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House votes to repeal SGR, reauthorize CHIP
After years of failed attempts and temporary fixes, the House of Representatives on March 26 passed H.R. 2, a bill to repeal the Medicare Sustainable Growth Rate formula (SGR) and replace it with an alternative system that temporarily would raise Medicare physician pay and focus on value-based performance. The bill also reauthorizes the Children’s Health Insurance Program (CHIP) for 2 years, as well as other provisions.
Check back for detailed analysis and next steps for the legislation later on March 26.
After years of failed attempts and temporary fixes, the House of Representatives on March 26 passed H.R. 2, a bill to repeal the Medicare Sustainable Growth Rate formula (SGR) and replace it with an alternative system that temporarily would raise Medicare physician pay and focus on value-based performance. The bill also reauthorizes the Children’s Health Insurance Program (CHIP) for 2 years, as well as other provisions.
Check back for detailed analysis and next steps for the legislation later on March 26.
After years of failed attempts and temporary fixes, the House of Representatives on March 26 passed H.R. 2, a bill to repeal the Medicare Sustainable Growth Rate formula (SGR) and replace it with an alternative system that temporarily would raise Medicare physician pay and focus on value-based performance. The bill also reauthorizes the Children’s Health Insurance Program (CHIP) for 2 years, as well as other provisions.
Check back for detailed analysis and next steps for the legislation later on March 26.
CMS: Stage 3 meaningful use by 2018
All physicians and hospitals would need to meet stage 3 meaningful use beginning in 2018, according to a recent proposal by the Centers for Medicare & Medicaid Services.
In the agency’s Stage 3 proposed rule, there would be no transition period from earlier stages for those just starting or those who were in an earlier stage. CMS said that this is “expected to be the final stage” and will incorporate elements of the previous two stages.
That change comes along with the proposal beginning in 2017 to permanently make the attestation period a full year, with a few exceptions. A full-year attestation period was supposed to go into effect for 2015 with Stage 2, but CMS announced that it would reduce attestation to a 90-day period because of low participation.
The final year in which participants in the EHR Incentive Programs can receive bonus payments for meeting meaningful use criteria is 2017; penalties for failing to meet criteria have already begun.
The American College of Cardiology said in a statement that it is “concerned” by the proposal that even new physicians and practices will have to jump immediately to stage 3 in 2018 without a transition period.
“Implementing an EHR system in a physician or a hospital is not as simple as flipping a switch; it takes time, financial investment, careful consideration and planning, as well as education for all staff. The program must take this learning curve into consideration,” Dr. Kim Allan Williams Sr., ACC president, said in a statement.
The proposed rule also contains a number of more stringent requirements. On the patient engagement front, the proposed rule calls for 25% of patients to access their data, although it also allows for third-party providers to access a patient’s account as a means of satisfying the requirement. Patient-generated data also are highlighted, with a proposed requirement that physicians collect information via mobile devices or apps from 15% of their patients.Under the proposed Stage 3 of meaningful use, physicians and eligible hospitals must meet two of three criteria: that more than 50% of referrals or transitions of care involve the passing of information by the referring provider; that more than 40% of transitions or referrals received by a provider seeing a patient for the first time include information imported into that new provider’s EHR; or that for more than 80% of those new patients seen in transition or by referral for the first time, a clinical reconciliation be done on the information received during the health information exchange, including a review of current medications, medication allergies, and current and active diagnoses.
The proposed rule is scheduled to be published in the Federal Register on March 30; comments will be accepted at www.regulations.gov until May 29.
All physicians and hospitals would need to meet stage 3 meaningful use beginning in 2018, according to a recent proposal by the Centers for Medicare & Medicaid Services.
In the agency’s Stage 3 proposed rule, there would be no transition period from earlier stages for those just starting or those who were in an earlier stage. CMS said that this is “expected to be the final stage” and will incorporate elements of the previous two stages.
That change comes along with the proposal beginning in 2017 to permanently make the attestation period a full year, with a few exceptions. A full-year attestation period was supposed to go into effect for 2015 with Stage 2, but CMS announced that it would reduce attestation to a 90-day period because of low participation.
The final year in which participants in the EHR Incentive Programs can receive bonus payments for meeting meaningful use criteria is 2017; penalties for failing to meet criteria have already begun.
The American College of Cardiology said in a statement that it is “concerned” by the proposal that even new physicians and practices will have to jump immediately to stage 3 in 2018 without a transition period.
“Implementing an EHR system in a physician or a hospital is not as simple as flipping a switch; it takes time, financial investment, careful consideration and planning, as well as education for all staff. The program must take this learning curve into consideration,” Dr. Kim Allan Williams Sr., ACC president, said in a statement.
The proposed rule also contains a number of more stringent requirements. On the patient engagement front, the proposed rule calls for 25% of patients to access their data, although it also allows for third-party providers to access a patient’s account as a means of satisfying the requirement. Patient-generated data also are highlighted, with a proposed requirement that physicians collect information via mobile devices or apps from 15% of their patients.Under the proposed Stage 3 of meaningful use, physicians and eligible hospitals must meet two of three criteria: that more than 50% of referrals or transitions of care involve the passing of information by the referring provider; that more than 40% of transitions or referrals received by a provider seeing a patient for the first time include information imported into that new provider’s EHR; or that for more than 80% of those new patients seen in transition or by referral for the first time, a clinical reconciliation be done on the information received during the health information exchange, including a review of current medications, medication allergies, and current and active diagnoses.
The proposed rule is scheduled to be published in the Federal Register on March 30; comments will be accepted at www.regulations.gov until May 29.
All physicians and hospitals would need to meet stage 3 meaningful use beginning in 2018, according to a recent proposal by the Centers for Medicare & Medicaid Services.
In the agency’s Stage 3 proposed rule, there would be no transition period from earlier stages for those just starting or those who were in an earlier stage. CMS said that this is “expected to be the final stage” and will incorporate elements of the previous two stages.
That change comes along with the proposal beginning in 2017 to permanently make the attestation period a full year, with a few exceptions. A full-year attestation period was supposed to go into effect for 2015 with Stage 2, but CMS announced that it would reduce attestation to a 90-day period because of low participation.
The final year in which participants in the EHR Incentive Programs can receive bonus payments for meeting meaningful use criteria is 2017; penalties for failing to meet criteria have already begun.
The American College of Cardiology said in a statement that it is “concerned” by the proposal that even new physicians and practices will have to jump immediately to stage 3 in 2018 without a transition period.
“Implementing an EHR system in a physician or a hospital is not as simple as flipping a switch; it takes time, financial investment, careful consideration and planning, as well as education for all staff. The program must take this learning curve into consideration,” Dr. Kim Allan Williams Sr., ACC president, said in a statement.
The proposed rule also contains a number of more stringent requirements. On the patient engagement front, the proposed rule calls for 25% of patients to access their data, although it also allows for third-party providers to access a patient’s account as a means of satisfying the requirement. Patient-generated data also are highlighted, with a proposed requirement that physicians collect information via mobile devices or apps from 15% of their patients.Under the proposed Stage 3 of meaningful use, physicians and eligible hospitals must meet two of three criteria: that more than 50% of referrals or transitions of care involve the passing of information by the referring provider; that more than 40% of transitions or referrals received by a provider seeing a patient for the first time include information imported into that new provider’s EHR; or that for more than 80% of those new patients seen in transition or by referral for the first time, a clinical reconciliation be done on the information received during the health information exchange, including a review of current medications, medication allergies, and current and active diagnoses.
The proposed rule is scheduled to be published in the Federal Register on March 30; comments will be accepted at www.regulations.gov until May 29.
Tennis, Anyone?
In 2011, the U.S. Tennis Association (USTA) announced its commitment to support “Joining Forces,” the initiative led by First Lady Michelle Obama and Dr. Jill Biden, and pledged to work with VA and local VA hospitals to expand tennis programs for veterans, their families, caregivers, and survivors. The pledge also extended to military service members and their families.
Related: Helping Patients Set Goals for Better Health
Making good on its promise, the USTA is teaming up with VA to offer tennis clinics at VA medical facilities. The USTA will consult on upgrading or building tennis courts as well as provide coaching, instruction, equipment, or use of courts or other technical assistance needed to sustain a tennis court.
The USTA has also developed the Warrior Tennis Curriculum, an electronic manual for rehabilitation therapists who are using tennis as a therapeutic option.
Related: Performance Status: In the Eye of the Beholder?
“We are very excited to be partnering with the USTA Foundation to improve veterans’ physical fitness and ultimately their overall health and well-being,” said VA Interim Under Secretary for Health Carolyn M. Clancy, MD.
In 2011, the U.S. Tennis Association (USTA) announced its commitment to support “Joining Forces,” the initiative led by First Lady Michelle Obama and Dr. Jill Biden, and pledged to work with VA and local VA hospitals to expand tennis programs for veterans, their families, caregivers, and survivors. The pledge also extended to military service members and their families.
Related: Helping Patients Set Goals for Better Health
Making good on its promise, the USTA is teaming up with VA to offer tennis clinics at VA medical facilities. The USTA will consult on upgrading or building tennis courts as well as provide coaching, instruction, equipment, or use of courts or other technical assistance needed to sustain a tennis court.
The USTA has also developed the Warrior Tennis Curriculum, an electronic manual for rehabilitation therapists who are using tennis as a therapeutic option.
Related: Performance Status: In the Eye of the Beholder?
“We are very excited to be partnering with the USTA Foundation to improve veterans’ physical fitness and ultimately their overall health and well-being,” said VA Interim Under Secretary for Health Carolyn M. Clancy, MD.
In 2011, the U.S. Tennis Association (USTA) announced its commitment to support “Joining Forces,” the initiative led by First Lady Michelle Obama and Dr. Jill Biden, and pledged to work with VA and local VA hospitals to expand tennis programs for veterans, their families, caregivers, and survivors. The pledge also extended to military service members and their families.
Related: Helping Patients Set Goals for Better Health
Making good on its promise, the USTA is teaming up with VA to offer tennis clinics at VA medical facilities. The USTA will consult on upgrading or building tennis courts as well as provide coaching, instruction, equipment, or use of courts or other technical assistance needed to sustain a tennis court.
The USTA has also developed the Warrior Tennis Curriculum, an electronic manual for rehabilitation therapists who are using tennis as a therapeutic option.
Related: Performance Status: In the Eye of the Beholder?
“We are very excited to be partnering with the USTA Foundation to improve veterans’ physical fitness and ultimately their overall health and well-being,” said VA Interim Under Secretary for Health Carolyn M. Clancy, MD.
FDA approves Anthrasil to treat inhalational anthrax
The Food and Drug Administration has approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), for treatment of inhalational anthrax when used with appropriate antibacterial drugs.
Inhalational anthrax is caused by breathing in Bacillus anthracis spores, which can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of spores. In a statement, Dr. Karen Midthun – director of the FDA’s Center for Biologics Evaluation and Research – explained that Anthrasil “will be stored in U.S. Strategic National Stockpile to facilitate its availability in response to an anthrax emergency.”
Anthrasil was purchased by the U.S. Department of Health & Human Services’ Biomedical Advanced Research and Development Authority (BARDA) in 2011, but because it was not approved, its use prior to FDA approval would have required an emergency use authorization from the FDA.
The efficacy of Anthrasil was studied in animals because it was not feasible or ethical to conduct adequately controlled efficacy studies in humans, the FDA said. Monkeys and rabbits were exposed to Bacillus anthracis spores, and subsequently given either Anthrasil or a placebo. The survival rate for monkeys given Anthrasil was between 36% and 70%, with a trend toward increased survival at higher doses of Anthrasil. None of the monkeys given placebo survived. Rabbits had a 26% survival rate when given the drug, compared to 2% of those given placebo. A separate study exposed rabbits to Bacillus anthracis and treated them with either antibiotics or a combination of antibiotics and Anthrasil; survival rates were 71% for those treated with the combination and 25% for those treated with antibiotics only.
Safety was tested in 74 healthy human volunteers and the most commonly reported side effects were headache, back pain, nausea, and pain and swelling at the infusion site.
Anthrasil is manufactured by Cangene Corporation, based in Winnipeg, Canada, which developed the drug in collaboration with BARDA.
The Food and Drug Administration has approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), for treatment of inhalational anthrax when used with appropriate antibacterial drugs.
Inhalational anthrax is caused by breathing in Bacillus anthracis spores, which can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of spores. In a statement, Dr. Karen Midthun – director of the FDA’s Center for Biologics Evaluation and Research – explained that Anthrasil “will be stored in U.S. Strategic National Stockpile to facilitate its availability in response to an anthrax emergency.”
Anthrasil was purchased by the U.S. Department of Health & Human Services’ Biomedical Advanced Research and Development Authority (BARDA) in 2011, but because it was not approved, its use prior to FDA approval would have required an emergency use authorization from the FDA.
The efficacy of Anthrasil was studied in animals because it was not feasible or ethical to conduct adequately controlled efficacy studies in humans, the FDA said. Monkeys and rabbits were exposed to Bacillus anthracis spores, and subsequently given either Anthrasil or a placebo. The survival rate for monkeys given Anthrasil was between 36% and 70%, with a trend toward increased survival at higher doses of Anthrasil. None of the monkeys given placebo survived. Rabbits had a 26% survival rate when given the drug, compared to 2% of those given placebo. A separate study exposed rabbits to Bacillus anthracis and treated them with either antibiotics or a combination of antibiotics and Anthrasil; survival rates were 71% for those treated with the combination and 25% for those treated with antibiotics only.
Safety was tested in 74 healthy human volunteers and the most commonly reported side effects were headache, back pain, nausea, and pain and swelling at the infusion site.
Anthrasil is manufactured by Cangene Corporation, based in Winnipeg, Canada, which developed the drug in collaboration with BARDA.
The Food and Drug Administration has approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), for treatment of inhalational anthrax when used with appropriate antibacterial drugs.
Inhalational anthrax is caused by breathing in Bacillus anthracis spores, which can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of spores. In a statement, Dr. Karen Midthun – director of the FDA’s Center for Biologics Evaluation and Research – explained that Anthrasil “will be stored in U.S. Strategic National Stockpile to facilitate its availability in response to an anthrax emergency.”
Anthrasil was purchased by the U.S. Department of Health & Human Services’ Biomedical Advanced Research and Development Authority (BARDA) in 2011, but because it was not approved, its use prior to FDA approval would have required an emergency use authorization from the FDA.
The efficacy of Anthrasil was studied in animals because it was not feasible or ethical to conduct adequately controlled efficacy studies in humans, the FDA said. Monkeys and rabbits were exposed to Bacillus anthracis spores, and subsequently given either Anthrasil or a placebo. The survival rate for monkeys given Anthrasil was between 36% and 70%, with a trend toward increased survival at higher doses of Anthrasil. None of the monkeys given placebo survived. Rabbits had a 26% survival rate when given the drug, compared to 2% of those given placebo. A separate study exposed rabbits to Bacillus anthracis and treated them with either antibiotics or a combination of antibiotics and Anthrasil; survival rates were 71% for those treated with the combination and 25% for those treated with antibiotics only.
Safety was tested in 74 healthy human volunteers and the most commonly reported side effects were headache, back pain, nausea, and pain and swelling at the infusion site.
Anthrasil is manufactured by Cangene Corporation, based in Winnipeg, Canada, which developed the drug in collaboration with BARDA.
VA Relaxes Rules for Choice Program
The VA will now calculate driving distance when determining eligibility for the Veterans Choice Program. The previously announced rule went into effect April 24, 2015, and is expected to double the number of veterans who are eligible for the program. According to a VA news release, the VA is now sending letters to newly eligible veterans. Any veteran with questions about the program can call (866) 606-8198.
Responding to criticism of the Veterans Choice Program, the VA had previously announced that it would relax eligibility requirements. Previously, VA calculated mileage as a “straight-line distance between a Veteran’s residence and nearest VA medical facility,” but according to a VA blog post, mileage will now be calculated based on driving distance. According to the VA, the change will double the number of eligible veterans.
Related: Committed to Showing Results at the VA
Reaction to the change has been largely positive. “We are pleased that Secretary McDonald is responding directly to concerns voiced by the Senate Veterans’ Affairs Committee and other members of Congress to ensure those reforms are working for all veterans throughout the nation,” said Republican Senator Johnny Isakson of Georgia and Democratic Senator Richard Blumenthal of Connecticut in a joint statement. “This is a common-sense adjustment to a rule that has the potential to significantly impact the success of the Veterans Choice Program.”
Related: VHA Clarifies VISN Restructuring Plan
The Veterans of Foreign Wars (VFW) also released a statement praising the change but demanding more changes in the program. “The VFW is glad the VA agreed to change the measurement to actual driving distances, but the VA and Congress must now eliminate the 40-mile bubble they placed around their medical facilities,” said VFW National Commander-in-Chief John W. Stroud. “If a local VA cannot meet someone’s medical requirements, then it is absurd to require any veteran to drive hundreds of miles to another VA that can.”
Related: VA Budget Grows 7.5%, but Draws Criticism From Republicans
“We realize that Congress had to fit this temporary ‘choice’ program within certain budgetary constraints, but common sense and fairness dictate that the distance criteria must be measured to a facility that can actually deliver the medical services the veteran is requesting,” Joseph A. Violante, Disabled American Veterans national legislative director said in a March 24, 2015, testimony before the Senate Veterans’ Affairs Committee.
For more information on the Veterans Choice Program, visit http://www.va.gov/opa/choiceact.
The VA will now calculate driving distance when determining eligibility for the Veterans Choice Program. The previously announced rule went into effect April 24, 2015, and is expected to double the number of veterans who are eligible for the program. According to a VA news release, the VA is now sending letters to newly eligible veterans. Any veteran with questions about the program can call (866) 606-8198.
Responding to criticism of the Veterans Choice Program, the VA had previously announced that it would relax eligibility requirements. Previously, VA calculated mileage as a “straight-line distance between a Veteran’s residence and nearest VA medical facility,” but according to a VA blog post, mileage will now be calculated based on driving distance. According to the VA, the change will double the number of eligible veterans.
Related: Committed to Showing Results at the VA
Reaction to the change has been largely positive. “We are pleased that Secretary McDonald is responding directly to concerns voiced by the Senate Veterans’ Affairs Committee and other members of Congress to ensure those reforms are working for all veterans throughout the nation,” said Republican Senator Johnny Isakson of Georgia and Democratic Senator Richard Blumenthal of Connecticut in a joint statement. “This is a common-sense adjustment to a rule that has the potential to significantly impact the success of the Veterans Choice Program.”
Related: VHA Clarifies VISN Restructuring Plan
The Veterans of Foreign Wars (VFW) also released a statement praising the change but demanding more changes in the program. “The VFW is glad the VA agreed to change the measurement to actual driving distances, but the VA and Congress must now eliminate the 40-mile bubble they placed around their medical facilities,” said VFW National Commander-in-Chief John W. Stroud. “If a local VA cannot meet someone’s medical requirements, then it is absurd to require any veteran to drive hundreds of miles to another VA that can.”
Related: VA Budget Grows 7.5%, but Draws Criticism From Republicans
“We realize that Congress had to fit this temporary ‘choice’ program within certain budgetary constraints, but common sense and fairness dictate that the distance criteria must be measured to a facility that can actually deliver the medical services the veteran is requesting,” Joseph A. Violante, Disabled American Veterans national legislative director said in a March 24, 2015, testimony before the Senate Veterans’ Affairs Committee.
For more information on the Veterans Choice Program, visit http://www.va.gov/opa/choiceact.
The VA will now calculate driving distance when determining eligibility for the Veterans Choice Program. The previously announced rule went into effect April 24, 2015, and is expected to double the number of veterans who are eligible for the program. According to a VA news release, the VA is now sending letters to newly eligible veterans. Any veteran with questions about the program can call (866) 606-8198.
Responding to criticism of the Veterans Choice Program, the VA had previously announced that it would relax eligibility requirements. Previously, VA calculated mileage as a “straight-line distance between a Veteran’s residence and nearest VA medical facility,” but according to a VA blog post, mileage will now be calculated based on driving distance. According to the VA, the change will double the number of eligible veterans.
Related: Committed to Showing Results at the VA
Reaction to the change has been largely positive. “We are pleased that Secretary McDonald is responding directly to concerns voiced by the Senate Veterans’ Affairs Committee and other members of Congress to ensure those reforms are working for all veterans throughout the nation,” said Republican Senator Johnny Isakson of Georgia and Democratic Senator Richard Blumenthal of Connecticut in a joint statement. “This is a common-sense adjustment to a rule that has the potential to significantly impact the success of the Veterans Choice Program.”
Related: VHA Clarifies VISN Restructuring Plan
The Veterans of Foreign Wars (VFW) also released a statement praising the change but demanding more changes in the program. “The VFW is glad the VA agreed to change the measurement to actual driving distances, but the VA and Congress must now eliminate the 40-mile bubble they placed around their medical facilities,” said VFW National Commander-in-Chief John W. Stroud. “If a local VA cannot meet someone’s medical requirements, then it is absurd to require any veteran to drive hundreds of miles to another VA that can.”
Related: VA Budget Grows 7.5%, but Draws Criticism From Republicans
“We realize that Congress had to fit this temporary ‘choice’ program within certain budgetary constraints, but common sense and fairness dictate that the distance criteria must be measured to a facility that can actually deliver the medical services the veteran is requesting,” Joseph A. Violante, Disabled American Veterans national legislative director said in a March 24, 2015, testimony before the Senate Veterans’ Affairs Committee.
For more information on the Veterans Choice Program, visit http://www.va.gov/opa/choiceact.
FDA: Avoid using amiodarone with some hepatitis C antivirals
Taking the antiarrythmic drug amiodarone with the hepatitis C antiviral drugs ledipasvir and sofosbuvir, or with sofosbuvir plus another direct-acting antiviral drug, has been associated with cases of symptomatic bradycardia – including a fatal cardiac arrest – according to the Food and Drug Administration.
Because of the reports, the antiviral drugs’ labels now recommend against using amiodarone with those hepatitis C drugs.
An FDA statement issued March 24 described the bradycardia cases as “serious and life-threatening.” Gilead Sciences markets the ledipasvir and sofosbuvir combination as Harvoni and markets sofosbuvir as Sovaldi to treat chronic hepatitis C virus (HCV) infection.
Gilead issued a “Dear Health Care Provider” letter that provides further details of the cases. There have been nine postmarketing reports of symptomatic bradycardia in patients who were taking amiodarone with Harvoni; amiodarone with Sovaldi plus another hepatitis C antiviral drug, simeprevir (Olysio); or amiodarone with an investigational hepatitis C antiviral drug, daclatasvir.
Of those cases, six occurred with in the first 24 hours of starting treatment with the antivirals, and three cases occurred within the first 2-12 days after antiviral therapy was started. A pacemaker was needed in three cases, and one case was a fatal cardiac arrest.
In three cases, a “rechallenge with HCV treatment in the setting of continued amiodarone therapy resulted in recurrence of symptomatic bradycardia,” according to the Gilead letter.
The effect of coadministration on the blood levels of the antiviral drugs is not known, nor is the mechanism behind the cardiac effect.
The labeling of the fixed-dose combination of ledipasvir and sofosbuvir (Harvoni) now includes a section on “serious symptomatic bradycardia” when coadministered with amiodarone, and says that coadministration is not recommended. The label adds that if a patient on amiodarone or Harvoni has no other alternative than to take that combination, patients should be counseled about the bradycardia risk.
Cardiac monitoring is recommended for inpatients during the first 48 hours the patient is taking the drugs, “after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment.”
The label notes that amiodarone has a long half-life, so cardiac monitoring is still necessary if the patient discontinues amiodarone just before starting treatment with Harvoni. Similar labeling changes have been made to the Sovaldi label.
Adverse events associated with Harvoni or Sovaldi should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/Safety/MedWatch/.
Taking the antiarrythmic drug amiodarone with the hepatitis C antiviral drugs ledipasvir and sofosbuvir, or with sofosbuvir plus another direct-acting antiviral drug, has been associated with cases of symptomatic bradycardia – including a fatal cardiac arrest – according to the Food and Drug Administration.
Because of the reports, the antiviral drugs’ labels now recommend against using amiodarone with those hepatitis C drugs.
An FDA statement issued March 24 described the bradycardia cases as “serious and life-threatening.” Gilead Sciences markets the ledipasvir and sofosbuvir combination as Harvoni and markets sofosbuvir as Sovaldi to treat chronic hepatitis C virus (HCV) infection.
Gilead issued a “Dear Health Care Provider” letter that provides further details of the cases. There have been nine postmarketing reports of symptomatic bradycardia in patients who were taking amiodarone with Harvoni; amiodarone with Sovaldi plus another hepatitis C antiviral drug, simeprevir (Olysio); or amiodarone with an investigational hepatitis C antiviral drug, daclatasvir.
Of those cases, six occurred with in the first 24 hours of starting treatment with the antivirals, and three cases occurred within the first 2-12 days after antiviral therapy was started. A pacemaker was needed in three cases, and one case was a fatal cardiac arrest.
In three cases, a “rechallenge with HCV treatment in the setting of continued amiodarone therapy resulted in recurrence of symptomatic bradycardia,” according to the Gilead letter.
The effect of coadministration on the blood levels of the antiviral drugs is not known, nor is the mechanism behind the cardiac effect.
The labeling of the fixed-dose combination of ledipasvir and sofosbuvir (Harvoni) now includes a section on “serious symptomatic bradycardia” when coadministered with amiodarone, and says that coadministration is not recommended. The label adds that if a patient on amiodarone or Harvoni has no other alternative than to take that combination, patients should be counseled about the bradycardia risk.
Cardiac monitoring is recommended for inpatients during the first 48 hours the patient is taking the drugs, “after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment.”
The label notes that amiodarone has a long half-life, so cardiac monitoring is still necessary if the patient discontinues amiodarone just before starting treatment with Harvoni. Similar labeling changes have been made to the Sovaldi label.
Adverse events associated with Harvoni or Sovaldi should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/Safety/MedWatch/.
Taking the antiarrythmic drug amiodarone with the hepatitis C antiviral drugs ledipasvir and sofosbuvir, or with sofosbuvir plus another direct-acting antiviral drug, has been associated with cases of symptomatic bradycardia – including a fatal cardiac arrest – according to the Food and Drug Administration.
Because of the reports, the antiviral drugs’ labels now recommend against using amiodarone with those hepatitis C drugs.
An FDA statement issued March 24 described the bradycardia cases as “serious and life-threatening.” Gilead Sciences markets the ledipasvir and sofosbuvir combination as Harvoni and markets sofosbuvir as Sovaldi to treat chronic hepatitis C virus (HCV) infection.
Gilead issued a “Dear Health Care Provider” letter that provides further details of the cases. There have been nine postmarketing reports of symptomatic bradycardia in patients who were taking amiodarone with Harvoni; amiodarone with Sovaldi plus another hepatitis C antiviral drug, simeprevir (Olysio); or amiodarone with an investigational hepatitis C antiviral drug, daclatasvir.
Of those cases, six occurred with in the first 24 hours of starting treatment with the antivirals, and three cases occurred within the first 2-12 days after antiviral therapy was started. A pacemaker was needed in three cases, and one case was a fatal cardiac arrest.
In three cases, a “rechallenge with HCV treatment in the setting of continued amiodarone therapy resulted in recurrence of symptomatic bradycardia,” according to the Gilead letter.
The effect of coadministration on the blood levels of the antiviral drugs is not known, nor is the mechanism behind the cardiac effect.
The labeling of the fixed-dose combination of ledipasvir and sofosbuvir (Harvoni) now includes a section on “serious symptomatic bradycardia” when coadministered with amiodarone, and says that coadministration is not recommended. The label adds that if a patient on amiodarone or Harvoni has no other alternative than to take that combination, patients should be counseled about the bradycardia risk.
Cardiac monitoring is recommended for inpatients during the first 48 hours the patient is taking the drugs, “after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment.”
The label notes that amiodarone has a long half-life, so cardiac monitoring is still necessary if the patient discontinues amiodarone just before starting treatment with Harvoni. Similar labeling changes have been made to the Sovaldi label.
Adverse events associated with Harvoni or Sovaldi should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/Safety/MedWatch/.
New bill consolidates SGR fix, CHIP reauthorization
Bipartisan lawmakers have introduced a bill that would repeal the Medicare Sustainable Growth Rate (SGR) formula, this time with language that would reauthorize the Children’s Health Insurance Program (CHIP) for 2 years.
Leaders on the House Energy and Commerce and House Ways and Means committees on March 24 announced H.R. 2, the Medicare Access and CHIP Reauthorization Act. The proposal builds on H.R. 1470, the SGR Repeal and Medicare Provider Payment Modernization Act – reintroduced March 19 – by extending CHIP funding through fiscal 2017. Funding for the program expires in September. The Medicare Access and CHIP Reauthorization Act also includes 2-year reauthorization of the Community Health Centers program, the National Health Service Corps, and the Teaching Health Centers program, all of which would expire in 2015.
The changes would be paid for by income-related premium adjustments for Medicare parts B and D, Medigap reforms, an increase of levy authority on payments to Medicare providers with delinquent tax debt, adjustments to inpatient hospital payment rates, a delay of Medicaid Disproportionate Share Hospital (DSH) changes until 2018, and a 1% market basket update for post–acute care providers.
The payment proposals of the bill reflect a working framework released by committee members March 20. A vote on the SGR package is expected this week.
The bill culminates years of efforts by lawmakers and stakeholders and will strengthen Medicare over the long term, according to Energy and Commerce Committee Chairman Fred Upton (R-Mich.).
“We can see the light at the end of the SGR tunnel – finally,” Rep. Upton said in a statement. “This responsible legislative package reflects years of bipartisan work, is a good deal for seniors, and a good deal for children, too. It’s time to put a stop once and for all to the repeated SGR crises and start to put Medicare on a stronger path forward for our seniors.”
The committee’s ranking member, Rep. Frank Pallone (D-N.J.) agreed.
“Finally, after a decade of trying, we have a bipartisan bill that will permanently repeal the flawed SGR and move Medicare to a health care system based on quality and efficiency, that is good for seniors and doctors alike,” Rep. Pallone said.
“As with any bipartisan effort, this legislation reflects give and take on both sides. However, we have come to a balanced compromise that will end uncertainty in the system, extend CHIP, fund Community Health Centers, and make permanent the Qualifying Individual (QI) program that helps low income seniors pay their Medicare premiums,” he added.
In addition to repealing the SGR, the final bill includes a 0.5% pay increase per year for the next 5 years; consolidates existing quality programs into a single value-based performance program; incentivizes physicians to use alternate payment models that focus on care coordination and preventive care; and pushes for more transparency of Medicare data for physicians, providers, and patients.
The latest bill comes a week before the current SGR patch expires on March 31. Without legislative action, physicians will see a 21% cut in Medicare pay.
Bipartisan lawmakers have introduced a bill that would repeal the Medicare Sustainable Growth Rate (SGR) formula, this time with language that would reauthorize the Children’s Health Insurance Program (CHIP) for 2 years.
Leaders on the House Energy and Commerce and House Ways and Means committees on March 24 announced H.R. 2, the Medicare Access and CHIP Reauthorization Act. The proposal builds on H.R. 1470, the SGR Repeal and Medicare Provider Payment Modernization Act – reintroduced March 19 – by extending CHIP funding through fiscal 2017. Funding for the program expires in September. The Medicare Access and CHIP Reauthorization Act also includes 2-year reauthorization of the Community Health Centers program, the National Health Service Corps, and the Teaching Health Centers program, all of which would expire in 2015.
The changes would be paid for by income-related premium adjustments for Medicare parts B and D, Medigap reforms, an increase of levy authority on payments to Medicare providers with delinquent tax debt, adjustments to inpatient hospital payment rates, a delay of Medicaid Disproportionate Share Hospital (DSH) changes until 2018, and a 1% market basket update for post–acute care providers.
The payment proposals of the bill reflect a working framework released by committee members March 20. A vote on the SGR package is expected this week.
The bill culminates years of efforts by lawmakers and stakeholders and will strengthen Medicare over the long term, according to Energy and Commerce Committee Chairman Fred Upton (R-Mich.).
“We can see the light at the end of the SGR tunnel – finally,” Rep. Upton said in a statement. “This responsible legislative package reflects years of bipartisan work, is a good deal for seniors, and a good deal for children, too. It’s time to put a stop once and for all to the repeated SGR crises and start to put Medicare on a stronger path forward for our seniors.”
The committee’s ranking member, Rep. Frank Pallone (D-N.J.) agreed.
“Finally, after a decade of trying, we have a bipartisan bill that will permanently repeal the flawed SGR and move Medicare to a health care system based on quality and efficiency, that is good for seniors and doctors alike,” Rep. Pallone said.
“As with any bipartisan effort, this legislation reflects give and take on both sides. However, we have come to a balanced compromise that will end uncertainty in the system, extend CHIP, fund Community Health Centers, and make permanent the Qualifying Individual (QI) program that helps low income seniors pay their Medicare premiums,” he added.
In addition to repealing the SGR, the final bill includes a 0.5% pay increase per year for the next 5 years; consolidates existing quality programs into a single value-based performance program; incentivizes physicians to use alternate payment models that focus on care coordination and preventive care; and pushes for more transparency of Medicare data for physicians, providers, and patients.
The latest bill comes a week before the current SGR patch expires on March 31. Without legislative action, physicians will see a 21% cut in Medicare pay.
Bipartisan lawmakers have introduced a bill that would repeal the Medicare Sustainable Growth Rate (SGR) formula, this time with language that would reauthorize the Children’s Health Insurance Program (CHIP) for 2 years.
Leaders on the House Energy and Commerce and House Ways and Means committees on March 24 announced H.R. 2, the Medicare Access and CHIP Reauthorization Act. The proposal builds on H.R. 1470, the SGR Repeal and Medicare Provider Payment Modernization Act – reintroduced March 19 – by extending CHIP funding through fiscal 2017. Funding for the program expires in September. The Medicare Access and CHIP Reauthorization Act also includes 2-year reauthorization of the Community Health Centers program, the National Health Service Corps, and the Teaching Health Centers program, all of which would expire in 2015.
The changes would be paid for by income-related premium adjustments for Medicare parts B and D, Medigap reforms, an increase of levy authority on payments to Medicare providers with delinquent tax debt, adjustments to inpatient hospital payment rates, a delay of Medicaid Disproportionate Share Hospital (DSH) changes until 2018, and a 1% market basket update for post–acute care providers.
The payment proposals of the bill reflect a working framework released by committee members March 20. A vote on the SGR package is expected this week.
The bill culminates years of efforts by lawmakers and stakeholders and will strengthen Medicare over the long term, according to Energy and Commerce Committee Chairman Fred Upton (R-Mich.).
“We can see the light at the end of the SGR tunnel – finally,” Rep. Upton said in a statement. “This responsible legislative package reflects years of bipartisan work, is a good deal for seniors, and a good deal for children, too. It’s time to put a stop once and for all to the repeated SGR crises and start to put Medicare on a stronger path forward for our seniors.”
The committee’s ranking member, Rep. Frank Pallone (D-N.J.) agreed.
“Finally, after a decade of trying, we have a bipartisan bill that will permanently repeal the flawed SGR and move Medicare to a health care system based on quality and efficiency, that is good for seniors and doctors alike,” Rep. Pallone said.
“As with any bipartisan effort, this legislation reflects give and take on both sides. However, we have come to a balanced compromise that will end uncertainty in the system, extend CHIP, fund Community Health Centers, and make permanent the Qualifying Individual (QI) program that helps low income seniors pay their Medicare premiums,” he added.
In addition to repealing the SGR, the final bill includes a 0.5% pay increase per year for the next 5 years; consolidates existing quality programs into a single value-based performance program; incentivizes physicians to use alternate payment models that focus on care coordination and preventive care; and pushes for more transparency of Medicare data for physicians, providers, and patients.
The latest bill comes a week before the current SGR patch expires on March 31. Without legislative action, physicians will see a 21% cut in Medicare pay.
Cherokee Nation Wins IHS Joint Venture Construction Award
A recent IHS Joint Venture Construction Program award was presented to the Cherokee Nation’s W.W. Hastings Hospital in Tahlequah, Oklahoma. The award provides up to $30 million per year for 20 years to supplement staffing and operation expenses.
Related: IHS Hiring More Veterans
Cherokee Nation operates the largest tribal health system in the U.S., with > 1 million patient visits per year. W.W. Hastings was built 30 years ago to serve 65,000 patients—it now has 400,000 patient visits a year. The addition will expand the campus by > 250,000 square feet, including > 100 examination rooms and dozens of specialty rooms.
Related: New Leadership at IHS as McSwain Replaces Roubideaux
The tribe was notified in January of the award. Calling it a “proud, proud day in the Cherokee Nation,” Principal Chief Bill John Baker said, “Our partnership with IHS will improve the health outcomes of Cherokees for the next 2 to 3 generations and beyond.”
Related: Taking a New Approach to Tribal Welfare
The Cherokee Nation, which was 1 of 3 tribes selected from a pool of 37 applicants for a Joint Venture Construction project, is also in the midst of a $100 million health care expansion plan using profits from the tribe’s business revenue, and new Ochelata and Jay health centers are under construction.
A recent IHS Joint Venture Construction Program award was presented to the Cherokee Nation’s W.W. Hastings Hospital in Tahlequah, Oklahoma. The award provides up to $30 million per year for 20 years to supplement staffing and operation expenses.
Related: IHS Hiring More Veterans
Cherokee Nation operates the largest tribal health system in the U.S., with > 1 million patient visits per year. W.W. Hastings was built 30 years ago to serve 65,000 patients—it now has 400,000 patient visits a year. The addition will expand the campus by > 250,000 square feet, including > 100 examination rooms and dozens of specialty rooms.
Related: New Leadership at IHS as McSwain Replaces Roubideaux
The tribe was notified in January of the award. Calling it a “proud, proud day in the Cherokee Nation,” Principal Chief Bill John Baker said, “Our partnership with IHS will improve the health outcomes of Cherokees for the next 2 to 3 generations and beyond.”
Related: Taking a New Approach to Tribal Welfare
The Cherokee Nation, which was 1 of 3 tribes selected from a pool of 37 applicants for a Joint Venture Construction project, is also in the midst of a $100 million health care expansion plan using profits from the tribe’s business revenue, and new Ochelata and Jay health centers are under construction.
A recent IHS Joint Venture Construction Program award was presented to the Cherokee Nation’s W.W. Hastings Hospital in Tahlequah, Oklahoma. The award provides up to $30 million per year for 20 years to supplement staffing and operation expenses.
Related: IHS Hiring More Veterans
Cherokee Nation operates the largest tribal health system in the U.S., with > 1 million patient visits per year. W.W. Hastings was built 30 years ago to serve 65,000 patients—it now has 400,000 patient visits a year. The addition will expand the campus by > 250,000 square feet, including > 100 examination rooms and dozens of specialty rooms.
Related: New Leadership at IHS as McSwain Replaces Roubideaux
The tribe was notified in January of the award. Calling it a “proud, proud day in the Cherokee Nation,” Principal Chief Bill John Baker said, “Our partnership with IHS will improve the health outcomes of Cherokees for the next 2 to 3 generations and beyond.”
Related: Taking a New Approach to Tribal Welfare
The Cherokee Nation, which was 1 of 3 tribes selected from a pool of 37 applicants for a Joint Venture Construction project, is also in the midst of a $100 million health care expansion plan using profits from the tribe’s business revenue, and new Ochelata and Jay health centers are under construction.
FDA calls study of unexplained olanzapine deaths ‘inconclusive’
The Food and Drug Administration’s review of a study that looked into the unexplained deaths of two patients days after receiving injections of the long-acting injectable formulation of the atypical antipsychotic olanzapine are “inconclusive,” and no labeling changes are currently recommended, the agency has announced.
“We are unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection,” according to the drug safety communication issued March 23 by the FDA.
Patients who receive olanzapine pamoate must be monitored for 3 hours after an injection because of the risk of post-injection delirium sedation (PDSS) associated with the injection. These patients, however, died 3 to 4 days after having received appropriate IM doses of olanzapine pamoate (Zyprexa Relprevv) and were found to have very high levels of the drug. The deaths and subsequent investigation were announced by the FDA in 2013.
The March 23 statement said an animal study, conducted by olanzapine manufacturer Eli Lilly at the FDA’s request to determine whether an IM injection could result in “postmortem redistribution” of olanzapine pamoate, “suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels” in the two patients.
Based on its review, the FDA is not recommending any changes to the prescribing information of olanzapine pamoate. However, the agency is advising health care professionals to continue to follow the Risk Evaluation and Mitigation Strategy in place for this drug, which includes mandatory enrollment of patients, prescribers, health care facilities, and pharmacies in the Zyprexa Relprevv Patient Care program. Patients “should not stop receiving treatment without first talking to their health care professionals,” the statement adds.
The REMS requirements include continuous monitoring of patients for 3 hours after the injection, which must be administered at a REMS-certified health care facility that has quick access to emergency response services. A medication guide explaining these and other risks associated with the drug are provided to patients.
The increased risk for severe sedation, including coma, and/or delirium after each olanzapine pamoate injection, also is described in a boxed warning in the prescribing information.
Adverse events associated with Zyprexa Relprevv should be reported to the FDA’s MedWatch program at 800-332-1088 or https://www.accessdata.fda.gov/scripts/medwatch/
The Food and Drug Administration’s review of a study that looked into the unexplained deaths of two patients days after receiving injections of the long-acting injectable formulation of the atypical antipsychotic olanzapine are “inconclusive,” and no labeling changes are currently recommended, the agency has announced.
“We are unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection,” according to the drug safety communication issued March 23 by the FDA.
Patients who receive olanzapine pamoate must be monitored for 3 hours after an injection because of the risk of post-injection delirium sedation (PDSS) associated with the injection. These patients, however, died 3 to 4 days after having received appropriate IM doses of olanzapine pamoate (Zyprexa Relprevv) and were found to have very high levels of the drug. The deaths and subsequent investigation were announced by the FDA in 2013.
The March 23 statement said an animal study, conducted by olanzapine manufacturer Eli Lilly at the FDA’s request to determine whether an IM injection could result in “postmortem redistribution” of olanzapine pamoate, “suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels” in the two patients.
Based on its review, the FDA is not recommending any changes to the prescribing information of olanzapine pamoate. However, the agency is advising health care professionals to continue to follow the Risk Evaluation and Mitigation Strategy in place for this drug, which includes mandatory enrollment of patients, prescribers, health care facilities, and pharmacies in the Zyprexa Relprevv Patient Care program. Patients “should not stop receiving treatment without first talking to their health care professionals,” the statement adds.
The REMS requirements include continuous monitoring of patients for 3 hours after the injection, which must be administered at a REMS-certified health care facility that has quick access to emergency response services. A medication guide explaining these and other risks associated with the drug are provided to patients.
The increased risk for severe sedation, including coma, and/or delirium after each olanzapine pamoate injection, also is described in a boxed warning in the prescribing information.
Adverse events associated with Zyprexa Relprevv should be reported to the FDA’s MedWatch program at 800-332-1088 or https://www.accessdata.fda.gov/scripts/medwatch/
The Food and Drug Administration’s review of a study that looked into the unexplained deaths of two patients days after receiving injections of the long-acting injectable formulation of the atypical antipsychotic olanzapine are “inconclusive,” and no labeling changes are currently recommended, the agency has announced.
“We are unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection,” according to the drug safety communication issued March 23 by the FDA.
Patients who receive olanzapine pamoate must be monitored for 3 hours after an injection because of the risk of post-injection delirium sedation (PDSS) associated with the injection. These patients, however, died 3 to 4 days after having received appropriate IM doses of olanzapine pamoate (Zyprexa Relprevv) and were found to have very high levels of the drug. The deaths and subsequent investigation were announced by the FDA in 2013.
The March 23 statement said an animal study, conducted by olanzapine manufacturer Eli Lilly at the FDA’s request to determine whether an IM injection could result in “postmortem redistribution” of olanzapine pamoate, “suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels” in the two patients.
Based on its review, the FDA is not recommending any changes to the prescribing information of olanzapine pamoate. However, the agency is advising health care professionals to continue to follow the Risk Evaluation and Mitigation Strategy in place for this drug, which includes mandatory enrollment of patients, prescribers, health care facilities, and pharmacies in the Zyprexa Relprevv Patient Care program. Patients “should not stop receiving treatment without first talking to their health care professionals,” the statement adds.
The REMS requirements include continuous monitoring of patients for 3 hours after the injection, which must be administered at a REMS-certified health care facility that has quick access to emergency response services. A medication guide explaining these and other risks associated with the drug are provided to patients.
The increased risk for severe sedation, including coma, and/or delirium after each olanzapine pamoate injection, also is described in a boxed warning in the prescribing information.
Adverse events associated with Zyprexa Relprevv should be reported to the FDA’s MedWatch program at 800-332-1088 or https://www.accessdata.fda.gov/scripts/medwatch/
Value-based payment: Time to start getting ready
WASHINGTON– Are physicians ready for the shift toward value-based compensation?
A report from the American Medical Association and the RAND Corporation aims to get physicians thinking about what investments they should expect to make and what obstacles they may encounter as they prepare for the federal government’s switch from fee-for-service to value-based medicine in 2018.
“There is a lot of enthusiasm for change,” Dr. Mark W. Friedberg, senior natural scientist at RAND in Boston and lead researcher on the report, said in an interview. “There is a lot of hope this will result in better patient care and physician success. It’s a matter of the details.”
The report is based on survey data from 34 practices across the country, all of which have some form of alternative payment structure in place, whether it be accountable care or bundled services. Practices were located in rural and urban settings ranging from hospital- to physician-owned or corporately managed, all with varying sizes of patient panels.
The top concern that practice managers faced was matching the appropriate alternative payment model to their particular patient population, researchers found. Other concerns included how best to use incentives without adversely affecting patient care and how to avoid physician burn-out.
These concerns, Dr. Friedberg said, point to a need for payers to offer guidance about what makes sense when and why. “We got the message that more communication between payers and physician practices tends to be a good thing.”
Many of the coming changes will require updated technology. Finding the money for such an overhaul is a universal preoccupation of many practice managers, and another reason some practices have yet to switch. “Some of the time, practices can get a loan, or have the reserves to do it on their own, but sometimes they don’t and they need to partner with a large organization like a hospital or a large physician group,” Dr. Friedberg said.
Payers are not likely to help foot the bill, according to Susan DeVore, president and chief executive officer of Premier Health, a performance improvement alliance of hospitals and other providers.
“It would be wonderful if the health plans would spend hundreds of millions of dollars for the technology enablement of the physician practices and the health systems,” Ms. DeVore said at the press conference. “The truth is, health systems and physicians are [already] spending the billions to build these technology infrastructures, and they need to do that together.”
She called for more systemwide transparent collaboration in how cost is determined and in how quality and outcomes are measured. “It’s not fair to say we need a coordinated system of care, but then we can’t do it for lots of regulatory reasons,” she said noting that ultimately, she believed such information sharing would be determined by Congress.
Payers, should, however, make sure that physicians and other providers have a seat at the table when performance metrics are determined, Dr. Friedberg said.
“Some of the concerns we heard were that, in addition to the number of measures, was also whether individual measures are clinically valid, and do they really reflect true differences in the quality of the patient care. Is it possible that the measure isn’t really reliable and not adequately risk adjusted, and therefore might not be ready for prime time in a payment contract?”
Although the report did not offer specific time frames practice managers could expect before a new structure would take hold, Ms. DeVore said she was aware of some practices that realized more than a third more profits within 3 years of switching to value-based care models.
Chet Burrell, president and CEO of CareFirst BlueCross BlueShield, said his group’s experience was that overall, physicians were not ready for the change to value-based care. This, despite the insurer’s announcement that $1 in every $5 it spends on reimbursement is now tied to quality care.
For physicians who are ready to make the shift to value-based payment, Mr. Burrell said an average of 5 years was necessary to fully integrate. “Each practice is its own ecosystem. Some physicians catch on very quickly, but some are hostile.”
On Twitter @whitneymcknight
WASHINGTON– Are physicians ready for the shift toward value-based compensation?
A report from the American Medical Association and the RAND Corporation aims to get physicians thinking about what investments they should expect to make and what obstacles they may encounter as they prepare for the federal government’s switch from fee-for-service to value-based medicine in 2018.
“There is a lot of enthusiasm for change,” Dr. Mark W. Friedberg, senior natural scientist at RAND in Boston and lead researcher on the report, said in an interview. “There is a lot of hope this will result in better patient care and physician success. It’s a matter of the details.”
The report is based on survey data from 34 practices across the country, all of which have some form of alternative payment structure in place, whether it be accountable care or bundled services. Practices were located in rural and urban settings ranging from hospital- to physician-owned or corporately managed, all with varying sizes of patient panels.
The top concern that practice managers faced was matching the appropriate alternative payment model to their particular patient population, researchers found. Other concerns included how best to use incentives without adversely affecting patient care and how to avoid physician burn-out.
These concerns, Dr. Friedberg said, point to a need for payers to offer guidance about what makes sense when and why. “We got the message that more communication between payers and physician practices tends to be a good thing.”
Many of the coming changes will require updated technology. Finding the money for such an overhaul is a universal preoccupation of many practice managers, and another reason some practices have yet to switch. “Some of the time, practices can get a loan, or have the reserves to do it on their own, but sometimes they don’t and they need to partner with a large organization like a hospital or a large physician group,” Dr. Friedberg said.
Payers are not likely to help foot the bill, according to Susan DeVore, president and chief executive officer of Premier Health, a performance improvement alliance of hospitals and other providers.
“It would be wonderful if the health plans would spend hundreds of millions of dollars for the technology enablement of the physician practices and the health systems,” Ms. DeVore said at the press conference. “The truth is, health systems and physicians are [already] spending the billions to build these technology infrastructures, and they need to do that together.”
She called for more systemwide transparent collaboration in how cost is determined and in how quality and outcomes are measured. “It’s not fair to say we need a coordinated system of care, but then we can’t do it for lots of regulatory reasons,” she said noting that ultimately, she believed such information sharing would be determined by Congress.
Payers, should, however, make sure that physicians and other providers have a seat at the table when performance metrics are determined, Dr. Friedberg said.
“Some of the concerns we heard were that, in addition to the number of measures, was also whether individual measures are clinically valid, and do they really reflect true differences in the quality of the patient care. Is it possible that the measure isn’t really reliable and not adequately risk adjusted, and therefore might not be ready for prime time in a payment contract?”
Although the report did not offer specific time frames practice managers could expect before a new structure would take hold, Ms. DeVore said she was aware of some practices that realized more than a third more profits within 3 years of switching to value-based care models.
Chet Burrell, president and CEO of CareFirst BlueCross BlueShield, said his group’s experience was that overall, physicians were not ready for the change to value-based care. This, despite the insurer’s announcement that $1 in every $5 it spends on reimbursement is now tied to quality care.
For physicians who are ready to make the shift to value-based payment, Mr. Burrell said an average of 5 years was necessary to fully integrate. “Each practice is its own ecosystem. Some physicians catch on very quickly, but some are hostile.”
On Twitter @whitneymcknight
WASHINGTON– Are physicians ready for the shift toward value-based compensation?
A report from the American Medical Association and the RAND Corporation aims to get physicians thinking about what investments they should expect to make and what obstacles they may encounter as they prepare for the federal government’s switch from fee-for-service to value-based medicine in 2018.
“There is a lot of enthusiasm for change,” Dr. Mark W. Friedberg, senior natural scientist at RAND in Boston and lead researcher on the report, said in an interview. “There is a lot of hope this will result in better patient care and physician success. It’s a matter of the details.”
The report is based on survey data from 34 practices across the country, all of which have some form of alternative payment structure in place, whether it be accountable care or bundled services. Practices were located in rural and urban settings ranging from hospital- to physician-owned or corporately managed, all with varying sizes of patient panels.
The top concern that practice managers faced was matching the appropriate alternative payment model to their particular patient population, researchers found. Other concerns included how best to use incentives without adversely affecting patient care and how to avoid physician burn-out.
These concerns, Dr. Friedberg said, point to a need for payers to offer guidance about what makes sense when and why. “We got the message that more communication between payers and physician practices tends to be a good thing.”
Many of the coming changes will require updated technology. Finding the money for such an overhaul is a universal preoccupation of many practice managers, and another reason some practices have yet to switch. “Some of the time, practices can get a loan, or have the reserves to do it on their own, but sometimes they don’t and they need to partner with a large organization like a hospital or a large physician group,” Dr. Friedberg said.
Payers are not likely to help foot the bill, according to Susan DeVore, president and chief executive officer of Premier Health, a performance improvement alliance of hospitals and other providers.
“It would be wonderful if the health plans would spend hundreds of millions of dollars for the technology enablement of the physician practices and the health systems,” Ms. DeVore said at the press conference. “The truth is, health systems and physicians are [already] spending the billions to build these technology infrastructures, and they need to do that together.”
She called for more systemwide transparent collaboration in how cost is determined and in how quality and outcomes are measured. “It’s not fair to say we need a coordinated system of care, but then we can’t do it for lots of regulatory reasons,” she said noting that ultimately, she believed such information sharing would be determined by Congress.
Payers, should, however, make sure that physicians and other providers have a seat at the table when performance metrics are determined, Dr. Friedberg said.
“Some of the concerns we heard were that, in addition to the number of measures, was also whether individual measures are clinically valid, and do they really reflect true differences in the quality of the patient care. Is it possible that the measure isn’t really reliable and not adequately risk adjusted, and therefore might not be ready for prime time in a payment contract?”
Although the report did not offer specific time frames practice managers could expect before a new structure would take hold, Ms. DeVore said she was aware of some practices that realized more than a third more profits within 3 years of switching to value-based care models.
Chet Burrell, president and CEO of CareFirst BlueCross BlueShield, said his group’s experience was that overall, physicians were not ready for the change to value-based care. This, despite the insurer’s announcement that $1 in every $5 it spends on reimbursement is now tied to quality care.
For physicians who are ready to make the shift to value-based payment, Mr. Burrell said an average of 5 years was necessary to fully integrate. “Each practice is its own ecosystem. Some physicians catch on very quickly, but some are hostile.”
On Twitter @whitneymcknight
AT AN AMA/RAND BRIEFING
