Reforming Stark/Anti-Kickback Policies

https://www.brookings.edu/events/reforming-stark-anti-kickback-policies/?utm_campaign=Economic%20Studies&utm_source=hs_email&utm_medium=email&utm_content=69407322

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An event from the USC-Brookings Schaeffer Initiative for Health Policy

In recent years, the health care system has accelerated experimentation into new payment and delivery models that reward care coordination, integration, and value.  However, observers and market participants have expressed concerns that long-standing anti-fraud rules in Medicare and Medicaid prevent innovation and hold back potentially promising new arrangements.  In 2018, the Trump administration sought stakeholder feedback on how the regulations implementing those laws might be modified to promote value-based, coordinated, integrated care delivery while protecting taxpayers and beneficiaries from fraud.

On January 30, 2019 the USC-Brookings Schaeffer Initiative for Health Policy will host Eric Hargan, the Deputy Secretary of Health and Human Services, for a discussion about this effort. Following his presentation, experts in health care payment and delivery system reform will discuss the issue and the path forward.

 

 

 

Duke, UNC Health among health systems to join value-based program with Blue Cross NC

https://www.fiercehealthcare.com/payer/duke-wake-forest-among-health-systems-to-join-value-based-arrangement-blue-cross-nc

Duke Medical

Five major health systems are teaming up with one of North Carolina’s largest insurers to launch a new value-based care program.

Duke University Medical Center, University of North Carolina Health Care, Wake Forest Baptist Health, WakeMed Health and Hospitals, Cone Health and their respective accountable care organizations (ACOs) will join the new program led by Blue Cross and Blue Shield of North Carolina (Blue Cross NC).

Under the new program, called Blue Premier, Blue Cross NC and the health systems will be jointly responsible for better health outcomes and patient experiences while lowering costs. The idea is to make providers share risk for higher costs and inefficiencies in the healthcare system in exchange for reaping the rewards of the savings.

The total payments to the health system under Blue Premier will be based on the health systems’ ability to manage the total cost of care and their overall performance.

“Historically, our healthcare system pays for services that may or may not improve a patient’s health, and our customers simply cannot afford this approach,” said Patrick Conway, M.D., Blue Cross NC president and CEO and the former head of the Center for Medicare and Medicaid Innovation (CMMI), in a statement. “Moving forward, insurers, doctors and hospitals must work together, and hold each other accountable for improving care and reducing costs.”

The news comes just a month after Blue Cross NC announced a partnership with Aledade, a well-funded startup that partners with primary care physicians to build and lead ACOs, to launch a new initiative that will support hundreds of independently owned and operated primary care physician clinics in the state in value-based care.

The insurer has an established history of working with the health systems to find ways to drive down costs. In August, Blue Cross NC worked out a deal with UNC Health in a move that reduced premiums on the ACA exchange. However, at the same time, the insurer cut ties with WakeMed and Duke Health by discontinuing its Blue Local exchange.

Blue Cross NC has said that by 2020, it plans to have at least half of its members with a provider who is working under a value-based contract. 

 

 

Loosening Up Stark and Anti-Kickback Laws: What Would It Look Like?

https://mailchi.mp/burroughshealthcare/pc9ctbv4ft-1611881?e=7d3f834d2f

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The Department of Health and Human Services under the Trump administration has taken a deregulatory approach toward healthcare delivery. Its efforts on the payer side includes expanding the availability of individual health insurance policies that don’t conform to the rules of the Affordable Care Act, and more recently liberalizing the use of tax credits to purchase them.

However, the HHS has made one of its boldest proposals on the provider side. Over the summer, the Centers for Medicare & Medicaid Services issued a request for information (RFI) regarding potentially loosening up the Stark and anti-kickback laws.

Originally signed into law in 1972, the Anti-Kickback Statute barred any sort of renumeration to a provider to induce the referral of a patient. The Stark Law, enacted in 1990, bars doctors from referring Medicare or Medicaid patients to any ‘designated facility’ in which they have any form of a financial relationship. Both laws have been updated – and strengthened – numerous times in the intervening years. The HHS’ proposed changes would signal a shift away from how those laws are interpreted.

According to Mark Hardiman, partner with the Nelson Hardiman healthcare law firm in Los Angeles, the move represents a desire by HHS “to move all payments away from fee-for-service and make the providers at risk on both the upside and downside.”

Although the proportion of fee-for-service payments made to Medicare providers has shrunk in recent years, it still comprises the majority. A total of $392 billion in Medicare fee-for-service payments were made in 2017, according to the Kaiser Family Foundation, 56 percent of all payments made from the program. Although that’s down from 70 percent of all Medicare payments made a decade prior, the continuing aging of the Baby Boomer population and healthcare cost inflation is putting pressure on CMS and HHS to find ways to continue to pare back costs. Coordinated care initiatives such as accountable care organizations comprise just a small fraction of all Medicare payments, and many providers are balking about taking on too much downside financial risk when forming accountable care organizations.

 According to HHS, the intent is to make it easier for providers to implement value-based care initiatives. “Removing unnecessary government obstacles to care coordination is a key priority for this administration,” said HHS Deputy Secretary Eric Hargan of the rationale behind the regulatory review. “We need to change the healthcare system so that it puts value and results at the forefront of care, and coordinated care plays a vital role in this transformation.”

Nonetheless, the hospital sector has been generally supportive of regulatory changes. In testimony to a U.S. House Ways and Means subcommittee over the summer, Michael Lappin, chief integration officer at Advocate Aurora Health, observed that strict liability rules discourage value-based arrangements.

So, what would the healthcare delivery environment resemble with looser regulations governing both laws?

   According to Hardiman, the changes HHS is seeking to the regulations are far from sweeping.
“They are really on the margins, and they are not signaling a fundamental shift in the enforcement of the Stark and  Anti-Kickback Law,” he said. 

Why would there not be a major regulatory unraveling? Hardiman notes that doing so would create chaos in healthcare delivery. Moreover, qui tam(whistleblower) lawsuits in healthcare have become a major source of income for attorneys, and they would object to too much of an unwinding. Data from the non-profit watchdog organization Taxpayers Against Fraud bears that out: Of the more than $3.7 billion in False Claims Act settlements reached in 2017, $2.4 billion involved litigation involving healthcare enterprises. It was the eighth consecutive year that healthcare case settlements topped $2 billion. Hardiman also noted that more and more litigation is being settled for large sums even when the U.S. Justice Department declines to intervene in a case.

Hardiman believes that if the regs are loosened, they would likeliest be in the form of a “series of fraud and abuse waivers.” They would cover initiatives such as managed care ventures or ACOs, making it easier for hospitals and physicians to collaborate on care coordination, as well create models to more equitably share expenses and profits and encourage cross-referrals.

“You are going to see a much more comprehensive definition as to what types of risk-sharing arrangements will not be reviewed as renumeration under the kickback statute,” Hardiman said. “I wouldn’t be surprised to see safe harbors around Medicare Advantages, ACOs, and participants in other innovative risk-sharing arrangements.”

Individual physicians and medical groups may also have the opportunity to pay inducements to patients to lose weight or engage in another health-enhancing activity – something they are currently barred from doing under most circumstances.

“Everybody knows we’re heading toward a value-based coordinated care model,” Hardiman said. “And promoting and incentivizing it is still a risky business. You want at least some practical guideposts.” 

 

Policy upheaval, tech giant disruption and megamergers: Healthcare Dive’s 10 best stories of 2018

https://www.healthcaredive.com/news/policy-upheaval-tech-giant-disruption-and-megamergers-healthcare-dives-1/543390/

Mobile health records and nurse protests also grabbed readers this year.

This year in healthcare was marked by sweeping changes, including seemingly constant vertical and horizontal consolidation, led by the $69 billion CVS grab of Aetna and Cigna’s $67 billion acquisition of Express Scripts.

As 2018 wound down, a federal judge took an ax to the Affordable Care Act as the Trump administration kept up its efforts to undermine the law, with CMS expanding short-term health plans many say are built to subvert the ACA. Elimination of the individual mandate penalty, Medicaid expansion and rising premiums all likely contributed to declined enrollment on ACA exchanges as well.

The administration encouraged states to use waivers to expand controversial Medicaid work requirements and proposed site-neutral payments, rattling health systems of all sizes that were already struggling under ferocious operating headwinds. Hospitals cut back on services and invested heavily in lucrative outpatient facilities in an attempt to reclaim volume.

Tech companies Apple and Amazon pushed further into the space, with the former focusing on mobile health apps and the latter focusing on, well, almost everything.

But that’s just scratching the surface. Here is a curated list of Healthcare Dive’s top stories from the last year.

    1. Optum a step ahead in vertical integration frenzy

      After a 2017 marked by failed horizontal mergers, vertical consolidation came into vogue during the year, led by CVS-Aetna, Cigna-Express Scripts and Humana-Kindred.

      Some smart observers saw a predecessor to these unions in UnitedHealth Group’s Optum: a pharmacy benefit manager plus a care services unit that employs over 30,000 physicians, using data analytics to capitalize on consumerism and value-based care.

      Our piece on Optum’s solid foothold in the space, and its likelihood of staying ahead of the nascent competition, was Healthcare Dive’s most-read article in 2018. Read More »

    2. New Medicare Advantage rules hold big potential for pop health

      A novel Medicare Advantage rule giving payers more flexibility to sell supplemental benefits to chronically ill enrollees sparked a fair amount of interest in our readers.

      The rule offered up a slate of new opportunities for insurers such as UnitedHealthcare and Humana that can now work with rideshare companies to provide transportation to medical appointments, air conditioners for beneficiaries with asthma and other measures around issues like food insecurity in a broad shift to recognizing social determinants of health. Read More »

    3. Apple debuts medical records on iPhone

      Outside players such as Apple, Amazon and Google moved forward in their bids to disrupt healthcare in 2018. Apple rang in the New Year with its announcement that customers would now be able to access their medical records on the Health app following months of speculation and buzz.

      The move looks to put access to personal, sensitive data back in the patients’ hands, an objective a lot of the entrenched healthcare ecosystem can get behind as well. Heavy hitters on the EHR side (Epic, Cerner, athenahealth) and the provider side (Johns Hopkins, Cedars-Sinai, Geisinger) are taking place in the initiative. Read More »

    4. At least 14 states have legislation addressing safe staffing currently, but California is the only one to implement a strict ratio at one nurse per every five patients. Looking to 2019, in Pennsylvania voters elected a governor who has voiced support for state legislation. Read More »
    5. More employers go direct to providers, sidestepping payers

      Employers ramped up their cost-containment creativity in 2018. One method? Cutting out the middleman and forging direct relationships with providers themselves, whether it’s contracting with an accountable care organization to manage an entire employee population or a simple advocacy role to fight for payment reform.

      Aside from some correlated CMS interest, big names forging inroads in the arena include General Motors, Walmart, Whole Foods, Boeing, Walt Disney and Intel, all with various levels of investment.

      Although only 6% of employers are doing so currently, 22% are considering solidifying some sort of provider relationship for next year according to a Willis Towers Watson survey. It’s also likely the Amazon-J.P. Morgan-Berkshire Hathaway venture will look at direct contracting in its (still vague) mission to lower employer costs. Read More »

    6. Amazon Business’ medical supply chain ambitions: 4 things to know

      Amazon’s B2B purchasing arm reached out and grabbed the healthcare supply chain this year, shaking a once-predictable business model.

      Under intense operating headwinds, supply chain professionals looked to trim the fat from traditional distribution and supplier models in 2018. Some looked to Amazon Business, which generated more than a billion dollars in sales its first year alone by relying on its marketplace model, streamlined ordering and a “tail spend” strategy.

      1. Healthcare Dive discussed this and more with global healthcare leader at Amazon Chris Holt in an exclusive interview that drove a lot of interest. Read More »

GE, Medtronic among those linking with hospitals for value-based care

Value-based care was a buzzword over the past year, with providers, payers and healthcare execs across the board looking (or saying they’re looking) for ways to cut costs and improve quality.

Although legal barriers stemming from the Anti-Kickback Statute and Stark Law persist, medical technology companies jumped on the bandwagon, with big names like GE, Philips and Medtronic coupling with hospitals to promote VBC initiatives. Read More »

  1. How Amazon, JPM, Berkshire Hathaway could disrupt healthcare (or not)

The combination of the e-commerce giant, a 200-year-old multinational investment bank and Warren Buffet’s redoubtable holding company joining forces to take on healthcare costs spooked investors in traditional industry players. The venture added a slew of big names to its C-suite, including Atul Gawande and Jack Stoddard for CEO and COO, respectively. Read More »

 

 

 

CMS Reevaluates Stark Law in Response to Value-Based Care Initiatives

http://www.managedhealthcareexecutive.com/health-law-and-policy/cms-reevaluates-stark-law-response-value-based-care-initiatives?rememberme=1&elq_mid=2696&elq_cid=876742&GUID=A13E56ED-9529-4BD1-98E9-318F5373C18F

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On June 20, 2018, CMS and HHS issued a “request for information” (RFI) seeking input on strategies to reduce the burden of the federal physician self-referral law or “Stark Law,” including the law’s impact on the transition to value-based care.

In the RFI, CMS solicits information on the ways in which the Stark Law creates challenges for coordinated, value-based care, and the transition to alternative payment and delivery models; it also seeks ideas and input on how the Stark Law may be changed to facilitate these models.

What’s driving the RFI

The RFI is launched as part of the agency’s “Regulatory Sprint to Coordinated Care” led by HHS Deputy Secretary Eric Hargan, which is directed at addressing regulatory barriers to coordinated care.  As such, the Regulatory Sprint and the RFI represent the administration’s efforts to reduce regulatory burden, while also demonstrating a commitment to the transition to more value-based, coordinated care and risk-based payment.  In public statements, HHS and CMS officials have suggested that the Regulatory Sprint may support similar flexibility in other laws, including the Anti-Kickback Statute.

Although the agency does not commit to any specific regulatory changes in this document, it is notable that HHS issued a similar RFI in 2010 just before it issued sweeping waivers of the Stark Law and Anti-Kickback Statute for the Medicare Shared Savings Program.  While many of the questions focus on “Alternative Payment Models” under the Quality Payment Program, the RFI is not limited to these programs.  Instead, the RFI invites the public to propose new exceptions and revised interpretations of the statute to advance the goals of coordinated care.

What CMS wants to know

In the RFI, CMS poses twenty specific questions related to the Stark Law, Alternative Payment Arrangements, and delivery system innovation strategies. The topics and questions range from:

  • Requests for details on Alternative Payment Models and innovations considered or engaged in by healthcare delivery system participants, including details on the financial and operational details of the arrangements, such as financial risk;
  • Solicitation of ideas and input on additional and/or new exceptions to the Stark Law that would facilitate existing and innovative arrangements;
  • Thoughts on changes to existing provisions of the final rule implementing the Stark Law, such as definitions of “commercial reasonableness” and “fair market value,” and thoughts on other potential definitions and terms such as “Alternative Payment Model,” clinical and financial integration and others;
  • Comments on key concepts in the existing law including compensation formulas that do and do not take into account the volume or value of referrals or other business within the meaning of the Stark Law and other novel financial arrangements; an
  • Requests for information on the Stark Law’s compliance cost, the potential role of increased transparency to promote compliance and how CMS should assess the Stark Law’s effectiveness in achieving its underling policy goals related to improper financial incentives.

The RFI may represent an important opportunity for the healthcare industry to educate CMS on current experiences and challenges, and to shape the content of future rules implementing changes to the Stark Law, particularly in a time of industry integration across the continuum of care.  The RFI also offers tangible evidence of the administration’s commitment to continue a migration to value-based care, and potentially reflects an enhanced commitment and desire to migrate away from fee-for-service payment to arrangements involving financial risk.

 

 

CMS seeks input on Stark Law changes amid value-based care shift

https://www.healthcaredive.com/news/cms-seeks-input-on-stark-law-changes-amid-value-based-care-shift/526239/

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Dive Brief:

  • The Centers for Medicare & Medicaid Services asked stakeholders Wednesday for input on how to change the Stark Law to allow for better care coordination and new alternative payment models or other novel financial arrangements.
  • The American Hospital Association has been vocal in pushing for changes to the physician self-referral law, calling it outdated. AHA argues the law presents “nearly impenetrable roadblocks in the move toward value-based care.”
  • The agency specifically is requesting input on what new exemptions to the Stark Law are needed to protect accountable care organization models, bundled payment models and other payment models, including how to allow coordination care outside of an alternative payment model. It also asks for help examining definitions for terminology such as risk-sharing, enrollee, gain-sharing and other terms.

Dive Insight:

The Stark Law, enacted in 1989, aims to cut down on financial incentives impacting physician care decisions. It prohibits certain Medicare-payable referrals to entities they have a financial or familial relationship with, and stops such entities from filing Medicare claims for referred services, unless exempted under certain instances.

CMS says that it is issuing the RFI in response to comments it has received that raised concern that the Stark Law is impeding participation in healthcare delivery and payment reform efforts.

“We are particularly interested in your thoughts on issues that include, but are not limited to, the structure of arrangements between parties that participate in alternative payment models or other novel financial arrangements, the need for revisions or additions to exceptions to the physician self-referral law, and terminology related to alternative payment models and the physician self-referral law,” the CMS notice states.

In a statement submitted by AHA to the House Subcommittee on Health of the Committee on Ways and Means, the group urged Congress to step in to change Stark Law to allow hospitals and physicians to more closely work together.

“Congress should create a clear and comprehensive safe harbor under the anti-kickback law for arrangements designed to foster collaboration in the delivery of health care and incentivize and reward efficiencies and improvement in care,” AHA said.  “In addition, the Stark Law should be reformed to focus exclusively on ownership arrangements. Compensation arrangements should be subject to oversight solely under the anti-kickback law.”

CMS Administrator Seema Verma appears to be sympathetic. In a Wednesday blog post, she said the Stark Law may be prohibiting value-based arrangements that HHS has made a priority to shift towards. Previously, Verma said that CMS was going to put together an inter-agency group to examine potential changes to the law.

“I think that Stark was developed a long time ago, and this gets to where we are going modernizing the program,” Verma told AHA President and CEO Rick Pollack during a webcast in January. “The payment systems and how we are operating is different, and we need to bring along some of those regulations and figure out what we can do. And I’m not sure that this is not going to require some congressional intervention as well.”

CMS is asking for comments to be submitted on the RFI by August 24.

 

‘No profit, no mission’ — Why this CEO believes every healthcare leader needs a strong understanding of finance

https://www.beckershospitalreview.com/hospital-management-administration/no-profit-no-mission-why-this-ceo-believes-every-healthcare-leader-needs-a-strong-understanding-of-finance.html

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In this special Speaker Series, Becker’s Healthcare caught up with Mark R. Anderson, CEO of AC Group, a healthcare technology and advisory research firm based in Montgomery, Texas.

Mr. Anderson will speak on a panel at Becker’s Hospital Review 7th Annual CEO + CFO Roundtable titled “The CEO paradox: Can you really have volume and value?” at 12:00 p.m. on Monday, Nov. 12. Learn more about the event and register to attend in Chicago.

Question: What keeps you excited and motivated to come to work each day?

Mark Anderson: The knowledge that we are finally moving away from fee-for-service billing to value-based reimbursement. For example, at AC Group, we have been able to cut medical costs for diabetic patients by 38 percent just by tracking blood sugar levels at home. Pay for results — don’t pay for just seeing the patient.

Q: What major challenges, financial or otherwise, are affecting hospitals in the markets you serve? How is your hospital responding?

MA: With hospital bankruptcies on the rise, we need to change how we deliver cost effective care and how we are paid. Because of high deductible health plans, the patient portion of the bill has increased from 9.4 percent in 2019 to 26.9 percent in 2017. How do we collect from the patient? How can we share clinical information about the patient with all providers without hurting our financial position?

Q: What initially piqued your interest in healthcare?

MA: It was my high school graduation present from my father. I wanted a trip to Hawaii and all I got was a letter stating, “Congratulations for finishing in the top 4 percent of your high school class. For your reward, you start work on Monday as the statistician for the hospital CEO.” Forty-five years and 250 hospitals later, I am still in hospital executive management.

Q: What is one of the most interesting healthcare industry changes you’ve observed in recent years?

MA: To name a few: Moving to electronic billing in 1985, moving from spending 2.1 percent on IT in 2005 to over 6.5 percent today (was it worth it?), forcing physicians to become data entry clerks so we can maximize coding with very little improvement in “health,” and moving to value-based reimbursement from fee-for-service so we are finally paid on quality, outcomes and our ability to lower costs through care coordination and remote patient monitoring. The four walls of the hospital are not the only care delivery system. Ninety-five percent of healthcare is delivered in the home.

Q: What is one piece of professional advice you would give to your younger self?

MA: Don’t enter the healthcare market without a strong financial knowledge base. Healthcare is a business. As the nuns told me back in 1976, no profit — no mission to help the poor and disadvantaged.