Rural hospitals had complained that the current wage index system worsens pay gaps between hospitals in high-wage areas and low-wage areas.
The Trump administration on Friday made public its 2020 final rule that increases the wage index for some low-wage index hospitals.
"The Trump Administration is providing relief to rural communities and addressing payment policies that have disadvantaged rural hospitals, making it harder for them to stay open and provide care to the one in five Americans living in rural areas," CMS Administrator Seema Verma said in a media release.
"The changes we're finalizing in today's rule are long overdue and improve the way Medicare pays hospitals, which will help many rural hospitals maintain their healthcare labor force, to ensure that patients have access to high-quality, affordable healthcare," she said.
Rural hospitals executives have long complained that the current wage index worsens pay gaps between hospitals in high-wage areas and low-wage areas, which tend to be rural.
Hospitals in areas with wages below the national average get a lower Medicare payment rate than hospitals in areas with above-average wages.
For example, CMS said a hospital in a low-wage rural community could receive a Medicare payment of about $4,000 for treating a pneumonia patient, while a hospital in a high-wage area could get a Medicare payment of nearly $6,000 for the same case because of wage index differences.
According to a CMS factsheet, the final rule will increase the wage index for hospitals with a wage index value below the 25th percentile.
"These hospitals' wage indexes will be increased by half the difference between the otherwise applicable wage index value for that hospital and the 25th percentile wage index value across all hospitals," CMS said.
This policy will begin at the start of Fiscal 2020 and will be effective for at least four years. In that span, CMS said, it is hoped that the additional funding could be used to increase employee compensation
The wage index increase is revenue neutral for Medicare. CMS said it is using a budget neutrality adjustment to the standardized amount that is applied across all Inpatient Prospective Payment System hospitals, rather than a decrease to the wage index for hospitals above the 75th percentile, as was initially proposed.
The American Hospital Association said the wage index adjustment benefits rural and low-volume hospitals at the expense of urban hospitals.
"We are concerned that CMS did not include our recommendation that the proposed area wage index policy designed to help certain low-wage rural hospitals be non-budget neutral," AHA Executive Vice President Tom Nickels said in a statement.
"While we support improving the wage index values for many struggling rural hospitals, this should not be done by penalizing all hospitals, especially when Medicare already pays far less than the cost of providing care. That's why we strongly urged the agency to use its existing statutory authority to increase the wage index in a non-budget neutral manner," he said.
CMS is also finalizing changes to the wage index "rural floor" that will remove urban to rural hospital reclassifications from the calculation of the rural floor wage index value beginning in FY 2020.
CMS said the rule change was needed because hospitals have used urban to rural hospital reclassifications to skew the rural floor wage index value.
CMS is finalizing a transition of a 5% cap for FY 2020 on any decrease in a hospital's wage index from its final wage index for FY 2019 to help mitigate any significant decreases in the wage index values of hospitals for FY 2020.
In other words, a hospital's final wage index for FY 2020 will not be less than 95% of its final wage index for FY 2019, CMS said.
In other areas:
The final rule increases Medicare inpatient prospective payment system rates by a net 3.1% in 2020 for hospitals that comply with meaningful use standards for electronic medical records.
CMS will make available $8.35 billion in disproportionate share payments, an increase of $78 million over last year, and will use 2015 cost data to determine how the DSH payments are doled out in 2020.
CMS also finalized its proposal to increase the marginal rate of the new technology add-on payments, including for Chimeric Antigen Receptor (CAR)-T therapies, from 50% to 65%.
The final rule increases Medicare new technology add-on payments (NTAP), including Chimeric Antigen Receptor (CAR)-T therapies from 50% to 65% for cases with high costs involving eligible new technologies.
CMS is updating payment policies for medical devices that meet the Food & Drug Administration's Breakthrough Devices designation, which would no longer be required to demonstrate evidence of "substantial clinical improvement" to qualify for new technology add-on payments.
CMS has created an alternative NTAP pathway, which would no longer require new antimicrobial drugs to meet the "substantial clinical improvement" criteria and would also increase the NTAP from 50% to 75%.
AI was taught to identify subtle differences in a normal EKG that would indicate changes in heart structure caused by afib.
Artificial intelligence has proved to be adept at detecting recent or impending atrial fibrillation, even if symptoms aren't noticeably apparent, new research shows.
In a study published in The Lancet, Mayo Clinic researchers found that AI can detect the signs of an irregular heart rhythm in an EKG, even if the heart is in normal rhythm at the time of a test.
Study senior author Paul Friedman, MD, chair of the Department of Cardiovascular Medicine at Mayo Clinic, says the findings could prove critically important when treating stroke victims.
"When people come in with a stroke, we really want to know if they had AF in the days before the stroke, because it guides the treatment," Friedman said in comments accompanying the study.
"Blood thinners are very effective for preventing another stroke in people with AF. But for those without AF, using blood thinners increases the risk of bleeding without substantial benefit," he said. "That's important knowledge. We want to know if a patient has AF."
Using 450,000 EKGs of the over 7 million EKGs in the Mayo Clinic digital data vault, the researchers taught AI to identify subtle differences in a normal EKG that would indicate changes in heart structure caused by afib. The changes were not detectable without AI.
The researchers then tested the AI on normal-rhythm EKGs of 36,280 patients, of whom 3,051 were known to have afib and found that the AI-enabled EKG correctly identified afib with 90% accuracy, the study said.
In addition to improving diagnoses for afib, Friedman said AI-guided EKGs can be processed using a smartphone or watch, making it readily available on a large scale.
"An EKG will always show the heart's electrical activity at the time of the test, but this is like looking at the ocean now and being able to tell that there were big waves yesterday," Friedman said.
"AI can provide powerful information about the invisible electrical signals that our bodies give off with each heartbeat — signals that have been hidden in plain sight," he said.
Participanting clinicians can request a Medicare beneficiary's claims data from CMS to get a full history of care, including from other healthcare providers.
The Centers for Medicare & Medicaid Services on Tuesday unveiled a new pilot program that will give clinicians direct access to Medicare beneficiaries' claims data.
CMS Administrator Seema Verma says the "Data at the Point of Care" pilot is designed to improve care, sharpen diagnoses, and reduce redundant services by knocking down silos that prevent patients and their providers from accessing their complete health history in one record.
"Technology, coupled with open data sharing, is how we will improve value, control costs and keep patients our healthcare system into the 21st century," Verma said in prepared remarks.
Clinicians in the DPC pilot program can request a Medicare beneficiary's claims data from CMS to get a full history of care, including from other healthcare providers.
The DPC pilot is the latest attempt to improve access to healthcare data for clinicians and beneficiaries that the Trump administration has rolled out over the past two years under its MyHealthEData initiative.
CMS launched Blue Button 2.0, the first-ever FHIR-based claims application programming interface that allows Medicare beneficiaries to securely connect their data to apps and other tools.
In February, CMS issued theInteroperability and Patient Access Proposed Rule, which would require all government and commercial health plans regulated by the rule to follow CMS's lead with Blue Button 2.0 by making data available on 85 million patients including those covered by Medicare Advantage, Medicaid, CHIP and health plans sold on the Federal exchanges.
(Clinicians who want to participate in the DPC pilot program can sign up by visiting: https://dpc.cms.gov. Beneficiaries who wish to opt out of data sharing can do so by calling 1-800-Medicare.)
Under the proposed rule hospitals would have to make their 'real, negotiated prices known to patients.'
The Centers for Medicare & Medicaid Services on Monday unveiled proposed rules that mandate "consumer-friendly" price transparency for hospitals, a proposal that the Trump administration says will increase competition among hospitals and lower healthcare costs for consumers.
In a conference call with reporters on Monday, CMS Administrator Seema Verma said the enhanced rules on price disclosure apply "not just for Medicare patients, (but) for the entire healthcare system at large."
"What we are proposing is that the hospitals would be required to post this on the Internet in a searchable format, and they would be required to post their negotiated rates by payer and by plan," she said.
The Trump administration last year mandated that hospitals publish their charge masters, but Verma noted that the information provided in charge masters is often confusing for consumers.
"With the proposals announced today, starting January 1 of 2020, hospitals will have to publish price information organized in a standardized way so patients will be able to do an apples-to-apples comparison on the price of a procedure across hospitals," she said.
"Hospitals would also be required to post all of their payers specific negotiated rates, which are the prices actually paid by insurers, in that standard format to give patients more useful pricing information," Verma said, repeating the statement for emphasis.
The proposal was one of several initiatives unveiled Monday by CMS that include an extension of Medicare site-neutral payments, and the continuation of cuts to the 340B Drug Pricing Program.
The proposed pricing transparency rules, which would take effect on January 1, 2020, would require hospitals to:
Make public their "standard charges" (gross charges and payer-specific negotiated charges) for all items and services.
Make public standard charges on the Internet in a machine-readable file that includes information such as common billing or accounting codes used by the hospital, and a description of the item or service. This provides a common framework for comparing standard charges from hospital to hospital.
Make public and "consumer friendly" payer-specific negotiated charges for common shoppable services, such as imaging, outpatient visits, and lab tests, and bundled services such as cesarean delivery.
"Consumer-friendly means the hospital charge information must be made public in a prominent location online (or in written form upon request) that it is easily accessible, without barriers, and searchable," CMS said in a media release.
"It also means the service descriptions are in 'plain language' and the shoppable service charges are displayed and grouped with charges for any ancillary services the hospital customarily provides with the primary shoppable service," CMS said.
Hospital stakeholders greeted the proposed rule with a chorus of boos.
American Hospital Association President and CEO Rick Pollack said the proposed rule "misses the mark, exceeds the administration's legal authority and should be abandoned."
"Mandating the disclosure of negotiated rates between insurers and hospitals is the wrong approach," Pollack said. "Instead, it could seriously limit the choices available to patients in the private market and fuel anticompetitive behavior among commercial health insurers in an already highly concentrated insurance industry."
Bruce Siegel, MD, president and CEO of America's Essential Hospitals, said the proposed rule would "create a heavy administrative burden for hospitals and undermine their ability to negotiate equitable payment, while giving consumers little actionable information with which to make informed care decisions."
Payers panned the proposal as well.
Matt Eyles, president and CEO of America’s Health Insurance Plans says that most health plans already allow consumers to comparison shop for physicians, and 90% of plans can show consumers their out-of-pocket costs, such as co-pays, coinsurance and deductibles for specific procedures and services.
"We share the Administration's commitment to empowering patients with better information about the costs of their care and lowering costs," Eyles said. "However, multiple experts, including the Federal Trade Commission, agree that disclosing privately negotiated rates will make it harder to bargain for lower rates, creating a floor – not a ceiling – for the prices that hospitals would be willing to accept."
"Publicly disclosing competitively negotiated, proprietary rates will push prices and premiums higher–not lower–for consumers, patients, and taxpayers," Eyles said.
Site-neutral payments
Hospitals also voiced their disapproval of the administrations plans to continue Medicare site-neutral payments that stakeholders say will cut by 60% the payments for outpatient clinic visits.
"By continuing payment cuts for hospital outpatient clinic visits, CMS has not only undermined clear congressional intent, but has threatened to impede access to care, especially in rural and other vulnerable communities," Pollack said.
"These cuts clearly exceed the administration’s legal authority, which is why the AHA has been working to overturn this rule through legal action and by working with the Congress," he said.
Siegel said CMS "puts care at risk for vulnerable people by maintaining its flawed policy of extending outpatient payment cuts to previously excepted clinics."
"These cuts fall hardest on hospitals that care for low-income patients and create barriers to expanding access to care in underserved communities," he said.
Continued Cuts to 340B Program
Siegel said CMS' plan to continue cuts to the 340B Drug Pricing Program ignores a federal court's unequivocal and explicit finding that the agency acted unlawfully when it imposed deeply damaging cuts to hospitals that rely on the program.
"This is unacceptable," Seigel said. "This proposed rule needlessly prolongs the uncertainty, confusion, and harm CMS created with these Part B cuts, which went beyond its statutory authority and continue to threaten access to care in communities nationwide."
Pollack said continuing the 340B cuts "only exacerbates the strain placed on hospitals serving vulnerable communities."
"Now that the court has ruled that those cuts are illegal and exceeded the administration’s authority, we urge CMS to refrain from doing more damage to impacted hospitals with another year of illegal cuts," he said. "Instead, as a remedy, CMS should be offering a plan to promptly restore funds to those affected by the illegal cuts.
CMS also proposed changes to the Hospital Outpatient Quality Reporting and Ambulatory Surgical Center Quality Reporting Programs that CMS said would "further meaningful measurement and reporting for quality of care in the outpatient surgical setting while limiting burden."
New research debunks the notion that July suffers more medical errors than any other month owing to an influx of new medical school grads starting their hospital training.
The "July Effect" is a fiction.
According to the lore surrounding the medical myth, July suffers more medical errors than any other month because of an influx of new medical school graduates starting their hospital training.
Researchers from Brigham and Women’s Hospital in Boston tapped the Nationwide Inpatient Sample and looked at more than 470,000 cardiac procedures such as coronary artery bypass grafting, aortic valve replacement, mitral valve repair or replacement, and thoracic aortic aneurysm replacement performed between 2012 and 2014 on adult patients.
For each procedure, overall trends were compared by academic year quartiles: Q1 (July to September with the least experienced residents) vs. Q4 (April to June with the most experienced residents), the study said.
The researchers observed no differences in mortality, in-hospital complications, costs, or length of stay between patients who were treated in Q1 compared to those in Q4, the study said.
Study author Sameer A. Hirji, MD, called the findings "encouraging."
"While the perception of the 'July effect' persists culturally among healthcare providers, we hope that this study reinforces the fact that hospital systems have in place processes that help provide the highest level of care and ensure patient safety,” Hirji said.
Study co-author Rohan M. Shah, MD, said the findings make sense because "cardiac surgery patients are managed in a multidisciplinary fashion."
"Therefore, the well-being of patients is not solely dependent on one individual, but rather on the entire caregiving team and so may be more resistant to changes in hospital staff," Shah said. "What this means for patients is that they should not be fearful or concerned about having surgery in July when the new residents are starting."
Hirji said that most cardiac surgery teams adopt "direct and strict" supervision of newly arriving trainees, with increased resident autonomy given as the year progresses.
"The balance between attending supervision and resident autonomy constantly shifts during teaching," he said. "This is a fine balance and, as indicated by this study, our specialty is doing a great job."
The report comes amid projections that Medicare spending will exceed $1.5 trillion by 2028, which is more than double the $708 billion in spending in 2017.
The Health and Human Services Office of Inspector General, relying on interviews and self-reporting from ACO officials, asked them to identify successful strategies they used to lower Medicare spending and improve care quality.
The report comes amid projections that Medicare spending will exceed $1.5 trillion by 2028, which is more than double the $708 billion in spending in 2017. The Shared Savings Program is one of the largest alternative payment models, accounting for $168 billion in Medicare expenditures over its first three years, 2013-2015.
This OIG study is a follow-up to a 2017 study that found ACOs saved Medicare about $1 billion from 2013 through 2015, while improving quality across most metrics.
OIG also found in the 2017 report that high-performing ACOs relied heavily on frequent primary care visits that reduced the use of emergency department visits, and lowered spending by an average of $673 per person.
The 20 ACOs examined by OIG for the new report started in the Shared Savings Program, but five of them moved to the Next Generation ACO Model at the time of the OIG review.
The 20 ACOs all demonstrated a reduction in spending and overall quality scores of 90 or higher over three years, however OIG acknowledged that their findings are somewhat limited because they rely upon unverified self-reporting.
OIG took the findings and grouped them across seven areas.
1. Work with physicians
ACOs report that working with physicians in the ACOs is critical to lowering costs and improving quality. However, ACOs say that physicians are often unaware of the cost of services and may order more expensive services than are necessary or refer to specialists without factoring in the cost of services. In addition, physicians are often overburdened by administrative tasks, thereby reducing the time they have to care for beneficiaries. ACOs also note that they need to work with physicians to address quality measures and to close gaps in care—particularly for screening beneficiaries for needed care.
2. Engage beneficiaries to improve their own health.
Encouraging beneficiaries to take a more active role in their health can lead to better health outcomes, but ACOs note that it is challenging to build relationships between physicians and beneficiaries. To address these challenges, many ACOs focus on increasing beneficiaries' utilization of annual wellness visits to build relationships with physicians and to engage beneficiaries in their health.
3. Manage beneficiaries with costly or complex care needs.
Almost all ACOs use care coordinators. They ensure that when beneficiaries leave the hospital, they have the correct medication and equipment, as well as a follow-up visit with their primary care provider. Care coordinators also help beneficiaries schedule appointments and ensure that beneficiaries have care plans in place. Many ACOs also periodically check with beneficiaries in between physician visits to monitor changes in their health. Over half of the ACOs have care coordinators or physicians who visit beneficiaries in their homes.
4. Reduce avoidable hospitalizations and improve hospital care
ACOs note that hospitals are often difficult to engage; they also find that hospitals often lack the incentive to lower their costs partly because they are reimbursed primarily based on the volume of admissions. ACOs face challenges with reducing avoidable hospitalizations and with encouraging beneficiaries to seek alternatives to emergency room care when possible. Most ACOs provide additional access to primary care services.
5. Control costs and improve quality in skilled nursing and home healthcare.
ACOs say their ability to coordinate care and influence cost is limited because SNFs and HHAs are not typically included in the ACOs, and that these providers may not share the same incentives to lower cost and improve quality. In addition, beneficiaries must be fully-admitted to a hospital for three nights to qualify for SNF benefits under Medicare Part A's "3-day rule." That can limit an ACO's ability to arrange the most appropriate and cost-effective care. Concerns exist that the 3-day rule can result in unnecessary hospitalizations when it is safe to transfer patients directly to a SNF without hospitalization or when fewer than 3 days of hospitalization are needed.
6. Address behavioral health needs and social determinants of health.
When left untreated, behavioral health conditions often result in costly services, such as avoidable emergency room visits and longer hospital stays. ACOs report a number of challenges with addressing beneficiaries’ behavioral needs. These most commonly include a lack of behavioral healthcare providers, limited availability of data to identify beneficiaries who have behavioral health needs, and fragmented approaches to physical and behavioral healthcare.
7. Use technology to increase information sharing among providers.
Sharing medical information is helpful to coordinate care among different providers and across different settings. However, ACOs report that they do not always have access to beneficiaries' medical information from other providers—including ACO providers and providers outside the ACO—that are involved in their beneficiaries' care. They note challenges with the interoperability of ACO providers' systems and with using State and regional data systems to communicate with providers outside their ACOs.
Suit alleges half of the company's sales were for procedures performed by surgeons who got kickbacks.
Medical device maker Life Spine Inc., its founder and a senior executive are the subject of a federal lawsuit alleging that the company paid millions of dollars in kickbacks to surgeons who used their implants, the Department of Justice said.
The federal government is intervening in a whistleblower lawsuit alleging that the surgeons who took the kickbacks generated half of Huntley, Illinois-based Life Spine's total domestic sales of spinal products from 2012 through 2018.
Life Spine CEO and founder Michael Butler and Vice President for Business Development Richard Greiber were also named as defendants in the suit.
Life Spine said in a media release that it had "recently become aware of a series of allegations made in a civil complaint" and that "the parties are engaged in discussions and look forward to resolving the matter."
The federal complaint alleges that the payments violated the Anti-Kickback Statute that ultimately resulted in false claims for payment from Medicare and Medicaid.
"Cases like this are why patients sometimes distrust the care they receive because they don’t know if it’s what the doctor actually thinks, or if there is a company pushing a new drug or new device," FBI Assistant Director William F. Sweeney Jr. said in a media release.
"People seeking medical treatment are dependent on the advice they get, they don't have the expertise to question the doctors," Sweeney said. "The FBI does all it can to stop those companies who overlook the patient who is just hoping to get better, and only sees the dollar signs."
According to a complaint unsealed this week in a Manhattan federal court, from 2012 through 2015 Geiber and Butler allegedly "aggressively recruited" dozens of surgeons with the potential to use a high volume of the company's products and hired them to serve as paid "consultants."
These paid consultants agreed to transfer their patents and patent applications to Life Spine in exchange for payments and promised support to bring the surgeons' new products to market, DOJ said.
The alleged kickbacks took the form of medical education agreements that paid surgeons to provide training and/or educational services; product development agreements that paid surgeons royalties for their positive input on new products; and intellectual property agreements that paid surgeons large up-front acquisition fees for their patents/patent applications.
"Life Spine paid surgeons millions of dollars in consulting fees, royalties, and intellectual property acquisitions pursuant to these agreements," DOJ said.
Butler allegedly tracked surgeons' use of Life Spine Products to ensure that surgeons were generating sales revenues for the company and were fulfilling their "commitment" to use Life Spine Products, DOJ said.
The company allegedly generated a report that compared surgeon consulting, royalty, and intellectual property payments to surgeon product usage levels, and then calculated an return on investment for each surgeon based on those figures. If a surgeon’s usage was too low, Life Spine managers, including Butler, pressured the surgeon to use more Life Spine Products, DOJ said.
Volume has long been considered one of the key metrics for predicting surgical success.
The "vast majority" of hospitals do not meet minimal hospital or surgeon volumes for eight high-risk procedures, or policies in place to monitor the appropriateness of surgeries, with rural hospitals lagging far behind uban hospitals, a new analysis from The Leapfrog Groupshows.
Less than 3% of the 2,000 hospitals who took part in the voluntary survey met the volume thresholds for two of the high-risk procedures: open abdominal aortic aneurysm repair, and esophageal resection for cancer. Adequate volumes for bariatric surgery were achieved by 38% of the hospitals, Leapfrog found.
"It's clear from this report that patients should be very careful before they choose a hospital for one of these high-risk procedures," Leapfrog CEO and President Leah Binder said in prepared remarks.
"Beyond the disturbing findings in this report, patients should worry even more about hospitals that decline to report this information at all, because candor and transparency is the necessary first step to improvement," she said.
This year's report is the first time that Leapfrog has included a volume metric for surgical procedures and whether hospitals monitored for surgical necessity.
Volume has long been considered one of the key metrics for predicting surgical success, although some studies suggest that surgical specialty is a better gauge of successful outcomes.
Erica Mobley, Leapfrog's director of operations, said "higher patient volumes does not necessarily mean higher quality, but lower volume is not adequate for patient safety."
"Hospitals and surgeons that do a very low number of a given procedure per year cannot hone the techniques and skills necessary to successfully perform these complex and high-risk procedures," she said.
In 2015, a U.S. News & World Report study estimated that as many as 11,000 deaths could have been prevented if patients who went to the lowest-volume hospitals went instead to the highest-volume hospitals.
"The reality is that in healthcare, particularly when it comes to highly specialized care, like transplants, NICU procedures or open-heart surgery, procedure volume is critical in order to have positive patient outcomes," John D. Couris, president and CEO of Tampa General Hospital, said in a recent HealthLeaders opinion piece.
"Research continues to demonstrate that the more times a hospital performs a surgery or other procedures, the better the outcomes, the better the patient care and the lower the cost," Couris said. "High-volume thresholds ensure proficiency in skill by the physicians, which, in return, reduces the amount of medical errors."
"Without CON in place, we are now more likely to experience an increase in hospitals where providers perform complex procedures less often, maybe only a handful of times," he said.
Mobley said the Leapfrog analysis didn’t specifically evaluate certificate of need laws or compare results to areas in which CON laws are in place.
"That said, any efforts that can help to ensure that hospitals and surgeons perform an adequate volume of surgeries per year will ultimately improve surgical safety for patients," she said. "Health systems in particular can help remediate this problem by consolidating surgical services for a high-risk procedure into a single facility rather than having multiple hospitals perform the same surgery only a handful of times each year."
Not surprisingly, the report also shows that urban hospitals consistently outperform rural hospitals across all eight high-risk procedures. No rural hospital met Leapfrog's volume standard for five of the eight procedures.
Mobley said the problem is that "hospitals and surgeons are performing surgeries when they shouldn’t be."
"Hospitals and surgeons without adequate, ongoing experience with a particular procedure should refer the patient to a different facility and physician that perform more of this surgery rather than doing it themselves at that location," she said. "This isn’t always an easy conversation, but it is critical in order to provide patients with the safest care."
In prior guidance, the Internal Revenue Service and the Treasury have not included preventative care for services or benefits meant to treat an existing condition.
The U.S. Treasury has expanded preventive care benefits provided by high deductible health plans for some chronic conditions.
Under a notice issued Wednesday, HDHP enrollees can deduct contributions to a health savings account for medical care and prescription drugs for conditions such as diabetes, asthma, depression, and heart failure.
In prior guidance, the Internal Revenue Service and the Treasury have not included preventative care for services or benefits meant to treat an existing condition.
"However, the Treasury Department and the IRS are aware that the cost barriers for care have resulted in some individuals who are diagnosed with certain chronic conditions failing to seek or utilize effective and necessary care that would prevent exacerbation of the chronic condition," Treasury said in the notice.
"Failure to address these chronic conditions has been demonstrated to lead to consequences, such as amputation, blindness, heart attacks, and strokes that require considerably more extensive medical intervention," the notice said.
Treasury Secretary Steve Mnuchin said the Trump administration's expansion of preventive care benefits and access to health savings accounts "will enable more Americans to exercise greater control over their medical care."
"Cost barriers should not prevent those suffering from chronic conditions from getting the medical care they need. This more inclusive coverage will empower Americans to make the best healthcare decisions for themselves and their families," Mnuchin said in prepared remarks.
The notice does not affect the status of any medical care previously recognized as preventive care.
Mark Fendrick, MD, director of the University of Michigan's Center for Value-based Insurance Design, said the coverage expansion comes "as more and more Americans are facing high deductibles…. (and) struggling to pay for their essential medical care."
"Our research has shown that this policy has the potential to lower out-of-pocket costs, reduce federal health care spending, and ultimately improve the health of millions diagnosed with chronic medical conditions," Fendrick said.
Matt Eyles, president and CEO of America’s Health Insurance Plans, said that, for the 22 million Americans enrolled in HSAs, the new guidance "improves access to affordable medications, treatment and medical equipment – all before patients must meet their deductible."
"With this new policy, insurance providers will be able to offer enhanced preventive care before facing any deductible costs to help patients better manage their chronic conditions and avoid serious complications," Eyles said in prepared remarks.
Kim Buckey, vice president of client services at health insurance consultants DirectPath, called the expanded preventive benefits "good news for employers and employees."
"Many employers have been covering these types of medications as 'preventive' for these types of patients for a while now, so it’s encouraging to see the IRS recognizing what’s becoming standard practice, Buckey said.
"Hopefully, covering these medications pre-deductible for HDHP participants will encourage patients to fill those prescriptions, stick to the regimen prescribed by their doctors and delay/prevent the onset of more serious and acute conditions—which, in turn, will save both the employer and the employee money," she said.
Research shows 'Rory's Regulations' are saving lives, but one physician urges other states to 'proceed with caution.'
New York's statewide sepsis protocols appear to be working, according to a new study out this week in JAMA.
The protocols–known as Rory's Regulations–became law in 2013, following the death of 12-year-old Rory Staunton from undiagnosed, untreated sepsis. The protocols mandate that all hospitals adopt evidence-based practices for the identification and treatment of sepsis.
University of Pittsburgh researchers examined more than a million sepsis admission records from New York and four control states–Florida, Maryland, Massachusetts, and New Jersey– in the years before and after Rory’s Regulations took effect. They found that sepsis mortality rates dropped 4.3% in New York and 2.9% in the control states, according to the JAMA report.
The Pitt researchers showed that New York's sepsis death rate was 3.2% lower following the regulations than would have been expected, relative to the control states.
Lead author Jeremy Kahn, MD, says the study is the first to conclusively link improvements in sepsis outcomes with the implementation of holistic, evidence-based regulations.
Kahn spoke with HealthLeaders about the study findings, what they're doing right in New York state, and how that model might –or might not– work for other states.
HLM:What specifically is it that they're doing in New York that is driving success?
Kahn: Three things. One is all hospitals are mandated to implement protocols for evidence-based treatment and recognition, and more patients are getting these evidence-based therapies, specifically, early antibiotics and early resuscitation. That's really the core element of the protocols.
They're also educating staff at all hospitals in New York state so that people are going to recognize and treat sepsis better.
The third thing is they're just paying attention to it. Sepsis has been not on the public health radar for many years that focuses on heart attacks and strokes and other things that are easier to recognize, and perhaps easier to treat. Just by turning our lens to sepsis, we're able to think about it in new ways, recognize it earlier and treat it more effectively.
HLM: Does the New York model shed any light on how people acquire sepsis in the first place?
Kahn: That's still is a big unknown, and the regulations don't address that. We don't yet understand why two people get the same infection, but one gets horrible sepsis and one seems to do fine. That's a much stickier wicket and another pressing public health issue.
HLM: How many states have these sepsis initiatives?
Kahn: Two other states have pulled the trigger. One is Illinois and the others New Jersey. There are 10 to 12 states that are actively considering these regulations, including my own state, Pennsylvania. This study will prompt the rest of the states to take a harder look at whether this regulatory approach to sepsis care is useful, because we show that at least in New York, it appears to have been.
HLM: As you note, sepsis is getting more attention, but the sepsis caseload also appears to be growing. What's going on?
Kahn: Part of the answer is we're looking for it more. Whenever you look for something, you're more likely to find it. Another part is that healthcare is just shifting over the last few decades. We're doing more high-risk surgeries, doing more chemotherapy, creating more immunosuppressed patients, and those things all increase the risk of sepsis.
HLM: Are you recommending that other states take up the New York model?
Kahn: My belief is that we proceed with caution. We now have very rigorous evidence that these policies can work, but we don't yet know whether they will work in other states, and we don't yet know what makes them work so well in New York. It's reasonable for other states to proceed, but with abundant caution, because there are downsides to these policy-based approaches to sepsis care.
HLM: What are those downsides?
Kahn: There are two downsides. One is the straightforward risk of overtreatment. There's the concern that when you're forcing hospitals through regulatory mandate to do the right thing, that we will treat people too aggressively.
We found evidence of that in New York because more patients got invasive central venous catheters and those have risks. More patients were admitted to the ICU and admission to the ICU has risks.
Those things also carry costs. Are we giving too many people antibiotics? Are we giving too many people fluids? The antibiotic issue is such a sticky wicket because there's antibiotic resistance concerns.
The other downside is a bit more conceptual, which is that this is quite a heavy hand. We're mandating that hospitals adopted these evidence-based practices. In the United States, we've not been so aggressive with our health policies in the past. We use more gentle nudges to get providers to do the right thing; things like financial incentives in the form of pay for performance and value-based purchasing.
We use public reporting, which is a market-driven approach, to get providers to better adopt evidence-based practices. This is a much blunter approach. And it raises concerns because the evidence might change. These regulations need to be flexible enough to accommodate those changes.
It does give pause for us to ask if this is how we want to get providers to do the right thing? My personal belief is that physicians and hospitals have had decades to do the right thing on their own, and if there's any consistent observation in healthcare in the last 20 years, it's the gap between evidence and practice. Given that sepsis is a public health crisis, it's not unreasonable to at least try these somewhat heavy-handed policies if we go in with an open eye and make sure they're not causing more harm than good.
HLM: What are some of the roadblocks to more widespread adaptation of aggressive sepsis measures?
Kahn: We need more resources. This is an unfunded mandate. We're not asking hospitals. We're telling hospitals to engage in quality improvement, and that's very expensive. That is particularly concerning for small hospitals, rural hospitals, safety-net hospitals. My concern then is by incentivizing this very extensive quality improvement, we might be widening health disparities. There's some evidence of that in New York.
One way to change these regulations is to include provisions that create a regional quality improvement collaborative that facilitates hospitals working together so we make sure that this rising tide lifts all boats, as opposed to most of the quality improvement happening in only selected hospitals.
HLM: How much did the New York model cost to implement? Is there a breakdown on the per-patient cost?
Kahn: No, we don't have data on that. We don't know either for the patient level, or the overall cost. We did find evidence that that the regulations lead to more intensive treatment, and obviously there's a cost to implementing those.
The real cost for hospitals is the effort in developing and maintaining these protocols. A lot of hospitals use IT to support responding to the regulations if they build in a sepsis alert into their electronic health records. Those things are very costly.
We also found a lot of hospitals are hiring dedicated sepsis coordinators to oversee sepsis quality improvement and that's a very, very expensive thing. When a hospital can afford it, it's likely to have an impact. But those costs are typically absorbed by the hospital, and that lowers overall margins. It's not to the point where it's threatening the financial health of any hospital, but it is important to consider that this is, at its core, an unfunded mandate.
HLM: Where should other states start if they want to emulate the New York model?
Kahn: The first thing is to get the right people at the table. One of the things that was most successful about the New York experience was that it wasn't just the regulators developing and implementing this policy. The health systems, the clinicians and the patients' advocates were all at the table in an exceptionally collaborative effort to develop and implement these policies.
