CMS and HHS Release New Proposed Rules Governing Health IT – Part 1: Overview of Proposed Rule on “Meaningful Use”

Issues surrounding the implementation of health information technology (HIT) have not garnered anywhere near the amount of attention as issues such as the public plan, the intersection of abortion and health insurance, pre-existing condition provisions, etc. There are a variety of reasons for this.

First, HIT is not as accessible as these other issues. Discussions of HIT often involve the heavy use of acronyms as well as technical jargon that can be intimidating and confusing. This will not likely change in the future. HIT will increase in complexity, especially as variegated computer systems used by providers and hospitals are to be linked together.

A second reason for the lack of coverage of HIT is that there have been few if any significant steps on the federal level towards implementing a national HIT system. As I will discuss below, this is beginning to change, and this change provides for an important New Year’s resolution that all of those interested in health policy should make: stay informed about the changes in the HIT landscape. To make this resolution easier, I will write a series of posts describing the changes.

One of the more recent changes occurred with the passing of the American Recovery and Reinvestment Act (ARRA), and more specifically, portions known as the Health Information Technology and Clinical Health Act (HITECH Act). The HITECH Act initiated, among other things, an incentive-driven paradigm for transforming our health information system. The general idea is that physicians and hospitals will be paid for using HIT. However, in order for this transformation to take place, guidelines must exist such that physicians, providers and vendors of HIT products understand how to operate within this new system.

On December 30^th 2009, CMS and the Office of the National Coordinator of Health and Human Services (ONC), released two rules. ONC released an interim final rule regarding the standards that will govern the Medicare and Medicaid incentive program. Additionally, CMS released their proposed rule on what is considered meaningful use.

The interim final rule regarding the standards can be found here.

The proposed rule regarding meaningful use can be found here.

Meaningful Use

CMS’s proposed rule on meaningful use is important because it defines how physicians and providers must implement HIT in order to qualify for CMS’s incentive payments for the use of such technology.  Much of the proposed rule is based on the HIT Policy Committee’s proposals on Meaningful Use, but comments had been solicited and incorporated from other committees, HIT vendors, and providers. The proposed rule states that incentive payments will begin in 2011, and that there will be two different payment methodologies: one for Medicare and one for Medicaid. Those receiving incentives must choose either the Medicaid or the Medicare plan. Furthermore, the rule states that hospitals and providers that are not meaningfully using HIT will have their payments from Medicare reduced, with the reductions taking effect in 2015.

The HITECH Act amended the Social Security Act, and in doing so, incorporated a broad definition of what constitutes a meaningful user of Electronic Health Records (EHR). Specifically for a provider to be a meaningful user they must:

1. Demonstrate use of certified EHR technology in a meaningful manner;
2. Demonstrate to the satisfaction of the Secretary that certified EHR technology is connected in a manner that provides for the electronic exchange of health information to improve the quality of health care such as promoting care coordination, in accordance with all laws and standards applicable to the exchange of information; and
3. Use its certified EHR technology, submits to the Secretary, in a form and manner specified by the Secretary, information on clinical quality measures and other measures specified by the Secretary.

The proposed rule is an extension of this definition, and aims to provide those EPs and hospitals with the proper information to become a meaningful user.

Specifically, the rule provides for two classes of providers to participate in the incentive system: eligible professionals (EPs) and hospitals.  EPs are defined as non-hospital-based physicians, who either receive reimbursement for services under the Medicare Fee-For-Service program (FFS) or have an employment or contractual relationship with a qualifying Medicare Advantage organization (MA); or healthcare professionals meeting other requirements. (See page 22 of PDF). Hospitals are defined as hospitals that either receive reimbursement for services under the Medicare FFS program or are affiliated with a qualifying MA organization as described in section 1853(m)(2) of the Act; critical access hospitals (CAHs); or acute care or children’s hospitals. (See page 22 of PDF).

Transitioning to the meaningful use of EHRs will be phased in, taking place in three stages. On page 40 of the proposed rule, CMS describes the stages as follows:

Stage 1 (beginning in 2011):  The Stage 1 meaningful use criteria focuses on electronically capturing health information in a coded format; using that information to track key clinical conditions and communicating that information for care coordination purposes (whether that information is structured or unstructured, but in structured format whenever feasible); consistent with other provisions of Medicare and Medicaid law, implementing clinical decision support tools to facilitate disease and medication management; and reporting clinical quality measures and public health information.

Stage 2: Stage 2 expands upon Stage 1 to use HIT for continuous quality improvement at the point of care and the exchange of information in the most structure format possible, such as the electronic transmission of orders entered using computerized provider order entry (CPOE) and the electronic transmission of diagnostic test results such as blood tests and nuclear imaging tests.

Stage 3: Stage 3 focuses on improving the quality, safety, and efficiency of health care, focusing on decision support for national high priority conditions, patient access to self-management tools, access to comprehensive patient data, and improving public health.

The proposed rule that was recently released only describes the specific criteria for Stage 1, with the criteria for Stage 2 and Stage 3 to be released at the end of 2011 and 2013 respectively. In terms of Stage 1 criteria, there is a hierarchy of organizational structure. At the broadest level there are “health outcome policy priorities.” Within each of these policy priorities there is a group of “care goals,” and associated with each group of care goals are the specific “objectives.” CMS has provided a very helpful table which breaks down the hierarchy, including the various objectives. I have extracted the table, which can be accessed here. However, for reference purposes, I have summarized the organization below, and provided the objectives for the first health policy priority. Note that there is a different list of objectives for hospitals, many of which are similar or identical.

The organization is as follows:

Health Outcome Policy Priority 1: Improving quality, safety, efficiency and reducing health disparities.

Care Goals: 1. Provide access to comprehensive patient health data for patient’s healthcare team 2. Use evidence-based order sets and computerized provider order entry (CPOE) 3. Apply clinical decision support at the point of care 4. Generate lists of patients who need care and use them to reach out+ to those patients. 5. Report information for quality improvement and public reporting.

Objectives for Eligible Professionals (EPs): 1. Use Computerized Physician Order Entry (CPOE) 2. Implement drug-drug, drug-allergy, drug-formulary checks. 3. Maintain an up-to-date problem list of current and active diagnoses based on ICD-9-CM or SNOMED CT®. 4. Generate and transmit permissible prescriptions electronically (eRx). 5. Maintain active medication list. 6. Maintain active medication allergy list. 7. Record demographics 8. Record and chart changes in the following vital signs 9. Record smoking status for patients 13 years old or older. 10. Incorporate clinical lab-test results into EHR as structured data. 11. Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, and outreach. 12. Report ambulatory quality measures to CMS (or, for EPs seeking the Medicaid incentive payment, the States) 13. Send reminders to patients per patient preference for preventive/follow-up care. 14. Implement five clinical decision support rules relevant to specialty or high clinical priority, including for diagnostic test ordering, along with the ability to track compliance with those rules. 15. Check insurance eligibility electronically from public and private payers. 16. Submit claims electronically to public and private payers.

Health Outcome Policy Priority 2: Engaging patients and families in their healthcare

1. Care Goal 1: Provide patients and families with timely access to data, knowledge, and tools to make informed decisions.

Health Outcome Policy Priority 3: Improving care coordination

1. Care Goal 1: Exchange meaningful clinical information among professional health care team.

Interestingly, for CPOE, EPs are required to use CPOE for at least 80 percent of all orders whereas hospitals are only required to use CPOE for 10 percent of orders. Why such a discrepancy exists is presently unclear.

In terms of the requirement for reporting clinical quality measures (as described in the original definition of meaningful use in the HITECH Act), the proposed rule adopts different measurements for EPs and hospitals. For EPs, the proposed rule utilizes the quality measures endorsed by the National Quality Forum (NQF) including selected for the Physician Quality Reporting Initiative (PQRI) program that had previously been endorsed by the NQF. For hospitals, the measures are a combination of the NQF measures and those measures from the Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU).

Reporting of these clinical quality measures would be accomplished by one of three methods. The primary method would require EPs or hospitals to log onto a CMS-designated portal and upload the clinical quality data in a specific data structure (as defined by the ONC’s standards). Alternatively, data could be submitted through a Health Information Exchange(HIE)/Health Information Organization (HIO) depending on whether the Secretary can access that network. Another alternative is submission through registries dependent upon the development of the necessary capacity and infrastructure to do so using certified EHRs. See page 169 of the PDF for more details on the uploading process.

As discussed earlier on this blog, one aspect of the transition that remains to be addressed is whether the incentives provided to EPs and hospitals will be sufficient to encourage physicians to take on the initial outlays associated with EHRs. H.R. 3014 ,a bill to provide loans guarantees to solo and small group practices, has been passed by the House and is currently being reviewed by the Senate Committee on  Small Business and Entrepreneurship. Without such measures to spur the initial implementation of EHRs, the incentives or downward payment adjustments may not be sufficient to implement the bold plan set out by CMS.

Convergence on Health Reform (Death of the Public Option)

Thomas (Tim) Greaney

Saint Louis University School of Law

So maybe the two parties are coming together on health reform after all.   Last night we learned that after days of “secret talks” among the “gang of ten” the Democrats have reached agreement to restructure their health care proposal.  The changes are significant:

• ditch the already-watered-down public option plan;
• create a new insurance exchange “option” for individuals and small groups consisting of a nonprofit plan as negotiated by the Office of Personnel Management;
• expand Medicare eligibility to cover uninsured individuals aged 55-64.

What does the Democrats’ “public option ultralight” compromise have  in common with Republicans’ alternative universe?  Well, consider the latter’s proposal to open interstate competition for all health insurers–a move they promise will immediately lower health care costs.   Besides being shameless attempts to offer simple solutions to complex problems, the two proposals are guilty of the same fundamental misunderstanding of health insurance. Simply put, they both ignore a critical economic truth of health insurance today: insurers require a provider network of hospitals and doctors or must have market leverage in order to negotiate for lower provider prices and for controls on excessive volume.

How, then, would a nonprofit insurer not presently competing in one of the concentrated markets succeed in putting competitive pressure on the incumbents?  As one insurance industry observer put it ,

So, Kaiser Permanente, which operates with highly organized and capital intensive networks in its markets, would now come into a state where it has no networks and offer a plan? Blue Cross of Nebraska might offer an individual and small group plan in Rhode Island? Tufts Health Plan out of Boston might offer a plan in Oregon?

Based upon what network of providers in those places where they do not now do business?

Likewise, in expanding Medicare, the Dems are taking a page out of the Republican playbook. For the last several weeks,  Senate Republicans have been loudly touting the benefits of Medicare.  By their lights, not only does the program produce unmatched (and untouchable) health care services in terms of quality of care and beneficiary satisfaction, but any cost-cutting constitutes a betrayal of our commitment to seniors.  As far as one can tell, the expansion proposal will do just that: offer the now-sacrosanct program to a few million almost-seniors.  As to the other 20 million citizens, forced to shop for insurance through an exchange flawed by inadequate competition and inadequate subsidies? Well, maybe the Democrats will borrow the rhetoric of Republican National Chairman Michael Steele: this is no time for a “government-run health-care experiment.”

Holiday Shopping for Health Care

With Black Friday done and out of the way, one cannot help but wonder if any Americans were bargain hunting for health coverage.  After all, barring exigent circumstances, in the current health care market, shopping around to compare prices seems like an economically sensible thing to do.  Individual health care plans have been charging higher and higher premiums; the rate of uninsured Americans is increasing, and those who are insured increasingly face greater deductibles and out-of-pocket expenses. Price can make a real difference.

One uninsured women in Seattle used PriceDoc.com to comparison shop to see which health care providers in her area provided the cheapest gynecological exam.  She said that the only real comparisons she made while searching for health care was price.  In the end, the Seattle woman was able to access what she considered to be quality care at a price she could afford.  But there is that old joke about the perils of looking for bargains in parachutes and brain surgeons to consider. A sheer price comparison implies fungible service.

Congress members are currently in the process of doing their own bargain hunting for health care that won’t break the country’s bank.  While Republicans are said to fear that insurance premiums will increase under the proposed health reform models– partly due to increased taxes on insurers, Democrats counter that the strict regulations to be imposed on insurance companies will drive costs down.  Democrats further talk about the benefits of the health care exchange model, in which the individual market will not be able to deny coverage or charge higher premiums based on preexisting conditions, age rating, or gender rating.  The Center for Studying Health System Change says that these rules, if set in place, will directly lower the premiums that people with medical problems and women will pay.

The Obama Administration has commended the House and Senate bills for incorporating cost-cutting tools.  As a guideline for measuring the cost-effectiveness of the health reform proposals, the Obama Administration has identified four pillars– as found in Ronald Brownstein’s “A Milestone In the Health Care Journey.” Those pillars are:

1.      Taxes on high-end health insurance plans;

2.      Payment reforms that focus on incentivizing doctors to provide quality, coordinated care;

3.      An independent Medicare commission to contain costs; and

4.      A bill that is at least deficit-neutral over the next ten years.

The House and Senate bills incorporate each of the pillars to varying degrees, with the Senate bill thus far the most inclusive.  Congress members say that such principles–and specifics– will be heavily discussed in the coming weeks of debate.

While Americans wait for reform to ring in easier times, they may, however, be left to fend for themselves.  In case you were hoping to give the gift of better health care to a loved one, check here to compare plans, and use these helpful tips to save money on health care.  And don’t forget to schedule necessary appointments to  use what’s left of your current health care allowances before benefits get taken away by the start of a new year!

“15 Years or 7 to Pay Off Your Debt. . .”

I have been watching the Alex Gibney documentary film version of Maggie Mahar’s book Money-Driven Medicine. It’s fascinating, and I’ll definitely do a few more blog posts on it. For now, I’d like to reflect on a quote from early in the film, from a Dr. Berwick who’s been a keen observer of the US health system. He notes that physicians who are specialists do lots of compensable and specific procedures, and therefore usually earn much more than primary care doctors, leading to an artificial glut of specialists. I’d known this for some time, but Dr. Berwick makes the fact particularly compelling by comparing the concrete choices faced by med students: “15 years or 7 to pay off” their educational debts. It’s no wonder there are so many specialists.

The quote reminded me of Jesse Larner’s recent idealized “health care speech” for President Obama, which would promise a “publicly paid medical education for qualified medical students, researchers, and other health care workers so that the profession is open to all who are bright and dedicated, regardless of financial resources.” Just as our tax code pushes the average citizen toward unnaturally high levels of debt via the mortgage deduction, medical education financing currently is biasing physicians toward unsustainable debt loads that ultimately drain the public weal by fueling an entrepreneurial mindset in a profession founded in the public interest.

The US already has some limited loan forgiveness programs for physicians who work in underserved regions. It is time to expand these subsidies to cover more physicians working in primary care.

More Institutional Health Economics, Please!

Today’s Nobel Prize award for institutional economists Oliver Williamson and Elinor Ostrom is a welcome step toward methodological pluralism in the profession. Both have looked outside markets to understand the organization of economic life. Ostrom is not even an economist–she is a political scientist by profession. As Bob Shiller observes:

This award is part of the merging of the social sciences. Economics has been too isolated and too stuck on the view that markets are efficient and self-regulating. It has derailed our thinking.

According to the NYT, “The Nobel judges, in their description of Mr. Williamson’s and Ms. Ostrom’s achievement, said that ‘economic science’ should extend beyond market theory and into actual behavior, and the two award winners, in their empirical work, had done this.”

There is a great need for more of this type of work in health economics. Joe White’s Markets and Medical Care: The United States, 1993–2005 is one good exemplar of needed work here; he eschews “discussions of how economic theory can be applied to medical care production and delivery” and instead “focuses on ‘the market’ in its actual, not theoretical, form, as it existed in the United States.” White describes case after case where consolidation, not medical need, drove industry structure. He leaves the reader with a clear and convincing image of a space where varying levels of provider and insurer power, not productivity, is the key to understanding changes in the profitability of services. I’ve seen few better brief explanations of rising medical costs than the following: Read more