Thoracic Surgery News (Archived)

PARIS – A unique drug-eluting coronary stent showed positive interim results in the DESSOLVE III trial presented at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

In DESSOLVE III, 1,398 patients undergoing percutaneous coronary intervention were randomized to the widely used Xience everolimus-eluting stent or to MiStent, a novel thin-strut stent with a polymer coating that is quickly absorbed after delivering microcrystalline sirolimus into the vessel wall for prolonged release at a near-linear rate.

At an interim analysis at 12 months of follow-up, the primary endpoint – a composite of cardiac death, target vessel MI, and clinically indicated target lesion revascularization – had occurred in 5.8% of the MiStent group and 6.5% of Xience recipients in the study, which was designed as a noninferiority trial, reported Robbert J. de Winter, MD, professor of clinical cardiology at the Academic Medical Center in Amsterdam.

[email protected]

PARIS – A unique drug-eluting coronary stent showed positive interim results in the DESSOLVE III trial presented at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

In DESSOLVE III, 1,398 patients undergoing percutaneous coronary intervention were randomized to the widely used Xience everolimus-eluting stent or to MiStent, a novel thin-strut stent with a polymer coating that is quickly absorbed after delivering microcrystalline sirolimus into the vessel wall for prolonged release at a near-linear rate.

At an interim analysis at 12 months of follow-up, the primary endpoint – a composite of cardiac death, target vessel MI, and clinically indicated target lesion revascularization – had occurred in 5.8% of the MiStent group and 6.5% of Xience recipients in the study, which was designed as a noninferiority trial, reported Robbert J. de Winter, MD, professor of clinical cardiology at the Academic Medical Center in Amsterdam.

[email protected]

PARIS – A unique drug-eluting coronary stent showed positive interim results in the DESSOLVE III trial presented at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

In DESSOLVE III, 1,398 patients undergoing percutaneous coronary intervention were randomized to the widely used Xience everolimus-eluting stent or to MiStent, a novel thin-strut stent with a polymer coating that is quickly absorbed after delivering microcrystalline sirolimus into the vessel wall for prolonged release at a near-linear rate.

At an interim analysis at 12 months of follow-up, the primary endpoint – a composite of cardiac death, target vessel MI, and clinically indicated target lesion revascularization – had occurred in 5.8% of the MiStent group and 6.5% of Xience recipients in the study, which was designed as a noninferiority trial, reported Robbert J. de Winter, MD, professor of clinical cardiology at the Academic Medical Center in Amsterdam.

[email protected]

CHICAGO – The question is not if a physician will face a Medicare or Medicaid billing audit, but when, according to Abby Pendleton, a New York–based health law attorney. That’s why it pays to know how to handle an audit before one probe disrupts your practice. At a recent American Bar Association meeting, Ms. Pendleton and H. Rusty Comley, a Jackson, Mississippi–based health law attorney, offered answers to top audit questions and provided guidance on how physicians can successfully appeal an audit.

When should you appeal?

There are a number of factors to consider when deciding whether to appeal audit findings. For starters, consider the cost of the payback amount and the basis of the findings.

What should you expect from an appeal?

Expect to go through more than one appeals process step to succeed. There are five stages to the appeals process .

“At the redetermination stage, I don’t see a whole lot of movement in terms of great success at that first stage,” Ms. Pendleton said. “So, don’t think, ‘If we get to that first level of appeal, we’re expecting to win.’ If you look at the statistics, it’s not really that realistic.”

Although a provider has 120 days to file an appeal, it’s smarter to file within the first 30 days, Ms. Pendleton advised. If an appeal is filed within 30 days, the government cannot recoup it’s demand from a doctor’s current Medicare payments.

Expect a lengthy time frame for a final outcome. Under federal law, once an appeal gets to the administrative law judge (ALJ) stage (the third stage), the appellant should receive a hearing decision within 90 days. However, because of heavy case backlogs, physicians typically don’t get a hearing for 3 years, Ms. Pendleton said.

“The problem is, your MAC [Medicare administrative contractor] can start taking your money after the [second] stage,” she said. “If it’s a huge dollar amount, you’re probably going to have to enter into a payment plan [with the government]. You will eventually get your money back, if you win, three to four years later.”

Note that physicians generally experience a higher degree of success at the ALJ stage, so it may be worth continuing the appeal through this stage, she noted.

Overall, more than one-third of audit findings are reversed in providers’ favor during the appeals process. Of 170,482 Medicare appeal decisions in 2015, 37% were made in favor of the health provider, an increase from 23% in 2014, according to 2015 Medicare data and 2014 reports.

The cost to appeal varies significantly between Medicaid and Medicare and depends largely on the complexity of the audit, Mr. Comley said. A Medicaid audit appeal, through an ALJ hearing and written appeal to a court, may cost between $20,000 to $60,000 depending on the circumstances, he said. By contrast, a Medicare appeal resolved in the first stage of appeal may only cost a few thousand dollars for a relatively simple audit.

“Of course, the costs will rise at each level of the Medicare appeal process, especially in the third stage involving the ALJ telephonic hearing, but, in most cases, the Medicare appeal costs will still be below a similar Medicaid appeal,” he said.
 

What strategies can help you win?

Consider reaching out to your congressional representative or senators, Mr. Comley advised. Particularly if the issue involves a medical treatment decision or a medically necessary determination, it may be helpful to copy “your favorite Congressman or senator’s office” on correspondence with the MAC. Clearly state your argument against the findings and how/why the medical decision was made. Legislators will often get involved and could help your appeal, Mr. Comley said.

Further, don’t just review the claims that auditors denied. Also evaluate the claims they have approved in the past, he added.

“In almost every case I’ve been involved in, they’ll approve claims that, on the other hand, they deny,” Mr. Comley said. “Under most legal standards, that’s a good way to win – it’s called arbitrary and capricious.”

Find the best experts to back your case, Ms. Pendleton advised. Consider including expert opinions in written responses to the government that support the services provided and/or have medical experts ready to testify during hearings. If the government based its findings on statistics or cited statistics in its review, involve a statistical expert who can argue against the government’s conclusion.

If the case is significant enough, consider skipping steps in the appeals process to get the case before a federal court sooner. Appellants can escalate their appeal through the process at nearly every stage if the government fails to respond within a timely manner. At the second stage, for example, if the qualified independent contractor does not issue a decision within 60 days, an appellant generally has the right to escalate the case to an administrative law judge. If the ALJ does not issue a decision within 90 days, the appeal can generally be escalated to the Appeals Council level, and, if the council does not issue a decision within 90 days, appellants can seek judicial review.

It may be worth it to have your day in court sooner, Ms. Pendleton said.

“It might be an option for providers if you have a large audit with a lot at stake,” she said. “Escalate it through. Get it to federal court and argue it.”

The 5 steps of the Medicare appeals process

There are five stages of the Medicare audit appeals process, according to the Centers for Medicare & Medicaid Services. They include:

1. Redetermination by the Fiscal Intermediary. A redetermination is an examination of a claim by a Medicare administrative contractor (MAC) separate from the personnel who made the initial claim determination. The appellant has 120 days from the date of initial claim determination receipt to file an appeal.

2. Reconsideration by a Qualified Independent Contractor (QIC). A QIC is an independent contractor who didn’t take part in the level 1 decision. The QIC will review the request for a reconsideration and make a decision. An appellant must file a request for reconsideration within 180 days of Medicare redetermination notice or remittance advice receipt.

3. Administrative Law Judge (ALJ) hearing. Appellants present their case to an ALJ who will review the facts of the appeal and listen to testimony before making a decision. An ALJ hearing is usually held by phone or video conference. Appellants can ask the ALJ to make a decision without a hearing. The ALJ may also issue a decision without holding a hearing if evidence in the record supports a decision that’s fully in the appellant’s favor.

4. Medicare Appeals Council review. If you disagree with the ALJ decision or wish to escalate the appeal because the ALJ ruling time frame has passed, a request for a Medicare Appeals Council review can be made. A request for a Medicare Appeals Council review must be made within 60 days of receipt of the ALJ’s decision or after the ALJ ruling time frame expires.

5. Judicial review in U.S. District Court. A party may file an action in federal district court within 60 calendar days after the date receiving notice of the Medicare Appeals Council’s decision or after a council notice that it is not able to reach a decision. To get a judicial review in federal district court, the case amount must meet a minimum dollar amount ($1,560 in 2017).

Each state has its own Medicaid appeals process. Contact your state’s Medicaid office to find out how to appeal a Medicaid audit finding.

[email protected]

On Twitter @legal_med

CHICAGO – The question is not if a physician will face a Medicare or Medicaid billing audit, but when, according to Abby Pendleton, a New York–based health law attorney. That’s why it pays to know how to handle an audit before one probe disrupts your practice. At a recent American Bar Association meeting, Ms. Pendleton and H. Rusty Comley, a Jackson, Mississippi–based health law attorney, offered answers to top audit questions and provided guidance on how physicians can successfully appeal an audit.

When should you appeal?

There are a number of factors to consider when deciding whether to appeal audit findings. For starters, consider the cost of the payback amount and the basis of the findings.

What should you expect from an appeal?

Expect to go through more than one appeals process step to succeed. There are five stages to the appeals process .

“At the redetermination stage, I don’t see a whole lot of movement in terms of great success at that first stage,” Ms. Pendleton said. “So, don’t think, ‘If we get to that first level of appeal, we’re expecting to win.’ If you look at the statistics, it’s not really that realistic.”

Although a provider has 120 days to file an appeal, it’s smarter to file within the first 30 days, Ms. Pendleton advised. If an appeal is filed within 30 days, the government cannot recoup it’s demand from a doctor’s current Medicare payments.

Expect a lengthy time frame for a final outcome. Under federal law, once an appeal gets to the administrative law judge (ALJ) stage (the third stage), the appellant should receive a hearing decision within 90 days. However, because of heavy case backlogs, physicians typically don’t get a hearing for 3 years, Ms. Pendleton said.

“The problem is, your MAC [Medicare administrative contractor] can start taking your money after the [second] stage,” she said. “If it’s a huge dollar amount, you’re probably going to have to enter into a payment plan [with the government]. You will eventually get your money back, if you win, three to four years later.”

Note that physicians generally experience a higher degree of success at the ALJ stage, so it may be worth continuing the appeal through this stage, she noted.

Overall, more than one-third of audit findings are reversed in providers’ favor during the appeals process. Of 170,482 Medicare appeal decisions in 2015, 37% were made in favor of the health provider, an increase from 23% in 2014, according to 2015 Medicare data and 2014 reports.

The cost to appeal varies significantly between Medicaid and Medicare and depends largely on the complexity of the audit, Mr. Comley said. A Medicaid audit appeal, through an ALJ hearing and written appeal to a court, may cost between $20,000 to $60,000 depending on the circumstances, he said. By contrast, a Medicare appeal resolved in the first stage of appeal may only cost a few thousand dollars for a relatively simple audit.

“Of course, the costs will rise at each level of the Medicare appeal process, especially in the third stage involving the ALJ telephonic hearing, but, in most cases, the Medicare appeal costs will still be below a similar Medicaid appeal,” he said.
 

What strategies can help you win?

Consider reaching out to your congressional representative or senators, Mr. Comley advised. Particularly if the issue involves a medical treatment decision or a medically necessary determination, it may be helpful to copy “your favorite Congressman or senator’s office” on correspondence with the MAC. Clearly state your argument against the findings and how/why the medical decision was made. Legislators will often get involved and could help your appeal, Mr. Comley said.

Further, don’t just review the claims that auditors denied. Also evaluate the claims they have approved in the past, he added.

“In almost every case I’ve been involved in, they’ll approve claims that, on the other hand, they deny,” Mr. Comley said. “Under most legal standards, that’s a good way to win – it’s called arbitrary and capricious.”

Find the best experts to back your case, Ms. Pendleton advised. Consider including expert opinions in written responses to the government that support the services provided and/or have medical experts ready to testify during hearings. If the government based its findings on statistics or cited statistics in its review, involve a statistical expert who can argue against the government’s conclusion.

If the case is significant enough, consider skipping steps in the appeals process to get the case before a federal court sooner. Appellants can escalate their appeal through the process at nearly every stage if the government fails to respond within a timely manner. At the second stage, for example, if the qualified independent contractor does not issue a decision within 60 days, an appellant generally has the right to escalate the case to an administrative law judge. If the ALJ does not issue a decision within 90 days, the appeal can generally be escalated to the Appeals Council level, and, if the council does not issue a decision within 90 days, appellants can seek judicial review.

It may be worth it to have your day in court sooner, Ms. Pendleton said.

“It might be an option for providers if you have a large audit with a lot at stake,” she said. “Escalate it through. Get it to federal court and argue it.”

The 5 steps of the Medicare appeals process

There are five stages of the Medicare audit appeals process, according to the Centers for Medicare & Medicaid Services. They include:

1. Redetermination by the Fiscal Intermediary. A redetermination is an examination of a claim by a Medicare administrative contractor (MAC) separate from the personnel who made the initial claim determination. The appellant has 120 days from the date of initial claim determination receipt to file an appeal.

2. Reconsideration by a Qualified Independent Contractor (QIC). A QIC is an independent contractor who didn’t take part in the level 1 decision. The QIC will review the request for a reconsideration and make a decision. An appellant must file a request for reconsideration within 180 days of Medicare redetermination notice or remittance advice receipt.

3. Administrative Law Judge (ALJ) hearing. Appellants present their case to an ALJ who will review the facts of the appeal and listen to testimony before making a decision. An ALJ hearing is usually held by phone or video conference. Appellants can ask the ALJ to make a decision without a hearing. The ALJ may also issue a decision without holding a hearing if evidence in the record supports a decision that’s fully in the appellant’s favor.

4. Medicare Appeals Council review. If you disagree with the ALJ decision or wish to escalate the appeal because the ALJ ruling time frame has passed, a request for a Medicare Appeals Council review can be made. A request for a Medicare Appeals Council review must be made within 60 days of receipt of the ALJ’s decision or after the ALJ ruling time frame expires.

5. Judicial review in U.S. District Court. A party may file an action in federal district court within 60 calendar days after the date receiving notice of the Medicare Appeals Council’s decision or after a council notice that it is not able to reach a decision. To get a judicial review in federal district court, the case amount must meet a minimum dollar amount ($1,560 in 2017).

Each state has its own Medicaid appeals process. Contact your state’s Medicaid office to find out how to appeal a Medicaid audit finding.

[email protected]

On Twitter @legal_med

CHICAGO – The question is not if a physician will face a Medicare or Medicaid billing audit, but when, according to Abby Pendleton, a New York–based health law attorney. That’s why it pays to know how to handle an audit before one probe disrupts your practice. At a recent American Bar Association meeting, Ms. Pendleton and H. Rusty Comley, a Jackson, Mississippi–based health law attorney, offered answers to top audit questions and provided guidance on how physicians can successfully appeal an audit.

When should you appeal?

There are a number of factors to consider when deciding whether to appeal audit findings. For starters, consider the cost of the payback amount and the basis of the findings.

What should you expect from an appeal?

Expect to go through more than one appeals process step to succeed. There are five stages to the appeals process .

“At the redetermination stage, I don’t see a whole lot of movement in terms of great success at that first stage,” Ms. Pendleton said. “So, don’t think, ‘If we get to that first level of appeal, we’re expecting to win.’ If you look at the statistics, it’s not really that realistic.”

Although a provider has 120 days to file an appeal, it’s smarter to file within the first 30 days, Ms. Pendleton advised. If an appeal is filed within 30 days, the government cannot recoup it’s demand from a doctor’s current Medicare payments.

Expect a lengthy time frame for a final outcome. Under federal law, once an appeal gets to the administrative law judge (ALJ) stage (the third stage), the appellant should receive a hearing decision within 90 days. However, because of heavy case backlogs, physicians typically don’t get a hearing for 3 years, Ms. Pendleton said.

“The problem is, your MAC [Medicare administrative contractor] can start taking your money after the [second] stage,” she said. “If it’s a huge dollar amount, you’re probably going to have to enter into a payment plan [with the government]. You will eventually get your money back, if you win, three to four years later.”

Note that physicians generally experience a higher degree of success at the ALJ stage, so it may be worth continuing the appeal through this stage, she noted.

Overall, more than one-third of audit findings are reversed in providers’ favor during the appeals process. Of 170,482 Medicare appeal decisions in 2015, 37% were made in favor of the health provider, an increase from 23% in 2014, according to 2015 Medicare data and 2014 reports.

The cost to appeal varies significantly between Medicaid and Medicare and depends largely on the complexity of the audit, Mr. Comley said. A Medicaid audit appeal, through an ALJ hearing and written appeal to a court, may cost between $20,000 to $60,000 depending on the circumstances, he said. By contrast, a Medicare appeal resolved in the first stage of appeal may only cost a few thousand dollars for a relatively simple audit.

“Of course, the costs will rise at each level of the Medicare appeal process, especially in the third stage involving the ALJ telephonic hearing, but, in most cases, the Medicare appeal costs will still be below a similar Medicaid appeal,” he said.
 

What strategies can help you win?

Consider reaching out to your congressional representative or senators, Mr. Comley advised. Particularly if the issue involves a medical treatment decision or a medically necessary determination, it may be helpful to copy “your favorite Congressman or senator’s office” on correspondence with the MAC. Clearly state your argument against the findings and how/why the medical decision was made. Legislators will often get involved and could help your appeal, Mr. Comley said.

Further, don’t just review the claims that auditors denied. Also evaluate the claims they have approved in the past, he added.

“In almost every case I’ve been involved in, they’ll approve claims that, on the other hand, they deny,” Mr. Comley said. “Under most legal standards, that’s a good way to win – it’s called arbitrary and capricious.”

Find the best experts to back your case, Ms. Pendleton advised. Consider including expert opinions in written responses to the government that support the services provided and/or have medical experts ready to testify during hearings. If the government based its findings on statistics or cited statistics in its review, involve a statistical expert who can argue against the government’s conclusion.

If the case is significant enough, consider skipping steps in the appeals process to get the case before a federal court sooner. Appellants can escalate their appeal through the process at nearly every stage if the government fails to respond within a timely manner. At the second stage, for example, if the qualified independent contractor does not issue a decision within 60 days, an appellant generally has the right to escalate the case to an administrative law judge. If the ALJ does not issue a decision within 90 days, the appeal can generally be escalated to the Appeals Council level, and, if the council does not issue a decision within 90 days, appellants can seek judicial review.

It may be worth it to have your day in court sooner, Ms. Pendleton said.

“It might be an option for providers if you have a large audit with a lot at stake,” she said. “Escalate it through. Get it to federal court and argue it.”

The 5 steps of the Medicare appeals process

There are five stages of the Medicare audit appeals process, according to the Centers for Medicare & Medicaid Services. They include:

1. Redetermination by the Fiscal Intermediary. A redetermination is an examination of a claim by a Medicare administrative contractor (MAC) separate from the personnel who made the initial claim determination. The appellant has 120 days from the date of initial claim determination receipt to file an appeal.

2. Reconsideration by a Qualified Independent Contractor (QIC). A QIC is an independent contractor who didn’t take part in the level 1 decision. The QIC will review the request for a reconsideration and make a decision. An appellant must file a request for reconsideration within 180 days of Medicare redetermination notice or remittance advice receipt.

3. Administrative Law Judge (ALJ) hearing. Appellants present their case to an ALJ who will review the facts of the appeal and listen to testimony before making a decision. An ALJ hearing is usually held by phone or video conference. Appellants can ask the ALJ to make a decision without a hearing. The ALJ may also issue a decision without holding a hearing if evidence in the record supports a decision that’s fully in the appellant’s favor.

4. Medicare Appeals Council review. If you disagree with the ALJ decision or wish to escalate the appeal because the ALJ ruling time frame has passed, a request for a Medicare Appeals Council review can be made. A request for a Medicare Appeals Council review must be made within 60 days of receipt of the ALJ’s decision or after the ALJ ruling time frame expires.

5. Judicial review in U.S. District Court. A party may file an action in federal district court within 60 calendar days after the date receiving notice of the Medicare Appeals Council’s decision or after a council notice that it is not able to reach a decision. To get a judicial review in federal district court, the case amount must meet a minimum dollar amount ($1,560 in 2017).

Each state has its own Medicaid appeals process. Contact your state’s Medicaid office to find out how to appeal a Medicaid audit finding.

[email protected]

On Twitter @legal_med

Paris – Fractional flow reserve is under study for a potential major application: guidance on percutaneous coronary intervention (PCI) optimization immediately after stent placement, Roberto Diletti, MD, said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/Frontline Medical News

[email protected]

Paris – Fractional flow reserve is under study for a potential major application: guidance on percutaneous coronary intervention (PCI) optimization immediately after stent placement, Roberto Diletti, MD, said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/Frontline Medical News

[email protected]

Paris – Fractional flow reserve is under study for a potential major application: guidance on percutaneous coronary intervention (PCI) optimization immediately after stent placement, Roberto Diletti, MD, said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/Frontline Medical News

[email protected]

Senate Republicans’ first attempt to repeal and replace the Affordable Care Act failed July 25 as nine Republican senators crossed the aisle to vote against a measure that had no chance of passing.

The process started with a dramatic appearance by Sen. John McCain (R-Ariz.), recovering from surgery to diagnose glioblastoma, who returned to Washington to cast a key vote that would allow debate to move forward. The Senate split 50-50 on that vote, with Sen. Susan Collins (R-Maine) and Sen. Lisa Murkowski (R-Alaska) crossing the aisle to vote with all the chamber’s Democrats against the motion to proceed. Vice President Mike Pence cast the tie-breaking vote in favor of beginning debate.

designer491/Thinkstock

[email protected]

Senate Republicans’ first attempt to repeal and replace the Affordable Care Act failed July 25 as nine Republican senators crossed the aisle to vote against a measure that had no chance of passing.

The process started with a dramatic appearance by Sen. John McCain (R-Ariz.), recovering from surgery to diagnose glioblastoma, who returned to Washington to cast a key vote that would allow debate to move forward. The Senate split 50-50 on that vote, with Sen. Susan Collins (R-Maine) and Sen. Lisa Murkowski (R-Alaska) crossing the aisle to vote with all the chamber’s Democrats against the motion to proceed. Vice President Mike Pence cast the tie-breaking vote in favor of beginning debate.

designer491/Thinkstock

[email protected]

Senate Republicans’ first attempt to repeal and replace the Affordable Care Act failed July 25 as nine Republican senators crossed the aisle to vote against a measure that had no chance of passing.

The process started with a dramatic appearance by Sen. John McCain (R-Ariz.), recovering from surgery to diagnose glioblastoma, who returned to Washington to cast a key vote that would allow debate to move forward. The Senate split 50-50 on that vote, with Sen. Susan Collins (R-Maine) and Sen. Lisa Murkowski (R-Alaska) crossing the aisle to vote with all the chamber’s Democrats against the motion to proceed. Vice President Mike Pence cast the tie-breaking vote in favor of beginning debate.

designer491/Thinkstock

[email protected]

For the first time, endoscopists have used focal cryoballoon ablation to eradicate early esophageal squamous cell neoplasias, including high-grade lesions in treatment-experienced patients.

A single session of treatment with the novel, portable nitrous oxide system (C2 Therapeutics, Redwood City, Calif.) produced complete pathologic and endoscopic responses at 3 months in 8 of 10 patients, reported Marcia Irene Canto, MD, of Johns Hopkins University in Baltimore, with her associates. Two to five sessions produced complete responses in the other two patients, and all patients were disease-free at their last visit (median follow-up, 10.7 months; interquartile range, 4-14 months). The study was published online July 15 in Gastrointestinal Endoscopy (2017. doi: 10.1016/j.gie.2017.07.013).

©Nephron/Wikimedia Commons/CC BY-SA 3.0/No changes

For the first time, endoscopists have used focal cryoballoon ablation to eradicate early esophageal squamous cell neoplasias, including high-grade lesions in treatment-experienced patients.

A single session of treatment with the novel, portable nitrous oxide system (C2 Therapeutics, Redwood City, Calif.) produced complete pathologic and endoscopic responses at 3 months in 8 of 10 patients, reported Marcia Irene Canto, MD, of Johns Hopkins University in Baltimore, with her associates. Two to five sessions produced complete responses in the other two patients, and all patients were disease-free at their last visit (median follow-up, 10.7 months; interquartile range, 4-14 months). The study was published online July 15 in Gastrointestinal Endoscopy (2017. doi: 10.1016/j.gie.2017.07.013).

©Nephron/Wikimedia Commons/CC BY-SA 3.0/No changes

For the first time, endoscopists have used focal cryoballoon ablation to eradicate early esophageal squamous cell neoplasias, including high-grade lesions in treatment-experienced patients.

A single session of treatment with the novel, portable nitrous oxide system (C2 Therapeutics, Redwood City, Calif.) produced complete pathologic and endoscopic responses at 3 months in 8 of 10 patients, reported Marcia Irene Canto, MD, of Johns Hopkins University in Baltimore, with her associates. Two to five sessions produced complete responses in the other two patients, and all patients were disease-free at their last visit (median follow-up, 10.7 months; interquartile range, 4-14 months). The study was published online July 15 in Gastrointestinal Endoscopy (2017. doi: 10.1016/j.gie.2017.07.013).

©Nephron/Wikimedia Commons/CC BY-SA 3.0/No changes

A genetic predisposition to higher serum calcium levels was significantly linked with coronary artery disease and myocardial infarction in a large mendelian randomization study published online July 25 in JAMA.

Each 0.5-mg rise in genetically predicted serum calcium concentration increased the odds of coronary artery disease (CAD) and myocardial infarction by about 25%, reported Susanna C. Larsson, Ph.D., of Karolinska Institutet in Stockholm, Sweden, and her associates. It remains unclear whether short- or medium-term calcium supplementation also increases the risk of these outcomes, they added.

Observational studies have linked high serum calcium with cardiovascular disease, but such studies are subject to confounding, the researchers noted. Randomized trials indicate that calcium supplementation might contribute to MI, but the trials are not designed to quantify long-term risks. Therefore, the investigators evaluated a proxy for lifelong hypercalcemia – six single nucleotide polymorphisms (SNPs) that have been linked to high serum calcium, but not to other CAD risk factors such as type 2 diabetes, fasting glucose and insulin levels, body mass index, waist-to-hip ratio, major lipids, or hypertension (JAMA. 2017 Jul 25;318[4]:371-80. doi: 10.1001/jama.2017.8981).

To examine how these SNPs affect the risk of CAD and MI, the researchers analyzed summary statistics for 184,305 individuals from a meta-analysis of CAD genome-wide association studies (Nat Genet. 2015;47:1121-30), including 60,801 cases (of whom about 70% also had MI) and 123,504 controls.

Together, these six SNPs explained about 0.8% of variations in serum calcium levels. Each 0.5-mg/dL (about one standard deviation) increase in genetically predicted serum calcium level significantly increased the risk of CAD (odds ratio, 1.25; 95% confidence interval, 1.08-1.45; P = .003) and MI (OR, 1.24; 95% CI, 1.05-1.46; P = .009). The genetic variant rs1801725 exerted the greatest effect on serum calcium levels, the investigators noted. This SNP affects the CASR gene, which encodes a calcium-sensing receptor that “plays a key role in calcium homeostasis.” However, four of the other five variants also had odds ratios above 1.0, and three had odds ratios above 1.25. A sensitivity analysis that excluded the CASR variant generated an identical odds ratio, although the confidence interval was wider. Studies of other risk factors for CAD have yielded odds ratios between 1.3 (triglyceride levels) and 1.7 (LDL cholesterol levels), the researchers noted.

A link between calcium supplementation and MI remains debatable. However, supplementation can lead to hypercalcemia and greater formation of insoluble calciprotein particles, the investigators said. Coronary artery disease might result from downstream effects on vascular calcification, vascular cells, blood coagulation pathways, or gene expression, but such mechanisms need more study, they added.

This analysis included men and women from the United States, Canada, the United Kingdom, Germany, Sweden, Ireland, the Netherlands, Finland, Iceland, Italy, Estonia, Lebanon, China, Korea, India, Pakistan and Greece. Participants tended to be men in their 50s and 60s, but more than half of studies lacked data on age and sex. Nearly all participants were of white European ancestry.

Karolinska Institutet supported Dr. Larsson. The investigators reported having no relevant conflicts of interest.

[email protected]

A genetic predisposition to higher serum calcium levels was significantly linked with coronary artery disease and myocardial infarction in a large mendelian randomization study published online July 25 in JAMA.

Each 0.5-mg rise in genetically predicted serum calcium concentration increased the odds of coronary artery disease (CAD) and myocardial infarction by about 25%, reported Susanna C. Larsson, Ph.D., of Karolinska Institutet in Stockholm, Sweden, and her associates. It remains unclear whether short- or medium-term calcium supplementation also increases the risk of these outcomes, they added.

Observational studies have linked high serum calcium with cardiovascular disease, but such studies are subject to confounding, the researchers noted. Randomized trials indicate that calcium supplementation might contribute to MI, but the trials are not designed to quantify long-term risks. Therefore, the investigators evaluated a proxy for lifelong hypercalcemia – six single nucleotide polymorphisms (SNPs) that have been linked to high serum calcium, but not to other CAD risk factors such as type 2 diabetes, fasting glucose and insulin levels, body mass index, waist-to-hip ratio, major lipids, or hypertension (JAMA. 2017 Jul 25;318[4]:371-80. doi: 10.1001/jama.2017.8981).

To examine how these SNPs affect the risk of CAD and MI, the researchers analyzed summary statistics for 184,305 individuals from a meta-analysis of CAD genome-wide association studies (Nat Genet. 2015;47:1121-30), including 60,801 cases (of whom about 70% also had MI) and 123,504 controls.

Together, these six SNPs explained about 0.8% of variations in serum calcium levels. Each 0.5-mg/dL (about one standard deviation) increase in genetically predicted serum calcium level significantly increased the risk of CAD (odds ratio, 1.25; 95% confidence interval, 1.08-1.45; P = .003) and MI (OR, 1.24; 95% CI, 1.05-1.46; P = .009). The genetic variant rs1801725 exerted the greatest effect on serum calcium levels, the investigators noted. This SNP affects the CASR gene, which encodes a calcium-sensing receptor that “plays a key role in calcium homeostasis.” However, four of the other five variants also had odds ratios above 1.0, and three had odds ratios above 1.25. A sensitivity analysis that excluded the CASR variant generated an identical odds ratio, although the confidence interval was wider. Studies of other risk factors for CAD have yielded odds ratios between 1.3 (triglyceride levels) and 1.7 (LDL cholesterol levels), the researchers noted.

A link between calcium supplementation and MI remains debatable. However, supplementation can lead to hypercalcemia and greater formation of insoluble calciprotein particles, the investigators said. Coronary artery disease might result from downstream effects on vascular calcification, vascular cells, blood coagulation pathways, or gene expression, but such mechanisms need more study, they added.

This analysis included men and women from the United States, Canada, the United Kingdom, Germany, Sweden, Ireland, the Netherlands, Finland, Iceland, Italy, Estonia, Lebanon, China, Korea, India, Pakistan and Greece. Participants tended to be men in their 50s and 60s, but more than half of studies lacked data on age and sex. Nearly all participants were of white European ancestry.

Karolinska Institutet supported Dr. Larsson. The investigators reported having no relevant conflicts of interest.

[email protected]

A genetic predisposition to higher serum calcium levels was significantly linked with coronary artery disease and myocardial infarction in a large mendelian randomization study published online July 25 in JAMA.

Each 0.5-mg rise in genetically predicted serum calcium concentration increased the odds of coronary artery disease (CAD) and myocardial infarction by about 25%, reported Susanna C. Larsson, Ph.D., of Karolinska Institutet in Stockholm, Sweden, and her associates. It remains unclear whether short- or medium-term calcium supplementation also increases the risk of these outcomes, they added.

Observational studies have linked high serum calcium with cardiovascular disease, but such studies are subject to confounding, the researchers noted. Randomized trials indicate that calcium supplementation might contribute to MI, but the trials are not designed to quantify long-term risks. Therefore, the investigators evaluated a proxy for lifelong hypercalcemia – six single nucleotide polymorphisms (SNPs) that have been linked to high serum calcium, but not to other CAD risk factors such as type 2 diabetes, fasting glucose and insulin levels, body mass index, waist-to-hip ratio, major lipids, or hypertension (JAMA. 2017 Jul 25;318[4]:371-80. doi: 10.1001/jama.2017.8981).

To examine how these SNPs affect the risk of CAD and MI, the researchers analyzed summary statistics for 184,305 individuals from a meta-analysis of CAD genome-wide association studies (Nat Genet. 2015;47:1121-30), including 60,801 cases (of whom about 70% also had MI) and 123,504 controls.

Together, these six SNPs explained about 0.8% of variations in serum calcium levels. Each 0.5-mg/dL (about one standard deviation) increase in genetically predicted serum calcium level significantly increased the risk of CAD (odds ratio, 1.25; 95% confidence interval, 1.08-1.45; P = .003) and MI (OR, 1.24; 95% CI, 1.05-1.46; P = .009). The genetic variant rs1801725 exerted the greatest effect on serum calcium levels, the investigators noted. This SNP affects the CASR gene, which encodes a calcium-sensing receptor that “plays a key role in calcium homeostasis.” However, four of the other five variants also had odds ratios above 1.0, and three had odds ratios above 1.25. A sensitivity analysis that excluded the CASR variant generated an identical odds ratio, although the confidence interval was wider. Studies of other risk factors for CAD have yielded odds ratios between 1.3 (triglyceride levels) and 1.7 (LDL cholesterol levels), the researchers noted.

A link between calcium supplementation and MI remains debatable. However, supplementation can lead to hypercalcemia and greater formation of insoluble calciprotein particles, the investigators said. Coronary artery disease might result from downstream effects on vascular calcification, vascular cells, blood coagulation pathways, or gene expression, but such mechanisms need more study, they added.

This analysis included men and women from the United States, Canada, the United Kingdom, Germany, Sweden, Ireland, the Netherlands, Finland, Iceland, Italy, Estonia, Lebanon, China, Korea, India, Pakistan and Greece. Participants tended to be men in their 50s and 60s, but more than half of studies lacked data on age and sex. Nearly all participants were of white European ancestry.

Karolinska Institutet supported Dr. Larsson. The investigators reported having no relevant conflicts of interest.

[email protected]

The official rules keeper in the Senate tossed a bucket of cold water July 21 on the Senate Republican health bill by advising that major parts of the bill cannot be passed with a simple majority, but rather would require 60 votes. Republicans hold only 52 seats in the Senate.

Senate Parliamentarian Elizabeth MacDonough said that a super-majority is needed for the temporary defunding of Planned Parenthood, abortion coverage restrictions to health plans purchased with tax credits, and the requirement that people with breaks in coverage wait 6 months before they can purchase new plans.

Alicia Ault/Frontline Medical News

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

The official rules keeper in the Senate tossed a bucket of cold water July 21 on the Senate Republican health bill by advising that major parts of the bill cannot be passed with a simple majority, but rather would require 60 votes. Republicans hold only 52 seats in the Senate.

Senate Parliamentarian Elizabeth MacDonough said that a super-majority is needed for the temporary defunding of Planned Parenthood, abortion coverage restrictions to health plans purchased with tax credits, and the requirement that people with breaks in coverage wait 6 months before they can purchase new plans.

Alicia Ault/Frontline Medical News

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

The official rules keeper in the Senate tossed a bucket of cold water July 21 on the Senate Republican health bill by advising that major parts of the bill cannot be passed with a simple majority, but rather would require 60 votes. Republicans hold only 52 seats in the Senate.

Senate Parliamentarian Elizabeth MacDonough said that a super-majority is needed for the temporary defunding of Planned Parenthood, abortion coverage restrictions to health plans purchased with tax credits, and the requirement that people with breaks in coverage wait 6 months before they can purchase new plans.

Alicia Ault/Frontline Medical News

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

President Donald Trump has vowed to “let Obamacare fail,” after legislative efforts to undo the Affordable Care Act have stalled.

He and congressional Republicans have repeatedly portrayed the Affordable Care Act insurance marketplaces, also known as exchanges, as being in a “death spiral.” But independent analyses have concluded that such spontaneous disintegration isn’t happening.

In a number of ways, the Trump administration’s policies are pushing Obamacare into the vortex.

Reports from Standard & Poor’s, the Congressional Budget Office and the Kaiser Family Foundation all suggest that the exchanges – where people can shop for coverage, often with the help of a government subsidy – are stabilizing. (Kaiser Health News is an editorially independent program of the foundation.)

Gage Skidmore/Wikimedia Commons/CC BY-SA 2.0

‘Cost-sharing reductions’

Under the ACA, when someone’s income falls between 100% and 250% of the federal poverty level – up to about $29,000 for an individual or around $61,000 for a family of four – marketplace carriers must offer a plan with “cost-sharing reductions” (CSRs) that reduce consumers’ out-of-pocket expenses.

Reducing cost-sharing – generally copayments and deductibles – makes plans more expensive for the insurers. The Obama administration used its rule-making power to set up direct payments to carriers to help offset this burden. The Trump White House has inherited that responsibility but also has the power to end the payment program.

The nonpartisan Congressional Budget Office estimated CSR subsidies in 2017 would total about $7 billion. Without that money, analysts say, more insurers might choose to exit, limiting options for consumers, and letting the insurers who remain charge higher prices.

Trump has been committedly noncommittal, publicly indicating he would like to halt the subsidies, but so far – on a month-to-month basis – letting them continue.

The uncertainty makes insurance companies skittish about participating, analysts noted. It’s also one reason some plans say they have had to increase their rates, noted Charles Gaba, a Michigan-based blogger who tracks ACA sign-ups. For instance: When filing plans for the 2018 marketplace, carriers on average raised premiums by about 34% – with about 20 points stemming from CSR uncertainty, Mr. Gaba said, based on an analysis of 21 states’ initial rate filings. Dropping the subsidies altogether would be even more damaging.

Weaken the mandate

The White House has already signaled it does not want to enforce the individual mandate – the health law’s requirement that all people have coverage. And administration officials have repeated that position.

Meanwhile, in January, it issued an executive order that encouraged U.S. agencies to grant exemptions and waive or defer health law provisions that could put financial strain on companies or individuals – which could also be applied to the individual mandate.

For 2016 tax returns, though, the Internal Revenue Service continued to impose a financial penalty on people who didn’t have health insurance and who didn’t qualify for an exemption.

But enforcement may be waning. This year, the IRS was supposed to reject tax returns if people didn’t indicate whether they had coverage, flagging them for a potential penalty. Instead, it continued processing them, citing Trump’s executive order.

If the IRS has already processed any tax refunds for consumers, then they “don’t have much leverage” when attempting to collect the mandate fee, said Timothy Jost, emeritus law professor at Washington and Lee University in Virginia and an expert on health reform.

Enforcement of the mandate, economists note, is crucial to ensuring that enough healthy people buy coverage to balance the costs of sicker beneficiaries.

But even with the mandate in effect, the efforts to defang it bring confusion.

“A lot of people believe the Trump administration is not enforcing it,” Mr. Jost said.

As a result, healthy people may become less likely to buy insurance, even as sick ones continue seeking it. That means higher prices, and a shakier pool.

“If they don’t think they’re going to get healthy people in the risk pool, they’re going to increase their rates further to protect themselves,” Mr. Jost said. “And as they raise their rates further to protect themselves, people … start to drop out.”

Thus, the president’s position on the mandate is leaving insurance carriers and commissioners “apprehensive,” noted Mike Kreidler, Washington state’s insurance commissioner.

A bare market

Skittishness on the part of insurers could lead them to drop out of some marketplaces, leaving consumers in some areas with few or no choices. Those “bare markets” are possible under even stable circumstances – and preventing them requires active federal involvement.

Under the Obama administration, high-level officials were “on the phone daily with insurance company executives … trying to get them to participate,” Ms. Corlette said. “It was very much an all-hands-on-deck, ‘we’re going to make it work for you guys’ kind of communication.”

And so far Trump’s Department of Health and Human Services doesn’t appear to be emphasizing this kind of essential outreach, both Ms. Corlette and Mr. Jost suggested. A few months ago, Mr. Kreidler agreed, HHS staffers appeared interested in helping states fill their bare counties – but that support has since dwindled.

“This may be sort of under the radar, but it can have real, lasting effects” for consumer choice, Ms. Corlette said.

All quiet on the enrollment front

The administration could further undermine the marketplace by dropping outreach to consumers. It’s already a shorter enrollment period this year – spanning 6 weeks instead of 3 months, from Nov. 1 to Dec. 15 – though that change was already slated to eventually take effect.

That shorter period means people may miss the memo on signing up – or at least need an extra push, Ms. Corlette said. And that’s another way the administration could undermine the marketplaces: simply choosing not to advertise them.

Last sign-up season, HHS stopped open enrollment advertising in January, pulling ads a few days before the period ended. Enrollment dropped compared with previous years, Mr. Jost and Mr. Gaba noted, with young, healthy people being more likely not to buy coverage.

The administration also just stopped funding federal contractors that supported efforts by community groups and other organizations in some of the nation’s largest cities to sign up people.

Dropping advertising, shortening open enrollment, or simply scaling back on technical maintenance for the marketplace website could all have significant impact, Ms. Corlette said. People who are sick and need insurance will likely seek it out, but those who are healthier – for whom health insurance is a less pressing priority – could miss the boat.

Again, Mr. Jost said, that affects insurer participation.

“Insurance is a product that needs to be sold,” he said. “If the insurers believe they’re not going to get any help at all in marketing their product,” he added, fewer will want to enter the marketplace.

Word of (bad) mouth

HHS has taken an active role in criticizing the health law – pushing press releases and videos that argue it has helped more than hurt. That strategy could do a lot of harm, experts said.

If consumers keep hearing the law is failing, Mr. Jost noted, some will ultimately believe it, buying coverage only if they need it and thereby skewing the insurance risk pool.

Perceived hostility also has an effect on insurers, steering them away from marketplace participation.

“When you undermine confidence in the marketplace, you don’t need a Ph.D. in economics to know it’s not good long term,” Ms. Corlette said.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

President Donald Trump has vowed to “let Obamacare fail,” after legislative efforts to undo the Affordable Care Act have stalled.

He and congressional Republicans have repeatedly portrayed the Affordable Care Act insurance marketplaces, also known as exchanges, as being in a “death spiral.” But independent analyses have concluded that such spontaneous disintegration isn’t happening.

In a number of ways, the Trump administration’s policies are pushing Obamacare into the vortex.

Reports from Standard & Poor’s, the Congressional Budget Office and the Kaiser Family Foundation all suggest that the exchanges – where people can shop for coverage, often with the help of a government subsidy – are stabilizing. (Kaiser Health News is an editorially independent program of the foundation.)

Gage Skidmore/Wikimedia Commons/CC BY-SA 2.0

‘Cost-sharing reductions’

Under the ACA, when someone’s income falls between 100% and 250% of the federal poverty level – up to about $29,000 for an individual or around $61,000 for a family of four – marketplace carriers must offer a plan with “cost-sharing reductions” (CSRs) that reduce consumers’ out-of-pocket expenses.

Reducing cost-sharing – generally copayments and deductibles – makes plans more expensive for the insurers. The Obama administration used its rule-making power to set up direct payments to carriers to help offset this burden. The Trump White House has inherited that responsibility but also has the power to end the payment program.

The nonpartisan Congressional Budget Office estimated CSR subsidies in 2017 would total about $7 billion. Without that money, analysts say, more insurers might choose to exit, limiting options for consumers, and letting the insurers who remain charge higher prices.

Trump has been committedly noncommittal, publicly indicating he would like to halt the subsidies, but so far – on a month-to-month basis – letting them continue.

The uncertainty makes insurance companies skittish about participating, analysts noted. It’s also one reason some plans say they have had to increase their rates, noted Charles Gaba, a Michigan-based blogger who tracks ACA sign-ups. For instance: When filing plans for the 2018 marketplace, carriers on average raised premiums by about 34% – with about 20 points stemming from CSR uncertainty, Mr. Gaba said, based on an analysis of 21 states’ initial rate filings. Dropping the subsidies altogether would be even more damaging.

Weaken the mandate

The White House has already signaled it does not want to enforce the individual mandate – the health law’s requirement that all people have coverage. And administration officials have repeated that position.

Meanwhile, in January, it issued an executive order that encouraged U.S. agencies to grant exemptions and waive or defer health law provisions that could put financial strain on companies or individuals – which could also be applied to the individual mandate.

For 2016 tax returns, though, the Internal Revenue Service continued to impose a financial penalty on people who didn’t have health insurance and who didn’t qualify for an exemption.

But enforcement may be waning. This year, the IRS was supposed to reject tax returns if people didn’t indicate whether they had coverage, flagging them for a potential penalty. Instead, it continued processing them, citing Trump’s executive order.

If the IRS has already processed any tax refunds for consumers, then they “don’t have much leverage” when attempting to collect the mandate fee, said Timothy Jost, emeritus law professor at Washington and Lee University in Virginia and an expert on health reform.

Enforcement of the mandate, economists note, is crucial to ensuring that enough healthy people buy coverage to balance the costs of sicker beneficiaries.

But even with the mandate in effect, the efforts to defang it bring confusion.

“A lot of people believe the Trump administration is not enforcing it,” Mr. Jost said.

As a result, healthy people may become less likely to buy insurance, even as sick ones continue seeking it. That means higher prices, and a shakier pool.

“If they don’t think they’re going to get healthy people in the risk pool, they’re going to increase their rates further to protect themselves,” Mr. Jost said. “And as they raise their rates further to protect themselves, people … start to drop out.”

Thus, the president’s position on the mandate is leaving insurance carriers and commissioners “apprehensive,” noted Mike Kreidler, Washington state’s insurance commissioner.

A bare market

Skittishness on the part of insurers could lead them to drop out of some marketplaces, leaving consumers in some areas with few or no choices. Those “bare markets” are possible under even stable circumstances – and preventing them requires active federal involvement.

Under the Obama administration, high-level officials were “on the phone daily with insurance company executives … trying to get them to participate,” Ms. Corlette said. “It was very much an all-hands-on-deck, ‘we’re going to make it work for you guys’ kind of communication.”

And so far Trump’s Department of Health and Human Services doesn’t appear to be emphasizing this kind of essential outreach, both Ms. Corlette and Mr. Jost suggested. A few months ago, Mr. Kreidler agreed, HHS staffers appeared interested in helping states fill their bare counties – but that support has since dwindled.

“This may be sort of under the radar, but it can have real, lasting effects” for consumer choice, Ms. Corlette said.

All quiet on the enrollment front

The administration could further undermine the marketplace by dropping outreach to consumers. It’s already a shorter enrollment period this year – spanning 6 weeks instead of 3 months, from Nov. 1 to Dec. 15 – though that change was already slated to eventually take effect.

That shorter period means people may miss the memo on signing up – or at least need an extra push, Ms. Corlette said. And that’s another way the administration could undermine the marketplaces: simply choosing not to advertise them.

Last sign-up season, HHS stopped open enrollment advertising in January, pulling ads a few days before the period ended. Enrollment dropped compared with previous years, Mr. Jost and Mr. Gaba noted, with young, healthy people being more likely not to buy coverage.

The administration also just stopped funding federal contractors that supported efforts by community groups and other organizations in some of the nation’s largest cities to sign up people.

Dropping advertising, shortening open enrollment, or simply scaling back on technical maintenance for the marketplace website could all have significant impact, Ms. Corlette said. People who are sick and need insurance will likely seek it out, but those who are healthier – for whom health insurance is a less pressing priority – could miss the boat.

Again, Mr. Jost said, that affects insurer participation.

“Insurance is a product that needs to be sold,” he said. “If the insurers believe they’re not going to get any help at all in marketing their product,” he added, fewer will want to enter the marketplace.

Word of (bad) mouth

HHS has taken an active role in criticizing the health law – pushing press releases and videos that argue it has helped more than hurt. That strategy could do a lot of harm, experts said.

If consumers keep hearing the law is failing, Mr. Jost noted, some will ultimately believe it, buying coverage only if they need it and thereby skewing the insurance risk pool.

Perceived hostility also has an effect on insurers, steering them away from marketplace participation.

“When you undermine confidence in the marketplace, you don’t need a Ph.D. in economics to know it’s not good long term,” Ms. Corlette said.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

President Donald Trump has vowed to “let Obamacare fail,” after legislative efforts to undo the Affordable Care Act have stalled.

He and congressional Republicans have repeatedly portrayed the Affordable Care Act insurance marketplaces, also known as exchanges, as being in a “death spiral.” But independent analyses have concluded that such spontaneous disintegration isn’t happening.

In a number of ways, the Trump administration’s policies are pushing Obamacare into the vortex.

Reports from Standard & Poor’s, the Congressional Budget Office and the Kaiser Family Foundation all suggest that the exchanges – where people can shop for coverage, often with the help of a government subsidy – are stabilizing. (Kaiser Health News is an editorially independent program of the foundation.)

Gage Skidmore/Wikimedia Commons/CC BY-SA 2.0

‘Cost-sharing reductions’

Under the ACA, when someone’s income falls between 100% and 250% of the federal poverty level – up to about $29,000 for an individual or around $61,000 for a family of four – marketplace carriers must offer a plan with “cost-sharing reductions” (CSRs) that reduce consumers’ out-of-pocket expenses.

Reducing cost-sharing – generally copayments and deductibles – makes plans more expensive for the insurers. The Obama administration used its rule-making power to set up direct payments to carriers to help offset this burden. The Trump White House has inherited that responsibility but also has the power to end the payment program.

The nonpartisan Congressional Budget Office estimated CSR subsidies in 2017 would total about $7 billion. Without that money, analysts say, more insurers might choose to exit, limiting options for consumers, and letting the insurers who remain charge higher prices.

Trump has been committedly noncommittal, publicly indicating he would like to halt the subsidies, but so far – on a month-to-month basis – letting them continue.

The uncertainty makes insurance companies skittish about participating, analysts noted. It’s also one reason some plans say they have had to increase their rates, noted Charles Gaba, a Michigan-based blogger who tracks ACA sign-ups. For instance: When filing plans for the 2018 marketplace, carriers on average raised premiums by about 34% – with about 20 points stemming from CSR uncertainty, Mr. Gaba said, based on an analysis of 21 states’ initial rate filings. Dropping the subsidies altogether would be even more damaging.

Weaken the mandate

The White House has already signaled it does not want to enforce the individual mandate – the health law’s requirement that all people have coverage. And administration officials have repeated that position.

Meanwhile, in January, it issued an executive order that encouraged U.S. agencies to grant exemptions and waive or defer health law provisions that could put financial strain on companies or individuals – which could also be applied to the individual mandate.

For 2016 tax returns, though, the Internal Revenue Service continued to impose a financial penalty on people who didn’t have health insurance and who didn’t qualify for an exemption.

But enforcement may be waning. This year, the IRS was supposed to reject tax returns if people didn’t indicate whether they had coverage, flagging them for a potential penalty. Instead, it continued processing them, citing Trump’s executive order.

If the IRS has already processed any tax refunds for consumers, then they “don’t have much leverage” when attempting to collect the mandate fee, said Timothy Jost, emeritus law professor at Washington and Lee University in Virginia and an expert on health reform.

Enforcement of the mandate, economists note, is crucial to ensuring that enough healthy people buy coverage to balance the costs of sicker beneficiaries.

But even with the mandate in effect, the efforts to defang it bring confusion.

“A lot of people believe the Trump administration is not enforcing it,” Mr. Jost said.

As a result, healthy people may become less likely to buy insurance, even as sick ones continue seeking it. That means higher prices, and a shakier pool.

“If they don’t think they’re going to get healthy people in the risk pool, they’re going to increase their rates further to protect themselves,” Mr. Jost said. “And as they raise their rates further to protect themselves, people … start to drop out.”

Thus, the president’s position on the mandate is leaving insurance carriers and commissioners “apprehensive,” noted Mike Kreidler, Washington state’s insurance commissioner.

A bare market

Skittishness on the part of insurers could lead them to drop out of some marketplaces, leaving consumers in some areas with few or no choices. Those “bare markets” are possible under even stable circumstances – and preventing them requires active federal involvement.

Under the Obama administration, high-level officials were “on the phone daily with insurance company executives … trying to get them to participate,” Ms. Corlette said. “It was very much an all-hands-on-deck, ‘we’re going to make it work for you guys’ kind of communication.”

And so far Trump’s Department of Health and Human Services doesn’t appear to be emphasizing this kind of essential outreach, both Ms. Corlette and Mr. Jost suggested. A few months ago, Mr. Kreidler agreed, HHS staffers appeared interested in helping states fill their bare counties – but that support has since dwindled.

“This may be sort of under the radar, but it can have real, lasting effects” for consumer choice, Ms. Corlette said.

All quiet on the enrollment front

The administration could further undermine the marketplace by dropping outreach to consumers. It’s already a shorter enrollment period this year – spanning 6 weeks instead of 3 months, from Nov. 1 to Dec. 15 – though that change was already slated to eventually take effect.

That shorter period means people may miss the memo on signing up – or at least need an extra push, Ms. Corlette said. And that’s another way the administration could undermine the marketplaces: simply choosing not to advertise them.

Last sign-up season, HHS stopped open enrollment advertising in January, pulling ads a few days before the period ended. Enrollment dropped compared with previous years, Mr. Jost and Mr. Gaba noted, with young, healthy people being more likely not to buy coverage.

The administration also just stopped funding federal contractors that supported efforts by community groups and other organizations in some of the nation’s largest cities to sign up people.

Dropping advertising, shortening open enrollment, or simply scaling back on technical maintenance for the marketplace website could all have significant impact, Ms. Corlette said. People who are sick and need insurance will likely seek it out, but those who are healthier – for whom health insurance is a less pressing priority – could miss the boat.

Again, Mr. Jost said, that affects insurer participation.

“Insurance is a product that needs to be sold,” he said. “If the insurers believe they’re not going to get any help at all in marketing their product,” he added, fewer will want to enter the marketplace.

Word of (bad) mouth

HHS has taken an active role in criticizing the health law – pushing press releases and videos that argue it has helped more than hurt. That strategy could do a lot of harm, experts said.

If consumers keep hearing the law is failing, Mr. Jost noted, some will ultimately believe it, buying coverage only if they need it and thereby skewing the insurance risk pool.

Perceived hostility also has an effect on insurers, steering them away from marketplace participation.

“When you undermine confidence in the marketplace, you don’t need a Ph.D. in economics to know it’s not good long term,” Ms. Corlette said.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Physicians working in large multispecialty groups saw their compensation increase in 2016, albeit at a slower pace than in 2015, according to survey results reported by AMGA.

The 2017 Medical Group Compensation and Productivity Survey shows that the overall weighted average increase in physician compensation for the calendar year 2016 was 2.9%, slightly lower than the 3.1% increase seen in 2015. Doctors in more than three-quarters (77%) of specialties saw increases in 2016.

thinkstockphotos.com

[email protected]

Physicians working in large multispecialty groups saw their compensation increase in 2016, albeit at a slower pace than in 2015, according to survey results reported by AMGA.

The 2017 Medical Group Compensation and Productivity Survey shows that the overall weighted average increase in physician compensation for the calendar year 2016 was 2.9%, slightly lower than the 3.1% increase seen in 2015. Doctors in more than three-quarters (77%) of specialties saw increases in 2016.

thinkstockphotos.com

[email protected]

Physicians working in large multispecialty groups saw their compensation increase in 2016, albeit at a slower pace than in 2015, according to survey results reported by AMGA.

The 2017 Medical Group Compensation and Productivity Survey shows that the overall weighted average increase in physician compensation for the calendar year 2016 was 2.9%, slightly lower than the 3.1% increase seen in 2015. Doctors in more than three-quarters (77%) of specialties saw increases in 2016.

thinkstockphotos.com

[email protected]

Two different approaches to shutting down the function of a human liver protein that inhibits lipoprotein lipase showed preliminary evidence of safely producing favorable lipid changes in healthy volunteers in two separate, phase 1 studies.

These findings, coupled with promising observational data from people who carry loss-of-function mutations in the gene for this protein, angiopoietin-like 3 (ANGPTL3), have raised hopes that interventions that interfere with the function of the ANGPTL3 protein may provide new and effective ways to improve lipid levels and cut the incidence of cardiovascular disease events.

“There is now a growing body of epidemiologic, genetic, and genomewide association studies supporting the hypothesis that lowering levels of ANGPTL3 in plasma by inhibiting hepatic ANGPTL3 synthesis will be beneficial in terms of reducing plasma levels of atherogenic apolipoprotein B and in improving metabolic measures associated with dyslipidemia,” wrote Mark J. Graham and his associates in a recently published article (N Engl J Med. 2017 Jul 20;377[3]:222-32).

The phase 1 study results reported by this group came from 44 healthy adults aged 18-65 years who received varying doses of a commercially developed antisense drug, ANGPTL3-LRX, as either single or serial subcutaneous injections. ANGPTL3-LRX is an oligonucleotide designed to inhibit production of messenger RNA for the ANGPTL3 protein.

Six people received the highest ANGPTL3-LRX dosage administered, 60 mg given as a weekly injection for 6 weeks, and after this regimen they showed an average 50% cut in triglycerides levels, compared with baseline, and an average 33% drop in their low LDL cholesterol levels from baseline. None of the 33 people treated with ANGPTL3-LRX in the trial had a documented serious adverse event, and the only treatment dropout was a patient who was lost to follow-up during the treatment phase, reported Mr. Graham, a researcher at Ionis Pharmaceuticals, the sponsor of the study and the company developing the antisense drug, and his associates.

The second phase 1 study examined a different way to block ANGPTL3 activity, with a human monoclonal antibody to this protein. The study involved 83 healthy adults aged 18-65 years with fasting triglyceride levels of 150-450 mg/dL and fasting LDL cholesterol levels of at least 100 mg/dL. Each participant received a single subcutaneous injection or intravenous dose of the antibody, evinacumab, at varying amounts or placebo. The maximum observed lipid changes seen was a drop in triglycerides of 76% and a fall in LDL cholesterol by 23%. Treatment also produced a maximum drop in HDL cholesterol of 18%. No person left the study because of an adverse event. The most common adverse event was headache, in seven people (11% of evinacumab recipients), reported Frederick E. Dewey, MD, a researcher at Regeneron Pharmaceuticals, the company developing evinacumab, and his associates (N Engl J Med. 2017 Jul 20;377[3]:211-21).

The Regeneron report also included results from population studies they ran. They reported performing genome sequencing on specimens from 58,335 adults enrolled in the DiscovEHR study, and identified 13 distinct loss-of-function variants in the ANGPTL3 genes that occurred individually in a small number of these people.

They then ran analyses of lipid levels and coronary artery disease prevalence rates in people who carry one of these 13 loss-of-function genetic signatures in one of their ANGTPL3 genes. Among 45,226 of the people in DiscovEHR those with a variant had on average a 27% lower triglyceride level, a 9% lower LDL cholesterol level, and a 4% lower HDL cholesterol level than noncarriers, after adjustment for covariates. Analysis of coronary artery disease prevalence showed that, after adjusting for age, sex, and ancestry, carrying a loss-of-function variant was linked with a statistically significant 41% lower prevalence of all coronary artery disease, and a 34% lower prevalence of myocardial infarction that fell short of statistical significance.

A second population study looked at links between loss-of-function variants and coronary artery disease in more than 130,000 Danish people. This showed a nonsignificant 37% lower prevalence of coronary artery disease in people with a variant. Two different types of meta-analyses of the data from both the DiscovEHR and Danish studies showed coronary disease rates reduced by either 31% or 39% in variant carriers depending on which meta-analysis approach the researchers used, both statistically significant reductions.

[email protected]

On Twitter @mitchelzoler

Two different approaches to shutting down the function of a human liver protein that inhibits lipoprotein lipase showed preliminary evidence of safely producing favorable lipid changes in healthy volunteers in two separate, phase 1 studies.

These findings, coupled with promising observational data from people who carry loss-of-function mutations in the gene for this protein, angiopoietin-like 3 (ANGPTL3), have raised hopes that interventions that interfere with the function of the ANGPTL3 protein may provide new and effective ways to improve lipid levels and cut the incidence of cardiovascular disease events.

“There is now a growing body of epidemiologic, genetic, and genomewide association studies supporting the hypothesis that lowering levels of ANGPTL3 in plasma by inhibiting hepatic ANGPTL3 synthesis will be beneficial in terms of reducing plasma levels of atherogenic apolipoprotein B and in improving metabolic measures associated with dyslipidemia,” wrote Mark J. Graham and his associates in a recently published article (N Engl J Med. 2017 Jul 20;377[3]:222-32).

The phase 1 study results reported by this group came from 44 healthy adults aged 18-65 years who received varying doses of a commercially developed antisense drug, ANGPTL3-LRX, as either single or serial subcutaneous injections. ANGPTL3-LRX is an oligonucleotide designed to inhibit production of messenger RNA for the ANGPTL3 protein.

Six people received the highest ANGPTL3-LRX dosage administered, 60 mg given as a weekly injection for 6 weeks, and after this regimen they showed an average 50% cut in triglycerides levels, compared with baseline, and an average 33% drop in their low LDL cholesterol levels from baseline. None of the 33 people treated with ANGPTL3-LRX in the trial had a documented serious adverse event, and the only treatment dropout was a patient who was lost to follow-up during the treatment phase, reported Mr. Graham, a researcher at Ionis Pharmaceuticals, the sponsor of the study and the company developing the antisense drug, and his associates.

The second phase 1 study examined a different way to block ANGPTL3 activity, with a human monoclonal antibody to this protein. The study involved 83 healthy adults aged 18-65 years with fasting triglyceride levels of 150-450 mg/dL and fasting LDL cholesterol levels of at least 100 mg/dL. Each participant received a single subcutaneous injection or intravenous dose of the antibody, evinacumab, at varying amounts or placebo. The maximum observed lipid changes seen was a drop in triglycerides of 76% and a fall in LDL cholesterol by 23%. Treatment also produced a maximum drop in HDL cholesterol of 18%. No person left the study because of an adverse event. The most common adverse event was headache, in seven people (11% of evinacumab recipients), reported Frederick E. Dewey, MD, a researcher at Regeneron Pharmaceuticals, the company developing evinacumab, and his associates (N Engl J Med. 2017 Jul 20;377[3]:211-21).

The Regeneron report also included results from population studies they ran. They reported performing genome sequencing on specimens from 58,335 adults enrolled in the DiscovEHR study, and identified 13 distinct loss-of-function variants in the ANGPTL3 genes that occurred individually in a small number of these people.

They then ran analyses of lipid levels and coronary artery disease prevalence rates in people who carry one of these 13 loss-of-function genetic signatures in one of their ANGTPL3 genes. Among 45,226 of the people in DiscovEHR those with a variant had on average a 27% lower triglyceride level, a 9% lower LDL cholesterol level, and a 4% lower HDL cholesterol level than noncarriers, after adjustment for covariates. Analysis of coronary artery disease prevalence showed that, after adjusting for age, sex, and ancestry, carrying a loss-of-function variant was linked with a statistically significant 41% lower prevalence of all coronary artery disease, and a 34% lower prevalence of myocardial infarction that fell short of statistical significance.

A second population study looked at links between loss-of-function variants and coronary artery disease in more than 130,000 Danish people. This showed a nonsignificant 37% lower prevalence of coronary artery disease in people with a variant. Two different types of meta-analyses of the data from both the DiscovEHR and Danish studies showed coronary disease rates reduced by either 31% or 39% in variant carriers depending on which meta-analysis approach the researchers used, both statistically significant reductions.

[email protected]

On Twitter @mitchelzoler

Two different approaches to shutting down the function of a human liver protein that inhibits lipoprotein lipase showed preliminary evidence of safely producing favorable lipid changes in healthy volunteers in two separate, phase 1 studies.

These findings, coupled with promising observational data from people who carry loss-of-function mutations in the gene for this protein, angiopoietin-like 3 (ANGPTL3), have raised hopes that interventions that interfere with the function of the ANGPTL3 protein may provide new and effective ways to improve lipid levels and cut the incidence of cardiovascular disease events.

“There is now a growing body of epidemiologic, genetic, and genomewide association studies supporting the hypothesis that lowering levels of ANGPTL3 in plasma by inhibiting hepatic ANGPTL3 synthesis will be beneficial in terms of reducing plasma levels of atherogenic apolipoprotein B and in improving metabolic measures associated with dyslipidemia,” wrote Mark J. Graham and his associates in a recently published article (N Engl J Med. 2017 Jul 20;377[3]:222-32).

The phase 1 study results reported by this group came from 44 healthy adults aged 18-65 years who received varying doses of a commercially developed antisense drug, ANGPTL3-LRX, as either single or serial subcutaneous injections. ANGPTL3-LRX is an oligonucleotide designed to inhibit production of messenger RNA for the ANGPTL3 protein.

Six people received the highest ANGPTL3-LRX dosage administered, 60 mg given as a weekly injection for 6 weeks, and after this regimen they showed an average 50% cut in triglycerides levels, compared with baseline, and an average 33% drop in their low LDL cholesterol levels from baseline. None of the 33 people treated with ANGPTL3-LRX in the trial had a documented serious adverse event, and the only treatment dropout was a patient who was lost to follow-up during the treatment phase, reported Mr. Graham, a researcher at Ionis Pharmaceuticals, the sponsor of the study and the company developing the antisense drug, and his associates.

The second phase 1 study examined a different way to block ANGPTL3 activity, with a human monoclonal antibody to this protein. The study involved 83 healthy adults aged 18-65 years with fasting triglyceride levels of 150-450 mg/dL and fasting LDL cholesterol levels of at least 100 mg/dL. Each participant received a single subcutaneous injection or intravenous dose of the antibody, evinacumab, at varying amounts or placebo. The maximum observed lipid changes seen was a drop in triglycerides of 76% and a fall in LDL cholesterol by 23%. Treatment also produced a maximum drop in HDL cholesterol of 18%. No person left the study because of an adverse event. The most common adverse event was headache, in seven people (11% of evinacumab recipients), reported Frederick E. Dewey, MD, a researcher at Regeneron Pharmaceuticals, the company developing evinacumab, and his associates (N Engl J Med. 2017 Jul 20;377[3]:211-21).

The Regeneron report also included results from population studies they ran. They reported performing genome sequencing on specimens from 58,335 adults enrolled in the DiscovEHR study, and identified 13 distinct loss-of-function variants in the ANGPTL3 genes that occurred individually in a small number of these people.

They then ran analyses of lipid levels and coronary artery disease prevalence rates in people who carry one of these 13 loss-of-function genetic signatures in one of their ANGTPL3 genes. Among 45,226 of the people in DiscovEHR those with a variant had on average a 27% lower triglyceride level, a 9% lower LDL cholesterol level, and a 4% lower HDL cholesterol level than noncarriers, after adjustment for covariates. Analysis of coronary artery disease prevalence showed that, after adjusting for age, sex, and ancestry, carrying a loss-of-function variant was linked with a statistically significant 41% lower prevalence of all coronary artery disease, and a 34% lower prevalence of myocardial infarction that fell short of statistical significance.

A second population study looked at links between loss-of-function variants and coronary artery disease in more than 130,000 Danish people. This showed a nonsignificant 37% lower prevalence of coronary artery disease in people with a variant. Two different types of meta-analyses of the data from both the DiscovEHR and Danish studies showed coronary disease rates reduced by either 31% or 39% in variant carriers depending on which meta-analysis approach the researchers used, both statistically significant reductions.

[email protected]

On Twitter @mitchelzoler