Massachusetts radiation therapy DON applications to be accepted October 1

At its July meeting held last week, the Massachusetts Public Health Council approved revisions to the Determination of Need guidelines for radiation therapy, finding need for an additional eight units.  This finding is based on population growth since the guidelines were last revisited, about seven years ago, and projected further growth.  The guidelines permit hospitals to expand existing radiation therapy programs outside of the eight-unit cap.  While one may debate whether there is a place for certificate of need (or, as we call it here in Massachusetts, determination of need) in today’s health care economy, the political reality is that it is not going away anytime soon.  Applications for radiation therapy projects may be filed on a special filing date of October 1, 2006. 

Medicare rates to increase for nursing facilities

CMS announced on July 27:

Medicare payments to nursing homes will increase by approximately $560 million in 2007. . . . 

The 3.1 percent increase will be reflected in Medicare payment rates to nursing facilities that furnish certain skilled nursing and rehabilitation care to Medicare beneficiaries recovering from serious health problems.

For further information, please see the CMS press release and the SNF PPS update notice.

Universal Health Care, Wal-Mart, Maryland and Massachusetts

Since the passage of the Massachusetts Universal Health Care Law, many folks have been wondering "what about ERISA pre-emption?"  (OK, maybe not that many.)  In a nutshell (and with apologies to ERISA lawyers), Federal ERISA law pre-empts state law that relates to insurance in the context of employee benefits.  Richard Bales, among others, has opined on his WorkplaceProfBlog that the Massachusetts law is pre-empted.  Others have taken the opposite view, in part due to the options afforded employers (“pay or play”).

This week, a federal judge struck down a Maryland law that required any employer with more than 10,000 employees in Maryland to contribute at least 8% of payroll to health insurance benefits (known as the Wal-Mart law because, you guessed it, the law applied to only one employer), holding that it was pre-empted by ERISA.  Feel free to peruse the decision and order, as well as commentary from bloggers in Maryland (Below the Beltway) and Massachusetts (A Healthy Blog).

This decision holds special interest for Massachusetts, since the universal health care law here has a similar "pay-or-play" provision.  The Massachusetts law, however, requires payment of $295 per employee, not 8% of payroll per employee.  The judge in the Maryland decision distinguished the Massachusetts law in a footnote, saying:

Of course, I am expressing no opinion on whether legislative approaches taken by other States to the problems of health care delivery and its attendant costs would be preempted by ERISA. For example, the Commonwealth of Massachusetts has recently enacted legislation that addresses health care issues comprehensively and in a manner that arguably has only incidental effects upon ERISA plans. In light of what is generally perceived as a national health care crisis, it would seem that to the extent ERISA allows, it is strongly in the public interest to permit states to perform their traditional role of serving as laboratories for experiment in controlling the costs and increasing the quality of health care for all citizens.

The key distinction for this judge between the Massachusetts and Maryland plans seems to be that the Massachusetts plan is more comprehensive. A more cynical view would be that the the “penalty” for noncompliance is significantly greater in Maryland, and that is what contributed to the decision going the way it did. It remains to be seen whether the state will appeal — and whether this decision emboldens any potential plaintiffs in Massachusetts.


Whither the retail-based clinic?

Over the years, various non-traditional models of health care delivery have sprung up and, more often than not, disappeared a short while later. 

Sometimes market forces bring about changes in traditional healthcare settings, such as same-day appointments in medical practices.  Sometimes they create new settings. One of the most powerful market forces in this field at present is consumer-directed healthcare (CDH), and one product of this force (and others) is the retail-based clinic.  In the main, these clinics are staffed by nurse practitioners and offer routine care in 15-minute encounters. 

Anybody who wasn’t paying attention to this phenomenon before this week certainly is now.  Business Week reports: 

On July 13, CVS Corp., the largest drugstore chain in the country, acquired Minneapolis-based MinuteClinic, the pioneer and largest provider of . . . retail-based health clinics in the U.S. "We’ve seen success by offering simple health-care solutions in the pathway of consumers," says Michael Howe, chief executive officer of MinuteClinic, which has grown from 19 clinics in two states to 83 in 10 states in just one year. The company plans to triple in size to 250 by the end of the year. The financial terms of the agreement were not disclosed.

Wal-Mart, Rite Aid, Osco and Walgreens all have arrangements with companies that have brought clinics into some of their stores as well.

This week, the California Healthcare Foundation published a timely report (pdf) on this phenomenon (summarized here), noting that these clinics are likely to take hold even in states with more stringent physician supervision requirements — such as California or my home state, Massachusetts.

CDH continues to be a very powerful idea, and the retail-based clinic is but one more arena in which this concept continues to be tested. It remains to be seen whether entrenched forces such as organized medicine and state regulators will act to slow or stop the retail-based clinics’ ability to make the leap from test markets to a nationwide presence, or whether they, together with payors, will work collaboratively to ensure that there is a rational framework within which these clinics can operate.

— David Harlow

No (patient) parking

CMS posted Survey & Certification Letter 06-21 on July 13.  The official summary reads as follows:

CMS has received reports from hospital emergency departments concerning patients being left on stretchers for extended periods of time with emergency medical service personnel in attendance, possibly in violation of the Emergency Medical Treatment and Labor Act. CMS recognizes the enormous strain and crowding many hospital emergency departments face every day; however, this practice is not a solution. "Parking" patients in hospitals impacts the ability of the emergency medical service personnel to provide emergency services to the rest of the community.

State survey agencies are required to disseminate this letter to the provider community by August 12.  This policy had been announced previously by CMS Region IV (Atlanta office) in December 2005 and by Region VI (Dallas) back in 2002.

There are many factors contributing to ED crowding, e.g., hospital closures, aging of the population, health insurance issues, diversion of ambulances as other EDs close to incoming ambulance traffic.  These factors are not likely to improve on their own in the near future, and will be exacerbated by seasonal and other issues as well (e.g., flu).  Due to the nature of the root causes of the problem, hospitals alone should not be held accountable for the solution.  In the near term, however, CMS is requiring that hosiptals and their ED staffs refrain from making this an ambulance service problem.

Does HIPAA work?

Development of a National Health Information Network (NHIN) — a uniform system of electronic health record architecture and interoperability — has been underway for a year or so under contracts awarded by U.S. HHS (see, e.g., last November’s award), and progress is monitored and reported through the National Committee on Vital and Health Statistics (NCVHS).

As reports this week:

Mark Rothstein, the influential privacy subcommittee chairman of [NCVHS] which provides guidance to HHS on implementation of the privacy regulation, sees the new [NHIN] as an opportunity to "rethink everything" related to the privacy rule.

In his recent report to HHS Secretary Mike Leavitt, Rothstein summarized testimony received over an 18-month period and made recommendations which confirm that he doesn’t think HIPAA is doing a very good job of maintaining confidentiality of PHI, a concern that is appropriately heightened in the face of the expansion of the use of EHR.  I think it’s worth listing all of his recommendations, just to get a sense of the scope of the issues highlighted by NCVHS as we come closer to having nearly ubiquitous EHR systems — whether through the eventual rollout of the NHIN or through the nearer-term development of various private EHR systems:

1. The method by which personal health information is stored by health care providers should be left to the health care providers.
2. Individuals should have the right to decide whether they want to have their personally identifiable electronic health records accessible via the NHIN. This recommendation is not intended to disturb traditional principles of public health reporting or other established legal requirements that might or might not be achieved via NHIN.
3. Providers should not be able to condition treatment on an individual’s agreement to have his or her health records accessible via the NHIN.
4. HHS should monitor the development of opt-in/opt-out approaches; consider local, regional, and provider variations; collect evidence on the health, economic, social, and other implications; and continue to evaluate in an open, transparent, and public process, whether a national policy on opt-in or opt-out is appropriate.
5. HHS should require that individuals be provided with understandable and culturally sensitive information and education to ensure that they realize the implications of their decisions as to whether to participate in the NHIN.
6. HHS should assess the desirability and feasibility of allowing individuals to control access to the specific content of their health records via the NHIN, and, if so, by what appropriate means. Decisions about whether individuals should have this right should be based on an open, transparent, and public process.
7. If individuals are given the right to control access to the specific content of their health records via the NHIN, the right should be limited, such as by being based on the age of the information, the nature of the condition or treatment, or the type of provider.
8. Role-based access should be employed as a means to limit the personal health information accessible via the NHIN and its components.
9. HHS should investigate the feasibility of applying contextual access criteria to EHRs and the NHIN, enabling personal information disclosed beyond the health care setting on the basis of an authorization to be limited to the information reasonably necessary to achieve the purpose of the disclosure.
10. HHS should support research and technology to develop contextual access criteria appropriate for application to EHRs and inclusion in the architecture of the NHIN.
11. HHS should convene or support efforts to convene a diversity of interested parties to design, define, and develop role-based access criteria and contextual access criteria appropriate for application to EHRs and the NHIN.
12. HHS should work with other federal agencies and the Congress to ensure that privacy and confidentiality rules apply to all individuals and entities that create, compile, store, transmit, or use personal health information in any form and in any setting, including employers, insurers, financial institutions, commercial data providers, application service providers, and schools.
13. HHS should explore ways to preserve some degree of state variation in health privacy law without losing systemic interoperability and essential protections for privacy and confidentiality.
14. HHS should harmonize the rules governing the NHIN with the HIPAA Privacy Rule, as well as other relevant federal regulations, including those regulating substance abuse treatment records.
15. HHS should incorporate fair information practices into the architecture of the NHIN.
16. HHS should use an open, transparent, and public process for developing the rules applicable to the NHIN, and it should solicit the active participation of affected individuals, groups, and organizations, including medically vulnerable and minority populations.
17. HHS should develop a set of strong enforcement measures that produces high levels of compliance with the rules applicable to the NHIN on the part of custodians of personal health information, but does not impose an excessive level of complexity or cost.
18. HHS should ensure that policies requiring a high level of compliance are built into the architecture of the NHIN.
19. HHS should adopt a rule providing that continued participation in the NHIN by an organization is contingent on compliance with the NHIN’s privacy, confidentiality, and security rules.
20. HHS should ensure that appropriate penalties be imposed for egregious privacy, confidentiality, or security violations committed by any individual or entity.
21. HHS should seek to ensure through legislative, regulatory, or other means that individuals whose privacy, confidentiality, or security is breached are entitled to reasonable compensation.
22. HHS should support legislative or regulatory measures to eliminate or reduce as much as possible the potential harmful discriminatory effects of personal health information disclosure.
23. NCVHS endorses strong enforcement of the HIPAA Privacy Rule with regard to business associates, and, if necessary, HHS should amend the Rule to increase the responsibility of covered entities to control the privacy, confidentiality, and security practices of business associates.
24. Public and professional education should be a top priority for HHS and all other entities of the NHIN.
25. Meaningful numbers of consumers should be appointed to serve on all national, regional, and local boards governing the NHIN.
26. HHS should establish and support ongoing research to assess the effectiveness and public confidence in the privacy, confidentiality, and security of the NHIN and its components.