TBD Meeting (5214-17)

 

CHICAGO – As the epidemic of opioid addiction and overdose deaths continues to surge, state and federal authorities are keeping a close eye on physicians who prescribe controlled substances.

Experts offer the following guidance on how well-meaning doctors can avoid coming under scrutiny for prescribing opioids and successfully manage investigations and audits.

1. Know who’s on the radar: The Drug Enforcement Agency (DEA) compiles a “black list” yearly of physicians and health care providers they plan to target for audits, said Natalia Mazina, a San Francisco–based attorney who specializes in health and pharmacy law. For 2017, the list includes physicians who have prior noncompliance records, providers who specialize in pain management, and those who dispense or administer large quantities of controlled substances.

However, physicians also can be randomly audited without falling under these categories, Ms. Mazina said during an interview at a conference held by the American Bar Association. Last year, for example, the DEA conducted random security audits to ensure security compliance controls were in place at certain practices that prescribed controlled substances.

In addition, family physicians, psychiatrists, and other specialists who come under investigation by a state medical board because of suspected inappropriate prescribing or reporting violations may also come under the purview of federal authorities, Ms. Mazina said.

“If they come on the medical board radar, they may come on the [DEA’s] radar as well,” she said during the interview. “They just have to watch how many prescriptions they write for controlled substances and make sure they are legitimate prescriptions.”

 

2. Maintain proper records: Poor record keeping is a top reason that the DEA investigates health care providers for potential prescribing violations, said Dennis A. Wichern, a DEA agent with the Chicago Field Division. Federal law requires that registered practitioners who store or dispense controlled substances keep records of controlled substances coming in and out of the practice. That includes physicians who hand out samples of controlled substances to patients and also pertains to samples provided to doctors by pharmaceutical companies.

Alicia Gallegos/Frontline Medical News

“Think bank, checkbook, and money; if you have controlled substances, you need to keep the same records,” Mr. Wichern said during the meeting. “If you’re dispensing drugs at your office, you have to keep dispensing records. It seems like most providers are unaware of this.”

Records should include whether the inventory was taken at the beginning or close of business, names of controlled substances, each finished form of the substances, the number of dosage units of each finished form in the commercial container, the number of commercial containers of each finished form, and disposition of the controlled substances.

Law requires that physicians take a new inventory of all controlled substances on hand every 2 years. Doctors are not required to keep records of controlled substances that are merely prescribed, unless such substances are prescribed in the course of maintenance or detoxification treatment.

Ms. Mazina notes that there are many software platforms that can assist practices with proper inventory and record keeping for opioids and other drugs.

 

3. Check the state database: Before prescribing opioids, check your state’s prescription drug monitoring program (PDMP) database, advises Ms. Mazina. At least 37 states have operational PDMPs that receive and distribute controlled substance prescription information to authorized users. About 11 states have enacted legislation to establish a PDMP, but some databases are not fully operational.

A state’s PDMP can reveal whether patients may be obtaining multiple controlled substance prescriptions from different doctors or doctor-shopping, Ms. Mazina said. Such due diligence helps inform treatment decisions and can assist a doctor’s case if a medical board or DEA investigation later arises.

“Even if your state law does not require you to check a patient’s history prior to prescribing, you have to check it to protect yourself,” she said. “If you want to avoid controlled substances problems, PDMP is the way to go.”

4. Establish an audit response plan: Have an audit response plan ready to roll should an inquiry arise, experts advise. The policies ensure that only approved information is released to authorities, and that all staff members are on the same page about how to react to audits, Ms. Mazina said.

Plans should clearly state what information can be collected and what data should be kept confidential. Financial information, for example, should be off limits, she said. Government agents are entitled to inventory, dispensary data, and records of receipts.

“Agents very often do the mirror image of the database, and they get too much information,” she said. “You don’t want to [allow] that.”

Train staff members how to respond to government authorities seeking audit information, and explain they have the right to refuse being interviewed, Ms. Mazina said.

“Train your employees on what’s going to happen if the DEA comes in,” she said. “If I don’t have clear policies and procedures, and I’m not trained, I might disclose everything and blame someone. That puts everyone in a [bad] position, because [authorities] will record everything and use it against [the practice].”

 

5. Confer with the experts: It doesn’t hurt to consult with other medical professionals, such as emergency physicians or pain management specialists, for practical advice on inventory policies or software suggestions. But when it comes to staying updated on new drug laws and regulations, confer with a health law attorney or compliance officer, Ms. Mazina said. The DEA website also includes useful information about recent laws and rules pertaining to prescription drugs, as does the Centers for Disease Control and Prevention website.

If an investigation or audit emerges, work with an attorney as early as possible. Often, practices wait until too late after an investigation begins to contact legal counsel, Ms. Mazina noted. The earlier an attorney gets involved, the sooner that person can build a strong case for the practice and work toward the best resolution.

“Very often, the physician thinks they are right, and there’s nothing for them to fear,” she said. “There is something for you to fear. There’s a lot at stake.”

[email protected]

On Twitter @legal_med

 

CHICAGO – As the epidemic of opioid addiction and overdose deaths continues to surge, state and federal authorities are keeping a close eye on physicians who prescribe controlled substances.

Experts offer the following guidance on how well-meaning doctors can avoid coming under scrutiny for prescribing opioids and successfully manage investigations and audits.

1. Know who’s on the radar: The Drug Enforcement Agency (DEA) compiles a “black list” yearly of physicians and health care providers they plan to target for audits, said Natalia Mazina, a San Francisco–based attorney who specializes in health and pharmacy law. For 2017, the list includes physicians who have prior noncompliance records, providers who specialize in pain management, and those who dispense or administer large quantities of controlled substances.

However, physicians also can be randomly audited without falling under these categories, Ms. Mazina said during an interview at a conference held by the American Bar Association. Last year, for example, the DEA conducted random security audits to ensure security compliance controls were in place at certain practices that prescribed controlled substances.

In addition, family physicians, psychiatrists, and other specialists who come under investigation by a state medical board because of suspected inappropriate prescribing or reporting violations may also come under the purview of federal authorities, Ms. Mazina said.

“If they come on the medical board radar, they may come on the [DEA’s] radar as well,” she said during the interview. “They just have to watch how many prescriptions they write for controlled substances and make sure they are legitimate prescriptions.”

 

2. Maintain proper records: Poor record keeping is a top reason that the DEA investigates health care providers for potential prescribing violations, said Dennis A. Wichern, a DEA agent with the Chicago Field Division. Federal law requires that registered practitioners who store or dispense controlled substances keep records of controlled substances coming in and out of the practice. That includes physicians who hand out samples of controlled substances to patients and also pertains to samples provided to doctors by pharmaceutical companies.

Alicia Gallegos/Frontline Medical News

“Think bank, checkbook, and money; if you have controlled substances, you need to keep the same records,” Mr. Wichern said during the meeting. “If you’re dispensing drugs at your office, you have to keep dispensing records. It seems like most providers are unaware of this.”

Records should include whether the inventory was taken at the beginning or close of business, names of controlled substances, each finished form of the substances, the number of dosage units of each finished form in the commercial container, the number of commercial containers of each finished form, and disposition of the controlled substances.

Law requires that physicians take a new inventory of all controlled substances on hand every 2 years. Doctors are not required to keep records of controlled substances that are merely prescribed, unless such substances are prescribed in the course of maintenance or detoxification treatment.

Ms. Mazina notes that there are many software platforms that can assist practices with proper inventory and record keeping for opioids and other drugs.

 

3. Check the state database: Before prescribing opioids, check your state’s prescription drug monitoring program (PDMP) database, advises Ms. Mazina. At least 37 states have operational PDMPs that receive and distribute controlled substance prescription information to authorized users. About 11 states have enacted legislation to establish a PDMP, but some databases are not fully operational.

A state’s PDMP can reveal whether patients may be obtaining multiple controlled substance prescriptions from different doctors or doctor-shopping, Ms. Mazina said. Such due diligence helps inform treatment decisions and can assist a doctor’s case if a medical board or DEA investigation later arises.

“Even if your state law does not require you to check a patient’s history prior to prescribing, you have to check it to protect yourself,” she said. “If you want to avoid controlled substances problems, PDMP is the way to go.”

4. Establish an audit response plan: Have an audit response plan ready to roll should an inquiry arise, experts advise. The policies ensure that only approved information is released to authorities, and that all staff members are on the same page about how to react to audits, Ms. Mazina said.

Plans should clearly state what information can be collected and what data should be kept confidential. Financial information, for example, should be off limits, she said. Government agents are entitled to inventory, dispensary data, and records of receipts.

“Agents very often do the mirror image of the database, and they get too much information,” she said. “You don’t want to [allow] that.”

Train staff members how to respond to government authorities seeking audit information, and explain they have the right to refuse being interviewed, Ms. Mazina said.

“Train your employees on what’s going to happen if the DEA comes in,” she said. “If I don’t have clear policies and procedures, and I’m not trained, I might disclose everything and blame someone. That puts everyone in a [bad] position, because [authorities] will record everything and use it against [the practice].”

 

5. Confer with the experts: It doesn’t hurt to consult with other medical professionals, such as emergency physicians or pain management specialists, for practical advice on inventory policies or software suggestions. But when it comes to staying updated on new drug laws and regulations, confer with a health law attorney or compliance officer, Ms. Mazina said. The DEA website also includes useful information about recent laws and rules pertaining to prescription drugs, as does the Centers for Disease Control and Prevention website.

If an investigation or audit emerges, work with an attorney as early as possible. Often, practices wait until too late after an investigation begins to contact legal counsel, Ms. Mazina noted. The earlier an attorney gets involved, the sooner that person can build a strong case for the practice and work toward the best resolution.

“Very often, the physician thinks they are right, and there’s nothing for them to fear,” she said. “There is something for you to fear. There’s a lot at stake.”

[email protected]

On Twitter @legal_med

 

CHICAGO – As the epidemic of opioid addiction and overdose deaths continues to surge, state and federal authorities are keeping a close eye on physicians who prescribe controlled substances.

Experts offer the following guidance on how well-meaning doctors can avoid coming under scrutiny for prescribing opioids and successfully manage investigations and audits.

1. Know who’s on the radar: The Drug Enforcement Agency (DEA) compiles a “black list” yearly of physicians and health care providers they plan to target for audits, said Natalia Mazina, a San Francisco–based attorney who specializes in health and pharmacy law. For 2017, the list includes physicians who have prior noncompliance records, providers who specialize in pain management, and those who dispense or administer large quantities of controlled substances.

However, physicians also can be randomly audited without falling under these categories, Ms. Mazina said during an interview at a conference held by the American Bar Association. Last year, for example, the DEA conducted random security audits to ensure security compliance controls were in place at certain practices that prescribed controlled substances.

In addition, family physicians, psychiatrists, and other specialists who come under investigation by a state medical board because of suspected inappropriate prescribing or reporting violations may also come under the purview of federal authorities, Ms. Mazina said.

“If they come on the medical board radar, they may come on the [DEA’s] radar as well,” she said during the interview. “They just have to watch how many prescriptions they write for controlled substances and make sure they are legitimate prescriptions.”

 

2. Maintain proper records: Poor record keeping is a top reason that the DEA investigates health care providers for potential prescribing violations, said Dennis A. Wichern, a DEA agent with the Chicago Field Division. Federal law requires that registered practitioners who store or dispense controlled substances keep records of controlled substances coming in and out of the practice. That includes physicians who hand out samples of controlled substances to patients and also pertains to samples provided to doctors by pharmaceutical companies.

Alicia Gallegos/Frontline Medical News

“Think bank, checkbook, and money; if you have controlled substances, you need to keep the same records,” Mr. Wichern said during the meeting. “If you’re dispensing drugs at your office, you have to keep dispensing records. It seems like most providers are unaware of this.”

Records should include whether the inventory was taken at the beginning or close of business, names of controlled substances, each finished form of the substances, the number of dosage units of each finished form in the commercial container, the number of commercial containers of each finished form, and disposition of the controlled substances.

Law requires that physicians take a new inventory of all controlled substances on hand every 2 years. Doctors are not required to keep records of controlled substances that are merely prescribed, unless such substances are prescribed in the course of maintenance or detoxification treatment.

Ms. Mazina notes that there are many software platforms that can assist practices with proper inventory and record keeping for opioids and other drugs.

 

3. Check the state database: Before prescribing opioids, check your state’s prescription drug monitoring program (PDMP) database, advises Ms. Mazina. At least 37 states have operational PDMPs that receive and distribute controlled substance prescription information to authorized users. About 11 states have enacted legislation to establish a PDMP, but some databases are not fully operational.

A state’s PDMP can reveal whether patients may be obtaining multiple controlled substance prescriptions from different doctors or doctor-shopping, Ms. Mazina said. Such due diligence helps inform treatment decisions and can assist a doctor’s case if a medical board or DEA investigation later arises.

“Even if your state law does not require you to check a patient’s history prior to prescribing, you have to check it to protect yourself,” she said. “If you want to avoid controlled substances problems, PDMP is the way to go.”

4. Establish an audit response plan: Have an audit response plan ready to roll should an inquiry arise, experts advise. The policies ensure that only approved information is released to authorities, and that all staff members are on the same page about how to react to audits, Ms. Mazina said.

Plans should clearly state what information can be collected and what data should be kept confidential. Financial information, for example, should be off limits, she said. Government agents are entitled to inventory, dispensary data, and records of receipts.

“Agents very often do the mirror image of the database, and they get too much information,” she said. “You don’t want to [allow] that.”

Train staff members how to respond to government authorities seeking audit information, and explain they have the right to refuse being interviewed, Ms. Mazina said.

“Train your employees on what’s going to happen if the DEA comes in,” she said. “If I don’t have clear policies and procedures, and I’m not trained, I might disclose everything and blame someone. That puts everyone in a [bad] position, because [authorities] will record everything and use it against [the practice].”

 

5. Confer with the experts: It doesn’t hurt to consult with other medical professionals, such as emergency physicians or pain management specialists, for practical advice on inventory policies or software suggestions. But when it comes to staying updated on new drug laws and regulations, confer with a health law attorney or compliance officer, Ms. Mazina said. The DEA website also includes useful information about recent laws and rules pertaining to prescription drugs, as does the Centers for Disease Control and Prevention website.

If an investigation or audit emerges, work with an attorney as early as possible. Often, practices wait until too late after an investigation begins to contact legal counsel, Ms. Mazina noted. The earlier an attorney gets involved, the sooner that person can build a strong case for the practice and work toward the best resolution.

“Very often, the physician thinks they are right, and there’s nothing for them to fear,” she said. “There is something for you to fear. There’s a lot at stake.”

[email protected]

On Twitter @legal_med

 

CHICAGO – If given the option, the majority of physicians would scrap both the Affordable Care Act and the proposed American Health Care Act (AHCA) and opt for a single payer health care system, according to a survey of 1,059 doctors by the Chicago Medical Society (CMS).

When asked their preferred health care structure, 53% of physician said they would prefer a single payer health system, while 26% preferred the Affordable Care Act, and 13% said they would like to see the ACA repealed and replaced with the AHCA. Another 8% of doctors stated they would prefer repeal of the ACA but did not offer a replacement option.

The high percentage of physicians who favored a single payer system was surprising, said A. Jay Chauhan, DO, secretary and chair of public health for the Chicago Medical Society.

“That is a shift from past surveys,” Dr. Chauhan said during an interview at a conference held by the American Bar Association. “It certainly speaks to the frustration that physicians are [feeling] and how difficult it is to practice. I think they’re trying to reach out for other alternatives because the current manner in which we’re practicing doesn’t seem to fulfill our desires to better take care of patients.”

When asked whether they felt favorable or unfavorable toward individual reform models, 77% of doctors felt unfavorable toward the AHCA and 23% felt favorable toward the legislation. Of physicians, 67% felt favorable toward a single payer system, and 33% said they felt unfavorable toward such a model. As for the ACA, 63% of doctors felt favorable toward the ACA, while 37% felt unfavorable toward the health care law.

Respondents also choose a single payer system as their top preference when asked which health care system they believed would provide “the best care to the greatest number of people for a given amount of funding.”

A primary takeaway from the survey is that physicians want to see better access to health care for their patients and more affordable insurance coverage, said Katherine M. Tynus, MD, immediate past president of the Chicago Medical Society and president-elect of the Illinois State Medical Society.

“I think what the Affordable Care Act did was raise expectations as far as access to care and people being able to afford their health care,” Dr. Tynus said in an interview at the meeting. “Since that system seems to be failing, the expectation remains. Now, we need to find an alternative solution to achieve that.”

The online survey, released at the Physicians Legal Issues Conference held by the American Bar Association, was conducted between March 2017 and May 2017 and featured questions about health reform. Survey participants were physicians primarily based in the Chicago area or within Illinois and the majority practiced in an urban area. Respondents represented a variety of political affiliations and medical specialties. The majority said they identifying as independent (43%), and the most common specialty was general medicine (19%).

[email protected]

On Twitter @legal_med

 

CHICAGO – If given the option, the majority of physicians would scrap both the Affordable Care Act and the proposed American Health Care Act (AHCA) and opt for a single payer health care system, according to a survey of 1,059 doctors by the Chicago Medical Society (CMS).

When asked their preferred health care structure, 53% of physician said they would prefer a single payer health system, while 26% preferred the Affordable Care Act, and 13% said they would like to see the ACA repealed and replaced with the AHCA. Another 8% of doctors stated they would prefer repeal of the ACA but did not offer a replacement option.

The high percentage of physicians who favored a single payer system was surprising, said A. Jay Chauhan, DO, secretary and chair of public health for the Chicago Medical Society.

“That is a shift from past surveys,” Dr. Chauhan said during an interview at a conference held by the American Bar Association. “It certainly speaks to the frustration that physicians are [feeling] and how difficult it is to practice. I think they’re trying to reach out for other alternatives because the current manner in which we’re practicing doesn’t seem to fulfill our desires to better take care of patients.”

When asked whether they felt favorable or unfavorable toward individual reform models, 77% of doctors felt unfavorable toward the AHCA and 23% felt favorable toward the legislation. Of physicians, 67% felt favorable toward a single payer system, and 33% said they felt unfavorable toward such a model. As for the ACA, 63% of doctors felt favorable toward the ACA, while 37% felt unfavorable toward the health care law.

Respondents also choose a single payer system as their top preference when asked which health care system they believed would provide “the best care to the greatest number of people for a given amount of funding.”

A primary takeaway from the survey is that physicians want to see better access to health care for their patients and more affordable insurance coverage, said Katherine M. Tynus, MD, immediate past president of the Chicago Medical Society and president-elect of the Illinois State Medical Society.

“I think what the Affordable Care Act did was raise expectations as far as access to care and people being able to afford their health care,” Dr. Tynus said in an interview at the meeting. “Since that system seems to be failing, the expectation remains. Now, we need to find an alternative solution to achieve that.”

The online survey, released at the Physicians Legal Issues Conference held by the American Bar Association, was conducted between March 2017 and May 2017 and featured questions about health reform. Survey participants were physicians primarily based in the Chicago area or within Illinois and the majority practiced in an urban area. Respondents represented a variety of political affiliations and medical specialties. The majority said they identifying as independent (43%), and the most common specialty was general medicine (19%).

[email protected]

On Twitter @legal_med

 

CHICAGO – If given the option, the majority of physicians would scrap both the Affordable Care Act and the proposed American Health Care Act (AHCA) and opt for a single payer health care system, according to a survey of 1,059 doctors by the Chicago Medical Society (CMS).

When asked their preferred health care structure, 53% of physician said they would prefer a single payer health system, while 26% preferred the Affordable Care Act, and 13% said they would like to see the ACA repealed and replaced with the AHCA. Another 8% of doctors stated they would prefer repeal of the ACA but did not offer a replacement option.

The high percentage of physicians who favored a single payer system was surprising, said A. Jay Chauhan, DO, secretary and chair of public health for the Chicago Medical Society.

“That is a shift from past surveys,” Dr. Chauhan said during an interview at a conference held by the American Bar Association. “It certainly speaks to the frustration that physicians are [feeling] and how difficult it is to practice. I think they’re trying to reach out for other alternatives because the current manner in which we’re practicing doesn’t seem to fulfill our desires to better take care of patients.”

When asked whether they felt favorable or unfavorable toward individual reform models, 77% of doctors felt unfavorable toward the AHCA and 23% felt favorable toward the legislation. Of physicians, 67% felt favorable toward a single payer system, and 33% said they felt unfavorable toward such a model. As for the ACA, 63% of doctors felt favorable toward the ACA, while 37% felt unfavorable toward the health care law.

Respondents also choose a single payer system as their top preference when asked which health care system they believed would provide “the best care to the greatest number of people for a given amount of funding.”

A primary takeaway from the survey is that physicians want to see better access to health care for their patients and more affordable insurance coverage, said Katherine M. Tynus, MD, immediate past president of the Chicago Medical Society and president-elect of the Illinois State Medical Society.

“I think what the Affordable Care Act did was raise expectations as far as access to care and people being able to afford their health care,” Dr. Tynus said in an interview at the meeting. “Since that system seems to be failing, the expectation remains. Now, we need to find an alternative solution to achieve that.”

The online survey, released at the Physicians Legal Issues Conference held by the American Bar Association, was conducted between March 2017 and May 2017 and featured questions about health reform. Survey participants were physicians primarily based in the Chicago area or within Illinois and the majority practiced in an urban area. Respondents represented a variety of political affiliations and medical specialties. The majority said they identifying as independent (43%), and the most common specialty was general medicine (19%).

[email protected]

On Twitter @legal_med