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Washington -- Medicare's flagship Physician Quality Reporting Initiative has left in its wake a sea of annoyed physicians who say the pay-for-reporting program is being poorly managed by an unresponsive administration.

In July, more than a year after nearly 100,000 doctors started reporting quality measures to Medicare for the first time, the Centers for Medicare & Medicaid Services started sending out the first of more than 55,000 bonus checks to those who reported enough measures to qualify in 2007. In August, CMS began allowing participants access to confidential reports to let them know if they achieved the reporting threshold for the measures they chose -- or by how much they fell short. So far, the reviews from doctors on both processes have been largely dismal.

For starters, nearly half of the physicians who tried for a 1.5% bonus failed to get one, prompting doctors who never received the anticipated check to download their reports and find out why. But many who tried to access the documents were defeated by stringent security measures, and some gave up before they could see their performance. Those who did found the data useless in telling them how to improve quality.

If any physician participants were going to qualify for a bonus, William L. Rich III, MD, figured he would. The Falls Church, Va., ophthalmologist was an early and enthusiastic supporter of the pay-for-reporting initiative. He not only persuaded members of his own practice to participate but also helped bring on board many members of his profession through his role as the American Academy of Ophthalmology's medical director of health policy.

That's why Dr. Rich was shocked to find he was not one of the members of his practice who received a check for the 2007 run. He meticulously had researched the minimum three quality measures to report and changed his billing software to send data to Medicare automatically. Still, his feedback showed he reported measures for only about half of applicable patients instead of the required 80%.

93% of practices reported problems accessing Medicare's PQRI reports.

"I'm the poster boy for this program, and even I could not manage to get a bonus," he said. He suspects that CMS may have used faulty algorithms that assumed he should have reported more measures than were applicable.

Jeffrey E. Kaufman, MD, a urologist in Santa Ana, Calif., still doesn't know why he didn't qualify. The key section of his confidential feedback document that would tell him the answer contained no data. And he reached this point only after frustrating steps to access the report, a multistage approval process that requires each practice to designate a separate security officer and user group administrator. "You'd think you were getting CIA clearance," he said.

Jeffrey L. Kaufman, MD, a vascular surgeon in Springfield, Mass., is still trying to figure out if he even received a bonus because his practice is in the midst of a reorganization and the check possibly was sent elsewhere. But he cannot track that down until he accesses his report, and so far, the process has stymied him.

The situation is particularly frustrating because of his long history with Medicare, he said. "They know me, and yet they're making me go through all this rigmarole, and I still can't get the data."

Physician practices nationwide have similar gripes with the 2007 round of the Medicare PQRI and complain that CMS has been of little help.

In a survey released Sept. 8 by the Medical Group Management Assn., nearly 93% of practice managers said they had difficulty accessing quality feedback reports. Practices spent an average of five hours obtaining the documents from the CMS Web site. Of those who were successful in downloading the information, nearly 70% experienced no or low satisfaction with the reports in terms of helping to improve quality.

CMS cannot wait 18 months after the program year starts before giving physicians a clue as to whether they are reporting correctly, said William F. Jessee, MD, MGMA's president and CEO. "To truly improve patient care, programs such as PQRI must provide timely, actionable clinical information to physicians. Our data show the program has penalized practices trying to do the right thing for their patients by wrapping them in red tape."

The AMA also called for a much more extensive CMS education campaign, especially given doctors' low success rate. "It is clear from this alarming statistic that there is significant confusion among physicians about how to successfully meet the requirements of the PQRI," said AMA Executive Vice President and CEO Michael D. Maves, MD, MBA.

Preventing an exodus

An official said CMS was sorry doctors were having problems accessing feedback and getting questions answered. "These things ended up being more complicated than thought at first blush," he said, noting this was the first year of a multiyear effort.

Nevertheless, the agency is sure it approved bonuses only for those who legitimately deserved them, the official said. Physicians who expected an award and didn't get one should check with carriers to see if one should have been sent. If not, doctors should review their remittance advice notices to see if all necessary data -- such as quality codes and National Provider Identifiers -- made it to the carriers. No appeals process exists for physicians denied bonuses.

The administration and physicians who are still committed to the quality reporting initiative are now scrambling to urge other doctors not to give up on the PQRI amid the frustrations. Dr. Kaufman, the urologist, said his colleagues are starting to ask why they should bother going through this ordeal when they see such little chances for financial or quality gains.

The fact that doctors are uncovering PQRI's problems late in the game is troublesome because the initiative is ongoing, Dr. Rich said. He has all but given up on qualifying for a bonus in 2008, the first full year of the program, because he hasn't changed tactics from the last half of 2007. Still, he remains confident the process can be fixed before the 2009 cycle, when doctors will be vying for a 2% bonus.

"The percentages had better improve, or this program is in trouble," Dr. Rich said.

Illinois' certificate-of-need law and similar statutes in other states undercut consumer choice, stifle innovation and generally have failed to keep health care costs down, according to a joint statement by the Federal Trade Commission and Dept. of Justice.

The federal antitrust agencies reiterated these long-held positions at a Sept. 15 hearing before the Illinois Task Force on Health Planning Reform, commissioned by the Legislature last year to evaluate the state's law. The report -- which echoed the findings of a 2004 Justice Dept. study -- came after at least 14 states amended certificate-of-need laws earlier this year in the face of ongoing debates over whether such programs work as intended, according to the National Conference of State Legislatures.

Thirty-six states and Washington, D.C., have CON laws, which require physicians and hospitals to demonstrate a community need for new projects and services before receiving state approval to offer them.

"There really is a role for competition in health care delivery that can be quite important for consumers, not just in controlling certain areas of price growth but in all sorts of quality competition in terms of what is available where and to whom," said Daniel J. Gilman, an attorney and adviser in the FTC's Office of Policy Planning.

Task force members will take the joint statement into account when advising state lawmakers on the future of the statute.

36 states and Washington, D.C., have CON laws requiring doctors to demonstrate need for projects or services.

The American Medical Association has long opposed certificate-of-need restrictions, and the Illinois State Medical Society has advocated repealing the state law. The Association provided testimony to the Illinois task force in April echoing the government's stance that little evidence exists to suggest CON regulations effectively rein in health care costs or promote access to care.

The AMA and the government report pointed to a recent growth in specialty hospitals, ambulatory surgery centers and other physician-owned facilities that has brought convenience, lower costs and better technology to patients while spurring hospitals to improve their services.

"With competition, hospitals are going to have to make changes to make sure they take care of patients better, whereas if they have a monopoly, they don't care as much," said Gordon Lang, MD, a Chicago-area nephrologist who testified before the task force. "We have to look at how to best take care of patients. We're not here to make sure these companies continue to make a profit."

After spending roughly $80,000 going through the certificate-of-need process in 2004, Dr. Lang was defeated in his effort to open a dialysis center in St. Charles after the major local hospital successfully argued it had open capacity. Still, many vulnerable dialysis patients had to drive at least 30 minutes to get to the hospital, Dr. Lang said. Once there, they often faced long wait times for treatment.

The FTC's Gilman noted that the CON process raised the potential for antitrust abuses. The federal report cited enforcement actions against hospitals for allegedly delaying the process intentionally, driving up expenses with their objections or colluding to prevent outside competition.

Hospitals disagree

But hospitals rejected the government's conclusions.

Traditional competition principles do not apply to health care because it is a government-regulated industry in which Medicare and Medicaid fail to pay the full cost of care, said Howard Peters, the Illinois Hospital Assn.'s senior vice president of government relations. His organization testified in favor of keeping the CON law but supports reforms to simplify the process.

Without the CON process to weed out unnecessary duplication, "profiteers can come in and cherry-pick by engaging in only those services where people can pay" using private insurance, he said. That leaves community hospitals with the burden of covering indigent and uncompensated care, and it can undercut hospitals' ability to subsidize emergency or charity services, he added.

Dr. Lang said physician owners continue to provide their fair share of charity care.

Reform or repeal

The Illinois Task Force on Health Planning Reform is expected to submit its recommendations on the CON program to the Illinois Legislature in November.

"If we can't reform the circumstances surrounding certificate-of-need, we need to abolish it," said Sen. Bill Brady, a Republican member of the commission. "The [process] can't be there to maintain a monopoly" over providing health care services.

Brady suggested changes that would reduce the health care services or projects currently subject to the CON process, account for factors such as patient transportation time and require the review board to show the potential adverse effects of a particular proposal before rejecting it. He also recommended including members from the hospital and physician communities on the board.

The Ambulatory Surgery Center Assn. of Illinois supports similar reforms for what it deems one of the most stringent CON statutes in the country. "We're coming from the political reality that if there is going to be a system, it needs to be improved," said Mark Mayo, the organization's executive director.

Washington -- The American Medical Association in September stood with lawmakers from both sides of the aisle calling on Congress and the next president to cover the tens of millions of people without health coverage.

AMA President Nancy H. Nielsen, MD, PhD, joined Sens. Ron Wyden (D, Ore.) and Bob Bennett (R, Utah) and Rep. Michael Burgess, MD (R, Texas), in the U.S. Capitol on Sept. 18 to call for action on the problem of the uninsured, most recently estimated to number 45.7 million.

The AMA used the opportunity to unveil its new broadcast, print and online ads, which will run until the Nov. 4 elections. They are the newest element of the Association's Voice for the Uninsured campaign, which launched a year ago.

In one of the new print ads, a physician's image is accompanied by the statement: "I took an oath to help all patients. Without insurance, the people that need to see me the most don't come to see me." Another ad features a child whose parents can't afford health coverage.

"This is not a problem of the nameless, faceless individual," Dr. Nielsen said. "This affects all of us. It is time now to get to a solution."

Wyden has introduced the Healthy Americans Act, a universal coverage measure that is co-sponsored by Bennett. It would require every American to buy private health insurance and would establish state-run insurance purchasing pools to offer coverage.

The measure would replace the tax exclusion for employer-sponsored health insurance with a standard tax deduction for individuals and families. It would maintain Medicare and military health care but shift most of those covered by Medicaid or the State Children's Health Insurance Program to the new insurance pools.

Although the AMA did not officially endorse the legislation, the bill follows many of the Association's principles for universal health system reform, according to a May 6 letter from AMA Executive Vice President and CEO Michael D. Maves, MD, MBA. It would encourage individual ownership of and personal responsibility for health coverage, subsidies for lower-income individuals, private competition and a leveling of tax benefits for buying health insurance, Dr. Maves wrote.

The Healthy Americans Act, which has bipartisan support in both houses, has attracted increased attention since the Congressional Budget Office in May estimated that the bill would begin to slow the growth of health spending by 2014 if adopted this year.

"You can fix health care without a massive infusion of additional spending," Wyden said.

Wyden hopes to move the universal coverage legislation after the new administration takes over in January 2009.

Washington -- Physicians would receive additional Medicare funds to implement electronic health records systems under a bill introduced by Rep. Pete Stark (D, Calif.) in September. For doctors who did not take the government up on that offer, Medicare penalties would start kicking in just as the bonuses are tapering off.

The Health-e Information Technology Act of 2008 would provide yearly bonuses starting in 2013 to every physician who has put into operation a federally approved EHR. The total additional payments would max out at just more than $40,000 over five years. Those who did not have a system in place by 2016 would start receiving Medicare reductions eventually reaching 3% annually, unless the physician could obtain a five-year hardship exemption.

Other bill provisions would establish a federal advisory panel tasked with finalizing health IT standards by 2011, provide additional grant money and open-source technology to doctors who needed it, and employ new security rules for the protection of confidential patient data in EHRs. Medicare bonuses would kick in more quickly if the open-source technology becomes available before 2013.

"If we want a uniform, interoperable health care system in America, time has shown us that we can't depend on the private sector to do it on their own," Stark said. "This is the perfect role for government. We should work with stakeholders to develop the standards, ensure an affordable product is available and pay providers to adopt it."

Stark, who is the House Ways and Means health subcommittee chair, modeled his incentive plan on a Medicare electronic prescribing measure enacted in July. Under that law, physicians who use e-prescribing technology would receive federal bonuses starting next year but would see penalties starting in 2012 if they are not compliant with the mandate.

The American Medical Association, which supported the Medicare physician payment legislation that contained this requirement, gave a nod to the federal assistance in Stark's bill and in several other pending health IT measures in Congress.

"The AMA commends members of Congress, including Chairman Stark, for recognizing the importance of moving toward an interoperable, nationwide health IT infrastructure and for recognizing the crucial role the federal government plays in assisting the health care industry accelerate the adoption and implementation of health IT systems and tools," said AMA Board of Trustees Chair-elect Rebecca J. Patchin, MD.

Stark expressed an interest in quickly moving the legislation to the full Ways and Means committee for consideration. Congressional aides acknowledged, however, that action on the measure before the end of the session is unlikely given the short time frame and the issue's complexity.

The Stark bill may figure prominently in the health IT debate in 2009 because of its use of the dual financial incentive tracks for adoption, a concept that found legislative success in the e-prescribing debate earlier this year. Other pending bills incorporate bonuses for physician adopters but don't reduce pay for those whose patient records stay on paper.

The Bush administration stirred the medical community in August by proposing a regulation reinforcing protections for physicians who object to providing abortion-related services based on moral or religious beliefs.

While some doctors welcomed the measure in the face of what they say are increasing pressures to compromise their medical ethical standards, other physicians worried that its broad language could inhibit access to care if allowed to take effect.

The Dept. of Health and Human Services said its proposal, released Aug. 21, was intended to harmonize and clarify more than three decades of existing federal conscience laws. Those statutes allow the government to withhold or revoke federal funding from federal, state or local entities that discriminate against doctors, nurses and others who opt not to offer or cover abortion services.

The latest rule, which could become final following a 30-day comment period, would establish a mechanism for enforcing the existing conscience protections by requiring recipients of certain federal funds to certify in writing their compliance with the federal laws. It also would authorize the HHS Office for Civil Rights to review complaints of any alleged discriminatory actions.

"This proposed regulation is about the legal right of a health care professional to practice according to [his or her] conscience," HHS Secretary Michael Leavitt said. "Doctors and other health care providers should not be forced to choose between good professional standing and violating their conscience."

An earlier draft of the rule floated in July included language abortion-rights supporters feared could apply to widely used contraception methods. It defined abortion as "any of the various procedures -- including the prescription and administration of any drug or the performance of any procedure or any other action -- that results in the termination of the life of a human being in utero between conception and natural birth, whether before or after implantation."

That language was dropped in the final rule. On his blog and in other statements, Leavitt said the definition of a woman's right to abortion would defer to long-standing court interpretations on the issue. He reiterated that the issue addressed in the proposal was not about abortion or contraceptives but doctors' conscience rights, which also are grounded in the First Amendment.

The proposed rule does not restrict health care entities from providing -- or patients from seeking -- legal medical services, Leavitt added.

Rule too vague for some

Some doctors and abortion-rights advocates worry that ambiguities in the scope of the regulation leave room for interpretation and ultimately could jeopardize access to care.

"Regulations are supposed to help clarify the law and help people comply with clear direction, but [this rule] just muddies the waters," said Susan Fogel, an attorney with the National Health Law Program, a national public interest law firm. The proposed rule, for example, extends protections to a range of health care workers who also "assist in" abortion or sterilization services. It also applies to "research activities."

"If I'm a physician and someone suddenly won't assist in my procedure or care for this patient, that interferes with the doctor-patient relationship," she said. This rule "says any employee in any part of the health care system might be able to step in and undermine the quality of care."

That could be especially troublesome for low-income patients who may not have the option of going elsewhere for care, Fogel said. In addition, the regulation fails to define clearly what types of actions, disciplinary or otherwise, might constitute discrimination.

Beth Jordan, MD, medical director of the Assn. of Reproductive Health Professionals, said the regulation would permit doctors' personal beliefs to trump medical science in the field of reproductive health. It "unabashedly expand[s] the power of individuals to refuse to provide even the most basic information, counseling on contraception and referral for important health care services."

The American College of Obstetricians and Gynecologists expressed similar fears in a letter to HHS contesting the initial draft of the rule. ACOG said it is reviewing the recent proposal and still has "grave concerns" that the document could limit access to legal health services.

The American Medical Association, in a letter addressing the early draft, voiced concerns that "several provisions and definitions are ambiguous, overly broad and could lead to differing interpretations causing unnecessary confusion and disruption among health care institutions and professionals."

At press time in mid-September, both the AMA and ACOG were drafting responses to the new rule.

Protecting physicians' rights

Other doctors and anti-abortion advocates praised the proposal for protecting what they say is a fundamental part of the practice of medicine.

"Those [medical] professionals who have moral objections ought to have rights just like any other citizen to opt in or out," said Gene Rudd, MD, senior vice president of the Christian Medical Assn. While in some cases that may involve denying contraception or referrals for abortion-related services, access to such care is readily available through other sources willing to provide them, he said.

Dr. Rudd cited examples of doctors missing training opportunities or leaving their jobs under pressure to participate in abortion activities. Leavitt said he proposed the regulation in response to ACOG guidelines that he feared put doctors at risk for losing their board certification for failing to participate. ACOG and the American Board of Obstetrics and Gynecology denied having such intentions.

"If we are going to turn health care into an over-the-counter transaction, we are toying with ideas that are going to undermine the doctor-patient relationship," Dr. Rudd said. Such an erosion could impact assisted suicide, end-of-life decisions and other issues.

Denise M. Burke, legal director of the anti-abortion group Americans United for Life, noted that the regulation does not expand on existing conscience protections but provides a compliance mechanism that did not exist before. "This is certainly going to increase the spotlight on the issue."