Moving Medicine Into the 21st Century Members of the House Energy and Commerce Committee from both sides of the aisle came together in April to advance draft legislation that, if enacted, would streamline the U.S. Food and Drug Administration's (FDA's) regulatory process, modernizing clinical trials and medical product regulation, and support the development of innovative cures. Shortly after the Committee released an updated discussion draft of the 21st Century Cures initiative, the Subcommittee on Health held a legislative hearing on Capitol Hill to review the draft and hear testimony from the FDA and National Institutes of Health (NIH). "[The] 21st Century Cures hearing continues to drive home the importance of innovation in health care as we all work together toward more cost-effective care and improved patient outcomes," said ACC President Kim Allan Williams, Sr., MD, FACC. "Our health care system cannot afford to remain stagnant; the increased funding for the NIH in the 21st Century Cures draft is an important acknowledgment of the need for robust research to generate new and improved ways to treat patients. The ACC appreciates the House Energy and Commerce Committee's collaborative approach and looks forward to ongoing dialogue with the Committee to continue the essential work of providing patients with better care." The Committee outlined key provisions included in the draft as follows: • Incorporate the patient perspective in the discovery, development and delivery process • Increase funding for the NIH, both through reauthorization and $10 billion over five years in mandatory funding, starting in fiscal year 2016 • Foster development of treatments for patients facing serious or life-threatening diseases • Repurpose drugs for serious or life-threatening diseases and conditions • Modernize clinical trials • Break down barriers to increased collaboration and data sharing among patients, researchers, providers and innovators • Help the development of personalized and precision medicines so the right patient can receive the right treatment at the right time • Provide for continued work in the telehealth space • Advance a truly interoperable health care system • Provide clarity for developers of software products used in health management and medical care The Committee noted that they've "done things differently with 21st Century Cures." The proposal is the result of months of bipartisan efforts to solicit feedback from "every corner of the health care innovation infrastructure." The ACC had a chance to provide insight into health care innovation when ACC Immediate Past President Patrick T. O'Gara, MD, MACC, shared cardiology's perspective during a roundtable discussion on personalized medicine last summer. The College also submitted two rounds of comments on the first discussion draft to help guide the Committee as it continues to refine the proposal. "While we have made significant progress over the last year, there is still work left to do, and our staffs, as they have done for months, will continue working round the clock to ensure that the finalized legislation can gain broad support," Committee leaders noted. Moving forward, the ACC will continue to help shape the future of cardiology by working with Congress to advance 21st Century Cures. Medicare Access and CHIP Reauthorization Act of 2015: What You Need to Know In April, President Barack Obama signed into law the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which permanently repeals the Sustainable Growth Rate (SGR), establishes a framework for rewarding clinicians for value over volume, streamlines quality reporting programs into one system and reauthorizes two years of funding for the Children's Health Insurance Program (CHIP). MACRA's passage into law is a culmination of over two years of close collaboration with members of Congress on both sides of the aisle and a broad array of stakeholders, including the ACC. The law touches upon many areas across the health care spectrum. As with any law, the language of MACRA is drafted with a high degree of flexibility to allow medical specialty organizations like the ACC to work closely with the Department of Health and Human Services (HHS) through the regulatory process to establish how the law will function. The passage of the law represents only the first step in a long process, albeit an important one. MACRA Timeline Beginning July 1, clinicians will begin receiving a 0.5 percent increase to Medicare payments. This payment increase will continue annually until Dec. 31, 2018. Starting in 2019, clinicians will choose from one of two pathways: the Merit-Based Incentive Payment System (MIPS) or Alternative Payment Models (APMs). What MACRA Does • Repeals the fl awed SGR formula used for determining Medicare payments to clinicians. The SGR henceforth does not exist. • Establishes a period of positive payment increases by providing an annual 0.5 percent payment increases for clinicians to support a predictable transition from fee-for-service to quality-based payment. • Promotes the transition to quality-based payment by implementing two payment pathways for clinicians beginning in 2019: the new MIPS or an APM. • Supports participation in APMs by providing annual payment increases of 0. 75 percent to those participating in a qualifying APM in 2026 and beyond, and 0.25 annual payment increases to all other clinicians. Other provisions included in MACRA include: • Reauthorization of funding for CHIP for two years through fiscal year 2017. • Delayed enforcement of the "two-midnight" rule until Oct. 1. Until then, contractors may only review claims to probe and educate, and claims submitted before Oct. 1 will not be subject to post-payment reviews by Recovery Audit Contractors. The "two-midnight" rule required patients spend at least two nights in the hospital to be considered inpatient for reimbursement purposes. • Prohibition of implementation of 2015 Medicare Physician Fee Schedule provisions requiring the transition of all 10-day and 90-day global surgical packages to 0-day global periods. • Expansion of the use of Medicare data for transparency and quality improvement by removing barriers and allowing for Medicare data to be provided to qualified clinical data registries to facilitate quality improvement. • Requirements that the HHS Secretary draft a plan for development of quality measures to assess professionals, including non-patient-facing professionals. • Declaration of a national objective to achieve widespread exchange of health information through interoperable certified electronic health record technology nationwide by Dec. 31, 2018. • Provision to protect clinicians by preventing quality program standards and measures (such as PQRS/MIPS) from being used as a standard or duty of care in medical liability cases. ACC Hosts Capitol Hill Briefings on How NCDR is Fostering Innovation and Improving Care The ACC continually seeks out opportunities to show lawmakers how the College is leading the transformation of care. Earlier this year, the ACC hosted separate House and Senate briefings on Capitol Hill to educate congressional staff about how the NCDR is fostering innovation and improving care for patients around the world. During the briefings, Ralph G. Brindis, MD, MPH, MACC, highlighted how ACC's registries work with more than 2,400 hospitals and nearly 3,500 outpatient providers to ensure evidence-based cardiovascular care, improve patient outcomes and lower health care costs. This was an opportunity to showcase how the NCDR is leading the way for harnessing clinical data and underscore the critical role registries play in the ever-changing health care landscape. Brindis pointed out that while the U.S. spends the highest percentage of its gross domestic product on health care, it is signifi cantly behind other nations on quality, access, efficiency, equity and healthy lives. As the U.S. health care system shifts from volume to value and strives to achieve the triple aim of lower costs, better health and better outcomes, the NCDR can serve as a model of success for measuring and improving care. Launched nearly two decades ago, the NCDR was created as an exploration into strategies for improving cardiovascular care through the use and application of clinical data. Today, the NCDR is a reputable and dependable quality improvement resource that continues to evolve to meet the demands of the changing health care environment. While measurement is crucial, Brindis noted that it's not enough. That's why the College has created a portfolio of quality improvement initiatives to disseminate evidence-based strategies and toolkits, promote best practice sharing, and build nationwide learning networks. On the topic of medical innovation, Brindis cited the STS/ ACC TVT Registry as an example of rationally infusing innovative technology into the cardiovascular field in a safe manner. In 2011, The Society of Thoracic Surgeons (STS) and the ACC launched the first-of-its-kind registry to monitor the safety and efficacy of a new minimally invasive heart therapy to treat aortic stenosis. In addition to working with partners like STS, the American Heart Association, the Society for Cardiovascular Angiography and Interventions, the American Diabetes Association and other medical societies, the ACC collaborates with the Centers for Medicare and Medicaid Services on national coverage determinations and the Food and Drug Administration on post-market surveillance. The Capitol Hill briefi ngs are just one way the College is educating Congress about the potential of clinical data registries and cementing ACC's reputation as a trusted expert in the field. Promoting the use of clinical data to improve care is one of the ACC's key advocacy priorities for 2015. The ACC will continue to advocate for the use of clinical data registries for quality improvement and research, recognition of clinical practice guidelines and appropriate use criteria, and improvements in health information technology. Other advocacy priorities include creating a value-driven health care system, ensuring patient access to care and cardiovascular practice stability, fostering research and innovation in cardiovascular care, improving population health, and preventing cardiovascular disease. Moving forward, ACC staff and members will continue taking cardiology's message to Capitol Hill and working with lawmakers to shape the future of cardiology. Deep Dive: Meaningful Use Stage 3 Proposed Rule In March, the Centers for Medicare and Medicaid Services (CMS) released its proposed rule for Stage 3 of the Electronic Health Record (EHR) Incentive Program, also called Meaningful Use (MU) Stage 3. The rule contains the proposed criteria that eligible professionals, eligible hospitals and critical access hospitals would need to meet in order to qualify for EHR incentive payments and avoid penalties for non-participation. CMS' stated objectives for the proposed rule are to increase simplicity and flexibility in the program while driving interoperability and focusing on patient outcomes in the MU program. CMS also makes it clear in the rule that it intends for its proposal to apply beyond EHRs to other categories of health information technology (IT). Stage 3 is expected to be the final stage of MU and builds on the groundwork established in Stages 1 and 2. Given the continued effort to improve care and expand health IT functionality, there may be future changes to the objectives and measures of MU, which could result in future rulemaking. The rule proposes that providers would have the option in 2017 of either participating in the previously prescribed stage, based on the year they entered the program, or participating in Stage 3, regardless of their fi rst year of program participation. Beginning in 2018, all providers would report at the Stage 3 level regardless of prior participation. As of Jan. 1, 2018, the rule proposes that all providers would need to begin reporting to the proposed single set of eight Stage 3 MU objectives and their respective measures and do so for a full year. This would eliminate the current 90-day EHR reporting period for eligible professionals, eligible hospitals and critical access hospitals demonstrating MU for the first time, thus creating a single reporting period for all providers aligned to the calendar year. This approach would provide better alignment with other CMS quality reporting programs such as Hospital Inpatient Quality Reporting and the Physician Quality Reporting System. A single reporting period based on the calendar year would also allow for a single attestation period, which CMS believes would enable the Department of Health and Human Services systems to better capture data, conduct enhanced stress testing and issue resolution, and improve quality assurance of systems before each deployment. However, this streamlining may hinder those implementing EHRs or demonstrating MU for the first time given the narrow window to allow for adjustments. By requiring that all providers meet all eight objectives, the proposal appears to continue to focus on "checking the box" or providing a pass/ fail approach to the program rather than changing care delivery to achieve the goal of improved patient care. In order to simplify the number of objectives from 17 or 16 to eight, CMS has proposed removing objectives and measures that the Agency believes are redundant, duplicative or "topped out." The ACC is working with its members to develop a response and intends to submit comments this spring.
Published by American College of Cardiology. View All Articles.
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