NHLBI is considering several proposals for large randomized controlled trials (RCT) assessing the impact of cardiovascular imaging on health outcomes. The ACC is sending a letter detailing our strong support for such a trial. A large RCT would address one of the major problems in CV care today: the lack of robust outcomes evidence to guide optimal use of new diagnostic imaging technology.

In our letter, we recommend to NHLBI that, “A successful trial will need to take an unbiased approach, emphasize real world effectiveness and compare the full spectrum of usual care with new technology across a variety of clinical practice settings.” We don’t offer specific support for any of the proposals, but it is our hope that NHLBI will fund a trial and that in the future, we will be able to help disseminate the much-needed data to our members.

Lots of news is coming from the state level: In New Mexico, ACC members have developed draft legislation establishing liability protection for physicians and nurses who respond to disasters. Other states will likely be added to this list later.

An Arizona bill proposes Appropriate Use Criteria and guidelines requirements for all medical services.

Arkansas lawmakers are following in the footsteps of their counterparts in Maryland with a bill that would ban self-referral.

In Kentucky, we’re hearing legislators may introduce a bill allowing PCI without surgical backup. A few of our Kentucky members feel the data from a pilot have not been sufficient to warrant the change.

Health care advocates in Pennsylvania successfully have blocked the proposed merger between Highmark and Independence Blue Cross. Opponents of the match argued that a merger could have serious anticompetitive effects and cause significant injury to physicians by lowering fees. This wouldn’t have happened without the AMA’s leadership. My old CMA General Counsel and colleague, Catherine Hanson, provided AMA’s legal background and arguments in this case — very impressive advocacy.

We met this week with Sen. Stabenow (D-Mich.) at her staff’s request to review how the College might develop a demonstration project around payment incentives for improved quality. While our strategy still is evolving -- it will be one of the big topics at the ACC Health System Reform Summit in Washington next week (Feb. 1 & 2) -- we need to get something on the table, even if we later ask for it to be amended. The Senator understands that we’re ready to pull ourselves out of the SGRrrrr muck and start working on real payment reform -- reform that will improve patient care and quality. It’s good to have a champion like her, and she is moving with our 7 – 10 percent payment increase for adherence to guidelines and improved quality concept. ACC President Doug Weaver, also a constituent, has really helped her become interested in this concept. More to come!

Sens. Grassley and Kohl have on Thursday introduced the Physician Payments Sunshine Act as promised. As not promised, a lot of our proposed amendments aren’t in there. It really isn’t traumatic, because there’s plenty of time for amendments, but here’s what they’ve done:

• They require pretty much ALL pharma and device manufacturers to report on gifts, payments, contributions, and even samples to physicians.
• At this time everything that exceeds $100 has to be reported.  I’m thinking that will get amended out in favor of a higher threshold.
• They also did not require that all the companies report to one common public Web site. Instead, at least in this version as I read it, each company reports on its own Web site. This makes it a lot less threatening because no one is going to take the time to look at all the infinite number of Web sites that will be up. I would suspect other members of Congress will want to see a common public site, but maybe that poses budgetary problems in these tight times for Congress. That said, other entities (like the Center for Science in the Public Interest) might fund a common site.
• It preempts less-demanding state laws, but allows more-demanding state laws to prevail.
• One of the reporting categories is the specialty of the physician. [For more details, see Policy and Medicine's post about it]

We should still support these Sunshine efforts. They will offset public distrust of those exceptions among professionals and companies who exercise bad judgment in their relationships with industry. We’ll work on adding some amendments that make this whole thing a bit more reasonable as it moves forward.

Congress is in the process of considering an $825 billion stimulus package, the “American Recovery and Reinvestment Act.” Among many provisions, the package would make a $1.1 billion investment in comparative effectiveness research. We hope the focus will be around actual patient value and science, rather than just cost effectiveness.

The stimulus package also would invest $20 billion in health IT. Of that amount, $2 billion would go to infrastructure and standards development, and the remainder would be used as incentive dollars for providers who adopt health IT. We’d like to see a good deal of that money going for incentive-based increases in payment for those who voluntarily report on meaningful measures to a workable and meaningful PQRI version 2.0 (the physician reporting program in CMS). It would be good to see the current 2 percent puny bonus go up to at least 6 or 7 percent and perhaps 10 percent for those who additionally report electronically. That would be a legit health IT adoption incentive.

Interestingly, all of Obama’s cabinet appointees are sailing through OTHER THAN Sen. Tom Daschle. He is a good man, but the Senate apparently is distressed over something in his tax records. There’s a frustrating silence about it, and a rumor that this may take a few weeks or more to resolve. I hope not, because without him centrally working for us as a champion, our part of the stimulus could be threatened.

More coverage of the health IT portion of the stimulus bill is available at EMR and HIPAA. Also, The Health Care Blog hosted a great discussion on "The Truth about Health IT Standards" on Friday.

… including the economic impact of physician-owned hospitals. These institutions will inject $2.3 billion into the Lone Star State’s economy this year. That’s more than in other states, including California, where there are only a few such facilities.  Physician-owned hospitals in Texas will also pay $86 million in property, payroll and income taxes. Texas law does not include a certificate of need policy for hospitals, which creates a friendly environment for physician-owned ventures. The law does, however, require physicians to disclose financial interest in a hospital to which they are referring patients. But the House version of sCHIP reauthorization proposed to tax only these hospitals (not all for-profits) to raise some of the money for the program. ACC thinks this is an ill-fated idea, and could reduce access for patients in some parts of the country, where these hospitals are the main sources of impatient care. We have conveyed that to the Senate.

UnitedHealth Group last week reached a record $350 million settlement — with no admission of wrongdoing — on charges it fixed the Ingenix database that determined what members paid out-of-network physicians. The suit was filed on behalf of health plan members, providers, the American Medical Association and state medical associations.

Sounds like we should have been with them.

The company also has entered into an agreement with the New York Attorney General that will create an independent pricing database to enhance the transparency of out-of-network physician fees. In a message sent to many medical professional societies, Reed Tuckson, M.D., Chief of Medical Affairs for United, says, "These settlements are a strong indication of our desire to further enhance the opportunities we have to work with you and your organization and directly with physicians to improve the quality and delivery of health care." Reed’s a good guy. But these activities weren’t good at all.

Last week week we released a congratulatory statement on the positive proposals laid out at the Senate Health, Education, Labor and Pensions (HELP) Committee’s Health IT hearing. I’m encouraged by the proactive position HELP is taking on promoting health IT adoption (with proposed big financial backing); we need to continue to encourage Congress and the new administration to support health IT — but, along with firm standards for interoperability. The statement says, "the money Obama's plan puts into the infrastructure will be wasted if interoperability standards are not also put into place." These standards will allow clinicians to access information from multiple sources to help make better informed medical decisions to avoid adverse drug events, and to encourage patients to adhere to evidence-based medication regimens.

More was cooking last week. The Progressive Policy Institute (a Blue-Dog Democrat think tank) also put out a statement promoting health IT investment that included a great deal of ACC policy consideration. With our help that statement did NOT include over-kill privacy protection language -- as first proposed -- that would place barriers in front of most chronic disease management, registries like NCDR, and interoperability. The patient should be able to protect and direct their data, but if requires affirmative authorizations at every step and every time information is exchanged, it can’t realistically occur. Maybe we need to mobilize the profession, along with consumer groups, to develop an “opt-in” unique patient identifier that would make all of this easier for patients who want their information available at the point of care (for life-saving reasons). Those greatly worried about privacy would not need to participate. The recommendations of the ACC Informatics Committee, chaired by Mike Mirro, M.D., F.A.C.C., have provided great input for these documents. [Mike contributed to the Lewin Report this month on health IT ... I encourage you to read and comment on his post.] The e-Health Initiative (we are members) also put out a very positive health IT promotion statement last week which we significantly helped to craft.

More health IT coverage in the blog-o-sphere this week:

• WSJ's Health Blog: E-Prescribing: Green Means Generic, Red Means Pricey Brand
• HealthBlog: Wielding Technology's Wonders to Improve Health in America
  

Bill Corr is an interesting choice for deputy secretary at HHS under Daschle. Usually this person is an administrative type without any health policy expertise. Corr was in fact chief of staff under Donna Shalala when she was secretary, but he spent the last four years as an executive at the Campaign for Tobacco Free Kids and is passionate about the issue — along with prevention in general. Looks like another interesting and wise appointment.

Beginning Tuesday, FDA Chief Scientist and Principal Deputy Commissioner Frank Torti became acting commissioner. There’s already an "acting" at NIH. Health and Human Services (HHS) announced the decision earlier this month, along with transition plans for the other key positions. Assistant HHS Secretary Charlie Johnson will take over when Michael Leavitt this week steps down. Johnson will serve as acting secretary until Secretary-designate Daschle takes office. CMS COO Charlene Frizzera will take over from Kerry Weems when he steps down this week.

In each case here, a civil servant is taking over as the acting director in place of the former Senate-confirmed appointee—because the appointees have been asked to resign by Bush, the Obama Transition, or both. Julie Gerberding at CDC wanted to stay, but was asked to go. Only one HHS key appointee did not get the resignation request: Carolyn Clancy, Director of AHRQ (Agency for Health Research and Quality). Why? Well, first, she’s one of few Dems appointed by the Bush Administration. But second, she’s great, and we work closely with her on many issues. Obama wants her to stay. This is good.