By Jane Norman, CQ HealthBeat Associate Editor

February 1, 2011 -- States were scrambling to figure out how and if to implement the health care law after a federal judge in a multi-state legal challenge in Florida ruled the entire measure is unconstitutional.

On the day after the ruling a second prong of the GOP-led attack on the law materialized in the Senate where Senate Minority Leader Mitch McConnell, R-Ky., sought to attach a health law repeal as an amendment to a pending Federal Aviation Administration reauthorization bill.

All of this is happening while state lawmakers in session around the nation have begun work on dozens of bills they would need to pass in order to comply with the law.

Some states that are plaintiffs in the suit appeared ready to stop implementing the measure, though details of how they would do that and for which parts of the law was not clear.

In Wisconsin, Attorney General J.B. Van Hollen said in a statement that District Court Judge Roger K. Vinson did not issue an injunction to stop the law, but that Vinson said in his decision that the declaratory judgment he made deeming the law unconstitutional was the "functional equivalent" of an injunction.

"This means that, for Wisconsin, the federal health care law is dead—unless and until it is revived by an appellate court," said Van Hollen, a Republican. "Effectively, Wisconsin was relieved of any obligations or duties that were created under terms of the federal health care law."

Steve Means, executive assistant for the Wisconsin Department of Justice, said in an interview that how the court decision is applied in practical terms will have to be discussed by Van Hollen and Gov. Scott Walker, a Republican. Other states face similar decisions, he said. But, Means said, "when a law is declared unconstitutional, it's taken off the books."

In Florida, Republican Gov. Rick Scott, a longtime foe of the law, told reporters that he doesn't see the point of continuing to implement the measure.

According to the Orlando Sentinel, Scott said that he has no plans to phase in any provisions that would take effect between now and whenever the Supreme Court might render a decision, perhaps in 2012. "I've personally always believed it was going to get repealed or declared unconstitutional, because it's a significant job killer," Scott said. "We're not going to spend a lot of time and money to try and get ready to implement that."

Administration Defends Law

Obama administration officials continued to insist that Vinson's decision in favor of a 26 states who brought the suit was wrong and simply one opinion of one judge in one court.

"Implementation will continue," said Stephanie Cutter, White House director of special projects, in a blog post. Two other federal district court judges have upheld the law, she stressed. Expectations are in the U.S. Supreme Court that ultimately will decide on the law's legality.

But legal experts suggested that the Obama administration might have to quickly seek a stay of the decision to keep the health care law's implementation on track in state legislatures and on the federal level. Unlike an earlier decision by a Virginia judge that only declared the individual mandate that goes into effect in 2014 as unconstitutional, Vinson ruled against the entire law and its provisions currently in effect.

If the Justice Department can't get a stay from a district or appellate court, or if the states challenge such a stay, the issue might be sent to the Supreme Court.

That could possibly provide an early look at the justices' sentiments when it comes to the health care law, said Brad Joondeph, a law professor at Santa Clara University who's been closely following the suits. "My guess is they will seek a stay," he said.

A Department of Justice spokeswoman said that lawyers were continuing to analyze the decision and decide what steps, if any, to take prior to an appeal to the Court of Appeals for the 11th Circuit in Atlanta.

Cutter said that the Department of Justice "has made clear that it is reviewing all of its options in responding to this case, as it does in all cases."

GOP AGs Differ On Implementation

A parade of Republican attorneys general and governors appearing on Fox News offered varying perspectives on what they'll do in the meantime, though they agreed they'd like the Supreme Court to settle the issue quickly.

South Carolina Gov. Nikki R. Haley said she planned to contact other governors and send a letter to President Obama asking him to expedite a Supreme Court ruling. "You know, this is something that you've got every state in chaos," said Haley. "We've got to make sure that we are taking care of this quickly so that we can move forward with our states."

Texas Attorney General Greg Abbott said on Fox that he's told state lawmakers that the ruling is important but it's still unclear what the Supreme Court will decide. "I think it is prudent for our legislature to continue making preparations so we can be ready in the event this district court ruling is overturned," said Abbott.

Michigan Attorney General Bill Schuette, asked if his state would operate as if the law did not exist, said, "Well, the judge made it clear in his declaratory ruling that he expects federal officials to adhere to his judgment. What I'm going to do is talk to the governor. We have a great new governor in the state of Michigan. We'll talk this through."
State legislatures, though, are at work on initiatives related to the health care law, said Richard Cauchi, program director for health at the National Conference of State Legislatures. He said lawmakers are in session now in 44 states and the NCSL has identified at least 250 bills related to implementation, with more likely to be introduced because some legislatures have only been in session a short time.

Cauchi said that more than 70 state bills deal with consumer protections, patient appeals, premium rate reviews, medical payouts, coverage for those with preexisting conditions and child-only insurance. "Many others address the question of establishing a state-administered exchange," he said in an e-mail. "Others propose structures, funding and authorization, Medicaid adjustments and other specific areas. More than 50 bills propose that their state challenge or not participate in certain elements of reform."

Obama administration officials and congressional Democrats defended the law in the aftermath of the ruling. "It would be a real mistake to have this law go down," said Centers for Medicare and Medicaid Services (CMS) Administrator Donald M. Berwick, speaking to reporters after a briefing on accountable care organizations at the Brookings Institution. "The benefits to seniors and to the country as a whole are enormous."

And Senate Finance Committee Chairman Max Baucus, D-Mont., an author of the law, noted that "the score is two to two" on court rulings, with two judges declaring the law unconstitutional on its merits and two upholding it.

"It'll be resolved by the Supremes," said Baucus. "We'll have to wait and see what that is." Asked if some states are dragging their feet now on implementation, he said it depends on the political makeup of states.

"Some states, I'm sure, are following verbatim repeal provisions that are proposed in other states," he said. "It's regrettable, but it happens. I just urge people in all areas, including this one, just to listen to the other side."

The Senate Judiciary Committee will hold a hearing on the constitutionality of the health care law that will feature both supporters and opponents. Witnesses will be John Kroger, the Oregon attorney general; Randy E. Barnett, professor of legal theory, Georgetown University Law Center; Michael A. Carvin, partner, Jones Day; Walter Dellinger, professor emeritus of law, Duke University School of Law; and Charles Fried, professor of law, Harvard Law School.

By John Reichard, CQ HealthBeat Editor

February 3, 2011 -- Medicare beneficiaries living in an area with a larger supply of doctors aren't any more satisfied with physician care and aren't able to spend more time with their doctors than beneficiaries living in areas with fewer physicians, according to a new study.

Based on a survey of 2,515 Medicare patients living in different parts of the country, the study also found no significant differences in access to specialists or availability of tests. The study was done by researchers from the Dartmouth Institute for Health Policy and Clinical Practice and the Centers for Medicare and Medicaid Services.

"Our results suggest that simply training more physicians is unlikely to lead to improved access to care," the researchers concluded. "Instead, focusing health policy on improving the quality and organization of care may be more beneficial."

The survey included 12 questions relating to perceptions of care and access. It found that in areas with the highest concentration of doctors, 95 percent of respondents said they have a personal physician, while in the lowest-concentration areas, 94.5 percent of respondents said they had one. A total of 88.7 percent in high-concentration areas said they had a primary care doctor as a personal physician compared to 89.3 percent in lowest-concentration areas.

When asked if their doctors always or usually spent enough time with them, 88.4 percent of respondents living in high-concentration areas said yes while 85 percent of those in low-concentration areas said their doctors did.

On a scale of one to 10, the proportion of beneficiaries giving their doctors an overall rating of 9 or 10 in terms of satisfaction of care was 56.5 percent in high-concentration areas compared to 58.8 percent in low-concentration areas.

"Policy discussions . . . often focus narrowly on potential workforce shortages based on physician supply per se," the researchers wrote in the study, posted by the policy research publication Health Affairs. "This happens despite the complexity of estimating workforce requirements and the fact that having a large workforce does not guarantee high-quality care."

Rather than simply invest in increasing the number of doctors in a given area, it might be possible to improve access to and satisfaction with care through less costly means, such as practicing in better-organized networks or at a more local level, the study suggested.

By John Reichard, CQ HealthBeat Editor

February 3, 2011 -- A day after he was hailed by health information technology developers at a Health and Human Services press conference as a "rock star," National Coordinator for Health Information Technology David Blumenthal announced he is stepping down.

A professor at Harvard before taking the post in early 2009, Blumenthal said in a memo to staff that "I will be returning to my academic home this spring, as was planned when I accepted the position."

While that may have been known to insiders, it wasn't known widely. His departure will raise questions about whether the momentum toward IT adoption that picked up with passage of health IT provisions in the economic stimulus law and their implementation under Blumenthal's leadership will be lost when he heads back north.

Blumenthal has been skilled at communicating the importance of the technology to lawmakers and the media, an attribute perhaps perfected because of his own lack of a technical background. Blumenthal quips that his wife is the one in his household that takes charge when the computer is on the fritz.

But he also has won praise from technical experts on the private sector side of IT, who joined in announcing recent strides in developing a national system of health information technology exchanges.

David Brailer, who preceded Blumenthal as head of the Office of the National Coordinator (ONC) for Health Information Technology, at once praises Blumenthal's contributions and says Blumenthal is not essential to continuing the momentum developed in IT adoption.

"What David did is turn the health IT movement and ONC from kind of an insurgency into an agency. David's turned it into a real agency that has real clout with real depth of working relationships with FDA and Medicare and Congress," Brailer said. "There are people like me who start new ideas and businesses, and people like David who turn it into a big successful thing." The depth of the agency will help carry IT programs forward, he added.

But Brailer said it's still an open question how widely doctors will take up health IT, despite strides made in areas such as funding, the creation of regional technical assistance centers, training of health IT technicians, and Medicare rulemaking to pay more to providers who make "meaningful use" of the technology.

With doctors continually facing Medicare payment cuts, it's not clear that incentive payments are going to be enough to spur their adoption of the technology, he said.

Brailer said he saw the departure coming because the tenure clock was ticking. "Harvard's one of the sticklers for 'you use it or lose it,' and if you don't go back on their clock, they have very little tolerance for people who do that."

Blumenthal's announcement to staff about his departure said "we still have important work to do together, including the assurance of a productive transition for ONC." But he pointed to hopeful signs concerning health IT adoption, while also noting various programs created under stimulus law provisions known as the Health Information Technology Economic and Clinical Health (HITECH) Act.

From 2008 to 2010 the percentage of primary care physicians who have adopted an electronic health record system climbed from 19.6 percent to 29.6 percent, he said. In addition, 41 percent of office-based doctors and 81 percent of hospitals said at the end of 2010 that they intended to take steps to qualify for higher Medicare payments made to those who meet the regulatory criteria for meaningful use.

HITECH allocated as much as $27 billion for incentives to adopt IT including the meaningful use standard. Blumenthal said the money is crucial but the key factor is the meaningful use concept developed in rulemaking. "Meaningful use provides, for the first time ever, a consensus goal on how information should be used to enhance care," Blumenthal told staff.

He also pointed to initiatives put in place with an additional $2 billion provided under HITECH. They include 62 "Regional Extension Centers" to answer questions from providers nationwide about adopting and running health IT systems, "with special attention to smaller primary care practices and rural hospitals."

An estimated 38,000 providers have registered for assistance from the centers.

Also, 84 community college programs have been established to help build a health IT workforce that includes training for nurses, physician assistants and other health care workers. Seventeen "Beacon" communities have been named to demonstrate how health IT resources have been pulled together to meet local health care needs.

The health industry has expressed during Blumenthal's tenure that government was pushing hard for IT adoption with no guarantees in place that the technology involved would be "interoperable" – that computer systems would work together. The meaningful use payments will hinge on whether the government has certified the technology used as interoperable, yet that program hadn't really gotten off the ground. But now a total of 291 electronic health record products have been certified as interoperable and therefore as qualifying for higher Medicare payments under the meaningful use standard.

HHS officials didn't immediately respond to queries on who might succeed Blumenthal or fill his spot on an acting basis. Farzad Mostashari, who oversaw health IT adoption by 1,500 providers as an official with the New York City Department of Health, serves as deputy national coordinator for programs and policy with the HHS Office of the National Coordinator for Health Information Technology.

By Rebecca Adams, CQ HealthBeat Associate Editor

If states had worked harder to get children the medical care they need and to enroll them in available insurance programs, 5 million more youngsters would be covered, 10 million more would have at least one preventive medical and dental visit each year and about 600,000 more would be vaccinated by age three, according to a new study.

Children's access to services varies dramatically depending on where they live, and even the best-performing states could do better, said the report from The Commonwealth Fund, a nonprofit health policy research group.

Coverage for children is seen as one of the health policy successes of the past decade: Roughly 10 percent of children do not have medical coverage, which is significantly better than the overall uninsured rate of about 17 percent.

Using existing data, researchers ranked states on 20 indicators, including access to insurance; the average cost of premiums; doctor visits; hospital admissions for asthma; child mortality, and the percentage of children with health problems, such as obesity or oral health problems. The study found that the top 14 states often did well in several areas, but that no state ranked in the top half of states on every measurement. In many cases, state laws or policies made a difference in improving medical care for kids.

Still, children in top-scoring states such as Iowa, Massachusetts, Vermont, Maine, and New Hampshire fared much better than those in low-performing states such as Florida, Texas, Arizona, Mississippi and, in last place, Nevada. Low-ranked states would have to improve their performance by about 60 percent to reach the level of states who scored best.

The data backing up the report's findings is not uniformly current, the study's authors acknowledged. Much of the data are from 2007 and some are as old as fiscal 2006. And that, said the researchers, is part of the problem. State officials should also do a better job of collecting and analyzing information that will indicate whether they are making progress toward goals to improve children's care, they said.

By John Reichard, CQ HealthBeat Editor

February 2, 2011 -- The Humphrey Building auditorium, with its dim lighting, is one of the dreariest venues for press conferences in Washington. So it bordered on the bizarre when a midday Health and Human Services press event on health information technology sounded more like the opening moments of a rock show at the 9:30 Club.

Fueling the excitement—whoops and hollers greeted each new speaker at the one-hour event—was the news that digitized health data has begun to flow from doctor to doctor or between doctors and hospitals under standards developed by Direct Project, a government-industry collaboration launched less than a year ago.

The standards aim to support the secure exchange of basic clinical information and public health data and spur the development of a nationwide health data exchange system.

HHS Chief Technology Officer Todd Park variously referred to the joint effort as "an explosion of mojo" and a "soon to be legendary" example of government-industry collaboration. David Blumenthal, the national coordinator for health IT who was hailed by another excited speaker as "a rock star," attempted to convey the importance of the project to the technophobic press.

Blumenthal (whose brother Richard is the new Democratic senator from Connecticut) explained that it's one thing to convert medical records into electronic form but quite another to actually transmit the digitized data from one health care setting to another.

Providers, government officials, and competing vendors and insurers have to agree on common standards for organizing medical information, easing its flow along computer systems and securing its privacy. "This is a way to get it out of your computer into someone else's computer," Blumenthal said.

Blumenthal made a couple of other attempts to explain Direct Project in layman's terms.

"I'm trying to think of analogies here," he said. "If that system is a bridge over a river, then what we're announcing today is a huge pillar for that bridge." It is going to be "one of the elementary methods of letting information travel," he said.

Direct Project is part of a larger project, he said—to create "a nationwide, interoperable, private and secure electronic health information system. That set of words has kind of a numbing quality to it," Blumenthal acknowledged wryly.

"If you talk to people, one of the things they most want from their health care system is for their doctors and nurses who are located in different places to be able to share what they know about them; to be able to share the X-rays, the laboratory results, the notes, so that they don't always have to fill out that clipboard, they don't always have to repeat what drugs they're on—that somehow the health care system retains what the health care system knows about them."

Blumenthal's third time, perhaps, was the charm.

He resorted to a highway analogy. "This is a lane in the information highway. It's not the only lane, but it's one lane that is easy to use, it's quick, the on ramps are simple, the off ramps are simple," he said.

An example of that is that the standards developed allow medical data to be transmitted via secure e-mail with attachments rather than by fax and through snail mail.

Some 200 participants from 60 companies and other organizations took part in development of the standards, which are being tested this year with the goal of formally adopting them and making them widely available for providers in 2012.

"It makes government a platform for innovation by those who really know the field," said Aneesh Chopra, White House technology officer. "Then it makes their work available for the public good, and it serves as a basis for competition among the very entities that brought it about."

Pilot programs that rely on Direct Project-based standards are already under way in Minnesota and Rhode Island. More pilots are planned in Tennessee, New York, Connecticut, Oklahoma, California, and south Texas.

In the Minnesota project, the Hennepin County Medical Center has been successfully sending immunization records to the Minnesota Department of Health. The Rhode Island project involves sending referrals from primary care doctors to specialists electronically, and making electronic health records available to providers, with the patient's consent, widely through a statewide information data exchange system.

Microsoft's Sean Nolan, who said he was "super excited to be here," said that next week the company's Health Vault product will be wired in a way that allows its users to obtain their digitized medical data more broadly thanks to the Direct Project standards. Health Vault is a free online product that allows individual consumers to gather their medical data in a single place and share it electronically.

Mark Briggs of VisionShare, a 10-year-old company that develops software to allow providers and insurers to transmit medical and financial data electronically, said at the briefing that "we're announcing today that VisionShare is making an investment of up to $50 million over the next year or so to provide the ability for all physicians, hospitals, and other health care providers across the country to join the network and transact over Direct."

That announcement was greeted with all the enthusiasm of an appreciative audience after a solid solo guitar riff.

"Wow!" another speaker interjected loudly, to the chuckles and applause of Direct Project participants who filled the front seats of the briefing room.

By Rebecca Adams, CQ HealthBeat Associate Editor

February 1, 2011 -- A proposal outlining the Obama administration's preferred ground rules for new accountable care organizations should be out within a month, says Donald M. Berwick, administrator of the Centers for Medicare and Medicaid Services.

And Berwick signaled that he may fund other experiments in coordination of care through the new Center for Medicare and Medicaid Innovation.

The health care law (PL 111-148, PL 111-152) called for CMS officials to fund a limited number of so-called accountable care organizations (ACOs), which are groups of health care providers who agree to be accountable for the quality, cost, and care of Medicare recipients. The ACOs could take a variety of forms, such as networks of physicians or partnerships between hospitals and physicians. These new groups would test out the concept by agreeing to care for at least 5,000 people for three years or longer. If an ACO saved money, then the medical providers who are part of the group would share in the savings.

Berwick declined to spell out what the proposed rule on ACOs will say, but he acknowledged that federal officials will have to sort through complicated and contentious issues. "It's going to be tough," Berwick said.

Among the potential questions that Berwick foresees:

• How will the quality of care for patients be measured? As Berwick noted, if measurements are too stringent, then fewer providers will be interested in participating.
• How will antitrust laws be relaxed so that providers can cooperate without being accused of monopolistic behavior?
• What kind of financial risk will providers have to assume in order to form an ACO?
• How can CMS officials make sure that the ACOs don't cherry-pick and recruit the healthiest patients to be part of a group, leaving sicker patients out of the network?
• How will patients be assigned to an ACO? Berwick said that the "law presumes choice," but it doesn't spell out the details of how seniors can join or be assigned to an ACO.
• When different medical groups join together, how can providers make sure that they're protecting patients' privacy?
• How can small practices get the capital to operate an ACO?

Berwick warned that he is looking for proposals that will represent significant shifts in how patient care is coordinated so that providers are really collaborating in a new way that respects patients' preferences.

"Parties will be out there who will wish to repackage the status quo. I don't think that will be enough," he said. "We're going to have to find a way to deliver care better. That means change."

As Berwick searches for the best models of coordinated care, the innovation center may separately fund what he called "pioneering" organizations that began working on such efforts without waiting for health law rules governing ACOs to be written. Groups funded by the innovation center aren't expected to have to adhere to the new ACO regulations.

Officials with the innovation center—which has been operating for two months and funded four major grants so far—are in the midst of a 60-day strategic planning process. Federal officials are coming up with a list of the type of projects that they want to support through federal financing. In remarks to reporters after the Brookings briefing, Berwick gushed about the structure of the innovation center, saying that it "allows us to move faster" than officials can by using the rulemaking process and can "invite reforms of exploration that wouldn't be possible" otherwise.