Alicia Ault

Dr. Karen DeSalvo is the fifth person to serve as National Coordinator for Health Information Technology at the Health and Human Services Department, but perhaps more than any of her predecessors, she is truly in the thick of the struggle to bring doctors, medical practices, and hospitals into the digital age.

Physicians face a major deadline this year: It’s the last year to sign up for the meaningful use incentive payment program created by the Health Information Technology for Economic and Clinical Health Act (HITECH). If they don’t participate, they lose out on the potential to recoup from the federal government at least a small portion of the money they’ve spent on electronic health record systems. And it’s becoming inevitable that not participating could mean being left behind by insurers, hospitals, and patients.

That’s causing a lot of anxiety. Dr. DeSalvo – a practicing internist – says that she feels doctors’ pain. She recently completed a national listening tour and says that what she learned from those sessions will help inform how the Office of the National Coordinator moves forward.

Dr. Karen DeSalvo is the fifth person to serve as National Coordinator for Health Information Technology at the Health and Human Services Department, but perhaps more than any of her predecessors, she is truly in the thick of the struggle to bring doctors, medical practices, and hospitals into the digital age.

Physicians face a major deadline this year: It’s the last year to sign up for the meaningful use incentive payment program created by the Health Information Technology for Economic and Clinical Health Act (HITECH). If they don’t participate, they lose out on the potential to recoup from the federal government at least a small portion of the money they’ve spent on electronic health record systems. And it’s becoming inevitable that not participating could mean being left behind by insurers, hospitals, and patients.

That’s causing a lot of anxiety. Dr. DeSalvo – a practicing internist – says that she feels doctors’ pain. She recently completed a national listening tour and says that what she learned from those sessions will help inform how the Office of the National Coordinator moves forward.

Dr. Karen DeSalvo is the fifth person to serve as National Coordinator for Health Information Technology at the Health and Human Services Department, but perhaps more than any of her predecessors, she is truly in the thick of the struggle to bring doctors, medical practices, and hospitals into the digital age.

Physicians face a major deadline this year: It’s the last year to sign up for the meaningful use incentive payment program created by the Health Information Technology for Economic and Clinical Health Act (HITECH). If they don’t participate, they lose out on the potential to recoup from the federal government at least a small portion of the money they’ve spent on electronic health record systems. And it’s becoming inevitable that not participating could mean being left behind by insurers, hospitals, and patients.

That’s causing a lot of anxiety. Dr. DeSalvo – a practicing internist – says that she feels doctors’ pain. She recently completed a national listening tour and says that what she learned from those sessions will help inform how the Office of the National Coordinator moves forward.

The U.S. Department of Health & Human Services has named a new chief executive officer to run the federal marketplace, which includes the healthcare.gov website.

Kevin Counihan, currently the CEO for Connecticut’s marketplace, has been named to run the federal marketplace. He also will be in charge of the Center for Consumer Information and Insurance Oversight (CCIIO), which regulates health insurance. HHS Secretary Sylvia Mathews Burwell announced in June that the department would be looking for a new CEO.

Mr. Counihan has served as CEO for Health Access CT since June 2012, after having served as chief marketing officer from 2006 to 2011 for the Commonwealth of Massachusetts Health Insurance Connector Authority, which administered that state’s health insurance exchange. Before that, he was a sales and marketing executive for Tufts Health Plan of Massachusetts and regional vice president for CIGNA.

"We are committed to instilling ongoing accountability for reaching milestones, measuring results, and ensuring a successful open enrollment period," Ms. Burwell said in a statement. Mr. Counihan "brings additional operational and technological expertise to the position and will be a clear, single point of contact for streamlined decision making."

Mr. Counihan will report to Centers for Medicare & Medicaid Services Administrator Marilyn Tavenner.

[email protected]

On Twitter @aliciaault

The U.S. Department of Health & Human Services has named a new chief executive officer to run the federal marketplace, which includes the healthcare.gov website.

Kevin Counihan, currently the CEO for Connecticut’s marketplace, has been named to run the federal marketplace. He also will be in charge of the Center for Consumer Information and Insurance Oversight (CCIIO), which regulates health insurance. HHS Secretary Sylvia Mathews Burwell announced in June that the department would be looking for a new CEO.

Mr. Counihan has served as CEO for Health Access CT since June 2012, after having served as chief marketing officer from 2006 to 2011 for the Commonwealth of Massachusetts Health Insurance Connector Authority, which administered that state’s health insurance exchange. Before that, he was a sales and marketing executive for Tufts Health Plan of Massachusetts and regional vice president for CIGNA.

"We are committed to instilling ongoing accountability for reaching milestones, measuring results, and ensuring a successful open enrollment period," Ms. Burwell said in a statement. Mr. Counihan "brings additional operational and technological expertise to the position and will be a clear, single point of contact for streamlined decision making."

Mr. Counihan will report to Centers for Medicare & Medicaid Services Administrator Marilyn Tavenner.

[email protected]

On Twitter @aliciaault

The U.S. Department of Health & Human Services has named a new chief executive officer to run the federal marketplace, which includes the healthcare.gov website.

Kevin Counihan, currently the CEO for Connecticut’s marketplace, has been named to run the federal marketplace. He also will be in charge of the Center for Consumer Information and Insurance Oversight (CCIIO), which regulates health insurance. HHS Secretary Sylvia Mathews Burwell announced in June that the department would be looking for a new CEO.

Mr. Counihan has served as CEO for Health Access CT since June 2012, after having served as chief marketing officer from 2006 to 2011 for the Commonwealth of Massachusetts Health Insurance Connector Authority, which administered that state’s health insurance exchange. Before that, he was a sales and marketing executive for Tufts Health Plan of Massachusetts and regional vice president for CIGNA.

"We are committed to instilling ongoing accountability for reaching milestones, measuring results, and ensuring a successful open enrollment period," Ms. Burwell said in a statement. Mr. Counihan "brings additional operational and technological expertise to the position and will be a clear, single point of contact for streamlined decision making."

Mr. Counihan will report to Centers for Medicare & Medicaid Services Administrator Marilyn Tavenner.

[email protected]

On Twitter @aliciaault

Physicians who are grandfathered from maintenance of certification requirements may soon be listed differently on the American Board of Internal Medicine website.

The ABIM site currently reports publicly whether or not physicians are "Meeting Maintenance of Certification Requirements," and that status means grandfathered physicians do not appear to be meeting MOC requirements on the American Board of Medical Specialties’ Certification Matters website.

"Not meeting MOC requirements’ is, in essence, a scarlet letter meant to pressure grandparents into enrolling in the current flawed MOC system," Dr. Mack Harrell, president of the American Association of Clinical Endocrinologists, said in a June 30 letter to the ABIM. The Endocrine Society and AACE have asked that no information be publicly reported until the ABIM addresses the MOC concerns of internal medicine specialists and subspecialists.

At an August meeting, ABIM agreed that the language "is causing legitimate confusion." Grandfathered physicians are encouraged but are not required to participate in MOC, yet they are still being listed as either meeting or not meeting the MOC requirements, according to an Aug. 15 statement from the board.

The board is "exploring what changes to the reporting language can be made," according to the statement. The issue is making sure that "reporting of certification status is clear and consistent across the community of specialty boards."

The nature and timing of the change has not yet been decided by the board, ABIM spokesperson Lorie Slass said. "We want to work with ABMS to make sure there is consistency and clarity in web reporting."

[email protected]

On Twitter @aliciaault

Physicians who are grandfathered from maintenance of certification requirements may soon be listed differently on the American Board of Internal Medicine website.

The ABIM site currently reports publicly whether or not physicians are "Meeting Maintenance of Certification Requirements," and that status means grandfathered physicians do not appear to be meeting MOC requirements on the American Board of Medical Specialties’ Certification Matters website.

"Not meeting MOC requirements’ is, in essence, a scarlet letter meant to pressure grandparents into enrolling in the current flawed MOC system," Dr. Mack Harrell, president of the American Association of Clinical Endocrinologists, said in a June 30 letter to the ABIM. The Endocrine Society and AACE have asked that no information be publicly reported until the ABIM addresses the MOC concerns of internal medicine specialists and subspecialists.

At an August meeting, ABIM agreed that the language "is causing legitimate confusion." Grandfathered physicians are encouraged but are not required to participate in MOC, yet they are still being listed as either meeting or not meeting the MOC requirements, according to an Aug. 15 statement from the board.

The board is "exploring what changes to the reporting language can be made," according to the statement. The issue is making sure that "reporting of certification status is clear and consistent across the community of specialty boards."

The nature and timing of the change has not yet been decided by the board, ABIM spokesperson Lorie Slass said. "We want to work with ABMS to make sure there is consistency and clarity in web reporting."

[email protected]

On Twitter @aliciaault

Physicians who are grandfathered from maintenance of certification requirements may soon be listed differently on the American Board of Internal Medicine website.

The ABIM site currently reports publicly whether or not physicians are "Meeting Maintenance of Certification Requirements," and that status means grandfathered physicians do not appear to be meeting MOC requirements on the American Board of Medical Specialties’ Certification Matters website.

"Not meeting MOC requirements’ is, in essence, a scarlet letter meant to pressure grandparents into enrolling in the current flawed MOC system," Dr. Mack Harrell, president of the American Association of Clinical Endocrinologists, said in a June 30 letter to the ABIM. The Endocrine Society and AACE have asked that no information be publicly reported until the ABIM addresses the MOC concerns of internal medicine specialists and subspecialists.

At an August meeting, ABIM agreed that the language "is causing legitimate confusion." Grandfathered physicians are encouraged but are not required to participate in MOC, yet they are still being listed as either meeting or not meeting the MOC requirements, according to an Aug. 15 statement from the board.

The board is "exploring what changes to the reporting language can be made," according to the statement. The issue is making sure that "reporting of certification status is clear and consistent across the community of specialty boards."

The nature and timing of the change has not yet been decided by the board, ABIM spokesperson Lorie Slass said. "We want to work with ABMS to make sure there is consistency and clarity in web reporting."

[email protected]

On Twitter @aliciaault

The Drug Enforcement Administration is making it harder to prescribe hydrocodone combination products.

The move was expected, as the agency proposed in February to move hydrocodone combinations from schedule III to schedule II in response to requests from both the U.S. Department of Health & Human Services and the Food and Drug Administration.

Some physician groups have opposed the move, saying that it will lead to more administrative burdens, do nothing to curb abuse and diversion, and potentially decrease access to medications.

The DEA will publish the final rule on the rescheduling in the Federal Register on Aug. 22. Manufacturers, distributors, and prescribers will have to comply by Oct. 13.

The agency said it is time to rein in opioid prescribing and that rescheduling will help accomplish that goal.

"Almost 7 million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents," DEA administrator Michele Leonhart said in a statement. "Today’s action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available."

Hydrocodone combination products were placed on schedule III by Congress in 1970 when it created the Controlled Substances Act, in part because it was believed that adding acetaminophen or other non-narcotics might lessen the abuse potential. Hydrocodone itself was placed on schedule II.

Now, "the scientific, medical, and epidemiological data are robust and support rescheduling [of hydrocodone combination products] into schedule II," according to the final rule.

Data show that the products are widely diverted and abused at rates similar to that of oxycodone products, which are schedule II, said the agency, which added that abuse is associated with severe psychological or physical dependence, and many are being admitted to addiction treatment.

The hydrocodone combinations are also associated with large numbers of deaths, said the agency. More than 16,000 deaths in 2010 were due to abuse of opioids, including hydrocodone combinations, according to the DEA.

About 137 million prescriptions for hydrocodone combinations were dispensed in 2013, the agency said. The most frequently prescribed combination is hydrocodone/acetaminophen.

In comments to the proposed rule in April, the American Medical Association, along with a group of organizations and companies in the long-term care field, asked the agency to delay the final rule until an exception was made for nursing homes and other long-term care facilities. The AMA’s House of Delegates had also voted in 2013 to oppose rescheduling.

The American College of Emergency Physicians also urged against rescheduling, telling the DEA in April that it would not likely solve the abuse and diversion problems, but would lead to a greater administrative hassle for physicians.

The DEA said it received 573 comments after it proposed rescheduling, with 52% in favor, 41% opposed, and 7% taking no position. The agency received the most comments from the general public (44%; 250 comments) and pharmacists and pharmacy students (21%; 122 comments), physicians (13%; 73 comments), patients (6%; 35 comments), and midlevel practitioners (5%; 31 comments). Just over half of the physician comments supported, or supported with qualification, rescheduling.

Most of the commenters who were opposed to rescheduling were pharmacists, pharmacy students, and patients. Those opposed were concerned about how it would affect prescribing practices and patient access to medicine, and how it might impact long-term care facilities. Commenters also said that it would not prevent abuse or diversion.

The DEA said that although moving to schedule II does, for instance, prohibit refills, it would not necessarily block physicians from writing prescriptions for supplies of longer than 30 days, or from writing multiple prescriptions at once. State laws might have limits, however, and those will take precedence over the DEA rule.

The DEA rescheduling follows an FDA advisory committee recommendation in Jan. 2013 to do so, and the FDA’s backing of the proposal in Oct. 2013. HHS followed with its own recommendation to the DEA.

In comments on the proposed rule, manufacturers and pharmacies asked for more time to implement the rescheduling, but the DEA said no, citing high rates of abuse, overdose, and deaths relating to hydrocodone combination products.

The rescheduling goes into effect on Oct. 13, 45 days from the date of the rule’s publication in the Federal Register.

[email protected]

On Twitter @aliciaault

The Drug Enforcement Administration is making it harder to prescribe hydrocodone combination products.

The move was expected, as the agency proposed in February to move hydrocodone combinations from schedule III to schedule II in response to requests from both the U.S. Department of Health & Human Services and the Food and Drug Administration.

Some physician groups have opposed the move, saying that it will lead to more administrative burdens, do nothing to curb abuse and diversion, and potentially decrease access to medications.

The DEA will publish the final rule on the rescheduling in the Federal Register on Aug. 22. Manufacturers, distributors, and prescribers will have to comply by Oct. 13.

The agency said it is time to rein in opioid prescribing and that rescheduling will help accomplish that goal.

"Almost 7 million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents," DEA administrator Michele Leonhart said in a statement. "Today’s action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available."

Hydrocodone combination products were placed on schedule III by Congress in 1970 when it created the Controlled Substances Act, in part because it was believed that adding acetaminophen or other non-narcotics might lessen the abuse potential. Hydrocodone itself was placed on schedule II.

Now, "the scientific, medical, and epidemiological data are robust and support rescheduling [of hydrocodone combination products] into schedule II," according to the final rule.

Data show that the products are widely diverted and abused at rates similar to that of oxycodone products, which are schedule II, said the agency, which added that abuse is associated with severe psychological or physical dependence, and many are being admitted to addiction treatment.

The hydrocodone combinations are also associated with large numbers of deaths, said the agency. More than 16,000 deaths in 2010 were due to abuse of opioids, including hydrocodone combinations, according to the DEA.

About 137 million prescriptions for hydrocodone combinations were dispensed in 2013, the agency said. The most frequently prescribed combination is hydrocodone/acetaminophen.

In comments to the proposed rule in April, the American Medical Association, along with a group of organizations and companies in the long-term care field, asked the agency to delay the final rule until an exception was made for nursing homes and other long-term care facilities. The AMA’s House of Delegates had also voted in 2013 to oppose rescheduling.

The American College of Emergency Physicians also urged against rescheduling, telling the DEA in April that it would not likely solve the abuse and diversion problems, but would lead to a greater administrative hassle for physicians.

The DEA said it received 573 comments after it proposed rescheduling, with 52% in favor, 41% opposed, and 7% taking no position. The agency received the most comments from the general public (44%; 250 comments) and pharmacists and pharmacy students (21%; 122 comments), physicians (13%; 73 comments), patients (6%; 35 comments), and midlevel practitioners (5%; 31 comments). Just over half of the physician comments supported, or supported with qualification, rescheduling.

Most of the commenters who were opposed to rescheduling were pharmacists, pharmacy students, and patients. Those opposed were concerned about how it would affect prescribing practices and patient access to medicine, and how it might impact long-term care facilities. Commenters also said that it would not prevent abuse or diversion.

The DEA said that although moving to schedule II does, for instance, prohibit refills, it would not necessarily block physicians from writing prescriptions for supplies of longer than 30 days, or from writing multiple prescriptions at once. State laws might have limits, however, and those will take precedence over the DEA rule.

The DEA rescheduling follows an FDA advisory committee recommendation in Jan. 2013 to do so, and the FDA’s backing of the proposal in Oct. 2013. HHS followed with its own recommendation to the DEA.

In comments on the proposed rule, manufacturers and pharmacies asked for more time to implement the rescheduling, but the DEA said no, citing high rates of abuse, overdose, and deaths relating to hydrocodone combination products.

The rescheduling goes into effect on Oct. 13, 45 days from the date of the rule’s publication in the Federal Register.

[email protected]

On Twitter @aliciaault

The Drug Enforcement Administration is making it harder to prescribe hydrocodone combination products.

The move was expected, as the agency proposed in February to move hydrocodone combinations from schedule III to schedule II in response to requests from both the U.S. Department of Health & Human Services and the Food and Drug Administration.

Some physician groups have opposed the move, saying that it will lead to more administrative burdens, do nothing to curb abuse and diversion, and potentially decrease access to medications.

The DEA will publish the final rule on the rescheduling in the Federal Register on Aug. 22. Manufacturers, distributors, and prescribers will have to comply by Oct. 13.

The agency said it is time to rein in opioid prescribing and that rescheduling will help accomplish that goal.

"Almost 7 million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents," DEA administrator Michele Leonhart said in a statement. "Today’s action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available."

Hydrocodone combination products were placed on schedule III by Congress in 1970 when it created the Controlled Substances Act, in part because it was believed that adding acetaminophen or other non-narcotics might lessen the abuse potential. Hydrocodone itself was placed on schedule II.

Now, "the scientific, medical, and epidemiological data are robust and support rescheduling [of hydrocodone combination products] into schedule II," according to the final rule.

Data show that the products are widely diverted and abused at rates similar to that of oxycodone products, which are schedule II, said the agency, which added that abuse is associated with severe psychological or physical dependence, and many are being admitted to addiction treatment.

The hydrocodone combinations are also associated with large numbers of deaths, said the agency. More than 16,000 deaths in 2010 were due to abuse of opioids, including hydrocodone combinations, according to the DEA.

About 137 million prescriptions for hydrocodone combinations were dispensed in 2013, the agency said. The most frequently prescribed combination is hydrocodone/acetaminophen.

In comments to the proposed rule in April, the American Medical Association, along with a group of organizations and companies in the long-term care field, asked the agency to delay the final rule until an exception was made for nursing homes and other long-term care facilities. The AMA’s House of Delegates had also voted in 2013 to oppose rescheduling.

The American College of Emergency Physicians also urged against rescheduling, telling the DEA in April that it would not likely solve the abuse and diversion problems, but would lead to a greater administrative hassle for physicians.

The DEA said it received 573 comments after it proposed rescheduling, with 52% in favor, 41% opposed, and 7% taking no position. The agency received the most comments from the general public (44%; 250 comments) and pharmacists and pharmacy students (21%; 122 comments), physicians (13%; 73 comments), patients (6%; 35 comments), and midlevel practitioners (5%; 31 comments). Just over half of the physician comments supported, or supported with qualification, rescheduling.

Most of the commenters who were opposed to rescheduling were pharmacists, pharmacy students, and patients. Those opposed were concerned about how it would affect prescribing practices and patient access to medicine, and how it might impact long-term care facilities. Commenters also said that it would not prevent abuse or diversion.

The DEA said that although moving to schedule II does, for instance, prohibit refills, it would not necessarily block physicians from writing prescriptions for supplies of longer than 30 days, or from writing multiple prescriptions at once. State laws might have limits, however, and those will take precedence over the DEA rule.

The DEA rescheduling follows an FDA advisory committee recommendation in Jan. 2013 to do so, and the FDA’s backing of the proposal in Oct. 2013. HHS followed with its own recommendation to the DEA.

In comments on the proposed rule, manufacturers and pharmacies asked for more time to implement the rescheduling, but the DEA said no, citing high rates of abuse, overdose, and deaths relating to hydrocodone combination products.

The rescheduling goes into effect on Oct. 13, 45 days from the date of the rule’s publication in the Federal Register.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved a new type of insomnia drug, the orexin receptor antagonist suvorexant (Belsomra).

It is the first drug in the class to be approved. Suvorexant blocks the binding of orexin A and B neuropeptides to orexin receptors, presumably inhibiting activation of neurons to the arousal system.

But it will not be available until the Drug Enforcement Administration makes a final determination of where it should fit on the schedule of controlled products. The FDA recommended scheduling, and the DEA proposed earlier this year that it receive a schedule IV classification under the Controlled Substances Act, according to suvorexant maker Merck.

The company said it expects suvorexant to be available in late 2014 or early 2015.

Merck had applied for approval in 2012. In May 2013, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee had questions about the safety of the company’s proposed starting doses. A few months later, the FDA advised Merck that it should make 10 mg the starting dose for most patients.

The company had not been prepared to manufacture that dose, so went back to work and created several new tablets.

Now, according to Dr. Ellis Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, "the FDA has approved Belsomra in four different strengths – 5, 10, 15, and 20 milligrams." Dr. Unger, in a statement, noted that "Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness."

The agency and the company say that suvorexant should only be taken once per night, within a half hour of going to bed and at least 7 hours before the person plans to wake up. Patients should not take more than 20 mg a day.

Drowsiness was the most common side effect. In FDA-required studies of next-day driving performance, patients who took 20 mg had impaired performance. Patients who take 20 mg should be warned about driving or conducting any activities that require mental alertness the next day, said the agency.

The drug also has the potential to lead to what the FDA calls "sleep-driving and other complex behaviors while not being fully awake," including preparing and eating food, making phone calls, or having sex. Patients and their families are urged to call their physician if that type of behavior is observed.

Suvorexant will be dispensed with a Medication Guide for patients that details safety information.

Although the drug was studied in three trials, none involved a comparison with other approved insomnia drugs, so its comparative effectiveness is not known, the FDA said.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved a new type of insomnia drug, the orexin receptor antagonist suvorexant (Belsomra).

It is the first drug in the class to be approved. Suvorexant blocks the binding of orexin A and B neuropeptides to orexin receptors, presumably inhibiting activation of neurons to the arousal system.

But it will not be available until the Drug Enforcement Administration makes a final determination of where it should fit on the schedule of controlled products. The FDA recommended scheduling, and the DEA proposed earlier this year that it receive a schedule IV classification under the Controlled Substances Act, according to suvorexant maker Merck.

The company said it expects suvorexant to be available in late 2014 or early 2015.

Merck had applied for approval in 2012. In May 2013, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee had questions about the safety of the company’s proposed starting doses. A few months later, the FDA advised Merck that it should make 10 mg the starting dose for most patients.

The company had not been prepared to manufacture that dose, so went back to work and created several new tablets.

Now, according to Dr. Ellis Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, "the FDA has approved Belsomra in four different strengths – 5, 10, 15, and 20 milligrams." Dr. Unger, in a statement, noted that "Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness."

The agency and the company say that suvorexant should only be taken once per night, within a half hour of going to bed and at least 7 hours before the person plans to wake up. Patients should not take more than 20 mg a day.

Drowsiness was the most common side effect. In FDA-required studies of next-day driving performance, patients who took 20 mg had impaired performance. Patients who take 20 mg should be warned about driving or conducting any activities that require mental alertness the next day, said the agency.

The drug also has the potential to lead to what the FDA calls "sleep-driving and other complex behaviors while not being fully awake," including preparing and eating food, making phone calls, or having sex. Patients and their families are urged to call their physician if that type of behavior is observed.

Suvorexant will be dispensed with a Medication Guide for patients that details safety information.

Although the drug was studied in three trials, none involved a comparison with other approved insomnia drugs, so its comparative effectiveness is not known, the FDA said.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved a new type of insomnia drug, the orexin receptor antagonist suvorexant (Belsomra).

It is the first drug in the class to be approved. Suvorexant blocks the binding of orexin A and B neuropeptides to orexin receptors, presumably inhibiting activation of neurons to the arousal system.

But it will not be available until the Drug Enforcement Administration makes a final determination of where it should fit on the schedule of controlled products. The FDA recommended scheduling, and the DEA proposed earlier this year that it receive a schedule IV classification under the Controlled Substances Act, according to suvorexant maker Merck.

The company said it expects suvorexant to be available in late 2014 or early 2015.

Merck had applied for approval in 2012. In May 2013, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee had questions about the safety of the company’s proposed starting doses. A few months later, the FDA advised Merck that it should make 10 mg the starting dose for most patients.

The company had not been prepared to manufacture that dose, so went back to work and created several new tablets.

Now, according to Dr. Ellis Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, "the FDA has approved Belsomra in four different strengths – 5, 10, 15, and 20 milligrams." Dr. Unger, in a statement, noted that "Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness."

The agency and the company say that suvorexant should only be taken once per night, within a half hour of going to bed and at least 7 hours before the person plans to wake up. Patients should not take more than 20 mg a day.

Drowsiness was the most common side effect. In FDA-required studies of next-day driving performance, patients who took 20 mg had impaired performance. Patients who take 20 mg should be warned about driving or conducting any activities that require mental alertness the next day, said the agency.

The drug also has the potential to lead to what the FDA calls "sleep-driving and other complex behaviors while not being fully awake," including preparing and eating food, making phone calls, or having sex. Patients and their families are urged to call their physician if that type of behavior is observed.

Suvorexant will be dispensed with a Medication Guide for patients that details safety information.

Although the drug was studied in three trials, none involved a comparison with other approved insomnia drugs, so its comparative effectiveness is not known, the FDA said.

[email protected]

On Twitter @aliciaault

Expressing continuing frustration with the American Board of Internal Medicine, the American Association of Clinical Endocrinologists is exploring its own avenue for maintenance of certification.

In a video message e-mailed to members Aug. 13, Dr. R. Mack Harrell, AACE president, discussed events from a July 15 meeting between ABIM board members and representatives from the 26 subspecialty organizations that receive certification from the ABIM.

AACE representatives told the ABIM that the secure exam is outmoded and not reflective of how medicine is practiced, and that its members questioned the utility and applicability of the practice modules. The organization also said it wanted the ABIM to describe physicians as either "participating" or "not participating" in MOC on its Certification Matters website.

ABIM representatives said that all this and more would be considered at an Aug. 5 board meeting.

Now, AACE is waiting to see what kind of response it will get, Dr. Harrell said in the video.

"If we get the wrong answers after the ABIM board meets, we’re going to have to entertain forming alternative pathways for certification," he said. "It’s our belief that with the right coalition of subspecialty societies, we can put together an alternative pathway for lifelong learning."

He also told members that foregoing any kind of MOC is not an option. Going back to a system in which physicians get their initial certification and then show a certain amount of continuing education credits each year "is not going to fly in the current American health care environment," he said in the video.

The old system won’t work in part, because so much CME is either "not documented, or quite frankly, bad," Dr. Harrell said in an interview, adding that insurers, health care organizations, and other stakeholders needed more. "We have to come up with some way to be very clear about how we document that people actually attended CME and learned something."

As far as AACE creating its own pathway for MOC, "it’s something that’s doable, though it will require a good deal of work," he added. "If it’s necessary, we’ll do it."

Dr. Richard J. Baron, president and CEO of ABIM, said that setting up an MOC process is not easy, nor for the faint of heart. "If AACE wants to offer a separate credentialing pathway, I’m in a great position to acknowledge how complicated a task that is, how challenging it is to do it well, and I wish them luck," he said in an interview.

He noted that the ABIM was created very deliberately by the American College of Physicians and the American Medical Association because they believed that a society might not be able to set credible standards as a membership organization.

Dr. Baron said that he could not currently disclose what was discussed at the ABIM board meeting on Aug. 5, but that the ABIM would be issuing a communication shortly.

[email protected]

On Twitter @aliciaault

Expressing continuing frustration with the American Board of Internal Medicine, the American Association of Clinical Endocrinologists is exploring its own avenue for maintenance of certification.

In a video message e-mailed to members Aug. 13, Dr. R. Mack Harrell, AACE president, discussed events from a July 15 meeting between ABIM board members and representatives from the 26 subspecialty organizations that receive certification from the ABIM.

AACE representatives told the ABIM that the secure exam is outmoded and not reflective of how medicine is practiced, and that its members questioned the utility and applicability of the practice modules. The organization also said it wanted the ABIM to describe physicians as either "participating" or "not participating" in MOC on its Certification Matters website.

ABIM representatives said that all this and more would be considered at an Aug. 5 board meeting.

Now, AACE is waiting to see what kind of response it will get, Dr. Harrell said in the video.

"If we get the wrong answers after the ABIM board meets, we’re going to have to entertain forming alternative pathways for certification," he said. "It’s our belief that with the right coalition of subspecialty societies, we can put together an alternative pathway for lifelong learning."

He also told members that foregoing any kind of MOC is not an option. Going back to a system in which physicians get their initial certification and then show a certain amount of continuing education credits each year "is not going to fly in the current American health care environment," he said in the video.

The old system won’t work in part, because so much CME is either "not documented, or quite frankly, bad," Dr. Harrell said in an interview, adding that insurers, health care organizations, and other stakeholders needed more. "We have to come up with some way to be very clear about how we document that people actually attended CME and learned something."

As far as AACE creating its own pathway for MOC, "it’s something that’s doable, though it will require a good deal of work," he added. "If it’s necessary, we’ll do it."

Dr. Richard J. Baron, president and CEO of ABIM, said that setting up an MOC process is not easy, nor for the faint of heart. "If AACE wants to offer a separate credentialing pathway, I’m in a great position to acknowledge how complicated a task that is, how challenging it is to do it well, and I wish them luck," he said in an interview.

He noted that the ABIM was created very deliberately by the American College of Physicians and the American Medical Association because they believed that a society might not be able to set credible standards as a membership organization.

Dr. Baron said that he could not currently disclose what was discussed at the ABIM board meeting on Aug. 5, but that the ABIM would be issuing a communication shortly.

[email protected]

On Twitter @aliciaault

Expressing continuing frustration with the American Board of Internal Medicine, the American Association of Clinical Endocrinologists is exploring its own avenue for maintenance of certification.

In a video message e-mailed to members Aug. 13, Dr. R. Mack Harrell, AACE president, discussed events from a July 15 meeting between ABIM board members and representatives from the 26 subspecialty organizations that receive certification from the ABIM.

AACE representatives told the ABIM that the secure exam is outmoded and not reflective of how medicine is practiced, and that its members questioned the utility and applicability of the practice modules. The organization also said it wanted the ABIM to describe physicians as either "participating" or "not participating" in MOC on its Certification Matters website.

ABIM representatives said that all this and more would be considered at an Aug. 5 board meeting.

Now, AACE is waiting to see what kind of response it will get, Dr. Harrell said in the video.

"If we get the wrong answers after the ABIM board meets, we’re going to have to entertain forming alternative pathways for certification," he said. "It’s our belief that with the right coalition of subspecialty societies, we can put together an alternative pathway for lifelong learning."

He also told members that foregoing any kind of MOC is not an option. Going back to a system in which physicians get their initial certification and then show a certain amount of continuing education credits each year "is not going to fly in the current American health care environment," he said in the video.

The old system won’t work in part, because so much CME is either "not documented, or quite frankly, bad," Dr. Harrell said in an interview, adding that insurers, health care organizations, and other stakeholders needed more. "We have to come up with some way to be very clear about how we document that people actually attended CME and learned something."

As far as AACE creating its own pathway for MOC, "it’s something that’s doable, though it will require a good deal of work," he added. "If it’s necessary, we’ll do it."

Dr. Richard J. Baron, president and CEO of ABIM, said that setting up an MOC process is not easy, nor for the faint of heart. "If AACE wants to offer a separate credentialing pathway, I’m in a great position to acknowledge how complicated a task that is, how challenging it is to do it well, and I wish them luck," he said in an interview.

He noted that the ABIM was created very deliberately by the American College of Physicians and the American Medical Association because they believed that a society might not be able to set credible standards as a membership organization.

Dr. Baron said that he could not currently disclose what was discussed at the ABIM board meeting on Aug. 5, but that the ABIM would be issuing a communication shortly.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved another noninvasive alternative to colonoscopy for screening for colorectal cancer, this one a stool-based test that detects the presence of red blood cells and DNA mutations.

And the same day as the FDA approval, the Centers for Medicare & Medicaid Services said that it was starting to review the technology with an eye toward approving it for Medicare beneficiaries.

The Cologuard, made by Exact Sciences of Madison, Wisc., is prescribed by a physician. It is mailed to the patient, who collects a stool sample and sends it to Exact Sciences for analysis. The $599 diagnostic detects hemoglobin and certain mutations associated with colorectal cancer in the DNA of cells shed by advanced adenomas as stool moves through the large intestine and rectum. Results – which are simply positive or negative for precancerous polyps or cancer – are reported by the prescribing physician. Patients with positive results are advised to undergo a diagnostic colonoscopy.

The test is not a substitute for colonoscopy; it is an alternative to fecal occult testing, and in trials, the Cologuard "detected more cancers than a commonly used fecal occult test," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement.

The FDA pointed out that approval does not change the currently recommended colorectal cancer screening protocols. Stool DNA testing is not recommended by the United States Preventive Services Task Force, for instance. Among other guidelines, the USPSTF recommends adults aged 50-75 years, at average risk for colon cancer, be screened using fecal occult blood testing, sigmoidoscopy, or colonoscopy.

"This approval offers patients and physicians another option to screen for colorectal cancer," said Dr. Gutierrez.

Dr. David A. Ahlquist, a Mayo Clinic gastroenterologist who was a coinventor of the test, said in a statement issued by Exact Sciences that the clinical studies had "proven that this noninvasive test is highly sensitive in detecting both early stage colorectal cancer and the most advanced precancerous polyps most likely to develop into cancer."

According to the FDA, in the 10,000-patient study, Cologuard accurately detected cancers and advanced adenomas more often than did the fecal occult test. Cologuard detected 92% of colorectal cancers and 42% of advanced adenomas; fecal occult screening detected 74% of cancers and 24% of advanced adenomas. Cologuard, however, was less accurate than fecal occult was at correctly identifying subjects negative for colorectal cancer or advanced adenomas.

For the first time ever, the CMS also proposed coverage of a product on the same day as it was approved, said Dr. Patrick Conway, chief medical officer and deputy administrator for innovation and quality at CMS, in a statement. The CMS analysis "will provide timely access for Medicare beneficiaries to an innovative screening test to help in the early detection of colorectal cancer," said Dr. Conway.

The agency is proposing to cover Cologuard once every 3 years for Medicare beneficiaries who are aged 50-85 years, asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test), and are at average risk of developing colorectal cancer.

The CMS is accepting comments until Sept. 11, 2014. It did not give a timeline for when it would make a final coverage decision.

Dr. Ahlquist and the Mayo Clinic will share equity and royalties from Exact Sciences.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved another noninvasive alternative to colonoscopy for screening for colorectal cancer, this one a stool-based test that detects the presence of red blood cells and DNA mutations.

And the same day as the FDA approval, the Centers for Medicare & Medicaid Services said that it was starting to review the technology with an eye toward approving it for Medicare beneficiaries.

The Cologuard, made by Exact Sciences of Madison, Wisc., is prescribed by a physician. It is mailed to the patient, who collects a stool sample and sends it to Exact Sciences for analysis. The $599 diagnostic detects hemoglobin and certain mutations associated with colorectal cancer in the DNA of cells shed by advanced adenomas as stool moves through the large intestine and rectum. Results – which are simply positive or negative for precancerous polyps or cancer – are reported by the prescribing physician. Patients with positive results are advised to undergo a diagnostic colonoscopy.

The test is not a substitute for colonoscopy; it is an alternative to fecal occult testing, and in trials, the Cologuard "detected more cancers than a commonly used fecal occult test," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement.

The FDA pointed out that approval does not change the currently recommended colorectal cancer screening protocols. Stool DNA testing is not recommended by the United States Preventive Services Task Force, for instance. Among other guidelines, the USPSTF recommends adults aged 50-75 years, at average risk for colon cancer, be screened using fecal occult blood testing, sigmoidoscopy, or colonoscopy.

"This approval offers patients and physicians another option to screen for colorectal cancer," said Dr. Gutierrez.

Dr. David A. Ahlquist, a Mayo Clinic gastroenterologist who was a coinventor of the test, said in a statement issued by Exact Sciences that the clinical studies had "proven that this noninvasive test is highly sensitive in detecting both early stage colorectal cancer and the most advanced precancerous polyps most likely to develop into cancer."

According to the FDA, in the 10,000-patient study, Cologuard accurately detected cancers and advanced adenomas more often than did the fecal occult test. Cologuard detected 92% of colorectal cancers and 42% of advanced adenomas; fecal occult screening detected 74% of cancers and 24% of advanced adenomas. Cologuard, however, was less accurate than fecal occult was at correctly identifying subjects negative for colorectal cancer or advanced adenomas.

For the first time ever, the CMS also proposed coverage of a product on the same day as it was approved, said Dr. Patrick Conway, chief medical officer and deputy administrator for innovation and quality at CMS, in a statement. The CMS analysis "will provide timely access for Medicare beneficiaries to an innovative screening test to help in the early detection of colorectal cancer," said Dr. Conway.

The agency is proposing to cover Cologuard once every 3 years for Medicare beneficiaries who are aged 50-85 years, asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test), and are at average risk of developing colorectal cancer.

The CMS is accepting comments until Sept. 11, 2014. It did not give a timeline for when it would make a final coverage decision.

Dr. Ahlquist and the Mayo Clinic will share equity and royalties from Exact Sciences.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved another noninvasive alternative to colonoscopy for screening for colorectal cancer, this one a stool-based test that detects the presence of red blood cells and DNA mutations.

And the same day as the FDA approval, the Centers for Medicare & Medicaid Services said that it was starting to review the technology with an eye toward approving it for Medicare beneficiaries.

The Cologuard, made by Exact Sciences of Madison, Wisc., is prescribed by a physician. It is mailed to the patient, who collects a stool sample and sends it to Exact Sciences for analysis. The $599 diagnostic detects hemoglobin and certain mutations associated with colorectal cancer in the DNA of cells shed by advanced adenomas as stool moves through the large intestine and rectum. Results – which are simply positive or negative for precancerous polyps or cancer – are reported by the prescribing physician. Patients with positive results are advised to undergo a diagnostic colonoscopy.

The test is not a substitute for colonoscopy; it is an alternative to fecal occult testing, and in trials, the Cologuard "detected more cancers than a commonly used fecal occult test," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement.

The FDA pointed out that approval does not change the currently recommended colorectal cancer screening protocols. Stool DNA testing is not recommended by the United States Preventive Services Task Force, for instance. Among other guidelines, the USPSTF recommends adults aged 50-75 years, at average risk for colon cancer, be screened using fecal occult blood testing, sigmoidoscopy, or colonoscopy.

"This approval offers patients and physicians another option to screen for colorectal cancer," said Dr. Gutierrez.

Dr. David A. Ahlquist, a Mayo Clinic gastroenterologist who was a coinventor of the test, said in a statement issued by Exact Sciences that the clinical studies had "proven that this noninvasive test is highly sensitive in detecting both early stage colorectal cancer and the most advanced precancerous polyps most likely to develop into cancer."

According to the FDA, in the 10,000-patient study, Cologuard accurately detected cancers and advanced adenomas more often than did the fecal occult test. Cologuard detected 92% of colorectal cancers and 42% of advanced adenomas; fecal occult screening detected 74% of cancers and 24% of advanced adenomas. Cologuard, however, was less accurate than fecal occult was at correctly identifying subjects negative for colorectal cancer or advanced adenomas.

For the first time ever, the CMS also proposed coverage of a product on the same day as it was approved, said Dr. Patrick Conway, chief medical officer and deputy administrator for innovation and quality at CMS, in a statement. The CMS analysis "will provide timely access for Medicare beneficiaries to an innovative screening test to help in the early detection of colorectal cancer," said Dr. Conway.

The agency is proposing to cover Cologuard once every 3 years for Medicare beneficiaries who are aged 50-85 years, asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test), and are at average risk of developing colorectal cancer.

The CMS is accepting comments until Sept. 11, 2014. It did not give a timeline for when it would make a final coverage decision.

Dr. Ahlquist and the Mayo Clinic will share equity and royalties from Exact Sciences.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved another noninvasive alternative to colonoscopy for screening for colorectal cancer, this one a stool-based test that detects the presence of red blood cells and DNA mutations.

And the same day as the FDA approval, the Centers for Medicare & Medicaid Services said that it was starting to review the technology with an eye toward approving it for Medicare beneficiaries.

The Cologuard, made by Exact Sciences of Madison, Wisc., is prescribed by a physician. It is mailed to the patient, who collects a stool sample and sends it to Exact Sciences for analysis. The $599 diagnostic detects hemoglobin and certain mutations associated with colorectal cancer in the DNA of cells shed by advanced adenomas as stool moves through the large intestine and rectum. Results – which are simply positive or negative for precancerous polyps or cancer – are reported by the prescribing physician. Patients with positive results are advised to undergo a diagnostic colonoscopy.

The test is not a substitute for colonoscopy; it is an alternative to fecal occult testing, and in trials, the Cologuard "detected more cancers than a commonly used fecal occult test," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement.

The FDA pointed out that approval does not change the currently recommended colorectal cancer screening protocols. Stool DNA testing is not recommended by the United States Preventive Services Task Force, for instance. Among other guidelines, the USPSTF recommends adults aged 50-75 years, at average risk for colon cancer, be screened using fecal occult blood testing, sigmoidoscopy, or colonoscopy.

"This approval offers patients and physicians another option to screen for colorectal cancer," said Dr. Gutierrez.

Dr. David A. Ahlquist, a Mayo Clinic gastroenterologist who was a coinventor of the test, said in a statement issued by Exact Sciences that the clinical studies had "proven that this noninvasive test is highly sensitive in detecting both early stage colorectal cancer and the most advanced precancerous polyps most likely to develop into cancer."

According to the FDA, in the 10,000-patient study, Cologuard accurately detected cancers and advanced adenomas more often than did the fecal occult test. Cologuard detected 92% of colorectal cancers and 42% of advanced adenomas; fecal occult screening detected 74% of cancers and 24% of advanced adenomas. Cologuard, however, was less accurate than fecal occult was at correctly identifying subjects negative for colorectal cancer or advanced adenomas.

For the first time ever, the CMS also proposed coverage of a product on the same day as it was approved, said Dr. Patrick Conway, chief medical officer and deputy administrator for innovation and quality at CMS, in a statement. The CMS analysis "will provide timely access for Medicare beneficiaries to an innovative screening test to help in the early detection of colorectal cancer," said Dr. Conway.

The agency is proposing to cover Cologuard once every 3 years for Medicare beneficiaries who are aged 50-85 years, asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test), and are at average risk of developing colorectal cancer.

The CMS is accepting comments until Sept. 11, 2014. It did not give a timeline for when it would make a final coverage decision.

Dr. Ahlquist and the Mayo Clinic will share equity and royalties from Exact Sciences.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved another noninvasive alternative to colonoscopy for screening for colorectal cancer, this one a stool-based test that detects the presence of red blood cells and DNA mutations.

And the same day as the FDA approval, the Centers for Medicare & Medicaid Services said that it was starting to review the technology with an eye toward approving it for Medicare beneficiaries.

The Cologuard, made by Exact Sciences of Madison, Wisc., is prescribed by a physician. It is mailed to the patient, who collects a stool sample and sends it to Exact Sciences for analysis. The $599 diagnostic detects hemoglobin and certain mutations associated with colorectal cancer in the DNA of cells shed by advanced adenomas as stool moves through the large intestine and rectum. Results – which are simply positive or negative for precancerous polyps or cancer – are reported by the prescribing physician. Patients with positive results are advised to undergo a diagnostic colonoscopy.

The test is not a substitute for colonoscopy; it is an alternative to fecal occult testing, and in trials, the Cologuard "detected more cancers than a commonly used fecal occult test," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement.

The FDA pointed out that approval does not change the currently recommended colorectal cancer screening protocols. Stool DNA testing is not recommended by the United States Preventive Services Task Force, for instance. Among other guidelines, the USPSTF recommends adults aged 50-75 years, at average risk for colon cancer, be screened using fecal occult blood testing, sigmoidoscopy, or colonoscopy.

"This approval offers patients and physicians another option to screen for colorectal cancer," said Dr. Gutierrez.

Dr. David A. Ahlquist, a Mayo Clinic gastroenterologist who was a coinventor of the test, said in a statement issued by Exact Sciences that the clinical studies had "proven that this noninvasive test is highly sensitive in detecting both early stage colorectal cancer and the most advanced precancerous polyps most likely to develop into cancer."

According to the FDA, in the 10,000-patient study, Cologuard accurately detected cancers and advanced adenomas more often than did the fecal occult test. Cologuard detected 92% of colorectal cancers and 42% of advanced adenomas; fecal occult screening detected 74% of cancers and 24% of advanced adenomas. Cologuard, however, was less accurate than fecal occult was at correctly identifying subjects negative for colorectal cancer or advanced adenomas.

For the first time ever, the CMS also proposed coverage of a product on the same day as it was approved, said Dr. Patrick Conway, chief medical officer and deputy administrator for innovation and quality at CMS, in a statement. The CMS analysis "will provide timely access for Medicare beneficiaries to an innovative screening test to help in the early detection of colorectal cancer," said Dr. Conway.

The agency is proposing to cover Cologuard once every 3 years for Medicare beneficiaries who are aged 50-85 years, asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test), and are at average risk of developing colorectal cancer.

The CMS is accepting comments until Sept. 11, 2014. It did not give a timeline for when it would make a final coverage decision.

Dr. Ahlquist and the Mayo Clinic will share equity and royalties from Exact Sciences.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved another noninvasive alternative to colonoscopy for screening for colorectal cancer, this one a stool-based test that detects the presence of red blood cells and DNA mutations.

And the same day as the FDA approval, the Centers for Medicare & Medicaid Services said that it was starting to review the technology with an eye toward approving it for Medicare beneficiaries.

The Cologuard, made by Exact Sciences of Madison, Wisc., is prescribed by a physician. It is mailed to the patient, who collects a stool sample and sends it to Exact Sciences for analysis. The $599 diagnostic detects hemoglobin and certain mutations associated with colorectal cancer in the DNA of cells shed by advanced adenomas as stool moves through the large intestine and rectum. Results – which are simply positive or negative for precancerous polyps or cancer – are reported by the prescribing physician. Patients with positive results are advised to undergo a diagnostic colonoscopy.

The test is not a substitute for colonoscopy; it is an alternative to fecal occult testing, and in trials, the Cologuard "detected more cancers than a commonly used fecal occult test," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement.

The FDA pointed out that approval does not change the currently recommended colorectal cancer screening protocols. Stool DNA testing is not recommended by the United States Preventive Services Task Force, for instance. Among other guidelines, the USPSTF recommends adults aged 50-75 years, at average risk for colon cancer, be screened using fecal occult blood testing, sigmoidoscopy, or colonoscopy.

"This approval offers patients and physicians another option to screen for colorectal cancer," said Dr. Gutierrez.

Dr. David A. Ahlquist, a Mayo Clinic gastroenterologist who was a coinventor of the test, said in a statement issued by Exact Sciences that the clinical studies had "proven that this noninvasive test is highly sensitive in detecting both early stage colorectal cancer and the most advanced precancerous polyps most likely to develop into cancer."

According to the FDA, in the 10,000-patient study, Cologuard accurately detected cancers and advanced adenomas more often than did the fecal occult test. Cologuard detected 92% of colorectal cancers and 42% of advanced adenomas; fecal occult screening detected 74% of cancers and 24% of advanced adenomas. Cologuard, however, was less accurate than fecal occult was at correctly identifying subjects negative for colorectal cancer or advanced adenomas.

For the first time ever, the CMS also proposed coverage of a product on the same day as it was approved, said Dr. Patrick Conway, chief medical officer and deputy administrator for innovation and quality at CMS, in a statement. The CMS analysis "will provide timely access for Medicare beneficiaries to an innovative screening test to help in the early detection of colorectal cancer," said Dr. Conway.

The agency is proposing to cover Cologuard once every 3 years for Medicare beneficiaries who are aged 50-85 years, asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test), and are at average risk of developing colorectal cancer.

The CMS is accepting comments until Sept. 11, 2014. It did not give a timeline for when it would make a final coverage decision.

Dr. Ahlquist and the Mayo Clinic will share equity and royalties from Exact Sciences.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved Invokamet, a fixed-dose combination of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, and metformin, for type 2 diabetes.

Janssen Pharmaceuticals, which will market Invokamet in the United States, says that it’s the first such combination approved by the FDA. Specifically, the indication is "as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled by treatment that includes either canagliflozin or metformin, or who are already being treated with both canagliflozin and metformin as separate medications."

The drug will be available in four dosage combinations containing canagliflozin 50 mg or 150 mg and metformin 500 mg or 1000 mg. The recommended dose is twice daily.

Canagliflozin was originally approved by the FDA in March 2013. During three phase III trials of canagliflozin plus metformin, the combination "lowered blood sugar and, in pre-specified secondary endpoints, was associated with significant reductions in body weight and systolic blood pressure," according to the statement. The most common adverse events were female genital mycotic infections, urinary tract infections, and increased urination. The most common adverse reactions with metformin were diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. Canagliflozin can increase the risk of hypoglycemia when combined with insulin or a sulfonylurea. The company says that lower doses of those therapies may be required to minimize the risk of hypoglycemia when used in combination with Invokamet.

There is also a boxed warning on the potential for lactic acidosis.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved Invokamet, a fixed-dose combination of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, and metformin, for type 2 diabetes.

Janssen Pharmaceuticals, which will market Invokamet in the United States, says that it’s the first such combination approved by the FDA. Specifically, the indication is "as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled by treatment that includes either canagliflozin or metformin, or who are already being treated with both canagliflozin and metformin as separate medications."

The drug will be available in four dosage combinations containing canagliflozin 50 mg or 150 mg and metformin 500 mg or 1000 mg. The recommended dose is twice daily.

Canagliflozin was originally approved by the FDA in March 2013. During three phase III trials of canagliflozin plus metformin, the combination "lowered blood sugar and, in pre-specified secondary endpoints, was associated with significant reductions in body weight and systolic blood pressure," according to the statement. The most common adverse events were female genital mycotic infections, urinary tract infections, and increased urination. The most common adverse reactions with metformin were diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. Canagliflozin can increase the risk of hypoglycemia when combined with insulin or a sulfonylurea. The company says that lower doses of those therapies may be required to minimize the risk of hypoglycemia when used in combination with Invokamet.

There is also a boxed warning on the potential for lactic acidosis.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved Invokamet, a fixed-dose combination of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, and metformin, for type 2 diabetes.

Janssen Pharmaceuticals, which will market Invokamet in the United States, says that it’s the first such combination approved by the FDA. Specifically, the indication is "as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled by treatment that includes either canagliflozin or metformin, or who are already being treated with both canagliflozin and metformin as separate medications."

The drug will be available in four dosage combinations containing canagliflozin 50 mg or 150 mg and metformin 500 mg or 1000 mg. The recommended dose is twice daily.

Canagliflozin was originally approved by the FDA in March 2013. During three phase III trials of canagliflozin plus metformin, the combination "lowered blood sugar and, in pre-specified secondary endpoints, was associated with significant reductions in body weight and systolic blood pressure," according to the statement. The most common adverse events were female genital mycotic infections, urinary tract infections, and increased urination. The most common adverse reactions with metformin were diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. Canagliflozin can increase the risk of hypoglycemia when combined with insulin or a sulfonylurea. The company says that lower doses of those therapies may be required to minimize the risk of hypoglycemia when used in combination with Invokamet.

There is also a boxed warning on the potential for lactic acidosis.

[email protected]

On Twitter @aliciaault

As expected, the Centers for Medicare & Medicaid Services says it will cover transcatheter mitral valve repair procedures, subject to conditions.

The final decision, issued Aug. 7, came not long after the agency proposed in May to pay for the procedure under its coverage with evidence development policy.

Despite the conditions, the decision opens up a potentially wide universe of people who could receive transcatheter mitral valve repair (TMVR).

According to the CMS, mitral regurgitation is the most common type of heart valve insufficiency in the United States. In 2000, 2-3 million Americans had the condition, and that number is expected to double by 2030. The standard treatment is open surgical repair, but there are many people who are not suitable candidates.

Only one TMVR device is currently approved by the Food and Drug Administration – Abbott Vascular’s MitraClip, approved in October 2013 – but others are in development.

The request to consider coverage of TMVR was initiated by the Society of Thoracic Surgeons, the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, and the American Association for Thoracic Surgery.

The agency said TMVR would now be covered for the treatment of significant symptomatic degenerative mitral regurgitation, when furnished according to an FDA-approved indication and when certain conditions are met.

Among those:

• TMVR must be performed by an interventional cardiologist or a cardiothoracic surgeon.

• Both a cardiothoracic surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease have independently examined the patient face to face, evaluated the patient’s suitability for mitral valve surgery, and made a determination of prohibitive risk, and both physicians have documented the rationale for their clinical judgment, and the rationale is available to the heart team.

• The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multidisciplinary team of medical professionals.

• The procedure has to be done in a hospital with specific infrastructure, including a valvular heart disease surgical program, a cardiac catheterization lab, noninvasive imaging expertise, an intensive care facility with personnel who have experience with patients who have undergone open-heart valve procedures, and space to accommodate cases that might have complications.

The agency also imposed volume requirements. The surgical program must perform at least 25 mitral valve surgical procedures for severe mitral regurgitation annually, 10 of which must be mitral valve repairs. The interventional cardiology program has to perform more than 1,000 catheterizations per year.

The heart team and hospital also have to participate in a prospective, national audited registry that accepts all manufactured devices, follows the patient for at least 1 year, and tracks all-cause mortality, stroke, repeat mitral valve surgery or other mitral procedures, worsening mitral regurgitation, transient ischemic events, major vascular events, renal complications, functional capacity, and, quality of life.

[email protected]

On Twitter @aliciaault

As expected, the Centers for Medicare & Medicaid Services says it will cover transcatheter mitral valve repair procedures, subject to conditions.

The final decision, issued Aug. 7, came not long after the agency proposed in May to pay for the procedure under its coverage with evidence development policy.

Despite the conditions, the decision opens up a potentially wide universe of people who could receive transcatheter mitral valve repair (TMVR).

According to the CMS, mitral regurgitation is the most common type of heart valve insufficiency in the United States. In 2000, 2-3 million Americans had the condition, and that number is expected to double by 2030. The standard treatment is open surgical repair, but there are many people who are not suitable candidates.

Only one TMVR device is currently approved by the Food and Drug Administration – Abbott Vascular’s MitraClip, approved in October 2013 – but others are in development.

The request to consider coverage of TMVR was initiated by the Society of Thoracic Surgeons, the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, and the American Association for Thoracic Surgery.

The agency said TMVR would now be covered for the treatment of significant symptomatic degenerative mitral regurgitation, when furnished according to an FDA-approved indication and when certain conditions are met.

Among those:

• TMVR must be performed by an interventional cardiologist or a cardiothoracic surgeon.

• Both a cardiothoracic surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease have independently examined the patient face to face, evaluated the patient’s suitability for mitral valve surgery, and made a determination of prohibitive risk, and both physicians have documented the rationale for their clinical judgment, and the rationale is available to the heart team.

• The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multidisciplinary team of medical professionals.

• The procedure has to be done in a hospital with specific infrastructure, including a valvular heart disease surgical program, a cardiac catheterization lab, noninvasive imaging expertise, an intensive care facility with personnel who have experience with patients who have undergone open-heart valve procedures, and space to accommodate cases that might have complications.

The agency also imposed volume requirements. The surgical program must perform at least 25 mitral valve surgical procedures for severe mitral regurgitation annually, 10 of which must be mitral valve repairs. The interventional cardiology program has to perform more than 1,000 catheterizations per year.

The heart team and hospital also have to participate in a prospective, national audited registry that accepts all manufactured devices, follows the patient for at least 1 year, and tracks all-cause mortality, stroke, repeat mitral valve surgery or other mitral procedures, worsening mitral regurgitation, transient ischemic events, major vascular events, renal complications, functional capacity, and, quality of life.

[email protected]

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As expected, the Centers for Medicare & Medicaid Services says it will cover transcatheter mitral valve repair procedures, subject to conditions.

The final decision, issued Aug. 7, came not long after the agency proposed in May to pay for the procedure under its coverage with evidence development policy.

Despite the conditions, the decision opens up a potentially wide universe of people who could receive transcatheter mitral valve repair (TMVR).

According to the CMS, mitral regurgitation is the most common type of heart valve insufficiency in the United States. In 2000, 2-3 million Americans had the condition, and that number is expected to double by 2030. The standard treatment is open surgical repair, but there are many people who are not suitable candidates.

Only one TMVR device is currently approved by the Food and Drug Administration – Abbott Vascular’s MitraClip, approved in October 2013 – but others are in development.

The request to consider coverage of TMVR was initiated by the Society of Thoracic Surgeons, the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, and the American Association for Thoracic Surgery.

The agency said TMVR would now be covered for the treatment of significant symptomatic degenerative mitral regurgitation, when furnished according to an FDA-approved indication and when certain conditions are met.

Among those:

• TMVR must be performed by an interventional cardiologist or a cardiothoracic surgeon.

• Both a cardiothoracic surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease have independently examined the patient face to face, evaluated the patient’s suitability for mitral valve surgery, and made a determination of prohibitive risk, and both physicians have documented the rationale for their clinical judgment, and the rationale is available to the heart team.

• The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multidisciplinary team of medical professionals.

• The procedure has to be done in a hospital with specific infrastructure, including a valvular heart disease surgical program, a cardiac catheterization lab, noninvasive imaging expertise, an intensive care facility with personnel who have experience with patients who have undergone open-heart valve procedures, and space to accommodate cases that might have complications.

The agency also imposed volume requirements. The surgical program must perform at least 25 mitral valve surgical procedures for severe mitral regurgitation annually, 10 of which must be mitral valve repairs. The interventional cardiology program has to perform more than 1,000 catheterizations per year.

The heart team and hospital also have to participate in a prospective, national audited registry that accepts all manufactured devices, follows the patient for at least 1 year, and tracks all-cause mortality, stroke, repeat mitral valve surgery or other mitral procedures, worsening mitral regurgitation, transient ischemic events, major vascular events, renal complications, functional capacity, and, quality of life.

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On Twitter @aliciaault