Alicia Gallegos

Potentially inaccurate data posted on the federal Physician Compare website could misinform patients and lead to incorrect assumptions about the quality of care individual doctors provide.

With the most recent update of Physician Compare, the Centers for Medicare & Medicaid Services for the first time has posted individual physician performance scores on the 40,000 individual health care professionals who are part of the Physician Quality Reporting System (PQRS).

“Given the widespread accuracy issues with the 2014 PQRS calculations, the newly released information is premature,” American Medical Association President Steven J. Stack said in a statement. “The data inaccuracies and difficulties with CMS’s processes grew over the last couple of months and, while CMS has acknowledged these problems, it has failed to address the underlying issues. Most importantly, consumers visiting the Physician Compare website are likely to get a false impression that it provides accurate quality information for all physicians, when in fact, due to significant data problems, the newly added information covers only about 40,000 physicians.”

Although the concept of Physician Compare makes sense, the CMS needs to resolve data inconsistencies and improve how the information is being presented before posting new information to the site, said Dr. Wanda Filer, president of the American Academy of Family Physicians (AAFP). Performance scores on each measure are displayed on Physician Compare as stars followed by a percent, with each star representing 20%.

“A star rating system is too simplistic to provide for informed decisions [and] doesn’t reflect the complexity or context of care that undergirds those measures,” Dr. Filer said in an interview. “Given that complexity, it is likely that inaccurate data will be attributed to a physician’s care.”

In an effort to reduce inaccuracies, the AAFP had called for an extended period – from the current 30 days to 90 – for physicians to review their data before the data are published, Dr. Filer said.

She added that the CMS takes too long to communicate with physicians about their performance scores. Doctors do not receive reports for 6-9 months, reducing the opportunity for them to improve their performance before the next reporting period, she said.

“CMS needs to provide feedback to physicians much sooner so improvement can take place before their data are posted on the next Physician Compare,” Dr. Filer said. “Moreover, CMS must do a better job educating physicians about this website and their opportunity to review and correct any accuracies in what is reported.”

In addition to posting new PQRS measures on Physician Compare, the CMS also has posted 2014 data from group practices that report patient experience measures through the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for PQRS survey. The CAHPS survey measures Medicare patients’ feedback about their care experiences. Updated performance scores for accountable care organizations, including clinical quality of care and patient experience measures for Shared Savings Program ACOs and 20 Pioneer ACOs were also added.

The reporting of the new data may be welcome for some physicians or group practices that are achieving high scores under quality-reporting programs, noted Philadelphia health law attorney Karl A. Thallner Jr.

“However, a physician who does not participate or who does not have high scores may feel that the reported data does not provide an accurate picture of the quality of care that he/she provides to patients, and therefore may be misleading to consumers,” Mr. Thallner said in an interview. “Also, physicians may not report data consistently, making differences between physicians less relevant.”

[email protected]

On Twitter@legal_med

Potentially inaccurate data posted on the federal Physician Compare website could misinform patients and lead to incorrect assumptions about the quality of care individual doctors provide.

With the most recent update of Physician Compare, the Centers for Medicare & Medicaid Services for the first time has posted individual physician performance scores on the 40,000 individual health care professionals who are part of the Physician Quality Reporting System (PQRS).

“Given the widespread accuracy issues with the 2014 PQRS calculations, the newly released information is premature,” American Medical Association President Steven J. Stack said in a statement. “The data inaccuracies and difficulties with CMS’s processes grew over the last couple of months and, while CMS has acknowledged these problems, it has failed to address the underlying issues. Most importantly, consumers visiting the Physician Compare website are likely to get a false impression that it provides accurate quality information for all physicians, when in fact, due to significant data problems, the newly added information covers only about 40,000 physicians.”

Although the concept of Physician Compare makes sense, the CMS needs to resolve data inconsistencies and improve how the information is being presented before posting new information to the site, said Dr. Wanda Filer, president of the American Academy of Family Physicians (AAFP). Performance scores on each measure are displayed on Physician Compare as stars followed by a percent, with each star representing 20%.

“A star rating system is too simplistic to provide for informed decisions [and] doesn’t reflect the complexity or context of care that undergirds those measures,” Dr. Filer said in an interview. “Given that complexity, it is likely that inaccurate data will be attributed to a physician’s care.”

In an effort to reduce inaccuracies, the AAFP had called for an extended period – from the current 30 days to 90 – for physicians to review their data before the data are published, Dr. Filer said.

She added that the CMS takes too long to communicate with physicians about their performance scores. Doctors do not receive reports for 6-9 months, reducing the opportunity for them to improve their performance before the next reporting period, she said.

“CMS needs to provide feedback to physicians much sooner so improvement can take place before their data are posted on the next Physician Compare,” Dr. Filer said. “Moreover, CMS must do a better job educating physicians about this website and their opportunity to review and correct any accuracies in what is reported.”

In addition to posting new PQRS measures on Physician Compare, the CMS also has posted 2014 data from group practices that report patient experience measures through the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for PQRS survey. The CAHPS survey measures Medicare patients’ feedback about their care experiences. Updated performance scores for accountable care organizations, including clinical quality of care and patient experience measures for Shared Savings Program ACOs and 20 Pioneer ACOs were also added.

The reporting of the new data may be welcome for some physicians or group practices that are achieving high scores under quality-reporting programs, noted Philadelphia health law attorney Karl A. Thallner Jr.

“However, a physician who does not participate or who does not have high scores may feel that the reported data does not provide an accurate picture of the quality of care that he/she provides to patients, and therefore may be misleading to consumers,” Mr. Thallner said in an interview. “Also, physicians may not report data consistently, making differences between physicians less relevant.”

[email protected]

On Twitter@legal_med

Potentially inaccurate data posted on the federal Physician Compare website could misinform patients and lead to incorrect assumptions about the quality of care individual doctors provide.

With the most recent update of Physician Compare, the Centers for Medicare & Medicaid Services for the first time has posted individual physician performance scores on the 40,000 individual health care professionals who are part of the Physician Quality Reporting System (PQRS).

“Given the widespread accuracy issues with the 2014 PQRS calculations, the newly released information is premature,” American Medical Association President Steven J. Stack said in a statement. “The data inaccuracies and difficulties with CMS’s processes grew over the last couple of months and, while CMS has acknowledged these problems, it has failed to address the underlying issues. Most importantly, consumers visiting the Physician Compare website are likely to get a false impression that it provides accurate quality information for all physicians, when in fact, due to significant data problems, the newly added information covers only about 40,000 physicians.”

Although the concept of Physician Compare makes sense, the CMS needs to resolve data inconsistencies and improve how the information is being presented before posting new information to the site, said Dr. Wanda Filer, president of the American Academy of Family Physicians (AAFP). Performance scores on each measure are displayed on Physician Compare as stars followed by a percent, with each star representing 20%.

“A star rating system is too simplistic to provide for informed decisions [and] doesn’t reflect the complexity or context of care that undergirds those measures,” Dr. Filer said in an interview. “Given that complexity, it is likely that inaccurate data will be attributed to a physician’s care.”

In an effort to reduce inaccuracies, the AAFP had called for an extended period – from the current 30 days to 90 – for physicians to review their data before the data are published, Dr. Filer said.

She added that the CMS takes too long to communicate with physicians about their performance scores. Doctors do not receive reports for 6-9 months, reducing the opportunity for them to improve their performance before the next reporting period, she said.

“CMS needs to provide feedback to physicians much sooner so improvement can take place before their data are posted on the next Physician Compare,” Dr. Filer said. “Moreover, CMS must do a better job educating physicians about this website and their opportunity to review and correct any accuracies in what is reported.”

In addition to posting new PQRS measures on Physician Compare, the CMS also has posted 2014 data from group practices that report patient experience measures through the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for PQRS survey. The CAHPS survey measures Medicare patients’ feedback about their care experiences. Updated performance scores for accountable care organizations, including clinical quality of care and patient experience measures for Shared Savings Program ACOs and 20 Pioneer ACOs were also added.

The reporting of the new data may be welcome for some physicians or group practices that are achieving high scores under quality-reporting programs, noted Philadelphia health law attorney Karl A. Thallner Jr.

“However, a physician who does not participate or who does not have high scores may feel that the reported data does not provide an accurate picture of the quality of care that he/she provides to patients, and therefore may be misleading to consumers,” Mr. Thallner said in an interview. “Also, physicians may not report data consistently, making differences between physicians less relevant.”

[email protected]

On Twitter@legal_med

The American Medical Association is asking the Centers for Medicare & Medicaid Services to revise the meaningful use program to better align with requirements of last year’s Medicare Access and CHIP Reauthorization Act (MACRA) and to allow for smoother transition to value-based payment models.

In a Dec. 15 letter to CMS, the AMA issued a list of recommendations for meaningful use Stage 3 that aim to address challenges with using electronic health records (EHRs) and to help move toward MACRA’s alternative payment models (APM) and Merit-Based Incentive Payment System (MIPS).

“Doctors want to spend their time with patients, not measuring the number of clicks,” Dr. Steven J. Stack, AMA president, said in a statement. “We want a successful transition to digital health records, and we also want the new Medicare law to succeed. It will take thoughtful changes in the regulations to support physicians as they treat patients through new models of care.”

The AMA’s recommendations come in response to CMS’ final rule for meaningful use Stage 3, effective Dec. 15. The final rule simplified Stage 3 and gave doctors 1 more year – until Jan. 1, 2018 – to comply.

The AMA requested that CMS immediately adopt the association’s revisions for meaningful use Stage 3, including that the agency provide more flexibility and allow for multiple methods/paths to achieve desired end goals; remove threshold requirements for measures outside physicians’ control; and eliminate its pass-fail program design. Scrapping a pass-fail approach is the only way the ... program can align and operate within MIPS and APMs, Dr. James L. Madara, AMA executive vice president and CEO wrote in the letter.

The AMA also criticized Stage 3 for taking a poor approach to interoperability. The current measures are too focused on the quantity of information moved and “not the relevance of exchanges or the underlying business case for transmitting data,” Dr. Madara wrote. The AMA wants the measures to be refocused to address specific instances of data exchange, such as closing the referral loop, team-based care, and notification of tests/admissions.

According to the AMA, CMS should:

• Re-orient measures away from process-based tasks to highlight goals that are useful to patients and physicians.

• Encourage new technology functions to be the focus of certification rather than placing requirements on physicians and patients that may not yet be feasible.

• Support the reuse of data to reduce the burden on documentation.

The AMA’s recommendations are in line with concerns by the American Academy of Family Physicians over Stage 3, according to Dr. Robert L. Wergin, AAFP board chair. In a Dec. 2 letter to CMS, the AAFP said the final rule fell short of expectations and, in fact, places further obstacles in the way of improved health, better health care, and lower cost.

Interoperability challenges remain a top concern with the program, Dr. Wergin said in an interview. He cited a 27% decrease in physician satisfaction with EHRs since the launch of the meaningful use program, according to a 2014 survey.

“The whole concept of electronic health records, as family physicians, we saw the potential to help us care for our patients and help us track their progress,” Dr. Wergin said. “I would call it a potential unrealized. It really hasn’t developed into what we thought it could do. There’s a lot of frustrations.”

The AAFP calls for CMS to hit the pause button on meaningful use until 2019 – long enough to allow:

• The health care industry time to focus on interoperability issues.

• Vendors, physicians, and other health care professionals time to focus on designing and implementing the functionality and work flows necessary to achieve value-based payment.

• Regulators time to modify meaningful use regulations and align them with pending MACRA rules.

Similar concerns were expressed in a Nov. 20 letter from the GOP Doctors Caucus to Speaker of the House Paul Ryan (R-Wisc.). The 18-member caucus requested Speaker Ryan’s help in pressing for a delay of Stage 3 and a blanket hardship waiver exception for Stage 2. Implementation of more-stringent criteria is likely to create “a chilling effect on further EMR adoption as physicians conclude that the cost of implementation is simply not worth the bureaucratic hassle,” according to the letter. “Members of our caucus, as well as numerous congressional health care leaders, have engaged CMS on these issues to warn them of the potential negative consequences of placing these new requirements on providers in order to meet an arbitrary deadline. CMS has ignored Congress. Congressional action is the only solution left for preserving patient access, choice and quality.”

But Dr. Rocky D. Bilhartz, an interventional cardiologist in private practice in College Station, Tex., does not believe that the AMA’s recommendations nor other changes to the meaningful use program will make it better.

“I think they’re going about this entirely the wrong way,” said Dr. Bilhartz who blogs at bilhartzmd.com. “Meaningful use should not be delayed, but frankly abandoned. I don’t necessarily believe that the Department of Health & Human Service set out to try to design a system that would impair a physician’s ability to care for patients. I do believe without a doubt, that is exactly what has happened.”

[email protected]

On Twitter @legal_med

The American Medical Association is asking the Centers for Medicare & Medicaid Services to revise the meaningful use program to better align with requirements of last year’s Medicare Access and CHIP Reauthorization Act (MACRA) and to allow for smoother transition to value-based payment models.

In a Dec. 15 letter to CMS, the AMA issued a list of recommendations for meaningful use Stage 3 that aim to address challenges with using electronic health records (EHRs) and to help move toward MACRA’s alternative payment models (APM) and Merit-Based Incentive Payment System (MIPS).

“Doctors want to spend their time with patients, not measuring the number of clicks,” Dr. Steven J. Stack, AMA president, said in a statement. “We want a successful transition to digital health records, and we also want the new Medicare law to succeed. It will take thoughtful changes in the regulations to support physicians as they treat patients through new models of care.”

The AMA’s recommendations come in response to CMS’ final rule for meaningful use Stage 3, effective Dec. 15. The final rule simplified Stage 3 and gave doctors 1 more year – until Jan. 1, 2018 – to comply.

The AMA requested that CMS immediately adopt the association’s revisions for meaningful use Stage 3, including that the agency provide more flexibility and allow for multiple methods/paths to achieve desired end goals; remove threshold requirements for measures outside physicians’ control; and eliminate its pass-fail program design. Scrapping a pass-fail approach is the only way the ... program can align and operate within MIPS and APMs, Dr. James L. Madara, AMA executive vice president and CEO wrote in the letter.

The AMA also criticized Stage 3 for taking a poor approach to interoperability. The current measures are too focused on the quantity of information moved and “not the relevance of exchanges or the underlying business case for transmitting data,” Dr. Madara wrote. The AMA wants the measures to be refocused to address specific instances of data exchange, such as closing the referral loop, team-based care, and notification of tests/admissions.

According to the AMA, CMS should:

• Re-orient measures away from process-based tasks to highlight goals that are useful to patients and physicians.

• Encourage new technology functions to be the focus of certification rather than placing requirements on physicians and patients that may not yet be feasible.

• Support the reuse of data to reduce the burden on documentation.

The AMA’s recommendations are in line with concerns by the American Academy of Family Physicians over Stage 3, according to Dr. Robert L. Wergin, AAFP board chair. In a Dec. 2 letter to CMS, the AAFP said the final rule fell short of expectations and, in fact, places further obstacles in the way of improved health, better health care, and lower cost.

Interoperability challenges remain a top concern with the program, Dr. Wergin said in an interview. He cited a 27% decrease in physician satisfaction with EHRs since the launch of the meaningful use program, according to a 2014 survey.

“The whole concept of electronic health records, as family physicians, we saw the potential to help us care for our patients and help us track their progress,” Dr. Wergin said. “I would call it a potential unrealized. It really hasn’t developed into what we thought it could do. There’s a lot of frustrations.”

The AAFP calls for CMS to hit the pause button on meaningful use until 2019 – long enough to allow:

• The health care industry time to focus on interoperability issues.

• Vendors, physicians, and other health care professionals time to focus on designing and implementing the functionality and work flows necessary to achieve value-based payment.

• Regulators time to modify meaningful use regulations and align them with pending MACRA rules.

Similar concerns were expressed in a Nov. 20 letter from the GOP Doctors Caucus to Speaker of the House Paul Ryan (R-Wisc.). The 18-member caucus requested Speaker Ryan’s help in pressing for a delay of Stage 3 and a blanket hardship waiver exception for Stage 2. Implementation of more-stringent criteria is likely to create “a chilling effect on further EMR adoption as physicians conclude that the cost of implementation is simply not worth the bureaucratic hassle,” according to the letter. “Members of our caucus, as well as numerous congressional health care leaders, have engaged CMS on these issues to warn them of the potential negative consequences of placing these new requirements on providers in order to meet an arbitrary deadline. CMS has ignored Congress. Congressional action is the only solution left for preserving patient access, choice and quality.”

But Dr. Rocky D. Bilhartz, an interventional cardiologist in private practice in College Station, Tex., does not believe that the AMA’s recommendations nor other changes to the meaningful use program will make it better.

“I think they’re going about this entirely the wrong way,” said Dr. Bilhartz who blogs at bilhartzmd.com. “Meaningful use should not be delayed, but frankly abandoned. I don’t necessarily believe that the Department of Health & Human Service set out to try to design a system that would impair a physician’s ability to care for patients. I do believe without a doubt, that is exactly what has happened.”

[email protected]

On Twitter @legal_med

The American Medical Association is asking the Centers for Medicare & Medicaid Services to revise the meaningful use program to better align with requirements of last year’s Medicare Access and CHIP Reauthorization Act (MACRA) and to allow for smoother transition to value-based payment models.

In a Dec. 15 letter to CMS, the AMA issued a list of recommendations for meaningful use Stage 3 that aim to address challenges with using electronic health records (EHRs) and to help move toward MACRA’s alternative payment models (APM) and Merit-Based Incentive Payment System (MIPS).

“Doctors want to spend their time with patients, not measuring the number of clicks,” Dr. Steven J. Stack, AMA president, said in a statement. “We want a successful transition to digital health records, and we also want the new Medicare law to succeed. It will take thoughtful changes in the regulations to support physicians as they treat patients through new models of care.”

The AMA’s recommendations come in response to CMS’ final rule for meaningful use Stage 3, effective Dec. 15. The final rule simplified Stage 3 and gave doctors 1 more year – until Jan. 1, 2018 – to comply.

The AMA requested that CMS immediately adopt the association’s revisions for meaningful use Stage 3, including that the agency provide more flexibility and allow for multiple methods/paths to achieve desired end goals; remove threshold requirements for measures outside physicians’ control; and eliminate its pass-fail program design. Scrapping a pass-fail approach is the only way the ... program can align and operate within MIPS and APMs, Dr. James L. Madara, AMA executive vice president and CEO wrote in the letter.

The AMA also criticized Stage 3 for taking a poor approach to interoperability. The current measures are too focused on the quantity of information moved and “not the relevance of exchanges or the underlying business case for transmitting data,” Dr. Madara wrote. The AMA wants the measures to be refocused to address specific instances of data exchange, such as closing the referral loop, team-based care, and notification of tests/admissions.

According to the AMA, CMS should:

• Re-orient measures away from process-based tasks to highlight goals that are useful to patients and physicians.

• Encourage new technology functions to be the focus of certification rather than placing requirements on physicians and patients that may not yet be feasible.

• Support the reuse of data to reduce the burden on documentation.

The AMA’s recommendations are in line with concerns by the American Academy of Family Physicians over Stage 3, according to Dr. Robert L. Wergin, AAFP board chair. In a Dec. 2 letter to CMS, the AAFP said the final rule fell short of expectations and, in fact, places further obstacles in the way of improved health, better health care, and lower cost.

Interoperability challenges remain a top concern with the program, Dr. Wergin said in an interview. He cited a 27% decrease in physician satisfaction with EHRs since the launch of the meaningful use program, according to a 2014 survey.

“The whole concept of electronic health records, as family physicians, we saw the potential to help us care for our patients and help us track their progress,” Dr. Wergin said. “I would call it a potential unrealized. It really hasn’t developed into what we thought it could do. There’s a lot of frustrations.”

The AAFP calls for CMS to hit the pause button on meaningful use until 2019 – long enough to allow:

• The health care industry time to focus on interoperability issues.

• Vendors, physicians, and other health care professionals time to focus on designing and implementing the functionality and work flows necessary to achieve value-based payment.

• Regulators time to modify meaningful use regulations and align them with pending MACRA rules.

Similar concerns were expressed in a Nov. 20 letter from the GOP Doctors Caucus to Speaker of the House Paul Ryan (R-Wisc.). The 18-member caucus requested Speaker Ryan’s help in pressing for a delay of Stage 3 and a blanket hardship waiver exception for Stage 2. Implementation of more-stringent criteria is likely to create “a chilling effect on further EMR adoption as physicians conclude that the cost of implementation is simply not worth the bureaucratic hassle,” according to the letter. “Members of our caucus, as well as numerous congressional health care leaders, have engaged CMS on these issues to warn them of the potential negative consequences of placing these new requirements on providers in order to meet an arbitrary deadline. CMS has ignored Congress. Congressional action is the only solution left for preserving patient access, choice and quality.”

But Dr. Rocky D. Bilhartz, an interventional cardiologist in private practice in College Station, Tex., does not believe that the AMA’s recommendations nor other changes to the meaningful use program will make it better.

“I think they’re going about this entirely the wrong way,” said Dr. Bilhartz who blogs at bilhartzmd.com. “Meaningful use should not be delayed, but frankly abandoned. I don’t necessarily believe that the Department of Health & Human Service set out to try to design a system that would impair a physician’s ability to care for patients. I do believe without a doubt, that is exactly what has happened.”

[email protected]

On Twitter @legal_med

By the time Dr. Karen Edison saw the 41-year-old patient, several days had passed since his wife had first noticed a discolored spot on his back. Harvest season was underway, and the North Central Missouri farmer was reluctant to leave the fields and visit a physician.

Making matters more challenging, the family lived in a rural area nearly 3 hours away from a major medical center. The patient’s wife finally convinced her husband to visit a local hospital that had a telemedicine unit. Miles away at University of Missouri Health in Columbia, Dr. Edison viewed high-quality digital photos of the man’s back and spoke to the patient via video conferencing. Dr. Edison determined the blotch was a melanoma with a 1.1-mm Breslow measurement. The patient underwent a wide local excision along with a sentinel lymph node biopsy, which turned out to be negative.

Provided by Dr. Karen Edison

“It makes me feel grateful for the technology and how it lets us reach patients earlier and gets them diagnosed correctly,” said Dr. Edison, Philip C. Anderson Professor and chair of the dermatology department at University of Missouri Health and medical director for the Missouri Telehealth Network. “This saves patients’ suffering and can save patients’ lives. It certainly did in this case,” he said.

Similar outcomes are playing out across the country as telemedicine use continues to grow, especially among dermatologists. Analysts predict the number of health providers offering telemedicine will rise from 22% in 2014 to 37% in 2015, according to research by Towers Watson, a professional services company. Another report, BCC Research, a market research company, shows the global telehospital/clinic and telehome market is expected to reach about $43 billion in 2019, up from $19 billion in 2014.

Dermatologists fit rather smoothly into the telemedicine space, said Dr. Edison, who has used telemedicine in some form for 20 years. “Dermatology is uniquely suited for use of the technology because we are a visual specialty,” she said in an interview. “The value of our expertise is in the training we [have] to diagnose.”

Best teledermatology uses

Teledermatology is one of the most active applications of telemedicine rendered in the United States, according to the American Telemedicine Association (ATA). Common uses include “store and forward,” a technique that uses asynchronous still digital image technology for communication, and “real-time interactive,” which uses videoconferencing technology. Dermatologist Raja Sivamani of the University of California Davis Health System is taking these approaches one step further by working to integrate mobile phone photography and cloud-based communications.

UC Davis

“Previously, the technology had to be separated between the photography and the communication,” Dr. Sivamani said in an interview. “However, now we are seeing that this can be combined on the same platform, making the communications less cumbersome.”

Dr. Sivamani and his colleagues are currently using the technology for research studies and to set up communication channels overseas between hospital dermatologists, remote villages, and health outposts in both Nepal and Sri Lanka, he said.

Consults with other specialists also top the list of beneficial uses of teledermatology. In a survey of 2,016 doctors by American Well, a telehealth services company, physicians ranked dermatology video consults as the most valuable video consult of all the specialties. To address this need, the American Academy of Dermatology and the University of Pennsylvania jointly developed AccessDerm, a national program that provides primary care providers who work in participating clinics with free access to the expertise of dermatologists, who are AAD members. The program allows primary care clinicians to submit consultations that dermatologists receive on their personal mobile devices or the Internet via HIPAA-secure means. AccessDerm is now being used in 16 states, but the AAD is seeking to increase participation by clinics in all 50 states.

“In addition to addressing physician shortages from a clinical standpoint, teledermatology programs are very important for vulnerable citizens in the United States and abroad,” Dr. William D. James, vice chair of the department of dermatology for Penn Medicine and a past AAD president said in a statement. “It is wonderful that the impact of these teledermatology consultations continues to expand.”

An essential key to teledermatology is image quality, noted Dr. Dennis H. Oh of the University of California, San Francisco. He is assistant chief of dermatology at the San Francisco VA Medical Center and a member of the ATA’s Teledermatology Special Interest Group. At the VA Medical Center in San Francisco, photography is done by dedicated imagers trained and certified through a standardized curriculum, Dr. Oh said in an interview. The quality of images is also regularly monitored, he added.

“Image quality is of course very important,” Dr. Oh said. “There are resources to help train imagers and maintain their competence, such as those provided by the [ATA].”

Telemedicine challenges abound

Despite the perks, dermatologists and other doctors who practice telemedicine face a host of challenges that come with the virtual territory. Barriers include reimbursement, licensing, malpractice, and regulation. Topping the barriers is a lack of uniform standards for practices. A key question: What constitutes the responsible use of telemedicine?

States have differing ideas. Some require a physical examination by a physician prior to telemedicine. Some allow an encounter to be conducted via telemedicine, while others mandate that the visit be in person. Alabama, Georgia, and Texas require an in-person follow-up visit after a telemedicine encounter, according to 2015 data from the ATA. Sixteen states and Washington, D.C., have informed consent requirements for telemedicine patients. Still other states have no defined rules for the practice of telemedicine.

To promote consistency and better usage, the Federation of State Medical Boards (FSMB) in 2014 issued a model policy to state medical boards about the recommended practice of telemedicine. The policy maintains that the same standard of care applied to face-to-face encounters be applied to telemedicine encounters, explained Lisa A. Robin, chief advocacy officer for the Federation of State Medical Boards. At least 29 state boards have telemedicine rules that are consistent with the model policy, Ms. Robin said in an interview.

“As telemedicine continues to evolve, we believe there must be a very strong focus on ensuring patient safety through sound policy-making and regulatory practices,” she said.

Medical specialty societies have weighed in on acceptable telehealth practices for doctors. AAD policy, amended in 2015, supports the use of telemedicine services as long as teledermatology care is of high quality, contributes to care coordination – rather than fragmentation, meets state licensure and other legal requirements, maintains patient choice and transparency, and protects patient privacy. Guidance issued by the American Medical Association makes it clear that physicians who practice telemedicine need to first establish a patient-physician relationship. The FSMB guidance also states that doctors should establish a relationship with patients before practicing telemedicine.

But how that relationship is created is up for debate. In Texas, disagreement over what creates a physician-patient relationship has led to litigation between the national telemedicine company Teladoc and the Texas Medical Board. The case centers on a medical board rule that requires physicians to have a face-to-face visit with patients before treating them through telemedicine. The relationship can be created through telemedicine at an established medical site, but it may not be established through an online questionnaire, an email, a text, a chat, or a telephonic evaluation or consultation. Teladoc sued the medical board in April claiming the rule violates federal antitrust laws. A judge temporarily halted the rule’s enforcement in May.

Such ongoing disputes show that telemedicine best practices still need alignment and standardization, according to teledermatology experts.

“Telemedicine is gaining support, but there are many rules that need to be worked out,” Dr. Sivamani said. “Some include how these services are being reimbursed. Another concern is how medical board licensing allows or disallows practice within a region or across state lines. These challenges will need to be worked out and may require coordination between states in their legislation.”

Regardless of how these rules are standardized, teledermatology will be a large part of the telemedicine landscape, Dr. Oh added.

“Teledermatology used to be perceived as a relative niche novelty, but it is clearly going to be an increasing part of current routine care, and indeed is already integral to some practices and health systems,” he said.

[email protected]

On Twitter @legal_med

By the time Dr. Karen Edison saw the 41-year-old patient, several days had passed since his wife had first noticed a discolored spot on his back. Harvest season was underway, and the North Central Missouri farmer was reluctant to leave the fields and visit a physician.

Making matters more challenging, the family lived in a rural area nearly 3 hours away from a major medical center. The patient’s wife finally convinced her husband to visit a local hospital that had a telemedicine unit. Miles away at University of Missouri Health in Columbia, Dr. Edison viewed high-quality digital photos of the man’s back and spoke to the patient via video conferencing. Dr. Edison determined the blotch was a melanoma with a 1.1-mm Breslow measurement. The patient underwent a wide local excision along with a sentinel lymph node biopsy, which turned out to be negative.

Provided by Dr. Karen Edison

“It makes me feel grateful for the technology and how it lets us reach patients earlier and gets them diagnosed correctly,” said Dr. Edison, Philip C. Anderson Professor and chair of the dermatology department at University of Missouri Health and medical director for the Missouri Telehealth Network. “This saves patients’ suffering and can save patients’ lives. It certainly did in this case,” he said.

Similar outcomes are playing out across the country as telemedicine use continues to grow, especially among dermatologists. Analysts predict the number of health providers offering telemedicine will rise from 22% in 2014 to 37% in 2015, according to research by Towers Watson, a professional services company. Another report, BCC Research, a market research company, shows the global telehospital/clinic and telehome market is expected to reach about $43 billion in 2019, up from $19 billion in 2014.

Dermatologists fit rather smoothly into the telemedicine space, said Dr. Edison, who has used telemedicine in some form for 20 years. “Dermatology is uniquely suited for use of the technology because we are a visual specialty,” she said in an interview. “The value of our expertise is in the training we [have] to diagnose.”

Best teledermatology uses

Teledermatology is one of the most active applications of telemedicine rendered in the United States, according to the American Telemedicine Association (ATA). Common uses include “store and forward,” a technique that uses asynchronous still digital image technology for communication, and “real-time interactive,” which uses videoconferencing technology. Dermatologist Raja Sivamani of the University of California Davis Health System is taking these approaches one step further by working to integrate mobile phone photography and cloud-based communications.

UC Davis

“Previously, the technology had to be separated between the photography and the communication,” Dr. Sivamani said in an interview. “However, now we are seeing that this can be combined on the same platform, making the communications less cumbersome.”

Dr. Sivamani and his colleagues are currently using the technology for research studies and to set up communication channels overseas between hospital dermatologists, remote villages, and health outposts in both Nepal and Sri Lanka, he said.

Consults with other specialists also top the list of beneficial uses of teledermatology. In a survey of 2,016 doctors by American Well, a telehealth services company, physicians ranked dermatology video consults as the most valuable video consult of all the specialties. To address this need, the American Academy of Dermatology and the University of Pennsylvania jointly developed AccessDerm, a national program that provides primary care providers who work in participating clinics with free access to the expertise of dermatologists, who are AAD members. The program allows primary care clinicians to submit consultations that dermatologists receive on their personal mobile devices or the Internet via HIPAA-secure means. AccessDerm is now being used in 16 states, but the AAD is seeking to increase participation by clinics in all 50 states.

“In addition to addressing physician shortages from a clinical standpoint, teledermatology programs are very important for vulnerable citizens in the United States and abroad,” Dr. William D. James, vice chair of the department of dermatology for Penn Medicine and a past AAD president said in a statement. “It is wonderful that the impact of these teledermatology consultations continues to expand.”

An essential key to teledermatology is image quality, noted Dr. Dennis H. Oh of the University of California, San Francisco. He is assistant chief of dermatology at the San Francisco VA Medical Center and a member of the ATA’s Teledermatology Special Interest Group. At the VA Medical Center in San Francisco, photography is done by dedicated imagers trained and certified through a standardized curriculum, Dr. Oh said in an interview. The quality of images is also regularly monitored, he added.

“Image quality is of course very important,” Dr. Oh said. “There are resources to help train imagers and maintain their competence, such as those provided by the [ATA].”

Telemedicine challenges abound

Despite the perks, dermatologists and other doctors who practice telemedicine face a host of challenges that come with the virtual territory. Barriers include reimbursement, licensing, malpractice, and regulation. Topping the barriers is a lack of uniform standards for practices. A key question: What constitutes the responsible use of telemedicine?

States have differing ideas. Some require a physical examination by a physician prior to telemedicine. Some allow an encounter to be conducted via telemedicine, while others mandate that the visit be in person. Alabama, Georgia, and Texas require an in-person follow-up visit after a telemedicine encounter, according to 2015 data from the ATA. Sixteen states and Washington, D.C., have informed consent requirements for telemedicine patients. Still other states have no defined rules for the practice of telemedicine.

To promote consistency and better usage, the Federation of State Medical Boards (FSMB) in 2014 issued a model policy to state medical boards about the recommended practice of telemedicine. The policy maintains that the same standard of care applied to face-to-face encounters be applied to telemedicine encounters, explained Lisa A. Robin, chief advocacy officer for the Federation of State Medical Boards. At least 29 state boards have telemedicine rules that are consistent with the model policy, Ms. Robin said in an interview.

“As telemedicine continues to evolve, we believe there must be a very strong focus on ensuring patient safety through sound policy-making and regulatory practices,” she said.

Medical specialty societies have weighed in on acceptable telehealth practices for doctors. AAD policy, amended in 2015, supports the use of telemedicine services as long as teledermatology care is of high quality, contributes to care coordination – rather than fragmentation, meets state licensure and other legal requirements, maintains patient choice and transparency, and protects patient privacy. Guidance issued by the American Medical Association makes it clear that physicians who practice telemedicine need to first establish a patient-physician relationship. The FSMB guidance also states that doctors should establish a relationship with patients before practicing telemedicine.

But how that relationship is created is up for debate. In Texas, disagreement over what creates a physician-patient relationship has led to litigation between the national telemedicine company Teladoc and the Texas Medical Board. The case centers on a medical board rule that requires physicians to have a face-to-face visit with patients before treating them through telemedicine. The relationship can be created through telemedicine at an established medical site, but it may not be established through an online questionnaire, an email, a text, a chat, or a telephonic evaluation or consultation. Teladoc sued the medical board in April claiming the rule violates federal antitrust laws. A judge temporarily halted the rule’s enforcement in May.

Such ongoing disputes show that telemedicine best practices still need alignment and standardization, according to teledermatology experts.

“Telemedicine is gaining support, but there are many rules that need to be worked out,” Dr. Sivamani said. “Some include how these services are being reimbursed. Another concern is how medical board licensing allows or disallows practice within a region or across state lines. These challenges will need to be worked out and may require coordination between states in their legislation.”

Regardless of how these rules are standardized, teledermatology will be a large part of the telemedicine landscape, Dr. Oh added.

“Teledermatology used to be perceived as a relative niche novelty, but it is clearly going to be an increasing part of current routine care, and indeed is already integral to some practices and health systems,” he said.

[email protected]

On Twitter @legal_med

By the time Dr. Karen Edison saw the 41-year-old patient, several days had passed since his wife had first noticed a discolored spot on his back. Harvest season was underway, and the North Central Missouri farmer was reluctant to leave the fields and visit a physician.

Making matters more challenging, the family lived in a rural area nearly 3 hours away from a major medical center. The patient’s wife finally convinced her husband to visit a local hospital that had a telemedicine unit. Miles away at University of Missouri Health in Columbia, Dr. Edison viewed high-quality digital photos of the man’s back and spoke to the patient via video conferencing. Dr. Edison determined the blotch was a melanoma with a 1.1-mm Breslow measurement. The patient underwent a wide local excision along with a sentinel lymph node biopsy, which turned out to be negative.

Provided by Dr. Karen Edison

“It makes me feel grateful for the technology and how it lets us reach patients earlier and gets them diagnosed correctly,” said Dr. Edison, Philip C. Anderson Professor and chair of the dermatology department at University of Missouri Health and medical director for the Missouri Telehealth Network. “This saves patients’ suffering and can save patients’ lives. It certainly did in this case,” he said.

Similar outcomes are playing out across the country as telemedicine use continues to grow, especially among dermatologists. Analysts predict the number of health providers offering telemedicine will rise from 22% in 2014 to 37% in 2015, according to research by Towers Watson, a professional services company. Another report, BCC Research, a market research company, shows the global telehospital/clinic and telehome market is expected to reach about $43 billion in 2019, up from $19 billion in 2014.

Dermatologists fit rather smoothly into the telemedicine space, said Dr. Edison, who has used telemedicine in some form for 20 years. “Dermatology is uniquely suited for use of the technology because we are a visual specialty,” she said in an interview. “The value of our expertise is in the training we [have] to diagnose.”

Best teledermatology uses

Teledermatology is one of the most active applications of telemedicine rendered in the United States, according to the American Telemedicine Association (ATA). Common uses include “store and forward,” a technique that uses asynchronous still digital image technology for communication, and “real-time interactive,” which uses videoconferencing technology. Dermatologist Raja Sivamani of the University of California Davis Health System is taking these approaches one step further by working to integrate mobile phone photography and cloud-based communications.

UC Davis

“Previously, the technology had to be separated between the photography and the communication,” Dr. Sivamani said in an interview. “However, now we are seeing that this can be combined on the same platform, making the communications less cumbersome.”

Dr. Sivamani and his colleagues are currently using the technology for research studies and to set up communication channels overseas between hospital dermatologists, remote villages, and health outposts in both Nepal and Sri Lanka, he said.

Consults with other specialists also top the list of beneficial uses of teledermatology. In a survey of 2,016 doctors by American Well, a telehealth services company, physicians ranked dermatology video consults as the most valuable video consult of all the specialties. To address this need, the American Academy of Dermatology and the University of Pennsylvania jointly developed AccessDerm, a national program that provides primary care providers who work in participating clinics with free access to the expertise of dermatologists, who are AAD members. The program allows primary care clinicians to submit consultations that dermatologists receive on their personal mobile devices or the Internet via HIPAA-secure means. AccessDerm is now being used in 16 states, but the AAD is seeking to increase participation by clinics in all 50 states.

“In addition to addressing physician shortages from a clinical standpoint, teledermatology programs are very important for vulnerable citizens in the United States and abroad,” Dr. William D. James, vice chair of the department of dermatology for Penn Medicine and a past AAD president said in a statement. “It is wonderful that the impact of these teledermatology consultations continues to expand.”

An essential key to teledermatology is image quality, noted Dr. Dennis H. Oh of the University of California, San Francisco. He is assistant chief of dermatology at the San Francisco VA Medical Center and a member of the ATA’s Teledermatology Special Interest Group. At the VA Medical Center in San Francisco, photography is done by dedicated imagers trained and certified through a standardized curriculum, Dr. Oh said in an interview. The quality of images is also regularly monitored, he added.

“Image quality is of course very important,” Dr. Oh said. “There are resources to help train imagers and maintain their competence, such as those provided by the [ATA].”

Telemedicine challenges abound

Despite the perks, dermatologists and other doctors who practice telemedicine face a host of challenges that come with the virtual territory. Barriers include reimbursement, licensing, malpractice, and regulation. Topping the barriers is a lack of uniform standards for practices. A key question: What constitutes the responsible use of telemedicine?

States have differing ideas. Some require a physical examination by a physician prior to telemedicine. Some allow an encounter to be conducted via telemedicine, while others mandate that the visit be in person. Alabama, Georgia, and Texas require an in-person follow-up visit after a telemedicine encounter, according to 2015 data from the ATA. Sixteen states and Washington, D.C., have informed consent requirements for telemedicine patients. Still other states have no defined rules for the practice of telemedicine.

To promote consistency and better usage, the Federation of State Medical Boards (FSMB) in 2014 issued a model policy to state medical boards about the recommended practice of telemedicine. The policy maintains that the same standard of care applied to face-to-face encounters be applied to telemedicine encounters, explained Lisa A. Robin, chief advocacy officer for the Federation of State Medical Boards. At least 29 state boards have telemedicine rules that are consistent with the model policy, Ms. Robin said in an interview.

“As telemedicine continues to evolve, we believe there must be a very strong focus on ensuring patient safety through sound policy-making and regulatory practices,” she said.

Medical specialty societies have weighed in on acceptable telehealth practices for doctors. AAD policy, amended in 2015, supports the use of telemedicine services as long as teledermatology care is of high quality, contributes to care coordination – rather than fragmentation, meets state licensure and other legal requirements, maintains patient choice and transparency, and protects patient privacy. Guidance issued by the American Medical Association makes it clear that physicians who practice telemedicine need to first establish a patient-physician relationship. The FSMB guidance also states that doctors should establish a relationship with patients before practicing telemedicine.

But how that relationship is created is up for debate. In Texas, disagreement over what creates a physician-patient relationship has led to litigation between the national telemedicine company Teladoc and the Texas Medical Board. The case centers on a medical board rule that requires physicians to have a face-to-face visit with patients before treating them through telemedicine. The relationship can be created through telemedicine at an established medical site, but it may not be established through an online questionnaire, an email, a text, a chat, or a telephonic evaluation or consultation. Teladoc sued the medical board in April claiming the rule violates federal antitrust laws. A judge temporarily halted the rule’s enforcement in May.

Such ongoing disputes show that telemedicine best practices still need alignment and standardization, according to teledermatology experts.

“Telemedicine is gaining support, but there are many rules that need to be worked out,” Dr. Sivamani said. “Some include how these services are being reimbursed. Another concern is how medical board licensing allows or disallows practice within a region or across state lines. These challenges will need to be worked out and may require coordination between states in their legislation.”

Regardless of how these rules are standardized, teledermatology will be a large part of the telemedicine landscape, Dr. Oh added.

“Teledermatology used to be perceived as a relative niche novelty, but it is clearly going to be an increasing part of current routine care, and indeed is already integral to some practices and health systems,” he said.

[email protected]

On Twitter @legal_med

WASHINGTON – While the line between an inadvertent billing mistake and intentional coding deception might be blurry, federal investigators are crystal clear about what drives them to exclude health providers from government health programs.

Rejection from Medicaid and Medicare comes down to severity and accountability, said Lisa Re, branch chief of administrative and civil remedies for the Health and Human Services Department Office of Counsel to Inspector General.

“At the end of the day, what we’re looking at is the seriousness of the conduct, cooperation with the compliance program, and whether or not there’s been a sense of financial responsibility – that the program has been made whole from the harm that was done,” Ms. Re said at a meeting sponsored by the American Bar Association.

In 2015, the Office of Inspector General (OIG) excluded 4,112 individuals and entities from participation in federal health care programs, up from 4,017 in 2014, according to a the OIG’s semiannual report to Congress published Nov. 30.

The office expects to recover nearly $3.4 billion in incorrect payments in 2015, down from $4.9 billion last year. The office also reported 925 criminal actions and 682 civil actions in 2015 involving false claims, unjust-enrichment lawsuits, civil settlements, and administrative recoveries.

When it comes to exclusions, investigators rely on the facts and circumstances of each individual case, Ms. Re said. Certain behaviors such as repeated disregard of government inquires and ongoing overbilling can lead to exclusions.

“We’re not trying to punish anyone,” Ms. Re said. “Exclusion is purely remedial. It’s a question of whether or not you have demonstrated sufficient trustworthiness for us to continue doing business with you.”

The OIG considers two types of exclusions – mandatory and permissive. The agency is obligated to exclude a provider if that professional is convicted of program-related crimes, is convicted of patient abuse or neglect, receives a felony health fraud conviction, or is convicted of two mandatory exclusion offenses. The OIG can use its discretion in situations in which a provider receives a misdemeanor conviction related to health fraud, has a license suspended or revoked, fails to disclose required information, fails to take corrective action, or makes false statements to the government, among others. Reinstatement of excluded entities and individuals is not automatic once the exclusion period ends. Those wishing to again participate in a federal health care program must apply for and receive reinstatement permission from the OIG.

Ms. Re stressed that her office is transparent about possible or upcoming exclusions during a payment investigation. If health professionals come under billing scrutiny, she encourages them and their attorneys to contact OIG officials to inquire whether an exclusion is likely or expected.

[email protected]

On Twitter @legal_med

WASHINGTON – While the line between an inadvertent billing mistake and intentional coding deception might be blurry, federal investigators are crystal clear about what drives them to exclude health providers from government health programs.

Rejection from Medicaid and Medicare comes down to severity and accountability, said Lisa Re, branch chief of administrative and civil remedies for the Health and Human Services Department Office of Counsel to Inspector General.

“At the end of the day, what we’re looking at is the seriousness of the conduct, cooperation with the compliance program, and whether or not there’s been a sense of financial responsibility – that the program has been made whole from the harm that was done,” Ms. Re said at a meeting sponsored by the American Bar Association.

In 2015, the Office of Inspector General (OIG) excluded 4,112 individuals and entities from participation in federal health care programs, up from 4,017 in 2014, according to a the OIG’s semiannual report to Congress published Nov. 30.

The office expects to recover nearly $3.4 billion in incorrect payments in 2015, down from $4.9 billion last year. The office also reported 925 criminal actions and 682 civil actions in 2015 involving false claims, unjust-enrichment lawsuits, civil settlements, and administrative recoveries.

When it comes to exclusions, investigators rely on the facts and circumstances of each individual case, Ms. Re said. Certain behaviors such as repeated disregard of government inquires and ongoing overbilling can lead to exclusions.

“We’re not trying to punish anyone,” Ms. Re said. “Exclusion is purely remedial. It’s a question of whether or not you have demonstrated sufficient trustworthiness for us to continue doing business with you.”

The OIG considers two types of exclusions – mandatory and permissive. The agency is obligated to exclude a provider if that professional is convicted of program-related crimes, is convicted of patient abuse or neglect, receives a felony health fraud conviction, or is convicted of two mandatory exclusion offenses. The OIG can use its discretion in situations in which a provider receives a misdemeanor conviction related to health fraud, has a license suspended or revoked, fails to disclose required information, fails to take corrective action, or makes false statements to the government, among others. Reinstatement of excluded entities and individuals is not automatic once the exclusion period ends. Those wishing to again participate in a federal health care program must apply for and receive reinstatement permission from the OIG.

Ms. Re stressed that her office is transparent about possible or upcoming exclusions during a payment investigation. If health professionals come under billing scrutiny, she encourages them and their attorneys to contact OIG officials to inquire whether an exclusion is likely or expected.

[email protected]

On Twitter @legal_med

WASHINGTON – While the line between an inadvertent billing mistake and intentional coding deception might be blurry, federal investigators are crystal clear about what drives them to exclude health providers from government health programs.

Rejection from Medicaid and Medicare comes down to severity and accountability, said Lisa Re, branch chief of administrative and civil remedies for the Health and Human Services Department Office of Counsel to Inspector General.

“At the end of the day, what we’re looking at is the seriousness of the conduct, cooperation with the compliance program, and whether or not there’s been a sense of financial responsibility – that the program has been made whole from the harm that was done,” Ms. Re said at a meeting sponsored by the American Bar Association.

In 2015, the Office of Inspector General (OIG) excluded 4,112 individuals and entities from participation in federal health care programs, up from 4,017 in 2014, according to a the OIG’s semiannual report to Congress published Nov. 30.

The office expects to recover nearly $3.4 billion in incorrect payments in 2015, down from $4.9 billion last year. The office also reported 925 criminal actions and 682 civil actions in 2015 involving false claims, unjust-enrichment lawsuits, civil settlements, and administrative recoveries.

When it comes to exclusions, investigators rely on the facts and circumstances of each individual case, Ms. Re said. Certain behaviors such as repeated disregard of government inquires and ongoing overbilling can lead to exclusions.

“We’re not trying to punish anyone,” Ms. Re said. “Exclusion is purely remedial. It’s a question of whether or not you have demonstrated sufficient trustworthiness for us to continue doing business with you.”

The OIG considers two types of exclusions – mandatory and permissive. The agency is obligated to exclude a provider if that professional is convicted of program-related crimes, is convicted of patient abuse or neglect, receives a felony health fraud conviction, or is convicted of two mandatory exclusion offenses. The OIG can use its discretion in situations in which a provider receives a misdemeanor conviction related to health fraud, has a license suspended or revoked, fails to disclose required information, fails to take corrective action, or makes false statements to the government, among others. Reinstatement of excluded entities and individuals is not automatic once the exclusion period ends. Those wishing to again participate in a federal health care program must apply for and receive reinstatement permission from the OIG.

Ms. Re stressed that her office is transparent about possible or upcoming exclusions during a payment investigation. If health professionals come under billing scrutiny, she encourages them and their attorneys to contact OIG officials to inquire whether an exclusion is likely or expected.

[email protected]

On Twitter @legal_med

Emergency physician leaders are outraged over a new federal regulation that they say could drastically lower payments for out-of-network emergency services. The final regulation, which affirms interim regulations by the U.S. Department of Health & Human Services, allows health plans to use a vague methodology to calculate reimbursement for out-of-network emergency services.

The American College of Emergency Physicians has worked for years to have the rule’s language revised, said Dr. Jeffrey Bettinger, a member of ACEP’s reimbursement committee and founder of a health care business consulting firm in Pinecrest, Fla. “They released final regulations which not only kept worrisome language ... but it actually made it worse.”

The regulation, published Nov. 18 in the Federal Register, outlines patient protections under the Affordable Care Act, including how health plans must calculate coverage for out-of-network emergency services. The regulation states that a patient’s group health plan must reimburse out-of-network emergency services by paying the greatest of three possible (GOT) amounts:

• The median amount negotiated with in-network providers for the emergency service furnished.

• The amount for the emergency service calculated using the same method the plan generally uses to determine payments for out-of-network services (such as the usual, customary, and reasonable amount).

• The amount that would be paid under Medicare for the emergency service.

Under these options, the second choice is nearly always the greatest of the three amounts, and the last option – Medicare’s rate – is likely to be lowest, Dr. Bettinger said.

ACEP has long been concerned about the second option because it lacks specificity and essentially leaves it up to health insurance plans to establish a Medicare-related method to reimburse emergency physicians for out-of-network services. The college lobbied for government officials to require more transparency from insurers who chose to pay under option two – for instance, by tying their methods to a usual, customary, and reasonable database or another model that was academically validated, Dr. Bettinger said. The interim rule used the language, “such as the usual, customary, and reasonable charges,” rather than “amount” under option two. Under the final rule, the phrase “usual, customary, and reasonable amount,” is even more ambiguous than the proposed language, Dr. Bettinger said.

“It’s a nebulous term,” he said. “Its totally nontransparent. There’s no database that we know of that keeps track of what that number is. Honestly it’s interpreted by the insurance companies to dramatically lower the payments they are making for out-of-network emergency services.”

In the final regulation, HHS acknowledged concerns by health providers about the level of payment for out-of-network emergency services and the need for more transparency by insurers.

“The departments believe that this concern is addressed by our requirement that the amount be the greatest of the three amounts specified,” according to the regulation.

America’s Health Insurance Plans (AHIP), the national trade association for health insurers, declined to comment specifically about the final rule. However, AHIP spokesman Courtney Jay said that ACEP “isn’t addressing the amount patients are being charged for emergency services.” He noted a recent AHIP report finding that average billed charges submitted by out-of-network providers, including emergency physicians, far exceed Medicare reimbursement for the same service performed in the same geographic area. According to the September 2015 analysis, among 97 procedures studied, average out-of-network billed charges were from 118% to 1,382% of amounts paid by Medicare. High out-of-network charges impose significant burdens on consumers and result in high out-of-network expenses for patients due to balance billing by providers, according to AHIP.

The final regulation does not prohibit balance billing; however, if a patient resides in a state that bans balance billing, the “greatest of three” rule does not apply. Rather, emergency physicians in such states would be reimbursed based on the unique reimbursement method for out-of-network emergency services in their state. This could problematic for emergency physicians in states that prohibit balance billing, Dr. Bettinger said.

“Some states that have specific payment regulations won’t be impacted to a large degree,” he said. “Other states that have prohibitions have less clearly defined payment formulas. These states will be impacted by the final rule.”

ACEP is considering taking legal action against the government over the rule, said ACEP President Jay A. Kaplan.

“This new ruling will significantly benefit health insurance companies at the expense of physicians, because they know hospital emergency departments have a federal mandate to care for everyone, regardless of ability to pay,” Dr. Kaplan said in a statement. “They will continue to shift costs onto patients and medical providers, as well as shrink the number of doctors available in plans. Instead of requiring health plans to pay fairly, this ruling guarantees that insurance companies can pay whatever they want for emergency care. If history tells us anything, it’s that insurance companies prefer to pay as close to nothing as possible, while building their war chest for profits and litigation.”

HHS officials did not respond to requests for comment.

[email protected]

On Twitter @legal_med

Emergency physician leaders are outraged over a new federal regulation that they say could drastically lower payments for out-of-network emergency services. The final regulation, which affirms interim regulations by the U.S. Department of Health & Human Services, allows health plans to use a vague methodology to calculate reimbursement for out-of-network emergency services.

The American College of Emergency Physicians has worked for years to have the rule’s language revised, said Dr. Jeffrey Bettinger, a member of ACEP’s reimbursement committee and founder of a health care business consulting firm in Pinecrest, Fla. “They released final regulations which not only kept worrisome language ... but it actually made it worse.”

The regulation, published Nov. 18 in the Federal Register, outlines patient protections under the Affordable Care Act, including how health plans must calculate coverage for out-of-network emergency services. The regulation states that a patient’s group health plan must reimburse out-of-network emergency services by paying the greatest of three possible (GOT) amounts:

• The median amount negotiated with in-network providers for the emergency service furnished.

• The amount for the emergency service calculated using the same method the plan generally uses to determine payments for out-of-network services (such as the usual, customary, and reasonable amount).

• The amount that would be paid under Medicare for the emergency service.

Under these options, the second choice is nearly always the greatest of the three amounts, and the last option – Medicare’s rate – is likely to be lowest, Dr. Bettinger said.

ACEP has long been concerned about the second option because it lacks specificity and essentially leaves it up to health insurance plans to establish a Medicare-related method to reimburse emergency physicians for out-of-network services. The college lobbied for government officials to require more transparency from insurers who chose to pay under option two – for instance, by tying their methods to a usual, customary, and reasonable database or another model that was academically validated, Dr. Bettinger said. The interim rule used the language, “such as the usual, customary, and reasonable charges,” rather than “amount” under option two. Under the final rule, the phrase “usual, customary, and reasonable amount,” is even more ambiguous than the proposed language, Dr. Bettinger said.

“It’s a nebulous term,” he said. “Its totally nontransparent. There’s no database that we know of that keeps track of what that number is. Honestly it’s interpreted by the insurance companies to dramatically lower the payments they are making for out-of-network emergency services.”

In the final regulation, HHS acknowledged concerns by health providers about the level of payment for out-of-network emergency services and the need for more transparency by insurers.

“The departments believe that this concern is addressed by our requirement that the amount be the greatest of the three amounts specified,” according to the regulation.

America’s Health Insurance Plans (AHIP), the national trade association for health insurers, declined to comment specifically about the final rule. However, AHIP spokesman Courtney Jay said that ACEP “isn’t addressing the amount patients are being charged for emergency services.” He noted a recent AHIP report finding that average billed charges submitted by out-of-network providers, including emergency physicians, far exceed Medicare reimbursement for the same service performed in the same geographic area. According to the September 2015 analysis, among 97 procedures studied, average out-of-network billed charges were from 118% to 1,382% of amounts paid by Medicare. High out-of-network charges impose significant burdens on consumers and result in high out-of-network expenses for patients due to balance billing by providers, according to AHIP.

The final regulation does not prohibit balance billing; however, if a patient resides in a state that bans balance billing, the “greatest of three” rule does not apply. Rather, emergency physicians in such states would be reimbursed based on the unique reimbursement method for out-of-network emergency services in their state. This could problematic for emergency physicians in states that prohibit balance billing, Dr. Bettinger said.

“Some states that have specific payment regulations won’t be impacted to a large degree,” he said. “Other states that have prohibitions have less clearly defined payment formulas. These states will be impacted by the final rule.”

ACEP is considering taking legal action against the government over the rule, said ACEP President Jay A. Kaplan.

“This new ruling will significantly benefit health insurance companies at the expense of physicians, because they know hospital emergency departments have a federal mandate to care for everyone, regardless of ability to pay,” Dr. Kaplan said in a statement. “They will continue to shift costs onto patients and medical providers, as well as shrink the number of doctors available in plans. Instead of requiring health plans to pay fairly, this ruling guarantees that insurance companies can pay whatever they want for emergency care. If history tells us anything, it’s that insurance companies prefer to pay as close to nothing as possible, while building their war chest for profits and litigation.”

HHS officials did not respond to requests for comment.

[email protected]

On Twitter @legal_med

Emergency physician leaders are outraged over a new federal regulation that they say could drastically lower payments for out-of-network emergency services. The final regulation, which affirms interim regulations by the U.S. Department of Health & Human Services, allows health plans to use a vague methodology to calculate reimbursement for out-of-network emergency services.

The American College of Emergency Physicians has worked for years to have the rule’s language revised, said Dr. Jeffrey Bettinger, a member of ACEP’s reimbursement committee and founder of a health care business consulting firm in Pinecrest, Fla. “They released final regulations which not only kept worrisome language ... but it actually made it worse.”

The regulation, published Nov. 18 in the Federal Register, outlines patient protections under the Affordable Care Act, including how health plans must calculate coverage for out-of-network emergency services. The regulation states that a patient’s group health plan must reimburse out-of-network emergency services by paying the greatest of three possible (GOT) amounts:

• The median amount negotiated with in-network providers for the emergency service furnished.

• The amount for the emergency service calculated using the same method the plan generally uses to determine payments for out-of-network services (such as the usual, customary, and reasonable amount).

• The amount that would be paid under Medicare for the emergency service.

Under these options, the second choice is nearly always the greatest of the three amounts, and the last option – Medicare’s rate – is likely to be lowest, Dr. Bettinger said.

ACEP has long been concerned about the second option because it lacks specificity and essentially leaves it up to health insurance plans to establish a Medicare-related method to reimburse emergency physicians for out-of-network services. The college lobbied for government officials to require more transparency from insurers who chose to pay under option two – for instance, by tying their methods to a usual, customary, and reasonable database or another model that was academically validated, Dr. Bettinger said. The interim rule used the language, “such as the usual, customary, and reasonable charges,” rather than “amount” under option two. Under the final rule, the phrase “usual, customary, and reasonable amount,” is even more ambiguous than the proposed language, Dr. Bettinger said.

“It’s a nebulous term,” he said. “Its totally nontransparent. There’s no database that we know of that keeps track of what that number is. Honestly it’s interpreted by the insurance companies to dramatically lower the payments they are making for out-of-network emergency services.”

In the final regulation, HHS acknowledged concerns by health providers about the level of payment for out-of-network emergency services and the need for more transparency by insurers.

“The departments believe that this concern is addressed by our requirement that the amount be the greatest of the three amounts specified,” according to the regulation.

America’s Health Insurance Plans (AHIP), the national trade association for health insurers, declined to comment specifically about the final rule. However, AHIP spokesman Courtney Jay said that ACEP “isn’t addressing the amount patients are being charged for emergency services.” He noted a recent AHIP report finding that average billed charges submitted by out-of-network providers, including emergency physicians, far exceed Medicare reimbursement for the same service performed in the same geographic area. According to the September 2015 analysis, among 97 procedures studied, average out-of-network billed charges were from 118% to 1,382% of amounts paid by Medicare. High out-of-network charges impose significant burdens on consumers and result in high out-of-network expenses for patients due to balance billing by providers, according to AHIP.

The final regulation does not prohibit balance billing; however, if a patient resides in a state that bans balance billing, the “greatest of three” rule does not apply. Rather, emergency physicians in such states would be reimbursed based on the unique reimbursement method for out-of-network emergency services in their state. This could problematic for emergency physicians in states that prohibit balance billing, Dr. Bettinger said.

“Some states that have specific payment regulations won’t be impacted to a large degree,” he said. “Other states that have prohibitions have less clearly defined payment formulas. These states will be impacted by the final rule.”

ACEP is considering taking legal action against the government over the rule, said ACEP President Jay A. Kaplan.

“This new ruling will significantly benefit health insurance companies at the expense of physicians, because they know hospital emergency departments have a federal mandate to care for everyone, regardless of ability to pay,” Dr. Kaplan said in a statement. “They will continue to shift costs onto patients and medical providers, as well as shrink the number of doctors available in plans. Instead of requiring health plans to pay fairly, this ruling guarantees that insurance companies can pay whatever they want for emergency care. If history tells us anything, it’s that insurance companies prefer to pay as close to nothing as possible, while building their war chest for profits and litigation.”

HHS officials did not respond to requests for comment.

[email protected]

On Twitter @legal_med

Malpractice concerns increase the likelihood that dermatopathologists who interpret melanocytic skin lesions will order more specialized pathology tests, obtain recuts, and seek a second opinion, according to a study that surveyed dermatopathologists in different states. However, the analysis found no evidence that such practice behaviors were influenced by personal medical malpractice experience.

The results of the study, published online on Nov. 7 in the Journal of the American Academy of Dermatology, suggest that fear of lawsuits influences dermatopathologists’ interpretive behavior, regardless of actual past litigation.

Dr. Patricia A. Carney of Oregon Health and Science University, Portland, and her colleagues surveyed 207 dermatopathologists in 10 states who interpret melanocytic skin lesions. They assessed dermatopathologists’ demographic and clinical practice characteristics, perceptions of how medical malpractice concerns influence their practices, and doctors’ past litigation experiences. The majority were male (59%), had no affiliations with academic medical centers (71.5%), and had not been board certified or fellowship trained in dermatopathology (61%).

Of the 207 dermatopathologists, 67% reported no previous malpractice claims against them, and 33% reported one case or more. Physician characteristics associated with having a malpractice claim included older age and lack of board certification or fellowship training in dermatopathology.

Clinical practice characteristics associated with having a past malpractice claim included a greater number of years interpreting melanocytic lesions, lower representation of melanocytic lesions in their caseloads, a higher frequency of providing second opinions on melanocytic lesions, and being considered an expert in assessment of melanocytic lesions by colleagues. About 70% said that interpreting melanocytic skin lesions made them more nervous than other types of pathology, and nearly 75% agreed with the statement that they were concerned about patient safety and “potential harm to patients” that could result from their assessment of melanocytic lesions.

However, 64% of those surveyed said they were “moderately or extremely confident” in their melanocytic interpretations.

Of those surveyed, 92% reported that medical malpractice concerns increased their requests for second opinions. These concerns also prompted requests for additional slides to be cut from tissue blocks in 87% of those surveyed, ordering that additional surgical samples be taken from patients in 66%, and choosing a more severe diagnosis for cases considered borderline in 53%. But the researchers found no evidence that having had a malpractice claim influenced any of these behaviors.

“Dermatopathologists, like other physicians, are likely well aware of malpractice and discuss these experiences among colleagues,” they wrote. “Thus, a lawsuit is not needed for dermatopathologists to be aware of and undertake behaviors that might protect them from a suit.”

The results, they added, “indicate that most dermatopathologists have concerns about patient harms associated with their interpretations of melanocytic lesions; thus, they are not just concerned for themselves.”

The authors note that as far as they know, this study is the first to evaluate “how dermatopathologists view their clinical practices are influenced by malpractice.”

[email protected]

On Twitter @legal_med

Malpractice concerns increase the likelihood that dermatopathologists who interpret melanocytic skin lesions will order more specialized pathology tests, obtain recuts, and seek a second opinion, according to a study that surveyed dermatopathologists in different states. However, the analysis found no evidence that such practice behaviors were influenced by personal medical malpractice experience.

The results of the study, published online on Nov. 7 in the Journal of the American Academy of Dermatology, suggest that fear of lawsuits influences dermatopathologists’ interpretive behavior, regardless of actual past litigation.

Dr. Patricia A. Carney of Oregon Health and Science University, Portland, and her colleagues surveyed 207 dermatopathologists in 10 states who interpret melanocytic skin lesions. They assessed dermatopathologists’ demographic and clinical practice characteristics, perceptions of how medical malpractice concerns influence their practices, and doctors’ past litigation experiences. The majority were male (59%), had no affiliations with academic medical centers (71.5%), and had not been board certified or fellowship trained in dermatopathology (61%).

Of the 207 dermatopathologists, 67% reported no previous malpractice claims against them, and 33% reported one case or more. Physician characteristics associated with having a malpractice claim included older age and lack of board certification or fellowship training in dermatopathology.

Clinical practice characteristics associated with having a past malpractice claim included a greater number of years interpreting melanocytic lesions, lower representation of melanocytic lesions in their caseloads, a higher frequency of providing second opinions on melanocytic lesions, and being considered an expert in assessment of melanocytic lesions by colleagues. About 70% said that interpreting melanocytic skin lesions made them more nervous than other types of pathology, and nearly 75% agreed with the statement that they were concerned about patient safety and “potential harm to patients” that could result from their assessment of melanocytic lesions.

However, 64% of those surveyed said they were “moderately or extremely confident” in their melanocytic interpretations.

Of those surveyed, 92% reported that medical malpractice concerns increased their requests for second opinions. These concerns also prompted requests for additional slides to be cut from tissue blocks in 87% of those surveyed, ordering that additional surgical samples be taken from patients in 66%, and choosing a more severe diagnosis for cases considered borderline in 53%. But the researchers found no evidence that having had a malpractice claim influenced any of these behaviors.

“Dermatopathologists, like other physicians, are likely well aware of malpractice and discuss these experiences among colleagues,” they wrote. “Thus, a lawsuit is not needed for dermatopathologists to be aware of and undertake behaviors that might protect them from a suit.”

The results, they added, “indicate that most dermatopathologists have concerns about patient harms associated with their interpretations of melanocytic lesions; thus, they are not just concerned for themselves.”

The authors note that as far as they know, this study is the first to evaluate “how dermatopathologists view their clinical practices are influenced by malpractice.”

[email protected]

On Twitter @legal_med

Malpractice concerns increase the likelihood that dermatopathologists who interpret melanocytic skin lesions will order more specialized pathology tests, obtain recuts, and seek a second opinion, according to a study that surveyed dermatopathologists in different states. However, the analysis found no evidence that such practice behaviors were influenced by personal medical malpractice experience.

The results of the study, published online on Nov. 7 in the Journal of the American Academy of Dermatology, suggest that fear of lawsuits influences dermatopathologists’ interpretive behavior, regardless of actual past litigation.

Dr. Patricia A. Carney of Oregon Health and Science University, Portland, and her colleagues surveyed 207 dermatopathologists in 10 states who interpret melanocytic skin lesions. They assessed dermatopathologists’ demographic and clinical practice characteristics, perceptions of how medical malpractice concerns influence their practices, and doctors’ past litigation experiences. The majority were male (59%), had no affiliations with academic medical centers (71.5%), and had not been board certified or fellowship trained in dermatopathology (61%).

Of the 207 dermatopathologists, 67% reported no previous malpractice claims against them, and 33% reported one case or more. Physician characteristics associated with having a malpractice claim included older age and lack of board certification or fellowship training in dermatopathology.

Clinical practice characteristics associated with having a past malpractice claim included a greater number of years interpreting melanocytic lesions, lower representation of melanocytic lesions in their caseloads, a higher frequency of providing second opinions on melanocytic lesions, and being considered an expert in assessment of melanocytic lesions by colleagues. About 70% said that interpreting melanocytic skin lesions made them more nervous than other types of pathology, and nearly 75% agreed with the statement that they were concerned about patient safety and “potential harm to patients” that could result from their assessment of melanocytic lesions.

However, 64% of those surveyed said they were “moderately or extremely confident” in their melanocytic interpretations.

Of those surveyed, 92% reported that medical malpractice concerns increased their requests for second opinions. These concerns also prompted requests for additional slides to be cut from tissue blocks in 87% of those surveyed, ordering that additional surgical samples be taken from patients in 66%, and choosing a more severe diagnosis for cases considered borderline in 53%. But the researchers found no evidence that having had a malpractice claim influenced any of these behaviors.

“Dermatopathologists, like other physicians, are likely well aware of malpractice and discuss these experiences among colleagues,” they wrote. “Thus, a lawsuit is not needed for dermatopathologists to be aware of and undertake behaviors that might protect them from a suit.”

The results, they added, “indicate that most dermatopathologists have concerns about patient harms associated with their interpretations of melanocytic lesions; thus, they are not just concerned for themselves.”

The authors note that as far as they know, this study is the first to evaluate “how dermatopathologists view their clinical practices are influenced by malpractice.”

[email protected]

On Twitter @legal_med

Physicians who treat hepatitis C patients were hardly surprised by a recent Senate investigation that found the maker of a hepatitis C drug allegedly put profits ahead of accessibility in pricing its medication. The final wholesale price – $1,000 per pill, or $84,000 for a single course of treatment – led to $1.3 billion in spending by state Medicaid programs, but few low-income patients actually received the drug.

“Even if sofosbuvir [Sovaldi] and Harvoni were priced 50% lower, the reality is that the burden to the health care system would still be tremendous, and it would still not be possible to treat all patients with hepatitis C,” said Dr. Sean W.P. Koppe, director of hepatology at the University of Illinois Hospital & Health Sciences System, Chicago. “Large organizations, such as [Veterans Affairs], can leverage their purchasing power to force some deeper discounting of the drug, [but] until some sort of mechanism is in place to harness the purchasing power of Medicare and Medicaid to negotiate deeper discounts, this scenario is bound to repeat itself with other drugs.”

After an 18-month analysis, investigators with the Senate Committee on Finance found that Gilead Sciences pursued a marketing strategy and wholesale price of Sovaldi that would maximize its revenue with little regard to affordable access, according to a report published Dec. 1. Building on Sovaldi’s price, Harvoni was later introduced at $94,500 per treatment course under the same marketing scheme. The investigation found no evidence that research costs or the multibillion dollar acquisition of Pharmasset, the drug’s first developer, factored into how Gilead set its prices. Investigators drew their conclusions from 20,000 pages of internal company documents, interviews with health care experts, and a trove of data from Medicaid programs in 50 states and the District of Columbia.

“Gilead pursued a calculated scheme for pricing and marketing its hepatitis C drug, based on one primary goal – maximizing revenue – regardless of the human consequences,” Sen. Ron Wyden (D-Ore.), Senate Finance Committee ranking member, said in a statement. “Gilead knew these prices would put treatment out of the reach of millions and cause extraordinary problems for Medicare and Medicaid, but still the company went ahead. If Gilead’s approach to pricing is the future of how blockbuster drugs are launched, it will cost billions and billions of dollars to treat just a fraction of patients.”

In a statement, a Gilead representative said the company respectfully disagreed with the report’s conclusions.

“We stand behind the pricing of our therapies because of the benefit they bring to patients and the significant value they represent to payers, providers, and our entire health care system by reducing the long-term costs associated with managing chronic HCV [hepatitis C virus],” Gilead spokeswoman Michele Rest said in an emailed statement. “Enabling patient access to Sovaldi and Harvoni is a top priority for Gilead. We have programs in place in the U.S. to help uninsured individuals and those who need financial assistance to access our therapies, and we will continue our efforts to make the medications available to people in need in the United States and around the world.”

Medicare, Medicaid, and the Bureau of Prisons were hit hardest by Sovaldi’s price tag, according to the report. In the 18 months following Sovaldi’s approval, Medicare has spent nearly $8.2 billion before rebates on Sovaldi and Harvoni, a sixfold monthly spending increase on hepatitis C treatments for the agency. In 2014 alone, Medicare and Medicaid spent a combined $5 billion on Sovaldi and Harvoni before rebates, a number projected to climb in 2015. The cost of Sovaldi meant many states were forced to effectively ration the drugs, providing them to only the sickest patients and requiring that patients be under the care of hepatologists or other specialists prior to receiving the drugs, according to the Senate report. Data show that state Medicaid programs nationwide spent $1.3 billion before rebates on Sovaldi in 2014, but that less than 2.4% of Medicaid enrollees with hepatitis C were treated with the drug. Sovaldi was the top drug spending item for 14 state Medicaid agencies in 2014, and the second-highest spending item for 15 more states.

“What we face is not a drug cost problem, it is a drug price problem,” Lynne Saxton, director of the Oregon Health Authority, wrote in a letter to Sen. Wyden. “State Medicaid programs are limited in [their] ability to control pharmacy benefit expenditure, particularly as federal law requires us to provide a pathway to coverage for all FDA-approved drugs, no matter how minimal the likely benefit per dollar spent. While federally mandated rebates help, they provide limited relief.”

Financial records show Gilead generated $14.3 billion in net product sales from its HCV drugs through the first 9 months of 2015, bringing its 21-month total for its HCV drugs to $26.6 billion, $20.6 billion of which is from sales to U.S. patients. Gilead justified Sovaldi’s high price point based on price-per-cure, according to the report. Documents acquired during the investigation illustrate that Gilead officials knew they were in a position to create clear savings for payers but chose to pursue a “regimen neutral” price justified by “cost-per-cure” calculations that resulted in greater revenue per treatment than previous direct-acting antivirals.

The Senate report was eye-opening and provides a likely snapshot of how future medications will be priced by drug companies, said Dr. Rajat Chander, an internist and gastroenterologist in private practice in Raleigh, N.C. “While newer drugs for hep C will ultimately drive the price lower, this Senate investigation is enlightening as to ‘price-per-cure’ for future drugs for other diseases,” he said in an interview. “As physicians, we often find ourselves on the front lines, scrambling to find discounts and rebates for individual patients. However, we need just this kind of bipartisan Senate and government regulatory oversight to balance innovation with affordability. Drug companies like Gilead perform miracles by curing hepatitis C, but we have to make sure these new drugs are affordable.”

The report underscores the frustration felt by physicians who see many hepatitis C patients go without treatment because of high drug prices, Dr. Koppe adds.

“We would all prefer to treat every single compliant patient with hepatitis C who comes through our office,” Dr. Koppe said in an interview. “We now have to spend time explaining the economics of the situation to patients and why they are denied treatment, rather than simply focusing on their medical care.”

Senate investigators note that while competition has now entered the market, concerns remain about the cost of treatment for hepatitis C patients and future medication prices.

“Even as competition lowered prices for therapies, this report documents that concerns remain, particularly in the public payer community, about high costs for treating millions of people in the U.S. infected with hepatitis C, as well as the budgetary effects of a future single-source innovator that might not face competition as quickly,” the report stated.

[email protected]

On Twitter @legal_med

Physicians who treat hepatitis C patients were hardly surprised by a recent Senate investigation that found the maker of a hepatitis C drug allegedly put profits ahead of accessibility in pricing its medication. The final wholesale price – $1,000 per pill, or $84,000 for a single course of treatment – led to $1.3 billion in spending by state Medicaid programs, but few low-income patients actually received the drug.

“Even if sofosbuvir [Sovaldi] and Harvoni were priced 50% lower, the reality is that the burden to the health care system would still be tremendous, and it would still not be possible to treat all patients with hepatitis C,” said Dr. Sean W.P. Koppe, director of hepatology at the University of Illinois Hospital & Health Sciences System, Chicago. “Large organizations, such as [Veterans Affairs], can leverage their purchasing power to force some deeper discounting of the drug, [but] until some sort of mechanism is in place to harness the purchasing power of Medicare and Medicaid to negotiate deeper discounts, this scenario is bound to repeat itself with other drugs.”

After an 18-month analysis, investigators with the Senate Committee on Finance found that Gilead Sciences pursued a marketing strategy and wholesale price of Sovaldi that would maximize its revenue with little regard to affordable access, according to a report published Dec. 1. Building on Sovaldi’s price, Harvoni was later introduced at $94,500 per treatment course under the same marketing scheme. The investigation found no evidence that research costs or the multibillion dollar acquisition of Pharmasset, the drug’s first developer, factored into how Gilead set its prices. Investigators drew their conclusions from 20,000 pages of internal company documents, interviews with health care experts, and a trove of data from Medicaid programs in 50 states and the District of Columbia.

“Gilead pursued a calculated scheme for pricing and marketing its hepatitis C drug, based on one primary goal – maximizing revenue – regardless of the human consequences,” Sen. Ron Wyden (D-Ore.), Senate Finance Committee ranking member, said in a statement. “Gilead knew these prices would put treatment out of the reach of millions and cause extraordinary problems for Medicare and Medicaid, but still the company went ahead. If Gilead’s approach to pricing is the future of how blockbuster drugs are launched, it will cost billions and billions of dollars to treat just a fraction of patients.”

In a statement, a Gilead representative said the company respectfully disagreed with the report’s conclusions.

“We stand behind the pricing of our therapies because of the benefit they bring to patients and the significant value they represent to payers, providers, and our entire health care system by reducing the long-term costs associated with managing chronic HCV [hepatitis C virus],” Gilead spokeswoman Michele Rest said in an emailed statement. “Enabling patient access to Sovaldi and Harvoni is a top priority for Gilead. We have programs in place in the U.S. to help uninsured individuals and those who need financial assistance to access our therapies, and we will continue our efforts to make the medications available to people in need in the United States and around the world.”

Medicare, Medicaid, and the Bureau of Prisons were hit hardest by Sovaldi’s price tag, according to the report. In the 18 months following Sovaldi’s approval, Medicare has spent nearly $8.2 billion before rebates on Sovaldi and Harvoni, a sixfold monthly spending increase on hepatitis C treatments for the agency. In 2014 alone, Medicare and Medicaid spent a combined $5 billion on Sovaldi and Harvoni before rebates, a number projected to climb in 2015. The cost of Sovaldi meant many states were forced to effectively ration the drugs, providing them to only the sickest patients and requiring that patients be under the care of hepatologists or other specialists prior to receiving the drugs, according to the Senate report. Data show that state Medicaid programs nationwide spent $1.3 billion before rebates on Sovaldi in 2014, but that less than 2.4% of Medicaid enrollees with hepatitis C were treated with the drug. Sovaldi was the top drug spending item for 14 state Medicaid agencies in 2014, and the second-highest spending item for 15 more states.

“What we face is not a drug cost problem, it is a drug price problem,” Lynne Saxton, director of the Oregon Health Authority, wrote in a letter to Sen. Wyden. “State Medicaid programs are limited in [their] ability to control pharmacy benefit expenditure, particularly as federal law requires us to provide a pathway to coverage for all FDA-approved drugs, no matter how minimal the likely benefit per dollar spent. While federally mandated rebates help, they provide limited relief.”

Financial records show Gilead generated $14.3 billion in net product sales from its HCV drugs through the first 9 months of 2015, bringing its 21-month total for its HCV drugs to $26.6 billion, $20.6 billion of which is from sales to U.S. patients. Gilead justified Sovaldi’s high price point based on price-per-cure, according to the report. Documents acquired during the investigation illustrate that Gilead officials knew they were in a position to create clear savings for payers but chose to pursue a “regimen neutral” price justified by “cost-per-cure” calculations that resulted in greater revenue per treatment than previous direct-acting antivirals.

The Senate report was eye-opening and provides a likely snapshot of how future medications will be priced by drug companies, said Dr. Rajat Chander, an internist and gastroenterologist in private practice in Raleigh, N.C. “While newer drugs for hep C will ultimately drive the price lower, this Senate investigation is enlightening as to ‘price-per-cure’ for future drugs for other diseases,” he said in an interview. “As physicians, we often find ourselves on the front lines, scrambling to find discounts and rebates for individual patients. However, we need just this kind of bipartisan Senate and government regulatory oversight to balance innovation with affordability. Drug companies like Gilead perform miracles by curing hepatitis C, but we have to make sure these new drugs are affordable.”

The report underscores the frustration felt by physicians who see many hepatitis C patients go without treatment because of high drug prices, Dr. Koppe adds.

“We would all prefer to treat every single compliant patient with hepatitis C who comes through our office,” Dr. Koppe said in an interview. “We now have to spend time explaining the economics of the situation to patients and why they are denied treatment, rather than simply focusing on their medical care.”

Senate investigators note that while competition has now entered the market, concerns remain about the cost of treatment for hepatitis C patients and future medication prices.

“Even as competition lowered prices for therapies, this report documents that concerns remain, particularly in the public payer community, about high costs for treating millions of people in the U.S. infected with hepatitis C, as well as the budgetary effects of a future single-source innovator that might not face competition as quickly,” the report stated.

[email protected]

On Twitter @legal_med

Physicians who treat hepatitis C patients were hardly surprised by a recent Senate investigation that found the maker of a hepatitis C drug allegedly put profits ahead of accessibility in pricing its medication. The final wholesale price – $1,000 per pill, or $84,000 for a single course of treatment – led to $1.3 billion in spending by state Medicaid programs, but few low-income patients actually received the drug.

“Even if sofosbuvir [Sovaldi] and Harvoni were priced 50% lower, the reality is that the burden to the health care system would still be tremendous, and it would still not be possible to treat all patients with hepatitis C,” said Dr. Sean W.P. Koppe, director of hepatology at the University of Illinois Hospital & Health Sciences System, Chicago. “Large organizations, such as [Veterans Affairs], can leverage their purchasing power to force some deeper discounting of the drug, [but] until some sort of mechanism is in place to harness the purchasing power of Medicare and Medicaid to negotiate deeper discounts, this scenario is bound to repeat itself with other drugs.”

After an 18-month analysis, investigators with the Senate Committee on Finance found that Gilead Sciences pursued a marketing strategy and wholesale price of Sovaldi that would maximize its revenue with little regard to affordable access, according to a report published Dec. 1. Building on Sovaldi’s price, Harvoni was later introduced at $94,500 per treatment course under the same marketing scheme. The investigation found no evidence that research costs or the multibillion dollar acquisition of Pharmasset, the drug’s first developer, factored into how Gilead set its prices. Investigators drew their conclusions from 20,000 pages of internal company documents, interviews with health care experts, and a trove of data from Medicaid programs in 50 states and the District of Columbia.

“Gilead pursued a calculated scheme for pricing and marketing its hepatitis C drug, based on one primary goal – maximizing revenue – regardless of the human consequences,” Sen. Ron Wyden (D-Ore.), Senate Finance Committee ranking member, said in a statement. “Gilead knew these prices would put treatment out of the reach of millions and cause extraordinary problems for Medicare and Medicaid, but still the company went ahead. If Gilead’s approach to pricing is the future of how blockbuster drugs are launched, it will cost billions and billions of dollars to treat just a fraction of patients.”

In a statement, a Gilead representative said the company respectfully disagreed with the report’s conclusions.

“We stand behind the pricing of our therapies because of the benefit they bring to patients and the significant value they represent to payers, providers, and our entire health care system by reducing the long-term costs associated with managing chronic HCV [hepatitis C virus],” Gilead spokeswoman Michele Rest said in an emailed statement. “Enabling patient access to Sovaldi and Harvoni is a top priority for Gilead. We have programs in place in the U.S. to help uninsured individuals and those who need financial assistance to access our therapies, and we will continue our efforts to make the medications available to people in need in the United States and around the world.”

Medicare, Medicaid, and the Bureau of Prisons were hit hardest by Sovaldi’s price tag, according to the report. In the 18 months following Sovaldi’s approval, Medicare has spent nearly $8.2 billion before rebates on Sovaldi and Harvoni, a sixfold monthly spending increase on hepatitis C treatments for the agency. In 2014 alone, Medicare and Medicaid spent a combined $5 billion on Sovaldi and Harvoni before rebates, a number projected to climb in 2015. The cost of Sovaldi meant many states were forced to effectively ration the drugs, providing them to only the sickest patients and requiring that patients be under the care of hepatologists or other specialists prior to receiving the drugs, according to the Senate report. Data show that state Medicaid programs nationwide spent $1.3 billion before rebates on Sovaldi in 2014, but that less than 2.4% of Medicaid enrollees with hepatitis C were treated with the drug. Sovaldi was the top drug spending item for 14 state Medicaid agencies in 2014, and the second-highest spending item for 15 more states.

“What we face is not a drug cost problem, it is a drug price problem,” Lynne Saxton, director of the Oregon Health Authority, wrote in a letter to Sen. Wyden. “State Medicaid programs are limited in [their] ability to control pharmacy benefit expenditure, particularly as federal law requires us to provide a pathway to coverage for all FDA-approved drugs, no matter how minimal the likely benefit per dollar spent. While federally mandated rebates help, they provide limited relief.”

Financial records show Gilead generated $14.3 billion in net product sales from its HCV drugs through the first 9 months of 2015, bringing its 21-month total for its HCV drugs to $26.6 billion, $20.6 billion of which is from sales to U.S. patients. Gilead justified Sovaldi’s high price point based on price-per-cure, according to the report. Documents acquired during the investigation illustrate that Gilead officials knew they were in a position to create clear savings for payers but chose to pursue a “regimen neutral” price justified by “cost-per-cure” calculations that resulted in greater revenue per treatment than previous direct-acting antivirals.

The Senate report was eye-opening and provides a likely snapshot of how future medications will be priced by drug companies, said Dr. Rajat Chander, an internist and gastroenterologist in private practice in Raleigh, N.C. “While newer drugs for hep C will ultimately drive the price lower, this Senate investigation is enlightening as to ‘price-per-cure’ for future drugs for other diseases,” he said in an interview. “As physicians, we often find ourselves on the front lines, scrambling to find discounts and rebates for individual patients. However, we need just this kind of bipartisan Senate and government regulatory oversight to balance innovation with affordability. Drug companies like Gilead perform miracles by curing hepatitis C, but we have to make sure these new drugs are affordable.”

The report underscores the frustration felt by physicians who see many hepatitis C patients go without treatment because of high drug prices, Dr. Koppe adds.

“We would all prefer to treat every single compliant patient with hepatitis C who comes through our office,” Dr. Koppe said in an interview. “We now have to spend time explaining the economics of the situation to patients and why they are denied treatment, rather than simply focusing on their medical care.”

Senate investigators note that while competition has now entered the market, concerns remain about the cost of treatment for hepatitis C patients and future medication prices.

“Even as competition lowered prices for therapies, this report documents that concerns remain, particularly in the public payer community, about high costs for treating millions of people in the U.S. infected with hepatitis C, as well as the budgetary effects of a future single-source innovator that might not face competition as quickly,” the report stated.

[email protected]

On Twitter @legal_med

New research proves wrong early predictions of widespread premium rate increases for patients purchasing health insurance through state marketplaces.

Contrary to double-digit increase predictions, a November Urban Institute analysis found only a 4% increase in the average premium of the lowest-cost silver plan across 20 states and D.C. in 2016.

©Mathier/thinkstockphotos.com

Urban Institute researchers, with funding from the Robert Wood Johnson Foundation, studied each insurer’s lowest-cost silver marketplace plan premium for a 40-year-old, non–tobacco-using patient in selected areas within 20 states and the District of Columbia in 2015 and 2016. Investigators gathered 2016 premium data from publicly available rate filings posted on the websites of state departments of insurance. 2015 premiums were obtained from Healthcare.gov and state-based marketplace websites. Findings showed the average premium for the lowest-cost silver plan rose by less than 5% in five states, increased between 5% and 10% in five states, and increased by more than 10% in four states. In six states and D.C., the average premium of the lowest-cost silver plan decreased.

Researchers noted that regions with lower 2015 premiums tended to have larger cost increases in 2016 than did states that began with higher 2015 baseline premiums. The overall 4% increase average premium rate increase for lowest-cost silver plans in 2016 is up from a 3% average increase in 2015. Authors conclude that insurers may have priced aggressively early to gain market share, then modified their strategies this year. Authors forecast that it will take a few more years for insurance risk pools and premiums to stabilize.

[email protected]

On Twitter @legal_med

New research proves wrong early predictions of widespread premium rate increases for patients purchasing health insurance through state marketplaces.

Contrary to double-digit increase predictions, a November Urban Institute analysis found only a 4% increase in the average premium of the lowest-cost silver plan across 20 states and D.C. in 2016.

©Mathier/thinkstockphotos.com

Urban Institute researchers, with funding from the Robert Wood Johnson Foundation, studied each insurer’s lowest-cost silver marketplace plan premium for a 40-year-old, non–tobacco-using patient in selected areas within 20 states and the District of Columbia in 2015 and 2016. Investigators gathered 2016 premium data from publicly available rate filings posted on the websites of state departments of insurance. 2015 premiums were obtained from Healthcare.gov and state-based marketplace websites. Findings showed the average premium for the lowest-cost silver plan rose by less than 5% in five states, increased between 5% and 10% in five states, and increased by more than 10% in four states. In six states and D.C., the average premium of the lowest-cost silver plan decreased.

Researchers noted that regions with lower 2015 premiums tended to have larger cost increases in 2016 than did states that began with higher 2015 baseline premiums. The overall 4% increase average premium rate increase for lowest-cost silver plans in 2016 is up from a 3% average increase in 2015. Authors conclude that insurers may have priced aggressively early to gain market share, then modified their strategies this year. Authors forecast that it will take a few more years for insurance risk pools and premiums to stabilize.

[email protected]

On Twitter @legal_med

New research proves wrong early predictions of widespread premium rate increases for patients purchasing health insurance through state marketplaces.

Contrary to double-digit increase predictions, a November Urban Institute analysis found only a 4% increase in the average premium of the lowest-cost silver plan across 20 states and D.C. in 2016.

©Mathier/thinkstockphotos.com

Urban Institute researchers, with funding from the Robert Wood Johnson Foundation, studied each insurer’s lowest-cost silver marketplace plan premium for a 40-year-old, non–tobacco-using patient in selected areas within 20 states and the District of Columbia in 2015 and 2016. Investigators gathered 2016 premium data from publicly available rate filings posted on the websites of state departments of insurance. 2015 premiums were obtained from Healthcare.gov and state-based marketplace websites. Findings showed the average premium for the lowest-cost silver plan rose by less than 5% in five states, increased between 5% and 10% in five states, and increased by more than 10% in four states. In six states and D.C., the average premium of the lowest-cost silver plan decreased.

Researchers noted that regions with lower 2015 premiums tended to have larger cost increases in 2016 than did states that began with higher 2015 baseline premiums. The overall 4% increase average premium rate increase for lowest-cost silver plans in 2016 is up from a 3% average increase in 2015. Authors conclude that insurers may have priced aggressively early to gain market share, then modified their strategies this year. Authors forecast that it will take a few more years for insurance risk pools and premiums to stabilize.

[email protected]

On Twitter @legal_med

The American Congress of Obstetricians and Gynecologists is sounding the alarm about looming access to care problems if states are able to remove Planned Parenthood clinics and affiliates from their Medicaid programs.

“Preventing health centers affiliated with Planned Parenthood from treating women in Texas or other states, will, without question, keep women from getting important preventative care and screening services,” Dr. Hal C. Lawrence III, executive vice president and CEO of the American Congress of Obstetricians and Gynecologists, said during a Nov. 23 press conference. “We are already confronting challenges to care for Medicaid patients. Across the country, Medicaid programs have reported provider shortages. … Now is the time to look at ways to improve how we serve Medicaid patients, not to make it even harder for them to find a doctor by removing so many health centers from the program.”

In recent months, lawmakers across the country have voted to defund Planned Parenthood clinics and their affiliates largely in response to controversial hidden camera videos released over the summer that purportedly show Planned Parenthood officials discussing the collection of fetal tissue. Critics say the videos show that Planned Parenthood is illegally profitting from the sale of fetal tissue, but Planned Parenthood has denied that claim and in October announced that they would stop accepting reimbursement for expenses associated with fetal tissue collection and donation.

Ohio is the latest state to move toward defunding Planned Parenthood. On Nov. 17, the Ohio House of Representatives passed a bill that would block state and federal money from reaching Planned Parenthood clinics. The legislation would redirect state-administered grants – about $1.3 million – to federally qualified health centers, health departments, and other health centers that do not perform elective abortions or contract with organizations that provide such services. Gov. John Kasich (R), who is also a candidate for president, has indicated support for the bill.

Earlier this year, Louisiana Gov. Bobby Jindal (R) moved to strip Medicaid funding from Planned Parenthood clinics in his state. A federal judge temporarily halted the payment ban on Oct. 29.

And federal courts have blocked similar efforts to remove Planned Parenthood affiliates from state Medicaid programs in Alabama, Arkansas, and Utah.

Meanwhile, Planned Parenthood of Greater Texas sued the state’s Health and Human Services Commission on Nov. 23 after Gov. Greg Abbott (R) axed Medicaid funding from the health provider in late October.

Three days after the state announced plans to end Medicaid contracts for Planned Parenthood affiliates in Texas, state officials raided health centers in Houston, Dallas, San Antonio, and Brownsville with orders to turn over patient and employee records, according to the complaint. Government investigators would not discuss the investigation with the media.

In the Texas lawsuit, Planned Parenthood argues the state’s attempts to terminate its provider agreement with Medicaid violates federal law because it prevents Medicaid-enrolled patients from obtaining care from their provider of choice.

“We have seen the very real and very devastating consequences for Texas women when politicians block access to care at Planned Parenthood, with tens of thousands going without access to birth control, HIV tests, and cancer screenings,” Cecile Richards, president of the Planned Parenthood Federation of America said in a statement. “Texas is a cautionary tale for the whole nation – with politicians in Arkansas, Alabama, Ohio, and Louisiana trying to do the very same thing. Taken together, these measures threaten to devastate access to critical health care and education across vast regions of the country – all in the name of politics.”

A spokesman for the Texas Health and Human Services Commission declined to comment, stating that the commission does not discuss pending litigation. In an Oct. 19 notice of Medicaid termination sent to Planned Parenthood affiliates, Texas Inspector General Stuart W. Bowen Jr. wrote the state had determined that the group was “no longer capable of performing medical services in a professionally competent, safe, legal, and ethical manner.”

Texas – and it’s approach to regulating abortion – will be in the national spotlight in 2016 as the U.S. Supreme Court takes up the case of Whole Woman’s Health v. Cole, which challenges a state law setting strict requirements for abortion facilities. If the Texas law is upheld, about 75% of women’s health clinics that provide abortion would be forced to close, according to the Center for Reproductive Rights. A decision is expected in June 2016.

[email protected]

On Twitter @legal_med

The American Congress of Obstetricians and Gynecologists is sounding the alarm about looming access to care problems if states are able to remove Planned Parenthood clinics and affiliates from their Medicaid programs.

“Preventing health centers affiliated with Planned Parenthood from treating women in Texas or other states, will, without question, keep women from getting important preventative care and screening services,” Dr. Hal C. Lawrence III, executive vice president and CEO of the American Congress of Obstetricians and Gynecologists, said during a Nov. 23 press conference. “We are already confronting challenges to care for Medicaid patients. Across the country, Medicaid programs have reported provider shortages. … Now is the time to look at ways to improve how we serve Medicaid patients, not to make it even harder for them to find a doctor by removing so many health centers from the program.”

In recent months, lawmakers across the country have voted to defund Planned Parenthood clinics and their affiliates largely in response to controversial hidden camera videos released over the summer that purportedly show Planned Parenthood officials discussing the collection of fetal tissue. Critics say the videos show that Planned Parenthood is illegally profitting from the sale of fetal tissue, but Planned Parenthood has denied that claim and in October announced that they would stop accepting reimbursement for expenses associated with fetal tissue collection and donation.

Ohio is the latest state to move toward defunding Planned Parenthood. On Nov. 17, the Ohio House of Representatives passed a bill that would block state and federal money from reaching Planned Parenthood clinics. The legislation would redirect state-administered grants – about $1.3 million – to federally qualified health centers, health departments, and other health centers that do not perform elective abortions or contract with organizations that provide such services. Gov. John Kasich (R), who is also a candidate for president, has indicated support for the bill.

Earlier this year, Louisiana Gov. Bobby Jindal (R) moved to strip Medicaid funding from Planned Parenthood clinics in his state. A federal judge temporarily halted the payment ban on Oct. 29.

And federal courts have blocked similar efforts to remove Planned Parenthood affiliates from state Medicaid programs in Alabama, Arkansas, and Utah.

Meanwhile, Planned Parenthood of Greater Texas sued the state’s Health and Human Services Commission on Nov. 23 after Gov. Greg Abbott (R) axed Medicaid funding from the health provider in late October.

Three days after the state announced plans to end Medicaid contracts for Planned Parenthood affiliates in Texas, state officials raided health centers in Houston, Dallas, San Antonio, and Brownsville with orders to turn over patient and employee records, according to the complaint. Government investigators would not discuss the investigation with the media.

In the Texas lawsuit, Planned Parenthood argues the state’s attempts to terminate its provider agreement with Medicaid violates federal law because it prevents Medicaid-enrolled patients from obtaining care from their provider of choice.

“We have seen the very real and very devastating consequences for Texas women when politicians block access to care at Planned Parenthood, with tens of thousands going without access to birth control, HIV tests, and cancer screenings,” Cecile Richards, president of the Planned Parenthood Federation of America said in a statement. “Texas is a cautionary tale for the whole nation – with politicians in Arkansas, Alabama, Ohio, and Louisiana trying to do the very same thing. Taken together, these measures threaten to devastate access to critical health care and education across vast regions of the country – all in the name of politics.”

A spokesman for the Texas Health and Human Services Commission declined to comment, stating that the commission does not discuss pending litigation. In an Oct. 19 notice of Medicaid termination sent to Planned Parenthood affiliates, Texas Inspector General Stuart W. Bowen Jr. wrote the state had determined that the group was “no longer capable of performing medical services in a professionally competent, safe, legal, and ethical manner.”

Texas – and it’s approach to regulating abortion – will be in the national spotlight in 2016 as the U.S. Supreme Court takes up the case of Whole Woman’s Health v. Cole, which challenges a state law setting strict requirements for abortion facilities. If the Texas law is upheld, about 75% of women’s health clinics that provide abortion would be forced to close, according to the Center for Reproductive Rights. A decision is expected in June 2016.

[email protected]

On Twitter @legal_med

The American Congress of Obstetricians and Gynecologists is sounding the alarm about looming access to care problems if states are able to remove Planned Parenthood clinics and affiliates from their Medicaid programs.

“Preventing health centers affiliated with Planned Parenthood from treating women in Texas or other states, will, without question, keep women from getting important preventative care and screening services,” Dr. Hal C. Lawrence III, executive vice president and CEO of the American Congress of Obstetricians and Gynecologists, said during a Nov. 23 press conference. “We are already confronting challenges to care for Medicaid patients. Across the country, Medicaid programs have reported provider shortages. … Now is the time to look at ways to improve how we serve Medicaid patients, not to make it even harder for them to find a doctor by removing so many health centers from the program.”

In recent months, lawmakers across the country have voted to defund Planned Parenthood clinics and their affiliates largely in response to controversial hidden camera videos released over the summer that purportedly show Planned Parenthood officials discussing the collection of fetal tissue. Critics say the videos show that Planned Parenthood is illegally profitting from the sale of fetal tissue, but Planned Parenthood has denied that claim and in October announced that they would stop accepting reimbursement for expenses associated with fetal tissue collection and donation.

Ohio is the latest state to move toward defunding Planned Parenthood. On Nov. 17, the Ohio House of Representatives passed a bill that would block state and federal money from reaching Planned Parenthood clinics. The legislation would redirect state-administered grants – about $1.3 million – to federally qualified health centers, health departments, and other health centers that do not perform elective abortions or contract with organizations that provide such services. Gov. John Kasich (R), who is also a candidate for president, has indicated support for the bill.

Earlier this year, Louisiana Gov. Bobby Jindal (R) moved to strip Medicaid funding from Planned Parenthood clinics in his state. A federal judge temporarily halted the payment ban on Oct. 29.

And federal courts have blocked similar efforts to remove Planned Parenthood affiliates from state Medicaid programs in Alabama, Arkansas, and Utah.

Meanwhile, Planned Parenthood of Greater Texas sued the state’s Health and Human Services Commission on Nov. 23 after Gov. Greg Abbott (R) axed Medicaid funding from the health provider in late October.

Three days after the state announced plans to end Medicaid contracts for Planned Parenthood affiliates in Texas, state officials raided health centers in Houston, Dallas, San Antonio, and Brownsville with orders to turn over patient and employee records, according to the complaint. Government investigators would not discuss the investigation with the media.

In the Texas lawsuit, Planned Parenthood argues the state’s attempts to terminate its provider agreement with Medicaid violates federal law because it prevents Medicaid-enrolled patients from obtaining care from their provider of choice.

“We have seen the very real and very devastating consequences for Texas women when politicians block access to care at Planned Parenthood, with tens of thousands going without access to birth control, HIV tests, and cancer screenings,” Cecile Richards, president of the Planned Parenthood Federation of America said in a statement. “Texas is a cautionary tale for the whole nation – with politicians in Arkansas, Alabama, Ohio, and Louisiana trying to do the very same thing. Taken together, these measures threaten to devastate access to critical health care and education across vast regions of the country – all in the name of politics.”

A spokesman for the Texas Health and Human Services Commission declined to comment, stating that the commission does not discuss pending litigation. In an Oct. 19 notice of Medicaid termination sent to Planned Parenthood affiliates, Texas Inspector General Stuart W. Bowen Jr. wrote the state had determined that the group was “no longer capable of performing medical services in a professionally competent, safe, legal, and ethical manner.”

Texas – and it’s approach to regulating abortion – will be in the national spotlight in 2016 as the U.S. Supreme Court takes up the case of Whole Woman’s Health v. Cole, which challenges a state law setting strict requirements for abortion facilities. If the Texas law is upheld, about 75% of women’s health clinics that provide abortion would be forced to close, according to the Center for Reproductive Rights. A decision is expected in June 2016.

[email protected]

On Twitter @legal_med

Medicare has relaxed some requirements of the Stark Law through its 2016 fee schedule and created new exceptions for compensation arrangements under the statute. The changes make it easier to recruit nonphysician employees, share rental space, and operate on expired contracts without fear of violating the law.

“These rules show the government was seeking to give some flexibility in the area of Stark procedure or technical issues,” said Julie E. Kass, a Washington area health law attorney who specializes in Stark and antikickback laws. “I think what [the Centers for Medicare & Medicaid Services] was seeing, and the kinds of issues being disclosed, weren’t things that were going to raise the risk of fraud or abuse to the program. Recognizing that, they wanted to make sure there weren’t unnecessary concerns about these, or unnecessary [efforts].”

What should you know about the Stark Law modifications? Ms. Kass and Philadelphia-based health law attorney Karl A. Thallner Jr. discussed the latest changes in a recent interview.

Nonphysician recruitment

Starting in 2016, hospitals can assist in the recruitment of nonphysician health professionals for physician practices. In the past, hospitals could not because remuneration could be considered a compensation relationship between the hospital and the practice.

In the fee schedule final rule, CMS expands its definition of nonphysician provider to mean physician assistant, nurse practitioner, clinical nurse specialist, certified nurse-midwife, clinical psychologist, or clinical social worker. Hospitals, rural health clinics, and federally qualified health centers can provide recruitment assistance and retention payments to physician practices to employ nonphysician providers. CMS also loosened its original proposal that said the nonphysician provider would have to be a bona fide employee of the physician practice. Instead, they can be independent contractors as long as they contract directly with the practice, according to the final rule. Third-party companies do not qualify.

While the change is primarily positive, it does have limitations, Mr. Thallner said. The subsidy amount from the hospital for example, can be only 50% of employment costs and can last just 2 years.

“At some point, the practice is going to have to assume the full risk of the person,” he said. “But one might envision some scenarios where this might be helpful to physician practice in a community where there’s some need for start-up support.”

Holdover extension

Physicians who have compensation arrangements that fall under a Stark Law exception no longer need to panic if their agreement expires and they neglect to redraft a new contract. The 2016 rule releases doctors from potential violations if such an agreement expires, but the arrangement continues under the same terms.

In the past, doctors had a 6-month grace period to renew an arrangement agreement once the contract expired. CMS noted it receives numerous disclosures of actual or potential violations relating to writing requirements of compensation exceptions through the self-referral disclosure protocol, which allows providers and suppliers to disclose actual or potential violations of the physician self-referral law to CMS and authorizes the Health & Human Services department to reduce the amount potentially owed for disclosed violations. However, arrangements that continue beyond the 6-month period do not necessarily pose a risk of program or patient abuse, provided that the arrangement continues to satisfy the specific requirements of the applicable exception, the agency stated.

The agency has eliminated the time limitation on contract holdovers if the agreements meet requirements related to fair market value and so long as the compensation does not take into account the volume or value of referrals or other business generated between the parties.

“This one [is] helpful if you find you have an agreement that has slipped through the cracks,” Mr. Thallner said.

Practices should still be monitoring agreements after they expire to ensure that compensation levels remain appropriate and take efforts to redraft if changes are identified, he stressed.

Timeshare reprieve

Timeshare arrangements for office space, equipment, personnel, supplies, and other services are allowed starting in 2016.

Previously, physicians who did not require traditional office spaces could only lease from sources who could pose a referral relationship on a part-time basis and those rentals had to me meet specific rental criteria. The renter was required to have exclusive use of the space and 1-year contract.

CMS now acknowledges that in some cases – such as in rural or underserved areas – there may be a community need for short-term specialty services in which exclusive use of an office is not necessary. Under a timeshare arrangement, a hospital or local practice may ask a specialist from a neighboring community to use space owned by the hospital or practice on a limited or as-needed basis. Often, the specialist does not establish an additional office, but instead creates a timeshare-like arrangement for the space, equipment, and services necessary to treat patients.

To timeshare, doctors must meet the following requirements:

• The arrangement is set out in writing, signed by the parties, and specifies the premises, equipment, personnel, items, supplies, and services covered by the arrangement.

• The arrangement is between a physician and a hospital or a physician organization of which the physician is not an owner, employee, or contractor.

• The arrangement is not conditioned on the licensee’s referral of patients to the licensor.

• The compensation over the term of the arrangement is set in advance, consistent with fair market value.

The timeshare exception reduces hassles and makes it easier for doctors to share work spaces for short durations of time, Ms. Kass said.

“Physicians are able to either license or be the licensor or licensee of a timeshare arrangement rather than having a lease on a part-time basis,” she said. “You can still create a lease on a part-time basis using the old rental of space rules, but if you’re leasing a whole office, complete with all of the equipment and personnel and the space, you are able to do that for a day, for a week, in periods of time. Now one single exception can help you with that.”

[email protected]

On Twitter @legal_med

Medicare has relaxed some requirements of the Stark Law through its 2016 fee schedule and created new exceptions for compensation arrangements under the statute. The changes make it easier to recruit nonphysician employees, share rental space, and operate on expired contracts without fear of violating the law.

“These rules show the government was seeking to give some flexibility in the area of Stark procedure or technical issues,” said Julie E. Kass, a Washington area health law attorney who specializes in Stark and antikickback laws. “I think what [the Centers for Medicare & Medicaid Services] was seeing, and the kinds of issues being disclosed, weren’t things that were going to raise the risk of fraud or abuse to the program. Recognizing that, they wanted to make sure there weren’t unnecessary concerns about these, or unnecessary [efforts].”

What should you know about the Stark Law modifications? Ms. Kass and Philadelphia-based health law attorney Karl A. Thallner Jr. discussed the latest changes in a recent interview.

Nonphysician recruitment

Starting in 2016, hospitals can assist in the recruitment of nonphysician health professionals for physician practices. In the past, hospitals could not because remuneration could be considered a compensation relationship between the hospital and the practice.

In the fee schedule final rule, CMS expands its definition of nonphysician provider to mean physician assistant, nurse practitioner, clinical nurse specialist, certified nurse-midwife, clinical psychologist, or clinical social worker. Hospitals, rural health clinics, and federally qualified health centers can provide recruitment assistance and retention payments to physician practices to employ nonphysician providers. CMS also loosened its original proposal that said the nonphysician provider would have to be a bona fide employee of the physician practice. Instead, they can be independent contractors as long as they contract directly with the practice, according to the final rule. Third-party companies do not qualify.

While the change is primarily positive, it does have limitations, Mr. Thallner said. The subsidy amount from the hospital for example, can be only 50% of employment costs and can last just 2 years.

“At some point, the practice is going to have to assume the full risk of the person,” he said. “But one might envision some scenarios where this might be helpful to physician practice in a community where there’s some need for start-up support.”

Holdover extension

Physicians who have compensation arrangements that fall under a Stark Law exception no longer need to panic if their agreement expires and they neglect to redraft a new contract. The 2016 rule releases doctors from potential violations if such an agreement expires, but the arrangement continues under the same terms.

In the past, doctors had a 6-month grace period to renew an arrangement agreement once the contract expired. CMS noted it receives numerous disclosures of actual or potential violations relating to writing requirements of compensation exceptions through the self-referral disclosure protocol, which allows providers and suppliers to disclose actual or potential violations of the physician self-referral law to CMS and authorizes the Health & Human Services department to reduce the amount potentially owed for disclosed violations. However, arrangements that continue beyond the 6-month period do not necessarily pose a risk of program or patient abuse, provided that the arrangement continues to satisfy the specific requirements of the applicable exception, the agency stated.

The agency has eliminated the time limitation on contract holdovers if the agreements meet requirements related to fair market value and so long as the compensation does not take into account the volume or value of referrals or other business generated between the parties.

“This one [is] helpful if you find you have an agreement that has slipped through the cracks,” Mr. Thallner said.

Practices should still be monitoring agreements after they expire to ensure that compensation levels remain appropriate and take efforts to redraft if changes are identified, he stressed.

Timeshare reprieve

Timeshare arrangements for office space, equipment, personnel, supplies, and other services are allowed starting in 2016.

Previously, physicians who did not require traditional office spaces could only lease from sources who could pose a referral relationship on a part-time basis and those rentals had to me meet specific rental criteria. The renter was required to have exclusive use of the space and 1-year contract.

CMS now acknowledges that in some cases – such as in rural or underserved areas – there may be a community need for short-term specialty services in which exclusive use of an office is not necessary. Under a timeshare arrangement, a hospital or local practice may ask a specialist from a neighboring community to use space owned by the hospital or practice on a limited or as-needed basis. Often, the specialist does not establish an additional office, but instead creates a timeshare-like arrangement for the space, equipment, and services necessary to treat patients.

To timeshare, doctors must meet the following requirements:

• The arrangement is set out in writing, signed by the parties, and specifies the premises, equipment, personnel, items, supplies, and services covered by the arrangement.

• The arrangement is between a physician and a hospital or a physician organization of which the physician is not an owner, employee, or contractor.

• The arrangement is not conditioned on the licensee’s referral of patients to the licensor.

• The compensation over the term of the arrangement is set in advance, consistent with fair market value.

The timeshare exception reduces hassles and makes it easier for doctors to share work spaces for short durations of time, Ms. Kass said.

“Physicians are able to either license or be the licensor or licensee of a timeshare arrangement rather than having a lease on a part-time basis,” she said. “You can still create a lease on a part-time basis using the old rental of space rules, but if you’re leasing a whole office, complete with all of the equipment and personnel and the space, you are able to do that for a day, for a week, in periods of time. Now one single exception can help you with that.”

[email protected]

On Twitter @legal_med

Medicare has relaxed some requirements of the Stark Law through its 2016 fee schedule and created new exceptions for compensation arrangements under the statute. The changes make it easier to recruit nonphysician employees, share rental space, and operate on expired contracts without fear of violating the law.

“These rules show the government was seeking to give some flexibility in the area of Stark procedure or technical issues,” said Julie E. Kass, a Washington area health law attorney who specializes in Stark and antikickback laws. “I think what [the Centers for Medicare & Medicaid Services] was seeing, and the kinds of issues being disclosed, weren’t things that were going to raise the risk of fraud or abuse to the program. Recognizing that, they wanted to make sure there weren’t unnecessary concerns about these, or unnecessary [efforts].”

What should you know about the Stark Law modifications? Ms. Kass and Philadelphia-based health law attorney Karl A. Thallner Jr. discussed the latest changes in a recent interview.

Nonphysician recruitment

Starting in 2016, hospitals can assist in the recruitment of nonphysician health professionals for physician practices. In the past, hospitals could not because remuneration could be considered a compensation relationship between the hospital and the practice.

In the fee schedule final rule, CMS expands its definition of nonphysician provider to mean physician assistant, nurse practitioner, clinical nurse specialist, certified nurse-midwife, clinical psychologist, or clinical social worker. Hospitals, rural health clinics, and federally qualified health centers can provide recruitment assistance and retention payments to physician practices to employ nonphysician providers. CMS also loosened its original proposal that said the nonphysician provider would have to be a bona fide employee of the physician practice. Instead, they can be independent contractors as long as they contract directly with the practice, according to the final rule. Third-party companies do not qualify.

While the change is primarily positive, it does have limitations, Mr. Thallner said. The subsidy amount from the hospital for example, can be only 50% of employment costs and can last just 2 years.

“At some point, the practice is going to have to assume the full risk of the person,” he said. “But one might envision some scenarios where this might be helpful to physician practice in a community where there’s some need for start-up support.”

Holdover extension

Physicians who have compensation arrangements that fall under a Stark Law exception no longer need to panic if their agreement expires and they neglect to redraft a new contract. The 2016 rule releases doctors from potential violations if such an agreement expires, but the arrangement continues under the same terms.

In the past, doctors had a 6-month grace period to renew an arrangement agreement once the contract expired. CMS noted it receives numerous disclosures of actual or potential violations relating to writing requirements of compensation exceptions through the self-referral disclosure protocol, which allows providers and suppliers to disclose actual or potential violations of the physician self-referral law to CMS and authorizes the Health & Human Services department to reduce the amount potentially owed for disclosed violations. However, arrangements that continue beyond the 6-month period do not necessarily pose a risk of program or patient abuse, provided that the arrangement continues to satisfy the specific requirements of the applicable exception, the agency stated.

The agency has eliminated the time limitation on contract holdovers if the agreements meet requirements related to fair market value and so long as the compensation does not take into account the volume or value of referrals or other business generated between the parties.

“This one [is] helpful if you find you have an agreement that has slipped through the cracks,” Mr. Thallner said.

Practices should still be monitoring agreements after they expire to ensure that compensation levels remain appropriate and take efforts to redraft if changes are identified, he stressed.

Timeshare reprieve

Timeshare arrangements for office space, equipment, personnel, supplies, and other services are allowed starting in 2016.

Previously, physicians who did not require traditional office spaces could only lease from sources who could pose a referral relationship on a part-time basis and those rentals had to me meet specific rental criteria. The renter was required to have exclusive use of the space and 1-year contract.

CMS now acknowledges that in some cases – such as in rural or underserved areas – there may be a community need for short-term specialty services in which exclusive use of an office is not necessary. Under a timeshare arrangement, a hospital or local practice may ask a specialist from a neighboring community to use space owned by the hospital or practice on a limited or as-needed basis. Often, the specialist does not establish an additional office, but instead creates a timeshare-like arrangement for the space, equipment, and services necessary to treat patients.

To timeshare, doctors must meet the following requirements:

• The arrangement is set out in writing, signed by the parties, and specifies the premises, equipment, personnel, items, supplies, and services covered by the arrangement.

• The arrangement is between a physician and a hospital or a physician organization of which the physician is not an owner, employee, or contractor.

• The arrangement is not conditioned on the licensee’s referral of patients to the licensor.

• The compensation over the term of the arrangement is set in advance, consistent with fair market value.

The timeshare exception reduces hassles and makes it easier for doctors to share work spaces for short durations of time, Ms. Kass said.

“Physicians are able to either license or be the licensor or licensee of a timeshare arrangement rather than having a lease on a part-time basis,” she said. “You can still create a lease on a part-time basis using the old rental of space rules, but if you’re leasing a whole office, complete with all of the equipment and personnel and the space, you are able to do that for a day, for a week, in periods of time. Now one single exception can help you with that.”

[email protected]

On Twitter @legal_med