Whether Congress will act this year to address the affordability of prescription drugs – a high priority among voters – remains uncertain. But states aren’t waiting.

So far this year, 33 states have enacted a record 51 laws to address drug prices, affordability, and access. That tops the previous record of 45 laws enacted in 28 states set just last year, according to the National Academy for State Health Policy, a nonprofit advocacy group that develops model legislation and promotes such laws.

Among the new measures are those that authorize importing prescription drugs, screen for excessive price increases by drug companies, and establish oversight boards to set the prices states will pay for drugs.

“Legislative activity in this area is escalating,” said Trish Riley, NASHP’s executive director. “This year, some states moved to launch programs that directly impact what they and consumers pay for high-cost drugs.”

And more laws could be coming before year’s end. Of the handful of states still in legislative session – including California, Massachusetts, Michigan, New Jersey, Ohio, and Pennsylvania – debate continues on dozens of prescription drug bills. In New Jersey alone, some 20 proposed laws are under consideration.

“Both Democrat and Republican leaders have shown a willingness to pursue strong measures that help consumers but also protect state taxpayer dollars,” said Hemi Tewarson, director of the National Governors Association’s health programs.

Ms. Riley, Ms. Tewarson, and others note, however, that states can go only so far in addressing rising drug prices, and that federal legislation would be necessary to have a major effect on the way the marketplace works.

Federal lawmakers are keeping a close eye on the state initiatives, Ms. Tewarson said, to gauge where legislative compromise may lie – even as Congress debates more than a dozen bills that target drug costs.

The pharmaceutical industry has opposed most – though not all – state bills, said Priscilla VanderVeer, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, the industry’s main trade group.

“We agree that what consumers now pay for drugs out-of-pocket is a serious problem,” said Ms. VanderVeer. “Many states have passed bills that look good on paper but that we don’t believe will save consumers money.”
 

Limiting gag rules for pharmacists

At least 16 states have enacted 20 laws governing the behavior of pharmacy benefit managers. The so-called PBMs serve as middlemen among drugmakers, insurance companies, and pharmacies, largely with pharmaceutical industry support.

Those laws add to the 28 passed in 2018. Most of the new laws ban “gag clauses” that some PBMs impose on pharmacists. The clauses, written into pharmacy contracts, stop pharmacists from discussing with customers whether a drug’s cash price would be lower than its out-of-pocket cost under insurance.

With widespread public outrage over gag clauses pushing states to act, federal lawmakers got the message. In October, Congress passed a federal law banning such clauses in PBM-pharmacy contracts nationwide and under the Medicare Part D prescription drug benefit. The Senate passed it 98-2. Even so, many of this year’s PBM laws contain additional gag clause limitations that go beyond the 2018 federal law.
 

Importing cheaper drugs

Four states – Colorado, Florida, Maine, and Vermont – this year have enacted measures to establish programs to import cheaper prescription drugs from Canada and, in Florida’s case, potentially other countries. Six other states are considering such legislation.

Medicines in Canada and other countries are less expensive because those nations negotiate directly with drugmakers to set prices.

“This is an area where states once feared to tread,” said Jane Horvath, a consultant who has advised Maryland and Oregon, among other states, on prescription drug policy. “Now both Republicans and Democrats view it as a way to infuse more price competition into the marketplace.”Hurdles remain, however. A 2003 law allows states to import cheaper drugs from Canada but only if the federal Health & Human Services Department approves a state’s plan and certifies its safety. Between 2004 and 2009, the federal government halted nascent drug import efforts in five states.

Even so, momentum for importation has built in recent years in states and Congress as drug prices have continued to rise. And the Trump administration this summer threw its support behind the idea.

Florida Gov. Ron DeSantis, a Republican and close ally of President Trump, signed his state’s measure into law on June 11, claiming he did so after Trump personally promised him the White House would back the initiative.

On July 31, HHS announced an “action plan” to “lay the foundation for safe importation of certain prescription drugs.” The plan includes a process to authorize state initiatives. It also requires formal regulatory review, including establishing Food and Drug Administration safety criteria. That process could take up to 2 years.

Two big problems remain: In the weeks since the announcement, the Canadian government has opposed any plan that would rely solely on Canada as a source of imported drugs. The pharmaceutical industry also opposes the plan.
 

Creating drug affordability boards

Maine and Maryland enacted laws this year that establish state agencies to review the costs of drugs and take action against those whose price increases exceed a certain threshold.

Maryland’s law establishes a five-member board to review the list prices and costs of drugs purchased by the state and Maryland’s county and local governments. The board will probe drugs that increase in price by $3,000 or more per year and new medicines that enter the market costing $30,000 or more per year or over the course of treatment.

If approved by future legislation, upper payment limits on drugs with excessive price increases or annual costs would take effect in January 2022.

“My constituents have signaled loud and clear that bringing drug prices down is one of their top priorities,” said state Sen. Katherine Klausmeier, a Democrat representing Baltimore, who sponsored the legislation.

Maine’s law also establishes a five-member board. Beginning in 2021, the board will set annual spending targets for drugs purchased by the state and local governments.

Increasing price transparency

This year, four states – Colorado, Oregon, Texas, and Washington – became the latest to enact laws requiring drug companies to provide information to states and consumers on the list prices of drugs and planned price increases.

The majority of states now have such transparency laws, and most post the data on public websites. The details vary, but all states with such laws seek to identify drugs with price increases above 10% or more a year, and drugs with price increases above set dollar values.

Oregon’s new law, for example, requires manufacturers to notify the state 60 days in advance of any planned increase of 10% or more in the price of brand-name drugs, and any 25% or greater increase in the price of generic drugs.

“That 60-days’ notice was very important to us,” said Rep. Andrea Salinas, chair of the Oregon House’s health committee, who represents Lake Oswego. “It gives doctors and patients advance notice and a chance to adjust and consider what to do.”
 

AGA Resource

AGA advocates that drug affordability should be focused on decreasing out-of-pocket expenses for patients, maintaining reasonable incentives for innovation, increasing cost transparency, promoting shared decision making, and boosting competition. Learn more about our drug affordability principles at https://www.gastro.org/advocacy-and-policy/issues-and-news/top-issues/drug-affordability-principles.

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Whether Congress will act this year to address the affordability of prescription drugs – a high priority among voters – remains uncertain. But states aren’t waiting.

So far this year, 33 states have enacted a record 51 laws to address drug prices, affordability, and access. That tops the previous record of 45 laws enacted in 28 states set just last year, according to the National Academy for State Health Policy, a nonprofit advocacy group that develops model legislation and promotes such laws.

Among the new measures are those that authorize importing prescription drugs, screen for excessive price increases by drug companies, and establish oversight boards to set the prices states will pay for drugs.

“Legislative activity in this area is escalating,” said Trish Riley, NASHP’s executive director. “This year, some states moved to launch programs that directly impact what they and consumers pay for high-cost drugs.”

And more laws could be coming before year’s end. Of the handful of states still in legislative session – including California, Massachusetts, Michigan, New Jersey, Ohio, and Pennsylvania – debate continues on dozens of prescription drug bills. In New Jersey alone, some 20 proposed laws are under consideration.

“Both Democrat and Republican leaders have shown a willingness to pursue strong measures that help consumers but also protect state taxpayer dollars,” said Hemi Tewarson, director of the National Governors Association’s health programs.

Ms. Riley, Ms. Tewarson, and others note, however, that states can go only so far in addressing rising drug prices, and that federal legislation would be necessary to have a major effect on the way the marketplace works.

Federal lawmakers are keeping a close eye on the state initiatives, Ms. Tewarson said, to gauge where legislative compromise may lie – even as Congress debates more than a dozen bills that target drug costs.

The pharmaceutical industry has opposed most – though not all – state bills, said Priscilla VanderVeer, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, the industry’s main trade group.

“We agree that what consumers now pay for drugs out-of-pocket is a serious problem,” said Ms. VanderVeer. “Many states have passed bills that look good on paper but that we don’t believe will save consumers money.”
 

Limiting gag rules for pharmacists

At least 16 states have enacted 20 laws governing the behavior of pharmacy benefit managers. The so-called PBMs serve as middlemen among drugmakers, insurance companies, and pharmacies, largely with pharmaceutical industry support.

Those laws add to the 28 passed in 2018. Most of the new laws ban “gag clauses” that some PBMs impose on pharmacists. The clauses, written into pharmacy contracts, stop pharmacists from discussing with customers whether a drug’s cash price would be lower than its out-of-pocket cost under insurance.

With widespread public outrage over gag clauses pushing states to act, federal lawmakers got the message. In October, Congress passed a federal law banning such clauses in PBM-pharmacy contracts nationwide and under the Medicare Part D prescription drug benefit. The Senate passed it 98-2. Even so, many of this year’s PBM laws contain additional gag clause limitations that go beyond the 2018 federal law.
 

Importing cheaper drugs

Four states – Colorado, Florida, Maine, and Vermont – this year have enacted measures to establish programs to import cheaper prescription drugs from Canada and, in Florida’s case, potentially other countries. Six other states are considering such legislation.

Medicines in Canada and other countries are less expensive because those nations negotiate directly with drugmakers to set prices.

“This is an area where states once feared to tread,” said Jane Horvath, a consultant who has advised Maryland and Oregon, among other states, on prescription drug policy. “Now both Republicans and Democrats view it as a way to infuse more price competition into the marketplace.”Hurdles remain, however. A 2003 law allows states to import cheaper drugs from Canada but only if the federal Health & Human Services Department approves a state’s plan and certifies its safety. Between 2004 and 2009, the federal government halted nascent drug import efforts in five states.

Even so, momentum for importation has built in recent years in states and Congress as drug prices have continued to rise. And the Trump administration this summer threw its support behind the idea.

Florida Gov. Ron DeSantis, a Republican and close ally of President Trump, signed his state’s measure into law on June 11, claiming he did so after Trump personally promised him the White House would back the initiative.

On July 31, HHS announced an “action plan” to “lay the foundation for safe importation of certain prescription drugs.” The plan includes a process to authorize state initiatives. It also requires formal regulatory review, including establishing Food and Drug Administration safety criteria. That process could take up to 2 years.

Two big problems remain: In the weeks since the announcement, the Canadian government has opposed any plan that would rely solely on Canada as a source of imported drugs. The pharmaceutical industry also opposes the plan.
 

Creating drug affordability boards

Maine and Maryland enacted laws this year that establish state agencies to review the costs of drugs and take action against those whose price increases exceed a certain threshold.

Maryland’s law establishes a five-member board to review the list prices and costs of drugs purchased by the state and Maryland’s county and local governments. The board will probe drugs that increase in price by $3,000 or more per year and new medicines that enter the market costing $30,000 or more per year or over the course of treatment.

If approved by future legislation, upper payment limits on drugs with excessive price increases or annual costs would take effect in January 2022.

“My constituents have signaled loud and clear that bringing drug prices down is one of their top priorities,” said state Sen. Katherine Klausmeier, a Democrat representing Baltimore, who sponsored the legislation.

Maine’s law also establishes a five-member board. Beginning in 2021, the board will set annual spending targets for drugs purchased by the state and local governments.

Increasing price transparency

This year, four states – Colorado, Oregon, Texas, and Washington – became the latest to enact laws requiring drug companies to provide information to states and consumers on the list prices of drugs and planned price increases.

The majority of states now have such transparency laws, and most post the data on public websites. The details vary, but all states with such laws seek to identify drugs with price increases above 10% or more a year, and drugs with price increases above set dollar values.

Oregon’s new law, for example, requires manufacturers to notify the state 60 days in advance of any planned increase of 10% or more in the price of brand-name drugs, and any 25% or greater increase in the price of generic drugs.

“That 60-days’ notice was very important to us,” said Rep. Andrea Salinas, chair of the Oregon House’s health committee, who represents Lake Oswego. “It gives doctors and patients advance notice and a chance to adjust and consider what to do.”
 

AGA Resource

AGA advocates that drug affordability should be focused on decreasing out-of-pocket expenses for patients, maintaining reasonable incentives for innovation, increasing cost transparency, promoting shared decision making, and boosting competition. Learn more about our drug affordability principles at https://www.gastro.org/advocacy-and-policy/issues-and-news/top-issues/drug-affordability-principles.

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Whether Congress will act this year to address the affordability of prescription drugs – a high priority among voters – remains uncertain. But states aren’t waiting.

So far this year, 33 states have enacted a record 51 laws to address drug prices, affordability, and access. That tops the previous record of 45 laws enacted in 28 states set just last year, according to the National Academy for State Health Policy, a nonprofit advocacy group that develops model legislation and promotes such laws.

Among the new measures are those that authorize importing prescription drugs, screen for excessive price increases by drug companies, and establish oversight boards to set the prices states will pay for drugs.

“Legislative activity in this area is escalating,” said Trish Riley, NASHP’s executive director. “This year, some states moved to launch programs that directly impact what they and consumers pay for high-cost drugs.”

And more laws could be coming before year’s end. Of the handful of states still in legislative session – including California, Massachusetts, Michigan, New Jersey, Ohio, and Pennsylvania – debate continues on dozens of prescription drug bills. In New Jersey alone, some 20 proposed laws are under consideration.

“Both Democrat and Republican leaders have shown a willingness to pursue strong measures that help consumers but also protect state taxpayer dollars,” said Hemi Tewarson, director of the National Governors Association’s health programs.

Ms. Riley, Ms. Tewarson, and others note, however, that states can go only so far in addressing rising drug prices, and that federal legislation would be necessary to have a major effect on the way the marketplace works.

Federal lawmakers are keeping a close eye on the state initiatives, Ms. Tewarson said, to gauge where legislative compromise may lie – even as Congress debates more than a dozen bills that target drug costs.

The pharmaceutical industry has opposed most – though not all – state bills, said Priscilla VanderVeer, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, the industry’s main trade group.

“We agree that what consumers now pay for drugs out-of-pocket is a serious problem,” said Ms. VanderVeer. “Many states have passed bills that look good on paper but that we don’t believe will save consumers money.”
 

Limiting gag rules for pharmacists

At least 16 states have enacted 20 laws governing the behavior of pharmacy benefit managers. The so-called PBMs serve as middlemen among drugmakers, insurance companies, and pharmacies, largely with pharmaceutical industry support.

Those laws add to the 28 passed in 2018. Most of the new laws ban “gag clauses” that some PBMs impose on pharmacists. The clauses, written into pharmacy contracts, stop pharmacists from discussing with customers whether a drug’s cash price would be lower than its out-of-pocket cost under insurance.

With widespread public outrage over gag clauses pushing states to act, federal lawmakers got the message. In October, Congress passed a federal law banning such clauses in PBM-pharmacy contracts nationwide and under the Medicare Part D prescription drug benefit. The Senate passed it 98-2. Even so, many of this year’s PBM laws contain additional gag clause limitations that go beyond the 2018 federal law.
 

Importing cheaper drugs

Four states – Colorado, Florida, Maine, and Vermont – this year have enacted measures to establish programs to import cheaper prescription drugs from Canada and, in Florida’s case, potentially other countries. Six other states are considering such legislation.

Medicines in Canada and other countries are less expensive because those nations negotiate directly with drugmakers to set prices.

“This is an area where states once feared to tread,” said Jane Horvath, a consultant who has advised Maryland and Oregon, among other states, on prescription drug policy. “Now both Republicans and Democrats view it as a way to infuse more price competition into the marketplace.”Hurdles remain, however. A 2003 law allows states to import cheaper drugs from Canada but only if the federal Health & Human Services Department approves a state’s plan and certifies its safety. Between 2004 and 2009, the federal government halted nascent drug import efforts in five states.

Even so, momentum for importation has built in recent years in states and Congress as drug prices have continued to rise. And the Trump administration this summer threw its support behind the idea.

Florida Gov. Ron DeSantis, a Republican and close ally of President Trump, signed his state’s measure into law on June 11, claiming he did so after Trump personally promised him the White House would back the initiative.

On July 31, HHS announced an “action plan” to “lay the foundation for safe importation of certain prescription drugs.” The plan includes a process to authorize state initiatives. It also requires formal regulatory review, including establishing Food and Drug Administration safety criteria. That process could take up to 2 years.

Two big problems remain: In the weeks since the announcement, the Canadian government has opposed any plan that would rely solely on Canada as a source of imported drugs. The pharmaceutical industry also opposes the plan.
 

Creating drug affordability boards

Maine and Maryland enacted laws this year that establish state agencies to review the costs of drugs and take action against those whose price increases exceed a certain threshold.

Maryland’s law establishes a five-member board to review the list prices and costs of drugs purchased by the state and Maryland’s county and local governments. The board will probe drugs that increase in price by $3,000 or more per year and new medicines that enter the market costing $30,000 or more per year or over the course of treatment.

If approved by future legislation, upper payment limits on drugs with excessive price increases or annual costs would take effect in January 2022.

“My constituents have signaled loud and clear that bringing drug prices down is one of their top priorities,” said state Sen. Katherine Klausmeier, a Democrat representing Baltimore, who sponsored the legislation.

Maine’s law also establishes a five-member board. Beginning in 2021, the board will set annual spending targets for drugs purchased by the state and local governments.

Increasing price transparency

This year, four states – Colorado, Oregon, Texas, and Washington – became the latest to enact laws requiring drug companies to provide information to states and consumers on the list prices of drugs and planned price increases.

The majority of states now have such transparency laws, and most post the data on public websites. The details vary, but all states with such laws seek to identify drugs with price increases above 10% or more a year, and drugs with price increases above set dollar values.

Oregon’s new law, for example, requires manufacturers to notify the state 60 days in advance of any planned increase of 10% or more in the price of brand-name drugs, and any 25% or greater increase in the price of generic drugs.

“That 60-days’ notice was very important to us,” said Rep. Andrea Salinas, chair of the Oregon House’s health committee, who represents Lake Oswego. “It gives doctors and patients advance notice and a chance to adjust and consider what to do.”
 

AGA Resource

AGA advocates that drug affordability should be focused on decreasing out-of-pocket expenses for patients, maintaining reasonable incentives for innovation, increasing cost transparency, promoting shared decision making, and boosting competition. Learn more about our drug affordability principles at https://www.gastro.org/advocacy-and-policy/issues-and-news/top-issues/drug-affordability-principles.

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

A district court has dismissed a lawsuit levied by a group of physicians against the American Board of Internal Medicine (ABIM) over its maintenance of certification (MOC) program, calling the legal challenge “flawed.”

In a Sept. 26 decision, U.S. District Court Judge for the Eastern District of Pennsylvania Robert F. Kelly Sr. said the plaintiffs failed to demonstrate sufficient evidence for their antitrust and unjust enrichment claims against ABIM. The doctors also did not establish any showing of anticompetitive conduct by ABIM to support a monopolization claim, the judge ruled.

“We disagree with plaintiffs and find that ABIM’s initial certification and MOC products are part of a single product and do not occupy distinct markets,” Judge Kelly wrote in his decision. “Not only are we unconvinced by plaintiffs’ arguments, we find that plaintiffs’ entire framing of the ABIM certification to be flawed. In essence, plaintiffs are arguing that, in order to purchase ABIM’s initial certification, internists are forced to purchase MOC products as well. However, this is not the case. ... Nowhere in the amended complaint do plaintiffs allege that they were forced to buy MOC products in order to purchase the initial certification.”

The judge dismissed the suit, but allowed the plaintiffs 14 days to submit an amended complaint reoutlining their claims of illegal monopolization and racketeering against the board. If the amended complaint passes legal muster, the judge could revive those claims.

ABIM President Richard J. Baron, MD, expressed satisfaction that the court granted the board’s motion to dismiss the case for failure to state a valid claim.

“ABIM is pleased that the United States District Court for the Eastern District of Pennsylvania dismissed in its entirety a lawsuit that alleged physicians were harmed by the requirements for maintaining ABIM board certification,” Dr. Baron said in a statement.

C. Philip Curley, a Chicago-based attorney for the physician plaintiffs, said the case is far from over.

“The four internists who brought the lawsuit were invited to file amended claims, which is certainly being considered,” Mr. Curley said in an interview. “If necessary, all available appeals will also be pursued to the fullest. No one was under the impression that the fight to bring MOC to an end would be quick or easy.”

The original lawsuit, filed Dec. 6, 2018, in a Pennsylvania district court, claims that ABIM is charging inflated monopoly prices for maintaining certification, that the organization is forcing physicians to purchase MOC, and that ABIM is inducing employers and others to require ABIM certification. On Jan. 23 of this year the legal challenge was amended to include racketeering and unjust enrichment claims.

The four plaintiff-physicians want the court to find ABIM in violation of federal antitrust law and to bar the board from continuing its MOC process. The suit is filed as a class action on behalf of all internists and subspecialists required by ABIM to purchase MOC to maintain their ABIM certifications.

Two other lawsuits challenging MOC, one against the American Board of Psychiatry and Neurology and another against the American Board of Radiology, are ongoing. A fourth lawsuit against the American Board of Medical Specialties, the American Board of Emergency Medicine, and the American Board of Anesthesiology was filed in February.

Chicago-based cardiologist Wes Fisher, MD, and fellow physicians with the Practicing Physicians of America are funding the plaintiffs’ legal efforts through a fundraising campaign that has raised more than $300,000.

In an interview, Dr. Fisher called the legal fight against ABIM “a David versus Goliath effort” and said the battle will continue.

“The ABIM may have won this first round, but ... they have only dodged the antitrust tying claim and unjust enrichment claims,” Dr. Fisher said. “The monopoly claim and racketeering claims are still very much open. Plaintiffs have 14 days to amend their compliant.”










 

A district court has dismissed a lawsuit levied by a group of physicians against the American Board of Internal Medicine (ABIM) over its maintenance of certification (MOC) program, calling the legal challenge “flawed.”

In a Sept. 26 decision, U.S. District Court Judge for the Eastern District of Pennsylvania Robert F. Kelly Sr. said the plaintiffs failed to demonstrate sufficient evidence for their antitrust and unjust enrichment claims against ABIM. The doctors also did not establish any showing of anticompetitive conduct by ABIM to support a monopolization claim, the judge ruled.

“We disagree with plaintiffs and find that ABIM’s initial certification and MOC products are part of a single product and do not occupy distinct markets,” Judge Kelly wrote in his decision. “Not only are we unconvinced by plaintiffs’ arguments, we find that plaintiffs’ entire framing of the ABIM certification to be flawed. In essence, plaintiffs are arguing that, in order to purchase ABIM’s initial certification, internists are forced to purchase MOC products as well. However, this is not the case. ... Nowhere in the amended complaint do plaintiffs allege that they were forced to buy MOC products in order to purchase the initial certification.”

The judge dismissed the suit, but allowed the plaintiffs 14 days to submit an amended complaint reoutlining their claims of illegal monopolization and racketeering against the board. If the amended complaint passes legal muster, the judge could revive those claims.

ABIM President Richard J. Baron, MD, expressed satisfaction that the court granted the board’s motion to dismiss the case for failure to state a valid claim.

“ABIM is pleased that the United States District Court for the Eastern District of Pennsylvania dismissed in its entirety a lawsuit that alleged physicians were harmed by the requirements for maintaining ABIM board certification,” Dr. Baron said in a statement.

C. Philip Curley, a Chicago-based attorney for the physician plaintiffs, said the case is far from over.

“The four internists who brought the lawsuit were invited to file amended claims, which is certainly being considered,” Mr. Curley said in an interview. “If necessary, all available appeals will also be pursued to the fullest. No one was under the impression that the fight to bring MOC to an end would be quick or easy.”

The original lawsuit, filed Dec. 6, 2018, in a Pennsylvania district court, claims that ABIM is charging inflated monopoly prices for maintaining certification, that the organization is forcing physicians to purchase MOC, and that ABIM is inducing employers and others to require ABIM certification. On Jan. 23 of this year the legal challenge was amended to include racketeering and unjust enrichment claims.

The four plaintiff-physicians want the court to find ABIM in violation of federal antitrust law and to bar the board from continuing its MOC process. The suit is filed as a class action on behalf of all internists and subspecialists required by ABIM to purchase MOC to maintain their ABIM certifications.

Two other lawsuits challenging MOC, one against the American Board of Psychiatry and Neurology and another against the American Board of Radiology, are ongoing. A fourth lawsuit against the American Board of Medical Specialties, the American Board of Emergency Medicine, and the American Board of Anesthesiology was filed in February.

Chicago-based cardiologist Wes Fisher, MD, and fellow physicians with the Practicing Physicians of America are funding the plaintiffs’ legal efforts through a fundraising campaign that has raised more than $300,000.

In an interview, Dr. Fisher called the legal fight against ABIM “a David versus Goliath effort” and said the battle will continue.

“The ABIM may have won this first round, but ... they have only dodged the antitrust tying claim and unjust enrichment claims,” Dr. Fisher said. “The monopoly claim and racketeering claims are still very much open. Plaintiffs have 14 days to amend their compliant.”










 

A district court has dismissed a lawsuit levied by a group of physicians against the American Board of Internal Medicine (ABIM) over its maintenance of certification (MOC) program, calling the legal challenge “flawed.”

In a Sept. 26 decision, U.S. District Court Judge for the Eastern District of Pennsylvania Robert F. Kelly Sr. said the plaintiffs failed to demonstrate sufficient evidence for their antitrust and unjust enrichment claims against ABIM. The doctors also did not establish any showing of anticompetitive conduct by ABIM to support a monopolization claim, the judge ruled.

“We disagree with plaintiffs and find that ABIM’s initial certification and MOC products are part of a single product and do not occupy distinct markets,” Judge Kelly wrote in his decision. “Not only are we unconvinced by plaintiffs’ arguments, we find that plaintiffs’ entire framing of the ABIM certification to be flawed. In essence, plaintiffs are arguing that, in order to purchase ABIM’s initial certification, internists are forced to purchase MOC products as well. However, this is not the case. ... Nowhere in the amended complaint do plaintiffs allege that they were forced to buy MOC products in order to purchase the initial certification.”

The judge dismissed the suit, but allowed the plaintiffs 14 days to submit an amended complaint reoutlining their claims of illegal monopolization and racketeering against the board. If the amended complaint passes legal muster, the judge could revive those claims.

ABIM President Richard J. Baron, MD, expressed satisfaction that the court granted the board’s motion to dismiss the case for failure to state a valid claim.

“ABIM is pleased that the United States District Court for the Eastern District of Pennsylvania dismissed in its entirety a lawsuit that alleged physicians were harmed by the requirements for maintaining ABIM board certification,” Dr. Baron said in a statement.

C. Philip Curley, a Chicago-based attorney for the physician plaintiffs, said the case is far from over.

“The four internists who brought the lawsuit were invited to file amended claims, which is certainly being considered,” Mr. Curley said in an interview. “If necessary, all available appeals will also be pursued to the fullest. No one was under the impression that the fight to bring MOC to an end would be quick or easy.”

The original lawsuit, filed Dec. 6, 2018, in a Pennsylvania district court, claims that ABIM is charging inflated monopoly prices for maintaining certification, that the organization is forcing physicians to purchase MOC, and that ABIM is inducing employers and others to require ABIM certification. On Jan. 23 of this year the legal challenge was amended to include racketeering and unjust enrichment claims.

The four plaintiff-physicians want the court to find ABIM in violation of federal antitrust law and to bar the board from continuing its MOC process. The suit is filed as a class action on behalf of all internists and subspecialists required by ABIM to purchase MOC to maintain their ABIM certifications.

Two other lawsuits challenging MOC, one against the American Board of Psychiatry and Neurology and another against the American Board of Radiology, are ongoing. A fourth lawsuit against the American Board of Medical Specialties, the American Board of Emergency Medicine, and the American Board of Anesthesiology was filed in February.

Chicago-based cardiologist Wes Fisher, MD, and fellow physicians with the Practicing Physicians of America are funding the plaintiffs’ legal efforts through a fundraising campaign that has raised more than $300,000.

In an interview, Dr. Fisher called the legal fight against ABIM “a David versus Goliath effort” and said the battle will continue.

“The ABIM may have won this first round, but ... they have only dodged the antitrust tying claim and unjust enrichment claims,” Dr. Fisher said. “The monopoly claim and racketeering claims are still very much open. Plaintiffs have 14 days to amend their compliant.”










 

SAN FRANCISCO – Using the guidewire for rapid pacing of the left ventricle during transcatheter aortic valve implantation (TAVI) instead of the usual approach – right ventricular pacing through a lead snaked up the femoral vein – significantly reduced procedure duration, fluoroscopy time, and cost, without affecting efficacy or safety, in a 10-center randomized controlled trial in France.

Pacing using the 0.035-inch guidewire in the left ventricle eliminates “the need for a transvenous temporary pacing lead or additional venous access in most cases,”said investigators led by Benjamin Faurie, MD, an interventional cardiologist at the Cardiovascular Institute, Groupe Hospitalier Mutualiste, Grenoble, France. It simplifies TAVI “and should be considered as the default strategy for rapid ventricular pacing.”

“If risk factors for development of high-grade conduction disturbances are present, upfront RV [right ventricular] stimulation with a temporary pacing lead should be considered; otherwise LV [left ventricular] stimulation might be used.” LV stimulation in TAVI “is particularly attractive in patients with an indwelling permanent pacemaker to avoid the risk of pacemaker lead dislodgement with a temporary pacing lead,” they said.

“This technique may also be useful in transcatheter heart valve implantation in the mitral position and in transcatheter tricuspid valve interventions, where having a standard temporary pacing lead across the tricuspid valve may interfere with the procedure,” the investigators said.

Rapid ventricular pacing ensures cardiac standstill during TAVI, but the RV approach carries the risk of vascular complications and RV perforation. LV guidewire pacing, a technique borrowed from pediatric balloon aortic valvuloplasty, avoids the risks. The French study – dubbed Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI (EASY-TAVI) – is the first randomized trial to compare the technique with conventional RV stimulation, and it was published to coincide with a presentation at Transcatheter Cardiovascular Therapeutics annual meeting (JACC Cardiovasc Interv. 2019 Sep 14. doi: 10.1016/j.jcin.2019.09.029).

The patients were undergoing transfemoral TAVI with a Sapien 3 valve (Edwards Lifesciences); 151 were randomized to LV stimulation through the guidewire, and 152 to RV stimulation through a temporary pacing lead.

Both procedure duration (48.4 minutes vs. 55.6 minutes) and fluoroscopy time (13.48 minutes vs. 14.6 minutes) were significantly shorter in the LV group than in the RV group. The procedure was also less costly (€18,807 vs. €19,437) because of shorter catheterization lab time and materials savings.

There were no significant difference between LV and RV groups in rates of effective stimulation (84.9% vs. 87.1%, respectively), procedural success (100% vs. 99.3%), 30-day TAVI-related major adverse cardiovascular events (13.9% vs. 17.1%), or permanent pacemaker implantation within 30 days (17.9% vs. 11.8%). There were two cases of cardiac tamponade in the RV group from the temporary lead; there were no guidewire related tamponades in the LV group.

Fourteen LV patients (9%) needed bailout with an RV lead because of new-onset left bundle branch block or atrioventricular block. The temporary pacing lead, meanwhile, was left in place in 38 RV patients (25%), which suggests “a lower threshold for an indwelling temporary pacing lead post procedure when there is already one in place,” the investigators said.

To deliver LV stimulation, the cathode of an external pacemaker was attached to the distal external end of the guidewire using a crocodile clip. A second crocodile clip – the anode – was attached to the incised skin at the sheath insertion site in the groin. The valve delivery system provided the required insulation.

The investigators noted that “the benefit of LV-stimulation may be less with self-expanding valves due to the significantly higher incidence of conduction disturbances requiring permanent pacemaker implantation post procedure.”

Patients were a mean age of 83 years, with about equal numbers of men and women. They had an intermediate risk of dying during the procedure. “However, we feel that the results are generalizable to the classical patient at high predicted risk of surgical mortality undergoing TAVI. Such patients tend to have higher rates of comorbidities, including peripheral vascular disease, placing them at higher risk of vascular complications and tend to have thinner RV walls, placing them at higher risk of RV-perforation,” the investigators said.

The work was funded by Edwards Lifesciences and others. Dr. Faurie had no disclosures. The senior author is a proctor for Edwards Lifesciences

[email protected]

SOURCE: Faurie B et al. TCT 2019. JACC Cardiovasc Interv. 2019 Sep 14. doi: 10.1016/j.jcin.2019.09.029.

SAN FRANCISCO – Using the guidewire for rapid pacing of the left ventricle during transcatheter aortic valve implantation (TAVI) instead of the usual approach – right ventricular pacing through a lead snaked up the femoral vein – significantly reduced procedure duration, fluoroscopy time, and cost, without affecting efficacy or safety, in a 10-center randomized controlled trial in France.

Pacing using the 0.035-inch guidewire in the left ventricle eliminates “the need for a transvenous temporary pacing lead or additional venous access in most cases,”said investigators led by Benjamin Faurie, MD, an interventional cardiologist at the Cardiovascular Institute, Groupe Hospitalier Mutualiste, Grenoble, France. It simplifies TAVI “and should be considered as the default strategy for rapid ventricular pacing.”

“If risk factors for development of high-grade conduction disturbances are present, upfront RV [right ventricular] stimulation with a temporary pacing lead should be considered; otherwise LV [left ventricular] stimulation might be used.” LV stimulation in TAVI “is particularly attractive in patients with an indwelling permanent pacemaker to avoid the risk of pacemaker lead dislodgement with a temporary pacing lead,” they said.

“This technique may also be useful in transcatheter heart valve implantation in the mitral position and in transcatheter tricuspid valve interventions, where having a standard temporary pacing lead across the tricuspid valve may interfere with the procedure,” the investigators said.

Rapid ventricular pacing ensures cardiac standstill during TAVI, but the RV approach carries the risk of vascular complications and RV perforation. LV guidewire pacing, a technique borrowed from pediatric balloon aortic valvuloplasty, avoids the risks. The French study – dubbed Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI (EASY-TAVI) – is the first randomized trial to compare the technique with conventional RV stimulation, and it was published to coincide with a presentation at Transcatheter Cardiovascular Therapeutics annual meeting (JACC Cardiovasc Interv. 2019 Sep 14. doi: 10.1016/j.jcin.2019.09.029).

The patients were undergoing transfemoral TAVI with a Sapien 3 valve (Edwards Lifesciences); 151 were randomized to LV stimulation through the guidewire, and 152 to RV stimulation through a temporary pacing lead.

Both procedure duration (48.4 minutes vs. 55.6 minutes) and fluoroscopy time (13.48 minutes vs. 14.6 minutes) were significantly shorter in the LV group than in the RV group. The procedure was also less costly (€18,807 vs. €19,437) because of shorter catheterization lab time and materials savings.

There were no significant difference between LV and RV groups in rates of effective stimulation (84.9% vs. 87.1%, respectively), procedural success (100% vs. 99.3%), 30-day TAVI-related major adverse cardiovascular events (13.9% vs. 17.1%), or permanent pacemaker implantation within 30 days (17.9% vs. 11.8%). There were two cases of cardiac tamponade in the RV group from the temporary lead; there were no guidewire related tamponades in the LV group.

Fourteen LV patients (9%) needed bailout with an RV lead because of new-onset left bundle branch block or atrioventricular block. The temporary pacing lead, meanwhile, was left in place in 38 RV patients (25%), which suggests “a lower threshold for an indwelling temporary pacing lead post procedure when there is already one in place,” the investigators said.

To deliver LV stimulation, the cathode of an external pacemaker was attached to the distal external end of the guidewire using a crocodile clip. A second crocodile clip – the anode – was attached to the incised skin at the sheath insertion site in the groin. The valve delivery system provided the required insulation.

The investigators noted that “the benefit of LV-stimulation may be less with self-expanding valves due to the significantly higher incidence of conduction disturbances requiring permanent pacemaker implantation post procedure.”

Patients were a mean age of 83 years, with about equal numbers of men and women. They had an intermediate risk of dying during the procedure. “However, we feel that the results are generalizable to the classical patient at high predicted risk of surgical mortality undergoing TAVI. Such patients tend to have higher rates of comorbidities, including peripheral vascular disease, placing them at higher risk of vascular complications and tend to have thinner RV walls, placing them at higher risk of RV-perforation,” the investigators said.

The work was funded by Edwards Lifesciences and others. Dr. Faurie had no disclosures. The senior author is a proctor for Edwards Lifesciences

[email protected]

SOURCE: Faurie B et al. TCT 2019. JACC Cardiovasc Interv. 2019 Sep 14. doi: 10.1016/j.jcin.2019.09.029.

SAN FRANCISCO – Using the guidewire for rapid pacing of the left ventricle during transcatheter aortic valve implantation (TAVI) instead of the usual approach – right ventricular pacing through a lead snaked up the femoral vein – significantly reduced procedure duration, fluoroscopy time, and cost, without affecting efficacy or safety, in a 10-center randomized controlled trial in France.

Pacing using the 0.035-inch guidewire in the left ventricle eliminates “the need for a transvenous temporary pacing lead or additional venous access in most cases,”said investigators led by Benjamin Faurie, MD, an interventional cardiologist at the Cardiovascular Institute, Groupe Hospitalier Mutualiste, Grenoble, France. It simplifies TAVI “and should be considered as the default strategy for rapid ventricular pacing.”

“If risk factors for development of high-grade conduction disturbances are present, upfront RV [right ventricular] stimulation with a temporary pacing lead should be considered; otherwise LV [left ventricular] stimulation might be used.” LV stimulation in TAVI “is particularly attractive in patients with an indwelling permanent pacemaker to avoid the risk of pacemaker lead dislodgement with a temporary pacing lead,” they said.

“This technique may also be useful in transcatheter heart valve implantation in the mitral position and in transcatheter tricuspid valve interventions, where having a standard temporary pacing lead across the tricuspid valve may interfere with the procedure,” the investigators said.

Rapid ventricular pacing ensures cardiac standstill during TAVI, but the RV approach carries the risk of vascular complications and RV perforation. LV guidewire pacing, a technique borrowed from pediatric balloon aortic valvuloplasty, avoids the risks. The French study – dubbed Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI (EASY-TAVI) – is the first randomized trial to compare the technique with conventional RV stimulation, and it was published to coincide with a presentation at Transcatheter Cardiovascular Therapeutics annual meeting (JACC Cardiovasc Interv. 2019 Sep 14. doi: 10.1016/j.jcin.2019.09.029).

The patients were undergoing transfemoral TAVI with a Sapien 3 valve (Edwards Lifesciences); 151 were randomized to LV stimulation through the guidewire, and 152 to RV stimulation through a temporary pacing lead.

Both procedure duration (48.4 minutes vs. 55.6 minutes) and fluoroscopy time (13.48 minutes vs. 14.6 minutes) were significantly shorter in the LV group than in the RV group. The procedure was also less costly (€18,807 vs. €19,437) because of shorter catheterization lab time and materials savings.

There were no significant difference between LV and RV groups in rates of effective stimulation (84.9% vs. 87.1%, respectively), procedural success (100% vs. 99.3%), 30-day TAVI-related major adverse cardiovascular events (13.9% vs. 17.1%), or permanent pacemaker implantation within 30 days (17.9% vs. 11.8%). There were two cases of cardiac tamponade in the RV group from the temporary lead; there were no guidewire related tamponades in the LV group.

Fourteen LV patients (9%) needed bailout with an RV lead because of new-onset left bundle branch block or atrioventricular block. The temporary pacing lead, meanwhile, was left in place in 38 RV patients (25%), which suggests “a lower threshold for an indwelling temporary pacing lead post procedure when there is already one in place,” the investigators said.

To deliver LV stimulation, the cathode of an external pacemaker was attached to the distal external end of the guidewire using a crocodile clip. A second crocodile clip – the anode – was attached to the incised skin at the sheath insertion site in the groin. The valve delivery system provided the required insulation.

The investigators noted that “the benefit of LV-stimulation may be less with self-expanding valves due to the significantly higher incidence of conduction disturbances requiring permanent pacemaker implantation post procedure.”

Patients were a mean age of 83 years, with about equal numbers of men and women. They had an intermediate risk of dying during the procedure. “However, we feel that the results are generalizable to the classical patient at high predicted risk of surgical mortality undergoing TAVI. Such patients tend to have higher rates of comorbidities, including peripheral vascular disease, placing them at higher risk of vascular complications and tend to have thinner RV walls, placing them at higher risk of RV-perforation,” the investigators said.

The work was funded by Edwards Lifesciences and others. Dr. Faurie had no disclosures. The senior author is a proctor for Edwards Lifesciences

[email protected]

SOURCE: Faurie B et al. TCT 2019. JACC Cardiovasc Interv. 2019 Sep 14. doi: 10.1016/j.jcin.2019.09.029.

MINNEAPOLIS -- Oncologist Mark Klein, MD, may have just stepped down as president of the Association of VA Hematology/Oncology (AVAHO), but his main legacy—a foundation that AVAHO can call its own—is set in stone.

Over the past year, Klein has guided AVAHO as it leveraged its remarkable growth in recent years into the landmark creation of a foundation devoted to research. “We want to provide funds to researchers and support access to clinical trials for patients within the VA,” said Klein in an interview after he stepped down as association president at the 2019 AVAHO annual meeting.

Dr. Klein, who works for the Minneapolis VA Healthcare System and University of Minnesota in Minneapolis said the foundation is being seeded with $250,000. One goal is to use the foundation to support unique research projects that may not otherwise draw funding, he said.

For example, he said, the foundation could fund a research project by dietitians into severe weight loss in cancer. Or it could support a study by speech pathologists into swallowing in cancer patients.

In addition, he said, the foundation will focus on providing grants to support junior faculty, including researchers who aren’t MDs. And its funds will be used to boost access to clinical trials in cancer.

Klein said he has also focused on strategic planning and developing partnerships with industry and the leadership of both the VA and the National Cancer Institute. “We’re working to come up with unique ways to get people thinking about the barriers to clinical trials and providing better access for veterans.”

He is especially proud of AVAHO’s partnership with National Association of Veterans’ Research and Education Foundations, which includes partial support of a program manager position.

On the corporate front, he said, “we’re going to start offering corporate memberships so that we can form more industry relationships. That’s another new change and a step in our growth as we work to help more veterans and make a bigger difference.”

MINNEAPOLIS -- Oncologist Mark Klein, MD, may have just stepped down as president of the Association of VA Hematology/Oncology (AVAHO), but his main legacy—a foundation that AVAHO can call its own—is set in stone.

Over the past year, Klein has guided AVAHO as it leveraged its remarkable growth in recent years into the landmark creation of a foundation devoted to research. “We want to provide funds to researchers and support access to clinical trials for patients within the VA,” said Klein in an interview after he stepped down as association president at the 2019 AVAHO annual meeting.

Dr. Klein, who works for the Minneapolis VA Healthcare System and University of Minnesota in Minneapolis said the foundation is being seeded with $250,000. One goal is to use the foundation to support unique research projects that may not otherwise draw funding, he said.

For example, he said, the foundation could fund a research project by dietitians into severe weight loss in cancer. Or it could support a study by speech pathologists into swallowing in cancer patients.

In addition, he said, the foundation will focus on providing grants to support junior faculty, including researchers who aren’t MDs. And its funds will be used to boost access to clinical trials in cancer.

Klein said he has also focused on strategic planning and developing partnerships with industry and the leadership of both the VA and the National Cancer Institute. “We’re working to come up with unique ways to get people thinking about the barriers to clinical trials and providing better access for veterans.”

He is especially proud of AVAHO’s partnership with National Association of Veterans’ Research and Education Foundations, which includes partial support of a program manager position.

On the corporate front, he said, “we’re going to start offering corporate memberships so that we can form more industry relationships. That’s another new change and a step in our growth as we work to help more veterans and make a bigger difference.”

MINNEAPOLIS -- Oncologist Mark Klein, MD, may have just stepped down as president of the Association of VA Hematology/Oncology (AVAHO), but his main legacy—a foundation that AVAHO can call its own—is set in stone.

Over the past year, Klein has guided AVAHO as it leveraged its remarkable growth in recent years into the landmark creation of a foundation devoted to research. “We want to provide funds to researchers and support access to clinical trials for patients within the VA,” said Klein in an interview after he stepped down as association president at the 2019 AVAHO annual meeting.

Dr. Klein, who works for the Minneapolis VA Healthcare System and University of Minnesota in Minneapolis said the foundation is being seeded with $250,000. One goal is to use the foundation to support unique research projects that may not otherwise draw funding, he said.

For example, he said, the foundation could fund a research project by dietitians into severe weight loss in cancer. Or it could support a study by speech pathologists into swallowing in cancer patients.

In addition, he said, the foundation will focus on providing grants to support junior faculty, including researchers who aren’t MDs. And its funds will be used to boost access to clinical trials in cancer.

Klein said he has also focused on strategic planning and developing partnerships with industry and the leadership of both the VA and the National Cancer Institute. “We’re working to come up with unique ways to get people thinking about the barriers to clinical trials and providing better access for veterans.”

He is especially proud of AVAHO’s partnership with National Association of Veterans’ Research and Education Foundations, which includes partial support of a program manager position.

On the corporate front, he said, “we’re going to start offering corporate memberships so that we can form more industry relationships. That’s another new change and a step in our growth as we work to help more veterans and make a bigger difference.”

The Food and Drug Administration has expanded the indication of abobotulinumtoxinA (Dysport) for upper-limb spasticity to include patients aged 2 years and older, according to a release from Ipsen. This botulinum toxin product received approval for this indication in adults in 2015 and approval for lower-limb spasticity in patients aged 2 years and older in 2016. Notably, Orphan Drug Exclusivity prevents it from being indicated for patients with cerebral palsy because another botulinum toxin product, onabotulinumtoxinA (Botox), already was approved for the indication in June 2019.

Olivier Le Moal/Getty Images

Spasticity affects the muscles and joints of extremities, especially in growing children, and is usually caused by nerve damage, such as head trauma or spinal cord injury. The degree of spasticity can vary from mild muscle stiffness to severe, painful, and uncontrollable muscle spasms.

AbobotulinumtoxinA was evaluated for upper-limb spasticity in a phase 3, randomized, double-blind, low-dose controlled, multicenter study; the study enrolled 210 children aged 2-17 years with the condition and a Modified Ashworth Scale grade 2 or greater for elbow and wrist flexors. The children were randomized 1:1:1 to injections of either 8 units/kg, 16 units/kg, or 2 units/kg into the elbow flexors and wrist flexors. At 6 weeks, there were statistically significant improvements in Modified Ashworth Scale grade, the primary endpoint, with least-square mean changes from baseline of –2.0, –2.3, and –1.6, respectively.

AbobotulinumtoxinA and all other botulinum toxin products carry a boxed warning, the most serious warning the FDA issues. This warning refers to risk of botulism-like symptoms caused by the botulinum toxin spreading away from the injection area; these symptoms can included sometimes life-threatening difficulty swallowing or breathing. AbobotulinumtoxinA is contraindicated in patients with known hypersensitivity to any botulinum toxin or any of the components, those with presence of infection at proposed injection site(s), and those with known allergy to cow’s milk protein. It is also important to note that botulinum toxin preparations are not interchangeable; the potency units of one are not the same as those of another. Full prescribing information can be found on the Ipsen website.
 

[email protected]

The Food and Drug Administration has expanded the indication of abobotulinumtoxinA (Dysport) for upper-limb spasticity to include patients aged 2 years and older, according to a release from Ipsen. This botulinum toxin product received approval for this indication in adults in 2015 and approval for lower-limb spasticity in patients aged 2 years and older in 2016. Notably, Orphan Drug Exclusivity prevents it from being indicated for patients with cerebral palsy because another botulinum toxin product, onabotulinumtoxinA (Botox), already was approved for the indication in June 2019.

Olivier Le Moal/Getty Images

Spasticity affects the muscles and joints of extremities, especially in growing children, and is usually caused by nerve damage, such as head trauma or spinal cord injury. The degree of spasticity can vary from mild muscle stiffness to severe, painful, and uncontrollable muscle spasms.

AbobotulinumtoxinA was evaluated for upper-limb spasticity in a phase 3, randomized, double-blind, low-dose controlled, multicenter study; the study enrolled 210 children aged 2-17 years with the condition and a Modified Ashworth Scale grade 2 or greater for elbow and wrist flexors. The children were randomized 1:1:1 to injections of either 8 units/kg, 16 units/kg, or 2 units/kg into the elbow flexors and wrist flexors. At 6 weeks, there were statistically significant improvements in Modified Ashworth Scale grade, the primary endpoint, with least-square mean changes from baseline of –2.0, –2.3, and –1.6, respectively.

AbobotulinumtoxinA and all other botulinum toxin products carry a boxed warning, the most serious warning the FDA issues. This warning refers to risk of botulism-like symptoms caused by the botulinum toxin spreading away from the injection area; these symptoms can included sometimes life-threatening difficulty swallowing or breathing. AbobotulinumtoxinA is contraindicated in patients with known hypersensitivity to any botulinum toxin or any of the components, those with presence of infection at proposed injection site(s), and those with known allergy to cow’s milk protein. It is also important to note that botulinum toxin preparations are not interchangeable; the potency units of one are not the same as those of another. Full prescribing information can be found on the Ipsen website.
 

[email protected]

The Food and Drug Administration has expanded the indication of abobotulinumtoxinA (Dysport) for upper-limb spasticity to include patients aged 2 years and older, according to a release from Ipsen. This botulinum toxin product received approval for this indication in adults in 2015 and approval for lower-limb spasticity in patients aged 2 years and older in 2016. Notably, Orphan Drug Exclusivity prevents it from being indicated for patients with cerebral palsy because another botulinum toxin product, onabotulinumtoxinA (Botox), already was approved for the indication in June 2019.

Olivier Le Moal/Getty Images

Spasticity affects the muscles and joints of extremities, especially in growing children, and is usually caused by nerve damage, such as head trauma or spinal cord injury. The degree of spasticity can vary from mild muscle stiffness to severe, painful, and uncontrollable muscle spasms.

AbobotulinumtoxinA was evaluated for upper-limb spasticity in a phase 3, randomized, double-blind, low-dose controlled, multicenter study; the study enrolled 210 children aged 2-17 years with the condition and a Modified Ashworth Scale grade 2 or greater for elbow and wrist flexors. The children were randomized 1:1:1 to injections of either 8 units/kg, 16 units/kg, or 2 units/kg into the elbow flexors and wrist flexors. At 6 weeks, there were statistically significant improvements in Modified Ashworth Scale grade, the primary endpoint, with least-square mean changes from baseline of –2.0, –2.3, and –1.6, respectively.

AbobotulinumtoxinA and all other botulinum toxin products carry a boxed warning, the most serious warning the FDA issues. This warning refers to risk of botulism-like symptoms caused by the botulinum toxin spreading away from the injection area; these symptoms can included sometimes life-threatening difficulty swallowing or breathing. AbobotulinumtoxinA is contraindicated in patients with known hypersensitivity to any botulinum toxin or any of the components, those with presence of infection at proposed injection site(s), and those with known allergy to cow’s milk protein. It is also important to note that botulinum toxin preparations are not interchangeable; the potency units of one are not the same as those of another. Full prescribing information can be found on the Ipsen website.
 

[email protected]

WASHINGTON – The federal official who helps oversee Medicare’s use of quality measures predicted a continued emphasis on patient-reported outcomes in the assessments of physician performance.

Reena Duseja, MD, chief medical officer for quality measurement at the Centers for Medicare & Medicaid Services, said she has seen “more emphasis” in her 2 years with the agency in collecting outcome measures, including ones reported by patients. In doing this, CMS officials are also looking to identify the core elements that willl be part of patient-reported outcomes (PROs).

“We really have to get better at standardization,” Dr. Duseja said during a policy summit sponsored by the National Comprehensive Cancer Network (NCCN). “There is room for improvement there. We’re continuing to think of ways that we can support that.”

She also said the CMS is working, in general, to try to give physicians feedback sooner on how they are faring on measurements.

“The commitment of our agency is trying to think about how we collect data in a way that shortens the cycle of measure development” and speeds the delivery of this data back to providers, Dr. Duseja said.

Her fellow panelists discussed the difficulties in designing PRO measures, including the need to account for special challenges for patients living in or near poverty. Avoiding emergency department visits and hospitalizations, for example, may be a key priority for people who are paid hourly wages, said Kashyap Patel, MD, managing partner of Carolina Blood and Cancer Care in Rock Hill, S.C. These patients will not only face the inconvenience and cost of a hospital stay, but will also lose wages from missed work. He urged policymakers to take these factors into consideration in designing quality measures, and not to forget that “there is a human being behind this.”

Ronald S. Walters, MD, associate head of the Institute for Cancer Care Innovation at the University of Texas MD Anderson Cancer Center, and chair of NCCN’s board of directors, cautioned against continued attempts to devise a “Nirvana” list of outcome measures that can be universally applied. Instead, payers may be better off with a “mix and match” approach. Certain measures may be used across the board, such as pain and quality of life metrics, while other measures could be more tailored.

Dr. Walters also called out a missed opportunity to tie PROs to Medicare payment in the area of chimeric antigen receptor (CAR) T-cell therapy.

In 2018, the CMS indicated it was considering the use of PROs in connection with CAR T-cell payment. The CMS asked its Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to consider the role of PROs in connection with payment for CAR T-cell therapy. At an August 2018 meeting, MEDCAC panelists generally expressed confidence in PROs in a series of votes about the use of this approach to quality measurement in cancer trials.

But drugmakers and physician groups raised strong objections at the MEDCAC meeting. In its national coverage decision on CAR T, issued in August 2019, the CMS said it had received many comments on PROs “ranging from support of their collection to recommendations for additional assessment tools to request to remove PRO requirements.” The CMS opted at this time to encourage participation in the Center for International Blood and Marrow Transplantation Research (CIBMTR) database “that currently collects health outcomes (and aims to collect patient reported outcomes in the future) on patients who have received CAR T-cell treatments.”

For Dr. Walters, this setback for the use of PROs in CAR T therapy payment is telling, as the treatment is known to produce serious side effects and is administered in well-controlled circumstances.

“If you can’t organize collecting patient-reported outcomes after CAR T cell, that kind of tells you the state of where we are on collecting them on everybody,” Dr. Walters said.

WASHINGTON – The federal official who helps oversee Medicare’s use of quality measures predicted a continued emphasis on patient-reported outcomes in the assessments of physician performance.

Reena Duseja, MD, chief medical officer for quality measurement at the Centers for Medicare & Medicaid Services, said she has seen “more emphasis” in her 2 years with the agency in collecting outcome measures, including ones reported by patients. In doing this, CMS officials are also looking to identify the core elements that willl be part of patient-reported outcomes (PROs).

“We really have to get better at standardization,” Dr. Duseja said during a policy summit sponsored by the National Comprehensive Cancer Network (NCCN). “There is room for improvement there. We’re continuing to think of ways that we can support that.”

She also said the CMS is working, in general, to try to give physicians feedback sooner on how they are faring on measurements.

“The commitment of our agency is trying to think about how we collect data in a way that shortens the cycle of measure development” and speeds the delivery of this data back to providers, Dr. Duseja said.

Her fellow panelists discussed the difficulties in designing PRO measures, including the need to account for special challenges for patients living in or near poverty. Avoiding emergency department visits and hospitalizations, for example, may be a key priority for people who are paid hourly wages, said Kashyap Patel, MD, managing partner of Carolina Blood and Cancer Care in Rock Hill, S.C. These patients will not only face the inconvenience and cost of a hospital stay, but will also lose wages from missed work. He urged policymakers to take these factors into consideration in designing quality measures, and not to forget that “there is a human being behind this.”

Ronald S. Walters, MD, associate head of the Institute for Cancer Care Innovation at the University of Texas MD Anderson Cancer Center, and chair of NCCN’s board of directors, cautioned against continued attempts to devise a “Nirvana” list of outcome measures that can be universally applied. Instead, payers may be better off with a “mix and match” approach. Certain measures may be used across the board, such as pain and quality of life metrics, while other measures could be more tailored.

Dr. Walters also called out a missed opportunity to tie PROs to Medicare payment in the area of chimeric antigen receptor (CAR) T-cell therapy.

In 2018, the CMS indicated it was considering the use of PROs in connection with CAR T-cell payment. The CMS asked its Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to consider the role of PROs in connection with payment for CAR T-cell therapy. At an August 2018 meeting, MEDCAC panelists generally expressed confidence in PROs in a series of votes about the use of this approach to quality measurement in cancer trials.

But drugmakers and physician groups raised strong objections at the MEDCAC meeting. In its national coverage decision on CAR T, issued in August 2019, the CMS said it had received many comments on PROs “ranging from support of their collection to recommendations for additional assessment tools to request to remove PRO requirements.” The CMS opted at this time to encourage participation in the Center for International Blood and Marrow Transplantation Research (CIBMTR) database “that currently collects health outcomes (and aims to collect patient reported outcomes in the future) on patients who have received CAR T-cell treatments.”

For Dr. Walters, this setback for the use of PROs in CAR T therapy payment is telling, as the treatment is known to produce serious side effects and is administered in well-controlled circumstances.

“If you can’t organize collecting patient-reported outcomes after CAR T cell, that kind of tells you the state of where we are on collecting them on everybody,” Dr. Walters said.

WASHINGTON – The federal official who helps oversee Medicare’s use of quality measures predicted a continued emphasis on patient-reported outcomes in the assessments of physician performance.

Reena Duseja, MD, chief medical officer for quality measurement at the Centers for Medicare & Medicaid Services, said she has seen “more emphasis” in her 2 years with the agency in collecting outcome measures, including ones reported by patients. In doing this, CMS officials are also looking to identify the core elements that willl be part of patient-reported outcomes (PROs).

“We really have to get better at standardization,” Dr. Duseja said during a policy summit sponsored by the National Comprehensive Cancer Network (NCCN). “There is room for improvement there. We’re continuing to think of ways that we can support that.”

She also said the CMS is working, in general, to try to give physicians feedback sooner on how they are faring on measurements.

“The commitment of our agency is trying to think about how we collect data in a way that shortens the cycle of measure development” and speeds the delivery of this data back to providers, Dr. Duseja said.

Her fellow panelists discussed the difficulties in designing PRO measures, including the need to account for special challenges for patients living in or near poverty. Avoiding emergency department visits and hospitalizations, for example, may be a key priority for people who are paid hourly wages, said Kashyap Patel, MD, managing partner of Carolina Blood and Cancer Care in Rock Hill, S.C. These patients will not only face the inconvenience and cost of a hospital stay, but will also lose wages from missed work. He urged policymakers to take these factors into consideration in designing quality measures, and not to forget that “there is a human being behind this.”

Ronald S. Walters, MD, associate head of the Institute for Cancer Care Innovation at the University of Texas MD Anderson Cancer Center, and chair of NCCN’s board of directors, cautioned against continued attempts to devise a “Nirvana” list of outcome measures that can be universally applied. Instead, payers may be better off with a “mix and match” approach. Certain measures may be used across the board, such as pain and quality of life metrics, while other measures could be more tailored.

Dr. Walters also called out a missed opportunity to tie PROs to Medicare payment in the area of chimeric antigen receptor (CAR) T-cell therapy.

In 2018, the CMS indicated it was considering the use of PROs in connection with CAR T-cell payment. The CMS asked its Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to consider the role of PROs in connection with payment for CAR T-cell therapy. At an August 2018 meeting, MEDCAC panelists generally expressed confidence in PROs in a series of votes about the use of this approach to quality measurement in cancer trials.

But drugmakers and physician groups raised strong objections at the MEDCAC meeting. In its national coverage decision on CAR T, issued in August 2019, the CMS said it had received many comments on PROs “ranging from support of their collection to recommendations for additional assessment tools to request to remove PRO requirements.” The CMS opted at this time to encourage participation in the Center for International Blood and Marrow Transplantation Research (CIBMTR) database “that currently collects health outcomes (and aims to collect patient reported outcomes in the future) on patients who have received CAR T-cell treatments.”

For Dr. Walters, this setback for the use of PROs in CAR T therapy payment is telling, as the treatment is known to produce serious side effects and is administered in well-controlled circumstances.

“If you can’t organize collecting patient-reported outcomes after CAR T cell, that kind of tells you the state of where we are on collecting them on everybody,” Dr. Walters said.

Legislators sparred about the best way to lower drug prices during a Sept. 25 hearing, bickering along partisan lines over new legislation by U.S. House Speaker Nancy Pelosi, (D-Calif.) that would require Medicare to negotiate drug prices with manufacturers.

Alicia Gallegos/MDedge News

The more than 4-hour hearing by the House Committee on Energy & Commerce Subcommittee on Health centered on HR 3, the “Lower Drug Costs Now Act of 2019,” introduced by Speaker Pelosi on Sept. 24, which would compel the Centers for Medicare & Medicaid Services to make deals with manufacturers on the maximum, reasonable price for the top 250 highest-cost drugs. If a drug maker refused to participate in the negotiation, the company would face a steep noncompliance fee, according to the bill, while manufacturers that overcharged Medicare or failed to offer the negotiated price would be subject to a civil penalty equal to 10 times the cost difference. The legislation includes a $2,000 out-of-pocket limit for Medicare patients.

If enacted, the legislation would transform the pricing landscape of medications and allow more families to access needed treatments, Speaker Pelosi said during the hearing.

“What it does, as you know; it ends the ban – imagine, there’s a ban on negotiating for lower drug prices,” she said. “So, it ends the ban for the [U.S. Department of Health and Human Services] Secretary now to have the opportunity to negotiate for lower prices. But, the even better news is that these drug prices will be lower not just for Medicare recipients, which was one of the original proposals, but for everyone. It will stop companies from ripping us off by charging five times, four times, three times what is charged in other countries.”

However, Republican legislators spent much of the hearing criticizing the bill, claiming the legislation was crafted behind closed doors by Democrats who made no efforts to gain Republican feedback.

“There is no debate that Republicans and Democrats want to work together to lower drug cost for consumers,” Ranking Member Greg Walden (R-Ore.) said during the hearing. “Madam chair, I have to strongly express my great frustration about the decision to sabotage both the tradition of this committee and the bipartisan work that you know was well underway to tackle high-cost drugs. ... We’ve worked in a bipartisan way up until now. I thought we were headed in a good faith down that same path until the speaker’s office dropped this partisan plan on our [progress]. This is partisan politics at its worst, and it’s an avoidable failure.”

Amid the partisan squabbling, legislators heard differing views from economists about the logistics of the legislation and whether the pricing negotiation model makes sense for the United States.

Gerard F. Anderson, PhD, a professor at Johns Hopkins University and director of the Johns Hopkins Center for Hospital Finance and Management in Baltimore told congressional leaders that negotiation between the government and drug makers is both possible and results in lower prices, even for drugs without therapeutic competition. He noted that the Medicaid program currently negotiates prices for supplemental rebates and that the Veterans Administration and the Department of Defense routinely negotiate discounts greater than the federal supply schedule. Dr. Anderson estimated that the Veterans Administration and the Department of Defense pay an average of 30%-40% less than Medicare prescription drug plans for the same medications.

[email protected]

Legislators sparred about the best way to lower drug prices during a Sept. 25 hearing, bickering along partisan lines over new legislation by U.S. House Speaker Nancy Pelosi, (D-Calif.) that would require Medicare to negotiate drug prices with manufacturers.

Alicia Gallegos/MDedge News

The more than 4-hour hearing by the House Committee on Energy & Commerce Subcommittee on Health centered on HR 3, the “Lower Drug Costs Now Act of 2019,” introduced by Speaker Pelosi on Sept. 24, which would compel the Centers for Medicare & Medicaid Services to make deals with manufacturers on the maximum, reasonable price for the top 250 highest-cost drugs. If a drug maker refused to participate in the negotiation, the company would face a steep noncompliance fee, according to the bill, while manufacturers that overcharged Medicare or failed to offer the negotiated price would be subject to a civil penalty equal to 10 times the cost difference. The legislation includes a $2,000 out-of-pocket limit for Medicare patients.

If enacted, the legislation would transform the pricing landscape of medications and allow more families to access needed treatments, Speaker Pelosi said during the hearing.

“What it does, as you know; it ends the ban – imagine, there’s a ban on negotiating for lower drug prices,” she said. “So, it ends the ban for the [U.S. Department of Health and Human Services] Secretary now to have the opportunity to negotiate for lower prices. But, the even better news is that these drug prices will be lower not just for Medicare recipients, which was one of the original proposals, but for everyone. It will stop companies from ripping us off by charging five times, four times, three times what is charged in other countries.”

However, Republican legislators spent much of the hearing criticizing the bill, claiming the legislation was crafted behind closed doors by Democrats who made no efforts to gain Republican feedback.

“There is no debate that Republicans and Democrats want to work together to lower drug cost for consumers,” Ranking Member Greg Walden (R-Ore.) said during the hearing. “Madam chair, I have to strongly express my great frustration about the decision to sabotage both the tradition of this committee and the bipartisan work that you know was well underway to tackle high-cost drugs. ... We’ve worked in a bipartisan way up until now. I thought we were headed in a good faith down that same path until the speaker’s office dropped this partisan plan on our [progress]. This is partisan politics at its worst, and it’s an avoidable failure.”

Amid the partisan squabbling, legislators heard differing views from economists about the logistics of the legislation and whether the pricing negotiation model makes sense for the United States.

Gerard F. Anderson, PhD, a professor at Johns Hopkins University and director of the Johns Hopkins Center for Hospital Finance and Management in Baltimore told congressional leaders that negotiation between the government and drug makers is both possible and results in lower prices, even for drugs without therapeutic competition. He noted that the Medicaid program currently negotiates prices for supplemental rebates and that the Veterans Administration and the Department of Defense routinely negotiate discounts greater than the federal supply schedule. Dr. Anderson estimated that the Veterans Administration and the Department of Defense pay an average of 30%-40% less than Medicare prescription drug plans for the same medications.

[email protected]

Legislators sparred about the best way to lower drug prices during a Sept. 25 hearing, bickering along partisan lines over new legislation by U.S. House Speaker Nancy Pelosi, (D-Calif.) that would require Medicare to negotiate drug prices with manufacturers.

Alicia Gallegos/MDedge News

The more than 4-hour hearing by the House Committee on Energy & Commerce Subcommittee on Health centered on HR 3, the “Lower Drug Costs Now Act of 2019,” introduced by Speaker Pelosi on Sept. 24, which would compel the Centers for Medicare & Medicaid Services to make deals with manufacturers on the maximum, reasonable price for the top 250 highest-cost drugs. If a drug maker refused to participate in the negotiation, the company would face a steep noncompliance fee, according to the bill, while manufacturers that overcharged Medicare or failed to offer the negotiated price would be subject to a civil penalty equal to 10 times the cost difference. The legislation includes a $2,000 out-of-pocket limit for Medicare patients.

If enacted, the legislation would transform the pricing landscape of medications and allow more families to access needed treatments, Speaker Pelosi said during the hearing.

“What it does, as you know; it ends the ban – imagine, there’s a ban on negotiating for lower drug prices,” she said. “So, it ends the ban for the [U.S. Department of Health and Human Services] Secretary now to have the opportunity to negotiate for lower prices. But, the even better news is that these drug prices will be lower not just for Medicare recipients, which was one of the original proposals, but for everyone. It will stop companies from ripping us off by charging five times, four times, three times what is charged in other countries.”

However, Republican legislators spent much of the hearing criticizing the bill, claiming the legislation was crafted behind closed doors by Democrats who made no efforts to gain Republican feedback.

“There is no debate that Republicans and Democrats want to work together to lower drug cost for consumers,” Ranking Member Greg Walden (R-Ore.) said during the hearing. “Madam chair, I have to strongly express my great frustration about the decision to sabotage both the tradition of this committee and the bipartisan work that you know was well underway to tackle high-cost drugs. ... We’ve worked in a bipartisan way up until now. I thought we were headed in a good faith down that same path until the speaker’s office dropped this partisan plan on our [progress]. This is partisan politics at its worst, and it’s an avoidable failure.”

Amid the partisan squabbling, legislators heard differing views from economists about the logistics of the legislation and whether the pricing negotiation model makes sense for the United States.

Gerard F. Anderson, PhD, a professor at Johns Hopkins University and director of the Johns Hopkins Center for Hospital Finance and Management in Baltimore told congressional leaders that negotiation between the government and drug makers is both possible and results in lower prices, even for drugs without therapeutic competition. He noted that the Medicaid program currently negotiates prices for supplemental rebates and that the Veterans Administration and the Department of Defense routinely negotiate discounts greater than the federal supply schedule. Dr. Anderson estimated that the Veterans Administration and the Department of Defense pay an average of 30%-40% less than Medicare prescription drug plans for the same medications.

[email protected]

Growth continues among palliative care programs in the United States, although access often depends “more upon accidents of geography than it does upon the needs of patients,” according to the Center to Advance Palliative Care and the National Palliative Care Research Center.

“As is true for many aspects of health care, geography is destiny. Where you live determines your access to the best quality of life and highest quality of care during a serious illness,” said Diane E. Meier, MD, director of the Center to Advance Palliative Care, in a written statement.

In 2019, more than 72% of U.S. hospitals with 50 or more beds have a palliative care team, compared with 67% of hospitals in 2015 and 53% in 2008, the two organizations said in their 2019 report card on palliative care access. What hasn’t changed since 2015, however, is the country’s overall grade, which remains a B.

Delaware, New Hampshire, Rhode Island, and Vermont have a palliative care program in all of their hospitals with 50 or more beds and each earned a grade of A (palliative care rate of greater than 80%), along with 17 other states. The lowest-performing states – Alabama, Mississippi, New Mexico, Oklahoma, and Wyoming – all received Ds for having a rate below 40%, the CAPC said.

The urban/rural divide also is prominent in palliative care: “90% of hospitals with palliative care are in urban areas. Only 17% of rural hospitals with fifty or more beds report palliative care programs,” the report said.

Hospital type is another source of disparity. Small, nonprofit hospitals are much more likely to offer access to palliative care than either for-profit or public facilities of the same size, but the gap closes as size increases, at least between nonprofit and public hospitals. For the largest institutions, the public hospitals pull into the lead, 98% versus 97%, over the nonprofits, with the for-profit facilities well behind at 63%.

“High quality palliative care has been shown to improve patient and family quality of life, improve patients’ and families’ health care experiences, and in certain diseases, prolong life. Palliative care has also been shown to improve hospital efficiency and reduce unnecessary spending,” said R. Sean Morrison, MD, director of the National Palliative Care Research Center.

The report card is based on data from the American Hospital Association’s Annual Survey Database, with additional data from the National Palliative Care Registry and Center to Advance Palliative Care’s Mapping Community Palliative Care initiative. The final sample included 2,409 hospitals with 50 or more beds.

[email protected]

Growth continues among palliative care programs in the United States, although access often depends “more upon accidents of geography than it does upon the needs of patients,” according to the Center to Advance Palliative Care and the National Palliative Care Research Center.

“As is true for many aspects of health care, geography is destiny. Where you live determines your access to the best quality of life and highest quality of care during a serious illness,” said Diane E. Meier, MD, director of the Center to Advance Palliative Care, in a written statement.

In 2019, more than 72% of U.S. hospitals with 50 or more beds have a palliative care team, compared with 67% of hospitals in 2015 and 53% in 2008, the two organizations said in their 2019 report card on palliative care access. What hasn’t changed since 2015, however, is the country’s overall grade, which remains a B.

Delaware, New Hampshire, Rhode Island, and Vermont have a palliative care program in all of their hospitals with 50 or more beds and each earned a grade of A (palliative care rate of greater than 80%), along with 17 other states. The lowest-performing states – Alabama, Mississippi, New Mexico, Oklahoma, and Wyoming – all received Ds for having a rate below 40%, the CAPC said.

The urban/rural divide also is prominent in palliative care: “90% of hospitals with palliative care are in urban areas. Only 17% of rural hospitals with fifty or more beds report palliative care programs,” the report said.

Hospital type is another source of disparity. Small, nonprofit hospitals are much more likely to offer access to palliative care than either for-profit or public facilities of the same size, but the gap closes as size increases, at least between nonprofit and public hospitals. For the largest institutions, the public hospitals pull into the lead, 98% versus 97%, over the nonprofits, with the for-profit facilities well behind at 63%.

“High quality palliative care has been shown to improve patient and family quality of life, improve patients’ and families’ health care experiences, and in certain diseases, prolong life. Palliative care has also been shown to improve hospital efficiency and reduce unnecessary spending,” said R. Sean Morrison, MD, director of the National Palliative Care Research Center.

The report card is based on data from the American Hospital Association’s Annual Survey Database, with additional data from the National Palliative Care Registry and Center to Advance Palliative Care’s Mapping Community Palliative Care initiative. The final sample included 2,409 hospitals with 50 or more beds.

[email protected]

Growth continues among palliative care programs in the United States, although access often depends “more upon accidents of geography than it does upon the needs of patients,” according to the Center to Advance Palliative Care and the National Palliative Care Research Center.

“As is true for many aspects of health care, geography is destiny. Where you live determines your access to the best quality of life and highest quality of care during a serious illness,” said Diane E. Meier, MD, director of the Center to Advance Palliative Care, in a written statement.

In 2019, more than 72% of U.S. hospitals with 50 or more beds have a palliative care team, compared with 67% of hospitals in 2015 and 53% in 2008, the two organizations said in their 2019 report card on palliative care access. What hasn’t changed since 2015, however, is the country’s overall grade, which remains a B.

Delaware, New Hampshire, Rhode Island, and Vermont have a palliative care program in all of their hospitals with 50 or more beds and each earned a grade of A (palliative care rate of greater than 80%), along with 17 other states. The lowest-performing states – Alabama, Mississippi, New Mexico, Oklahoma, and Wyoming – all received Ds for having a rate below 40%, the CAPC said.

The urban/rural divide also is prominent in palliative care: “90% of hospitals with palliative care are in urban areas. Only 17% of rural hospitals with fifty or more beds report palliative care programs,” the report said.

Hospital type is another source of disparity. Small, nonprofit hospitals are much more likely to offer access to palliative care than either for-profit or public facilities of the same size, but the gap closes as size increases, at least between nonprofit and public hospitals. For the largest institutions, the public hospitals pull into the lead, 98% versus 97%, over the nonprofits, with the for-profit facilities well behind at 63%.

“High quality palliative care has been shown to improve patient and family quality of life, improve patients’ and families’ health care experiences, and in certain diseases, prolong life. Palliative care has also been shown to improve hospital efficiency and reduce unnecessary spending,” said R. Sean Morrison, MD, director of the National Palliative Care Research Center.

The report card is based on data from the American Hospital Association’s Annual Survey Database, with additional data from the National Palliative Care Registry and Center to Advance Palliative Care’s Mapping Community Palliative Care initiative. The final sample included 2,409 hospitals with 50 or more beds.

[email protected]

WASHINGTON – Federal officials are considering how they might extend a test of payment approaches meant to spur more coordinated cancer care beyond the program’s current 2021 end date.

Alexandra Chong, PhD, the team lead for the Oncology Care Model at the Center for Medicare and Medicaid Innovation (CMMI), said her agency found strong support for sustaining this kind of effort at “practice transformation.” The Oncology Care Model, which kicked off in 2016, involves about 175 practices and 10 insurers.

“As we look forward, we certainly recognize and appreciate the importance of the impact that [the Oncology Care Model] made and the desire for a continuation, either in an iteration of the current model or a different model,” Dr. Chong said during a panel discussion at a policy summit sponsored by the National Comprehensive Cancer Network (NCCN).

Dr. Chong said the Centers for Medicare & Medicaid Services is aware that there is “a lot of interest” in the future of the program. “We have heard from our practices that this model has been an opportunity for them to provide the care that they really want to provide,” Dr. Chong said.

A fellow panelist at the NCCN event, Kerin Adelson, MD, chief quality officer of Yale’s Smilow Cancer Hospital, New Haven, Conn., pressed for continuation of this kind of a payment test. Smilow has used revenue from the Oncology Care Model program to develop dashboards to measure individual clinicians’ patterns of care and share data with them, Dr. Adelson said.

The changes have been “transformative,” including allowing for hiring of additional support staff, Dr. Adelson said.

“I am terrified about what’s going to happen at the end of the program if there is not another model to transition to,” Dr. Adelson said. “We will potentially be looking at layoffs of these people who are so incredible and have done so much for the care we are giving.”

In May 2019, some of Dr. Chong’s CMMI colleagues published a report in the Journal of the National Cancer Institute about the experiences of clinics participating in the Oncology Care Model. For instance, the U.S. Oncology Network used Monthly Enhanced Oncology Services [MEOS] payments through the program for new hires such as navigators, social workers, additional advanced practice providers, “and even data analysts,” according to the report.

Still, there have been “growing pains” with the start-up of the model, Dr. Chong said. Fellow participants on the NCCN panel cited the introduction of costly new drugs as one wrinkle in the early days of the Oncology Care Model. Another is that physicians in practices signed up for the program sometimes are unaware of it.

The American Society of Clinical Oncology also is advocating for a continuation of a model along the lines of the Oncology Care Model.

“It would be good to see it continue. We’re certainly supportive of continuing to work on this model and refine it and see where it goes,” Stephen S. Grubbs, MD, ASCO’s vice president for clinical affairs, said in an interview.

Dr. Grubbs said that CMS’s Oncology Care Model could not be greatly expanded in its current form, as it imposes a steep administrative burden for both practices who participate, as well as for CMMI. The current model also does not serve smaller and rural practices well, he said.

ASCO is refining its own proposal for an alternative payment approach. The group plans to present its Patient-Centered Oncology Payment (PCOP) model, first published in 2015, before an influential federal advisory group, the Physician-Focused Payment Model Technical Advisory Committee (PTAC), at a meeting in 2020.

WASHINGTON – Federal officials are considering how they might extend a test of payment approaches meant to spur more coordinated cancer care beyond the program’s current 2021 end date.

Alexandra Chong, PhD, the team lead for the Oncology Care Model at the Center for Medicare and Medicaid Innovation (CMMI), said her agency found strong support for sustaining this kind of effort at “practice transformation.” The Oncology Care Model, which kicked off in 2016, involves about 175 practices and 10 insurers.

“As we look forward, we certainly recognize and appreciate the importance of the impact that [the Oncology Care Model] made and the desire for a continuation, either in an iteration of the current model or a different model,” Dr. Chong said during a panel discussion at a policy summit sponsored by the National Comprehensive Cancer Network (NCCN).

Dr. Chong said the Centers for Medicare & Medicaid Services is aware that there is “a lot of interest” in the future of the program. “We have heard from our practices that this model has been an opportunity for them to provide the care that they really want to provide,” Dr. Chong said.

A fellow panelist at the NCCN event, Kerin Adelson, MD, chief quality officer of Yale’s Smilow Cancer Hospital, New Haven, Conn., pressed for continuation of this kind of a payment test. Smilow has used revenue from the Oncology Care Model program to develop dashboards to measure individual clinicians’ patterns of care and share data with them, Dr. Adelson said.

The changes have been “transformative,” including allowing for hiring of additional support staff, Dr. Adelson said.

“I am terrified about what’s going to happen at the end of the program if there is not another model to transition to,” Dr. Adelson said. “We will potentially be looking at layoffs of these people who are so incredible and have done so much for the care we are giving.”

In May 2019, some of Dr. Chong’s CMMI colleagues published a report in the Journal of the National Cancer Institute about the experiences of clinics participating in the Oncology Care Model. For instance, the U.S. Oncology Network used Monthly Enhanced Oncology Services [MEOS] payments through the program for new hires such as navigators, social workers, additional advanced practice providers, “and even data analysts,” according to the report.

Still, there have been “growing pains” with the start-up of the model, Dr. Chong said. Fellow participants on the NCCN panel cited the introduction of costly new drugs as one wrinkle in the early days of the Oncology Care Model. Another is that physicians in practices signed up for the program sometimes are unaware of it.

The American Society of Clinical Oncology also is advocating for a continuation of a model along the lines of the Oncology Care Model.

“It would be good to see it continue. We’re certainly supportive of continuing to work on this model and refine it and see where it goes,” Stephen S. Grubbs, MD, ASCO’s vice president for clinical affairs, said in an interview.

Dr. Grubbs said that CMS’s Oncology Care Model could not be greatly expanded in its current form, as it imposes a steep administrative burden for both practices who participate, as well as for CMMI. The current model also does not serve smaller and rural practices well, he said.

ASCO is refining its own proposal for an alternative payment approach. The group plans to present its Patient-Centered Oncology Payment (PCOP) model, first published in 2015, before an influential federal advisory group, the Physician-Focused Payment Model Technical Advisory Committee (PTAC), at a meeting in 2020.

WASHINGTON – Federal officials are considering how they might extend a test of payment approaches meant to spur more coordinated cancer care beyond the program’s current 2021 end date.

Alexandra Chong, PhD, the team lead for the Oncology Care Model at the Center for Medicare and Medicaid Innovation (CMMI), said her agency found strong support for sustaining this kind of effort at “practice transformation.” The Oncology Care Model, which kicked off in 2016, involves about 175 practices and 10 insurers.

“As we look forward, we certainly recognize and appreciate the importance of the impact that [the Oncology Care Model] made and the desire for a continuation, either in an iteration of the current model or a different model,” Dr. Chong said during a panel discussion at a policy summit sponsored by the National Comprehensive Cancer Network (NCCN).

Dr. Chong said the Centers for Medicare & Medicaid Services is aware that there is “a lot of interest” in the future of the program. “We have heard from our practices that this model has been an opportunity for them to provide the care that they really want to provide,” Dr. Chong said.

A fellow panelist at the NCCN event, Kerin Adelson, MD, chief quality officer of Yale’s Smilow Cancer Hospital, New Haven, Conn., pressed for continuation of this kind of a payment test. Smilow has used revenue from the Oncology Care Model program to develop dashboards to measure individual clinicians’ patterns of care and share data with them, Dr. Adelson said.

The changes have been “transformative,” including allowing for hiring of additional support staff, Dr. Adelson said.

“I am terrified about what’s going to happen at the end of the program if there is not another model to transition to,” Dr. Adelson said. “We will potentially be looking at layoffs of these people who are so incredible and have done so much for the care we are giving.”

In May 2019, some of Dr. Chong’s CMMI colleagues published a report in the Journal of the National Cancer Institute about the experiences of clinics participating in the Oncology Care Model. For instance, the U.S. Oncology Network used Monthly Enhanced Oncology Services [MEOS] payments through the program for new hires such as navigators, social workers, additional advanced practice providers, “and even data analysts,” according to the report.

Still, there have been “growing pains” with the start-up of the model, Dr. Chong said. Fellow participants on the NCCN panel cited the introduction of costly new drugs as one wrinkle in the early days of the Oncology Care Model. Another is that physicians in practices signed up for the program sometimes are unaware of it.

The American Society of Clinical Oncology also is advocating for a continuation of a model along the lines of the Oncology Care Model.

“It would be good to see it continue. We’re certainly supportive of continuing to work on this model and refine it and see where it goes,” Stephen S. Grubbs, MD, ASCO’s vice president for clinical affairs, said in an interview.

Dr. Grubbs said that CMS’s Oncology Care Model could not be greatly expanded in its current form, as it imposes a steep administrative burden for both practices who participate, as well as for CMMI. The current model also does not serve smaller and rural practices well, he said.

ASCO is refining its own proposal for an alternative payment approach. The group plans to present its Patient-Centered Oncology Payment (PCOP) model, first published in 2015, before an influential federal advisory group, the Physician-Focused Payment Model Technical Advisory Committee (PTAC), at a meeting in 2020.

A live-attenuated herpes zoster vaccine can be used in individuals with systemic lupus erythematosus (SLE) if they are not intensively immunosuppressed and their condition is dormant, research suggests.

A paper published in Annals of the Rheumatic Diseases reported the outcomes of a randomized, placebo-controlled trial of the Zostavax herpes zoster vaccine in 90 adults with clinically stable SLE. Participants had to have been on a stable dose of immunosuppressive agents for at least 6 months and have a history of chicken pox or herpes zoster infection.

Chi Chiu Mok, MD, of the Tuen Mun Hospital in Hong Kong and coauthors wrote that herpes zoster reactivation has been reported to occur in 6.4 to 91.4 individuals with SLE per 1,000 patient-years, with consequences including postherpetic neuralgia and even death from disseminated infection. But because Zostavax is live-attenuated, it has not been widely used in immunocompromised people.

After a single subcutaneous dose of either the vaccine or placebo, researchers saw a significant increase in anti–varicella zoster virus (VZV) IgG antibodies in vaccinated individuals over 6 weeks. The magnitude of the increase in anti-VZV IgG seen in vaccinated individuals was on par with that previously seen in vaccinated healthy controls, although the authors noted that the absolute increase in values was lower.

“While the reason is not apparent, one contributing factor is the high rate of previous exposure to VZV infection in most participants, which could have led to a higher baseline anti-IgG anti-VZV value that limited its rise after vaccination,” the authors wrote.

In contrast, IgG reactivity declined in those who received the placebo injection, and the difference between the two groups was statistically significant after adjustment for baseline antibody titers.

The study also looked at the cell-mediated immune response to the vaccine and found the number of interferon-gamma secreting CD4+ T-cell spots increased in the vaccinated patients but decreased in the placebo arm, and by week 6 it was significantly higher in the treated group. The increase in the vaccine-treated patients was again similar to that previously seen in healthy controls.

However, prednisolone use at baseline may have attenuated the vaccine response. Vaccinated patients who were treated with prednisolone at baseline had a lower increase in T-cell spots and lower anti-VZV IgG reactivity after the vaccination than did those not taking prednisolone, although the difference between the two groups was not statistically significant. The study did not see any effect of age, sex, baseline lymphocyte count, disease activity scores, and other factors on response to the vaccine.

None of the patients who received the vaccine withdrew from the study because of serious adverse events. The most common adverse events reported were injection-site redness and pain, which were more common in the vaccine-treated group than in the placebo group. However these symptoms were mild and resolved by themselves after a few days. Two patients in the vaccine group and one in the placebo group experienced mild or moderate SLE flares.

The authors commented that this was the first randomized, controlled trial examining the safety and immune response of a live-attenuated herpes zoster vaccine in individuals with SLE and this trial showed it was safe and well tolerated in those with stable disease who were not on intensive immunosuppressive therapy.

“Despite the increased risk of HZ [herpes zoster] infection, SLE had the lowest HZ vaccination rates among age-eligible subjects, probably because of the concern of vaccine safety, the principle of contraindication to live-attenuated vaccines in immunocompromised hosts, as well as the current ambiguous guidelines for HZ vaccination in SLE,” they wrote.

But they also stressed that their results did not apply to patients with active disease or on more intensive immunosuppression and that longer-term data on the persistence of vaccine immunogenicity was still being collected.

The study was funded by the Hong Kong Research Fund Secretariat. No conflicts of interest were declared.

SOURCE: Mok CC et al. Ann Rheum Dis. 2019 Sep 17. doi: 10.1136/annrheumdis-2019-215925

A live-attenuated herpes zoster vaccine can be used in individuals with systemic lupus erythematosus (SLE) if they are not intensively immunosuppressed and their condition is dormant, research suggests.

A paper published in Annals of the Rheumatic Diseases reported the outcomes of a randomized, placebo-controlled trial of the Zostavax herpes zoster vaccine in 90 adults with clinically stable SLE. Participants had to have been on a stable dose of immunosuppressive agents for at least 6 months and have a history of chicken pox or herpes zoster infection.

Chi Chiu Mok, MD, of the Tuen Mun Hospital in Hong Kong and coauthors wrote that herpes zoster reactivation has been reported to occur in 6.4 to 91.4 individuals with SLE per 1,000 patient-years, with consequences including postherpetic neuralgia and even death from disseminated infection. But because Zostavax is live-attenuated, it has not been widely used in immunocompromised people.

After a single subcutaneous dose of either the vaccine or placebo, researchers saw a significant increase in anti–varicella zoster virus (VZV) IgG antibodies in vaccinated individuals over 6 weeks. The magnitude of the increase in anti-VZV IgG seen in vaccinated individuals was on par with that previously seen in vaccinated healthy controls, although the authors noted that the absolute increase in values was lower.

“While the reason is not apparent, one contributing factor is the high rate of previous exposure to VZV infection in most participants, which could have led to a higher baseline anti-IgG anti-VZV value that limited its rise after vaccination,” the authors wrote.

In contrast, IgG reactivity declined in those who received the placebo injection, and the difference between the two groups was statistically significant after adjustment for baseline antibody titers.

The study also looked at the cell-mediated immune response to the vaccine and found the number of interferon-gamma secreting CD4+ T-cell spots increased in the vaccinated patients but decreased in the placebo arm, and by week 6 it was significantly higher in the treated group. The increase in the vaccine-treated patients was again similar to that previously seen in healthy controls.

However, prednisolone use at baseline may have attenuated the vaccine response. Vaccinated patients who were treated with prednisolone at baseline had a lower increase in T-cell spots and lower anti-VZV IgG reactivity after the vaccination than did those not taking prednisolone, although the difference between the two groups was not statistically significant. The study did not see any effect of age, sex, baseline lymphocyte count, disease activity scores, and other factors on response to the vaccine.

None of the patients who received the vaccine withdrew from the study because of serious adverse events. The most common adverse events reported were injection-site redness and pain, which were more common in the vaccine-treated group than in the placebo group. However these symptoms were mild and resolved by themselves after a few days. Two patients in the vaccine group and one in the placebo group experienced mild or moderate SLE flares.

The authors commented that this was the first randomized, controlled trial examining the safety and immune response of a live-attenuated herpes zoster vaccine in individuals with SLE and this trial showed it was safe and well tolerated in those with stable disease who were not on intensive immunosuppressive therapy.

“Despite the increased risk of HZ [herpes zoster] infection, SLE had the lowest HZ vaccination rates among age-eligible subjects, probably because of the concern of vaccine safety, the principle of contraindication to live-attenuated vaccines in immunocompromised hosts, as well as the current ambiguous guidelines for HZ vaccination in SLE,” they wrote.

But they also stressed that their results did not apply to patients with active disease or on more intensive immunosuppression and that longer-term data on the persistence of vaccine immunogenicity was still being collected.

The study was funded by the Hong Kong Research Fund Secretariat. No conflicts of interest were declared.

SOURCE: Mok CC et al. Ann Rheum Dis. 2019 Sep 17. doi: 10.1136/annrheumdis-2019-215925

A live-attenuated herpes zoster vaccine can be used in individuals with systemic lupus erythematosus (SLE) if they are not intensively immunosuppressed and their condition is dormant, research suggests.

A paper published in Annals of the Rheumatic Diseases reported the outcomes of a randomized, placebo-controlled trial of the Zostavax herpes zoster vaccine in 90 adults with clinically stable SLE. Participants had to have been on a stable dose of immunosuppressive agents for at least 6 months and have a history of chicken pox or herpes zoster infection.

Chi Chiu Mok, MD, of the Tuen Mun Hospital in Hong Kong and coauthors wrote that herpes zoster reactivation has been reported to occur in 6.4 to 91.4 individuals with SLE per 1,000 patient-years, with consequences including postherpetic neuralgia and even death from disseminated infection. But because Zostavax is live-attenuated, it has not been widely used in immunocompromised people.

After a single subcutaneous dose of either the vaccine or placebo, researchers saw a significant increase in anti–varicella zoster virus (VZV) IgG antibodies in vaccinated individuals over 6 weeks. The magnitude of the increase in anti-VZV IgG seen in vaccinated individuals was on par with that previously seen in vaccinated healthy controls, although the authors noted that the absolute increase in values was lower.

“While the reason is not apparent, one contributing factor is the high rate of previous exposure to VZV infection in most participants, which could have led to a higher baseline anti-IgG anti-VZV value that limited its rise after vaccination,” the authors wrote.

In contrast, IgG reactivity declined in those who received the placebo injection, and the difference between the two groups was statistically significant after adjustment for baseline antibody titers.

The study also looked at the cell-mediated immune response to the vaccine and found the number of interferon-gamma secreting CD4+ T-cell spots increased in the vaccinated patients but decreased in the placebo arm, and by week 6 it was significantly higher in the treated group. The increase in the vaccine-treated patients was again similar to that previously seen in healthy controls.

However, prednisolone use at baseline may have attenuated the vaccine response. Vaccinated patients who were treated with prednisolone at baseline had a lower increase in T-cell spots and lower anti-VZV IgG reactivity after the vaccination than did those not taking prednisolone, although the difference between the two groups was not statistically significant. The study did not see any effect of age, sex, baseline lymphocyte count, disease activity scores, and other factors on response to the vaccine.

None of the patients who received the vaccine withdrew from the study because of serious adverse events. The most common adverse events reported were injection-site redness and pain, which were more common in the vaccine-treated group than in the placebo group. However these symptoms were mild and resolved by themselves after a few days. Two patients in the vaccine group and one in the placebo group experienced mild or moderate SLE flares.

The authors commented that this was the first randomized, controlled trial examining the safety and immune response of a live-attenuated herpes zoster vaccine in individuals with SLE and this trial showed it was safe and well tolerated in those with stable disease who were not on intensive immunosuppressive therapy.

“Despite the increased risk of HZ [herpes zoster] infection, SLE had the lowest HZ vaccination rates among age-eligible subjects, probably because of the concern of vaccine safety, the principle of contraindication to live-attenuated vaccines in immunocompromised hosts, as well as the current ambiguous guidelines for HZ vaccination in SLE,” they wrote.

But they also stressed that their results did not apply to patients with active disease or on more intensive immunosuppression and that longer-term data on the persistence of vaccine immunogenicity was still being collected.

The study was funded by the Hong Kong Research Fund Secretariat. No conflicts of interest were declared.

SOURCE: Mok CC et al. Ann Rheum Dis. 2019 Sep 17. doi: 10.1136/annrheumdis-2019-215925