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Report: Part B funds stable, hospital trust running out
Medicare’s Part B trust fund is well funded and stable enough to pay physicians through the foreseeable future, according to an annual report by the Medicare Board of Trustees.
The Supplemental Medical Insurance (SMI) trust fund, which covers Medicare Part B and D, contained $104 billion in assets at the end of 2018 and is expected to be adequately financed in all years because of continued premium and general revenue income, according to the report, which was released April 22.
However, the Hospital Insurance (HI) trust fund, which funds Medicare Part A, is expected to run out by 2026, the same projection as last year, the trustees reported.
In addition, trustees said that total Medicare costs – including both HI and SMI expenditures – will grow from about 4% of gross domestic product (GDP) in 2018 to about 6% of GDP by 2038 and then increase gradually thereafter to about 6.5% of GDP by 2093.
The faster rate of growth in Medicare spending, compared with GDP growth, is attributable to a growing number of Medicare patients and increased volume and intensity of health care services, according to the report. Alone, SMI costs are projected to grow steadily from 2% of GDP in 2018 to about 4% of GDP in 2038 because of the aging population and rising health care costs.
The report delivers a dose of reality, reminding the country that the program’s main trust for hospital services can pay full benefits for only 7 more years, Seema Verma, administrator of the Centers for Medicare & Medicaid Services said.
“The Trump administration is working hard to protect and strengthen Medicare and lower costs while improving quality in order to protect the program for future generations of seniors who have paid into the program their whole lives,” Ms. Verma said in a statement. “If we do not take the fiscal crisis in Medicare seriously, we will jeopardize access to health care for millions of seniors.”
Department of Health & Human Services Secretary Alex M. Azar II said the annual report provides a sobering reminder that more work is necessary to support current and future generations of seniors.
“Instead of trying to expand Medicare into a universal entitlement that even covers wealthy Americans of working age, as some have proposed, we need to fulfill Medicare’s promise to our seniors,” Mr. Azar said in a statement, referring to proposals to expand government health care by some Democrats.
The trustees report notes that Medicare has introduced a number of initiatives to strengthen and protect the program and finalized a number of rules that advance a patient-driven health care system through competition.
“In particular, CMS is strengthening Medicare through increasing choice in Medicare Advantage and adding supplemental benefits to the program, offering more care options for people with diabetes, providing new telehealth services, and lowering prescription drug costs for seniors,” the agency stated in a press release. “CMS is also continuing work to advance policies to increase price transparency and help beneficiaries compare costs across different providers.”
Medicare’s Part B trust fund is well funded and stable enough to pay physicians through the foreseeable future, according to an annual report by the Medicare Board of Trustees.
The Supplemental Medical Insurance (SMI) trust fund, which covers Medicare Part B and D, contained $104 billion in assets at the end of 2018 and is expected to be adequately financed in all years because of continued premium and general revenue income, according to the report, which was released April 22.
However, the Hospital Insurance (HI) trust fund, which funds Medicare Part A, is expected to run out by 2026, the same projection as last year, the trustees reported.
In addition, trustees said that total Medicare costs – including both HI and SMI expenditures – will grow from about 4% of gross domestic product (GDP) in 2018 to about 6% of GDP by 2038 and then increase gradually thereafter to about 6.5% of GDP by 2093.
The faster rate of growth in Medicare spending, compared with GDP growth, is attributable to a growing number of Medicare patients and increased volume and intensity of health care services, according to the report. Alone, SMI costs are projected to grow steadily from 2% of GDP in 2018 to about 4% of GDP in 2038 because of the aging population and rising health care costs.
The report delivers a dose of reality, reminding the country that the program’s main trust for hospital services can pay full benefits for only 7 more years, Seema Verma, administrator of the Centers for Medicare & Medicaid Services said.
“The Trump administration is working hard to protect and strengthen Medicare and lower costs while improving quality in order to protect the program for future generations of seniors who have paid into the program their whole lives,” Ms. Verma said in a statement. “If we do not take the fiscal crisis in Medicare seriously, we will jeopardize access to health care for millions of seniors.”
Department of Health & Human Services Secretary Alex M. Azar II said the annual report provides a sobering reminder that more work is necessary to support current and future generations of seniors.
“Instead of trying to expand Medicare into a universal entitlement that even covers wealthy Americans of working age, as some have proposed, we need to fulfill Medicare’s promise to our seniors,” Mr. Azar said in a statement, referring to proposals to expand government health care by some Democrats.
The trustees report notes that Medicare has introduced a number of initiatives to strengthen and protect the program and finalized a number of rules that advance a patient-driven health care system through competition.
“In particular, CMS is strengthening Medicare through increasing choice in Medicare Advantage and adding supplemental benefits to the program, offering more care options for people with diabetes, providing new telehealth services, and lowering prescription drug costs for seniors,” the agency stated in a press release. “CMS is also continuing work to advance policies to increase price transparency and help beneficiaries compare costs across different providers.”
Medicare’s Part B trust fund is well funded and stable enough to pay physicians through the foreseeable future, according to an annual report by the Medicare Board of Trustees.
The Supplemental Medical Insurance (SMI) trust fund, which covers Medicare Part B and D, contained $104 billion in assets at the end of 2018 and is expected to be adequately financed in all years because of continued premium and general revenue income, according to the report, which was released April 22.
However, the Hospital Insurance (HI) trust fund, which funds Medicare Part A, is expected to run out by 2026, the same projection as last year, the trustees reported.
In addition, trustees said that total Medicare costs – including both HI and SMI expenditures – will grow from about 4% of gross domestic product (GDP) in 2018 to about 6% of GDP by 2038 and then increase gradually thereafter to about 6.5% of GDP by 2093.
The faster rate of growth in Medicare spending, compared with GDP growth, is attributable to a growing number of Medicare patients and increased volume and intensity of health care services, according to the report. Alone, SMI costs are projected to grow steadily from 2% of GDP in 2018 to about 4% of GDP in 2038 because of the aging population and rising health care costs.
The report delivers a dose of reality, reminding the country that the program’s main trust for hospital services can pay full benefits for only 7 more years, Seema Verma, administrator of the Centers for Medicare & Medicaid Services said.
“The Trump administration is working hard to protect and strengthen Medicare and lower costs while improving quality in order to protect the program for future generations of seniors who have paid into the program their whole lives,” Ms. Verma said in a statement. “If we do not take the fiscal crisis in Medicare seriously, we will jeopardize access to health care for millions of seniors.”
Department of Health & Human Services Secretary Alex M. Azar II said the annual report provides a sobering reminder that more work is necessary to support current and future generations of seniors.
“Instead of trying to expand Medicare into a universal entitlement that even covers wealthy Americans of working age, as some have proposed, we need to fulfill Medicare’s promise to our seniors,” Mr. Azar said in a statement, referring to proposals to expand government health care by some Democrats.
The trustees report notes that Medicare has introduced a number of initiatives to strengthen and protect the program and finalized a number of rules that advance a patient-driven health care system through competition.
“In particular, CMS is strengthening Medicare through increasing choice in Medicare Advantage and adding supplemental benefits to the program, offering more care options for people with diabetes, providing new telehealth services, and lowering prescription drug costs for seniors,” the agency stated in a press release. “CMS is also continuing work to advance policies to increase price transparency and help beneficiaries compare costs across different providers.”
MAT access helps address opioid use disorder
PHILADELPHIA –
That was the key takeaway from a presentation given by Charles Reznikoff, MD, at the annual meeting of the American College of Physicians.
“There is fairly robust evidence on medication assisted therapy for OUD [opioid use disorder],” said Dr. Reznikoff of the University of Minnesota, Minneapolis. “MAT lowers mortality 70% in people with OUD all-cause mortality.”
He mentioned some examples in Europe, where access to medication assisted therapy has had a dramatic effect on opioid overdoses and deaths.
For example, any doctor in France since 1995 can prescribe drugs to help with OUD treatment and most buprenorphine prescriptions are written by primary care physicians. As a result, there has been a tenfold increase in the number of patients suffering from OUD receiving medication assisted treatment. In addition, there has been an 80% drop in the overdose death rate.
But Dr. Reznikoff’s recommendation on the need for more MAT was more about methadone and Suboxone, which contains a combination of buprenorphine and naloxone, than the current drive to expand the distribution of naloxone alone. He noted that naloxone is good but it really serves as a short-term fix that slows the rate of overdose deaths and provides time to implement other long-term fixes. Many states are providing naloxone to first responders to help treat patients who are overdosing on opioids, but little is being done to expand access to other medication assisted treatments, he said.
“I am bringing it up to try to illustrate what is happening in American policy making that we are reaching for naloxone first and we are not reaching for MAT first,” Dr. Reznikoff said, noting that you can give naloxone to patients without changing the underlying system of care.
He also stressed the need to get more medication assisted treatment into the penal system.
“If you have opioid use disorder [and] you are incarcerated, almost nowhere in America can you get medication assisted therapy while incarcerated,” Dr. Reznikoff said. “You lose your tolerance, but you still have addiction. You are released from incarceration and your rate of death is 20-fold the average OUD rate of death in the first 2 weeks after release.”
As a counter example, he noted that Portugal in 2001 switched its approach to OUD from criminal to a public health issue and stopped incarcerating people with opioid addiction. This led to a decrease by 75% in active heroin users, and the country now boasts the lowest rate of drug-related death in Western Europe, 1/50th of the rate in America.
“We pretty strongly believe that if they were given medication while incarcerated or just not incarcerated, they would not have that 20-fold risk of death after release,” he said. “Incarceration is actually an accelerant in the opioid epidemic and we are not going to get out of this without addressing that tough issue.”
Another effective policy option that should be expanded further is the use of prescription drug monitoring programs, which can be effective in controlling the amount of prescriptions written, said Rebecca Haffajee, PhD, assistant professor, health management and policy, University of Michigan School of Public Health, Ann Arbor.
“We do have good evidence on the prescribing outcomes and particularly attributable to a few key features, [such as] use mandates, registration mandates, delegate access, all of those features have been shown across different types of patient populations – Medicaid, Medicare, commercially insured – to reduce overall opioid prescribing and some high risk measures, polypharmacy, doctor shopping, pharmacy shopping, those sorts of things,” noted Dr. Haffajee.
Twenty percent of state laws enacted to address the opioid crisis have involved prescription drug monitoring programs, she added.
There is not enough evidence to determine whether other laws, such as those that limit quantity and dosage levels, are effective in the fight against opioid use disorder, added Dr. Reznikoff.
The speakers did not report any conflicts.
PHILADELPHIA –
That was the key takeaway from a presentation given by Charles Reznikoff, MD, at the annual meeting of the American College of Physicians.
“There is fairly robust evidence on medication assisted therapy for OUD [opioid use disorder],” said Dr. Reznikoff of the University of Minnesota, Minneapolis. “MAT lowers mortality 70% in people with OUD all-cause mortality.”
He mentioned some examples in Europe, where access to medication assisted therapy has had a dramatic effect on opioid overdoses and deaths.
For example, any doctor in France since 1995 can prescribe drugs to help with OUD treatment and most buprenorphine prescriptions are written by primary care physicians. As a result, there has been a tenfold increase in the number of patients suffering from OUD receiving medication assisted treatment. In addition, there has been an 80% drop in the overdose death rate.
But Dr. Reznikoff’s recommendation on the need for more MAT was more about methadone and Suboxone, which contains a combination of buprenorphine and naloxone, than the current drive to expand the distribution of naloxone alone. He noted that naloxone is good but it really serves as a short-term fix that slows the rate of overdose deaths and provides time to implement other long-term fixes. Many states are providing naloxone to first responders to help treat patients who are overdosing on opioids, but little is being done to expand access to other medication assisted treatments, he said.
“I am bringing it up to try to illustrate what is happening in American policy making that we are reaching for naloxone first and we are not reaching for MAT first,” Dr. Reznikoff said, noting that you can give naloxone to patients without changing the underlying system of care.
He also stressed the need to get more medication assisted treatment into the penal system.
“If you have opioid use disorder [and] you are incarcerated, almost nowhere in America can you get medication assisted therapy while incarcerated,” Dr. Reznikoff said. “You lose your tolerance, but you still have addiction. You are released from incarceration and your rate of death is 20-fold the average OUD rate of death in the first 2 weeks after release.”
As a counter example, he noted that Portugal in 2001 switched its approach to OUD from criminal to a public health issue and stopped incarcerating people with opioid addiction. This led to a decrease by 75% in active heroin users, and the country now boasts the lowest rate of drug-related death in Western Europe, 1/50th of the rate in America.
“We pretty strongly believe that if they were given medication while incarcerated or just not incarcerated, they would not have that 20-fold risk of death after release,” he said. “Incarceration is actually an accelerant in the opioid epidemic and we are not going to get out of this without addressing that tough issue.”
Another effective policy option that should be expanded further is the use of prescription drug monitoring programs, which can be effective in controlling the amount of prescriptions written, said Rebecca Haffajee, PhD, assistant professor, health management and policy, University of Michigan School of Public Health, Ann Arbor.
“We do have good evidence on the prescribing outcomes and particularly attributable to a few key features, [such as] use mandates, registration mandates, delegate access, all of those features have been shown across different types of patient populations – Medicaid, Medicare, commercially insured – to reduce overall opioid prescribing and some high risk measures, polypharmacy, doctor shopping, pharmacy shopping, those sorts of things,” noted Dr. Haffajee.
Twenty percent of state laws enacted to address the opioid crisis have involved prescription drug monitoring programs, she added.
There is not enough evidence to determine whether other laws, such as those that limit quantity and dosage levels, are effective in the fight against opioid use disorder, added Dr. Reznikoff.
The speakers did not report any conflicts.
PHILADELPHIA –
That was the key takeaway from a presentation given by Charles Reznikoff, MD, at the annual meeting of the American College of Physicians.
“There is fairly robust evidence on medication assisted therapy for OUD [opioid use disorder],” said Dr. Reznikoff of the University of Minnesota, Minneapolis. “MAT lowers mortality 70% in people with OUD all-cause mortality.”
He mentioned some examples in Europe, where access to medication assisted therapy has had a dramatic effect on opioid overdoses and deaths.
For example, any doctor in France since 1995 can prescribe drugs to help with OUD treatment and most buprenorphine prescriptions are written by primary care physicians. As a result, there has been a tenfold increase in the number of patients suffering from OUD receiving medication assisted treatment. In addition, there has been an 80% drop in the overdose death rate.
But Dr. Reznikoff’s recommendation on the need for more MAT was more about methadone and Suboxone, which contains a combination of buprenorphine and naloxone, than the current drive to expand the distribution of naloxone alone. He noted that naloxone is good but it really serves as a short-term fix that slows the rate of overdose deaths and provides time to implement other long-term fixes. Many states are providing naloxone to first responders to help treat patients who are overdosing on opioids, but little is being done to expand access to other medication assisted treatments, he said.
“I am bringing it up to try to illustrate what is happening in American policy making that we are reaching for naloxone first and we are not reaching for MAT first,” Dr. Reznikoff said, noting that you can give naloxone to patients without changing the underlying system of care.
He also stressed the need to get more medication assisted treatment into the penal system.
“If you have opioid use disorder [and] you are incarcerated, almost nowhere in America can you get medication assisted therapy while incarcerated,” Dr. Reznikoff said. “You lose your tolerance, but you still have addiction. You are released from incarceration and your rate of death is 20-fold the average OUD rate of death in the first 2 weeks after release.”
As a counter example, he noted that Portugal in 2001 switched its approach to OUD from criminal to a public health issue and stopped incarcerating people with opioid addiction. This led to a decrease by 75% in active heroin users, and the country now boasts the lowest rate of drug-related death in Western Europe, 1/50th of the rate in America.
“We pretty strongly believe that if they were given medication while incarcerated or just not incarcerated, they would not have that 20-fold risk of death after release,” he said. “Incarceration is actually an accelerant in the opioid epidemic and we are not going to get out of this without addressing that tough issue.”
Another effective policy option that should be expanded further is the use of prescription drug monitoring programs, which can be effective in controlling the amount of prescriptions written, said Rebecca Haffajee, PhD, assistant professor, health management and policy, University of Michigan School of Public Health, Ann Arbor.
“We do have good evidence on the prescribing outcomes and particularly attributable to a few key features, [such as] use mandates, registration mandates, delegate access, all of those features have been shown across different types of patient populations – Medicaid, Medicare, commercially insured – to reduce overall opioid prescribing and some high risk measures, polypharmacy, doctor shopping, pharmacy shopping, those sorts of things,” noted Dr. Haffajee.
Twenty percent of state laws enacted to address the opioid crisis have involved prescription drug monitoring programs, she added.
There is not enough evidence to determine whether other laws, such as those that limit quantity and dosage levels, are effective in the fight against opioid use disorder, added Dr. Reznikoff.
The speakers did not report any conflicts.
REPORTING FROM INTERNAL MEDICINE 2019
ONC’s Dr. Rucker: Era of provider-controlled data is over
“The era of the provider controlling all of this, I think this is over,” Donald Rucker, MD, head of the Office of the National Coordinator (ONC) for Health Information Technology within the Department of Health and Human Services, said at an annual conference on health data and innovation. We need a “formal path to put patients back in control of their medical data.”
That path can be found in a pair of proposed rules issued earlier this year, one from the Centers for Medicare & Medicaid Services and the other from ONC, that are designed to give patients that control.
With smartphone apps under development that will allow patient access to health care data from a single point of entry, “technology now allows us to move from having to go portal to portal to portal to really having us in control,” Dr. Rucker said. “I think it is going to transform [health care] in the same way that the smartphone app has transformed other sectors. We are very excited about that.”
Access to data and information should further the transition to value-based care as patients become the center of the decision tree, Dr. Rucker said, making decisions based on benefits in a way that is not possible now.
“In particular, we think patients are going to start being able to shop for care,” he said, adding that if “they don’t like the price of the care they are getting, they are going to be able to move their business elsewhere.”
To that end, he said that much of the talk about interoperability “is really a conversation about affordability and the vast expenses in health care and how you get some control over that.”
“The era of the provider controlling all of this, I think this is over,” Donald Rucker, MD, head of the Office of the National Coordinator (ONC) for Health Information Technology within the Department of Health and Human Services, said at an annual conference on health data and innovation. We need a “formal path to put patients back in control of their medical data.”
That path can be found in a pair of proposed rules issued earlier this year, one from the Centers for Medicare & Medicaid Services and the other from ONC, that are designed to give patients that control.
With smartphone apps under development that will allow patient access to health care data from a single point of entry, “technology now allows us to move from having to go portal to portal to portal to really having us in control,” Dr. Rucker said. “I think it is going to transform [health care] in the same way that the smartphone app has transformed other sectors. We are very excited about that.”
Access to data and information should further the transition to value-based care as patients become the center of the decision tree, Dr. Rucker said, making decisions based on benefits in a way that is not possible now.
“In particular, we think patients are going to start being able to shop for care,” he said, adding that if “they don’t like the price of the care they are getting, they are going to be able to move their business elsewhere.”
To that end, he said that much of the talk about interoperability “is really a conversation about affordability and the vast expenses in health care and how you get some control over that.”
“The era of the provider controlling all of this, I think this is over,” Donald Rucker, MD, head of the Office of the National Coordinator (ONC) for Health Information Technology within the Department of Health and Human Services, said at an annual conference on health data and innovation. We need a “formal path to put patients back in control of their medical data.”
That path can be found in a pair of proposed rules issued earlier this year, one from the Centers for Medicare & Medicaid Services and the other from ONC, that are designed to give patients that control.
With smartphone apps under development that will allow patient access to health care data from a single point of entry, “technology now allows us to move from having to go portal to portal to portal to really having us in control,” Dr. Rucker said. “I think it is going to transform [health care] in the same way that the smartphone app has transformed other sectors. We are very excited about that.”
Access to data and information should further the transition to value-based care as patients become the center of the decision tree, Dr. Rucker said, making decisions based on benefits in a way that is not possible now.
“In particular, we think patients are going to start being able to shop for care,” he said, adding that if “they don’t like the price of the care they are getting, they are going to be able to move their business elsewhere.”
To that end, he said that much of the talk about interoperability “is really a conversation about affordability and the vast expenses in health care and how you get some control over that.”
REPORTING FROM HEALTH DATAPALOOZA 2019
FDA chief calls for stricter scrutiny of electronic health records
“What we really need is a much more tailored approach, so that we have appropriate oversight of EHRs when they’re doing things that could create risk for patients,” Dr. Gottlieb said in an interview with Kaiser Health News.
Dr. Gottlieb was responding to “Botched Operation,” a report published March 18 by KHN and Fortune magazine. The investigation found that the federal government has spent more than $36 billion over the past 10 years to switch doctors and hospitals from paper to digital records systems. In that time, thousands of reports of deaths, injuries, and near misses linked to EHRs have piled up in databases – including at least one run by the FDA.
Dr. Gottlieb said Congress would need to enact legislation to define when an EHR would require government oversight. He said that the digital records systems, which store a patient’s medical history, don’t fit neatly under the agency’s existing mandate to regulate items such as drugs and medical devices.
Dr. Gottlieb said the best approach might be to say that an EHR that has a certain capability becomes a medical device. He called EHRs a “unique tool,” noting that the risks posed by their use aren’t the same as for a traditional medical device implanted in a patient. “You need a much different regulatory scheme,” he said.
The 21st Century Cures Act of 2016 excludes the FDA from having oversight over EHRs as a medical device.
Dr. Gottlieb said that health IT companies could add new functions that would improve EHRs, but they have been reluctant to do so because they didn’t want their products to fall under FDA jurisdiction. He added that he was “not calling” for FDA to take over such a duty, however, and suggested that any new approach could be years away. Proponents have long argued that widespread use of EHRs can make medicine safer by alerting doctors to potential medical errors, though critics counter that software glitches and user errors may cause new varieties of medical mistakes.
How closely the FDA should watch over the digital medical record revolution has been controversial for years. The agency’s interest in the issue perked up after Congress decided in February 2009 to spend billions of dollars on digital medical records as part of an economic stimulus program.
At the time, many industry groups argued that FDA regulation would “stifle innovation” and stall the national drive to bring medicine into the modern era. Federal officials responsible for doling out billions in subsidies to doctors and hospitals generally sympathized with that view and were skeptical of allowing the FDA to play a role.
The debate became public in February 2010, when Jeffrey Shuren, MD, an FDA official, testified at a public hearing that the agency had tied 6 deaths and more than 200 injuries to health information technology. In all, the FDA said, it had logged 260 reports in the previous 2 years of “malfunctions with the potential for patient harm.”
The agency said the findings were based largely on reports voluntarily submitted to the FDA and suggested “significant clinical implications and public safety issues.” In one case cited, lab tests done in a hospital emergency department were sent to the wrong patient’s file. Since then, several government and private repositories have associated thousands of injuries, near misses, and deaths to EHR technology.
Dr. Shuren said in 2010 that the agency recognized that health information technology had great potential to improve patient care, but also needed oversight to “assure patient safety.”
While some safety proponents agree that EHRs offer tremendous benefits, they also see a greater opportunities to improve their safety.
Dean Sittig, PhD, a professor of bioinformatics and bioengineering at the University of Texas, Houston, said EHRs have improved safety within the health care system, but they have not eliminated errors to the extent that he would have expected. Federal officials were initially pushing for rapid adoption and ‘there wasn’t a lot of interest in talking about things that could go wrong,’ ” Dr. Sittig told KHN and Fortune.
Earlier in March, Gottlieb announced his resignation from the FDA. His last day is scheduled to be April 5.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN correspondents Sarah Jane Tribble, Sydney Lupkin, and Julie Rovner contributed to this report.
“What we really need is a much more tailored approach, so that we have appropriate oversight of EHRs when they’re doing things that could create risk for patients,” Dr. Gottlieb said in an interview with Kaiser Health News.
Dr. Gottlieb was responding to “Botched Operation,” a report published March 18 by KHN and Fortune magazine. The investigation found that the federal government has spent more than $36 billion over the past 10 years to switch doctors and hospitals from paper to digital records systems. In that time, thousands of reports of deaths, injuries, and near misses linked to EHRs have piled up in databases – including at least one run by the FDA.
Dr. Gottlieb said Congress would need to enact legislation to define when an EHR would require government oversight. He said that the digital records systems, which store a patient’s medical history, don’t fit neatly under the agency’s existing mandate to regulate items such as drugs and medical devices.
Dr. Gottlieb said the best approach might be to say that an EHR that has a certain capability becomes a medical device. He called EHRs a “unique tool,” noting that the risks posed by their use aren’t the same as for a traditional medical device implanted in a patient. “You need a much different regulatory scheme,” he said.
The 21st Century Cures Act of 2016 excludes the FDA from having oversight over EHRs as a medical device.
Dr. Gottlieb said that health IT companies could add new functions that would improve EHRs, but they have been reluctant to do so because they didn’t want their products to fall under FDA jurisdiction. He added that he was “not calling” for FDA to take over such a duty, however, and suggested that any new approach could be years away. Proponents have long argued that widespread use of EHRs can make medicine safer by alerting doctors to potential medical errors, though critics counter that software glitches and user errors may cause new varieties of medical mistakes.
How closely the FDA should watch over the digital medical record revolution has been controversial for years. The agency’s interest in the issue perked up after Congress decided in February 2009 to spend billions of dollars on digital medical records as part of an economic stimulus program.
At the time, many industry groups argued that FDA regulation would “stifle innovation” and stall the national drive to bring medicine into the modern era. Federal officials responsible for doling out billions in subsidies to doctors and hospitals generally sympathized with that view and were skeptical of allowing the FDA to play a role.
The debate became public in February 2010, when Jeffrey Shuren, MD, an FDA official, testified at a public hearing that the agency had tied 6 deaths and more than 200 injuries to health information technology. In all, the FDA said, it had logged 260 reports in the previous 2 years of “malfunctions with the potential for patient harm.”
The agency said the findings were based largely on reports voluntarily submitted to the FDA and suggested “significant clinical implications and public safety issues.” In one case cited, lab tests done in a hospital emergency department were sent to the wrong patient’s file. Since then, several government and private repositories have associated thousands of injuries, near misses, and deaths to EHR technology.
Dr. Shuren said in 2010 that the agency recognized that health information technology had great potential to improve patient care, but also needed oversight to “assure patient safety.”
While some safety proponents agree that EHRs offer tremendous benefits, they also see a greater opportunities to improve their safety.
Dean Sittig, PhD, a professor of bioinformatics and bioengineering at the University of Texas, Houston, said EHRs have improved safety within the health care system, but they have not eliminated errors to the extent that he would have expected. Federal officials were initially pushing for rapid adoption and ‘there wasn’t a lot of interest in talking about things that could go wrong,’ ” Dr. Sittig told KHN and Fortune.
Earlier in March, Gottlieb announced his resignation from the FDA. His last day is scheduled to be April 5.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN correspondents Sarah Jane Tribble, Sydney Lupkin, and Julie Rovner contributed to this report.
“What we really need is a much more tailored approach, so that we have appropriate oversight of EHRs when they’re doing things that could create risk for patients,” Dr. Gottlieb said in an interview with Kaiser Health News.
Dr. Gottlieb was responding to “Botched Operation,” a report published March 18 by KHN and Fortune magazine. The investigation found that the federal government has spent more than $36 billion over the past 10 years to switch doctors and hospitals from paper to digital records systems. In that time, thousands of reports of deaths, injuries, and near misses linked to EHRs have piled up in databases – including at least one run by the FDA.
Dr. Gottlieb said Congress would need to enact legislation to define when an EHR would require government oversight. He said that the digital records systems, which store a patient’s medical history, don’t fit neatly under the agency’s existing mandate to regulate items such as drugs and medical devices.
Dr. Gottlieb said the best approach might be to say that an EHR that has a certain capability becomes a medical device. He called EHRs a “unique tool,” noting that the risks posed by their use aren’t the same as for a traditional medical device implanted in a patient. “You need a much different regulatory scheme,” he said.
The 21st Century Cures Act of 2016 excludes the FDA from having oversight over EHRs as a medical device.
Dr. Gottlieb said that health IT companies could add new functions that would improve EHRs, but they have been reluctant to do so because they didn’t want their products to fall under FDA jurisdiction. He added that he was “not calling” for FDA to take over such a duty, however, and suggested that any new approach could be years away. Proponents have long argued that widespread use of EHRs can make medicine safer by alerting doctors to potential medical errors, though critics counter that software glitches and user errors may cause new varieties of medical mistakes.
How closely the FDA should watch over the digital medical record revolution has been controversial for years. The agency’s interest in the issue perked up after Congress decided in February 2009 to spend billions of dollars on digital medical records as part of an economic stimulus program.
At the time, many industry groups argued that FDA regulation would “stifle innovation” and stall the national drive to bring medicine into the modern era. Federal officials responsible for doling out billions in subsidies to doctors and hospitals generally sympathized with that view and were skeptical of allowing the FDA to play a role.
The debate became public in February 2010, when Jeffrey Shuren, MD, an FDA official, testified at a public hearing that the agency had tied 6 deaths and more than 200 injuries to health information technology. In all, the FDA said, it had logged 260 reports in the previous 2 years of “malfunctions with the potential for patient harm.”
The agency said the findings were based largely on reports voluntarily submitted to the FDA and suggested “significant clinical implications and public safety issues.” In one case cited, lab tests done in a hospital emergency department were sent to the wrong patient’s file. Since then, several government and private repositories have associated thousands of injuries, near misses, and deaths to EHR technology.
Dr. Shuren said in 2010 that the agency recognized that health information technology had great potential to improve patient care, but also needed oversight to “assure patient safety.”
While some safety proponents agree that EHRs offer tremendous benefits, they also see a greater opportunities to improve their safety.
Dean Sittig, PhD, a professor of bioinformatics and bioengineering at the University of Texas, Houston, said EHRs have improved safety within the health care system, but they have not eliminated errors to the extent that he would have expected. Federal officials were initially pushing for rapid adoption and ‘there wasn’t a lot of interest in talking about things that could go wrong,’ ” Dr. Sittig told KHN and Fortune.
Earlier in March, Gottlieb announced his resignation from the FDA. His last day is scheduled to be April 5.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN correspondents Sarah Jane Tribble, Sydney Lupkin, and Julie Rovner contributed to this report.
The power of policy at HM19
Mini-track features CMS insights
Due to the steadily growing interest of SHM members in health care policy and advocacy issues, the 2019 Annual Conference will include a mini-track dedicated to policy issues.
To be held on Monday, March 25th at HM19 in Orlando, the health care policy mini-track will update conference attendees on some of the Washington developments that affect hospitalists, said Josh Boswell, director of government relations at SHM.
“Many of the policy developments in D.C. are directly impacting our members’ practices,” he said. “A couple of years ago, it was decided to add a specific track at the annual conference to cover some of these policy issues, and we’ve generally had positive feedback on the sessions.”
This year, the mini-track will consist of two separate sessions, held back to back. “Both sessions are designed to give attendees an entrée into health policy and explain developments that are happening right now in Washington that impact their practice,” said Joshua Lapps, government relations manager at SHM.
The first session – “CMS Policy Update: An Overview of Meaningful Measures and the Quality Payment Program” – will take place from 2:00 to 3:30 p.m., and will feature Reena Duseja, MD, MS, the acting director for Quality Measurement and Value-Based Incentives Group in the Centers for Clinical Standards and Quality at the Centers for Medicare & Medicaid Services. Dr. Duseja oversees the development of measures and analyses for a variety of CMS quality reporting and value-based purchasing programs. She is also an emergency medicine physician and was an associate professor at the University of California, San Francisco, in the department of emergency medicine, where she led quality improvement activities.
“The session with Dr. Duseja will be an inside look into the approach that CMS is taking for quality measurement and pay-for-performance programs, specifically looking at the quality payment program which came out of the Medicare Access and Chip Reauthorization Act,” Mr. Lapps said. “It will be a high-level discussion about how the programs affect hospitalists, and how hospitalists participate in the programs. It’s also a chance for attendees to hear some of the thinking inside CMS.”
Dr. Duseja is also hoping to get feedback from HM19 attendees. “She wants the session to be educational for our members, as well as an opportunity for her to learn from hospitalists,” Mr. Lapps said.
According to Dr. Duseja, her presentation will provide attendees with an overview of the Quality Payment Program under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), specifically highlighting policy changes from 2018 to 2019 to the Merit-based Incentive Payment System (MIPS) and Meaningful Measures Initiative. Attendees will learn more about CMS’s approach to quality and quality measurement, as well as the future of quality reporting programs.
Following Dr. Duseja’s presentation, the second mini-track session will take place from 3:40 to 4:25 p.m. It will focus more intently on the processes around health care policy making.
“We heard from our members who attended this mini-track at the past two annual conferences that they would like us to explain how policy making works: the play-by-play in D.C. on how we get to where we are,” Mr. Boswell said.
The second session will feature a presentation by Jennifer Bell, founding partner at Chamber Hill Strategies, who represents SHM in Washington. “Jennifer will be discussing how Washington works, the policy process and the pressure points at which SHM and its members can exert influence,” Mr. Lapps said.
Attendees can expect to learn a lot from either session, Mr. Lapps said. “Attendees will learn about the basic contours of the Quality Payment Program that Medicare oversees, and some of the specific new elements of that program this year that were designed with hospitalists in mind. For example, Dr. Duseja will be talking about a facility-based reporting option under the Merit-Based Incentive Payment System. I think our members should gain a concrete understanding of some of the new directions that CMS is heading this year. Overall, they’ll have a better sense of the vision behind quality measures and quality measurement. This is a really exciting opportunity to hear from someone who is both a clinician and works on policy at CMS.”
The policy mini-track offers hospitalists a chance to get a look “behind the curtain” at policy making from someone who is helping to write the rules.
“Attendees will gain insight on where they fit in these programs – and also have the opportunity to tell Dr. Duseja if they don’t feel these programs are a good fit for them,” Mr. Boswell said. “Oftentimes these programs are not structured ideally for hospitalists. So, hearing directly from hospitalists who are experiencing problems would be extraordinarily helpful to a CMS official. I think attendees should view the policy track not only as an opportunity to learn from CMS, but as an opportunity to educate CMS about our issues.”
Mini-track features CMS insights
Mini-track features CMS insights
Due to the steadily growing interest of SHM members in health care policy and advocacy issues, the 2019 Annual Conference will include a mini-track dedicated to policy issues.
To be held on Monday, March 25th at HM19 in Orlando, the health care policy mini-track will update conference attendees on some of the Washington developments that affect hospitalists, said Josh Boswell, director of government relations at SHM.
“Many of the policy developments in D.C. are directly impacting our members’ practices,” he said. “A couple of years ago, it was decided to add a specific track at the annual conference to cover some of these policy issues, and we’ve generally had positive feedback on the sessions.”
This year, the mini-track will consist of two separate sessions, held back to back. “Both sessions are designed to give attendees an entrée into health policy and explain developments that are happening right now in Washington that impact their practice,” said Joshua Lapps, government relations manager at SHM.
The first session – “CMS Policy Update: An Overview of Meaningful Measures and the Quality Payment Program” – will take place from 2:00 to 3:30 p.m., and will feature Reena Duseja, MD, MS, the acting director for Quality Measurement and Value-Based Incentives Group in the Centers for Clinical Standards and Quality at the Centers for Medicare & Medicaid Services. Dr. Duseja oversees the development of measures and analyses for a variety of CMS quality reporting and value-based purchasing programs. She is also an emergency medicine physician and was an associate professor at the University of California, San Francisco, in the department of emergency medicine, where she led quality improvement activities.
“The session with Dr. Duseja will be an inside look into the approach that CMS is taking for quality measurement and pay-for-performance programs, specifically looking at the quality payment program which came out of the Medicare Access and Chip Reauthorization Act,” Mr. Lapps said. “It will be a high-level discussion about how the programs affect hospitalists, and how hospitalists participate in the programs. It’s also a chance for attendees to hear some of the thinking inside CMS.”
Dr. Duseja is also hoping to get feedback from HM19 attendees. “She wants the session to be educational for our members, as well as an opportunity for her to learn from hospitalists,” Mr. Lapps said.
According to Dr. Duseja, her presentation will provide attendees with an overview of the Quality Payment Program under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), specifically highlighting policy changes from 2018 to 2019 to the Merit-based Incentive Payment System (MIPS) and Meaningful Measures Initiative. Attendees will learn more about CMS’s approach to quality and quality measurement, as well as the future of quality reporting programs.
Following Dr. Duseja’s presentation, the second mini-track session will take place from 3:40 to 4:25 p.m. It will focus more intently on the processes around health care policy making.
“We heard from our members who attended this mini-track at the past two annual conferences that they would like us to explain how policy making works: the play-by-play in D.C. on how we get to where we are,” Mr. Boswell said.
The second session will feature a presentation by Jennifer Bell, founding partner at Chamber Hill Strategies, who represents SHM in Washington. “Jennifer will be discussing how Washington works, the policy process and the pressure points at which SHM and its members can exert influence,” Mr. Lapps said.
Attendees can expect to learn a lot from either session, Mr. Lapps said. “Attendees will learn about the basic contours of the Quality Payment Program that Medicare oversees, and some of the specific new elements of that program this year that were designed with hospitalists in mind. For example, Dr. Duseja will be talking about a facility-based reporting option under the Merit-Based Incentive Payment System. I think our members should gain a concrete understanding of some of the new directions that CMS is heading this year. Overall, they’ll have a better sense of the vision behind quality measures and quality measurement. This is a really exciting opportunity to hear from someone who is both a clinician and works on policy at CMS.”
The policy mini-track offers hospitalists a chance to get a look “behind the curtain” at policy making from someone who is helping to write the rules.
“Attendees will gain insight on where they fit in these programs – and also have the opportunity to tell Dr. Duseja if they don’t feel these programs are a good fit for them,” Mr. Boswell said. “Oftentimes these programs are not structured ideally for hospitalists. So, hearing directly from hospitalists who are experiencing problems would be extraordinarily helpful to a CMS official. I think attendees should view the policy track not only as an opportunity to learn from CMS, but as an opportunity to educate CMS about our issues.”
Due to the steadily growing interest of SHM members in health care policy and advocacy issues, the 2019 Annual Conference will include a mini-track dedicated to policy issues.
To be held on Monday, March 25th at HM19 in Orlando, the health care policy mini-track will update conference attendees on some of the Washington developments that affect hospitalists, said Josh Boswell, director of government relations at SHM.
“Many of the policy developments in D.C. are directly impacting our members’ practices,” he said. “A couple of years ago, it was decided to add a specific track at the annual conference to cover some of these policy issues, and we’ve generally had positive feedback on the sessions.”
This year, the mini-track will consist of two separate sessions, held back to back. “Both sessions are designed to give attendees an entrée into health policy and explain developments that are happening right now in Washington that impact their practice,” said Joshua Lapps, government relations manager at SHM.
The first session – “CMS Policy Update: An Overview of Meaningful Measures and the Quality Payment Program” – will take place from 2:00 to 3:30 p.m., and will feature Reena Duseja, MD, MS, the acting director for Quality Measurement and Value-Based Incentives Group in the Centers for Clinical Standards and Quality at the Centers for Medicare & Medicaid Services. Dr. Duseja oversees the development of measures and analyses for a variety of CMS quality reporting and value-based purchasing programs. She is also an emergency medicine physician and was an associate professor at the University of California, San Francisco, in the department of emergency medicine, where she led quality improvement activities.
“The session with Dr. Duseja will be an inside look into the approach that CMS is taking for quality measurement and pay-for-performance programs, specifically looking at the quality payment program which came out of the Medicare Access and Chip Reauthorization Act,” Mr. Lapps said. “It will be a high-level discussion about how the programs affect hospitalists, and how hospitalists participate in the programs. It’s also a chance for attendees to hear some of the thinking inside CMS.”
Dr. Duseja is also hoping to get feedback from HM19 attendees. “She wants the session to be educational for our members, as well as an opportunity for her to learn from hospitalists,” Mr. Lapps said.
According to Dr. Duseja, her presentation will provide attendees with an overview of the Quality Payment Program under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), specifically highlighting policy changes from 2018 to 2019 to the Merit-based Incentive Payment System (MIPS) and Meaningful Measures Initiative. Attendees will learn more about CMS’s approach to quality and quality measurement, as well as the future of quality reporting programs.
Following Dr. Duseja’s presentation, the second mini-track session will take place from 3:40 to 4:25 p.m. It will focus more intently on the processes around health care policy making.
“We heard from our members who attended this mini-track at the past two annual conferences that they would like us to explain how policy making works: the play-by-play in D.C. on how we get to where we are,” Mr. Boswell said.
The second session will feature a presentation by Jennifer Bell, founding partner at Chamber Hill Strategies, who represents SHM in Washington. “Jennifer will be discussing how Washington works, the policy process and the pressure points at which SHM and its members can exert influence,” Mr. Lapps said.
Attendees can expect to learn a lot from either session, Mr. Lapps said. “Attendees will learn about the basic contours of the Quality Payment Program that Medicare oversees, and some of the specific new elements of that program this year that were designed with hospitalists in mind. For example, Dr. Duseja will be talking about a facility-based reporting option under the Merit-Based Incentive Payment System. I think our members should gain a concrete understanding of some of the new directions that CMS is heading this year. Overall, they’ll have a better sense of the vision behind quality measures and quality measurement. This is a really exciting opportunity to hear from someone who is both a clinician and works on policy at CMS.”
The policy mini-track offers hospitalists a chance to get a look “behind the curtain” at policy making from someone who is helping to write the rules.
“Attendees will gain insight on where they fit in these programs – and also have the opportunity to tell Dr. Duseja if they don’t feel these programs are a good fit for them,” Mr. Boswell said. “Oftentimes these programs are not structured ideally for hospitalists. So, hearing directly from hospitalists who are experiencing problems would be extraordinarily helpful to a CMS official. I think attendees should view the policy track not only as an opportunity to learn from CMS, but as an opportunity to educate CMS about our issues.”
Scott Gottlieb to step down as FDA commissioner
According to reports, he is stepping down to spend more time with his family, who live in Westport, Conn. He splits time between there and Washington. He was confirmed by the Senate in May 2017 with five Democrats and one independent joining Republicans in voting him in.
President Trump confirmed Dr. Gottlieb’s resignation, praising him in a tweet for the “terrific job” he has done in this role and commending his efforts to help “us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. ”
Dr. Gottlieb’s legacy may be his work on regulating e-cigarettes, although that work is unfinished. His passion for this subject can be found in a statement made in Nov. 2018, announcing an advanced notice of proposed rule making to regulate e-cigarettes.
“Today, I’m pursuing actions aimed at addressing the disturbing trend of youth nicotine use and continuing to advance the historic declines we’ve achieved in recent years in the rates of combustible cigarette use among kids,” Dr. Gottlieb said in the statement.
More recently, the agency announced March 4 enforcement actions aimed at both retailers and manufacturers, including requesting a meeting with Walgreens to discuss the nearly 1,800 violations the chain has amassed across the country for selling tobacco products to minors.
“Because tobacco use is almost always initiated and established during adolescence, early intervention ‒ including making sure tobacco products aren’t being marketed to, sold to, or used by kids ‒ is critical,” he said in announcing the enforcement actions. He added that the FDA will “continue vigorous enforcement activities, with a sustained campaign to monitor, penalize, and help prevent e-cigarette sales to minors in retail locations, including manufacturers’ Internet storefronts, as well as take additional steps to tackle other concerns related to the youth access and appeal of these products. The FDA is also exploring additional enforcement avenues to target violative sales and marketing practices by manufacturers and retailers.”
The American Heart Association praised Dr. Gottlieb’s work.
“Commissioner Gottlieb departs the FDA having established himself as a tireless champion of tobacco control,” the organization said in a statement. “He elevated the war on tobacco use – and particularly the epidemic of electronic cigarette use among youth – to unprecedented levels. Because of his efforts, millions more people nationwide are aware of the grave threats posed by e-cigarettes and other tobacco products that are addicting a new generation of youth. We urge the FDA in the strongest possible terms to move forward with effective regulation of an industry that continues to prioritize profits over the lives of consumers.”
Department of Health & Human Services Secretary Alex Azar acknowledged Dr. Gottlieb’s work in combating youth e-cigarette use among a number of areas that the outgoing official has had a positive impact on.
“Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more,” Secretary Azar said in a statement. “The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”
Under his leadership, FDA has approved a record number of generic drugs, although many still are not on the market yet.
In the area of opioids, his tenure could be a mixed bag as the FDA on the one hand removed an opioid product from the market, but on the other, controversially approved a new, powerful one.
According to reports, he is stepping down to spend more time with his family, who live in Westport, Conn. He splits time between there and Washington. He was confirmed by the Senate in May 2017 with five Democrats and one independent joining Republicans in voting him in.
President Trump confirmed Dr. Gottlieb’s resignation, praising him in a tweet for the “terrific job” he has done in this role and commending his efforts to help “us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. ”
Dr. Gottlieb’s legacy may be his work on regulating e-cigarettes, although that work is unfinished. His passion for this subject can be found in a statement made in Nov. 2018, announcing an advanced notice of proposed rule making to regulate e-cigarettes.
“Today, I’m pursuing actions aimed at addressing the disturbing trend of youth nicotine use and continuing to advance the historic declines we’ve achieved in recent years in the rates of combustible cigarette use among kids,” Dr. Gottlieb said in the statement.
More recently, the agency announced March 4 enforcement actions aimed at both retailers and manufacturers, including requesting a meeting with Walgreens to discuss the nearly 1,800 violations the chain has amassed across the country for selling tobacco products to minors.
“Because tobacco use is almost always initiated and established during adolescence, early intervention ‒ including making sure tobacco products aren’t being marketed to, sold to, or used by kids ‒ is critical,” he said in announcing the enforcement actions. He added that the FDA will “continue vigorous enforcement activities, with a sustained campaign to monitor, penalize, and help prevent e-cigarette sales to minors in retail locations, including manufacturers’ Internet storefronts, as well as take additional steps to tackle other concerns related to the youth access and appeal of these products. The FDA is also exploring additional enforcement avenues to target violative sales and marketing practices by manufacturers and retailers.”
The American Heart Association praised Dr. Gottlieb’s work.
“Commissioner Gottlieb departs the FDA having established himself as a tireless champion of tobacco control,” the organization said in a statement. “He elevated the war on tobacco use – and particularly the epidemic of electronic cigarette use among youth – to unprecedented levels. Because of his efforts, millions more people nationwide are aware of the grave threats posed by e-cigarettes and other tobacco products that are addicting a new generation of youth. We urge the FDA in the strongest possible terms to move forward with effective regulation of an industry that continues to prioritize profits over the lives of consumers.”
Department of Health & Human Services Secretary Alex Azar acknowledged Dr. Gottlieb’s work in combating youth e-cigarette use among a number of areas that the outgoing official has had a positive impact on.
“Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more,” Secretary Azar said in a statement. “The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”
Under his leadership, FDA has approved a record number of generic drugs, although many still are not on the market yet.
In the area of opioids, his tenure could be a mixed bag as the FDA on the one hand removed an opioid product from the market, but on the other, controversially approved a new, powerful one.
According to reports, he is stepping down to spend more time with his family, who live in Westport, Conn. He splits time between there and Washington. He was confirmed by the Senate in May 2017 with five Democrats and one independent joining Republicans in voting him in.
President Trump confirmed Dr. Gottlieb’s resignation, praising him in a tweet for the “terrific job” he has done in this role and commending his efforts to help “us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. ”
Dr. Gottlieb’s legacy may be his work on regulating e-cigarettes, although that work is unfinished. His passion for this subject can be found in a statement made in Nov. 2018, announcing an advanced notice of proposed rule making to regulate e-cigarettes.
“Today, I’m pursuing actions aimed at addressing the disturbing trend of youth nicotine use and continuing to advance the historic declines we’ve achieved in recent years in the rates of combustible cigarette use among kids,” Dr. Gottlieb said in the statement.
More recently, the agency announced March 4 enforcement actions aimed at both retailers and manufacturers, including requesting a meeting with Walgreens to discuss the nearly 1,800 violations the chain has amassed across the country for selling tobacco products to minors.
“Because tobacco use is almost always initiated and established during adolescence, early intervention ‒ including making sure tobacco products aren’t being marketed to, sold to, or used by kids ‒ is critical,” he said in announcing the enforcement actions. He added that the FDA will “continue vigorous enforcement activities, with a sustained campaign to monitor, penalize, and help prevent e-cigarette sales to minors in retail locations, including manufacturers’ Internet storefronts, as well as take additional steps to tackle other concerns related to the youth access and appeal of these products. The FDA is also exploring additional enforcement avenues to target violative sales and marketing practices by manufacturers and retailers.”
The American Heart Association praised Dr. Gottlieb’s work.
“Commissioner Gottlieb departs the FDA having established himself as a tireless champion of tobacco control,” the organization said in a statement. “He elevated the war on tobacco use – and particularly the epidemic of electronic cigarette use among youth – to unprecedented levels. Because of his efforts, millions more people nationwide are aware of the grave threats posed by e-cigarettes and other tobacco products that are addicting a new generation of youth. We urge the FDA in the strongest possible terms to move forward with effective regulation of an industry that continues to prioritize profits over the lives of consumers.”
Department of Health & Human Services Secretary Alex Azar acknowledged Dr. Gottlieb’s work in combating youth e-cigarette use among a number of areas that the outgoing official has had a positive impact on.
“Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more,” Secretary Azar said in a statement. “The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”
Under his leadership, FDA has approved a record number of generic drugs, although many still are not on the market yet.
In the area of opioids, his tenure could be a mixed bag as the FDA on the one hand removed an opioid product from the market, but on the other, controversially approved a new, powerful one.
Hospitalists on the Hill
Advocating for HM in DC
Another Hill Day is coming – the all-day advocacy event on Capitol Hill is scheduled in conjunction with the Society of Hospital Medicine’s Annual Conference whenever it is held in Washington, DC. In 2019, Hill Day will take place on March 27, the final day of HM19.
This will be the fourth Hill Day, and the last for some time, said Ron Greeno, MD, FCCP, MHM, senior advisor for government affairs at SHM and the society’s immediate past president. For at least the next 5 years, SHM’s annual conferences won’t be held in Washington, so there will not be any opportunities to plan a Hill Day during that time. “Members may want to take advantage of this opportunity,” Dr. Greeno said. “The people who do this never forget it.”
How Hill Day works
Sign up for Hill Day and you’ll spend a day visiting legislators and their health care staffers to educate them on what hospital medicine is, what a hospitalist does, and some of the pressing issues that affect the profession, said Joshua Lenchus, DO, RPh, FACP, SFHM, chair of the SHM Public Policy Committee. “We try to leverage participants’ work and home addresses to pair them up with legislators from that area. Some hospitalists have personal or professional relationships with some of the legislators, and even if they’re not in their area, we’ll try to leverage that. And for people who have expertise in a particular topic, we try to arrange an audience with a member of Congress who may be promoting or sponsoring a bill related to that.”
Hill Day volunteers will attend an orientation to learn more about what the day will look like and what they’ll be talking about in their meetings. “We’ll only have time to cover one or two issues, and we’re in the process now of choosing the issues we want to address. We orient participants on those subjects so everybody is kind of saying the same thing,” Dr. Greeno said. “People shouldn’t be afraid of not being conversant with the issues because we do sufficient orientation that everybody gets comfortable enough to do a good job.”
Registration for Hill Day is happening online now. HM19 attendees can register at https://s1.goeshow.com/shm/annual/2019/registration_form.cfm.
“We beg people: If you sign up, show up, because we have many more people trying to participate than we can accommodate,” Dr. Greeno said. “If you change your mind, that’s fine because we have a waiting list, but please let us know because somebody else wants to take your place.”
The purpose of Hill Day
Educating legislators and their health care staff is the goal of the day, and it’s an important job. “Hospital medicine is still a relatively new field,” Dr. Lenchus said. “There are a fair number of legislators who still don’t know what a hospitalist is or what hospital medicine is. Part of our visits is always to educate them about what we do and what our impact is on the health care landscape of the country.” He added that educating Hill staff about the most pressing issues is another primary goal.
“Finally, and this is what separates us from other organizations that do legislative advocacy, we try to leave them with the idea that we’re here to help,” Dr. Lenchus said. “If there’s an issue or a particular bill that we’re asking them to sponsor or cosponsor, that’s one part of a visit. But by and large, we are trying to leave them with the sense that SHM is a resource when it comes to health care–related issues. We want to be there for legislators so that they can understand our position accurately from the outset.”
In short, Hill Day offers a rare opportunity to have direct access to the people who are voting on new legislation affecting hospitalists and affecting the implementation of existing legislation. “This is where the rubber meets the road,” Dr. Lenchus said. Each time a Hill Day is held, he noted, attendance increases. “That’s a true testament to the level of involvement and the interest that hospitalists have across the country. If you’re at all interested, you should absolutely sign up. This will be an amazing experience.”
The lasting impact
Though it’s just one day, Hill Day’s effects are significant.
“Before I started doing this work, I often thought, ‘What impact could someone have going into a legislator’s office?’ ” Dr. Greeno said. “But the answer is ‘A lot.’ The members and staff really do listen – especially if an advocate is highly educated and represent what legislators consider an important constituency, like health care providers. Health care is a hot topic, and it’s probably going to be one of the hot topics in the next election. Hospitalists have good ideas, and as a result these meetings are extremely influential; we wouldn’t do it otherwise. It is fun, but we’re not doing it for fun. We’re doing it because we know we can make a difference.”
In fact, in terms of impact on Capitol Hill, SHM punches above its weight, he added.
“We’re a relatively new society; we’re not huge. There are lots of societies that are much bigger than us and have many more resources, but people on the Hill have told us they like talking with us because they know we’re not looking at things the same way,” Dr. Greeno revealed. “We’re trying to help, and the issues that we’re addressing are not necessarily self-serving. We’re not saying, ‘You need to do this because it will make more money for our doctors.’ Instead, we’re saying, ‘You need to do this because the way it’s being done now is hurting patients. It’s hurting the health care system, and we have ideas about how to make that better.’ ”
SHM’s impressive track record has earned the society a positive reputation that will underlie the Hill Day meetings. “When we first set up the policy shop at SHM, we wanted to be seen as providers who cared about the American health care system and our patients,” Dr. Greeno said. “We have established that reputation, and that has led members on Capitol Hill to recognize us as being well intentioned and knowledgeable. So we have an outsize influence in Congress for our age and our size. When 200 hospitalists go to Capitol Hill, it’s an important thing.”
For more information about Hill Day, including details about participation, visit shmannualconference.org/hill-day/.
Advocating for HM in DC
Advocating for HM in DC
Another Hill Day is coming – the all-day advocacy event on Capitol Hill is scheduled in conjunction with the Society of Hospital Medicine’s Annual Conference whenever it is held in Washington, DC. In 2019, Hill Day will take place on March 27, the final day of HM19.
This will be the fourth Hill Day, and the last for some time, said Ron Greeno, MD, FCCP, MHM, senior advisor for government affairs at SHM and the society’s immediate past president. For at least the next 5 years, SHM’s annual conferences won’t be held in Washington, so there will not be any opportunities to plan a Hill Day during that time. “Members may want to take advantage of this opportunity,” Dr. Greeno said. “The people who do this never forget it.”
How Hill Day works
Sign up for Hill Day and you’ll spend a day visiting legislators and their health care staffers to educate them on what hospital medicine is, what a hospitalist does, and some of the pressing issues that affect the profession, said Joshua Lenchus, DO, RPh, FACP, SFHM, chair of the SHM Public Policy Committee. “We try to leverage participants’ work and home addresses to pair them up with legislators from that area. Some hospitalists have personal or professional relationships with some of the legislators, and even if they’re not in their area, we’ll try to leverage that. And for people who have expertise in a particular topic, we try to arrange an audience with a member of Congress who may be promoting or sponsoring a bill related to that.”
Hill Day volunteers will attend an orientation to learn more about what the day will look like and what they’ll be talking about in their meetings. “We’ll only have time to cover one or two issues, and we’re in the process now of choosing the issues we want to address. We orient participants on those subjects so everybody is kind of saying the same thing,” Dr. Greeno said. “People shouldn’t be afraid of not being conversant with the issues because we do sufficient orientation that everybody gets comfortable enough to do a good job.”
Registration for Hill Day is happening online now. HM19 attendees can register at https://s1.goeshow.com/shm/annual/2019/registration_form.cfm.
“We beg people: If you sign up, show up, because we have many more people trying to participate than we can accommodate,” Dr. Greeno said. “If you change your mind, that’s fine because we have a waiting list, but please let us know because somebody else wants to take your place.”
The purpose of Hill Day
Educating legislators and their health care staff is the goal of the day, and it’s an important job. “Hospital medicine is still a relatively new field,” Dr. Lenchus said. “There are a fair number of legislators who still don’t know what a hospitalist is or what hospital medicine is. Part of our visits is always to educate them about what we do and what our impact is on the health care landscape of the country.” He added that educating Hill staff about the most pressing issues is another primary goal.
“Finally, and this is what separates us from other organizations that do legislative advocacy, we try to leave them with the idea that we’re here to help,” Dr. Lenchus said. “If there’s an issue or a particular bill that we’re asking them to sponsor or cosponsor, that’s one part of a visit. But by and large, we are trying to leave them with the sense that SHM is a resource when it comes to health care–related issues. We want to be there for legislators so that they can understand our position accurately from the outset.”
In short, Hill Day offers a rare opportunity to have direct access to the people who are voting on new legislation affecting hospitalists and affecting the implementation of existing legislation. “This is where the rubber meets the road,” Dr. Lenchus said. Each time a Hill Day is held, he noted, attendance increases. “That’s a true testament to the level of involvement and the interest that hospitalists have across the country. If you’re at all interested, you should absolutely sign up. This will be an amazing experience.”
The lasting impact
Though it’s just one day, Hill Day’s effects are significant.
“Before I started doing this work, I often thought, ‘What impact could someone have going into a legislator’s office?’ ” Dr. Greeno said. “But the answer is ‘A lot.’ The members and staff really do listen – especially if an advocate is highly educated and represent what legislators consider an important constituency, like health care providers. Health care is a hot topic, and it’s probably going to be one of the hot topics in the next election. Hospitalists have good ideas, and as a result these meetings are extremely influential; we wouldn’t do it otherwise. It is fun, but we’re not doing it for fun. We’re doing it because we know we can make a difference.”
In fact, in terms of impact on Capitol Hill, SHM punches above its weight, he added.
“We’re a relatively new society; we’re not huge. There are lots of societies that are much bigger than us and have many more resources, but people on the Hill have told us they like talking with us because they know we’re not looking at things the same way,” Dr. Greeno revealed. “We’re trying to help, and the issues that we’re addressing are not necessarily self-serving. We’re not saying, ‘You need to do this because it will make more money for our doctors.’ Instead, we’re saying, ‘You need to do this because the way it’s being done now is hurting patients. It’s hurting the health care system, and we have ideas about how to make that better.’ ”
SHM’s impressive track record has earned the society a positive reputation that will underlie the Hill Day meetings. “When we first set up the policy shop at SHM, we wanted to be seen as providers who cared about the American health care system and our patients,” Dr. Greeno said. “We have established that reputation, and that has led members on Capitol Hill to recognize us as being well intentioned and knowledgeable. So we have an outsize influence in Congress for our age and our size. When 200 hospitalists go to Capitol Hill, it’s an important thing.”
For more information about Hill Day, including details about participation, visit shmannualconference.org/hill-day/.
Another Hill Day is coming – the all-day advocacy event on Capitol Hill is scheduled in conjunction with the Society of Hospital Medicine’s Annual Conference whenever it is held in Washington, DC. In 2019, Hill Day will take place on March 27, the final day of HM19.
This will be the fourth Hill Day, and the last for some time, said Ron Greeno, MD, FCCP, MHM, senior advisor for government affairs at SHM and the society’s immediate past president. For at least the next 5 years, SHM’s annual conferences won’t be held in Washington, so there will not be any opportunities to plan a Hill Day during that time. “Members may want to take advantage of this opportunity,” Dr. Greeno said. “The people who do this never forget it.”
How Hill Day works
Sign up for Hill Day and you’ll spend a day visiting legislators and their health care staffers to educate them on what hospital medicine is, what a hospitalist does, and some of the pressing issues that affect the profession, said Joshua Lenchus, DO, RPh, FACP, SFHM, chair of the SHM Public Policy Committee. “We try to leverage participants’ work and home addresses to pair them up with legislators from that area. Some hospitalists have personal or professional relationships with some of the legislators, and even if they’re not in their area, we’ll try to leverage that. And for people who have expertise in a particular topic, we try to arrange an audience with a member of Congress who may be promoting or sponsoring a bill related to that.”
Hill Day volunteers will attend an orientation to learn more about what the day will look like and what they’ll be talking about in their meetings. “We’ll only have time to cover one or two issues, and we’re in the process now of choosing the issues we want to address. We orient participants on those subjects so everybody is kind of saying the same thing,” Dr. Greeno said. “People shouldn’t be afraid of not being conversant with the issues because we do sufficient orientation that everybody gets comfortable enough to do a good job.”
Registration for Hill Day is happening online now. HM19 attendees can register at https://s1.goeshow.com/shm/annual/2019/registration_form.cfm.
“We beg people: If you sign up, show up, because we have many more people trying to participate than we can accommodate,” Dr. Greeno said. “If you change your mind, that’s fine because we have a waiting list, but please let us know because somebody else wants to take your place.”
The purpose of Hill Day
Educating legislators and their health care staff is the goal of the day, and it’s an important job. “Hospital medicine is still a relatively new field,” Dr. Lenchus said. “There are a fair number of legislators who still don’t know what a hospitalist is or what hospital medicine is. Part of our visits is always to educate them about what we do and what our impact is on the health care landscape of the country.” He added that educating Hill staff about the most pressing issues is another primary goal.
“Finally, and this is what separates us from other organizations that do legislative advocacy, we try to leave them with the idea that we’re here to help,” Dr. Lenchus said. “If there’s an issue or a particular bill that we’re asking them to sponsor or cosponsor, that’s one part of a visit. But by and large, we are trying to leave them with the sense that SHM is a resource when it comes to health care–related issues. We want to be there for legislators so that they can understand our position accurately from the outset.”
In short, Hill Day offers a rare opportunity to have direct access to the people who are voting on new legislation affecting hospitalists and affecting the implementation of existing legislation. “This is where the rubber meets the road,” Dr. Lenchus said. Each time a Hill Day is held, he noted, attendance increases. “That’s a true testament to the level of involvement and the interest that hospitalists have across the country. If you’re at all interested, you should absolutely sign up. This will be an amazing experience.”
The lasting impact
Though it’s just one day, Hill Day’s effects are significant.
“Before I started doing this work, I often thought, ‘What impact could someone have going into a legislator’s office?’ ” Dr. Greeno said. “But the answer is ‘A lot.’ The members and staff really do listen – especially if an advocate is highly educated and represent what legislators consider an important constituency, like health care providers. Health care is a hot topic, and it’s probably going to be one of the hot topics in the next election. Hospitalists have good ideas, and as a result these meetings are extremely influential; we wouldn’t do it otherwise. It is fun, but we’re not doing it for fun. We’re doing it because we know we can make a difference.”
In fact, in terms of impact on Capitol Hill, SHM punches above its weight, he added.
“We’re a relatively new society; we’re not huge. There are lots of societies that are much bigger than us and have many more resources, but people on the Hill have told us they like talking with us because they know we’re not looking at things the same way,” Dr. Greeno revealed. “We’re trying to help, and the issues that we’re addressing are not necessarily self-serving. We’re not saying, ‘You need to do this because it will make more money for our doctors.’ Instead, we’re saying, ‘You need to do this because the way it’s being done now is hurting patients. It’s hurting the health care system, and we have ideas about how to make that better.’ ”
SHM’s impressive track record has earned the society a positive reputation that will underlie the Hill Day meetings. “When we first set up the policy shop at SHM, we wanted to be seen as providers who cared about the American health care system and our patients,” Dr. Greeno said. “We have established that reputation, and that has led members on Capitol Hill to recognize us as being well intentioned and knowledgeable. So we have an outsize influence in Congress for our age and our size. When 200 hospitalists go to Capitol Hill, it’s an important thing.”
For more information about Hill Day, including details about participation, visit shmannualconference.org/hill-day/.
Medicare’s two-midnight rule
What hospitalists must know
Most hospitalists’ training likely included caring for patients in the ambulatory clinic, urgent care, and ED settings. One of the most important aspects of medical training is deciding which of the patients seen in these settings need to “be admitted” to a hospital because of risk, severity of illness, and/or need for certain medical services. In this context, “admit” is a synonym for “hospitalize.”
However, in today’s health care system, in which hospitalization costs are usually borne by a third-party payer, “admit” can have a very different meaning. For most payers, “admit” means “hospitalize as inpatient.” This is distinct from “hospitalize as an outpatient.” (“Observation” or “obs” is the most common example of a hospitalization as an outpatient.) In the medical payer world, inpatient and outpatient are often referred to as “statuses.” The distinction between inpatient versus outpatient status can affect payment and is based on rules that a hospital and payer have agreed upon. (Inpatient hospital care is generally paid at a higher rate than outpatient hospital care.) It is important for hospitalists to have a basic understanding of these rules because it can affect hospital billing, the hospitalist’s professional fees, beneficiary liability, and payer denials of inpatient care.
For years, Medicare’s definition of an inpatient hospitalization was primarily based on an expectation of a hospitalization of at least 24 hours and a physician’s judgment of the beneficiary’s need for inpatient hospital services. This judgment was to be based on the physician’s assessment of the patient’s severity of illness, the risk of an adverse outcome, and the hospital services required. (The exact definition by Centers for Medicare & Medicaid Services is much longer and can be found in the Medicare Benefits Policy Manual.1) Under Medicare, defining a hospitalization as inpatient versus outpatient is especially important because they are billed to different Medicare programs (Part A for inpatient, Part B for outpatient), and both hospital reimbursement and the patient liability can vary significantly.
Not surprisingly, CMS found that how physicians were making status decisions for medically similar hospitalized patients varied greatly. CMS noted two major concerns: an overuse of inpatient for patients hospitalized overnight leading to increased charges to CMS and multiday observation hospitalizations for lower-acuity patients leading to excessive liability for Medicare beneficiaries. (Observation stays are billed under Part B, under which the beneficiary generally has a 20% copay.)
To address these concerns, in October 2013, CMS adjusted the definition of inpatient to include “the two-midnight rule.” Basically, CMS said that, in order to qualify for inpatient, the admitting physician should expect the beneficiary to require hospital care spanning at least two midnights, rather than the previous 24-hour benchmark, regardless of the severity of illness or risk of adverse outcome. (There are exceptions and exemptions to the two-midnight rule, which are discussed later in this article.)
The idea of the two-midnight rule was to address the two concerns noted above. Under this rule, most expected overnight hospitalizations should be outpatients, even if they are more than 24 hours in length, and any medically necessary outpatient hospitalization should be “converted” to inpatient if and when it is clear that a second midnight of hospitalization is medically necessary.
In January 2016, CMS amended the two-midnight rule to recognize, as it had done prior to October 2013, that some hospitalizations, based on physician judgment, would be appropriate for inpatient without an expectation of a hospitalization that spans at least two midnights. Unfortunately, CMS has not been forthcoming with guidance of examples of which hospitalizations would fall into this new category, other than to say they expect the use of this new provision would generally not be appropriate for a hospital stay of less than 24 hours.
As of today, physicians should order inpatient services under the following three situations:
- The physician expects the beneficiary to require hospital care spanning at least two midnights.
- The physician provides a service on Medicare’s inpatient-only list.
- The physician expects the beneficiary to require hospital care for less than two midnights but feels that inpatient services are nevertheless appropriate.
This most recently updated version of the two-midnight rule can be found in Section 42 CFR §412.3 of the Code of Federal Regulations.2 Each of these three situations warrants additional discussion.
Care expected to span two midnights
The first situation is the one most applicable to hospitalists. In this circumstance there are three key points to remember.
The first point is that the two-midnight rule is based on a reasonable expectation of a need for hospitalization for at least two nights, not the actual length of hospitalization. Auditors, based on long-standing guidance from the CMS, should consider only the information known (or that should have been known) to the provider at the time the inpatient decision is made.
For example, if the expectation of the need for hospitalization of at least 2 midnights is well documented in the admission note, but the beneficiary improves more rapidly than expected and can be discharged before the second midnight, billing Medicare under Part A for inpatient admission remains appropriate. Auditors may look for provider documentation describing the unexpected improvement, and while such documentation is not an absolute requirement, its presence can be helpful in defending inpatient billing.
Other situations in which there can be an expectation of hospitalization of at least two midnights, but the actual length of stay does not meet this benchmark, are death, patients leaving against medical advice, or transfer to another hospital. For example, if a patient is hospitalized as an inpatient for bacterial endocarditis, and the documented plan of care includes at least 2 days of IV antibiotics and monitoring of cultures, inpatient remains appropriate even if the patient signs out against medical advice the following day.
The second key point to understand is that a night must be “medically necessary” to count toward the two-midnight benchmark. Hospital time spent receiving custodial care, because of excessive delays, or incurred because of the convenience of the beneficiary or provider does not count toward the two-midnight benchmark. For example, imagine a patient hospitalized with chest pain on Saturday evening and the attending physician determines that the patient requires serial cardiac isoenzymes and ECGs followed, most likely, by a noninvasive stress test. The attending physician, knowing that the hospital does not offer stress testing on Sunday, expects the patient to remain hospitalized at least until Monday, thus two midnights. However, in this situation, the second midnight (Sunday night) was not medically necessary and does not count toward the two midnight expectation.
The third key point to know is that the clock for calculating the two-midnight rule begins when the beneficiary starts receiving hospital care, not when the inpatient order is placed. Further, care that starts in the ED or at another hospital counts, too. In contrast, care at an outpatient clinic, an urgent care facility, or waiting-room time in an ED does not count.
When CMS implemented the two-midnight rule in 2013, they said that they would be open to exceptions. The first and only exception to date to the two-midnight rule is newly initiated and unanticipated mechanical ventilation. (This excludes anticipated intubations related to other care, such as procedures.) For example, inpatient is appropriate for a patient who requires hospitalization for an anaphylactic reaction or a drug overdose and needs intubation and mechanical ventilation, even if discharge is expected before a second midnight of hospital care.
CMS’s inpatient-only list
Each year, CMS publishes a list of procedures that CMS will pay only under Part A (that is, as inpatient). This list is updated quarterly (Addendum E) and can be found on the CMS website.3 Hospitalizations associated with the procedures on this list should always be inpatient, regardless of the expected length of stay.
It is important to note that the inpatient-only list is dynamic; it is revised annually, and procedures can come on or off the list. Notably, in January 2018, elective total knee replacements and laparoscopic radical prostatectomies came off the inpatient-only list. Most surgeons and proceduralists know whether the procedure they are performing is on this list, and they should advise hospitalists accordingly if the hospitalist is to be the attending of record and will be writing the admission order.
Inpatient services are nevertheless appropriate
The third situation, in which an inpatient admission is appropriate even when the admitting provider does not expect a two-midnight stay, was added to the two-midnight rule in January 2016. CMS states that the factors used in making this determination can be based on physician judgment and documented in the medical record.
At first reading, one might think that CMS is, in effect, returning to the definition of an inpatient prior to the two-midnight rule’s implementation in 2013. However, CMS has not offered clear guidance for its use, and they did not remove any of the previous two-midnight rule guidance. In the absence of clear guidance, hospitalists may be best served by not using this latest change to the two-midnight rule in determining which Medicare beneficiary hospitalizations are appropriate for inpatient designation.
A final, and critical, point about the two-midnight rule is that it only applies to traditional Medicare, and it does not apply to other payers, including commercial insurance and Medicaid. Medicare Advantage plans may or may not follow the two-midnight rule, depending on their contract with the hospital. Which patients are appropriate for inpatient designations are usually determined by the individual contract that the hospital has signed with that payer.
A better understanding of the two-midnight rule including to whom it applies, when it applies, and how to apply it will help you accurately determine which hospitalizations are appropriate for inpatient payment. With this understanding you will quickly become the hero of your hospital’s case managers and billing department.
Dr. Locke is senior physician advisor at the Johns Hopkins Hospital in Baltimore and president-elect of the American College of Physician Advisors. Dr. Hu is executive director of physician advisor services at the University of North Carolina Health Care System, Chapel Hill, and president of the American College of Physician Advisors.
References
1. Medicare Benefit Policy Manual. Chapter 1 - Inpatient Hospital Services Covered Under Part A. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c01.pdf.
2. Code of Federal Regulations. https://www.ecfr.gov/cgi-bin/text-idx?SID=958ee67a826285698204a34e1e5d6406&node=42:2.0.1.2.12.1.47.3&rgn=div8.
3. Current Procedural Terminology, Fourth Edition. https://www.cms.gov/apps/ama/license.asp?file=/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/CMS-1695-FC-2019-OPPS-FR-Addenda.zip.
What hospitalists must know
What hospitalists must know
Most hospitalists’ training likely included caring for patients in the ambulatory clinic, urgent care, and ED settings. One of the most important aspects of medical training is deciding which of the patients seen in these settings need to “be admitted” to a hospital because of risk, severity of illness, and/or need for certain medical services. In this context, “admit” is a synonym for “hospitalize.”
However, in today’s health care system, in which hospitalization costs are usually borne by a third-party payer, “admit” can have a very different meaning. For most payers, “admit” means “hospitalize as inpatient.” This is distinct from “hospitalize as an outpatient.” (“Observation” or “obs” is the most common example of a hospitalization as an outpatient.) In the medical payer world, inpatient and outpatient are often referred to as “statuses.” The distinction between inpatient versus outpatient status can affect payment and is based on rules that a hospital and payer have agreed upon. (Inpatient hospital care is generally paid at a higher rate than outpatient hospital care.) It is important for hospitalists to have a basic understanding of these rules because it can affect hospital billing, the hospitalist’s professional fees, beneficiary liability, and payer denials of inpatient care.
For years, Medicare’s definition of an inpatient hospitalization was primarily based on an expectation of a hospitalization of at least 24 hours and a physician’s judgment of the beneficiary’s need for inpatient hospital services. This judgment was to be based on the physician’s assessment of the patient’s severity of illness, the risk of an adverse outcome, and the hospital services required. (The exact definition by Centers for Medicare & Medicaid Services is much longer and can be found in the Medicare Benefits Policy Manual.1) Under Medicare, defining a hospitalization as inpatient versus outpatient is especially important because they are billed to different Medicare programs (Part A for inpatient, Part B for outpatient), and both hospital reimbursement and the patient liability can vary significantly.
Not surprisingly, CMS found that how physicians were making status decisions for medically similar hospitalized patients varied greatly. CMS noted two major concerns: an overuse of inpatient for patients hospitalized overnight leading to increased charges to CMS and multiday observation hospitalizations for lower-acuity patients leading to excessive liability for Medicare beneficiaries. (Observation stays are billed under Part B, under which the beneficiary generally has a 20% copay.)
To address these concerns, in October 2013, CMS adjusted the definition of inpatient to include “the two-midnight rule.” Basically, CMS said that, in order to qualify for inpatient, the admitting physician should expect the beneficiary to require hospital care spanning at least two midnights, rather than the previous 24-hour benchmark, regardless of the severity of illness or risk of adverse outcome. (There are exceptions and exemptions to the two-midnight rule, which are discussed later in this article.)
The idea of the two-midnight rule was to address the two concerns noted above. Under this rule, most expected overnight hospitalizations should be outpatients, even if they are more than 24 hours in length, and any medically necessary outpatient hospitalization should be “converted” to inpatient if and when it is clear that a second midnight of hospitalization is medically necessary.
In January 2016, CMS amended the two-midnight rule to recognize, as it had done prior to October 2013, that some hospitalizations, based on physician judgment, would be appropriate for inpatient without an expectation of a hospitalization that spans at least two midnights. Unfortunately, CMS has not been forthcoming with guidance of examples of which hospitalizations would fall into this new category, other than to say they expect the use of this new provision would generally not be appropriate for a hospital stay of less than 24 hours.
As of today, physicians should order inpatient services under the following three situations:
- The physician expects the beneficiary to require hospital care spanning at least two midnights.
- The physician provides a service on Medicare’s inpatient-only list.
- The physician expects the beneficiary to require hospital care for less than two midnights but feels that inpatient services are nevertheless appropriate.
This most recently updated version of the two-midnight rule can be found in Section 42 CFR §412.3 of the Code of Federal Regulations.2 Each of these three situations warrants additional discussion.
Care expected to span two midnights
The first situation is the one most applicable to hospitalists. In this circumstance there are three key points to remember.
The first point is that the two-midnight rule is based on a reasonable expectation of a need for hospitalization for at least two nights, not the actual length of hospitalization. Auditors, based on long-standing guidance from the CMS, should consider only the information known (or that should have been known) to the provider at the time the inpatient decision is made.
For example, if the expectation of the need for hospitalization of at least 2 midnights is well documented in the admission note, but the beneficiary improves more rapidly than expected and can be discharged before the second midnight, billing Medicare under Part A for inpatient admission remains appropriate. Auditors may look for provider documentation describing the unexpected improvement, and while such documentation is not an absolute requirement, its presence can be helpful in defending inpatient billing.
Other situations in which there can be an expectation of hospitalization of at least two midnights, but the actual length of stay does not meet this benchmark, are death, patients leaving against medical advice, or transfer to another hospital. For example, if a patient is hospitalized as an inpatient for bacterial endocarditis, and the documented plan of care includes at least 2 days of IV antibiotics and monitoring of cultures, inpatient remains appropriate even if the patient signs out against medical advice the following day.
The second key point to understand is that a night must be “medically necessary” to count toward the two-midnight benchmark. Hospital time spent receiving custodial care, because of excessive delays, or incurred because of the convenience of the beneficiary or provider does not count toward the two-midnight benchmark. For example, imagine a patient hospitalized with chest pain on Saturday evening and the attending physician determines that the patient requires serial cardiac isoenzymes and ECGs followed, most likely, by a noninvasive stress test. The attending physician, knowing that the hospital does not offer stress testing on Sunday, expects the patient to remain hospitalized at least until Monday, thus two midnights. However, in this situation, the second midnight (Sunday night) was not medically necessary and does not count toward the two midnight expectation.
The third key point to know is that the clock for calculating the two-midnight rule begins when the beneficiary starts receiving hospital care, not when the inpatient order is placed. Further, care that starts in the ED or at another hospital counts, too. In contrast, care at an outpatient clinic, an urgent care facility, or waiting-room time in an ED does not count.
When CMS implemented the two-midnight rule in 2013, they said that they would be open to exceptions. The first and only exception to date to the two-midnight rule is newly initiated and unanticipated mechanical ventilation. (This excludes anticipated intubations related to other care, such as procedures.) For example, inpatient is appropriate for a patient who requires hospitalization for an anaphylactic reaction or a drug overdose and needs intubation and mechanical ventilation, even if discharge is expected before a second midnight of hospital care.
CMS’s inpatient-only list
Each year, CMS publishes a list of procedures that CMS will pay only under Part A (that is, as inpatient). This list is updated quarterly (Addendum E) and can be found on the CMS website.3 Hospitalizations associated with the procedures on this list should always be inpatient, regardless of the expected length of stay.
It is important to note that the inpatient-only list is dynamic; it is revised annually, and procedures can come on or off the list. Notably, in January 2018, elective total knee replacements and laparoscopic radical prostatectomies came off the inpatient-only list. Most surgeons and proceduralists know whether the procedure they are performing is on this list, and they should advise hospitalists accordingly if the hospitalist is to be the attending of record and will be writing the admission order.
Inpatient services are nevertheless appropriate
The third situation, in which an inpatient admission is appropriate even when the admitting provider does not expect a two-midnight stay, was added to the two-midnight rule in January 2016. CMS states that the factors used in making this determination can be based on physician judgment and documented in the medical record.
At first reading, one might think that CMS is, in effect, returning to the definition of an inpatient prior to the two-midnight rule’s implementation in 2013. However, CMS has not offered clear guidance for its use, and they did not remove any of the previous two-midnight rule guidance. In the absence of clear guidance, hospitalists may be best served by not using this latest change to the two-midnight rule in determining which Medicare beneficiary hospitalizations are appropriate for inpatient designation.
A final, and critical, point about the two-midnight rule is that it only applies to traditional Medicare, and it does not apply to other payers, including commercial insurance and Medicaid. Medicare Advantage plans may or may not follow the two-midnight rule, depending on their contract with the hospital. Which patients are appropriate for inpatient designations are usually determined by the individual contract that the hospital has signed with that payer.
A better understanding of the two-midnight rule including to whom it applies, when it applies, and how to apply it will help you accurately determine which hospitalizations are appropriate for inpatient payment. With this understanding you will quickly become the hero of your hospital’s case managers and billing department.
Dr. Locke is senior physician advisor at the Johns Hopkins Hospital in Baltimore and president-elect of the American College of Physician Advisors. Dr. Hu is executive director of physician advisor services at the University of North Carolina Health Care System, Chapel Hill, and president of the American College of Physician Advisors.
References
1. Medicare Benefit Policy Manual. Chapter 1 - Inpatient Hospital Services Covered Under Part A. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c01.pdf.
2. Code of Federal Regulations. https://www.ecfr.gov/cgi-bin/text-idx?SID=958ee67a826285698204a34e1e5d6406&node=42:2.0.1.2.12.1.47.3&rgn=div8.
3. Current Procedural Terminology, Fourth Edition. https://www.cms.gov/apps/ama/license.asp?file=/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/CMS-1695-FC-2019-OPPS-FR-Addenda.zip.
Most hospitalists’ training likely included caring for patients in the ambulatory clinic, urgent care, and ED settings. One of the most important aspects of medical training is deciding which of the patients seen in these settings need to “be admitted” to a hospital because of risk, severity of illness, and/or need for certain medical services. In this context, “admit” is a synonym for “hospitalize.”
However, in today’s health care system, in which hospitalization costs are usually borne by a third-party payer, “admit” can have a very different meaning. For most payers, “admit” means “hospitalize as inpatient.” This is distinct from “hospitalize as an outpatient.” (“Observation” or “obs” is the most common example of a hospitalization as an outpatient.) In the medical payer world, inpatient and outpatient are often referred to as “statuses.” The distinction between inpatient versus outpatient status can affect payment and is based on rules that a hospital and payer have agreed upon. (Inpatient hospital care is generally paid at a higher rate than outpatient hospital care.) It is important for hospitalists to have a basic understanding of these rules because it can affect hospital billing, the hospitalist’s professional fees, beneficiary liability, and payer denials of inpatient care.
For years, Medicare’s definition of an inpatient hospitalization was primarily based on an expectation of a hospitalization of at least 24 hours and a physician’s judgment of the beneficiary’s need for inpatient hospital services. This judgment was to be based on the physician’s assessment of the patient’s severity of illness, the risk of an adverse outcome, and the hospital services required. (The exact definition by Centers for Medicare & Medicaid Services is much longer and can be found in the Medicare Benefits Policy Manual.1) Under Medicare, defining a hospitalization as inpatient versus outpatient is especially important because they are billed to different Medicare programs (Part A for inpatient, Part B for outpatient), and both hospital reimbursement and the patient liability can vary significantly.
Not surprisingly, CMS found that how physicians were making status decisions for medically similar hospitalized patients varied greatly. CMS noted two major concerns: an overuse of inpatient for patients hospitalized overnight leading to increased charges to CMS and multiday observation hospitalizations for lower-acuity patients leading to excessive liability for Medicare beneficiaries. (Observation stays are billed under Part B, under which the beneficiary generally has a 20% copay.)
To address these concerns, in October 2013, CMS adjusted the definition of inpatient to include “the two-midnight rule.” Basically, CMS said that, in order to qualify for inpatient, the admitting physician should expect the beneficiary to require hospital care spanning at least two midnights, rather than the previous 24-hour benchmark, regardless of the severity of illness or risk of adverse outcome. (There are exceptions and exemptions to the two-midnight rule, which are discussed later in this article.)
The idea of the two-midnight rule was to address the two concerns noted above. Under this rule, most expected overnight hospitalizations should be outpatients, even if they are more than 24 hours in length, and any medically necessary outpatient hospitalization should be “converted” to inpatient if and when it is clear that a second midnight of hospitalization is medically necessary.
In January 2016, CMS amended the two-midnight rule to recognize, as it had done prior to October 2013, that some hospitalizations, based on physician judgment, would be appropriate for inpatient without an expectation of a hospitalization that spans at least two midnights. Unfortunately, CMS has not been forthcoming with guidance of examples of which hospitalizations would fall into this new category, other than to say they expect the use of this new provision would generally not be appropriate for a hospital stay of less than 24 hours.
As of today, physicians should order inpatient services under the following three situations:
- The physician expects the beneficiary to require hospital care spanning at least two midnights.
- The physician provides a service on Medicare’s inpatient-only list.
- The physician expects the beneficiary to require hospital care for less than two midnights but feels that inpatient services are nevertheless appropriate.
This most recently updated version of the two-midnight rule can be found in Section 42 CFR §412.3 of the Code of Federal Regulations.2 Each of these three situations warrants additional discussion.
Care expected to span two midnights
The first situation is the one most applicable to hospitalists. In this circumstance there are three key points to remember.
The first point is that the two-midnight rule is based on a reasonable expectation of a need for hospitalization for at least two nights, not the actual length of hospitalization. Auditors, based on long-standing guidance from the CMS, should consider only the information known (or that should have been known) to the provider at the time the inpatient decision is made.
For example, if the expectation of the need for hospitalization of at least 2 midnights is well documented in the admission note, but the beneficiary improves more rapidly than expected and can be discharged before the second midnight, billing Medicare under Part A for inpatient admission remains appropriate. Auditors may look for provider documentation describing the unexpected improvement, and while such documentation is not an absolute requirement, its presence can be helpful in defending inpatient billing.
Other situations in which there can be an expectation of hospitalization of at least two midnights, but the actual length of stay does not meet this benchmark, are death, patients leaving against medical advice, or transfer to another hospital. For example, if a patient is hospitalized as an inpatient for bacterial endocarditis, and the documented plan of care includes at least 2 days of IV antibiotics and monitoring of cultures, inpatient remains appropriate even if the patient signs out against medical advice the following day.
The second key point to understand is that a night must be “medically necessary” to count toward the two-midnight benchmark. Hospital time spent receiving custodial care, because of excessive delays, or incurred because of the convenience of the beneficiary or provider does not count toward the two-midnight benchmark. For example, imagine a patient hospitalized with chest pain on Saturday evening and the attending physician determines that the patient requires serial cardiac isoenzymes and ECGs followed, most likely, by a noninvasive stress test. The attending physician, knowing that the hospital does not offer stress testing on Sunday, expects the patient to remain hospitalized at least until Monday, thus two midnights. However, in this situation, the second midnight (Sunday night) was not medically necessary and does not count toward the two midnight expectation.
The third key point to know is that the clock for calculating the two-midnight rule begins when the beneficiary starts receiving hospital care, not when the inpatient order is placed. Further, care that starts in the ED or at another hospital counts, too. In contrast, care at an outpatient clinic, an urgent care facility, or waiting-room time in an ED does not count.
When CMS implemented the two-midnight rule in 2013, they said that they would be open to exceptions. The first and only exception to date to the two-midnight rule is newly initiated and unanticipated mechanical ventilation. (This excludes anticipated intubations related to other care, such as procedures.) For example, inpatient is appropriate for a patient who requires hospitalization for an anaphylactic reaction or a drug overdose and needs intubation and mechanical ventilation, even if discharge is expected before a second midnight of hospital care.
CMS’s inpatient-only list
Each year, CMS publishes a list of procedures that CMS will pay only under Part A (that is, as inpatient). This list is updated quarterly (Addendum E) and can be found on the CMS website.3 Hospitalizations associated with the procedures on this list should always be inpatient, regardless of the expected length of stay.
It is important to note that the inpatient-only list is dynamic; it is revised annually, and procedures can come on or off the list. Notably, in January 2018, elective total knee replacements and laparoscopic radical prostatectomies came off the inpatient-only list. Most surgeons and proceduralists know whether the procedure they are performing is on this list, and they should advise hospitalists accordingly if the hospitalist is to be the attending of record and will be writing the admission order.
Inpatient services are nevertheless appropriate
The third situation, in which an inpatient admission is appropriate even when the admitting provider does not expect a two-midnight stay, was added to the two-midnight rule in January 2016. CMS states that the factors used in making this determination can be based on physician judgment and documented in the medical record.
At first reading, one might think that CMS is, in effect, returning to the definition of an inpatient prior to the two-midnight rule’s implementation in 2013. However, CMS has not offered clear guidance for its use, and they did not remove any of the previous two-midnight rule guidance. In the absence of clear guidance, hospitalists may be best served by not using this latest change to the two-midnight rule in determining which Medicare beneficiary hospitalizations are appropriate for inpatient designation.
A final, and critical, point about the two-midnight rule is that it only applies to traditional Medicare, and it does not apply to other payers, including commercial insurance and Medicaid. Medicare Advantage plans may or may not follow the two-midnight rule, depending on their contract with the hospital. Which patients are appropriate for inpatient designations are usually determined by the individual contract that the hospital has signed with that payer.
A better understanding of the two-midnight rule including to whom it applies, when it applies, and how to apply it will help you accurately determine which hospitalizations are appropriate for inpatient payment. With this understanding you will quickly become the hero of your hospital’s case managers and billing department.
Dr. Locke is senior physician advisor at the Johns Hopkins Hospital in Baltimore and president-elect of the American College of Physician Advisors. Dr. Hu is executive director of physician advisor services at the University of North Carolina Health Care System, Chapel Hill, and president of the American College of Physician Advisors.
References
1. Medicare Benefit Policy Manual. Chapter 1 - Inpatient Hospital Services Covered Under Part A. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c01.pdf.
2. Code of Federal Regulations. https://www.ecfr.gov/cgi-bin/text-idx?SID=958ee67a826285698204a34e1e5d6406&node=42:2.0.1.2.12.1.47.3&rgn=div8.
3. Current Procedural Terminology, Fourth Edition. https://www.cms.gov/apps/ama/license.asp?file=/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/CMS-1695-FC-2019-OPPS-FR-Addenda.zip.
A novel approach to MIPS quality reporting for facility-based providers
A cornerstone of hospital medicine is the delivery of high-quality inpatient care by improving the performance of the systems and facilities in which hospitalists work. By extension, hospitalists are often held accountable, in varying ways, for improving the performance of facility metrics, such as those in the Hospital Value-Based Purchasing (HVBP), Inpatient Quality Reporting, and Hospital Readmissions Reduction programs.
Despite the work hospitalists were already doing to improve both efficiency and quality within their institutions, the 2010 Affordable Care Act introduced penalties for clinicians who did not submit qualifying provider-level data via the Physician Quality Reporting System program. Initially only an incentive program, PQRS was ultimately incorporated into the Physician Value-Based Payment (VBP) Modifier to make performance-based payment adjustments to Medicare physician payment. At this point, many hospitalists were not only accountable for helping to improve the metrics of their facilities, but also required to report individually or within their groups on provider-level measures, many of which were irrelevant to hospital medicine practice.
With this dual burden becoming evident, the Society of Hospital Medicine approached the Centers for Medicare & Medicaid Services with a possible solution. Could hospitalists elect to use their facilities’ metrics as a stand-in for the provider level metrics? Not only would this reduce the burden of reporting irrelevant metrics, but it would also help alleviate some of the disadvantages hospitalists face within Physician VBP.
The CMS was initially very supportive of the concept, but informed the SHM such alignment was not possible under existing law. In brief, the law required Physician VBP to remain completely within the Physician Fee Schedule and its related metrics; facility level metrics from a different payment system could not be used.
Undeterred, the SHM sought opportunities to change the law. As Congress was developing the Medicare Access and Chip Reauthorization Act (MACRA), the SHM worked closely with lawmakers to include language that would permit measures in “other payment systems” to be used for physician performance assessment. This language was retained in the final version of MACRA that was signed into law on April 16, 2015.
The SHM continued its advocacy, working closely with the CMS and its new authority to shape an option to align Medicare’s facility metrics and scores with provider reporting. Today that idea is a reality. Beginning this year, the CMS will have a new Merit-based Incentive Payment System (MIPS) reporting option available for hospitalists: facility-based measurement.
Facility-based measurement enables clinicians to receive a score for the Quality and Cost categories of the MIPS, without the need to collect and report on measures separately. Eligible providers would receive the MIPS score in those categories associated with the same percentile as their hospital’s score in HVBP. No more administrative work necessary to collect, clean and report on data for quality measures in the MIPS. If you are eligible, the CMS will automatically calculate a Quality and Cost score and combine this with your score from Improvement Activities and Promoting Interoperability (if you are not exempt) to give you a final MIPS score. If you decide to report on quality measures through the traditional MIPS pathway as well, the CMS will give you the higher of the scores.
There are certainly trade-offs associated with the facility-based measurement option. You do not have the burden of reporting measures on your own, but you do not get to pick what measures and what facility’s score you receive. Facility-level measures may be more difficult to improve performance, particularly as an individual, but the automatic application of facility-based measurement to eligible clinicians and groups serves as a backstop for MIPS reporting.
Aligning facility and clinician performance should encourage collaboration and innovation to meet these shared goals. As such, facility-based measurement represents a massive philosophical and practical shift in CMS measure reporting. As we enter these uncharted waters together, we hope to continue learning from your experiences and perspectives and working to refine facility-based measurement in the future.
For more information about facility-based reporting and the MIPS in general, visit www.macraforhm.org.
Mr. Lapps is government relations senior manager and Mr. Boswell is government relations director at the Society of Hospital Medicine.
Who is eligible for facility-based measurement?
- Individual providers who bill more than 75% of their Medicare Part B professional services in Place of Service 21 (Emergency Department), 22 (Hospital Outpatient), and 23 (Inpatient Hospital), billing at least one service in POS 21 or 23, and work in a hospital with an HVBP score.
- Groups who have at least 75% of their individual clinicians who meet the eligibility criteria.
- Nearly all hospitalists should qualify for facility-based measurement as individuals, while group eligibility depends on the demographics of their staff.
A cornerstone of hospital medicine is the delivery of high-quality inpatient care by improving the performance of the systems and facilities in which hospitalists work. By extension, hospitalists are often held accountable, in varying ways, for improving the performance of facility metrics, such as those in the Hospital Value-Based Purchasing (HVBP), Inpatient Quality Reporting, and Hospital Readmissions Reduction programs.
Despite the work hospitalists were already doing to improve both efficiency and quality within their institutions, the 2010 Affordable Care Act introduced penalties for clinicians who did not submit qualifying provider-level data via the Physician Quality Reporting System program. Initially only an incentive program, PQRS was ultimately incorporated into the Physician Value-Based Payment (VBP) Modifier to make performance-based payment adjustments to Medicare physician payment. At this point, many hospitalists were not only accountable for helping to improve the metrics of their facilities, but also required to report individually or within their groups on provider-level measures, many of which were irrelevant to hospital medicine practice.
With this dual burden becoming evident, the Society of Hospital Medicine approached the Centers for Medicare & Medicaid Services with a possible solution. Could hospitalists elect to use their facilities’ metrics as a stand-in for the provider level metrics? Not only would this reduce the burden of reporting irrelevant metrics, but it would also help alleviate some of the disadvantages hospitalists face within Physician VBP.
The CMS was initially very supportive of the concept, but informed the SHM such alignment was not possible under existing law. In brief, the law required Physician VBP to remain completely within the Physician Fee Schedule and its related metrics; facility level metrics from a different payment system could not be used.
Undeterred, the SHM sought opportunities to change the law. As Congress was developing the Medicare Access and Chip Reauthorization Act (MACRA), the SHM worked closely with lawmakers to include language that would permit measures in “other payment systems” to be used for physician performance assessment. This language was retained in the final version of MACRA that was signed into law on April 16, 2015.
The SHM continued its advocacy, working closely with the CMS and its new authority to shape an option to align Medicare’s facility metrics and scores with provider reporting. Today that idea is a reality. Beginning this year, the CMS will have a new Merit-based Incentive Payment System (MIPS) reporting option available for hospitalists: facility-based measurement.
Facility-based measurement enables clinicians to receive a score for the Quality and Cost categories of the MIPS, without the need to collect and report on measures separately. Eligible providers would receive the MIPS score in those categories associated with the same percentile as their hospital’s score in HVBP. No more administrative work necessary to collect, clean and report on data for quality measures in the MIPS. If you are eligible, the CMS will automatically calculate a Quality and Cost score and combine this with your score from Improvement Activities and Promoting Interoperability (if you are not exempt) to give you a final MIPS score. If you decide to report on quality measures through the traditional MIPS pathway as well, the CMS will give you the higher of the scores.
There are certainly trade-offs associated with the facility-based measurement option. You do not have the burden of reporting measures on your own, but you do not get to pick what measures and what facility’s score you receive. Facility-level measures may be more difficult to improve performance, particularly as an individual, but the automatic application of facility-based measurement to eligible clinicians and groups serves as a backstop for MIPS reporting.
Aligning facility and clinician performance should encourage collaboration and innovation to meet these shared goals. As such, facility-based measurement represents a massive philosophical and practical shift in CMS measure reporting. As we enter these uncharted waters together, we hope to continue learning from your experiences and perspectives and working to refine facility-based measurement in the future.
For more information about facility-based reporting and the MIPS in general, visit www.macraforhm.org.
Mr. Lapps is government relations senior manager and Mr. Boswell is government relations director at the Society of Hospital Medicine.
Who is eligible for facility-based measurement?
- Individual providers who bill more than 75% of their Medicare Part B professional services in Place of Service 21 (Emergency Department), 22 (Hospital Outpatient), and 23 (Inpatient Hospital), billing at least one service in POS 21 or 23, and work in a hospital with an HVBP score.
- Groups who have at least 75% of their individual clinicians who meet the eligibility criteria.
- Nearly all hospitalists should qualify for facility-based measurement as individuals, while group eligibility depends on the demographics of their staff.
A cornerstone of hospital medicine is the delivery of high-quality inpatient care by improving the performance of the systems and facilities in which hospitalists work. By extension, hospitalists are often held accountable, in varying ways, for improving the performance of facility metrics, such as those in the Hospital Value-Based Purchasing (HVBP), Inpatient Quality Reporting, and Hospital Readmissions Reduction programs.
Despite the work hospitalists were already doing to improve both efficiency and quality within their institutions, the 2010 Affordable Care Act introduced penalties for clinicians who did not submit qualifying provider-level data via the Physician Quality Reporting System program. Initially only an incentive program, PQRS was ultimately incorporated into the Physician Value-Based Payment (VBP) Modifier to make performance-based payment adjustments to Medicare physician payment. At this point, many hospitalists were not only accountable for helping to improve the metrics of their facilities, but also required to report individually or within their groups on provider-level measures, many of which were irrelevant to hospital medicine practice.
With this dual burden becoming evident, the Society of Hospital Medicine approached the Centers for Medicare & Medicaid Services with a possible solution. Could hospitalists elect to use their facilities’ metrics as a stand-in for the provider level metrics? Not only would this reduce the burden of reporting irrelevant metrics, but it would also help alleviate some of the disadvantages hospitalists face within Physician VBP.
The CMS was initially very supportive of the concept, but informed the SHM such alignment was not possible under existing law. In brief, the law required Physician VBP to remain completely within the Physician Fee Schedule and its related metrics; facility level metrics from a different payment system could not be used.
Undeterred, the SHM sought opportunities to change the law. As Congress was developing the Medicare Access and Chip Reauthorization Act (MACRA), the SHM worked closely with lawmakers to include language that would permit measures in “other payment systems” to be used for physician performance assessment. This language was retained in the final version of MACRA that was signed into law on April 16, 2015.
The SHM continued its advocacy, working closely with the CMS and its new authority to shape an option to align Medicare’s facility metrics and scores with provider reporting. Today that idea is a reality. Beginning this year, the CMS will have a new Merit-based Incentive Payment System (MIPS) reporting option available for hospitalists: facility-based measurement.
Facility-based measurement enables clinicians to receive a score for the Quality and Cost categories of the MIPS, without the need to collect and report on measures separately. Eligible providers would receive the MIPS score in those categories associated with the same percentile as their hospital’s score in HVBP. No more administrative work necessary to collect, clean and report on data for quality measures in the MIPS. If you are eligible, the CMS will automatically calculate a Quality and Cost score and combine this with your score from Improvement Activities and Promoting Interoperability (if you are not exempt) to give you a final MIPS score. If you decide to report on quality measures through the traditional MIPS pathway as well, the CMS will give you the higher of the scores.
There are certainly trade-offs associated with the facility-based measurement option. You do not have the burden of reporting measures on your own, but you do not get to pick what measures and what facility’s score you receive. Facility-level measures may be more difficult to improve performance, particularly as an individual, but the automatic application of facility-based measurement to eligible clinicians and groups serves as a backstop for MIPS reporting.
Aligning facility and clinician performance should encourage collaboration and innovation to meet these shared goals. As such, facility-based measurement represents a massive philosophical and practical shift in CMS measure reporting. As we enter these uncharted waters together, we hope to continue learning from your experiences and perspectives and working to refine facility-based measurement in the future.
For more information about facility-based reporting and the MIPS in general, visit www.macraforhm.org.
Mr. Lapps is government relations senior manager and Mr. Boswell is government relations director at the Society of Hospital Medicine.
Who is eligible for facility-based measurement?
- Individual providers who bill more than 75% of their Medicare Part B professional services in Place of Service 21 (Emergency Department), 22 (Hospital Outpatient), and 23 (Inpatient Hospital), billing at least one service in POS 21 or 23, and work in a hospital with an HVBP score.
- Groups who have at least 75% of their individual clinicians who meet the eligibility criteria.
- Nearly all hospitalists should qualify for facility-based measurement as individuals, while group eligibility depends on the demographics of their staff.
ONC aims to help docs, patients with information sharing in proposed rule
The Office of the National Coordinator of Health Information Technology is looking to adopt standardized application programming interfaces (APIs) in an effort to boost interoperability of health data.
The Department of Health & Human Services office posted a proposed rule Feb. 11, 2019, that would, according to an agency press release, “help allow individuals to securely and easily access structured and unstructured EHI [electronic health information] formats using smartphones and other mobile devices.”
“We think our rule is going to help reduce burden and improve care,” Michael Lipinski, director of the Regulatory Affairs Division in the ONC Office of Policy, said in an interview. “It is going to do that through technology. With the APIs, you should be able to get to your information easier and have it readily available. Whether that is from another health care provider or using other health care products through the API to improve care, you will have that ability between the certified API and the information blocking policies to use third party developers and their products.”
The proposed rule also included a requirement that EHRs certified by ONC be able to easily export information contained within the EHR and make the format used to extract and export the data contained within the EHR publicly available.
“Another third party developer can build to that and offer competing services to pull that information out,” Mr. Lipinski said. “That would obviously help if you were choosing to switch [EHRs] if you didn’t like the features you were getting from your EHR. ... That functionality should help if you want to do that.”
The standardizing of APIs to help the delivery of data will go hand in hand with information blocking aspects of the proposed rule, which defines the few exceptions where an activity would not be considered information blocking, such as when engaging in practices will prevent patient harm; engaging in consistent, nondiscriminatory practices to protect patient privacy; and implementing practices to promote the security of health information.
Mr. Lipinski said these changes will help prevent providers from hiding behind HIPAA rules as the excuse to not share patient information, which will help with care coordination. “From a provider’s perspective, this should help them get more access to information, more access in a structured way and then easily get and share that information.”
Ultimately, Mr. Lipinski said, the goal is “to increase competition and lower cost while still improving the quality of care for patients.”
The Office of the National Coordinator of Health Information Technology is looking to adopt standardized application programming interfaces (APIs) in an effort to boost interoperability of health data.
The Department of Health & Human Services office posted a proposed rule Feb. 11, 2019, that would, according to an agency press release, “help allow individuals to securely and easily access structured and unstructured EHI [electronic health information] formats using smartphones and other mobile devices.”
“We think our rule is going to help reduce burden and improve care,” Michael Lipinski, director of the Regulatory Affairs Division in the ONC Office of Policy, said in an interview. “It is going to do that through technology. With the APIs, you should be able to get to your information easier and have it readily available. Whether that is from another health care provider or using other health care products through the API to improve care, you will have that ability between the certified API and the information blocking policies to use third party developers and their products.”
The proposed rule also included a requirement that EHRs certified by ONC be able to easily export information contained within the EHR and make the format used to extract and export the data contained within the EHR publicly available.
“Another third party developer can build to that and offer competing services to pull that information out,” Mr. Lipinski said. “That would obviously help if you were choosing to switch [EHRs] if you didn’t like the features you were getting from your EHR. ... That functionality should help if you want to do that.”
The standardizing of APIs to help the delivery of data will go hand in hand with information blocking aspects of the proposed rule, which defines the few exceptions where an activity would not be considered information blocking, such as when engaging in practices will prevent patient harm; engaging in consistent, nondiscriminatory practices to protect patient privacy; and implementing practices to promote the security of health information.
Mr. Lipinski said these changes will help prevent providers from hiding behind HIPAA rules as the excuse to not share patient information, which will help with care coordination. “From a provider’s perspective, this should help them get more access to information, more access in a structured way and then easily get and share that information.”
Ultimately, Mr. Lipinski said, the goal is “to increase competition and lower cost while still improving the quality of care for patients.”
The Office of the National Coordinator of Health Information Technology is looking to adopt standardized application programming interfaces (APIs) in an effort to boost interoperability of health data.
The Department of Health & Human Services office posted a proposed rule Feb. 11, 2019, that would, according to an agency press release, “help allow individuals to securely and easily access structured and unstructured EHI [electronic health information] formats using smartphones and other mobile devices.”
“We think our rule is going to help reduce burden and improve care,” Michael Lipinski, director of the Regulatory Affairs Division in the ONC Office of Policy, said in an interview. “It is going to do that through technology. With the APIs, you should be able to get to your information easier and have it readily available. Whether that is from another health care provider or using other health care products through the API to improve care, you will have that ability between the certified API and the information blocking policies to use third party developers and their products.”
The proposed rule also included a requirement that EHRs certified by ONC be able to easily export information contained within the EHR and make the format used to extract and export the data contained within the EHR publicly available.
“Another third party developer can build to that and offer competing services to pull that information out,” Mr. Lipinski said. “That would obviously help if you were choosing to switch [EHRs] if you didn’t like the features you were getting from your EHR. ... That functionality should help if you want to do that.”
The standardizing of APIs to help the delivery of data will go hand in hand with information blocking aspects of the proposed rule, which defines the few exceptions where an activity would not be considered information blocking, such as when engaging in practices will prevent patient harm; engaging in consistent, nondiscriminatory practices to protect patient privacy; and implementing practices to promote the security of health information.
Mr. Lipinski said these changes will help prevent providers from hiding behind HIPAA rules as the excuse to not share patient information, which will help with care coordination. “From a provider’s perspective, this should help them get more access to information, more access in a structured way and then easily get and share that information.”
Ultimately, Mr. Lipinski said, the goal is “to increase competition and lower cost while still improving the quality of care for patients.”