Alicia Gallegos

The American Board of Internal Medicine’s current Maintenance of Certification program does not meet the educational needs of rheumatologists and should be modified to include more relevant professional development requirements, according to an Aug. 26 announcement by the American College of Rheumatology.

“Rheumatologists without a doubt believe in the value of continuing medical education,” Dr. E. William St.Clair, ACR president, said in a statement. “However, our members strongly feel the ABIM MOC [American Board of Internal Medicine Maintenance of Certification] program not only fails to appropriately assess their competence but lacks evidence that patients are benefiting from their involvement with it.”

The ACR released a position statementthat includes several ways in which ABIM should change its MOC process, including dropping its secure, closed-book MOC examination, and permanently removing the practice assessment, patient voice, and patient safety requirements as part of its recertification process.

In an interview, Dr. Richard J. Baron, ABIM president, said his association welcomes the ideas presented by the ACR and that as with other feedback from medical societies, ABIM will review the suggestions for possible implementation.

“We have invited all of the internal medicine societies to cocreate the MOC program with us,” Dr. Baron said. “The American College of Rheumatology took that invitation seriously. They created a physician paper to constructively help inform the development of future MOC programs. We are absolutely prepared to engage in conversations with them based on these kinds of efforts.”

As part of its statement, the college said the practice assessment, patient voice, and patient safety requirements should not be reinstated because they are redundant with existing requirements that measure and report quality of care. The secure, closed-book exam is not an appropriate means of assessing clinical knowledge or decision-making for the purpose of recertification, according to the position statement. The ACR also wants ABIM to eliminate its MOC medical knowledge points, saying that continuing medical education (CME) activities already are highly regulated, and that another layer of mandated educational activities is not necessary. Instead, physicians should have the autonomy to identify and access appropriate CME resources.

The college calls for the cost and scope of the MOC program to be reduced and for an independent review to be conducted. The external review should examine the performance and impact of the MOC program, including policies, procedures, organizational structure and governance, according to the position paper.

“We are encouraged by the recent changes the ABIM has made and hope the ABIM will strongly take into consideration the position of the college and our members as it continues to reform the MOC program,” said Dr. Joel Block, ACR Committee on Education chair. “We share the same goal of ensuring our patients receive the highest quality of care available, but we have identified numerous areas where the current MOC process fails in this aim while substantially adding to physicians’ administrative and cost burdens. It is our desire to see barriers that prevent our members from pursuing meaningful educational activities in order to meet MOC requirements removed.”

ABIM plans to meet with medical societies through subspecialty boards over the course of the fall and work through ideas and proposals, Dr. Baron said.

“Part of where we started was trying to find common ground with the community, and that common ground is that all of us in the internal medicine community believe that physicians should stay current in knowledge and practice over course of their careers,” Dr. Baron said in an interview. “The role that many members of the community see ABIM playing is designing a program that speaks to that. How the program does those things is a matter of ongoing implementation and change.”

ABIM has made a growing number of changes to its MOC program following a February announcement by the association apologizing to physicians for a program that “clearly got it wrong.” At the time, ABIM pledged to make the program more consistent with physicians’ practice and values. Among the immediate changes are updates to its internal medicine exam; suspension of the practice assessment, patient voice, and patient safety requirements for at least 2 years; and setting MOC enrollment fees at or below 2014 levels through at least 2017.

In August, ABIM announced a partnership with the Accreditation Council for Continuing Medical Education that aims to unify continuing education activities with MOC requirements and expand doctors’ options for MOC credit. On Aug. 4, ABIM announced that physicians who do not enroll in its MOC program will no longer automatically lose their board certification status.

In July, ABIM announced that no disciplines within its MOC program will require underlying certification and that all ABIM diplomates can choose the certifications they wish to maintain. The policy goes into effect Jan. 1, 2016. In early June, ABIM rolled out changes to its exam outline and score report. Starting with spring 2015 exams, physicians will receive enhanced score reports with more performance details, according to ABIM.

[email protected]

On Twitter @legal_med

The American Board of Internal Medicine’s current Maintenance of Certification program does not meet the educational needs of rheumatologists and should be modified to include more relevant professional development requirements, according to an Aug. 26 announcement by the American College of Rheumatology.

“Rheumatologists without a doubt believe in the value of continuing medical education,” Dr. E. William St.Clair, ACR president, said in a statement. “However, our members strongly feel the ABIM MOC [American Board of Internal Medicine Maintenance of Certification] program not only fails to appropriately assess their competence but lacks evidence that patients are benefiting from their involvement with it.”

The ACR released a position statementthat includes several ways in which ABIM should change its MOC process, including dropping its secure, closed-book MOC examination, and permanently removing the practice assessment, patient voice, and patient safety requirements as part of its recertification process.

In an interview, Dr. Richard J. Baron, ABIM president, said his association welcomes the ideas presented by the ACR and that as with other feedback from medical societies, ABIM will review the suggestions for possible implementation.

“We have invited all of the internal medicine societies to cocreate the MOC program with us,” Dr. Baron said. “The American College of Rheumatology took that invitation seriously. They created a physician paper to constructively help inform the development of future MOC programs. We are absolutely prepared to engage in conversations with them based on these kinds of efforts.”

As part of its statement, the college said the practice assessment, patient voice, and patient safety requirements should not be reinstated because they are redundant with existing requirements that measure and report quality of care. The secure, closed-book exam is not an appropriate means of assessing clinical knowledge or decision-making for the purpose of recertification, according to the position statement. The ACR also wants ABIM to eliminate its MOC medical knowledge points, saying that continuing medical education (CME) activities already are highly regulated, and that another layer of mandated educational activities is not necessary. Instead, physicians should have the autonomy to identify and access appropriate CME resources.

The college calls for the cost and scope of the MOC program to be reduced and for an independent review to be conducted. The external review should examine the performance and impact of the MOC program, including policies, procedures, organizational structure and governance, according to the position paper.

“We are encouraged by the recent changes the ABIM has made and hope the ABIM will strongly take into consideration the position of the college and our members as it continues to reform the MOC program,” said Dr. Joel Block, ACR Committee on Education chair. “We share the same goal of ensuring our patients receive the highest quality of care available, but we have identified numerous areas where the current MOC process fails in this aim while substantially adding to physicians’ administrative and cost burdens. It is our desire to see barriers that prevent our members from pursuing meaningful educational activities in order to meet MOC requirements removed.”

ABIM plans to meet with medical societies through subspecialty boards over the course of the fall and work through ideas and proposals, Dr. Baron said.

“Part of where we started was trying to find common ground with the community, and that common ground is that all of us in the internal medicine community believe that physicians should stay current in knowledge and practice over course of their careers,” Dr. Baron said in an interview. “The role that many members of the community see ABIM playing is designing a program that speaks to that. How the program does those things is a matter of ongoing implementation and change.”

ABIM has made a growing number of changes to its MOC program following a February announcement by the association apologizing to physicians for a program that “clearly got it wrong.” At the time, ABIM pledged to make the program more consistent with physicians’ practice and values. Among the immediate changes are updates to its internal medicine exam; suspension of the practice assessment, patient voice, and patient safety requirements for at least 2 years; and setting MOC enrollment fees at or below 2014 levels through at least 2017.

In August, ABIM announced a partnership with the Accreditation Council for Continuing Medical Education that aims to unify continuing education activities with MOC requirements and expand doctors’ options for MOC credit. On Aug. 4, ABIM announced that physicians who do not enroll in its MOC program will no longer automatically lose their board certification status.

In July, ABIM announced that no disciplines within its MOC program will require underlying certification and that all ABIM diplomates can choose the certifications they wish to maintain. The policy goes into effect Jan. 1, 2016. In early June, ABIM rolled out changes to its exam outline and score report. Starting with spring 2015 exams, physicians will receive enhanced score reports with more performance details, according to ABIM.

[email protected]

On Twitter @legal_med

The American Board of Internal Medicine’s current Maintenance of Certification program does not meet the educational needs of rheumatologists and should be modified to include more relevant professional development requirements, according to an Aug. 26 announcement by the American College of Rheumatology.

“Rheumatologists without a doubt believe in the value of continuing medical education,” Dr. E. William St.Clair, ACR president, said in a statement. “However, our members strongly feel the ABIM MOC [American Board of Internal Medicine Maintenance of Certification] program not only fails to appropriately assess their competence but lacks evidence that patients are benefiting from their involvement with it.”

The ACR released a position statementthat includes several ways in which ABIM should change its MOC process, including dropping its secure, closed-book MOC examination, and permanently removing the practice assessment, patient voice, and patient safety requirements as part of its recertification process.

In an interview, Dr. Richard J. Baron, ABIM president, said his association welcomes the ideas presented by the ACR and that as with other feedback from medical societies, ABIM will review the suggestions for possible implementation.

“We have invited all of the internal medicine societies to cocreate the MOC program with us,” Dr. Baron said. “The American College of Rheumatology took that invitation seriously. They created a physician paper to constructively help inform the development of future MOC programs. We are absolutely prepared to engage in conversations with them based on these kinds of efforts.”

As part of its statement, the college said the practice assessment, patient voice, and patient safety requirements should not be reinstated because they are redundant with existing requirements that measure and report quality of care. The secure, closed-book exam is not an appropriate means of assessing clinical knowledge or decision-making for the purpose of recertification, according to the position statement. The ACR also wants ABIM to eliminate its MOC medical knowledge points, saying that continuing medical education (CME) activities already are highly regulated, and that another layer of mandated educational activities is not necessary. Instead, physicians should have the autonomy to identify and access appropriate CME resources.

The college calls for the cost and scope of the MOC program to be reduced and for an independent review to be conducted. The external review should examine the performance and impact of the MOC program, including policies, procedures, organizational structure and governance, according to the position paper.

“We are encouraged by the recent changes the ABIM has made and hope the ABIM will strongly take into consideration the position of the college and our members as it continues to reform the MOC program,” said Dr. Joel Block, ACR Committee on Education chair. “We share the same goal of ensuring our patients receive the highest quality of care available, but we have identified numerous areas where the current MOC process fails in this aim while substantially adding to physicians’ administrative and cost burdens. It is our desire to see barriers that prevent our members from pursuing meaningful educational activities in order to meet MOC requirements removed.”

ABIM plans to meet with medical societies through subspecialty boards over the course of the fall and work through ideas and proposals, Dr. Baron said.

“Part of where we started was trying to find common ground with the community, and that common ground is that all of us in the internal medicine community believe that physicians should stay current in knowledge and practice over course of their careers,” Dr. Baron said in an interview. “The role that many members of the community see ABIM playing is designing a program that speaks to that. How the program does those things is a matter of ongoing implementation and change.”

ABIM has made a growing number of changes to its MOC program following a February announcement by the association apologizing to physicians for a program that “clearly got it wrong.” At the time, ABIM pledged to make the program more consistent with physicians’ practice and values. Among the immediate changes are updates to its internal medicine exam; suspension of the practice assessment, patient voice, and patient safety requirements for at least 2 years; and setting MOC enrollment fees at or below 2014 levels through at least 2017.

In August, ABIM announced a partnership with the Accreditation Council for Continuing Medical Education that aims to unify continuing education activities with MOC requirements and expand doctors’ options for MOC credit. On Aug. 4, ABIM announced that physicians who do not enroll in its MOC program will no longer automatically lose their board certification status.

In July, ABIM announced that no disciplines within its MOC program will require underlying certification and that all ABIM diplomates can choose the certifications they wish to maintain. The policy goes into effect Jan. 1, 2016. In early June, ABIM rolled out changes to its exam outline and score report. Starting with spring 2015 exams, physicians will receive enhanced score reports with more performance details, according to ABIM.

[email protected]

On Twitter @legal_med

The American Board of Internal Medicine (ABIM) and the Accreditation Council for Continuing Medical Education (ACCME) have announced a partnership that aims to unify continuing education activities with Maintenance of Certification (MOC) requirements and expand doctors’ options for MOC credit.

As part of the change, ABIM will no longer require CME providers to submit applications to ABIM for activity approval and peer review. Instead, accredited CME providers can use a shared system to record information about CME and ABIM MOC activities. The network will provide additional choices for internists without adding new ACCME requirements, according to an Aug. 12 ABIM announcement.

The American College of Physicians (ACP) praised the move, saying it will provide internists more choices.

“The American College of Physicians has long advocated for a process that gives MOC credit for activities that physicians are already doing,” Dr. Wayne J. Riley, ACP president, said in an interview. “We support an easier process and more options for diplomates to get credit for the Part 2 (Self-Assessment of Knowledge) component of MOC.”

While ABIM already offers more than 300 medical knowledge options to physicians engaged in MOC, diplomates wanted a more streamlined process that enabled them to more seamlessly combine their ongoing educational activities with MOC requirements, ABIM President Richard J. Baron said in a statement.

“By collaborating with ACCME, ABIM will open the door to even more options for physicians engaged in MOC and will allow them to get MOC credit for high-quality CME activities they are already doing,” Dr. Baron said in the statement.

ABIM noted that accredited CME providers in the ACCME system already use the ACCME Program and Activity Reporting System (PARS) to enter data about CME activities. With the new partnership, CME providers can also use PARS to register activities for ABIM MOC. CME administrators can submit learner data and attest to compliance with ABIM-specific requirements for the Medical Knowledge Assessment Recognition Program. ABIM and ACCME will start beta testing the technology later this month, and the associations expect to open the process for accredited CME providers by the end of 2015.

Additionally, ACCME will maintain on its website a list of activities that meet ABIM requirements and that are registered for MOC credit. Data verifying that doctors have completed CME activities will be communicated to ABIM through PARS.

“This collaboration will generate many more opportunities for accredited CME providers to serve as a strategic resource by delivering relevant, effective, independent, practice-based education that counts for MOC,” ACCME PresidentGraham T. McMahon said in the statement. “I look forward to working together with ABIM, our community of accredited CME providers, and our community of diplomates to leverage the power of education to drive quality in our medical profession and improve care for the patients we serve.”

The partnership is the latest in an ongoing series of modifications to ABIM’s MOC process. Earlier this month, ABIM announced that physicians who do not enroll in its MOC program will no longer automatically lose their board certification status. In July, the board announced that no disciplines within its MOC program will require underlying certification and that all diplomates can choose the certifications they wish to maintain. The policy goes into effect Jan. 1, 2016.

In early June, ABIM rolled out changes to its exam outline and score report. Starting with spring 2015 exams, physicians will receive enhanced score reports with more performance details, according to ABIM. The board also updated its internal medicine MOC blueprint – the exam content outline – to ensure that the exam reflects how internists are practicing today and to provide more detailed explanations of topics that may be included in the exam.

The growing list of changes follows a February announcement by ABIM apologizing to physicians for an MOC program that “clearly got it wrong.” ABIM pledged to make the program more consistent with physicians’ practice and values. Among the immediate changes are updates to its internal medicine exam; suspension of the practice assessment, patient voice, and patient safety requirements for at least 2 years; and setting MOC enrollment fees at or below 2014 levels through at least 2017.

[email protected]

On Twitter @legal_med

The American Board of Internal Medicine (ABIM) and the Accreditation Council for Continuing Medical Education (ACCME) have announced a partnership that aims to unify continuing education activities with Maintenance of Certification (MOC) requirements and expand doctors’ options for MOC credit.

As part of the change, ABIM will no longer require CME providers to submit applications to ABIM for activity approval and peer review. Instead, accredited CME providers can use a shared system to record information about CME and ABIM MOC activities. The network will provide additional choices for internists without adding new ACCME requirements, according to an Aug. 12 ABIM announcement.

The American College of Physicians (ACP) praised the move, saying it will provide internists more choices.

“The American College of Physicians has long advocated for a process that gives MOC credit for activities that physicians are already doing,” Dr. Wayne J. Riley, ACP president, said in an interview. “We support an easier process and more options for diplomates to get credit for the Part 2 (Self-Assessment of Knowledge) component of MOC.”

While ABIM already offers more than 300 medical knowledge options to physicians engaged in MOC, diplomates wanted a more streamlined process that enabled them to more seamlessly combine their ongoing educational activities with MOC requirements, ABIM President Richard J. Baron said in a statement.

“By collaborating with ACCME, ABIM will open the door to even more options for physicians engaged in MOC and will allow them to get MOC credit for high-quality CME activities they are already doing,” Dr. Baron said in the statement.

ABIM noted that accredited CME providers in the ACCME system already use the ACCME Program and Activity Reporting System (PARS) to enter data about CME activities. With the new partnership, CME providers can also use PARS to register activities for ABIM MOC. CME administrators can submit learner data and attest to compliance with ABIM-specific requirements for the Medical Knowledge Assessment Recognition Program. ABIM and ACCME will start beta testing the technology later this month, and the associations expect to open the process for accredited CME providers by the end of 2015.

Additionally, ACCME will maintain on its website a list of activities that meet ABIM requirements and that are registered for MOC credit. Data verifying that doctors have completed CME activities will be communicated to ABIM through PARS.

“This collaboration will generate many more opportunities for accredited CME providers to serve as a strategic resource by delivering relevant, effective, independent, practice-based education that counts for MOC,” ACCME PresidentGraham T. McMahon said in the statement. “I look forward to working together with ABIM, our community of accredited CME providers, and our community of diplomates to leverage the power of education to drive quality in our medical profession and improve care for the patients we serve.”

The partnership is the latest in an ongoing series of modifications to ABIM’s MOC process. Earlier this month, ABIM announced that physicians who do not enroll in its MOC program will no longer automatically lose their board certification status. In July, the board announced that no disciplines within its MOC program will require underlying certification and that all diplomates can choose the certifications they wish to maintain. The policy goes into effect Jan. 1, 2016.

In early June, ABIM rolled out changes to its exam outline and score report. Starting with spring 2015 exams, physicians will receive enhanced score reports with more performance details, according to ABIM. The board also updated its internal medicine MOC blueprint – the exam content outline – to ensure that the exam reflects how internists are practicing today and to provide more detailed explanations of topics that may be included in the exam.

The growing list of changes follows a February announcement by ABIM apologizing to physicians for an MOC program that “clearly got it wrong.” ABIM pledged to make the program more consistent with physicians’ practice and values. Among the immediate changes are updates to its internal medicine exam; suspension of the practice assessment, patient voice, and patient safety requirements for at least 2 years; and setting MOC enrollment fees at or below 2014 levels through at least 2017.

[email protected]

On Twitter @legal_med

The American Board of Internal Medicine (ABIM) and the Accreditation Council for Continuing Medical Education (ACCME) have announced a partnership that aims to unify continuing education activities with Maintenance of Certification (MOC) requirements and expand doctors’ options for MOC credit.

As part of the change, ABIM will no longer require CME providers to submit applications to ABIM for activity approval and peer review. Instead, accredited CME providers can use a shared system to record information about CME and ABIM MOC activities. The network will provide additional choices for internists without adding new ACCME requirements, according to an Aug. 12 ABIM announcement.

The American College of Physicians (ACP) praised the move, saying it will provide internists more choices.

“The American College of Physicians has long advocated for a process that gives MOC credit for activities that physicians are already doing,” Dr. Wayne J. Riley, ACP president, said in an interview. “We support an easier process and more options for diplomates to get credit for the Part 2 (Self-Assessment of Knowledge) component of MOC.”

While ABIM already offers more than 300 medical knowledge options to physicians engaged in MOC, diplomates wanted a more streamlined process that enabled them to more seamlessly combine their ongoing educational activities with MOC requirements, ABIM President Richard J. Baron said in a statement.

“By collaborating with ACCME, ABIM will open the door to even more options for physicians engaged in MOC and will allow them to get MOC credit for high-quality CME activities they are already doing,” Dr. Baron said in the statement.

ABIM noted that accredited CME providers in the ACCME system already use the ACCME Program and Activity Reporting System (PARS) to enter data about CME activities. With the new partnership, CME providers can also use PARS to register activities for ABIM MOC. CME administrators can submit learner data and attest to compliance with ABIM-specific requirements for the Medical Knowledge Assessment Recognition Program. ABIM and ACCME will start beta testing the technology later this month, and the associations expect to open the process for accredited CME providers by the end of 2015.

Additionally, ACCME will maintain on its website a list of activities that meet ABIM requirements and that are registered for MOC credit. Data verifying that doctors have completed CME activities will be communicated to ABIM through PARS.

“This collaboration will generate many more opportunities for accredited CME providers to serve as a strategic resource by delivering relevant, effective, independent, practice-based education that counts for MOC,” ACCME PresidentGraham T. McMahon said in the statement. “I look forward to working together with ABIM, our community of accredited CME providers, and our community of diplomates to leverage the power of education to drive quality in our medical profession and improve care for the patients we serve.”

The partnership is the latest in an ongoing series of modifications to ABIM’s MOC process. Earlier this month, ABIM announced that physicians who do not enroll in its MOC program will no longer automatically lose their board certification status. In July, the board announced that no disciplines within its MOC program will require underlying certification and that all diplomates can choose the certifications they wish to maintain. The policy goes into effect Jan. 1, 2016.

In early June, ABIM rolled out changes to its exam outline and score report. Starting with spring 2015 exams, physicians will receive enhanced score reports with more performance details, according to ABIM. The board also updated its internal medicine MOC blueprint – the exam content outline – to ensure that the exam reflects how internists are practicing today and to provide more detailed explanations of topics that may be included in the exam.

The growing list of changes follows a February announcement by ABIM apologizing to physicians for an MOC program that “clearly got it wrong.” ABIM pledged to make the program more consistent with physicians’ practice and values. Among the immediate changes are updates to its internal medicine exam; suspension of the practice assessment, patient voice, and patient safety requirements for at least 2 years; and setting MOC enrollment fees at or below 2014 levels through at least 2017.

[email protected]

On Twitter @legal_med

In a novel decision, the U.S. District Court for the Southern District of New York has ruled that the 60-day clock to return overpayments to the government begins ticking when a health provider receives notice a potential overpayment exists, not when an overpayment is conclusively ascertained.

Doctors should be concerned about the ruling, said Houston health law attorney Michael E. Clark, immediate past chair for the American Bar Association Health Law Section.

“This is a very troubling development because the judge has embraced the theory that certainty is not required as to what constitutes an identified overpayment,” Mr. Clark said in an interview. “Rather, knowledge can be established by recklessness under the facts. In short, practitioners must set up systems to alert them about potential overpayments so they can move quickly to avoid potentially ruinous False Claims Act liability.”

The Aug. 3 ruling in Kane v. Healthfirst is the first published decision to address the 60-day overpayment rule imposed under the Affordable Care Act and the Fraud Enforcement and Recovery Act (FERA). The rule requires that an overpayment be reported and returned by health providers within 60 days of the “date on which the overpayment was identified.” Health providers who retain an overpayment beyond that point are subject to liability under the False Claims Act (FCA).

In the Kane case, the federal government contends that three hospitals operated by Continuum Health Partners failed to report and return overpayments to Medicaid within 60 days of identification. Because of a computer glitch, Continuum billed both the government and a managed care organization for the same services, according to court documents. After the New York State Comptroller’s Office alerted Continuum to a possible overbilling, Continuum hired an employee, Robert P. Kane, to conduct an internal investigation into its billing. Mr. Kane – who was later fired – allegedly found 900 potentially improper Medicaid claims totaling $1 million, according to court documents. The government claims Continuum failed to repay the overpayments within 60 days and instead repaid only “small batches” of the affected claims over the next 2 years. Mr. Kane filed a whistleblower suit against Continuum, and the government intervened as a plaintiff.

But Continuum argued that the hospitals did not knowingly conceal the overpayments from the government, and that the overbillings had not been officially “identified.” The defendants were provided only notice of potential overpayments and did not identify actual overpayments so as to trigger the 60-day report and return clock, Continuum said in court documents. The health system requested the court throw out the government’s suit for lack of merit.

District Judge Edgardo Ramos agreed with the federal government and allowed the lawsuit to continue. Judge Ramos said the legislative history indicates that Congress intended for FCA liability to attach in circumstances where there is an established duty to pay money to the government, even if the precise amount due has yet to be determined.

“Here, after the comptroller alerted defendants to the software glitch and approached them with specific wrongful claims, and after Kane put defendants on notice of a set of claims likely to contain numerous overpayments, defendants had an established duty to report and return wrongly collected money,” Judge Ramos said in his opinion. “To allow defendants to evade liability because Kane’s email did not conclusively establish each erroneous claim and did not provide the specific amount owed to the government would contradict Congress’s intentions as expressed during the passage of the FERA.”

In an email, a spokesperson for the defendants said the hospitals are disappointed with the judge’s decision and will continue to vigorously defend its case in court. Attorneys for the government did not return messages seeking comment.

The judge’s ruling is encouraging to the federal government and for plaintiffs who wish to sue health providers for overbilling violations, said Joel M. Androphy, a Houston plaintiffs’ attorney.

“This is going to open the floodgates for lawyers now as part of their false claim and reporting practices to let the courts know about overpayment issues because they know the court and the government will be listening,” Mr. Androphy said in an interview. “It’s not going to be the sole basis for [a plaintiff’s] claim necessarily, but it could be an integral part.”

Mr. Androphy added that defendants can no longer complain they were confused by the 60-day overpayment rule and the meaning of “identification.” The judge’s ruling makes the regulation more clear and provides guidance to health providers about how the rule will be enforced, he said.

Washington health law attorney Robert T. Rhoad however, disagreed that the opinion clarifies application of the 60-day overpayment rule. The decision does not provide the bright lines for compliance that providers expect and need, said Mr. Rhoad.

“While the Kane decision provides an exposition of the etiology and perceived intent of the 60-day rule, its ultimate ruling was made through the narrow lens of the specific and arguably egregious [facts] alleged,” Mr. Rhoad said in an interview. “If anything, by finding that certainty is not required in identifying an overpayment triggering the 60-day rule, the decision may encourage the government and qui tam relators to come forward with expansive theories of what might constitute reckless disregard by a provider to identify an overpayment to invoke FCA liability by the running of the 60-day clock.”

To protect themselves from litigation, physicians should take prudent steps to conduct an appropriate investigation if faced with actual or constructive notice of a possible overpayment, Mr. Rhoad said. Showing that they acted with due diligence and without delay to investigate and, if identified, report an overpayment could help doctors withstand future governmental or judicial scrutiny.

[email protected]

On Twitter @legal_med

In a novel decision, the U.S. District Court for the Southern District of New York has ruled that the 60-day clock to return overpayments to the government begins ticking when a health provider receives notice a potential overpayment exists, not when an overpayment is conclusively ascertained.

Doctors should be concerned about the ruling, said Houston health law attorney Michael E. Clark, immediate past chair for the American Bar Association Health Law Section.

“This is a very troubling development because the judge has embraced the theory that certainty is not required as to what constitutes an identified overpayment,” Mr. Clark said in an interview. “Rather, knowledge can be established by recklessness under the facts. In short, practitioners must set up systems to alert them about potential overpayments so they can move quickly to avoid potentially ruinous False Claims Act liability.”

The Aug. 3 ruling in Kane v. Healthfirst is the first published decision to address the 60-day overpayment rule imposed under the Affordable Care Act and the Fraud Enforcement and Recovery Act (FERA). The rule requires that an overpayment be reported and returned by health providers within 60 days of the “date on which the overpayment was identified.” Health providers who retain an overpayment beyond that point are subject to liability under the False Claims Act (FCA).

In the Kane case, the federal government contends that three hospitals operated by Continuum Health Partners failed to report and return overpayments to Medicaid within 60 days of identification. Because of a computer glitch, Continuum billed both the government and a managed care organization for the same services, according to court documents. After the New York State Comptroller’s Office alerted Continuum to a possible overbilling, Continuum hired an employee, Robert P. Kane, to conduct an internal investigation into its billing. Mr. Kane – who was later fired – allegedly found 900 potentially improper Medicaid claims totaling $1 million, according to court documents. The government claims Continuum failed to repay the overpayments within 60 days and instead repaid only “small batches” of the affected claims over the next 2 years. Mr. Kane filed a whistleblower suit against Continuum, and the government intervened as a plaintiff.

But Continuum argued that the hospitals did not knowingly conceal the overpayments from the government, and that the overbillings had not been officially “identified.” The defendants were provided only notice of potential overpayments and did not identify actual overpayments so as to trigger the 60-day report and return clock, Continuum said in court documents. The health system requested the court throw out the government’s suit for lack of merit.

District Judge Edgardo Ramos agreed with the federal government and allowed the lawsuit to continue. Judge Ramos said the legislative history indicates that Congress intended for FCA liability to attach in circumstances where there is an established duty to pay money to the government, even if the precise amount due has yet to be determined.

“Here, after the comptroller alerted defendants to the software glitch and approached them with specific wrongful claims, and after Kane put defendants on notice of a set of claims likely to contain numerous overpayments, defendants had an established duty to report and return wrongly collected money,” Judge Ramos said in his opinion. “To allow defendants to evade liability because Kane’s email did not conclusively establish each erroneous claim and did not provide the specific amount owed to the government would contradict Congress’s intentions as expressed during the passage of the FERA.”

In an email, a spokesperson for the defendants said the hospitals are disappointed with the judge’s decision and will continue to vigorously defend its case in court. Attorneys for the government did not return messages seeking comment.

The judge’s ruling is encouraging to the federal government and for plaintiffs who wish to sue health providers for overbilling violations, said Joel M. Androphy, a Houston plaintiffs’ attorney.

“This is going to open the floodgates for lawyers now as part of their false claim and reporting practices to let the courts know about overpayment issues because they know the court and the government will be listening,” Mr. Androphy said in an interview. “It’s not going to be the sole basis for [a plaintiff’s] claim necessarily, but it could be an integral part.”

Mr. Androphy added that defendants can no longer complain they were confused by the 60-day overpayment rule and the meaning of “identification.” The judge’s ruling makes the regulation more clear and provides guidance to health providers about how the rule will be enforced, he said.

Washington health law attorney Robert T. Rhoad however, disagreed that the opinion clarifies application of the 60-day overpayment rule. The decision does not provide the bright lines for compliance that providers expect and need, said Mr. Rhoad.

“While the Kane decision provides an exposition of the etiology and perceived intent of the 60-day rule, its ultimate ruling was made through the narrow lens of the specific and arguably egregious [facts] alleged,” Mr. Rhoad said in an interview. “If anything, by finding that certainty is not required in identifying an overpayment triggering the 60-day rule, the decision may encourage the government and qui tam relators to come forward with expansive theories of what might constitute reckless disregard by a provider to identify an overpayment to invoke FCA liability by the running of the 60-day clock.”

To protect themselves from litigation, physicians should take prudent steps to conduct an appropriate investigation if faced with actual or constructive notice of a possible overpayment, Mr. Rhoad said. Showing that they acted with due diligence and without delay to investigate and, if identified, report an overpayment could help doctors withstand future governmental or judicial scrutiny.

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On Twitter @legal_med

In a novel decision, the U.S. District Court for the Southern District of New York has ruled that the 60-day clock to return overpayments to the government begins ticking when a health provider receives notice a potential overpayment exists, not when an overpayment is conclusively ascertained.

Doctors should be concerned about the ruling, said Houston health law attorney Michael E. Clark, immediate past chair for the American Bar Association Health Law Section.

“This is a very troubling development because the judge has embraced the theory that certainty is not required as to what constitutes an identified overpayment,” Mr. Clark said in an interview. “Rather, knowledge can be established by recklessness under the facts. In short, practitioners must set up systems to alert them about potential overpayments so they can move quickly to avoid potentially ruinous False Claims Act liability.”

The Aug. 3 ruling in Kane v. Healthfirst is the first published decision to address the 60-day overpayment rule imposed under the Affordable Care Act and the Fraud Enforcement and Recovery Act (FERA). The rule requires that an overpayment be reported and returned by health providers within 60 days of the “date on which the overpayment was identified.” Health providers who retain an overpayment beyond that point are subject to liability under the False Claims Act (FCA).

In the Kane case, the federal government contends that three hospitals operated by Continuum Health Partners failed to report and return overpayments to Medicaid within 60 days of identification. Because of a computer glitch, Continuum billed both the government and a managed care organization for the same services, according to court documents. After the New York State Comptroller’s Office alerted Continuum to a possible overbilling, Continuum hired an employee, Robert P. Kane, to conduct an internal investigation into its billing. Mr. Kane – who was later fired – allegedly found 900 potentially improper Medicaid claims totaling $1 million, according to court documents. The government claims Continuum failed to repay the overpayments within 60 days and instead repaid only “small batches” of the affected claims over the next 2 years. Mr. Kane filed a whistleblower suit against Continuum, and the government intervened as a plaintiff.

But Continuum argued that the hospitals did not knowingly conceal the overpayments from the government, and that the overbillings had not been officially “identified.” The defendants were provided only notice of potential overpayments and did not identify actual overpayments so as to trigger the 60-day report and return clock, Continuum said in court documents. The health system requested the court throw out the government’s suit for lack of merit.

District Judge Edgardo Ramos agreed with the federal government and allowed the lawsuit to continue. Judge Ramos said the legislative history indicates that Congress intended for FCA liability to attach in circumstances where there is an established duty to pay money to the government, even if the precise amount due has yet to be determined.

“Here, after the comptroller alerted defendants to the software glitch and approached them with specific wrongful claims, and after Kane put defendants on notice of a set of claims likely to contain numerous overpayments, defendants had an established duty to report and return wrongly collected money,” Judge Ramos said in his opinion. “To allow defendants to evade liability because Kane’s email did not conclusively establish each erroneous claim and did not provide the specific amount owed to the government would contradict Congress’s intentions as expressed during the passage of the FERA.”

In an email, a spokesperson for the defendants said the hospitals are disappointed with the judge’s decision and will continue to vigorously defend its case in court. Attorneys for the government did not return messages seeking comment.

The judge’s ruling is encouraging to the federal government and for plaintiffs who wish to sue health providers for overbilling violations, said Joel M. Androphy, a Houston plaintiffs’ attorney.

“This is going to open the floodgates for lawyers now as part of their false claim and reporting practices to let the courts know about overpayment issues because they know the court and the government will be listening,” Mr. Androphy said in an interview. “It’s not going to be the sole basis for [a plaintiff’s] claim necessarily, but it could be an integral part.”

Mr. Androphy added that defendants can no longer complain they were confused by the 60-day overpayment rule and the meaning of “identification.” The judge’s ruling makes the regulation more clear and provides guidance to health providers about how the rule will be enforced, he said.

Washington health law attorney Robert T. Rhoad however, disagreed that the opinion clarifies application of the 60-day overpayment rule. The decision does not provide the bright lines for compliance that providers expect and need, said Mr. Rhoad.

“While the Kane decision provides an exposition of the etiology and perceived intent of the 60-day rule, its ultimate ruling was made through the narrow lens of the specific and arguably egregious [facts] alleged,” Mr. Rhoad said in an interview. “If anything, by finding that certainty is not required in identifying an overpayment triggering the 60-day rule, the decision may encourage the government and qui tam relators to come forward with expansive theories of what might constitute reckless disregard by a provider to identify an overpayment to invoke FCA liability by the running of the 60-day clock.”

To protect themselves from litigation, physicians should take prudent steps to conduct an appropriate investigation if faced with actual or constructive notice of a possible overpayment, Mr. Rhoad said. Showing that they acted with due diligence and without delay to investigate and, if identified, report an overpayment could help doctors withstand future governmental or judicial scrutiny.

[email protected]

On Twitter @legal_med

Physicians who fail to enroll in the American Board of Internal Medicine’s Maintenance of Certification program will no longer automatically lose their board certification status, according to the latest change by ABIM to its MOC process.

Effective immediately, doctors who meet all other program requirements will not become “uncertified” for having not enrolled in MOC, ABIM President Richard J. Baron said in an Aug. 4 blog post.

“This change came from conversations with the community about how the program was working and how the program can be improved,” Dr. Baron said in an interview. “We’re serious about translating into action what we’re learning.”

The American College of Physicians praised the MOC modification as a necessary correction.

“ACP is pleased that ABIM changed its policy linking certification status with enrollment in the MOC program,” ACP President Wayne J. Riley said in an interview. “This was an important correction of an unintended consequence, and we appreciate ABIM’s acting on feedback from the internal medicine community to rectify the problem,” said Dr. Riley.

The change addresses a policy that previously tied board certification designation to MOC enrollment.

In 2014, ABIM made changes to simplify its fee structure by adding an annual payment option as an alternative to its 10-year fee. However, in an unintended consequence of the changes, doctors who did not enroll and pay for the program in years in which they did not have to complete any requirements were designated as “not certified,” according to ABIM’s announcement.

The policy had particularly negative effects on those in fellowships or those who had just completed training. For instance, doctors who had recently passed an internal medicine exam but were still undergoing training were advised that they needed to enroll in MOC, Dr. Baron said in an interview. The rule led to confusion and, in some cases, adversely affected job searches.

“When they tried to get moonlighting jobs, they discovered they were being reported as ‘not enrolled,’ ” he said. “That was not the board’s intention at all.”

The change will not impact all doctors, and Dr. Baron advises members to check their status page on ABIM’s website to see if the modification affects them.

The policy change means that:

• Diplomates who lost certification solely on the basis of failure to enroll in MOC or to pay MOC fees have now had their certification status updated to “certified.” There is no further action they must take.

• Diplomates who wish to be reported as “participating in MOC” must be enrolled in the MOC program, be current with their payments, and be meeting ongoing program requirements.

• Diplomates who earned initial certification since 2013 or renewed certification since 2014 and who no longer wish to be enrolled in MOC this year may, as a result of this policy change, be eligible for a refund of their 2015 MOC enrollment fees.

• Diplomates must still meet the 5- and 10-year MOC program milestones to maintain their certification.

American College of Cardiology President Kim Allan Williams Sr. called the policy change a much-needed modification that will equalize the playing field for all doctors.

“By tying together board certification and enrollment in Maintenance of Certification, the American Board of Internal Medicine appeared to devalue the secure examination passed by recently certified physicians, by setting different standards for them, compared to those certified in previous years,” Dr. Williams said in a statement.

“The ABIM should be commended for recognizing the negative impact of this policy on current and future employment opportunities, particularly for those in the early stages of their careers, and taking the steps necessary to reverse it,” Dr. Williams noted.

The certification/enrollment change is the latest in an ongoing series of modifications to ABIM’s MOC process. In July, ABIM announced that no disciplines within its MOC program will require underlying certification and that all ABIM diplomates can choose the certifications they wish to maintain. The policy goes into effect Jan. 1, 2016.

In early June, ABIM rolled out changes to its exam outline and score report. Starting with spring 2015 exams, physicians will receive enhanced score reports with more performance details, according to ABIM. The board also updated its internal medicine MOC blueprint – the exam content outline – to ensure that the exam reflects how internists are practicing today and to provide more detailed explanations of topics that may be included in the exam.

The growing list of changes follows a February announcement by ABIM apologizing to physicians for an MOC program that “clearly got it wrong.” ABIM pledged to make the program more consistent with physicians’ practice and values. Among the immediate changes are updates to its internal medicine exam; suspension of the practice assessment, patient voice, and patient safety requirements for at least 2 years; and setting MOC enrollment fees at or below 2014 levels through at least 2017.

[email protected]

On Twitter @legal_med

Physicians who fail to enroll in the American Board of Internal Medicine’s Maintenance of Certification program will no longer automatically lose their board certification status, according to the latest change by ABIM to its MOC process.

Effective immediately, doctors who meet all other program requirements will not become “uncertified” for having not enrolled in MOC, ABIM President Richard J. Baron said in an Aug. 4 blog post.

“This change came from conversations with the community about how the program was working and how the program can be improved,” Dr. Baron said in an interview. “We’re serious about translating into action what we’re learning.”

The American College of Physicians praised the MOC modification as a necessary correction.

“ACP is pleased that ABIM changed its policy linking certification status with enrollment in the MOC program,” ACP President Wayne J. Riley said in an interview. “This was an important correction of an unintended consequence, and we appreciate ABIM’s acting on feedback from the internal medicine community to rectify the problem,” said Dr. Riley.

The change addresses a policy that previously tied board certification designation to MOC enrollment.

In 2014, ABIM made changes to simplify its fee structure by adding an annual payment option as an alternative to its 10-year fee. However, in an unintended consequence of the changes, doctors who did not enroll and pay for the program in years in which they did not have to complete any requirements were designated as “not certified,” according to ABIM’s announcement.

The policy had particularly negative effects on those in fellowships or those who had just completed training. For instance, doctors who had recently passed an internal medicine exam but were still undergoing training were advised that they needed to enroll in MOC, Dr. Baron said in an interview. The rule led to confusion and, in some cases, adversely affected job searches.

“When they tried to get moonlighting jobs, they discovered they were being reported as ‘not enrolled,’ ” he said. “That was not the board’s intention at all.”

The change will not impact all doctors, and Dr. Baron advises members to check their status page on ABIM’s website to see if the modification affects them.

The policy change means that:

• Diplomates who lost certification solely on the basis of failure to enroll in MOC or to pay MOC fees have now had their certification status updated to “certified.” There is no further action they must take.

• Diplomates who wish to be reported as “participating in MOC” must be enrolled in the MOC program, be current with their payments, and be meeting ongoing program requirements.

• Diplomates who earned initial certification since 2013 or renewed certification since 2014 and who no longer wish to be enrolled in MOC this year may, as a result of this policy change, be eligible for a refund of their 2015 MOC enrollment fees.

• Diplomates must still meet the 5- and 10-year MOC program milestones to maintain their certification.

American College of Cardiology President Kim Allan Williams Sr. called the policy change a much-needed modification that will equalize the playing field for all doctors.

“By tying together board certification and enrollment in Maintenance of Certification, the American Board of Internal Medicine appeared to devalue the secure examination passed by recently certified physicians, by setting different standards for them, compared to those certified in previous years,” Dr. Williams said in a statement.

“The ABIM should be commended for recognizing the negative impact of this policy on current and future employment opportunities, particularly for those in the early stages of their careers, and taking the steps necessary to reverse it,” Dr. Williams noted.

The certification/enrollment change is the latest in an ongoing series of modifications to ABIM’s MOC process. In July, ABIM announced that no disciplines within its MOC program will require underlying certification and that all ABIM diplomates can choose the certifications they wish to maintain. The policy goes into effect Jan. 1, 2016.

In early June, ABIM rolled out changes to its exam outline and score report. Starting with spring 2015 exams, physicians will receive enhanced score reports with more performance details, according to ABIM. The board also updated its internal medicine MOC blueprint – the exam content outline – to ensure that the exam reflects how internists are practicing today and to provide more detailed explanations of topics that may be included in the exam.

The growing list of changes follows a February announcement by ABIM apologizing to physicians for an MOC program that “clearly got it wrong.” ABIM pledged to make the program more consistent with physicians’ practice and values. Among the immediate changes are updates to its internal medicine exam; suspension of the practice assessment, patient voice, and patient safety requirements for at least 2 years; and setting MOC enrollment fees at or below 2014 levels through at least 2017.

[email protected]

On Twitter @legal_med

Physicians who fail to enroll in the American Board of Internal Medicine’s Maintenance of Certification program will no longer automatically lose their board certification status, according to the latest change by ABIM to its MOC process.

Effective immediately, doctors who meet all other program requirements will not become “uncertified” for having not enrolled in MOC, ABIM President Richard J. Baron said in an Aug. 4 blog post.

“This change came from conversations with the community about how the program was working and how the program can be improved,” Dr. Baron said in an interview. “We’re serious about translating into action what we’re learning.”

The American College of Physicians praised the MOC modification as a necessary correction.

“ACP is pleased that ABIM changed its policy linking certification status with enrollment in the MOC program,” ACP President Wayne J. Riley said in an interview. “This was an important correction of an unintended consequence, and we appreciate ABIM’s acting on feedback from the internal medicine community to rectify the problem,” said Dr. Riley.

The change addresses a policy that previously tied board certification designation to MOC enrollment.

In 2014, ABIM made changes to simplify its fee structure by adding an annual payment option as an alternative to its 10-year fee. However, in an unintended consequence of the changes, doctors who did not enroll and pay for the program in years in which they did not have to complete any requirements were designated as “not certified,” according to ABIM’s announcement.

The policy had particularly negative effects on those in fellowships or those who had just completed training. For instance, doctors who had recently passed an internal medicine exam but were still undergoing training were advised that they needed to enroll in MOC, Dr. Baron said in an interview. The rule led to confusion and, in some cases, adversely affected job searches.

“When they tried to get moonlighting jobs, they discovered they were being reported as ‘not enrolled,’ ” he said. “That was not the board’s intention at all.”

The change will not impact all doctors, and Dr. Baron advises members to check their status page on ABIM’s website to see if the modification affects them.

The policy change means that:

• Diplomates who lost certification solely on the basis of failure to enroll in MOC or to pay MOC fees have now had their certification status updated to “certified.” There is no further action they must take.

• Diplomates who wish to be reported as “participating in MOC” must be enrolled in the MOC program, be current with their payments, and be meeting ongoing program requirements.

• Diplomates who earned initial certification since 2013 or renewed certification since 2014 and who no longer wish to be enrolled in MOC this year may, as a result of this policy change, be eligible for a refund of their 2015 MOC enrollment fees.

• Diplomates must still meet the 5- and 10-year MOC program milestones to maintain their certification.

American College of Cardiology President Kim Allan Williams Sr. called the policy change a much-needed modification that will equalize the playing field for all doctors.

“By tying together board certification and enrollment in Maintenance of Certification, the American Board of Internal Medicine appeared to devalue the secure examination passed by recently certified physicians, by setting different standards for them, compared to those certified in previous years,” Dr. Williams said in a statement.

“The ABIM should be commended for recognizing the negative impact of this policy on current and future employment opportunities, particularly for those in the early stages of their careers, and taking the steps necessary to reverse it,” Dr. Williams noted.

The certification/enrollment change is the latest in an ongoing series of modifications to ABIM’s MOC process. In July, ABIM announced that no disciplines within its MOC program will require underlying certification and that all ABIM diplomates can choose the certifications they wish to maintain. The policy goes into effect Jan. 1, 2016.

In early June, ABIM rolled out changes to its exam outline and score report. Starting with spring 2015 exams, physicians will receive enhanced score reports with more performance details, according to ABIM. The board also updated its internal medicine MOC blueprint – the exam content outline – to ensure that the exam reflects how internists are practicing today and to provide more detailed explanations of topics that may be included in the exam.

The growing list of changes follows a February announcement by ABIM apologizing to physicians for an MOC program that “clearly got it wrong.” ABIM pledged to make the program more consistent with physicians’ practice and values. Among the immediate changes are updates to its internal medicine exam; suspension of the practice assessment, patient voice, and patient safety requirements for at least 2 years; and setting MOC enrollment fees at or below 2014 levels through at least 2017.

[email protected]

On Twitter @legal_med

Coding mistakes made on behalf of physicians and other health providers led to more than $35 million in Medicare overpayments for outpatient drugs, a government watchdog has found.

An audit by the U.S. Department of Health & Human Services Office of Inspector General (OIG) discovered that Medicare contractors in 13 jurisdictions overpaid Medicare Part B providers by $35.8 million between July 2009 and June 2012. Erroneous codes and incorrect units of service submitted on behalf of those providers were the top reasons for the overpayments, according to the OIG report, released July 29.

©sndr/istockphoto.com

Incorrect units of service resulted in net overpayments of $26 million, according to the report. One provider, for instance, administered 6 units of rituximab to a patient and billed for 60 units. The same provider made this type of error on 21 separate occasions leading Medicare contractors to pay $811,562 when they should have paid $67,863. The medications most frequently overpaid because of incorrect units of service were: adenosine, rituximab, infliximab, leuprolide acetate, and bortezomib.

Other common billing mistakes by physicians that resulted in overpayments included, insufficient documentation about patient services, billing for outpatient drugs in which payment was already included in that of a primary procedure, incorrect use of Healthcare Common Procedure Coding System (HCPCS) codes, and billing Medicare for noncovered outpatient drugs.

As of May 4, the Centers for Medicare & Medicaid Services had recovered 63% of the overpayments found in the OIG audit, according to the report. However, the OIG also identified potential overpayments for outpatient drugs that were billed after its audit period. Specifically, officials said Medicare contractors could recover as much as $11.5 million in overpayments if they review outpatient drug payments billed from July 2012 through June 2014.

The OIG recommended that CMS collect the remaining overpayments, conduct reviews on the time period after the initial audit period, continue to educate providers on correct billing of outpatient drugs, and continue to implement line item and date-of-service Medically Unlikely Edits for additional outpatient drugs.

[email protected]

On Twitter @legal_med

Coding mistakes made on behalf of physicians and other health providers led to more than $35 million in Medicare overpayments for outpatient drugs, a government watchdog has found.

An audit by the U.S. Department of Health & Human Services Office of Inspector General (OIG) discovered that Medicare contractors in 13 jurisdictions overpaid Medicare Part B providers by $35.8 million between July 2009 and June 2012. Erroneous codes and incorrect units of service submitted on behalf of those providers were the top reasons for the overpayments, according to the OIG report, released July 29.

©sndr/istockphoto.com

Incorrect units of service resulted in net overpayments of $26 million, according to the report. One provider, for instance, administered 6 units of rituximab to a patient and billed for 60 units. The same provider made this type of error on 21 separate occasions leading Medicare contractors to pay $811,562 when they should have paid $67,863. The medications most frequently overpaid because of incorrect units of service were: adenosine, rituximab, infliximab, leuprolide acetate, and bortezomib.

Other common billing mistakes by physicians that resulted in overpayments included, insufficient documentation about patient services, billing for outpatient drugs in which payment was already included in that of a primary procedure, incorrect use of Healthcare Common Procedure Coding System (HCPCS) codes, and billing Medicare for noncovered outpatient drugs.

As of May 4, the Centers for Medicare & Medicaid Services had recovered 63% of the overpayments found in the OIG audit, according to the report. However, the OIG also identified potential overpayments for outpatient drugs that were billed after its audit period. Specifically, officials said Medicare contractors could recover as much as $11.5 million in overpayments if they review outpatient drug payments billed from July 2012 through June 2014.

The OIG recommended that CMS collect the remaining overpayments, conduct reviews on the time period after the initial audit period, continue to educate providers on correct billing of outpatient drugs, and continue to implement line item and date-of-service Medically Unlikely Edits for additional outpatient drugs.

[email protected]

On Twitter @legal_med

Coding mistakes made on behalf of physicians and other health providers led to more than $35 million in Medicare overpayments for outpatient drugs, a government watchdog has found.

An audit by the U.S. Department of Health & Human Services Office of Inspector General (OIG) discovered that Medicare contractors in 13 jurisdictions overpaid Medicare Part B providers by $35.8 million between July 2009 and June 2012. Erroneous codes and incorrect units of service submitted on behalf of those providers were the top reasons for the overpayments, according to the OIG report, released July 29.

©sndr/istockphoto.com

Incorrect units of service resulted in net overpayments of $26 million, according to the report. One provider, for instance, administered 6 units of rituximab to a patient and billed for 60 units. The same provider made this type of error on 21 separate occasions leading Medicare contractors to pay $811,562 when they should have paid $67,863. The medications most frequently overpaid because of incorrect units of service were: adenosine, rituximab, infliximab, leuprolide acetate, and bortezomib.

Other common billing mistakes by physicians that resulted in overpayments included, insufficient documentation about patient services, billing for outpatient drugs in which payment was already included in that of a primary procedure, incorrect use of Healthcare Common Procedure Coding System (HCPCS) codes, and billing Medicare for noncovered outpatient drugs.

As of May 4, the Centers for Medicare & Medicaid Services had recovered 63% of the overpayments found in the OIG audit, according to the report. However, the OIG also identified potential overpayments for outpatient drugs that were billed after its audit period. Specifically, officials said Medicare contractors could recover as much as $11.5 million in overpayments if they review outpatient drug payments billed from July 2012 through June 2014.

The OIG recommended that CMS collect the remaining overpayments, conduct reviews on the time period after the initial audit period, continue to educate providers on correct billing of outpatient drugs, and continue to implement line item and date-of-service Medically Unlikely Edits for additional outpatient drugs.

[email protected]

On Twitter @legal_med

Physicians certified in nine internal medicine subspecialties no longer have to maintain underlying certifications, according to a policy change from the American Board of Internal Medicine.

In a July 1 statement, ABIM announced that no disciplines within its maintenance of certification program will require underlying certification, and that all ABIM diplomates can choose the certifications they wish to maintain. The policy goes into effect on Jan. 1, 2016.

ABIM President and CEO Richard J. Baron said the underlying disciplines are important in building the foundation of knowledge for initial subspecialty certification, but that keeping the MOC requirement in place did not account for the increased specialization of physicians’ practices over their careers.

“As we work to increase the relevancy of the Maintenance of Certification program for physicians, we want to give them greater flexibility to choose to recertify in those areas that best reflect what they are doing in practice,” Dr. Baron said in a statement.

Of relevance to this readership, subspecialists in transplant hepatology will no longer be required to maintain underlying certification in gastroenterology.
The policy will not change requirements for initial certification in such subspecialties, and doctors will still need to be certified in a foundational discipline in order to initially certify in a subspecialty, according to ABIM.

The board decided to remove the MOC requirement after discussion and input from 15 medical specialty societies, including the American Gastroenterological Association. The team of physicians concluded that once the initial certification process is completed, physicians should be required to maintain only one specialty board certification, said Dr. John I. Allen, AGAF, AGA Institute past president.

“This is compatible with many other physician practices,” Dr. Allen said in an interview. “For example, I maintain GI boards but not internal medicine, which was required during my initial certification. We believe this policy facilitates consistency among all specialties.”

Dr. Allen noted that physicians can choose to maintain more than one certification.

The change to the underlying certification requirement is the latest in an ongoing series of modifications to ABIM’s MOC process. In early June, ABIM rolled out changes to its exam outline and score report. Starting with spring 2015 exams, physicians will receive enhanced score reports with more performance details, according to a June 9 announcement by ABIM. The board has also updated its internal medicine MOC blueprint – the exam content outline – to ensure that the exam reflects how internists are practicing today and to provide more detailed explanations of topics that may be included in the exam.

The growing list of changes follows a February announcement by ABIM apologizing to physicians for an MOC program that “clearly got it wrong.” ABIM pledged to make the program more consistent with physicians’ practice and values. Among the immediate changes are updates to its internal medicine exam; suspension of the practice assessment, patient voice, and patient safety requirements for at least 2 years; and setting MOC enrollment fees at or below 2014 levels through at least 2017.

[email protected]

On Twitter @legal_med

Physicians certified in nine internal medicine subspecialties no longer have to maintain underlying certifications, according to a policy change from the American Board of Internal Medicine.

In a July 1 statement, ABIM announced that no disciplines within its maintenance of certification program will require underlying certification, and that all ABIM diplomates can choose the certifications they wish to maintain. The policy goes into effect on Jan. 1, 2016.

ABIM President and CEO Richard J. Baron said the underlying disciplines are important in building the foundation of knowledge for initial subspecialty certification, but that keeping the MOC requirement in place did not account for the increased specialization of physicians’ practices over their careers.

“As we work to increase the relevancy of the Maintenance of Certification program for physicians, we want to give them greater flexibility to choose to recertify in those areas that best reflect what they are doing in practice,” Dr. Baron said in a statement.

Of relevance to this readership, subspecialists in transplant hepatology will no longer be required to maintain underlying certification in gastroenterology.
The policy will not change requirements for initial certification in such subspecialties, and doctors will still need to be certified in a foundational discipline in order to initially certify in a subspecialty, according to ABIM.

The board decided to remove the MOC requirement after discussion and input from 15 medical specialty societies, including the American Gastroenterological Association. The team of physicians concluded that once the initial certification process is completed, physicians should be required to maintain only one specialty board certification, said Dr. John I. Allen, AGAF, AGA Institute past president.

“This is compatible with many other physician practices,” Dr. Allen said in an interview. “For example, I maintain GI boards but not internal medicine, which was required during my initial certification. We believe this policy facilitates consistency among all specialties.”

Dr. Allen noted that physicians can choose to maintain more than one certification.

The change to the underlying certification requirement is the latest in an ongoing series of modifications to ABIM’s MOC process. In early June, ABIM rolled out changes to its exam outline and score report. Starting with spring 2015 exams, physicians will receive enhanced score reports with more performance details, according to a June 9 announcement by ABIM. The board has also updated its internal medicine MOC blueprint – the exam content outline – to ensure that the exam reflects how internists are practicing today and to provide more detailed explanations of topics that may be included in the exam.

The growing list of changes follows a February announcement by ABIM apologizing to physicians for an MOC program that “clearly got it wrong.” ABIM pledged to make the program more consistent with physicians’ practice and values. Among the immediate changes are updates to its internal medicine exam; suspension of the practice assessment, patient voice, and patient safety requirements for at least 2 years; and setting MOC enrollment fees at or below 2014 levels through at least 2017.

[email protected]

On Twitter @legal_med

Physicians certified in nine internal medicine subspecialties no longer have to maintain underlying certifications, according to a policy change from the American Board of Internal Medicine.

In a July 1 statement, ABIM announced that no disciplines within its maintenance of certification program will require underlying certification, and that all ABIM diplomates can choose the certifications they wish to maintain. The policy goes into effect on Jan. 1, 2016.

ABIM President and CEO Richard J. Baron said the underlying disciplines are important in building the foundation of knowledge for initial subspecialty certification, but that keeping the MOC requirement in place did not account for the increased specialization of physicians’ practices over their careers.

“As we work to increase the relevancy of the Maintenance of Certification program for physicians, we want to give them greater flexibility to choose to recertify in those areas that best reflect what they are doing in practice,” Dr. Baron said in a statement.

Of relevance to this readership, subspecialists in transplant hepatology will no longer be required to maintain underlying certification in gastroenterology.
The policy will not change requirements for initial certification in such subspecialties, and doctors will still need to be certified in a foundational discipline in order to initially certify in a subspecialty, according to ABIM.

The board decided to remove the MOC requirement after discussion and input from 15 medical specialty societies, including the American Gastroenterological Association. The team of physicians concluded that once the initial certification process is completed, physicians should be required to maintain only one specialty board certification, said Dr. John I. Allen, AGAF, AGA Institute past president.

“This is compatible with many other physician practices,” Dr. Allen said in an interview. “For example, I maintain GI boards but not internal medicine, which was required during my initial certification. We believe this policy facilitates consistency among all specialties.”

Dr. Allen noted that physicians can choose to maintain more than one certification.

The change to the underlying certification requirement is the latest in an ongoing series of modifications to ABIM’s MOC process. In early June, ABIM rolled out changes to its exam outline and score report. Starting with spring 2015 exams, physicians will receive enhanced score reports with more performance details, according to a June 9 announcement by ABIM. The board has also updated its internal medicine MOC blueprint – the exam content outline – to ensure that the exam reflects how internists are practicing today and to provide more detailed explanations of topics that may be included in the exam.

The growing list of changes follows a February announcement by ABIM apologizing to physicians for an MOC program that “clearly got it wrong.” ABIM pledged to make the program more consistent with physicians’ practice and values. Among the immediate changes are updates to its internal medicine exam; suspension of the practice assessment, patient voice, and patient safety requirements for at least 2 years; and setting MOC enrollment fees at or below 2014 levels through at least 2017.

[email protected]

On Twitter @legal_med

Patient access or program integrity? The question of which need outweighs the other was the theme of a Senate Finance Committee hearing that discussed the erroneous approval of subsidies by healthcare.gov for fake patients.

An investigation by the Government Accountability Office (GAO) found the federal exchange approved 11 of 12 telephone and online applications for fictitious applicants and paid $30,000 in annual insurance credits for the fake patients over a 2-year period. Investigators provided fake documents to the government, including Social Security numbers and proof of income, but encountered no barriers to obtaining taxpayer-funded credits, according to the report released July 15.

The findings are troubling and do not speak well of the management of healthcare.gov, the protection of taxpayer dollars, or the experience of enrollees, Senate Finance Committee Chairman Orrin Hatch (R-Utah) said during a July 16 hearing.

“The GAO’s investigation exposes not only huge gaps in federal exchange program integrity, but also flaws in how the exchange and [Centers for Medicare & Medicaid Services] contractors treat Americans who are trying to file or correct legitimate applications,” Chairman Hatch said during his opening statement. “The fact that GAO encountered mind-boggling levels of incompetence and inefficiency at nearly every turn does not bode well for the experience of your average, honest enrollee.”

CMS officials did not testify at the hearing nor did they respond to requests for comment.

The GAO’s investigation covered the marketplace’s first open-enrollment period from Oct. 1, 2013 to March 31, 2014, as well as follow-on work through 2014 and 2015. As part of its “secret shopper” investigation, GAO created 18 fictitious identities to apply for premium subsidies through the federal exchange by telephone, online, and in-person. The fake applicants were able to get health insurance and subsidies with fictitious information in nearly all cases. For 7 of the 11 fictitious applicants, GAO intentionally did not submit all required documentation to the marketplace, but CMS did not cancel the subsidized coverage.

“While these subsidies, including those granted to GAO’s fictitious applicants, are paid to health care insurers, and not directly to enrolled consumers, they nevertheless represent a benefit to consumers and a cost to the government,” according to the report.

Among the report’s findings:

• Information transmitted to the IRS for 3 of 11 fictitious enrollees, such as coverage periods and subsidy amounts, was incorrect.

• The marketplace automatically reenrolled coverage for all 11 fictitious enrollees for 2015.

• CMS terminated coverage for 6 of the 11 enrollees in 2015, stating that the fictitious enrollees had not provided necessary documentation. On appeal, five were reinstated and awarded higher subsidies.

The GAO tests were designed to identify potential control weaknesses in the market enrollment process and to inform the agency’s ongoing audit of these controls, Seto J. Bagdoyan, GAO director of forensic audits and investigative service, said at the hearing. GAO plans to provide recommendations about control efforts in a forthcoming report.

“A program of this scope and scale is inherently at risk for errors, including in proper payment and fraudulent activities,” Mr. Bagdoyan testified. “Accordingly, it is essential there are effective enrollment controls in place to help narrow the window of opportunities for such risks.”

Mr. Bagoyan noted that in response to the findings, CMS stated that they had limited capacity to respond to attempts at fraud within enrollment, and that officials must balance consumers’ ability to access coverage with program integrity concerns.

Sen Ron Wyden (D-Ore.) stressed the importance of this balance in his opening statement. He largely criticized the report, noting the study analyzed only fictitious cases and none involved a real person who filed taxes or received medical care.

“Part of any smart, ferocious strategy against fraud, on one hand, is drawing a distinction between aggressively going after scammers, and on the other, not harming a law-abiding American who’s made an honest, often technical mistake,” said Sen. Wyden, ranking member of the Finance Committee. “A retiree nearing Medicare age shouldn’t get kicked to the curb because she accidentally submitted an incorrect document. A transgender American shouldn’t lose health coverage after a name change because some forms don’t match. I can’t imagine the Congress wants a system that nixes the health insurance coverage of Americans because of simple issues like those.”

In the GAO report, CMS officials stated that there have been no cases of actual fraudulent marketplace applications or documentation referred to the Justice Department or the U.S. Department of Health & Human Services’ Office of Inspector General. Following the findings, CMS officials said they plan to conduct an assessment of the marketplace’s eligibility determination process, including the application process, and consistency surrounding the resolution process.

“CMS places a strong emphasis on program integrity and builds program integrity features into all aspects of implementation of the law,” CMS officials stated in the report.

[email protected]

On Twitter @legal_med

Patient access or program integrity? The question of which need outweighs the other was the theme of a Senate Finance Committee hearing that discussed the erroneous approval of subsidies by healthcare.gov for fake patients.

An investigation by the Government Accountability Office (GAO) found the federal exchange approved 11 of 12 telephone and online applications for fictitious applicants and paid $30,000 in annual insurance credits for the fake patients over a 2-year period. Investigators provided fake documents to the government, including Social Security numbers and proof of income, but encountered no barriers to obtaining taxpayer-funded credits, according to the report released July 15.

The findings are troubling and do not speak well of the management of healthcare.gov, the protection of taxpayer dollars, or the experience of enrollees, Senate Finance Committee Chairman Orrin Hatch (R-Utah) said during a July 16 hearing.

“The GAO’s investigation exposes not only huge gaps in federal exchange program integrity, but also flaws in how the exchange and [Centers for Medicare & Medicaid Services] contractors treat Americans who are trying to file or correct legitimate applications,” Chairman Hatch said during his opening statement. “The fact that GAO encountered mind-boggling levels of incompetence and inefficiency at nearly every turn does not bode well for the experience of your average, honest enrollee.”

CMS officials did not testify at the hearing nor did they respond to requests for comment.

The GAO’s investigation covered the marketplace’s first open-enrollment period from Oct. 1, 2013 to March 31, 2014, as well as follow-on work through 2014 and 2015. As part of its “secret shopper” investigation, GAO created 18 fictitious identities to apply for premium subsidies through the federal exchange by telephone, online, and in-person. The fake applicants were able to get health insurance and subsidies with fictitious information in nearly all cases. For 7 of the 11 fictitious applicants, GAO intentionally did not submit all required documentation to the marketplace, but CMS did not cancel the subsidized coverage.

“While these subsidies, including those granted to GAO’s fictitious applicants, are paid to health care insurers, and not directly to enrolled consumers, they nevertheless represent a benefit to consumers and a cost to the government,” according to the report.

Among the report’s findings:

• Information transmitted to the IRS for 3 of 11 fictitious enrollees, such as coverage periods and subsidy amounts, was incorrect.

• The marketplace automatically reenrolled coverage for all 11 fictitious enrollees for 2015.

• CMS terminated coverage for 6 of the 11 enrollees in 2015, stating that the fictitious enrollees had not provided necessary documentation. On appeal, five were reinstated and awarded higher subsidies.

The GAO tests were designed to identify potential control weaknesses in the market enrollment process and to inform the agency’s ongoing audit of these controls, Seto J. Bagdoyan, GAO director of forensic audits and investigative service, said at the hearing. GAO plans to provide recommendations about control efforts in a forthcoming report.

“A program of this scope and scale is inherently at risk for errors, including in proper payment and fraudulent activities,” Mr. Bagdoyan testified. “Accordingly, it is essential there are effective enrollment controls in place to help narrow the window of opportunities for such risks.”

Mr. Bagoyan noted that in response to the findings, CMS stated that they had limited capacity to respond to attempts at fraud within enrollment, and that officials must balance consumers’ ability to access coverage with program integrity concerns.

Sen Ron Wyden (D-Ore.) stressed the importance of this balance in his opening statement. He largely criticized the report, noting the study analyzed only fictitious cases and none involved a real person who filed taxes or received medical care.

“Part of any smart, ferocious strategy against fraud, on one hand, is drawing a distinction between aggressively going after scammers, and on the other, not harming a law-abiding American who’s made an honest, often technical mistake,” said Sen. Wyden, ranking member of the Finance Committee. “A retiree nearing Medicare age shouldn’t get kicked to the curb because she accidentally submitted an incorrect document. A transgender American shouldn’t lose health coverage after a name change because some forms don’t match. I can’t imagine the Congress wants a system that nixes the health insurance coverage of Americans because of simple issues like those.”

In the GAO report, CMS officials stated that there have been no cases of actual fraudulent marketplace applications or documentation referred to the Justice Department or the U.S. Department of Health & Human Services’ Office of Inspector General. Following the findings, CMS officials said they plan to conduct an assessment of the marketplace’s eligibility determination process, including the application process, and consistency surrounding the resolution process.

“CMS places a strong emphasis on program integrity and builds program integrity features into all aspects of implementation of the law,” CMS officials stated in the report.

[email protected]

On Twitter @legal_med

Patient access or program integrity? The question of which need outweighs the other was the theme of a Senate Finance Committee hearing that discussed the erroneous approval of subsidies by healthcare.gov for fake patients.

An investigation by the Government Accountability Office (GAO) found the federal exchange approved 11 of 12 telephone and online applications for fictitious applicants and paid $30,000 in annual insurance credits for the fake patients over a 2-year period. Investigators provided fake documents to the government, including Social Security numbers and proof of income, but encountered no barriers to obtaining taxpayer-funded credits, according to the report released July 15.

The findings are troubling and do not speak well of the management of healthcare.gov, the protection of taxpayer dollars, or the experience of enrollees, Senate Finance Committee Chairman Orrin Hatch (R-Utah) said during a July 16 hearing.

“The GAO’s investigation exposes not only huge gaps in federal exchange program integrity, but also flaws in how the exchange and [Centers for Medicare & Medicaid Services] contractors treat Americans who are trying to file or correct legitimate applications,” Chairman Hatch said during his opening statement. “The fact that GAO encountered mind-boggling levels of incompetence and inefficiency at nearly every turn does not bode well for the experience of your average, honest enrollee.”

CMS officials did not testify at the hearing nor did they respond to requests for comment.

The GAO’s investigation covered the marketplace’s first open-enrollment period from Oct. 1, 2013 to March 31, 2014, as well as follow-on work through 2014 and 2015. As part of its “secret shopper” investigation, GAO created 18 fictitious identities to apply for premium subsidies through the federal exchange by telephone, online, and in-person. The fake applicants were able to get health insurance and subsidies with fictitious information in nearly all cases. For 7 of the 11 fictitious applicants, GAO intentionally did not submit all required documentation to the marketplace, but CMS did not cancel the subsidized coverage.

“While these subsidies, including those granted to GAO’s fictitious applicants, are paid to health care insurers, and not directly to enrolled consumers, they nevertheless represent a benefit to consumers and a cost to the government,” according to the report.

Among the report’s findings:

• Information transmitted to the IRS for 3 of 11 fictitious enrollees, such as coverage periods and subsidy amounts, was incorrect.

• The marketplace automatically reenrolled coverage for all 11 fictitious enrollees for 2015.

• CMS terminated coverage for 6 of the 11 enrollees in 2015, stating that the fictitious enrollees had not provided necessary documentation. On appeal, five were reinstated and awarded higher subsidies.

The GAO tests were designed to identify potential control weaknesses in the market enrollment process and to inform the agency’s ongoing audit of these controls, Seto J. Bagdoyan, GAO director of forensic audits and investigative service, said at the hearing. GAO plans to provide recommendations about control efforts in a forthcoming report.

“A program of this scope and scale is inherently at risk for errors, including in proper payment and fraudulent activities,” Mr. Bagdoyan testified. “Accordingly, it is essential there are effective enrollment controls in place to help narrow the window of opportunities for such risks.”

Mr. Bagoyan noted that in response to the findings, CMS stated that they had limited capacity to respond to attempts at fraud within enrollment, and that officials must balance consumers’ ability to access coverage with program integrity concerns.

Sen Ron Wyden (D-Ore.) stressed the importance of this balance in his opening statement. He largely criticized the report, noting the study analyzed only fictitious cases and none involved a real person who filed taxes or received medical care.

“Part of any smart, ferocious strategy against fraud, on one hand, is drawing a distinction between aggressively going after scammers, and on the other, not harming a law-abiding American who’s made an honest, often technical mistake,” said Sen. Wyden, ranking member of the Finance Committee. “A retiree nearing Medicare age shouldn’t get kicked to the curb because she accidentally submitted an incorrect document. A transgender American shouldn’t lose health coverage after a name change because some forms don’t match. I can’t imagine the Congress wants a system that nixes the health insurance coverage of Americans because of simple issues like those.”

In the GAO report, CMS officials stated that there have been no cases of actual fraudulent marketplace applications or documentation referred to the Justice Department or the U.S. Department of Health & Human Services’ Office of Inspector General. Following the findings, CMS officials said they plan to conduct an assessment of the marketplace’s eligibility determination process, including the application process, and consistency surrounding the resolution process.

“CMS places a strong emphasis on program integrity and builds program integrity features into all aspects of implementation of the law,” CMS officials stated in the report.

[email protected]

On Twitter @legal_med

Sustaining an independent practice in today’s medical landscape isn’t easy, but it’s possible with the right care model, strong partnerships, and solid negotiation power.

There is no one-size-fits-all approach to maintaining independence, said David W. Hilgers, an Austin, Tex., health law attorney who specializes in advising independent practices and integrating systems.

“It depends on the market you’re in and the specialty you’re in,” Mr. Hilgers said in an interview. “It all comes down to how much leverage you can have, if you’re willing to consolidate to get that leverage, and if you’re willing to spend the money to have the technology that you need.”

It’s no secret that more physicians are becoming hospital and health system employees, in large part to escape a growing burden of government regulations and reimbursement woes. A 2015 physician survey by national staffing company Jackson Healthcare found the top reasons that doctors leave private practice include the high cost of maintaining a medical practice, reimbursement cuts, and a desire to focus on practicing medicine and patient care – rather than administrative hassles. Another study, released July 8 by the American Medical Association, found the share of physicians who worked directly for a hospital, or in practices that had at least some hospital ownership, increased from 29% in 2012 to 33% percent in 2014. The number of doctors who owned a practice fell from 53% to 51% during the same time period.

However, the AMA data show the majority of physicians (61%) were still in small practices of 10 or fewer physicians, and that practice size hardly changed between 2012 and 2014. Experts say the findings point to a strong desire by doctors to remain autonomous.

“There are benefits to being employed by a hospital or health care system as far as a steady income, but there’s also something very satisfying to physicians about controlling their own destiny,” said Heather F. Delgado, a Chicago health law attorney, who specializes in compliance and regulatory matters. Ms. Delgado and Mr. Hilgers recently spoke at an American Bar Association (ABA) conference about how physicians can sustain an independent practice.

To retain autonomy, physicians in smaller practices may want to consider changing their care delivery model to a less traditional structure, such as the concierge model, Mr. Hilgers advised. Primary care physicians may be more suited to this model than other specialties, he noted.

“For a very small practice, if you want to stay in practice, you need to look at concierge care and see if you can make that work,” Mr. Hilgers said in an interview. “If you’re in a larger town, you’re going to have a very difficult time remaining independent. If you’re in a small town, you may be able to continue because the insurance companies need you, but your income is going to be limited.”

Starting or joining an accountable care organization (ACO) is a good option for mid- to large-sized practices, Mr. Hilgers said. Doctors will want to analyze the type of technology they need to efficiently operate an ACO, he noted. Successful ACOs must possess an information technology infrastructure with specific competencies to support governance, operational, and clinical goals objectives. It also helps to have a stable patient base to bring to the ACO.

“If you’re in a larger practice, you need to expand your reach so that they can’t do without you,” Mr. Hilgers said in an interview. “The insurance plans have to have you. You need to perhaps [participate in] your own Medicare Advantage plan so that you are generating revenue from the federal government and insurers directly. You need to start looking at being more than just a medical group, but taking advantage of these alternative types of insurance plans.”

Consolidating with other physicians can also help secure a more stable place in the market, added attorney Albert D. Hutzler, a financial analyst at a health care valuation consulting firm in Delray, Fla. Adding more doctors can give a practice more leverage with insurance companies and better negotiating power to set rates. But once a practice grows, it’s vital to pay attention to ongoing recruitment, said Mr. Hutzler, who also spoke during the recent ABA meeting.

“A stable physician base is very important,” he said in an interview. “You need the ability to recruit others. That way if things don’t work out with somebody, you’ve got to have others in the pipeline.”

Physician-hospital partnerships – rather than employement relationships – also can provide strategies to stay independent, said Ms. Delgado. For example, doctors could opt for a clinically integrated system in which they maintain their office practice but become a preferred provider of a hospital. Other options include entering into a medical directorship or management services deal with a hospital or agreeing to staff a hospital clinic several days a week, she said.

“Maybe you enter into an agreement with a hospital that wouldn’t mean you are employed, but gives you a relationship with them so that you can work with them,” Ms. Delgado said in an interview. “That way, you are able to remain independent, but [are] able to get some benefits from the hospital.”

high-number/Thinkstock.com

Doctors determined to retain their private practice must also be mindful of their collections efforts, Mr. Hutzler said. Most practices are going to have some debt on their books, he noted, but it should not grow out of control, nor should physicians constantly be borrowing against the practice. Additionally, practices should ensure their contracts with insurers are firm and that they are receiving payment as outlined in their agreements.

“You don’t want lose out in private practice just because you do an ineffective job collecting from payers,” Mr. Hutzler said in an interview. “You need a solid business office to make sure you’re getting everything you can out of your payer contracts.”

Whether it’s worth it to remain independent depends on the physician and his or her goals, Mr. Hutzler said.

“They both have their pros and cons,” he said. “You have to decide which set of risks that you want” to take on.

[email protected]

On Twitter @legal_med

Sustaining an independent practice in today’s medical landscape isn’t easy, but it’s possible with the right care model, strong partnerships, and solid negotiation power.

There is no one-size-fits-all approach to maintaining independence, said David W. Hilgers, an Austin, Tex., health law attorney who specializes in advising independent practices and integrating systems.

“It depends on the market you’re in and the specialty you’re in,” Mr. Hilgers said in an interview. “It all comes down to how much leverage you can have, if you’re willing to consolidate to get that leverage, and if you’re willing to spend the money to have the technology that you need.”

It’s no secret that more physicians are becoming hospital and health system employees, in large part to escape a growing burden of government regulations and reimbursement woes. A 2015 physician survey by national staffing company Jackson Healthcare found the top reasons that doctors leave private practice include the high cost of maintaining a medical practice, reimbursement cuts, and a desire to focus on practicing medicine and patient care – rather than administrative hassles. Another study, released July 8 by the American Medical Association, found the share of physicians who worked directly for a hospital, or in practices that had at least some hospital ownership, increased from 29% in 2012 to 33% percent in 2014. The number of doctors who owned a practice fell from 53% to 51% during the same time period.

However, the AMA data show the majority of physicians (61%) were still in small practices of 10 or fewer physicians, and that practice size hardly changed between 2012 and 2014. Experts say the findings point to a strong desire by doctors to remain autonomous.

“There are benefits to being employed by a hospital or health care system as far as a steady income, but there’s also something very satisfying to physicians about controlling their own destiny,” said Heather F. Delgado, a Chicago health law attorney, who specializes in compliance and regulatory matters. Ms. Delgado and Mr. Hilgers recently spoke at an American Bar Association (ABA) conference about how physicians can sustain an independent practice.

To retain autonomy, physicians in smaller practices may want to consider changing their care delivery model to a less traditional structure, such as the concierge model, Mr. Hilgers advised. Primary care physicians may be more suited to this model than other specialties, he noted.

“For a very small practice, if you want to stay in practice, you need to look at concierge care and see if you can make that work,” Mr. Hilgers said in an interview. “If you’re in a larger town, you’re going to have a very difficult time remaining independent. If you’re in a small town, you may be able to continue because the insurance companies need you, but your income is going to be limited.”

Starting or joining an accountable care organization (ACO) is a good option for mid- to large-sized practices, Mr. Hilgers said. Doctors will want to analyze the type of technology they need to efficiently operate an ACO, he noted. Successful ACOs must possess an information technology infrastructure with specific competencies to support governance, operational, and clinical goals objectives. It also helps to have a stable patient base to bring to the ACO.

“If you’re in a larger practice, you need to expand your reach so that they can’t do without you,” Mr. Hilgers said in an interview. “The insurance plans have to have you. You need to perhaps [participate in] your own Medicare Advantage plan so that you are generating revenue from the federal government and insurers directly. You need to start looking at being more than just a medical group, but taking advantage of these alternative types of insurance plans.”

Consolidating with other physicians can also help secure a more stable place in the market, added attorney Albert D. Hutzler, a financial analyst at a health care valuation consulting firm in Delray, Fla. Adding more doctors can give a practice more leverage with insurance companies and better negotiating power to set rates. But once a practice grows, it’s vital to pay attention to ongoing recruitment, said Mr. Hutzler, who also spoke during the recent ABA meeting.

“A stable physician base is very important,” he said in an interview. “You need the ability to recruit others. That way if things don’t work out with somebody, you’ve got to have others in the pipeline.”

Physician-hospital partnerships – rather than employement relationships – also can provide strategies to stay independent, said Ms. Delgado. For example, doctors could opt for a clinically integrated system in which they maintain their office practice but become a preferred provider of a hospital. Other options include entering into a medical directorship or management services deal with a hospital or agreeing to staff a hospital clinic several days a week, she said.

“Maybe you enter into an agreement with a hospital that wouldn’t mean you are employed, but gives you a relationship with them so that you can work with them,” Ms. Delgado said in an interview. “That way, you are able to remain independent, but [are] able to get some benefits from the hospital.”

high-number/Thinkstock.com

Doctors determined to retain their private practice must also be mindful of their collections efforts, Mr. Hutzler said. Most practices are going to have some debt on their books, he noted, but it should not grow out of control, nor should physicians constantly be borrowing against the practice. Additionally, practices should ensure their contracts with insurers are firm and that they are receiving payment as outlined in their agreements.

“You don’t want lose out in private practice just because you do an ineffective job collecting from payers,” Mr. Hutzler said in an interview. “You need a solid business office to make sure you’re getting everything you can out of your payer contracts.”

Whether it’s worth it to remain independent depends on the physician and his or her goals, Mr. Hutzler said.

“They both have their pros and cons,” he said. “You have to decide which set of risks that you want” to take on.

[email protected]

On Twitter @legal_med

Sustaining an independent practice in today’s medical landscape isn’t easy, but it’s possible with the right care model, strong partnerships, and solid negotiation power.

There is no one-size-fits-all approach to maintaining independence, said David W. Hilgers, an Austin, Tex., health law attorney who specializes in advising independent practices and integrating systems.

“It depends on the market you’re in and the specialty you’re in,” Mr. Hilgers said in an interview. “It all comes down to how much leverage you can have, if you’re willing to consolidate to get that leverage, and if you’re willing to spend the money to have the technology that you need.”

It’s no secret that more physicians are becoming hospital and health system employees, in large part to escape a growing burden of government regulations and reimbursement woes. A 2015 physician survey by national staffing company Jackson Healthcare found the top reasons that doctors leave private practice include the high cost of maintaining a medical practice, reimbursement cuts, and a desire to focus on practicing medicine and patient care – rather than administrative hassles. Another study, released July 8 by the American Medical Association, found the share of physicians who worked directly for a hospital, or in practices that had at least some hospital ownership, increased from 29% in 2012 to 33% percent in 2014. The number of doctors who owned a practice fell from 53% to 51% during the same time period.

However, the AMA data show the majority of physicians (61%) were still in small practices of 10 or fewer physicians, and that practice size hardly changed between 2012 and 2014. Experts say the findings point to a strong desire by doctors to remain autonomous.

“There are benefits to being employed by a hospital or health care system as far as a steady income, but there’s also something very satisfying to physicians about controlling their own destiny,” said Heather F. Delgado, a Chicago health law attorney, who specializes in compliance and regulatory matters. Ms. Delgado and Mr. Hilgers recently spoke at an American Bar Association (ABA) conference about how physicians can sustain an independent practice.

To retain autonomy, physicians in smaller practices may want to consider changing their care delivery model to a less traditional structure, such as the concierge model, Mr. Hilgers advised. Primary care physicians may be more suited to this model than other specialties, he noted.

“For a very small practice, if you want to stay in practice, you need to look at concierge care and see if you can make that work,” Mr. Hilgers said in an interview. “If you’re in a larger town, you’re going to have a very difficult time remaining independent. If you’re in a small town, you may be able to continue because the insurance companies need you, but your income is going to be limited.”

Starting or joining an accountable care organization (ACO) is a good option for mid- to large-sized practices, Mr. Hilgers said. Doctors will want to analyze the type of technology they need to efficiently operate an ACO, he noted. Successful ACOs must possess an information technology infrastructure with specific competencies to support governance, operational, and clinical goals objectives. It also helps to have a stable patient base to bring to the ACO.

“If you’re in a larger practice, you need to expand your reach so that they can’t do without you,” Mr. Hilgers said in an interview. “The insurance plans have to have you. You need to perhaps [participate in] your own Medicare Advantage plan so that you are generating revenue from the federal government and insurers directly. You need to start looking at being more than just a medical group, but taking advantage of these alternative types of insurance plans.”

Consolidating with other physicians can also help secure a more stable place in the market, added attorney Albert D. Hutzler, a financial analyst at a health care valuation consulting firm in Delray, Fla. Adding more doctors can give a practice more leverage with insurance companies and better negotiating power to set rates. But once a practice grows, it’s vital to pay attention to ongoing recruitment, said Mr. Hutzler, who also spoke during the recent ABA meeting.

“A stable physician base is very important,” he said in an interview. “You need the ability to recruit others. That way if things don’t work out with somebody, you’ve got to have others in the pipeline.”

Physician-hospital partnerships – rather than employement relationships – also can provide strategies to stay independent, said Ms. Delgado. For example, doctors could opt for a clinically integrated system in which they maintain their office practice but become a preferred provider of a hospital. Other options include entering into a medical directorship or management services deal with a hospital or agreeing to staff a hospital clinic several days a week, she said.

“Maybe you enter into an agreement with a hospital that wouldn’t mean you are employed, but gives you a relationship with them so that you can work with them,” Ms. Delgado said in an interview. “That way, you are able to remain independent, but [are] able to get some benefits from the hospital.”

high-number/Thinkstock.com

Doctors determined to retain their private practice must also be mindful of their collections efforts, Mr. Hutzler said. Most practices are going to have some debt on their books, he noted, but it should not grow out of control, nor should physicians constantly be borrowing against the practice. Additionally, practices should ensure their contracts with insurers are firm and that they are receiving payment as outlined in their agreements.

“You don’t want lose out in private practice just because you do an ineffective job collecting from payers,” Mr. Hutzler said in an interview. “You need a solid business office to make sure you’re getting everything you can out of your payer contracts.”

Whether it’s worth it to remain independent depends on the physician and his or her goals, Mr. Hutzler said.

“They both have their pros and cons,” he said. “You have to decide which set of risks that you want” to take on.

[email protected]

On Twitter @legal_med

Pay close attention to the outcomes of three cases winding their way through the courts this summer, legal experts advise.

On deck are cases that could reshape Stark Law, the Anti-kickback Statute, and the 60-day federal overpayment rule. Decisions on these cases could affect billing practices and practices arrangements, as well as federal reporting obligations. Below is a selection of critical health law cases facing doctors and how they might impact practice.

1. Council for Urological Interests v. Sylvia Burwell et al.

Summary: This case centers on whether the federal Stark Law can prevent physicians from referring patients to hospitals to which the physicians lease equipment, among other things. In 2008, the U.S. Department of Health & Human Services (HHS) issued regulations that effectively prohibit physicians who lease medical equipment to hospitals from referring their Medicare patients to these same hospitals for outpatient care involving that equipment. The regulation prohibits physicians from charging hospitals for the leased equipment on a per-use basis, or a “per-click” basis as it is commonly known. In 2009, the Council for Urological Interests – a nonprofit corporation owned by urologists – sued, claiming the text and legislative history of the Stark Law preclude the HHS from enforcing the per-click ban. The regulation limits the ability of physicians who own joint ventures to refer their patients to receive services under these arrangements, the plaintiffs said. A district court ruled in favor of the HHS, and the Council appealed. A spokeswoman for the U.S. Department of Justice declined to comment for this story.

Case status: In June 2015, the U.S. Court of Appeals for the District of Columbia Circuit ruled that the HHS must reconsider its per-click referral ban. The court suggested that the agency may have misconstrued the legislative history of the Stark Law in order to enact the rule.

Why doctors should care: The ultimate outcome of the case will determine whether or not physicians can engage in per-click leases under Stark Law, said Chicago health law attorney Ericka L. Adler.

“When HHS changed the regulations to no longer allow the per-click arrangement where physicians were self-referring, it caused a lot of deals to be undone,” Ms. Adler said in an interview. “[Certainly], these lease arrangements could, in many cases, be restructured to look more like normal leases and meet the Stark equipment lease exception, but in some cases it created hardships, such as in rural areas.”

Reconsideration of the regulation could mean that the HHS creates more appropriate carve-outs to the rule, Ms. Adler noted.

In the meantime, the appeals court ruling means the per-click ban cannot be enforced while the government reconsiders, which is a positive development for physicians, said Washington health law attorney Thomas L. Mills, who represented the Council for Urological Interests.

“CMS’ permitting per-click leases to non–physician-owned companies while banning them for physician-owned entities made no sense, particularly when the medical procedure is not susceptible to overuse,” Mr. Mills said in an interview. “Perhaps more importantly, the [appeals] decision is a victory for the rule of law. It shows that CMS does not have carte blanche to disadvantage physicians by steering control of the implements of their practices to less important participants in the health care delivery system. ... Physicians should be free to band together to purchase the equipment they believe will provide the most effective treatment for their patients, instead of being forced to rely on the arbitrary procurement decisions of hospitals.”

2. United States v. Continuum Health Partners Inc.

Summary: The federal government contends that three hospitals failed to return overpayments to Medicaid in violation of an Affordable Care Act requirement that they be reported and repaid within 60 days of identification. The government alleges that because of a computer glitch, three hospitals that are operated by Continuum Health Partners Inc., billed both the government and a managed care organization (MCO) for the same services. After the New York State Comptroller’s Office alerted Continuum to a possible overbilling, Continuum conducted an internal investigation and allegedly found 900 potentially improper Medicaid claims totaling $1 million, according to court documents. The government claims that Continuum failed to repay the overpayments within 60 days and instead repaid only “small batches” of the affected claims over the next 2 years. Continuum argues that the hospitals did not knowingly conceal the overpayments from the government and that the overbillings had not been officially identified. Rather, Continuum argues there is only evidence that administrators discussed potential overpayments. The “mere notice of a potential overpayment does not give rise to an established duty until 60 days after the overpayment is identified,” Continuum said in court documents. Attorneys for the government and for Continuum did not return messages seeking comment.

Case status: The case is before the U.S. District Court for the Southern District of New York.

Why doctors should care: The Continuum case will provide significant guidance to health providers about the ACA 60-day overpayment rule, said Houston health law attorney Micheal E. Clark, who chairs the America Bar Association Health Law Section. As it stands, the federal rule is somewhat unclear, leading to confusion for doctors about their reporting obligations, he said.

“The agency hasn’t really defined what is ‘knowing,’ what is reasonable knowledge of a known overpayment,” Mr. Clark said in an interview. “It’s a gray area. [The ruling] will be very informative about what this is actually going to mean.”

3. Ameritox v. Millennium Laboratories

Summary: Ameritox revolves around whether a laboratory’s giveaway of urine specimen cups to physicians amounted to an illegal kickback. In 2012, lab testing company Ameritox sued Millennium in a Florida district court alleging that Millennium harmed its business by giving the urine cups to doctors in violation of the Stark Law. Physicians used the cups – which have chemically activated strips that contain patient information – to monitor patients’ use of pain medications. Millennium unlawfully obtained physician referrals through free cup agreements, according to Ameritox’s complaint. A federal jury found Millennium had violated the Stark Law as well as the Anti-Kickback Statute by providing the free cups in exchange for referrals and Ameritox was awarded $11 million. Attorneys for both parties did not return messages seeking comment.

Case status: Millennium appealed, and the case is before the 11th U.S. Circuit Court of Appeals. The federal Justice Department has weighed in on the side of Ameritox, arguing that the cup giveaway violated Stark Law and the Anti-Kickback Statute.

Why doctors should care: The Ameritox case makes it clear that doctors should never accept free point-of-care testing cups or similar medical equipment from a lab, said health law attorney Adrienne Dresevic of Southfield, Mich. The case also highlights the broad spectrum of “remuneration,” when it comes to free items or services to doctors, she noted. Under the Anti-Kickback Statute, remuneration refers to the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind.

“The takeaways in Ameritox are applicable to other relationships, such as in the radiology realm,” Ms. Dresevic said in an interview. “Physicians should closely scrutinize any free items or services offered to them to ensure it falls within the exception to what is considered ‘remuneration.’ ”

Exceptions to remuneration could include payments that are a return on an investment interest, such as a dividend or interest income. However, physicians should ensure they are familiar with all exceptions to the law before entering into such agreements, experts advise.

The Ameritox case is important for physicians because more laboratories are approaching doctors with various “arrangements,” and touting that the arrangements are compliant with federal regulations, Ms. Dresevic added. Many doctors are taking the labs’ word for the arrangements’ legality, leading to serious legal risk.

“Physicians need to know how to look beyond what the laboratory representative is presenting to them and make their own determinations, sometimes with the help of health care counsel, regarding the legality of a particular arrangement,” she said.

[email protected]

On Twitter @legal_med

Pay close attention to the outcomes of three cases winding their way through the courts this summer, legal experts advise.

On deck are cases that could reshape Stark Law, the Anti-kickback Statute, and the 60-day federal overpayment rule. Decisions on these cases could affect billing practices and practices arrangements, as well as federal reporting obligations. Below is a selection of critical health law cases facing doctors and how they might impact practice.

1. Council for Urological Interests v. Sylvia Burwell et al.

Summary: This case centers on whether the federal Stark Law can prevent physicians from referring patients to hospitals to which the physicians lease equipment, among other things. In 2008, the U.S. Department of Health & Human Services (HHS) issued regulations that effectively prohibit physicians who lease medical equipment to hospitals from referring their Medicare patients to these same hospitals for outpatient care involving that equipment. The regulation prohibits physicians from charging hospitals for the leased equipment on a per-use basis, or a “per-click” basis as it is commonly known. In 2009, the Council for Urological Interests – a nonprofit corporation owned by urologists – sued, claiming the text and legislative history of the Stark Law preclude the HHS from enforcing the per-click ban. The regulation limits the ability of physicians who own joint ventures to refer their patients to receive services under these arrangements, the plaintiffs said. A district court ruled in favor of the HHS, and the Council appealed. A spokeswoman for the U.S. Department of Justice declined to comment for this story.

Case status: In June 2015, the U.S. Court of Appeals for the District of Columbia Circuit ruled that the HHS must reconsider its per-click referral ban. The court suggested that the agency may have misconstrued the legislative history of the Stark Law in order to enact the rule.

Why doctors should care: The ultimate outcome of the case will determine whether or not physicians can engage in per-click leases under Stark Law, said Chicago health law attorney Ericka L. Adler.

“When HHS changed the regulations to no longer allow the per-click arrangement where physicians were self-referring, it caused a lot of deals to be undone,” Ms. Adler said in an interview. “[Certainly], these lease arrangements could, in many cases, be restructured to look more like normal leases and meet the Stark equipment lease exception, but in some cases it created hardships, such as in rural areas.”

Reconsideration of the regulation could mean that the HHS creates more appropriate carve-outs to the rule, Ms. Adler noted.

In the meantime, the appeals court ruling means the per-click ban cannot be enforced while the government reconsiders, which is a positive development for physicians, said Washington health law attorney Thomas L. Mills, who represented the Council for Urological Interests.

“CMS’ permitting per-click leases to non–physician-owned companies while banning them for physician-owned entities made no sense, particularly when the medical procedure is not susceptible to overuse,” Mr. Mills said in an interview. “Perhaps more importantly, the [appeals] decision is a victory for the rule of law. It shows that CMS does not have carte blanche to disadvantage physicians by steering control of the implements of their practices to less important participants in the health care delivery system. ... Physicians should be free to band together to purchase the equipment they believe will provide the most effective treatment for their patients, instead of being forced to rely on the arbitrary procurement decisions of hospitals.”

2. United States v. Continuum Health Partners Inc.

Summary: The federal government contends that three hospitals failed to return overpayments to Medicaid in violation of an Affordable Care Act requirement that they be reported and repaid within 60 days of identification. The government alleges that because of a computer glitch, three hospitals that are operated by Continuum Health Partners Inc., billed both the government and a managed care organization (MCO) for the same services. After the New York State Comptroller’s Office alerted Continuum to a possible overbilling, Continuum conducted an internal investigation and allegedly found 900 potentially improper Medicaid claims totaling $1 million, according to court documents. The government claims that Continuum failed to repay the overpayments within 60 days and instead repaid only “small batches” of the affected claims over the next 2 years. Continuum argues that the hospitals did not knowingly conceal the overpayments from the government and that the overbillings had not been officially identified. Rather, Continuum argues there is only evidence that administrators discussed potential overpayments. The “mere notice of a potential overpayment does not give rise to an established duty until 60 days after the overpayment is identified,” Continuum said in court documents. Attorneys for the government and for Continuum did not return messages seeking comment.

Case status: The case is before the U.S. District Court for the Southern District of New York.

Why doctors should care: The Continuum case will provide significant guidance to health providers about the ACA 60-day overpayment rule, said Houston health law attorney Micheal E. Clark, who chairs the America Bar Association Health Law Section. As it stands, the federal rule is somewhat unclear, leading to confusion for doctors about their reporting obligations, he said.

“The agency hasn’t really defined what is ‘knowing,’ what is reasonable knowledge of a known overpayment,” Mr. Clark said in an interview. “It’s a gray area. [The ruling] will be very informative about what this is actually going to mean.”

3. Ameritox v. Millennium Laboratories

Summary: Ameritox revolves around whether a laboratory’s giveaway of urine specimen cups to physicians amounted to an illegal kickback. In 2012, lab testing company Ameritox sued Millennium in a Florida district court alleging that Millennium harmed its business by giving the urine cups to doctors in violation of the Stark Law. Physicians used the cups – which have chemically activated strips that contain patient information – to monitor patients’ use of pain medications. Millennium unlawfully obtained physician referrals through free cup agreements, according to Ameritox’s complaint. A federal jury found Millennium had violated the Stark Law as well as the Anti-Kickback Statute by providing the free cups in exchange for referrals and Ameritox was awarded $11 million. Attorneys for both parties did not return messages seeking comment.

Case status: Millennium appealed, and the case is before the 11th U.S. Circuit Court of Appeals. The federal Justice Department has weighed in on the side of Ameritox, arguing that the cup giveaway violated Stark Law and the Anti-Kickback Statute.

Why doctors should care: The Ameritox case makes it clear that doctors should never accept free point-of-care testing cups or similar medical equipment from a lab, said health law attorney Adrienne Dresevic of Southfield, Mich. The case also highlights the broad spectrum of “remuneration,” when it comes to free items or services to doctors, she noted. Under the Anti-Kickback Statute, remuneration refers to the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind.

“The takeaways in Ameritox are applicable to other relationships, such as in the radiology realm,” Ms. Dresevic said in an interview. “Physicians should closely scrutinize any free items or services offered to them to ensure it falls within the exception to what is considered ‘remuneration.’ ”

Exceptions to remuneration could include payments that are a return on an investment interest, such as a dividend or interest income. However, physicians should ensure they are familiar with all exceptions to the law before entering into such agreements, experts advise.

The Ameritox case is important for physicians because more laboratories are approaching doctors with various “arrangements,” and touting that the arrangements are compliant with federal regulations, Ms. Dresevic added. Many doctors are taking the labs’ word for the arrangements’ legality, leading to serious legal risk.

“Physicians need to know how to look beyond what the laboratory representative is presenting to them and make their own determinations, sometimes with the help of health care counsel, regarding the legality of a particular arrangement,” she said.

[email protected]

On Twitter @legal_med

Pay close attention to the outcomes of three cases winding their way through the courts this summer, legal experts advise.

On deck are cases that could reshape Stark Law, the Anti-kickback Statute, and the 60-day federal overpayment rule. Decisions on these cases could affect billing practices and practices arrangements, as well as federal reporting obligations. Below is a selection of critical health law cases facing doctors and how they might impact practice.

1. Council for Urological Interests v. Sylvia Burwell et al.

Summary: This case centers on whether the federal Stark Law can prevent physicians from referring patients to hospitals to which the physicians lease equipment, among other things. In 2008, the U.S. Department of Health & Human Services (HHS) issued regulations that effectively prohibit physicians who lease medical equipment to hospitals from referring their Medicare patients to these same hospitals for outpatient care involving that equipment. The regulation prohibits physicians from charging hospitals for the leased equipment on a per-use basis, or a “per-click” basis as it is commonly known. In 2009, the Council for Urological Interests – a nonprofit corporation owned by urologists – sued, claiming the text and legislative history of the Stark Law preclude the HHS from enforcing the per-click ban. The regulation limits the ability of physicians who own joint ventures to refer their patients to receive services under these arrangements, the plaintiffs said. A district court ruled in favor of the HHS, and the Council appealed. A spokeswoman for the U.S. Department of Justice declined to comment for this story.

Case status: In June 2015, the U.S. Court of Appeals for the District of Columbia Circuit ruled that the HHS must reconsider its per-click referral ban. The court suggested that the agency may have misconstrued the legislative history of the Stark Law in order to enact the rule.

Why doctors should care: The ultimate outcome of the case will determine whether or not physicians can engage in per-click leases under Stark Law, said Chicago health law attorney Ericka L. Adler.

“When HHS changed the regulations to no longer allow the per-click arrangement where physicians were self-referring, it caused a lot of deals to be undone,” Ms. Adler said in an interview. “[Certainly], these lease arrangements could, in many cases, be restructured to look more like normal leases and meet the Stark equipment lease exception, but in some cases it created hardships, such as in rural areas.”

Reconsideration of the regulation could mean that the HHS creates more appropriate carve-outs to the rule, Ms. Adler noted.

In the meantime, the appeals court ruling means the per-click ban cannot be enforced while the government reconsiders, which is a positive development for physicians, said Washington health law attorney Thomas L. Mills, who represented the Council for Urological Interests.

“CMS’ permitting per-click leases to non–physician-owned companies while banning them for physician-owned entities made no sense, particularly when the medical procedure is not susceptible to overuse,” Mr. Mills said in an interview. “Perhaps more importantly, the [appeals] decision is a victory for the rule of law. It shows that CMS does not have carte blanche to disadvantage physicians by steering control of the implements of their practices to less important participants in the health care delivery system. ... Physicians should be free to band together to purchase the equipment they believe will provide the most effective treatment for their patients, instead of being forced to rely on the arbitrary procurement decisions of hospitals.”

2. United States v. Continuum Health Partners Inc.

Summary: The federal government contends that three hospitals failed to return overpayments to Medicaid in violation of an Affordable Care Act requirement that they be reported and repaid within 60 days of identification. The government alleges that because of a computer glitch, three hospitals that are operated by Continuum Health Partners Inc., billed both the government and a managed care organization (MCO) for the same services. After the New York State Comptroller’s Office alerted Continuum to a possible overbilling, Continuum conducted an internal investigation and allegedly found 900 potentially improper Medicaid claims totaling $1 million, according to court documents. The government claims that Continuum failed to repay the overpayments within 60 days and instead repaid only “small batches” of the affected claims over the next 2 years. Continuum argues that the hospitals did not knowingly conceal the overpayments from the government and that the overbillings had not been officially identified. Rather, Continuum argues there is only evidence that administrators discussed potential overpayments. The “mere notice of a potential overpayment does not give rise to an established duty until 60 days after the overpayment is identified,” Continuum said in court documents. Attorneys for the government and for Continuum did not return messages seeking comment.

Case status: The case is before the U.S. District Court for the Southern District of New York.

Why doctors should care: The Continuum case will provide significant guidance to health providers about the ACA 60-day overpayment rule, said Houston health law attorney Micheal E. Clark, who chairs the America Bar Association Health Law Section. As it stands, the federal rule is somewhat unclear, leading to confusion for doctors about their reporting obligations, he said.

“The agency hasn’t really defined what is ‘knowing,’ what is reasonable knowledge of a known overpayment,” Mr. Clark said in an interview. “It’s a gray area. [The ruling] will be very informative about what this is actually going to mean.”

3. Ameritox v. Millennium Laboratories

Summary: Ameritox revolves around whether a laboratory’s giveaway of urine specimen cups to physicians amounted to an illegal kickback. In 2012, lab testing company Ameritox sued Millennium in a Florida district court alleging that Millennium harmed its business by giving the urine cups to doctors in violation of the Stark Law. Physicians used the cups – which have chemically activated strips that contain patient information – to monitor patients’ use of pain medications. Millennium unlawfully obtained physician referrals through free cup agreements, according to Ameritox’s complaint. A federal jury found Millennium had violated the Stark Law as well as the Anti-Kickback Statute by providing the free cups in exchange for referrals and Ameritox was awarded $11 million. Attorneys for both parties did not return messages seeking comment.

Case status: Millennium appealed, and the case is before the 11th U.S. Circuit Court of Appeals. The federal Justice Department has weighed in on the side of Ameritox, arguing that the cup giveaway violated Stark Law and the Anti-Kickback Statute.

Why doctors should care: The Ameritox case makes it clear that doctors should never accept free point-of-care testing cups or similar medical equipment from a lab, said health law attorney Adrienne Dresevic of Southfield, Mich. The case also highlights the broad spectrum of “remuneration,” when it comes to free items or services to doctors, she noted. Under the Anti-Kickback Statute, remuneration refers to the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind.

“The takeaways in Ameritox are applicable to other relationships, such as in the radiology realm,” Ms. Dresevic said in an interview. “Physicians should closely scrutinize any free items or services offered to them to ensure it falls within the exception to what is considered ‘remuneration.’ ”

Exceptions to remuneration could include payments that are a return on an investment interest, such as a dividend or interest income. However, physicians should ensure they are familiar with all exceptions to the law before entering into such agreements, experts advise.

The Ameritox case is important for physicians because more laboratories are approaching doctors with various “arrangements,” and touting that the arrangements are compliant with federal regulations, Ms. Dresevic added. Many doctors are taking the labs’ word for the arrangements’ legality, leading to serious legal risk.

“Physicians need to know how to look beyond what the laboratory representative is presenting to them and make their own determinations, sometimes with the help of health care counsel, regarding the legality of a particular arrangement,” she said.

[email protected]

On Twitter @legal_med