Meet the New Acting Administrator – First 100 Days, 6 Questions with Andy Slavitt

Earlier this year, Andy Slavitt was named Acting Administrator for the Centers for Medicare & Medicaid Services (CMS). As Acting Administrator, Andy oversees programs that provide access to health care for 140 million Americans, including Medicaid, Medicare, the Children’s Health Insurance Program, and the Health Insurance Marketplace. 

1. You’ve been at CMS 100 days. Tell us about how you’ve spent your time. 

The best way to learn anything is to ask a lot of questions. Over the last 100 days, I’ve met with over 300 CMS employees in Washington, Baltimore, and at regional offices and I’ve talked with many more staff at all our employee meetings. I’ve also conducted well over 100 external constituent meetings. When I meet with people I like to ask: How does CMS need to improve? How does your work contribute to CMS’s mission? What do you want CMS to be known for? As I ask questions, I share a little of my personal philosophy on leading, thoughts about our priorities, and how we should get our work done. I talk about the power of an execution mindset; the importance of keeping the people we serve at the center of our work; the need for us to be good partners, which means being clear, consistent, urgent and foster simplification; and to not just drive change, but support it. Over the last couple of months, I’ve really enjoyed the opportunity to learn more about the Agency. I’ve been close to Medicare and Medicaid my entire career, but there’s nothing like learning from the people who are most invested in the success of these programs.

2. What do you see as the biggest priorities for the agency? 

Our priority is simple – continue to improve our health care system by providing better care, with a smarter payment system that keeps people healthier. The progress that has been made as we stand here at the 50th Anniversary of Medicare and Medicaid and at the 5th anniversary of the passage of the Affordable Care Act is encouraging, but it’s only a start. The opportunities before us are exciting. We are at the center of change—with the opportunity to expand the impact we have as we cover more people in new programs and purchase care differently to reward physicians and hospitals who deliver high-quality care. At CMS, we need to focus on the changing needs of our consumers, on providing access to high quality care, and to delivering on our commitment to do everything we do transparently, with urgency and with accountability. 

3. What are your formative career and health care experiences? How have they prepared you for this job?

Like many people who work in health care, a personal experience was a big shaper of my career. I lost one of my closest friends at a young age and helped his wife deal with the threat of personal bankruptcy in the wake of his death because of the medical expenses he incurred. I learned it was far from uncommon for a young mother with two babies to start her life over in bankruptcy for no other reason than her husband’s illness and that situations like hers happened to countless people every year. I left my job to create a company, HealthAllies, with the goal of helping solve this problem through a consumer web-based service that contracted nationwide for affordable care for the underinsured like my friend’s family. I will never forget the feeling of vulnerability that’s at the center of all of our experiences with the health care system. 

In many ways, everything I experienced in the private sector was preparatory work for my work here at CMS. I’ve been involved in Medicare, Medicaid, Children’s Health Insurance Programs, and the private sector delivery of health care – and the transformation of it – for nearly my entire career. From building primary care practices to developing the largest data and analytics tools and measures to driving innovation by using health care technology and population health.  During these years, I learned that so much of what the federal government does impacts what happens on the ground – to consumers and to physicians. If there’s one thing local communities want from us it’s to simplify things to allow care givers to spend more productive time with patients, keeping them well and keeping them at home.  Leading CMS is an enormous privilege and I am committed to what drove me into health care – to remembering that health care is local and it’s personal. My job and every other CMS employee’s job is to help make the health care system stronger through listening to the needs of consumers and being good supportive partners with the delivery systems, states and other stakeholders.

4. What grounds you in this job?

Today CMS serves 140 million beneficiaries and consumers. I wake-up every day thinking about them. How many are in a hospital, aching to go home? How many are struggling to find good care for an asthmatic child? How many are between jobs and looking for coverage and hoping for something affordable? The fact is: serving close to half the people in the country means the daily needs and circumstances are diverse and profound. That’s why whenever I travel, I visit nursing homes, health centers, and ERs. I ask about the discharge planning. I ask what can be done to simplify their relationship with us. The first thing I do every morning is to read and personally answer emails from beneficiaries and make sure their situations are being followed up on. It’s the single action I can take that lets people know what I think is important. 

The other people that ground my thinking are taxpayers. There’s no doubt I bring a business performance perspective to the job. If beneficiaries are our customers, then in a private sector analogy, taxpayers are our shareholders. American families invest their tax dollars every year to support the Medicare and Medicaid programs; they expect these programs to not only perform well today but to be available for them when and if they need them in the future. 

On any given day, you’re not going to make everyone happy in a job like this. I just need to go to sleep every night feeling like we’ve done the best job possible for the people who count on us the most and will count on us in the future. 

5. What motivated you to join the team at CMS?

I have been working in health care my entire career. As a country, we are transitioning from a time when the action was all about debating policy to a time when the focus needs to be on getting it done and making it work. I believe in the adage that success is 90% about implementation. From overseeing the health insurance exchanges to implementing Accountable Care Organizations and making improvements to the long term health of Medicare, Medicaid or CHIP, I have this vision of CMS as an arm of government that is all about providing access to quality health care to millions of Americans but also getting the job done right. We have a lot of important things to accomplish. If we can bring the speed, the focus, the accountability and the transparency that exists in the best of organizations to the job we’re doing every day at CMS, millions of people benefit. Before I took this job, I don’t think I realized how many good things could get done every day. It’s one reason why I love this job. 

6. Finally, how about something personal. How does your family feel about your taking this new role?

I’m not going to pretend that being away from my wife and my two teenage sons is easy. I fly home to Minnesota every weekend. We’re quite aware that the kids’ time at home is limited and precious. The four of us are extremely close and spend a lot of time laughing together, having serious conversations about the world, and finding ways to support one another. My wife knows what it’s like for people who struggle economically and health wise and she’s one of the smartest and most capable people most people know. Doing public service is something of great importance to both my wife and me and she does everything in her power to make sure I can focus on the important opportunity I have to do the job in front of me.

See also:

Affordable Care Act initiative supports care coordination in rural areas

– By Patrick Conway, M.D., Deputy Administrator for Innovation and Quality and Chief Medical Officer, Centers for Medicare & Medicaid Services

While we have accomplished a lot to make sure Americans have access to good, quality health care, continuing to reform our health care system by increasing quality and lowering costs will need everybody to be a part of the effort.  Part of that will mean continuing important work with health care providers to reform health care delivery, efforts that have already shown promising results, including through Accountable Care Organizations (ACOs).  ACOs are groups of doctors, hospitals, and other health care providers, who come together voluntarily to provide coordinated, high-quality care to their Medicare patients to help them deliver better care at lower cost.  Learn much more about ACOs in our fact sheet out today.

The Centers for Medicare & Medicaid Services (CMS) today announced two modifications to the design of the ACO Investment Model, which will help rural areas and small group practices gain more access to the benefits that ACOs have shown across the country.  These two changes will newly allow ACOs starting in the Medicare Shared Savings Program in 2015 to apply in the upcoming application round, and it will remove the 10,000 or fewer assigned beneficiary eligibility criteria for rural ACOs that started in the Medicare Shared Savings Program in 2015 (or will start in 2016).

These two changes reflect the Innovation Center’s commitment to listening to suggestions and ensuring that demonstrations are widespread, including rural providers and smaller physician groups.

The application for the second round of the ACO Investment Model was made available for viewing on  June 2nd. On July 1st, 2015, the application will open for ACOs that started in the Shared Savings Program in 2014 and 2015 – or are scheduled to start in 2016.

The ACO Investment Model is expected to provide a total of $114 million in upfront investments to up to 75 ACOs across the country. Making payments of shared savings in both upfront and ongoing amounts will help these ACOs invest in care coordination, health information technology, and population health platforms to help shift our health care system from one that provides reactive care to one that provides proactive, preventive care.

Through the CMS Innovation Center, this initiative will provide upfront and ongoing investments in infrastructure and redesigned care process to help eligible ACOs continue to provide higher quality care. This will help increase the number of beneficiaries that can benefit from lower costs and improved health care through Medicare ACOs. CMS will recover these payments through an offset of an ACO’s earned shared savings.

ACOs are one part of the overall effort provided by the Affordable Care Act to help lower costs and improve care and quality. For example, the Affordable Care Act has helped reduce hospital readmissions in Medicare by nearly eight percent between 2012 and 2013 – translating into 150,000 fewer readmissions – and quality improvements have resulted in saving 50,000 lives and $12 billion in health spending from 2010 to 2013.

For more information on the ACO Investment Model, please visit: http://innovation.cms.gov/initiatives/ACO-Investment-Model/.

Strong Start for Mothers and Newborns II First Annual Evaluation Report

By Patrick Conway, MD, Acting Principal Deputy Administrator of CMS

Today, we at the Centers for Medicare & Medicaid Services (CMS) are pleased to announce preliminary findings from the first annual evaluation report for Strong Start for Mothers and Newborns (Strong Start) strategy II cooperative agreements.  Strong Start is a federal initiative geared toward testing innovative approaches to improve maternal and infant health outcomes in low-income families. The work of the Partnership for Patients and the first strategy of Strong Start contributed to decreasing early elective deliveries 64.5 percent nationwide between 2010 and 2013, which may improve birth outcomes and increase numbers of healthy newborns. The second strategy seeks to build on this success by using innovative approaches to prenatal care for Medicaid and CHIP participants to promote maternal and infant health and to reduce preterm birth and low birth weight infants. Today’s preliminary results show the positive potential of strategy II to contribute to these goals.

We created the Strong Start initiative to leverage work conducted by the Partnership for Patients and decades of research that reiterate the health and financial risks associated with a lack of accessible, quality prenatal care available to Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries. This research consistently shows that infants born preterm (before 37 completed weeks of gestation) have higher mortality risks and may endure a lifetime of developmental and health problems. In addition to having enormous medical needs, children born preterm often require early intervention services and special education and may have conditions that affect their productivity through adulthood.

To address this care need, we partnered with 27 organizations with 213 provider sites in 30 states, Washington, D.C., and Puerto Rico. The three year program tests evidence-based approached to reducing the rate of preterm births through three approaches:

  • Group Care – Group prenatal care that incorporates peer-to-peer support in a facilitated setting for three components: health assessment, education and support.
  • Birth Centers – Comprehensive prenatal care facilitated by midwives and teams of health professionals, including peer counselors and doulas.
  • Maternity Care Homes – Enhanced prenatal care at traditional prenatal sites with enhanced continuity of care and expanded access to care coordination, education, and other services.

Preliminary results from the first year evaluation indicate that Strong Start participants have

  • lower rates of cesarean than national averages,
  • higher rates of breastfeeding than national averages, and
  • overall lower rates of preterm birth than national averages.

The CMS evaluation indicates that when beginning the program, Strong Start participants had high levels of emotional and psychosocial needs such as food insecurity, chronic unemployment, unstable housing, lack of reliable transportation, unmet dental and behavioral health needs and low knowledge about self-care, nutrition, and healthy pregnancy. Preliminary results indicate that a common element among the three prenatal care models is an emphasis on relationship-centered care, including providing education on pregnancy, preterm risks, and self-care and connecting participants to community resources.

The initiative’s enhanced programs are designed to meet the specific emotional and psychosocial needs of their local populations. Strong Start participants expressed overwhelming satisfaction with their prenatal care, with nearly 90% of participants stating that they were either very satisfied or extremely satisfied with their care.

Although many awardees and provider sites faced common implementation challenges such as enrolling participants and integrating enhanced services into existing models, they also shared common promising practices. These included

  • strategies to promote engaged relationships with providers and staff,
  • adapting programs to the needs of the target population, and
  • developing skilled and resourceful staff.

Results should be interpreted cautiously as awardees were in various stages of implementation during the first year.  Comparisons with national averages are descriptive only and are not controlled for important factors such as risk profiles or demographics.  We cannot yet be certain that results are a direct result of Strong Start or if these outcomes are similar to those found in these particular care approaches prior to the initiative.  Annual evaluations of the second and third years of operations are likely to indicate more definitive findings as more comprehensive data becomes available for analysis.

Much work remains to be done to reduce the risk of significant complications for women and infants.  As a practicing pediatrician, I know the importance of this work and its impact on patients and families.  We remain committed to working together to improve health delivery, health outcomes, and cost of quality care for low-income pregnant women and their newborns.

Proposed Rules Include Commitment to Better Care, Smarter Spending, and Healthier Medicare Beneficiaries as well as Implement the IMPACT Act

By: Patrick Conway and Sean Cavanaugh

In January, Secretary Burwell announced a new vision for the Medicare program, including clear goals and a timeline for shifting Medicare payments increasingly from volume to value.  Through this vision, we crystalized the work we have been pursuing across the agency into real, measurable goals.

Over the past few weeks, CMS began the annual process of updating the payment rates and policies that apply to providers who furnish care to Medicare fee-for-service beneficiaries. So far this month, we released proposed updates for hospital inpatient care, skilled nursing facilities, hospice providers, and a few others.

Through these updates, we’re proposing important updates that reflect how we want the Medicare program to help build a health care system that delivers better care, spends our health care dollars more wisely, and results in healthier people. For example:

  • Potentially Expanding Bundled Payments for Care Improvement – Through the CMS Innovation Center, CMS has been testing some promising new payment arrangements in an initiative called Bundled Payments for Care Improvement. In the proposed hospital inpatient prospective payment system (IPPS) rule, CMS is looking for public comment on issues we should consider if the initiative is expanded.
  • Updating the Hospital Value-Based Purchasing Program – At CMS, we’re always looking for opportunities to improve or sharpen our initiatives. CMS is proposing in the FY 2016 IPPS/LTCH proposed rule to expand the quality measures used in this program to assess hospital performance.
  • Introducing Value-Based Purchasing to Skilled Nursing Facilities – The proposed rule for Skilled Nursing Facility payments lays the groundwork for implementation of a new Value-Based Purchasing program, authorized by the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113–93), which will tie some portion of payments made to skilled nursing facilities to performance on a hospital readmission measure.

Implementation of the IMPACT Act

Several of the payment rules propose quality measurement requirements that implement the first stage of the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act). Enacted on October 6, 2014, the IMPACT Act requires the Secretary to collect standardized patient assessment data and data on quality, resource use, and other measures from four types of post-acute care providers: home health agencies, inpatient rehabilitation facilities, skilled nursing facilities and long term care hospitals. The IMPACT Act also requires the reporting of quality measures and resource use measures in specific domains.

In the recently published rules, CMS has proposed to adopt the following cross-cutting quality measures for three of these four settings: (1) new or worsening pressure ulcers; (2) falls with major injury; and (3) having an admission and discharge functional assessment with a care plan that addresses function.

Seeking Comments

As with all work we do through rulemaking, we are looking for input from stakeholders and the rest of the public. We use those comments to make our final rules better, and make sure we’re on track.

The Secretary has put forward an exciting vision for the future of the Medicare program.  We’re looking forward to finding new ways to put the beneficiary experience first, and to make that vision a reality.

 

Open Payments: Data review and dispute underway for physicians – log in today

By Shantanu Agrawal, M.D., CMS Deputy Administrator for Program Integrity

In its second year, the Open Payments program continues to promote transparency and accountability in health care by providing consumers with information about financial relationships between drug and medical device manufacturers and physicians and teaching hospitals. The data posted has been viewed nearly 6 million times and we’re pleased with the continuing engagement of stakeholders on this important transparency initiative.

All data for payments made in 2014 has been submitted by the drug and medical device manufacturers who are reporting the information. CMS is encouraging physicians and representatives of teaching hospitals to register in Open Payments now. Instructions and quick tips for registration are available here. While companies that are submitting payment records to CMS attest to the accuracy of the data, the continued success of the program relies on voluntary participation by physicians and teaching hospitals. This is the only opportunity for doctors and teaching hospitals to review the data submitted by manufacturers and group purchasing organizations (GPOs) before it is included in the public database on June 30, 2015.

CMS acknowledges the benefits of collaboration among physicians, teaching hospitals and drug and device manufacturers in the design and delivery of many life-saving drugs and devices. Open Payments has given patients a tool to become more involved and informed health care consumers by discussing these relationships with their physicians.

Last year, 26,000 physicians registered in the system and lodged over 12,500 disputes. In contrast, we published information about 4.45 million payments made to at least 366,000 physicians or teaching hospitals that were valued at $3.7 billion. I expect that the data reported this year will be on scale with the number and value of payments reported last year. For physicians, the only way for each of you to confirm that the data reported about you is correct is to register and review your payments before the review period ends.

To learn more about the program, visit cms.gov/openpayments today.

Physician Quality Reporting Programs Strategic Vision

By Patrick Conway, MD, Principal Deputy Administrator and Chief Medical Officer

As CMS releases statistics on the 2015 PQRS payment adjustment for the first time to the public, we are also announcing the publication of the Physician Quality Reporting Programs Strategic Vision (or “Strategic Vision”). This Strategic Vision, (http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/index.html), describes a long-term vision for CMS quality measurement for physicians and professionals and public reporting programs, and how they can be optimized and aligned to support better decision-making from doctors, consumers, and every part of the health care system. The physician quality programs support our vision of a health system that achieves better care, smarter spending, and healthier people. These programs support incentives to providers, encourage improvements in care delivery, and deliver information to consumers.

There are five principles we believe will ensure that  quality measurement and public reporting play a critical role in improving the healthcare delivered to millions of Americans:

  • Input from patients, caregivers, and healthcare professionals will guide the programs.
  • Feedback and data drives rapid cycle quality improvement.
  • Public reporting provides meaningful, transparent, and actionable information.
  • Quality reporting programs rely on an aligned measure portfolio.
  • Quality reporting and value-based purchasing program policies are aligned.

CMS relies heavily on quality measurement and public reporting to facilitate the delivery of high quality care. This Strategic Vision articulates how we will build upon our successful physician quality reporting programs to reach a future-state where quality measurement and public reporting are optimized to help achieve the CMS Quality Strategy’s goals and objectives, and therefore contribute to improved healthcare quality across the nation, including better care, smarter spending, and healthier people.

The Strategic Vision evolved out of our desire to plan for the future in how we administerthe Physician Quality Reporting System (PQRS), Physician Feedback/Value-Based Payment Modifier Program, and other physician quality reporting programs. With passage of HR2, key components of these physician programs will serve as the foundation for the Merit-based Incentive Payment System. The Strategic Vision describes in concrete terms how we will advance the goals and objectives for quality improvement outlined in the CMS Quality Strategy through these quality measurement and reporting programs.

These quality measurements and public reporting goals and initiatives encourage stakeholder engagement; reduce participation burden for healthcare professionals; and support meaningful public reporting. Our long-term vision for physician quality reporting programs and the improvement of these programs challenges us to continue striving for excellence in healthcare quality over the next several years.

FDA and CMS Form Task Force on LDT Quality Requirements

By: Jeffrey Shuren, M.D., J.D. and Patrick H. Conway, MD, MSc

Health care providers and their patients expect that laboratory tests used in clinical management of patients should be consistent and of high quality.

Under FDA’s Jeff Shuren, M.D., J.D.proposed framework for the oversight of laboratory developed tests (LDTs), outlined in draft guidance documents issued in October 2014, FDA would oversee the quality of these laboratory tests, along

—Jeff Shuren, M.D., J.D.side the Centers for Medicare and Medicaid Services (CMS), which regulate the laboratories themselves through the Clinical Laboratory Improvement Amendments (CLIA). We have heard stakeholder confusion about the roles of the two agencies in ensuring quality and concerns about potentially duplicative efforts. To coordinate efforts across the Department, FDA and CMS are establishing an interagency task force that will continue and expand on our collaboration related to the oversight of LDTs, which are tests intended for clinical use and designed, manufactured, and used within a single lab. The task force, comprised of leaders and subject matter experts from each agency, will work to address a range of issues, including those involving quality requirements for LDTs.

Patrick H. Conway, MD, MSc —Patrick H. Conway, MD, MScUnder the proposed LDT framework, FDA would phase in enforcement of premarket review requirements and the quality system regulation for some LDTs. FDA’s oversight of LDTs will assure that the tests are both analytically valid (able to accurately detect analytes) and clinically valid (able to measure or detect the clinical condition for which the test is intended). FDA is currently reviewing public comments on the draft guidances that it received through an open public docket and a two-day public meeting. In response to public comments, FDA may modify the proposed framework when we issue final guidance.

CMS, under CLIA, oversees the labs’ processes, rather than the tests they develop. CLIA and its implementing regulations include requirements for establishing and maintaining quality laboratory operations and ensuring the lab is staffed by qualified personnel. These laws do not require premarket review of tests or any evidence that a test is clinically valid.

When FDA’s proposed framework is implemented, both FDA and CMS will play a role in ensuring that LDTs are high quality—CMS through CLIA by continuing to focus on laboratory operations including the testing process and FDA by enforcing compliance with the agency’s quality systems regulation pertaining to the design and manufacture of the laboratory tests.

Although the roles of the agencies are different, FDA and CMS share an interest in ensuring effective and efficient oversight of LDTs so laboratories can offer tests to the American public with confidence that they are accurate and provide clinically meaningful information without unnecessary or duplicative agency oversight.

The goals of the FDA/CMS Task Force on LDT Quality Requirements include:

  • identifying areas of similarity between the FDA quality system regulation and requirements under CLIA;
  • working together to clarify responsibilities for laboratories that fall under the purview of both agencies; and
  • leveraging joint resources to avoid duplication and maximize efficiency.

The task force is currently exploring areas where collaboration may realize greater oversight efficiency and produce the greatest benefit to patients, providers, and laboratories. The task force understands stakeholders’ concerns about differences in terminology used by FDA and CMS. We intend to clarify the terms used so that labs may better understand what is expected of them.

Our new task force is committed to its stakeholders and intends to provide education and outreach, including an upcoming webinar series, to address additional needs that are identified during this collaboration. We welcome any feedback and encourage you to contact us at LDTFramework@fda.hhs.gov.

Jeffrey Shuren, M.D., J.D., is Director of FDA’s Center for Devices and Radiological Health

Patrick H. Conway, MD, MSc, is Acting Principal Deputy Administrator CMS Chief Medical Officer

This entry was posted in Drugs and tagged CLIA, Clinical Laboratory Improvement Amendments, CMS, disease, FDA, LDT, Medicaid, Medicare, medicine, patients, U.S. Food and Drug Administration by FDA Voice. Bookmark the permalink.

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