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Saturday, June 8, 2019

Heart (and Kidneys) Feature in Diabetes Trials in San Francisco

Results from 10 major clinical trials addressing prevention and management of type 2 diabetes will be featured at the American Diabetes Association 2019 Scientific Sessions.
Spread across the 5-day meeting from Friday June 7 through Tuesday June 11, the 10 “highly anticipated study announcements of 2019” will include new cardiovascular outcomes trial (CVOT) results for dulaglutide (Trulicity, Lilly), linagliptin (Tradjenta, Lilly/Boehringer Ingelheim), dapagliflozin (Farxiga/Forxiga, AstraZeneca), and oral semaglutide (Ozempic, Novo Nordisk), and new cardiorenal data for canagliflozin (Invokana, Janssen) and linagliptin.
Other major study results address the roles of vitamin D, lifestyle modification, and medication use in type 2 diabetes prevention.
“The hottest clinical areas in diabetes have to do with the potential cardiovascular and renal outcomes for some of the newer agents, especially the sodium-glucose cotransporter type 2 [SGLT2] inhibitors and glucagon-like peptide 1 receptor [GLP-1] agonists. Particularly salient at this meeting will be several trials regarding these outcomes,” program chair Jose C. Florez, MD, PhD, professor of medicine at Harvard and chief of the endocrine division at Massachusetts General Hospital, Boston, told Medscape Medical News.
Florez said that the recent flow of new data showing cardiovascular and renal benefits for glucose-lowering drugs “is really exciting to see. I think it’s really shifting the algorithm for what agents people use in type 2 diabetes and in what sequence.”
“Some of these trials will have a major impact on how we” practice medicine, said ADA Science and Medicine President Louis H. Philipson, MD, PhD, director of the Kovler Diabetes Center, and James C. Tyree professor of diabetes research and care, Departments of Medicine and Pediatrics, University of Chicago, Illinois.
And not forgetting type 1 diabetes, there are eagerly awaited data from a phase 2 trial of the anti-CD3 agent teplizumab for type 1 diabetes prevention in those with ≥ 2 islet autoantibodies and abnormal glucose tolerance. According to the ADA, “The question for this study is whether treatment at early stages of disease can delay progression to clinical (stage 3) type 1 diabetes.” Two-year clinical results from TrialNet’s low-dose ATG-GSCF trial in new-onset diabetes will also be presented as well as mechanistic data from TrialNet’s natural history and immune effects of oral insulin studies. These important results and mechanistic studies will be presented on Sunday June 9 from 8:00 to 10:00 am.
And for the first time, ADA has listed all of these trials on its 79th Scientific Sessions homepage under “highly anticipated study announcements of 2019.”

The Latest From CVOTs: REWIND, CAROLINA, and DECLARE-TIMI 58

As usual, the latest crop of CVOT results will each have their own 2-hour sessions. On Sunday June 9 at 2:15 pm, new data will be presented from the Dapagliflozin Effect on Cardiovascular Events (DECLARE-TIMI 58) study, the first CVOT to enroll a much broader and healthier population of patients with type 2 diabetes — those without pre-existing cardiovascular disease but with multiple risk factors — as well as some patients with pre-existing cardiovascular disease.
Primary results from the trial were presented in November at the American Heart Association (AHA) Scientific Sessions 2018 and showed that dapagliflozin significantly reduced hospitalizations for heart failure and nonsignificantly reduced major adverse cardiovascular events (MACE).
At ADA, those results will be reviewed along with new subanalyses, renal endpoints, and safety data for the SGLT2 inhibitor.
Next, on Sunday June 9 at 4:30 pm, comes the Researching CV Events With a Weekly Incretin in Diabetes (REWIND) trial, with 5-year results for dulaglutide, a once-weekly injectable GLP-1 agonist, in a large population of lower-risk adults. This is the first such study with a GLP-1 agonist to include a majority of patients who did not have established cardiovascular disease at baseline.
Top-line results from REWIND, announced in November 2018, showed dulaglutide significantly reduced the risk of MACE.
And on Monday June 10 at 4:30 pm, data will be presented from the Cardiovascular Safety of Linagliptin (CAROLINA) study, the longest CVOT so far (8 years) and the only one to include a head-to-head active comparator (the sulfonylurea glimepiride). In addition to the findings for linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, the results may also inform the longstanding debate about the cardiovascular safety of sulfonylureas.

Oral Semaglutide: A Game Changer?

A session on Tuesday morning at 9:45 am will cover the PIONEER program trials for oral semaglutide, the GLP-1 receptor agonist already approved as a once-weekly injectable.
Top-line results for PIONEER 6, announced in November 2018, showed reductions in cardiovascular and all-cause mortality but not the overall composite primary MACE endpoint.
Previously reported results from the PIONEER series of trials include PIONEER-1, which demonstrated the oral version’s glucose-lowering and weight loss capabilities, while in PIONEER-3 the drug reduced HbA1c more than sitagliptin.
Philipson commented, “Semaglutide has been on the market for some time but we’ve never had an oral [GLP-1 agonist]…before…I think this is a very big deal and potentially game changing for people with type 2 diabetes, so I’m very excited about that.”
“How much the oral semaglutide can recapitulate the benefits of the injected one is critical,” he stressed.

Proving Prevention: Vitamin D, Medications, and Lifestyle Interventions    

On Saturday June 8 at 4:00 pm, results from the Prevention of Diabetes in Europe and Around the World (PREVIEW) study, the largest-ever (N = 2326) to investigate diabetes prevention through lifestyle interventions, will be reviewed.
Data from PREVIEW, previously reported at the European Association for the Study of Diabetes (EASD) 2018 Annual Meeting, suggested a 2-month weight loss regimen using meal substitutes followed by long-term weight maintenance through diet and exercise may be an optimal approach to preventing type 2 diabetes through lifestyle.
Another prevention study, the multicenter Vitamin D and Type 2 Diabetes (D2d) clinical trial, supported by the National Institutes of Health, is the largest ever study specifically designed to determine whether vitamin D supplementation can reduce the risk of developing type 2 diabetes among people at risk. Final results will be presented on Friday at 11:30 am.
“There’s been a lot of epidemiological evidence that vitamin D is helpful for either beta-cell function or insulin action, but there’s never been a real randomized prospective trial, particularly for type 2 diabetes prevention,” Florez explained.
And Philipson commented, “This is a hot topic in diabetes…Many of us are measuring vitamin D levels and supplementing, but should we be? It’s not always reimbursed. Right now clinicians are deciding on their own.”
On Sunday at noon, results will be presented from the Adult Medication studyof the three-part Restoring Insulin Secretion (RISE) program looking at both prevention and early treatment of type 2 diabetes.
The RISE pediatric medication study, presented at ADA last year, showed that in adolescents with impaired glucose tolerance (prediabetes) or recent-onset type 2 diabetes, early intervention with long-acting insulin followed by metformin or metformin alone — both given for a year — failed to prevent deterioration of beta-cell function.
“These are really critical studies for our understanding of what’s happening in type 2 diabetes,” Philipson emphasized.

Kidney and Cardio: Latest Data from CREDENCE and CARMELINA

A single 2-hour session on Tuesday starting at 7:30 am will review data from the landmark Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation (CREDENCE) trial, which assessed progression of kidney disease and secondarily cardiovascular outcomes, and the Cardiovascular and Renal Microvascular Outcome Study with Linagliptin (CARMELINA), which assessed cardiovascular outcomes and secondarily kidney disease progression.
Primary findings from CREDENCE, presented in April at the International Society of Nephrology (ISN): 2019 World Congress, showed canagliflozin lowers the risk for progression to end-stage renal disease by 30% in patients with type 2 diabetes and chronic kidney disease, as well as lowers the risk for MACE.
And data from CARMELINA, first presented in October 2018 at the EASD meeting, showed adding linagliptin to standard of care in patients with type 2 diabetes at high cardiovascular risk did not worsen cardiovascular, heart failure, or renal events, even in those who already had kidney disease.
Key findings from both trials will be reviewed and new analyses presented.
“CREDENCE and CARMELINA are very big deals,” Philipson underlined. “These are follow-up studies that will help affirm the original report. They’re really exciting.”

A Tough Subject: Type 2 Diabetes in Youth

On Saturday June 8 at 1:45 pm, a 2-hour session will be devoted to the latest findings from the follow-up to the multicenter, multi-ethnic, randomized Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study.
The post-intervention follow-up, TODAY2, is tracking the youth into young adulthood to investigate rates of renal, cardiac, eye, and nerve complications, as well as pregnancy outcomes and healthcare utilization.
Philipson commented, “If there’s one ray of light that comes from this study it would be wonderful. But we have a strong feeling that children with type 2 diabetes actually do worse in some cases than children with type 1. It can be a profound disease that leads to early death, and in many cases we don’t even have a good approach to treating it. These talks will give us some indication of the outcomes of the study and what we might learn.”

Venture Outside Your Comfort Zone

Of course there’s much, much more to the meeting. Other highlights include sessions on the rational use of opioids for treating painful diabetic neuropathy, learning from atypical diabetes, an ADA consensus paper on nutrition therapy for adults with diabetes, new artificial pancreas trial results, and two keynote award lectures on obesity that “will be more clinical than usual,” Philipson observed.
Both Philipson and Florez urge delegates to attend sessions that may be outside their usual areas of focus.
Referring to the nutrition session, held under the “Behavioral Medicine, Clinical Nutrition, Education, and Exercise” track, Florez said, “We tend to just go to sessions that are in our comfort zones. But if you’re a clinician who takes care of people with diabetes you can’t just leave it to the nutritionists and the [certified diabetes educators] to attend this track on behavioral medicine and clinical nutrition.”
“I think it’s incumbent on all of us who take care of diabetes…to be up to date on the latest in nutrition therapy…This disease requires a multidisciplinary, multipronged approach. Physicians need to go beyond drugs to other forms of therapy. Don’t use the meeting to go over things you already know.”
Indeed, said Philipson, “I encourage people to go to lectures and meetings they wouldn’t normally go to…This meeting is really for everybody with an interest in diabetes, from basic scientists to practitioners, whether they’re MDs or psychologists or exercise physiologists, ophthalmologists, etc. That breadth is unmatched by any other meeting that includes diabetes.”
Florez has consulted for Janssen. Philipson has received research funding from Janssen, ADA, JDRF, Helmsley Foundation, and National Institutes of Health.
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Insulin-Producing Beta Cells Are Not Irreversibly Lost in Early Type 2 Diabetes

Analysis of data over a two-year period finds losing weight and minimizing weight regain can potentially lead to remission of type 2 diabetes
Pancreatic beta cells that do not produce sufficient insulin in people with type 2 diabetes (T2D) are not permanently damaged during the early stages of the disease and can be restored to normal function through the removal of excess fat in the cells, according to a study entitled “Remission of Type 2 Diabetes for Two Years Is Associated with Full Recovery of Beta-Cell Functional Mass in the Diabetes Remission Clinical Trial (DiRECT)” presented today at the American Diabetes Association’s® (ADA’s) 79th Scientific Sessions®. More than one-third (36%) of the participants who took part in an intensive weight management program saw remission of their T2D after two years.
Type 2 diabetes is a progressive disease over time, and previous research has suggested beta cell death is the root cause of increasing failure of insulin-production and severity of T2D. Findings presented today examined beta cell production within a geographically-defined subgroup of the original DiRECT participants who had already achieved remission of T2D through diet-induced weight loss. The study found, however, beta cells are not permanently damaged in early T2D and can be rescued by removing the metabolic stress of excess fat within the cells. The findings are the result of the examination of insulin production on a subgroup at baseline (starting weight), immediately after weight loss (five months), and upon follow up of one and two years. Researchers defined participants as “in remission” if long-term blood glucose levels (HbA1c) were less than 48mmol/mol (6.5%) and their fasting glucose plasma (FPG) levels were less than 126mg/dl, without the use of any T2D medications.
The researchers used a Stepped Insulin Secretion Test with Arginine (SISTA) to quantify functional beta cell mass (maximum insulin secretory response during hyperglycemia). Insulin secretion rates were estimated by de-convolution, and participants’ A1C and fasting plasma glucose (FPG) levels were assessed. Analysis determined that many from the group who had initially achieved remission of T2D – blood glucose levels capable of achieving non-diabetic blood glucose control although not considered normal – had remained in remission two years after the study. Within the 40 people who had initially achieved remission of T2D, 20 participants (13 male/seven female) remained in remission, 13 gained weight and relapsed, and seven did not maintain follow-up. Furthermore, when compared to a nondiabetic comparator (NDC) group used in the study, which matched the age/gender of the DiRECT intervention group participants after weight loss, the study participants’ maximum rate of insulin secretion was comparable. The intervention group participants’ insulin secretion increased from a median of 0.58 nmol/min/m2 at baseline to 0.94 nmol/min/m2 after two years, and the insulin secretion of the NDC group had a median insulin secretion rate of 1.02 nmol/min/m2 at 24-months follow up.
DiRECT is the latest in a series of studies to test the 2008 Twin Cycle hypothesis. Research released in 2011 reported a dramatic fall in liver fat and a significant decrease in intra-pancreatic fat levels following 33 pounds of weight loss with recovery of some beta cell function in people with T2D. In 2016, scientists reported that maintaining a healthy weight for nine months after a period of weight loss assisted in beta cell recovery. The open-labeled, cluster-randomized controlled trial involved 306 participants from 49 primary care practices in Scotland and England between 2014 and 2017. Patients ranged in ages from 20 to 65, had a body mass between 27-45 kg/m 2, were not receiving insulin and with up to six years duration of T2D. Practices were randomly selected to offer participants one of two treatments, both of which had already been shown to be effective. DiRECT aimed to ascertain which treatment option was more effective.
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More Anti-Obesity Drugs for Teens Coming, Devices Are Next Step

Few medical therapies have been approved to treat adolescents with obesity but that is about to change, and a next step will be to test endoscopic devices in teens, two experts have predicted here at the American Diabetes Association (ADA) 2019 Scientific Sessions.
“I think there is a place for medication in adolescent obesity,” but current options “continue to remain limited,” Daniel S. Hsia, MD, Pennington Biomedical Research Center, Baton Rouge, Louisiana, summarized to Medscape Medical News following his presentation here.
He had explained that only orlistat and phentermine are approved by the US Food and Drug Administration (FDA) to treat adolescents with obesity, whereas nine medical therapies have been approved for weight loss in adults.
“I think that off-label use is going to continue until we have more pediatric adolescent data and we have FDA approvals for [anti-obesity] medications” for adolescents, Hsia predicted.
However, “there is hope on the horizon,” he added, “for the specific [obese young] populations that need medical therapy that may not fit so much in bariatric surgery or may not have had quite the benefit from lifestyle modification.”
“Liraglutide (Saxenda, Novo Nordisk) [trial] results [in teens] will probably be available early next year,” Hsia expects. “That’s probably the one that will be the next one up,” to be approved for treating adolescents with obesity, he said.
A randomized controlled trial of lorcaserin (Belviq, Eisai) in adolescents with obesity is ongoing and still open for enrolment, he noted, and there is a phase 4 trial that is just starting for phentermine/topiramate (Qsymia, Vivus).
During the same session, Andrew C. Storm, MD, Mayo Clinic, Rochester, Minnesota, summarized the growing number of endoscopic devices that are approved or being tested for weight loss.
The approvals have happened “in the past 3 to 4 years and three to five have FDA approval trials ongoing or starting within the summer [in adults], so I expect to see — if not this year then definitely in the next year or two — quite a number of endoscopic therapies for obesity and metabolic disease available,” he told Medscape Medical News.
“It is pretty clear that obesity from childhood carries into adulthood,” Storm added. “Given that these [devices] are so safe and have such reasonable impacts in obesity upfront, I think the next step will be studying them in young adults.”
“It’s very exciting because there are new and evolving therapies in the field of the treatment of obesity [for adolescents],” session chair Amy E. Rothberg, MD, PhD, University of Michigan, Ann Arbor, told Medscape Medical News.
“It’s going to reshape the landscape and practitioners will be more comfortable prescribing these therapies,” she predicted.
“Stay tuned, but there are probably going to be double what we have in terms of pharmacotherapy and combination pharmacotherapy in the future” for treating adolescents, she said.
Asked if this will this make a dent in the obesity rate in young people, she replied: “I’m optimistic, so I certainly hope so.”

Only Orlistat and Phentermine Approved for Obese Teens

Endocrine Society guidelines published in 2017 (J Clin Endocrinol Metab. 2017;102:709-757) specify that pharmacotherapy with FDA-approved therapies can be suggested for adolescents who are obese if a formal lifestyle modification program fails to limit weight gain or improve comorbidities, Hsia noted.
The guidelines also advise discontinuing therapy if the patient does not achieve a greater than 4% reduction in body mass index (BMI)/BMI z-score by 12 weeks.
Orlistat is the only FDA-approved medication for long-term use in adolescents age 12 years or older, and it is associated with a 0.7 to 1.7 kg/m2 reduction in BMI. However, because of side effects of fecal urgency/incontinence and fatty/oily stools, it is of limited clinical use in this age group.
Phentermine, which suppresses appetite, is approved by the FDA for 12 weeks or less in individuals age 16 years and older. However, it may cause increased blood pressure and heart rate, and there are limited safety and efficacy data in adolescents.
Anti-obesity pharmacotherapies for adults included four drugs approved in the 1950s for short-term use, and the one most commonly still in use is phentermine, Hsia explained.
More recently, in 1999 to 2014, the FDA approved five drugs for long-term use for weight loss: Orlistat (Xenical), lorcaserin (Belviq), phentermine/topiramate(Qsymia), bupropion/naltrexone (Contrave), and liraglutide, a subcutaneous injectable glucagon-like peptide 1 (GLP-1) agonist first approved for type 2 diabetes (as Victoza, Novo Nordisk) but subsequently approved for obesity as Saxenda.
And when used off-label in adolescents, the type 2 diabetes agent metformindecreases BMI by about 1.2 kg/m2 over 6 to 12 months and the GLP-1 agonist exenatide decreases BMI by 1.1 to 1.7 kg/m2 over 3 months.
Similarly, off-label use in adolescents of antiepileptic drugs (topiramate and zonisamide) decreases BMI by about 1.3 to 4.1 kg/m2 over 6 months; growth hormone decreases fat mass in Prader-Willi syndrome; and octreotide may provide weight stabilization in hypothalamic obesity.
Moreover, three drugs approved in adults are currently being investigated in trials in adolescents: lorcaserin (Belviq) 20 mg/day is being studied in a 52-week randomized controlled trial in 12 to 17 year olds; phentermine/topiramate (Qsymia) is being studied in a 56-week phase 4 randomized controlled trial in 12 to 16 year olds; and liraglutide (Saxenda) is being studied in a 56-week trial in 12 to 17 year olds.
And in future, combination pharmacotherapy may come to the fore, as it may allow lower dosing of two drugs with different mechanisms, which might mitigate side effects, Hsia said.
Newer agents in the pipeline include centrally acting agents, gut hormone and incretin targets, leptin analogs, and dual-action GLP-1/glucagon receptor analogs.

Growing Number of Endoscopy Devices

Meanwhile, Storm explained that the number of “devices, techniques, and providers are growing to meet the demand of the obesity pandemic,” and there is strong level 1 evidence that endoscopic bariatric therapies can help patients achieve significant weight loss and metabolic improvement.
These devices are safe and cost-effective, and the procedures can be repeated.
FDA-approved intragastric balloons include Orbera, Reshape (a dual balloon system), and Obalon (a gas-filled balloon that is swallowed), which delay gastric emptying and have to be removed after 6 months.
And a pivotal trial is being conducted to obtain FDA approval for an investigational gastric balloon that could stay in place for 12 months, Storm noted.
The FDA has already approved endoscopic sleeve gastroplasty, a type of gastric remodeling that is “probably the most exciting” and “most promising” endoscopic technique, according to Storm, that reshapes the stomach down to the size of a banana, which is similar to bariatric sleeve gastrectomy but uses a minimally invasive procedure.
Another type of gastric remodeling, the primary obesity surgery endolumenal (POSE) procedure, is not yet approved.
Aspiration therapy, on the other hand, has received FDA approval.
And the FDA recently approved Gelesis100 (Plenity, Gelesis) hydrogel capsules, Rothberg added, as previously reported. “We’ll see in post-marketing data how that fares,” she noted.
“The big question,” Storm said, “is how to combine [endoscopic devices] with medication to achieve bariatric surgery levels of weight loss.”
ADA 2019 Scientific Sessions. Presented June 7, 2019.
Hsia has reported serving as principal investigator for studies sponsored by Novo Nordisk and Vivus, with funds paid directly to his institution. Storm has reported consulting for GI Dynamics and receiving research support from Boston Scientific.
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Medtronic teams up with Tidepool to develop interoperable insulin pump

Medtronic (NYSE:MDT) will collaborate with nonprofit Tidepool to develop an interoperable automated insulin pump system. Specifically, MDT will develop a Bluetooth-enabled MiniMed pump that will be compatible Tidepool Loop, an open source insulin delivery app for Apple’s iPhone and Apple Watch.
MDT will continue its financial support to Tidepool for its integration and software development activities to enable iPhone-to-pump communications. Both organizations will work with the FDA through the registration process.
Additional details remain confidential.
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Novo’s oral semaglutide successful in two late-stage T2D studies

Novo Nordisk (NYSE:NVO) announces positive results from two Phase 3 clinical trials evaluating its oral semaglutide in adults with type 2 diabetes (T2D). The data were presented at the American Diabetes Association Scientific Sessions in San Francisco.
In PIONEER 2, once-daily 14 mg doses of oral semaglutide demonstrated statistically significantly better HbA1C reduction compared to once-daily 25 mg doses Eli Lilly’s (NYSE:LLY) oral Jardiance (empagliflozin) at week 26 (1.3% vs. 0.9%; p<0.0001). Weight loss at weeks 26 and 52 (3.8 kg at both time points) slightly favored oral semaglutide versus Jardiance (3.7 kg, 3.6 kg) but the separation was not statistically valid.
In PIONEER 4,  once-daily doses of 14 mg of oral semaglutide demonstrated a non-inferior (no worse than) reduction in HbA1C compared to once-daily injections of Victoza (liraglutide) at week 26 (1.2% vs. 1.1%) while demonstrating superiority versus placebo (1.2% vs. 0.2%).
At week 52, the HbA1C-lowering effect in the oral semaglutide cohort was statistically significantly better than Victoza and control (1.2% vs. 0.9% and 0.2%, respectively) as was weight loss at weeks 26 (4.4 kg vs. 3.1 kg and 0.5 kg, respectively) and 52 (4.3 kg vs. 3.0 kg and 1.0 kg, respectively).
Previously reported results from another Phase 3, PIONEER 3, showed the superiority of oral semaglutide compared to Merck’s (NYSE:MRK) oral Januvia (sitagliptin).
The company filed its U.S. marketing application in late March with a Priority Review Voucher that cuts the action date to six months after the agency formally accepts it for review.
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For high stakes employer-based coverage, Senate eyes hospital contract reform

Some healthcare experts view the Senate health committee’s proposed reformsto hospital and insurer contracts as essential to try to sustain the employer-based insurance system in the face of bloating costs.
Yet even as the healthcare industry seems bent on defending the commercial market against calls for a single-payer system, hospitals are poised to fight at least some of these policies.
Comments on the draft legislation from Senate health committee Chair Lamar Alexander (R-Tenn.) and his Democratic counterpart, Sen. Patty Murray of Washington, are due Wednesday, and hospitals have already framed the potential restrictions to some of their contracting practices as another threat to rural healthcare.
The discussion draft includes a ban on “all-or-nothing” clauses, which force insurers to contract with all of a health system’s facilities or none of them. American Hospital Association Executive Vice President Tom Nickels said this “could lead to even more narrow networks with fewer provider choices for patients, while adversely affecting access to care at rural and community hospitals.”
The AHA declined to share all the group’s comments on all the contract provisions before they send full feedback to the Senate health committee this week.
But in an October letter to Senate Finance Committee Chair Chuck Grassley (R-Iowa) about transparency measures, Nickels argued that insurers usually have the upper hand with most hospitals and health systems. He also contended that hospitals typically use their contract provisions for “pro-competitive and pro-consumer purposes” such as “value-based care alternatives or protecting the hospital and its patients from unwarranted denials.”
The association echoed those criticisms in its comments on the Office of the National Coordinator for Health Information Technology’s proposals to force hospital and insurer negotiations into the public eye.
Disclosing “price information actually would inhibit competition because it would create a platform for price-fixing,” the AHA said. “Health plans would know what every other health plan was paying and could use that information indirectly to collude and drive prices below competitive levels, thereby reducing the incentives for actual competition in the marketplace, and threatening the viability of some of the nation’s most vulnerable hospitals.”
On rural healthcare specifically, an AHA representative pointed to the March Government Accountability Office report about insurance market consolidation — since states like Alabama, Alaska, Mississippi and Montana are dominated by a single company holding at least 80% of the market.
The rural healthcare argument draws strong skepticism from others.
“They do it because it’s effective,” Dr. Farzad Mostashari, co-founder and CEO of the primary-care company Aledade, said of the approach. “The Senate being what it is, and rurals and rural healthcare being a real concern, it really has political potency to talk about this. But in reality (fixing) the rural hospital closure problem would take a fraction of what they’re proposing, which is to hold all hospitals harmless from any reform.”
Mostashari also argued that the mere fact of bipartisan agreement in the Senate shows “how far beyond the pale hospitals and certain provider groups” have gone to get Congress to act.
“This is the thing: Congress hates to get involved in private contracts—hates it,” he said.
Meanwhile, advocates for the employer system say hospitals have to give up something on costs.
And for many on the employers’ side, the case to back the Senate proposals has been building in the courts.
North Carolina’s Atrium Health only recently settled with the U.S. Justice Department over its anticompetitive steering clauses. Alexander’s draft legislation would prohibit hospitals and insurers from entering into anti-steering agreements to keep patients from cheaper hospitals or clinics.
And California Attorney General Xavier Becerra’s antitrust lawsuit against Sutter Health almost presents the Senate-proposed reforms point by point.
Becerra’s case, filed in March 2018 and headed for oral arguments in August, described contracting strategies that allegedly caused regional healthcare costs to skyrocket in Northern California. One report from the University of California at Berkeley, detailed that average hospital inpatient procedures cost $90,000 per patient more in Northern California than Southern California.
The contracting tactics outlined in the Sutter Health lawsuit would get axed in the legislation from Alexander and Murray, who have proposed a ban on the “all-or-nothing” clauses deployed by Sutter, insurer-hospital collusion to keep patients from knowing the prices ahead of their treatments, and more.
Becerra blamed the “punitively high out-of-network hospital pricing in combination with the anticompetitive provisions in its agreements with network vendors” for making low-cost employer coverage “economically unfeasible.”
With about half of Californians covered through an employer plan, “the economic damage to the state is quite substantial,” the lawsuit said.
The panel’s draft legislation coincided with the fallout of a recent RAND Health study, which sampled 25 states and found that on average hospitals get 241% of Medicare rates from employer insurance.
Some hospitals and hospital groups have questioned the study’s accuracy, but the RAND researchers specifically highlighted hospital contractual clauses that inflate and obfuscate pricing—including “all-or-nothing” clauses and other gag clauses.
The White House has not commented specifically on the Senate health committee’s proposal, but an official said that legislation addressing high healthcare costs “is exactly what the American people want Congress to do.”
Mostashari predicted that the committee proposals will ultimately win out over any hospital objections.
“They’ve just gone too far,” Mostashari said. “And the issue is, like drug pricing, people can see it in their own lives. You just have to go on any local news or Twitter or constituent letters to see thousands of examples of these abuses. They’re going to try to do their usual lobbying tricks, but they don’t have much to stand on. Maybe they should save their bullets.”
Suzanne Delbanco, the executive director of the not-for-profit Catalyst for Payment Reform which helps employers try to find savings, said they have few options left now that they have come to rely on high-deductible plans that are proving too expensive for their workers.
“There are many parties who want to make sure employers can continue offering benefits, and employers want to,” Delbanco said. “But it is a really challenging job when there is so much money in healthcare, and so many entities are holding that money close that it can feel like people forget that healthcare is ultimately about the patient.”
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CMS plans to release list of 400 troubled nursing homes following Senate report

The Centers for Medicare & Medicaid Services said Wednesday it would release a list of nearly 400 poorly performing nursing homes that qualified for but have not received heightened federal scrutiny through what the agency calls the Special Focus Facility program.
The move comes after a Senate report this week revealed the federal government had identified far more troubled nursing homes that qualified for the program than it previously disclosed to the public, the Associated Press reported.
During a call with reporters, Kate Goodrich, M.D., director of CMS Center for Clinical Standards and Quality and chief medical officer, said the agency will be posting the Special Focus Facility candidate list after receiving numerous calls to release it.
“The recent heightened attention to and dialogue around the agency’s Special Focus Facilities program is welcome because it has amplified a very important national dialogue on national nursing home quality,” Goodrich said.
She declined to confirm when it would be posted, saying the agency was working to ensure it was in a format that was “understandable,” but she said it would be updated monthly once it is posted. She said the agency previously did not release the list because it already made a more comprehensive quality reporting tool available to the public, including star ratings, through its website Nursing Home Compare.

CMS contracts with state agencies, known as survey agencies, to investigate abuse allegations. That information is used for its oversight and is made available on the Nursing Home Compare website. Out of the 16,000 nursing homes around the country, about 3,000 have a one-star rating on their health inspection, Goodrich said.
There are 88 Special Focus Facility program slots for about 400 candidates for that program, Goodrich said. States help CMS narrow down which nursing homes are most in need of the available slots, she said.
Of those nursing homes that have entered the program, 90% have graduated from it after passing consecutive inspections and 10% have been terminated from qualifying to receive Medicare funds, she said.
“Certainly we think this is an important program that can lead to improved quality for nursing homes that are poor performers. But we are limited in the number of slots that we have available for the Special Focus Facilities program due to budgetary constraints,” she said.

President Donald Trump’s fiscal year 2020 budget also requests a $45 million increase for survey and certification—for an overall request of $442 million—to enable CMS to meet the statutory survey requirements while dealing with the increase in volume and severity of complaints as well as rising survey costs.
Officials said they’ve already made changes in nursing home oversight.
In April, CMS announced it was undertaking a comprehensive review of its regulations and processes when it came to ensuring safety and quality in nursing homes. The announcement came the same day the Government Accountability Office released a report saying CMS needs to do more to address gaps in federal oversight of nursing home investigations in Oregon.
At the time, CMS Administrator Seema Verma said her team has begun executing a five-point plan, including strengthening its oversight of nursing homes and improving enforcement of quality and safety policies by nursing homes.
Goodrich said the agency also began requiring a more “robust, standardized survey process, strengthened the staffing requirements for nursing homes, updated the way nursing homes report their staffing to CMS, then targeting nursing homes with staffing problems for off-hours and weekend surveys; and began to post all of the agency’s surveyor training online.”
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