Government and Regulations

The Centers for Medicare & Medicaid Services (CMS) in November announced the official launch of the Center for Medicare & Medicaid Innovation (CMMI). The CMI was authorized under the Affordable Care Act (ACA) to test innovative ways to reduce costs, while preserving or enhancing the quality. This sounds very similar to many other reform initiatives, so why have a separate center when ACOs, value-based purchasing, and payment bundling already are in the ACA?

A quick glance at the CMMI website didn’t provide much detail beyond uplifting language about the promise that the center represents. Don Berwick, MD, the new CMS administrator, has even gone so far as to call the center the “jewel in the crown” of the ACA.

Inspirational language aside, the center can be summed up using a simple analogy: The “other” ACA initiatives (bundling, VBP, etc.) are like a factory floor. The tools are in place, the processes are more or less defined, and they will be carried out regardless of the degree of positive impact. CMMI is more like a research and development lab, with the freedom to tinker with new ideas before wide-scale implementation.

The keys to CMMI success are twofold. First, it will implement pilot projects rather than demonstrations. A pilot gives the Secretary of Health and Human Services the power to implement and expand promising projects without Congressional approval. A demonstration requires Congressional approval for its continuation.. Second, CMMI does not require proposals to be budget neutral. Initial training and staffing costs alone can disqualify a program on budget neutrality grounds. Since CMMI does not require budget neutrality, promising programs with significant start-up costs are less likely to be cast aside.

Dr. Berwick has asked for provider partnership and input, and says he “would like to help forge an unprecedented level of shared aim, shared vision, and synergy in action among the public and private stewards and leaders of healthcare.” This vision and a $10 billion appropriation over the next decade present a tremendous opportunity for SHM’s quality initiatives, and the promising hospitalist-created protocol.

However, this large appropriation presents both the greatest strength and the greatest threat to the center. With the Republican takeover of the House of Representatives, the CMMI budget likely is to be a target for the “repeal, replace, or revise” agenda. Therefore, increasing awareness of CMMI’s role will be imperative over the coming months. Hospitalists can help by educating themselves, then passing their knowledge along to those who might not understand the importance of the center. TH

The Centers for Medicare & Medicaid Services (CMS) in November announced the official launch of the Center for Medicare & Medicaid Innovation (CMMI). The CMI was authorized under the Affordable Care Act (ACA) to test innovative ways to reduce costs, while preserving or enhancing the quality. This sounds very similar to many other reform initiatives, so why have a separate center when ACOs, value-based purchasing, and payment bundling already are in the ACA?

A quick glance at the CMMI website didn’t provide much detail beyond uplifting language about the promise that the center represents. Don Berwick, MD, the new CMS administrator, has even gone so far as to call the center the “jewel in the crown” of the ACA.

Inspirational language aside, the center can be summed up using a simple analogy: The “other” ACA initiatives (bundling, VBP, etc.) are like a factory floor. The tools are in place, the processes are more or less defined, and they will be carried out regardless of the degree of positive impact. CMMI is more like a research and development lab, with the freedom to tinker with new ideas before wide-scale implementation.

The keys to CMMI success are twofold. First, it will implement pilot projects rather than demonstrations. A pilot gives the Secretary of Health and Human Services the power to implement and expand promising projects without Congressional approval. A demonstration requires Congressional approval for its continuation.. Second, CMMI does not require proposals to be budget neutral. Initial training and staffing costs alone can disqualify a program on budget neutrality grounds. Since CMMI does not require budget neutrality, promising programs with significant start-up costs are less likely to be cast aside.

Dr. Berwick has asked for provider partnership and input, and says he “would like to help forge an unprecedented level of shared aim, shared vision, and synergy in action among the public and private stewards and leaders of healthcare.” This vision and a $10 billion appropriation over the next decade present a tremendous opportunity for SHM’s quality initiatives, and the promising hospitalist-created protocol.

However, this large appropriation presents both the greatest strength and the greatest threat to the center. With the Republican takeover of the House of Representatives, the CMMI budget likely is to be a target for the “repeal, replace, or revise” agenda. Therefore, increasing awareness of CMMI’s role will be imperative over the coming months. Hospitalists can help by educating themselves, then passing their knowledge along to those who might not understand the importance of the center. TH

The Centers for Medicare & Medicaid Services (CMS) in November announced the official launch of the Center for Medicare & Medicaid Innovation (CMMI). The CMI was authorized under the Affordable Care Act (ACA) to test innovative ways to reduce costs, while preserving or enhancing the quality. This sounds very similar to many other reform initiatives, so why have a separate center when ACOs, value-based purchasing, and payment bundling already are in the ACA?

A quick glance at the CMMI website didn’t provide much detail beyond uplifting language about the promise that the center represents. Don Berwick, MD, the new CMS administrator, has even gone so far as to call the center the “jewel in the crown” of the ACA.

Inspirational language aside, the center can be summed up using a simple analogy: The “other” ACA initiatives (bundling, VBP, etc.) are like a factory floor. The tools are in place, the processes are more or less defined, and they will be carried out regardless of the degree of positive impact. CMMI is more like a research and development lab, with the freedom to tinker with new ideas before wide-scale implementation.

The keys to CMMI success are twofold. First, it will implement pilot projects rather than demonstrations. A pilot gives the Secretary of Health and Human Services the power to implement and expand promising projects without Congressional approval. A demonstration requires Congressional approval for its continuation.. Second, CMMI does not require proposals to be budget neutral. Initial training and staffing costs alone can disqualify a program on budget neutrality grounds. Since CMMI does not require budget neutrality, promising programs with significant start-up costs are less likely to be cast aside.

Dr. Berwick has asked for provider partnership and input, and says he “would like to help forge an unprecedented level of shared aim, shared vision, and synergy in action among the public and private stewards and leaders of healthcare.” This vision and a $10 billion appropriation over the next decade present a tremendous opportunity for SHM’s quality initiatives, and the promising hospitalist-created protocol.

However, this large appropriation presents both the greatest strength and the greatest threat to the center. With the Republican takeover of the House of Representatives, the CMMI budget likely is to be a target for the “repeal, replace, or revise” agenda. Therefore, increasing awareness of CMMI’s role will be imperative over the coming months. Hospitalists can help by educating themselves, then passing their knowledge along to those who might not understand the importance of the center. TH

Recent media reports about the dangers surrounding unused prescription medications, including abuse by teens and medications finding their way into the water supply, have prompted an increase in inquiries to healthcare providers about disposing of unused medication. These issues are complicated when controlled substances are involved.

Often, providers are unsure how to respond to patient questions about medication disposal. For example, what would you do if a patient requests an alternative medication because of an unwanted side effect and brings the originally prescribed medication back to you? What if the family of a recently expired patient brings unused medication to you and asks you to donate it to other patients? What if you have a colleague who performs mission work; could you accept and donate unused medication for use in another country?

Unfortunately, the Controlled Substances Act (CSA) does not provide a readily available mechanism to accomplish efficient, secure, and environmentally sound methods to collect and use or dispose of unwanted controlled substances. This article explains the rules physicians must adhere to and guidelines for “taking back” controlled substances.

The Legislation

Enacted in 1970, the CSA combined all existing federal drug laws into a single statute. It created five “schedules” in which certain drugs are classified. These “scheduled” drugs are commonly referred to as controlled substances. A drug’s classification depends on its potential for abuse and its currently accepted medical use in the U.S. Additionally, provisions of international treaties impact classification.

Under the classification system, Schedule I drugs have a high potential for abuse and have no currently accepted medical use in treatment in the U.S. In contrast, Schedule V drugs have a low potential for abuse and do have a currently accepted medical use in treatment in the U.S.

The CSA governs the manufacture, import, export, possession, use, and distribution of controlled substances. In doing so, the CSA established a system to register those authorized to handle controlled substances. Manufacturers, dispensers, distributors, and individual practitioners who prescribe controlled substances must be registered with the Drug Enforcement Administration (DEA).

The CSA requires registrants to keep certain records for at least two years related to their handling of controlled substances. For example, physician registrants must keep records of controlled substances in Schedules II, III, IV, and V that are dispensed via methods other than prescribing or administering (e.g., industry samples). Inventories of controlled substances are required. Most notably, physicians generally are not required to keep records of prescribed medications; however, records must be kept if drugs are dispensed or administered. Moreover, there are heightened recordkeeping responsibilities for providers who prescribe, dispense, or administer for maintenance or detoxification.

Controlled Substance “Takeback”

The system of registration established by the CSA prohibits a DEA registrant from acquiring controlled substances from nonregistered entities and, in turn, bars an end-user from distributing pharmaceutical controlled substances to a DEA registrant. In other words, physicians cannot receive controlled substances from anyone who does not also have a registration. Thus, physicians may not “take back” prescribed medications from patients or their family members. Similarly, except in cases of a drug being recalled or a dispensing error, patients are not allowed to return controlled medications to a pharmacy.

Information on how a patient or family member should properly dispose of medication is commonly misunderstood. DEA regulations provide a process for nonregistrants to dispose of unused medication; however, it is cumbersome and meant to be used only when dealing with large quantities of controlled substances (e.g., large quantities of abandoned drugs). In such cases, the DEA special agent in charge (SAC) may instruct on disposal, which may include transfer of the substance to a DEA registrant, delivery to a DEA agent or office, destruction in the presence of an agent of the administration or other authorized person, or by other means. The person must submit a letter to the local SAC, which includes:

• Name and address of the person;
• Name and quantity of each controlled substance to be disposed of;
• Explanation of how the applicant obtained the controlled substance, if known; and
• Name, address, and registration number, if known, of the person who possessed the controlled substances prior to the applicant.

Federal legislation also provides a way for the DEA to grant approval to law-enforcement agencies to operate “takeback” programs. The regulation states that “any person in possession of a controlled substance and desiring to dispose of such substance may request assistance from the SAC in the area in which the person is located.” The regulation allows the SAC to authorize and specify the means of disposal to assure that the controlled substances do not become available to unauthorized persons.

State and local government agencies and community associations might hold takeback programs only if law enforcement makes the request, takes custody of the controlled substances, and is responsible for the disposal.

The U.S. Office of National Drug Control Policy has published guidelines for medication disposal. These guidelines advise flushing medications only if the prescription label or accompanying patient information specifically states to do so. Instead of flushing, the guidelines recommend that medications be disposed of through a takeback program or by:

• Taking the prescription drugs out of their original containers;
• Mixing the drugs with an undesirable substance, such as cat litter or used coffee grounds;
• Placing the mixture into a disposable container with a lid, such as an empty margarine tub, or into a sealable bag;
• Concealing or removing personal information, including Rx number, on the empty containers by covering it with black permanent marker or duct tape, or by scratching it off; and
• Placing the sealed container with the mixture, and the empty drug containers, in the trash.

Unused Medication Donation

The rising cost of prescription medication leaves many questioning whether there is a need for a safe method to allow unused medication to be donated to others. At least 10 states have passed laws allowing or encouraging the donation of unused pharmaceutical drugs. Many of these programs involve healthcare facilities, nursing homes, or pharmacies. The CSA and current DEA regulations, however, prohibit patients from delivering or distributing controlled substances to a DEA registrant, even if it is for the purpose of a donation. Moreover, the Food and Drug Administration (FDA) does not permit redistribution of medications, except under limited circumstances.

Consequently, state law may be inconsistent with federal law for donation and reuse of controlled substances.

Conclusion

Physicians who fail to comply with CSA handling requirements are subject to criminal charges, discipline against their DEA registration, and discipline against their license to practice medicine. Consequently, physicians should use caution whenever handling unused medication.

The application of various aspects of the CSA and implementing rules is situation-specific. Moreover, the DEA may issue additional regulations. Accordingly, if you have a question about a specific situation, consult an attorney, or contact your local DEA field division office and ask for the diversion duty agent. TH

Patrick O’Rourke works in the Office of University Counsel, Department of Litigation, University of Colorado Denver.

Recent media reports about the dangers surrounding unused prescription medications, including abuse by teens and medications finding their way into the water supply, have prompted an increase in inquiries to healthcare providers about disposing of unused medication. These issues are complicated when controlled substances are involved.

Often, providers are unsure how to respond to patient questions about medication disposal. For example, what would you do if a patient requests an alternative medication because of an unwanted side effect and brings the originally prescribed medication back to you? What if the family of a recently expired patient brings unused medication to you and asks you to donate it to other patients? What if you have a colleague who performs mission work; could you accept and donate unused medication for use in another country?

Unfortunately, the Controlled Substances Act (CSA) does not provide a readily available mechanism to accomplish efficient, secure, and environmentally sound methods to collect and use or dispose of unwanted controlled substances. This article explains the rules physicians must adhere to and guidelines for “taking back” controlled substances.

The Legislation

Enacted in 1970, the CSA combined all existing federal drug laws into a single statute. It created five “schedules” in which certain drugs are classified. These “scheduled” drugs are commonly referred to as controlled substances. A drug’s classification depends on its potential for abuse and its currently accepted medical use in the U.S. Additionally, provisions of international treaties impact classification.

Under the classification system, Schedule I drugs have a high potential for abuse and have no currently accepted medical use in treatment in the U.S. In contrast, Schedule V drugs have a low potential for abuse and do have a currently accepted medical use in treatment in the U.S.

The CSA governs the manufacture, import, export, possession, use, and distribution of controlled substances. In doing so, the CSA established a system to register those authorized to handle controlled substances. Manufacturers, dispensers, distributors, and individual practitioners who prescribe controlled substances must be registered with the Drug Enforcement Administration (DEA).

The CSA requires registrants to keep certain records for at least two years related to their handling of controlled substances. For example, physician registrants must keep records of controlled substances in Schedules II, III, IV, and V that are dispensed via methods other than prescribing or administering (e.g., industry samples). Inventories of controlled substances are required. Most notably, physicians generally are not required to keep records of prescribed medications; however, records must be kept if drugs are dispensed or administered. Moreover, there are heightened recordkeeping responsibilities for providers who prescribe, dispense, or administer for maintenance or detoxification.

Controlled Substance “Takeback”

The system of registration established by the CSA prohibits a DEA registrant from acquiring controlled substances from nonregistered entities and, in turn, bars an end-user from distributing pharmaceutical controlled substances to a DEA registrant. In other words, physicians cannot receive controlled substances from anyone who does not also have a registration. Thus, physicians may not “take back” prescribed medications from patients or their family members. Similarly, except in cases of a drug being recalled or a dispensing error, patients are not allowed to return controlled medications to a pharmacy.

Information on how a patient or family member should properly dispose of medication is commonly misunderstood. DEA regulations provide a process for nonregistrants to dispose of unused medication; however, it is cumbersome and meant to be used only when dealing with large quantities of controlled substances (e.g., large quantities of abandoned drugs). In such cases, the DEA special agent in charge (SAC) may instruct on disposal, which may include transfer of the substance to a DEA registrant, delivery to a DEA agent or office, destruction in the presence of an agent of the administration or other authorized person, or by other means. The person must submit a letter to the local SAC, which includes:

• Name and address of the person;
• Name and quantity of each controlled substance to be disposed of;
• Explanation of how the applicant obtained the controlled substance, if known; and
• Name, address, and registration number, if known, of the person who possessed the controlled substances prior to the applicant.

Federal legislation also provides a way for the DEA to grant approval to law-enforcement agencies to operate “takeback” programs. The regulation states that “any person in possession of a controlled substance and desiring to dispose of such substance may request assistance from the SAC in the area in which the person is located.” The regulation allows the SAC to authorize and specify the means of disposal to assure that the controlled substances do not become available to unauthorized persons.

State and local government agencies and community associations might hold takeback programs only if law enforcement makes the request, takes custody of the controlled substances, and is responsible for the disposal.

The U.S. Office of National Drug Control Policy has published guidelines for medication disposal. These guidelines advise flushing medications only if the prescription label or accompanying patient information specifically states to do so. Instead of flushing, the guidelines recommend that medications be disposed of through a takeback program or by:

• Taking the prescription drugs out of their original containers;
• Mixing the drugs with an undesirable substance, such as cat litter or used coffee grounds;
• Placing the mixture into a disposable container with a lid, such as an empty margarine tub, or into a sealable bag;
• Concealing or removing personal information, including Rx number, on the empty containers by covering it with black permanent marker or duct tape, or by scratching it off; and
• Placing the sealed container with the mixture, and the empty drug containers, in the trash.

Unused Medication Donation

The rising cost of prescription medication leaves many questioning whether there is a need for a safe method to allow unused medication to be donated to others. At least 10 states have passed laws allowing or encouraging the donation of unused pharmaceutical drugs. Many of these programs involve healthcare facilities, nursing homes, or pharmacies. The CSA and current DEA regulations, however, prohibit patients from delivering or distributing controlled substances to a DEA registrant, even if it is for the purpose of a donation. Moreover, the Food and Drug Administration (FDA) does not permit redistribution of medications, except under limited circumstances.

Consequently, state law may be inconsistent with federal law for donation and reuse of controlled substances.

Conclusion

Physicians who fail to comply with CSA handling requirements are subject to criminal charges, discipline against their DEA registration, and discipline against their license to practice medicine. Consequently, physicians should use caution whenever handling unused medication.

The application of various aspects of the CSA and implementing rules is situation-specific. Moreover, the DEA may issue additional regulations. Accordingly, if you have a question about a specific situation, consult an attorney, or contact your local DEA field division office and ask for the diversion duty agent. TH

Patrick O’Rourke works in the Office of University Counsel, Department of Litigation, University of Colorado Denver.

Recent media reports about the dangers surrounding unused prescription medications, including abuse by teens and medications finding their way into the water supply, have prompted an increase in inquiries to healthcare providers about disposing of unused medication. These issues are complicated when controlled substances are involved.

Often, providers are unsure how to respond to patient questions about medication disposal. For example, what would you do if a patient requests an alternative medication because of an unwanted side effect and brings the originally prescribed medication back to you? What if the family of a recently expired patient brings unused medication to you and asks you to donate it to other patients? What if you have a colleague who performs mission work; could you accept and donate unused medication for use in another country?

Unfortunately, the Controlled Substances Act (CSA) does not provide a readily available mechanism to accomplish efficient, secure, and environmentally sound methods to collect and use or dispose of unwanted controlled substances. This article explains the rules physicians must adhere to and guidelines for “taking back” controlled substances.

The Legislation

Enacted in 1970, the CSA combined all existing federal drug laws into a single statute. It created five “schedules” in which certain drugs are classified. These “scheduled” drugs are commonly referred to as controlled substances. A drug’s classification depends on its potential for abuse and its currently accepted medical use in the U.S. Additionally, provisions of international treaties impact classification.

Under the classification system, Schedule I drugs have a high potential for abuse and have no currently accepted medical use in treatment in the U.S. In contrast, Schedule V drugs have a low potential for abuse and do have a currently accepted medical use in treatment in the U.S.

The CSA governs the manufacture, import, export, possession, use, and distribution of controlled substances. In doing so, the CSA established a system to register those authorized to handle controlled substances. Manufacturers, dispensers, distributors, and individual practitioners who prescribe controlled substances must be registered with the Drug Enforcement Administration (DEA).

The CSA requires registrants to keep certain records for at least two years related to their handling of controlled substances. For example, physician registrants must keep records of controlled substances in Schedules II, III, IV, and V that are dispensed via methods other than prescribing or administering (e.g., industry samples). Inventories of controlled substances are required. Most notably, physicians generally are not required to keep records of prescribed medications; however, records must be kept if drugs are dispensed or administered. Moreover, there are heightened recordkeeping responsibilities for providers who prescribe, dispense, or administer for maintenance or detoxification.

Controlled Substance “Takeback”

The system of registration established by the CSA prohibits a DEA registrant from acquiring controlled substances from nonregistered entities and, in turn, bars an end-user from distributing pharmaceutical controlled substances to a DEA registrant. In other words, physicians cannot receive controlled substances from anyone who does not also have a registration. Thus, physicians may not “take back” prescribed medications from patients or their family members. Similarly, except in cases of a drug being recalled or a dispensing error, patients are not allowed to return controlled medications to a pharmacy.

Information on how a patient or family member should properly dispose of medication is commonly misunderstood. DEA regulations provide a process for nonregistrants to dispose of unused medication; however, it is cumbersome and meant to be used only when dealing with large quantities of controlled substances (e.g., large quantities of abandoned drugs). In such cases, the DEA special agent in charge (SAC) may instruct on disposal, which may include transfer of the substance to a DEA registrant, delivery to a DEA agent or office, destruction in the presence of an agent of the administration or other authorized person, or by other means. The person must submit a letter to the local SAC, which includes:

• Name and address of the person;
• Name and quantity of each controlled substance to be disposed of;
• Explanation of how the applicant obtained the controlled substance, if known; and
• Name, address, and registration number, if known, of the person who possessed the controlled substances prior to the applicant.

Federal legislation also provides a way for the DEA to grant approval to law-enforcement agencies to operate “takeback” programs. The regulation states that “any person in possession of a controlled substance and desiring to dispose of such substance may request assistance from the SAC in the area in which the person is located.” The regulation allows the SAC to authorize and specify the means of disposal to assure that the controlled substances do not become available to unauthorized persons.

State and local government agencies and community associations might hold takeback programs only if law enforcement makes the request, takes custody of the controlled substances, and is responsible for the disposal.

The U.S. Office of National Drug Control Policy has published guidelines for medication disposal. These guidelines advise flushing medications only if the prescription label or accompanying patient information specifically states to do so. Instead of flushing, the guidelines recommend that medications be disposed of through a takeback program or by:

• Taking the prescription drugs out of their original containers;
• Mixing the drugs with an undesirable substance, such as cat litter or used coffee grounds;
• Placing the mixture into a disposable container with a lid, such as an empty margarine tub, or into a sealable bag;
• Concealing or removing personal information, including Rx number, on the empty containers by covering it with black permanent marker or duct tape, or by scratching it off; and
• Placing the sealed container with the mixture, and the empty drug containers, in the trash.

Unused Medication Donation

The rising cost of prescription medication leaves many questioning whether there is a need for a safe method to allow unused medication to be donated to others. At least 10 states have passed laws allowing or encouraging the donation of unused pharmaceutical drugs. Many of these programs involve healthcare facilities, nursing homes, or pharmacies. The CSA and current DEA regulations, however, prohibit patients from delivering or distributing controlled substances to a DEA registrant, even if it is for the purpose of a donation. Moreover, the Food and Drug Administration (FDA) does not permit redistribution of medications, except under limited circumstances.

Consequently, state law may be inconsistent with federal law for donation and reuse of controlled substances.

Conclusion

Physicians who fail to comply with CSA handling requirements are subject to criminal charges, discipline against their DEA registration, and discipline against their license to practice medicine. Consequently, physicians should use caution whenever handling unused medication.

The application of various aspects of the CSA and implementing rules is situation-specific. Moreover, the DEA may issue additional regulations. Accordingly, if you have a question about a specific situation, consult an attorney, or contact your local DEA field division office and ask for the diversion duty agent. TH

Patrick O’Rourke works in the Office of University Counsel, Department of Litigation, University of Colorado Denver.

If every system is perfectly designed to get the results it gets …

And if 15 million patients are harmed every year from medical care …

And if as many as 98,000 people die every year due to medical errors in hospitals …

Then what does that say about the system we have designed?

A System Designed to Competently Hurt Many

By now you’ve no doubt heard, read, and possibly even uttered the above facts and figures yourself. I think we all have our opinions about the veracity of these numbers, but I don’t think any of us would argue with the sentiment. The U.S. healthcare system comprises the most competent, compassionate, well-meaning, and caring professionals on this planet—who harm, maim, and kill countless people every year.

What a discomforting paradox.

Equity: The Overlooked Quality Domain

Many years back, the Institute of Medicine (IOM) published a list of six “domains” of healthcare quality. You’ve no doubt stumbled across the IOM’s Safe … Timely … Effective … Efficient … Equitable … Patient-Centered mnemonic recipe—STEEEP—for high-quality care.¹ In fact, it’s hard to read a journal, attend a medical presentation, or open a local newspaper without finding reference to these domains. It’s all the rage to talk about wrong-site surgery (safe), access to care (timely), comparative-effectiveness research (effective), lean concepts (efficient), and individualized medicine (patient-centered). However, the sixth domain often seems to get the Jan Brady treatment—minimized, marginalized, and oft-forgotten.

The IOM defines equitable care as that which “does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status.”1 To be sure, there is some hum at the national level about issues of equity, especially around healthcare coverage for all. And this is important. However, what appears lost in the rant surrounding the inherent inequities in our tiered health insurance system is that we have blantant inequalities baked into the everyday machinery of our hospitals. And they affect all, regardless of skin color, gender, or insurance status.

Think for a moment about your hospital. Are the type, level, and access to care equal at all times? Does the level of care change when the streetlights come on? How about on weekends and holidays? Do your operating rooms run on Saturdays and Sundays? Can patients get chemotherapy on the weekends? Does your hospital alter its nursing staff ratios after hours? Can you get an ultrasound at midnight? How about a urology or neurosurgery consult at 2 a.m.? How about getting interventional radiology to place an IVC filter on a holiday?

Now scratch a bit closer to home. Does your hospitalist group downstaff on weekends and holidays, even though the volumes probably warrant more coverage? Are your night providers part of your group, or are they moonlighters? Do your after-hours providers cross-cover and admit a reasonable number of patients, or are they frequently overwhelmed? Do they cover patients or admit for services that they don’t typically care for during the day (e.g. ICU, neurosurgical, subspecialty cardiology or oncology patients)? For the intensely ill patients admitted to U.S. hospitals today, should the type and availability of care differ when it’s delivered at 3 p.m. or 3 a.m., Sunday or Monday?

Disregarding the macro-inequities in our societal approach to healthcare, can we even ensure equitable care within our own hospital walls 24 hours a day, seven days a week?

The Answer: An Unfortunate “No”

For the record, I hate working nights, abhor working weekends, and resent working holidays. But the thing I’d hate even more than working nights, weekends, and holidays would be being a patient admitted during a night, weekend, or holiday. To understand why, I have to look no further than my hospital parking lot. During bankers’ hours, I can barely find a parking spot on the top floor of our multilevel parking structure.

Fast-forward to Saturday, and I have my pick of empty football fields’ worth of spots on all floors. Ditto Sundays, nights, and holidays.

Why is it that nationally, a collectively near-trillion-dollar hospital enterprise finds it acceptable to effectively shutter itself for a quarter to a third of the week? Especially when doing so seems to counter their primary mission of providing safe, timely, effective, efficient, equitable, and patient-centered care.

The Weekend Effect

There are, of course, economic and operational reasons to downshift during off hours—some hospitals don’t have the elective procedures to run operating rooms seven days a week, and very few patients want to have their elective colonoscopy at 11 p.m. or their chemotherapy during Thanksgiving dinner. However, in most cases, the reasons for doing so center on hospital staff and physician satisfaction. Most us of just don’t like working off hours. As a result, studies have shown significantly less access to such high-level care as coronary angiography and percutaneous coronary intervention on weekends.^2,3

And the effects of this “weekend effect” can be devastating.

A recent paper in the New England Journal of Medicine reported that for every 1,000 patients admitted with a myocardial infarction on a weekend, nine more would die than a comparable group admitted during the week.⁴ Their offense? Having the misfortune to get ill on a Saturday morning. The authors concluded that this higher mortality was secondary to a lower rate of invasive cardiac procedures, presumably because they were less available. And the weekend effect isn’t just limited to coronary care. Poorer outcomes, including higher mortality rates, have been reported for weekend admissions to the neonatal ICU and adult ICU, as well as admission for epiglottitis, ruptured abdominal aortic aneurysms, and pulmonary embolism.^5,6,7

So let’s connect the dots: A system designed with inequal access to lifesaving therapies and appropriate staffing results in worse outcomes, more harm, more deaths.

To be clear, 98,000 people don’t die every year because of my disdain for working nights and weekends. This is a much deeper problem that hinges on many unsatisfactory systems working unsatisfactorily in tandem (e.g. see the other five IOM domains of quality care). Furthermore, I don’t mean to suggest that hospitalists necessarily have a lot of say in cardiac catheterization schedules. Yet we do control our own systems of care—how many patients we admit and cover during a shift, how strongly we advocate for timely testing and consultation, how we staff weekends and cover patients at night.

And, more and more, we are in a position to enhance the care delivery systems of the hospital and its providers that surround us. With that comes a responsibility to ensure that these systems are highly functioning and equitable, regardless of the time of day, day of the week.

If we are going to fundamentally enhance the quality of care, then we have to design safer systems of care. It will take time and resources to alter many of our bruised systems of care, but we can begin by at least ensuring equity in how we deliver care at our own institutions. That is, unless we are comfortable with a system perfectly designed to harm. TH

Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program.

References

1. Institute of Medicine (IOM). Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, D.C.: National Academy Press; 2001.
2. Bell CM, Redelmeier DA. Waiting for urgent procedures on the weekend among emergently hospitalized patients. Am J Med. 2004:117(3):175-181.
3. Magid DJ, Wang Y, Herrin J, et al. Relationship between time of day, day of week, timeliness of reperfusion, and in-hospital mortality for patients with acute ST-segment elevation myocardial infarction. JAMA. 2005;294(7):803-812.
4. Kostis WJ, Demissie K, Marcella SW, Shao YH, Wilson AC, Moreyra AE. Weekend versus weekday admission and mortality from myocardial infarction. N Eng J Med. 2007;356 (11):1099-1109.
5. Hendry RA. The weekend—a dangerous time to be born? Br J Obstet Gynaecol. 1981;88(12):1200-1203.
6. Barnett MJ, Kaboli PJ, Sirio CA, Rosenthal GE. Day of the week of intensive care admission and patient outcomes: a multisite regional evaluation. Med Care. 2002;40(6):530-539.
7. Bell CM, Redelmeier DA. Mortality among patients admitted to hospitals on weekends as compared with weekdays. N Eng J Med. 2001;345(9):663-668.

If every system is perfectly designed to get the results it gets …

And if 15 million patients are harmed every year from medical care …

And if as many as 98,000 people die every year due to medical errors in hospitals …

Then what does that say about the system we have designed?

A System Designed to Competently Hurt Many

By now you’ve no doubt heard, read, and possibly even uttered the above facts and figures yourself. I think we all have our opinions about the veracity of these numbers, but I don’t think any of us would argue with the sentiment. The U.S. healthcare system comprises the most competent, compassionate, well-meaning, and caring professionals on this planet—who harm, maim, and kill countless people every year.

What a discomforting paradox.

Equity: The Overlooked Quality Domain

Many years back, the Institute of Medicine (IOM) published a list of six “domains” of healthcare quality. You’ve no doubt stumbled across the IOM’s Safe … Timely … Effective … Efficient … Equitable … Patient-Centered mnemonic recipe—STEEEP—for high-quality care.¹ In fact, it’s hard to read a journal, attend a medical presentation, or open a local newspaper without finding reference to these domains. It’s all the rage to talk about wrong-site surgery (safe), access to care (timely), comparative-effectiveness research (effective), lean concepts (efficient), and individualized medicine (patient-centered). However, the sixth domain often seems to get the Jan Brady treatment—minimized, marginalized, and oft-forgotten.

The IOM defines equitable care as that which “does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status.”1 To be sure, there is some hum at the national level about issues of equity, especially around healthcare coverage for all. And this is important. However, what appears lost in the rant surrounding the inherent inequities in our tiered health insurance system is that we have blantant inequalities baked into the everyday machinery of our hospitals. And they affect all, regardless of skin color, gender, or insurance status.

Think for a moment about your hospital. Are the type, level, and access to care equal at all times? Does the level of care change when the streetlights come on? How about on weekends and holidays? Do your operating rooms run on Saturdays and Sundays? Can patients get chemotherapy on the weekends? Does your hospital alter its nursing staff ratios after hours? Can you get an ultrasound at midnight? How about a urology or neurosurgery consult at 2 a.m.? How about getting interventional radiology to place an IVC filter on a holiday?

Now scratch a bit closer to home. Does your hospitalist group downstaff on weekends and holidays, even though the volumes probably warrant more coverage? Are your night providers part of your group, or are they moonlighters? Do your after-hours providers cross-cover and admit a reasonable number of patients, or are they frequently overwhelmed? Do they cover patients or admit for services that they don’t typically care for during the day (e.g. ICU, neurosurgical, subspecialty cardiology or oncology patients)? For the intensely ill patients admitted to U.S. hospitals today, should the type and availability of care differ when it’s delivered at 3 p.m. or 3 a.m., Sunday or Monday?

Disregarding the macro-inequities in our societal approach to healthcare, can we even ensure equitable care within our own hospital walls 24 hours a day, seven days a week?

The Answer: An Unfortunate “No”

For the record, I hate working nights, abhor working weekends, and resent working holidays. But the thing I’d hate even more than working nights, weekends, and holidays would be being a patient admitted during a night, weekend, or holiday. To understand why, I have to look no further than my hospital parking lot. During bankers’ hours, I can barely find a parking spot on the top floor of our multilevel parking structure.

Fast-forward to Saturday, and I have my pick of empty football fields’ worth of spots on all floors. Ditto Sundays, nights, and holidays.

Why is it that nationally, a collectively near-trillion-dollar hospital enterprise finds it acceptable to effectively shutter itself for a quarter to a third of the week? Especially when doing so seems to counter their primary mission of providing safe, timely, effective, efficient, equitable, and patient-centered care.

The Weekend Effect

There are, of course, economic and operational reasons to downshift during off hours—some hospitals don’t have the elective procedures to run operating rooms seven days a week, and very few patients want to have their elective colonoscopy at 11 p.m. or their chemotherapy during Thanksgiving dinner. However, in most cases, the reasons for doing so center on hospital staff and physician satisfaction. Most us of just don’t like working off hours. As a result, studies have shown significantly less access to such high-level care as coronary angiography and percutaneous coronary intervention on weekends.^2,3

And the effects of this “weekend effect” can be devastating.

A recent paper in the New England Journal of Medicine reported that for every 1,000 patients admitted with a myocardial infarction on a weekend, nine more would die than a comparable group admitted during the week.⁴ Their offense? Having the misfortune to get ill on a Saturday morning. The authors concluded that this higher mortality was secondary to a lower rate of invasive cardiac procedures, presumably because they were less available. And the weekend effect isn’t just limited to coronary care. Poorer outcomes, including higher mortality rates, have been reported for weekend admissions to the neonatal ICU and adult ICU, as well as admission for epiglottitis, ruptured abdominal aortic aneurysms, and pulmonary embolism.^5,6,7

So let’s connect the dots: A system designed with inequal access to lifesaving therapies and appropriate staffing results in worse outcomes, more harm, more deaths.

To be clear, 98,000 people don’t die every year because of my disdain for working nights and weekends. This is a much deeper problem that hinges on many unsatisfactory systems working unsatisfactorily in tandem (e.g. see the other five IOM domains of quality care). Furthermore, I don’t mean to suggest that hospitalists necessarily have a lot of say in cardiac catheterization schedules. Yet we do control our own systems of care—how many patients we admit and cover during a shift, how strongly we advocate for timely testing and consultation, how we staff weekends and cover patients at night.

And, more and more, we are in a position to enhance the care delivery systems of the hospital and its providers that surround us. With that comes a responsibility to ensure that these systems are highly functioning and equitable, regardless of the time of day, day of the week.

If we are going to fundamentally enhance the quality of care, then we have to design safer systems of care. It will take time and resources to alter many of our bruised systems of care, but we can begin by at least ensuring equity in how we deliver care at our own institutions. That is, unless we are comfortable with a system perfectly designed to harm. TH

Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program.

References

1. Institute of Medicine (IOM). Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, D.C.: National Academy Press; 2001.
2. Bell CM, Redelmeier DA. Waiting for urgent procedures on the weekend among emergently hospitalized patients. Am J Med. 2004:117(3):175-181.
3. Magid DJ, Wang Y, Herrin J, et al. Relationship between time of day, day of week, timeliness of reperfusion, and in-hospital mortality for patients with acute ST-segment elevation myocardial infarction. JAMA. 2005;294(7):803-812.
4. Kostis WJ, Demissie K, Marcella SW, Shao YH, Wilson AC, Moreyra AE. Weekend versus weekday admission and mortality from myocardial infarction. N Eng J Med. 2007;356 (11):1099-1109.
5. Hendry RA. The weekend—a dangerous time to be born? Br J Obstet Gynaecol. 1981;88(12):1200-1203.
6. Barnett MJ, Kaboli PJ, Sirio CA, Rosenthal GE. Day of the week of intensive care admission and patient outcomes: a multisite regional evaluation. Med Care. 2002;40(6):530-539.
7. Bell CM, Redelmeier DA. Mortality among patients admitted to hospitals on weekends as compared with weekdays. N Eng J Med. 2001;345(9):663-668.

If every system is perfectly designed to get the results it gets …

And if 15 million patients are harmed every year from medical care …

And if as many as 98,000 people die every year due to medical errors in hospitals …

Then what does that say about the system we have designed?

A System Designed to Competently Hurt Many

By now you’ve no doubt heard, read, and possibly even uttered the above facts and figures yourself. I think we all have our opinions about the veracity of these numbers, but I don’t think any of us would argue with the sentiment. The U.S. healthcare system comprises the most competent, compassionate, well-meaning, and caring professionals on this planet—who harm, maim, and kill countless people every year.

What a discomforting paradox.

Equity: The Overlooked Quality Domain

Many years back, the Institute of Medicine (IOM) published a list of six “domains” of healthcare quality. You’ve no doubt stumbled across the IOM’s Safe … Timely … Effective … Efficient … Equitable … Patient-Centered mnemonic recipe—STEEEP—for high-quality care.¹ In fact, it’s hard to read a journal, attend a medical presentation, or open a local newspaper without finding reference to these domains. It’s all the rage to talk about wrong-site surgery (safe), access to care (timely), comparative-effectiveness research (effective), lean concepts (efficient), and individualized medicine (patient-centered). However, the sixth domain often seems to get the Jan Brady treatment—minimized, marginalized, and oft-forgotten.

The IOM defines equitable care as that which “does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status.”1 To be sure, there is some hum at the national level about issues of equity, especially around healthcare coverage for all. And this is important. However, what appears lost in the rant surrounding the inherent inequities in our tiered health insurance system is that we have blantant inequalities baked into the everyday machinery of our hospitals. And they affect all, regardless of skin color, gender, or insurance status.

Think for a moment about your hospital. Are the type, level, and access to care equal at all times? Does the level of care change when the streetlights come on? How about on weekends and holidays? Do your operating rooms run on Saturdays and Sundays? Can patients get chemotherapy on the weekends? Does your hospital alter its nursing staff ratios after hours? Can you get an ultrasound at midnight? How about a urology or neurosurgery consult at 2 a.m.? How about getting interventional radiology to place an IVC filter on a holiday?

Now scratch a bit closer to home. Does your hospitalist group downstaff on weekends and holidays, even though the volumes probably warrant more coverage? Are your night providers part of your group, or are they moonlighters? Do your after-hours providers cross-cover and admit a reasonable number of patients, or are they frequently overwhelmed? Do they cover patients or admit for services that they don’t typically care for during the day (e.g. ICU, neurosurgical, subspecialty cardiology or oncology patients)? For the intensely ill patients admitted to U.S. hospitals today, should the type and availability of care differ when it’s delivered at 3 p.m. or 3 a.m., Sunday or Monday?

Disregarding the macro-inequities in our societal approach to healthcare, can we even ensure equitable care within our own hospital walls 24 hours a day, seven days a week?

The Answer: An Unfortunate “No”

For the record, I hate working nights, abhor working weekends, and resent working holidays. But the thing I’d hate even more than working nights, weekends, and holidays would be being a patient admitted during a night, weekend, or holiday. To understand why, I have to look no further than my hospital parking lot. During bankers’ hours, I can barely find a parking spot on the top floor of our multilevel parking structure.

Fast-forward to Saturday, and I have my pick of empty football fields’ worth of spots on all floors. Ditto Sundays, nights, and holidays.

Why is it that nationally, a collectively near-trillion-dollar hospital enterprise finds it acceptable to effectively shutter itself for a quarter to a third of the week? Especially when doing so seems to counter their primary mission of providing safe, timely, effective, efficient, equitable, and patient-centered care.

The Weekend Effect

There are, of course, economic and operational reasons to downshift during off hours—some hospitals don’t have the elective procedures to run operating rooms seven days a week, and very few patients want to have their elective colonoscopy at 11 p.m. or their chemotherapy during Thanksgiving dinner. However, in most cases, the reasons for doing so center on hospital staff and physician satisfaction. Most us of just don’t like working off hours. As a result, studies have shown significantly less access to such high-level care as coronary angiography and percutaneous coronary intervention on weekends.^2,3

And the effects of this “weekend effect” can be devastating.

A recent paper in the New England Journal of Medicine reported that for every 1,000 patients admitted with a myocardial infarction on a weekend, nine more would die than a comparable group admitted during the week.⁴ Their offense? Having the misfortune to get ill on a Saturday morning. The authors concluded that this higher mortality was secondary to a lower rate of invasive cardiac procedures, presumably because they were less available. And the weekend effect isn’t just limited to coronary care. Poorer outcomes, including higher mortality rates, have been reported for weekend admissions to the neonatal ICU and adult ICU, as well as admission for epiglottitis, ruptured abdominal aortic aneurysms, and pulmonary embolism.^5,6,7

So let’s connect the dots: A system designed with inequal access to lifesaving therapies and appropriate staffing results in worse outcomes, more harm, more deaths.

To be clear, 98,000 people don’t die every year because of my disdain for working nights and weekends. This is a much deeper problem that hinges on many unsatisfactory systems working unsatisfactorily in tandem (e.g. see the other five IOM domains of quality care). Furthermore, I don’t mean to suggest that hospitalists necessarily have a lot of say in cardiac catheterization schedules. Yet we do control our own systems of care—how many patients we admit and cover during a shift, how strongly we advocate for timely testing and consultation, how we staff weekends and cover patients at night.

And, more and more, we are in a position to enhance the care delivery systems of the hospital and its providers that surround us. With that comes a responsibility to ensure that these systems are highly functioning and equitable, regardless of the time of day, day of the week.

If we are going to fundamentally enhance the quality of care, then we have to design safer systems of care. It will take time and resources to alter many of our bruised systems of care, but we can begin by at least ensuring equity in how we deliver care at our own institutions. That is, unless we are comfortable with a system perfectly designed to harm. TH

Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program.

References

1. Institute of Medicine (IOM). Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, D.C.: National Academy Press; 2001.
2. Bell CM, Redelmeier DA. Waiting for urgent procedures on the weekend among emergently hospitalized patients. Am J Med. 2004:117(3):175-181.
3. Magid DJ, Wang Y, Herrin J, et al. Relationship between time of day, day of week, timeliness of reperfusion, and in-hospital mortality for patients with acute ST-segment elevation myocardial infarction. JAMA. 2005;294(7):803-812.
4. Kostis WJ, Demissie K, Marcella SW, Shao YH, Wilson AC, Moreyra AE. Weekend versus weekday admission and mortality from myocardial infarction. N Eng J Med. 2007;356 (11):1099-1109.
5. Hendry RA. The weekend—a dangerous time to be born? Br J Obstet Gynaecol. 1981;88(12):1200-1203.
6. Barnett MJ, Kaboli PJ, Sirio CA, Rosenthal GE. Day of the week of intensive care admission and patient outcomes: a multisite regional evaluation. Med Care. 2002;40(6):530-539.
7. Bell CM, Redelmeier DA. Mortality among patients admitted to hospitals on weekends as compared with weekdays. N Eng J Med. 2001;345(9):663-668.