strongly endorsed by the federal employee unions.)

Weekend update / Miscellany

Interesting NFL games were played this weekend. I was in South Carolina when Arizona beat the Carolina Panthers to much local consternation. It would be astonishing if the Cardinals reached the Superbowl. Having watched the Eagles lose to the Redskins on December 21, I was surprised that the Eagles have reached the NFC championship game. Next week’s Steelers – Ravens game will be fun to watch. But onto the business at hand.

There were several FEHBP developments this past week.

The OPM Inspector General’s office posted on the web its semi-annual report to Congress for the period ending September 30, 2008.

OPM released the results of its 2009 Federal Human Capital Survey:

Satisfaction with health insurance and the flexible spending account programs show improvement since 2004. Employee satisfaction with health insurance (Q.65) continues to increase, up 6 percentage points since 2004. While satisfaction with flexible spending accounts (Q.68) was up 5 percentage points since 2004.

The Office of Management and Budget released an FY 2008 report on performance of the federal government. According to that report, Federal Employees Health Benefit Plan (FEHBP) overall enrollee satisfaction was 78% vs. health care industry standard of 60% (percent).

OMB also released agency performance and accountability scorecards. OPM received a green light on both its progress in eliminating improper payments and its health care quality and transparency initiative. According to OPM’s Improper Payments Improvement Act report for FY 2008, the improper payment rate for the FEHB Program as reported by OMB is 0.2%. In contrast, Medicare’s rate is 3.6%.

Events also transpired outside the FEHBP world. AHIC Successor, Inc. renamed itself the National eHealth Collaborative (is that really more catchy?). The collaborative also refreshed its website. Government Health IT News reports that

With a new administration coming to Washington, D.C., and a massive federal stimulus plan under consideration, some policy experts believe the environment for overhauling the country’s health care system is favorable. The Health Information and Management Systems Society has called on the new administration to spend a minimum of $25 billion on the adoption of electronic medical records by nongovernmental hospitals.

“Twenty-five billion [dollars] moving into this area could be a game-changer,” said John Loonsk, director of interoperability and standards at the Office of the National Coordinator of Health IT, at the board meeting.

Some critics have suggested that allocation of those funds should be deferred until interoperability standards are in place. But Loonsk, remarking on recent progress made in that area, told the board that a lack of technical standards is “no longer the major obstacle to advancing interoperability.”

He nonetheless conceded that implementing those standards “is very challenging.”

Business Insurance reported on another stimulus development. Congress is planning to provide a government contribution of the 50-60% of the COBRA continuation coverage premiums for workers who lose their jobs (perhaps subject to other eligibility criteria such as an earnings ceiling). The FEHBP analog is COBRA continuation coverage is TCC. The article does not explain whether the expected subsidy would be extend to TCC.

Finally, last week the Centers for Medicare and Medicaid Services (CMS) announced that the agency has

notified more than 3,000 of the nation’s hospitals that they will receive the full payment update for calendar year (CY) 2009 as part of the new Hospital Outpatient Quality Data Reporting Program.

The successful hospitals represent 99.3 percent of all hospitals that participated in the program that began in 2008 as an effort to strengthen the tie between the quality of care furnished to people with Medicare in hospital outpatient departments and the payments hospitals receive for those services.