Washington Beat

Washington Beat

By Michael Pretzer, Washington Editor

Regulation
Protecting patients' privacy isn't coming easy

Congress was supposed to pass a bill to safeguard medical records by August 1999. It's still thinking about what to do.

The Department of Health and Human Services was supposed to write regulations to safeguard medical records by February 2000. It's still thinking about what to write.

To be fair, HHS has moved more decisively than Congress. Last November, it published a set of tentative regulations and invited everyone interested to comment. What followed was an avalanche; some 40,000 responses poured in. HHS has delayed publication of its finalized regulations until, well, until it finishes digesting the thousands of opinions.

HHS must be a little disheartened right now. Many of the comments, at least from the medical community, are negative. The American Medical Association, for instance, rejects the regulations outright. They don't adequately protect patient confidentiality and privacy, and they substantially increase the administrative burden on physicians, says the AMA.

Here are some of the problems:

• The proposed regs permit providers, health plans, or "health care clearinghouses" to transmit medical records—without a patient's consent—for purposes of treatment, payment, or service to the public good. Recipients can range from billing companies to law enforcement agencies to medical researchers. The AMA argues that the permissible disclosures far exceed what patients imagine. With no regs, however, patients' records are protected only by inconsistent and often outdated state laws.

• HHS has no authority over legitimate recipients of medical records, such as researchers and billing outfits. Conceivably, these so-called "business partners" could transmit the records elsewhere. HHS has attempted to deal with this by requiring that providers keep tabs on their business partners. "To be responsible for monitoring and tracking all contractual agreements would be extremely costly and administratively difficult" for doctors and groups, says the America Medical Group Association. "Furthermore, noncompliance by a business partner could expose the physician to civil or criminal sanctions."

• The proposed regs say providers must not disclose more information than is necessary to the specific recipient. But who is to say what's necessary? "If those [who prepare the information for transmission] are not medical professionals, you run the risk of excising information that can be critically important to a physician or researcher," says the Healthcare Leadership Council, a coalition of health care executives that has been critical of some aspects of the proposed regulations. "If you assign nurses and physicians to review the data, you're taking vital resources away from patient care."

• As it stands now, patients have the right to inspect and copy their files, to know who has seen the records, and to amend them. But ensuring that patients see and amend their records—and are informed of every transmission—would be terribly expensive, says the AMGA.

• By law, HHS can regulate the transmission of electronic medical records only. The department has tried to broaden its jurisdiction by saying that its regulations also apply to records that become electronic. For a physician it will be difficult—probably impossible—to know what medical records are purely electronic, what records are now and will always be paper, and what records are paper on their way to becoming electronic.

• HHS wasn't authorized to write regulations that supersede state laws, and many see that as a problem. "Dual federal and state standards will only promote confusion on the part of patients, plans, and providers," argues the American Association of Health Plans.

HHS admits its regulations have shortcomings, mostly as a result of its limited authority. "We continue to urge Congress to pass comprehensive legislation," says a department spokesperson.

Tough Choices
The impact of patient protection on the uninsured

By most accounts, the passage of a patient protection act would increase the price of health insurance, thereby forcing some financially strapped people to drop their coverage. Collateral damage, the military would call it.

During the attempt to reconcile the Senate and House versions of the PPA, the discussion of the bills' impact on the uninsured sounded like generals talking about the number of war casualties they consider acceptable. Sen. James Jeffords, R-VT, a proponent of the Senate PPA, drew the line at 390,000 additional uninsured. Rep. Charlie Norwood, R-GA, a primary author of the House PPA, was willing to accept nearly 1.25 million—though he doubted the number would get that high.

Every 1 percent increase in premium costs drives 300,000 working Americans out of their health plans, Jeffords notes: "The Congressional Budget Office has estimated the House bill will increase costs another 4.1 percent, while the Senate bill provides the protections people really want at a cost increase of just 1.3 percent." Norwood countered that in "poll after poll, the people support the right to sue an HMO and all the other provisions in the Norwood-Dingell bill—even if the bill raised their health premiums by far more than 4.1 percent. We still believe the actual cost will be significantly less than the CBO estimate, maybe even zero, based on real-life experience with the Texas patient protection act."

In any case, a difficult tradeoff.

Collective Bargaining
Should physicians be exempt from antitrust laws?

A year ago, Rep. Tom Campbell, R-CA, introduced the Quality Health-Care Coalition Act, which would make it legal for doctors to bargain collectively with managed care organizations. It would not, however, give them the right to strike.

Many observers thought that HR 1304, as it's known, had no chance of passage and that the collective bargaining issue would be dead by now. But that's not quite the way it's playing out. Although the bill's future remains in doubt—the House plans to consider HR 1304 this year, but no one in the Senate has introduced companion legislation—the issue is alive and reasonably well.

The AMA is pushing hard for HR 1304, while the health plan trade group, AAHP, is fighting equally hard against it. A hypothetical debate between the two lobbying powerhouses would go something like this:

Is HR 1304 necessary?

AMA: Yes. Six giant health insurance companies now control the health care marketplace. These plans control quality, cost, and access to health care. Physicians have little or no opportunity to advocate for the best care. Independent physicians can jointly present information regarding patient care to health plans. But they have no ability to negotiate jointly. If physicians refuse to contract because a health plan won't listen, they risk antitrust charges and stiff penalties.

AAHP: No. Physicians can and do form organizations—group practices, IPAs, and PHOs—to gain leverage and negotiating strength. In addition, health plans have a variety of mechanisms that encourage physicians to help improve quality of care. In many of the areas, physician involvement is required by federal and state laws and regulations, National Association of Insurance Commissioners model acts, and private accreditation standards.

Isn't the real issue money, not quality?

AMA: No. HR 1304 is about giving health care professionals the power to negotiate all contract terms and conditions to promote quality health care. Many physicians are currently presented with contracts that, for example, prohibit discussion of treatment options, restrict access to specialty care, and contain payment schemes that limit medically necessary care. Those provisions are detrimental to patient care.

AAHP: Yes. Doctors' real complaint is that the antitrust laws prevent them from jointly negotiating fees. As Joel Klein, an assistant attorney with the US Department of Justice, testified before Congress, "Our investigations reveal that when health care professionals jointly negotiate with health insurers, [illegally and] without regard to antitrust laws, they typically seek to significantly increase their fees, sometimes by as much as 20 to 40 percent."

Would HR 1304 lead to more expensive health care?

AMA: No. The argument is a smokescreen. Every time physicians try to protect patients, insurers say the protections will drive up costs and increase the number of uninsured. Apparently it's okay to increase those things by raising premiums, but when it comes to patient protections, suddenly the plans are worried about costs and the uninsured.

AAHP: Yes. It would allow competing providers to raise prices and deny consumers the benefits of a competitive market. If providers can manipulate health care markets, fixing prices or collectively withholding or reducing services whenever it is to their economic advantage, consumers would be the losers.

What do the federal agencies that oversee antitrust activities think of the Campbell bill?

AMA: The Federal Trade Commission and the Department of Justice oppose HR 1304. Their opposition is based on academic theory, not the real world. They're afraid the bill would give health care professionals too much power. Today, health plans have all the power. Even though the antitrust laws were designed to protect the little guys from the big guys, nothing currently protects individual physicians from big insurers.

AAHP: Antitrust laws and enforcement are frequently misunderstood. Their objective is not to protect competitors—whether they're big or small, strong or weak, buyers or sellers, physicians or health plans. The basic purpose is to promote and preserve competition for the benefit of consumers. According to Robert Pitofsky, the FTC chairman, HR 1304 "would authorize a broad range of anticompetitive joint conduct that could seriously harm consumers."

The right to bargain collectively looms large for both the medical profession and managed care. Even if the Campbell legislation is voted down in the House or never gets to the Senate floor, debate over the issue will rage on.

Fraud 'N' Abuse
Telling doctors how to stay out of the slammer

During the past two years, HHS' Office of Inspector General has issued several sets of "compliance guidelines"—Washington-speak for a list of actions health care providers ought to take to lessen their chances of being charged with fraud in their dealings with Medicare and other federal health care programs. The guidelines have been aimed at hospitals, clinical labs, home health agencies, billing companies, and durable medical equipment companies.

Now it's physicians' turn. As early as next month, the OIG will publish guidelines for physicians practicing solo and in small groups.

In the previous guidelines, the OIG focused on seven items that it believes must be included in every "comprehensive compliance program." Many assume the physician guidelines will contain similar, if not identical, elements:

• Written policies and procedures.

• A compliance officer and committee.

• Training and education.

• Effective lines of communication.

• Publicized disciplinary procedures.

• Audits to monitor compliance.

• Procedures to correct fraudulent and abusive activities.

While organized medicine appreciates the pending guidelines, it has lots of reservations about the OIG's ability to create something applicable to solo and small group practices. OIG's medical-billing-company guidelines, which will be the model for the physician guidelines, run 36 pages and have more than 100 footnotes. Moreover, their recommendations are often impractical.

For example: "Every compliance program should require the development and distribution of written compliance policies, standards, and practices that identify specific areas of risk and vulnerability to the billing company. These policies should be developed under the direction and supervision of the chief compliance officer and the compliance committee (if such a committee is practicable) for the billing company and, at a minimum, should be provided to all individuals who are affected by the particular policy at issue." Concise, the guidelines are not.

Over the past few months, medical associations have offered advice to the OIG. In a nutshell, it's get real. "Omit the seven elements that have appeared in every OIG guidance to date," says the American College of Physicians-American Society of Internal Medicine. "Solo and small group practices are unlikely to hire a compliance officer, establish a compliance committee, perform background checks on every staff member, conduct formalized compliance training, perform audits, institute hotlines, or publicize disciplinary procedures and penalties."

The medical community has also suggested that OIG change its attitude. The word "compliance" has a pejorative connotation, complains ACP-ASIM, which thinks calling the guidelines "Helpful Tips for Properly Billing Medicare" would make them more palatable to doctors.

"It may not be appropriate to expect individual physicians and small groups to follow a rigid and cumbersome system to demonstrate that their intent is to be honest," adds the AMA. "Please understand that many physicians are distressed by the perceived need to take affirmative steps that simply demonstrate that they are complying with one of the very principles of medical ethics."

Why should doctors care about the guidelines at all? They're not compulsory. If they're stupid, just ignore them. Right?

Wrong. According to the American Medical Group Association, the government will be more inclined to give a physician who becomes the target of a fraud investigation the benefit of the doubt if he has set up a compliance program. ("A mitigating factor," the AMGA calls it.) So even if it rankles, it's wise for doctors to heed compliance guidelines.

The OIG has the responsibility of creating recommendations that are doable, observes AMGA. "Requiring compliance activities outside the reach of smaller and individual physician practices is unfair."

Children's Health
Pete Stark thinks Big Brother ought to take care of the kids

Rep. Pete Stark, D-CA, wants to create a new federal health care program, which he calls MediKids. At first glance, his idea seems sensible—and a little scary.

Stark is rather short on details right now, but here's what he envisions. Starting in 2002, every child born in the United States would be enrolled in MediKids—no exceptions. A child's parents would be taxed—to the tune of $180 a year, the congressman figures—to cover the MediKids premium. "The program will grow to ensure a source of health insurance to every child by the year 2023," explains Stark. "There'll be no means testing and no outreach problems. The program will exist as a safety net for children, regardless of income. It'll cover their health needs through changes in their parents' employment, marital status, and access to private insurance."

Aside from "coverage," however, Stark isn't saying what a MediKids kid will get from the program. He's leaving decisions about the benefits package to the secretary of the Department of Health and Human Services. But he offers some advice: The secretary should seek "input from the pediatric community."

Stark also isn't saying how much MediKids will cost the federal government. He suggests that money from the tobacco settlement plus revenue from the MediKids tax be used to fund the program for the first five years. After that? Well, Congress will doubtless come up with something.

Even Stark must admit that some things about MediKids are off-putting. Signing up every newborn for federal assistance seems overly bureaucratic, for instance. And having toddlers tote their MediKids cards to the pediatrician's office seems a bit Orwellian.

In addition, MediKids reverses the premise of most government assistance programs. Typically, they're need-based, and one must apply to get in. With MediKids, one is automatically in, and must maneuver to get out. The MediKids premium will be waived if proof that children have an alternate source of health insurance is included with a federal tax filing, says Stark.

Congress won't consider Stark's MediKids bill any time soon. The proposal is too brave-new-worldish, too much a stepchild of the single-payer health care system. But further down the road, who knows? Some ideas, including radical ones, linger a long time in Washington—until a day when people suddenly ask why Congress hasn't acted on something so sensible.

Michael Pretzer. Washington Beat. Medical Economics 2000;8:31.