Last Build Date: Thu, 19 Jan 2017 19:00:18 +0000
Thu, 19 Jan 2017 19:00:18 +0000As the professional association for health foundations and corporate-giving programs, Grantmakers In Health (GIH) connects the hundreds of health funders who are spread across the American landscape, keeping them up-to-date on rapidly changing developments and providing opportunities for them to share what they’re learning and doing in their respective communities. Times like now—when dramatic changes to the health care landscape are anticipated—accentuate the importance of this role. In 2017 it will be especially important that we help funders understand, and respond to, significant expected changes in public policies and programs that affect the communities they serve. We will not simply be in crisis mode, however. Our concern for both informing and shaping the bigger picture of philanthropy’s health and health care priorities is ongoing. As the year begins, the future of the Affordable Care Act (ACA) is naturally a high priority for us. Health funders are rightly anxious to understand the changes that are likely with a new Congress and presidential administration. Many grantmakers have invested for years at a national or state level to support the implementation of the ACA. They are keenly aware that rolling back the law will have consequences not only for people’s access to health care services, but also, more broadly, for jobs and state economies. In an immediate response to these concerns, GIH has organized a series of webinars for its membership that offers the perspectives of a range of policy experts. Immediately post-election, these topics included strategies for adapting health reform–related grant making, the future of Medicaid, and the election’s implications for the State Children’s Health Insurance Program (CHIP) and other children’s coverage. Upcoming webinars will include bipartisan views of the new Trump administration’s health priorities and plans, the implications of a possible repeal of the ACA without implementing an immediate “replace” strategy, and the 2016 election’s possible effects on the health of immigrant communities. Other ACA-related programming will include activities taking place at our annual conference in June, as well as meetings, calls with funders, and publications, including in-depth interviews about foundation strategies. Because changes to the ACA, Medicaid, and other programs will heighten the importance of state-level actions, our 2017 programming will pay special attention to elevating what funders are doing in states and sharing this information nationally. In addition to this focus on policy changes that will affect access and coverage, we also want to identify health investment areas in which the new administration seems to be interested. We anticipate that addiction, delivery system reform, veterans’ health, and rural health will be on that list. Addiction and substance use are elements of our behavioral health programming, which includes the integration of mental health and substance use, the integration of behavioral health into primary health care services, and investments to increase the quality of behavioral health. We will pursue opportunities to communicate with the White House and federal policy makers on these and other priorities that may emerge for them, with an eye to using what we learn to inform our members and facilitate their engagement with policy makers on topics of shared interest. Among health funders, there is a strong commitment to health equity, and GIH will continue to be a leading voice on this issue. Growing interest in equity within philanthropy as a whole presents us with valuable opportunities to partner with several of our fellow philanthropy-serving organizations. For example, in a recent meeting that the Funders’ Network for Smart Growth and Livable Communities organized, GIH, the Consultative Group on Biological Diversity, EDGE Funders Alliance, Environmental Grantmakers Association, Grantmakers Concerned with Immigrants and Refugees (GCIR), Health and Environmental Funders Network (HEFN), and Sustainable A[...]
Thu, 19 Jan 2017 18:29:49 +0000At a House Budget Committee hearing last fall on the Center for Medicare and Medicaid Innovation (CMMI), members of the majority expressed strong criticism of how the Congressional Budget Office (CBO) scores Medicare demonstration projects, continuing a long-running debate over CBO’s methods. Committee Chair Tom Price (R-GA), President-elect Trump’s pick to be Secretary of Health and Human Services, criticized CBO’s admitted inability to predict “which, if any, of the current demonstration projects CMMI has embarked upon will result in savings.” CBO plays an important role in the policy process. Based on CBO’s estimates of the budgetary impact of a given piece of proposed legislation—that is, whether the bill increases or decreases the federal budget deficit—Congress often decides to go forward with the bill, modify it to get a more favorable ‘score,’ or simply drop it. CBO certainly should (and, in fact, does) work to constantly improve its ability to develop reliable estimates. But all too often, criticisms of CBO’s methods are motivated by a misunderstanding of what CBO can and cannot be expected to do. As we engage in a new round of health policy debate, it is vital to examine the role of CBO in the legislative process. Examples of CBO’s Influence Health policy offers several historical examples of the influence of CBO’s estimates on health policy legislation: President Clinton’s health reform proposal, the Health Security Act of 1993, was the subject of extensive debate from the beginning, and CBO’s estimate of its effect on the federal budget played an important role in the debate and the bill’s failure. The budget savings enacted in the Balanced Budget Act of 1997 were driven primarily by changes in Medicare payment policy — changes largely driven by CBO’s estimates of their prospective budgetary impact. The Medicare Modernization Act of 2003 made prescription drug coverage available to Medicare beneficiaries. President Bush had offered $400 million in his budget to pay for the new benefit, leaving Congress to develop the details of the legislation — with those decisions heavily dependent on CBO’s cost estimates of alternative provisions and the related policy parameters. The development of the ACA also depended heavily on CBO’s cost estimates, as President Obama wanted to keep total outlays attributed to the bill below $1 trillion over 10 years and find ways to offset as much of that cost as possible. Given their importance, debates over CBO’s scores and the methods they use to produce them can be as controversial as the bills that are being considered. In fact, CBO may face criticism from both sides of a particular issue, with opponents of a proposal arguing that its score is too favorable and proponents that it is not favorable enough. But much of this criticism is misplaced, stemming from a tendency by policymakers to misinterpret and misuse the estimates that CBO produces. Recent Developments Understanding CBO’s role and the importance of protecting its ability to carry it out is particularly important in light of recent Congressional action. The recently adopted House rules contains a provision that precludes the agency from producing long-term estimates of the budget and coverage impact of repealing or reforming the Affordable Care Act of 2010 (ACA). That provision followed CBO’s announcement that it would define as insurance only “a comprehensive major medical policy that, at a minimum, covers high-cost medical events and various services, including those provided by physicians and hospitals.” Congress has thus placed itself in the position of appearing to prefer no information at all to information that might conflict with its political objectives. The January 17 release of CBO’s estimate that a previous bill aimed at repealing the ACA would increase the number of uninsured by 32 million and double premiums in the nongroup market by 2026 highlights the importance of CBO’s role, and of the appropriate use [...]
Thu, 19 Jan 2017 15:57:00 +0000American systems of oral and systemic health—training, licensure, service delivery, and insurance—continue to operate in parallel. It is a fracture rooted in sociologic, political, and market forces rather than underlying physiology. Although the distinction may be artificial, the consequences for patients and providers are real. A growing evidence base points to the cost and quality shortfalls associated with having separate systems treat the same person. Seeking to address these challenges, the Surgeon General recently called for more thorough integration of oral health and primary care. Roughly one in five Americans report needing dental care but lack adequate access, most often due to financial barriers. Integrating oral health services into routine primary care visits could help close this gap. Somewhat surprisingly, the converse is also true. One quarter of the 55 million Americans that do not receive outpatient medical care do see a dentist. Providing basic primary care services during dental visits could improve population health and chronic disease management. Growing awareness of this premise has accelerated efforts to develop integrated delivery models in the primary care setting. Federally Qualified Health Centers (FQHCs) have led the way. Many FQHCs, which often serve patients whose needs and circumstances expose them to vulnerabilities and disparities in both oral and systemic health, have integrated dental services into their health centers. Notwithstanding these important advances, true integration remains elusive. Co-location is a necessary but insufficient prerequisite to fully integrated oral and systemic health care delivery. Spurring additional progress will require innovation across three principal areas: interprofessional education and cross training, financial alignment, and supportive information technology. Interprofessional Education and Cross Training Integration requires close collaboration between medical and dental personnel. Absent collaborative practice, co-location does little to break down existing siloes. Improving collaboration requires upstream interventions to increase interprofessional education between oral and systemic health providers. Transitioning from co-location to integration also requires seamless service delivery among dental and medical personnel. Primary care personnel should be trained to provide oral health risk assessments, anticipatory guidance, specialist referral, and to deliver basic preventive measures such as fluoride therapy. Dental providers should be trained to provide select components of annual wellness exams (e.g. screening and immunizations) and assist in chronic disease management (e.g. medication adherence, blood pressure measurement, INR monitoring). Cross training and bidirectional service provision is essential for efficient resource use and to ensure that fewer patients are lost to follow up. In January 2016, the Harvard School of Dental Medicine (HSDM) launched a new initiative to address shortfalls in interprofessional education and cross training. Under the initiative, nurse practitioner (NP) students from Northeastern University join the Harvard Dental Center’s Teaching Practice clinics. NP and DMD students work together in the clinic, addressing patients’ oral and systemic health needs simultaneously. DMD students perform annual cleanings and other dental services while the NP students offer annual wellness exams and basic primary care, all under the supervision of experienced faculty from both schools. In addition to building collaborative, interprofessional relationships, the initiative is making early steps towards cross training medical and dental providers. NP students are learning to perform basic oral health exams and offer anticipatory guidance. DMD students are learning to provide basic primary care services and monitor chronic diseases under the supervision of primary care faculty from Harvard Medical School. Financial Alignment Operationalizing integrated service[...]
Wed, 18 Jan 2017 21:03:32 +0000
For the past few years, US lawmakers have considered legislation that would grant six additional months of market exclusivity for previously approved drugs that have been successfully tested and subsequently approved by the Food and Drug Administration (FDA) for treating rare diseases. This proposal is intended to incentivize pharmaceutical manufacturers to invest in rare disease research.
A new study, released by Health Affairs as a Web First, analyzed the thirteen supplemental applications approved by the FDA that earned rare disease status from 2005 through 2010 to estimate the costs of the clinical trials and potential economic gain arising from a six-month exclusivity extension. According to the authors, Aaron S. Kesselheim, Ben Rome, Ameet Sarpatwari, and Jerry Avorn, the median discounted financial gain for each drug would have been $94.6 million, with blockbuster drugs predictably enjoying the highest returns. The authors’ analysis also suggests that these manufacturers had spent a median of $29.8 million on trials that gained supplemental approval for rare disease indications.
“These results confirm that market exclusivity extensions can generate substantial returns to the manufacturers that are eligible for the incentive — sums that are generally much greater than the cost of performing the requisite clinical trials,” the authors conclude. As a result, “this solution could prove costly to the health care system.” They add, “Any proposal to extend market exclusivity protections in the US prescription drug market should undergo rigorous analysis that weighs the benefits of predicted investment in research against the costs of the incentives to governmental and private-sector payers.”
The authors are all affiliated with the Program on Regulation, Therapeutics, and Law (PORTAL) at the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School.
This study, which was supported by the Laura and John Arnold Foundation, will also appear in Health Affairs’ February issue.
Wed, 18 Jan 2017 17:15:20 +0000Anyone who followed the recent election cycle knows that President-elect Donald Trump made “repeal and replace” a cornerstone of his campaign — referring, of course, to the Affordable Care Act (ACA). He, like Mitt Romney and John McCain did in their respective bids for the presidency, has proposed permitting insurers to sell insurance plans across state lines as a possible alternative to the ACA, or at least as a component of a potential alternative. In this post, we’ll take a look at the possible advantages of allowing interstate insurance sales, as well as the reasons opponents say such a policy simply won’t work. First, though, let’s take a closer look at the current situation. The ACA already allows interstate insurance sales A provision in section 1333 of the Affordable Care Act allows states to establish what are called “health care choice compacts,” which permit insurers to sell policies to individuals and small businesses in any state that participates in the compact — provided they abide by specific rules. And several states have explored the possibility. In fact, a few have even enacted statutes pertaining to interstate compacts. But as of yet, nothing has materialized. Several explanations point to why: Complacency on the part of regulators, at both the federal and state level Lack of interest among insurers Lack of demand from consumers Prohibitively restrictive regulations Insufficient time so far for the concept to take root Whatever the reason or combination of reasons may be, the upshot is that interstate insurance sales are already legal under certain conditions. It’s also important to note that most large companies are self-insured, which means they are not affected by state regulations and this whole discussion of selling insurance across state lines doesn’t apply to them. From the proponents’ viewpoint Those who support the marketing of policies across state lines say it would increase competition in the marketplace, thereby causing insurers to lower the cost of premiums and making coverage more affordable. Supporters also say it would also give consumers more options: instead of being limited to plans sold within their own state, which might include certain mandated benefits they don’t want—such as coverage for fertility treatments, or acupuncture, or drug rehabilitation—consumers could purchase coverage in another state where those benefits aren’t mandated, and theoretically they could do so at a lower cost. Those who are happy with the plan they have in their state of residence can simply renew their policy. Permitting interstate insurance sales could also attenuate some of the inequalities between large and small employers by making insurance more affordable for small businesses. While these are good reasons to advocate for selling insurance across state lines, arguments against allowing interstate insurance sales make some valid points as well. The ‘race to the bottom’ Let’s go back to the provision of the Affordable Care Act that permits interstate insurance sales. It contains certain basic consumer protections that all insurers would be required to meet, regardless of where they conduct business, such as maternity services and mental health coverage. Repealing the ACA would eliminate basic consumer protections (or lift restrictions, from an insurer’s perspective) and in essence allow insurers to choose their own regulators. And plans would again be able to attract only healthy consumers to keep their costs low. In other words, even if insurers were required to be licensed in all states in which they market plans, they could choose to “domicile” their firm in a state that has little regulation of the nongroup (i.e., individual and small business) insurance market. If, as one could easily see happening, the majority of insurers choose to domicile in the state or states with the least restrictive regulations, consumers would lik[...]
Wed, 18 Jan 2017 16:00:46 +0000The two major political parties are in a contentious battle over the Affordable Care Act (ACA). Republicans would like to repeal and replace it. Democrats are doggedly defending it. But even if the ACA stays in place, there will still be almost 30 million people without health insurance and another 20 million or so who all too often face deductibles that are unreasonably high for moderate-income families and provider networks that are much too narrow for people with serious medical problems. If some Republicans get their way, things may not be much better. In fact, several Republican replacement plans are expected to insure even fewer people than under the current system. We believe the health care system is desperately in need of reform. But the focus of that reform should not be the Affordable Care Act. The initial goal should be: making sure everyone has access to health insurance that is affordable and that gives them dependable access to medical care. Further, we believe that goal can be accomplished with money already in the system. We don’t need any new taxes or any new spending programs. Most of the recommendations that follow are incorporated in bicameral legislation introduced in the House and the Senate by Pete Sessions and Bill Cassidy and in the Patient Freedom Act, sponsored by Senator Cassidy. Remove the Perverse Incentives From the Individual Market Figure 1 shows that there are currently about 21 million people obtaining health insurance in the individual market. About half are buying in the (Obamacare) exchanges and the rest are buying outside the exchanges. Unwise public policies have allowed this market to become a dumping ground for people who are older and sicker than average. The states were allowed to end their high-risk pools and send their enrollees to the exchanges. The federal government did the same thing with the (Obamacare) risk pool (the Pre-Existing Condition Insurance Plan). Cities and counties are ending their post-retirement health care programs (which are almost always unfunded) and sending people to the exchanges, where they pay premiums that are well below the cost of their care thanks to limited age rating. That includes, for example, 8,000 former employees of the city of Detroit. As premiums rise to meet the higher costs of the enrollees (they have roughly doubled in the past four years, on the average), healthier people are choosing to remain on the sidelines. Within the market, too many health plans are trying to survive by dumping their sickest, most costly enrollees on other plans — as they strive to attract the healthy and avoid the sick. Often they do this by offering narrow networks that omit the best doctors and the best hospitals and by saddling enrollees with high out-of-pocket costs. But, like a game of musical chairs, the sick don’t vanish — they simply move from plan to plan. In some states, the entire market is clearly in danger of entering a death spiral. Neither Republicans nor Democrats have been willing to face up to an obvious fact: We have to stop this destructive behavior. We don’t have all the answers, but we believe part of the answer is “health status risk adjustment,” under which plans that send high-cost enrollees to other plans must top up the new premium to an actuarially fair level. This type of risk adjustment is designed to protect enrollees, unlike the current risk adjustment, which is designed to protect health plans instead. Only then will health plans seek to enroll the most costly patients instead of competing to avoid them. John Goodman and John Cochrane, in separate publications, have provided general outlines of how free market risk adjustment could work. We cannot allow individuals to game the system by remaining uninsured while healthy and then enrolling after they get sick. The Medicare program seems to have solved this problem for Parts B and D and Medigap insurance — and it d[...]
Tue, 17 Jan 2017 18:41:49 +0000January 18 update. The National Taxpayer Advocate has released their 2016 Annual Report to Congress. The report contains data regarding premium tax credit (PTC) and individual shared responsibility payment (ISRP) filings, but these data are not as up-to-date as recent data released by IRS Director Koskinen, reported earlier on Health Affairs Blog and are not reported here. The report identifies a number of issues that the IRS has faced or is facing involving the ACA and makes a number of recommendations. These include: The IRS seems to have largely addressed early problems with ISRP overpayments through outreach conducted to tax practitioners and software providers. Reconciliation of PTCs with advance PTCs (APTCs) continues to cause problems, and has risen to the fourth highest category of Taxpayer Advocacy Service cases, accounting for nearly 11,000 cases in 2016. The primary problem seems to be the IRS holding up processing of returns when taxpayers fail to file a form 8962 and reconcile their advance PTC with their PTC. Processing of tax filings is delayed when APTC recipients incorrectly file form 1040-E, which does not allow for APTC reconciliation. The IRS is taking action to address “silent returns,” which do not either check the box indicating full-year coverage, claim an ISRP exemption, or pay the ISRP tax. The IRS will send a letter 12C requesting more information in these cases and assess the ISRP if no response is forthcoming. The Taxpayer Advocate recommends that the IRS should ease the burden on individuals claiming the religious exemption by allowing individuals exempt from the Social Security and Medicare taxes to simply indicate this on their form 8965 rather than requiring them to apply separately for an ISRP religious exemption. The Taxpayer Advocate recognizes that taxpayers who receive large Social Security Disability Payments may have to repay APTC received. There is no apparent administrative fix for this problem. The IRS needs to provide specialized training to its newly established ACA Business Exam unit, which handles employer ACA returns. The IRS may not be adequately prepared to handle ACA employer filings. It had expected 77 million 1095-Cs for 2016 and got 104 million, with 5.4 percent rejected. Original Post. On January 17, 2017, the Congressional Budget Office—Congress’ nonpartisan scorekeeper—released a report on how the enactment of reconciliation legislation to repeal the Affordable Care Act (ACA) similar to that adopted by Congress in 2015 (and vetoed by President Obama) would affect health insurance coverage and premiums. The report assumes that reconciliation legislation would repeal the individual mandate penalties and then, after a delay of two years, the premium tax credits and Medicaid expansions. The CBO further assumes that the legislation would leave intact the ACA’s insurance reforms, which presumably cannot be amended through reconciliation under the Senate’s reconciliation rules. These include the ACA’s essential health benefit and actuarial value requirements; its limitations on health status underwriting and pre-existing condition exclusions; and its rating requirements that allow premiums to vary only based on age, geographic locations, and tobacco use. The CBO projects that the repeal legislation would not have an immediate dramatic effect in 2017 because premium increases would already be established and enrollment set for 2017. In 2018, however, 18 million people would become uninsured, including 10 million fewer enrollees in the nongroup (or individual) insurance market, 5 million fewer with Medicaid coverage, and 3 million fewer with employment coverage. These increases would be due to a combination of people dropping coverage because it was no longer mandated and to insurers abandoning the nongroup market and increasing premiums because of adverse selection concerns. As of 2018, insure[...]
Tue, 17 Jan 2017 16:30:40 +0000If the U.S. Senate confirms the nomination of Representative Tom Price to serve as the 23rd U.S. Secretary of Health and Human Services (HHS) he will be only the third physician to lead that department since its formation in 1953. The first was Otis Bowen from Indiana, who served from 1985 to 1989 under President Ronald Reagan. I was the second physician, and served during the presidency of George H.W. Bush from 1989 to 1993. Since then, three eight-year presidencies have passed without an MD or other health professional in the department’s top role. Indeed, more lawyers than health professionals have led the department — which leads me to wonder how the public, Congress, and the legal profession would respond if a physician (or anyone, really, with no legal training) was appointed to lead the Justice Department. When I became Secretary in 1989, the Department of Health and Human Services (HHS) had 124,000 employees and more than 250 programs in agencies that included NIH, CDC, FDA, HCFA, the Social Security Administration, the Agency for Children and Families, and more. Leading such a large department with such far-ranging programs presented a number of challenges and opportunities. The first was to articulate the mission of the department and the key priorities for HHS during the George H.W. Bush administration. These priorities included: (1) improving the health of the nation; (2) reforming the health care system to make it more efficient, more effective, and less costly; (3) reducing the use of tobacco and other addicting substances; (4) enhancing the department’s support for prevention programs, wellness activities, and improving healthy behaviors of Americans; and (5) increasing the racial, ethnic, and gender diversity of the department’s leadership to make it more representative of our nation’s population. As I took office, I knew well from my experience as a physician that an individual’s health and the health of communities are affected by a wide array of factors that reach beyond the formal health system: such as people’s income, educational achievement, social customs, culture, belief systems, access to clean water and clean air, and the presence of social stress and tensions. It is with all of these factors in mind that I made it a priority to regularly communicate with and engage other secretaries leading the Departments of Education, Agriculture, Housing, Labor Interior, Defense, Commerce, and State, for example. This was a process that echoed my work treating patients, listening to their concerns, consulting with other specialists, and working together to find the most effective interventions to achieve the best possible outcomes. Later, in my collaboration with other cabinet officials, I found that although we did not always agree on every policy decision, we did share the common goals of serving the American people, improving their health, and supporting them in their quest for a more meaningful, successful, fulfilling life. These are the same goals that I underscored in the process of selecting, supporting, and motivating leaders within HHS — one of the most fundamental tasks I faced in my time as Secretary. I made it a priority to empower them to adopt and take ownership of our departmental priorities. And I ensured they felt they could give me honest feedback, advice, and recommendations. I am hopeful that Rep. Price will take a similar approach. Together, I believe we achieved many of our priorities during my time as secretary — with the notable exception of reforming the health care system. We did develop a promising plan President George H.W. Bush presented in a speech he gave to the Cleveland City Club in February 1992. But that was an election year of course and Congressional committees did not hold hearings or report the bill out for action by the full House and Senate. Aft[...]
Tue, 17 Jan 2017 15:30:28 +0000Data is the lifeblood of the value-based payment environment. Every time a doctor takes care of a patient, we have an opportunity to use information in ways that help patients get better care. The goal is to use the information from each patient encounter to make the next encounter better — across the entire health care system. But it is easier said than done. As we prepare to transition from this administration, we’d like to take stock of what our nation has accomplished and to lay out a potential roadmap for the next administration. Making data easy to use begins by putting it into secure, private, digital form. During the past seven years, we’ve made remarkable progress towards this goal: in 2015, over 77 percent of office-based physicians reported using a certified electronic health record (EHR) to inform clinical care, while the percentage of office-based physicians with any EHR has doubled since 2008. As we hoped, digital tools have helped us reduce medical errors by, for example, e-prescribing and having fewer follow-up items fall between the cracks. But we still have a lot of work to do. While the tools are improving, some clinicians remain frustrated by the limited usability of their technology and data, from their inability to easily enter and access key information when and where they need it at the point of care to challenges in accessing timely feedback on the quality of care in their practice. We need 21st century information technology, enabling ready and secure data access, to support a modern, value-based health care system. New Tools One obstacle is the efforts of some vendors to put up barriers to sharing data. Fortunately, the bipartisan 21st Century Cures Act, which was enacted in December 2016, takes a significant step toward overcoming that obstacle. The Act advances interoperability through several provisions including the prohibition of information blocking and authorization of penalties of up to $1 million per violation. The law also gives the Office of the National Coordinator for Health Information Technology (ONC) new authority to address usability and interoperability through additional conditions of certification for health information technology (health IT) developers related to: access, use, and exchange of electronic information; usability, security, and business practices; real-world testing; and publishing application programming interfaces (APIs). We have also launched new tools to address these challenges under the recently established Quality Payment Program (QPP). This program created by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) uses a number of tools to reward Medicare clinicians for quality of care over quantity of services provided. These tools include a web application and public API designed to help clinicians, registries, and others in the CMS vendor community more easily share and receive feedback about performance. By consolidating previous programs such as the Physician Quality Reporting System (PQRS) and the EHR Incentive Programs (Meaningful Use); creating more ways for clinicians to participate; significantly reducing requirements by reducing the number of measures; and providing additional flexibility in selecting meaningful measures, QPP also reduces administrative burden. Yet the Department of Health and Human Services (HHS) recognizes that clinicians work with many payers, not just Medicare alone; in fact, the average physician practice now contracts with 12 different insurers. And that can lead to an additional set of challenges: access to data across disparate payers and settings is variable; the lack of comparability from multiple sources makes it hard to obtain actionable insights to inform care; and clinicians face increased administrative complexity if they participate in alternative payment model programs ti[...]
Fri, 13 Jan 2017 16:15:28 +0000January 13 Update Judge Blocks Interim Final Rule On Disclosure By Renal Dialysis Facilities Offering Premium Assistance On January 12, 2017, Judge Amos Mazzant of the federal court for the Eastern District of Texas entered a temporary restraining order blocking the implementation of an interim final rule promulgated by HHS in December addressing renal dialysis facilities. The rule requires such facilities that make direct or indirect third-party payments for coverage in the individual market to make certain disclosures to patients and to insurers. The lawsuit was brought by a consumer group that represents dialysis patients and a dialysis provider. Insurers have persistently complained that marketplace risk pools are being destabilized by high-cost consumers who are enrolling in marketplace coverage with premium assistance from third-party payers. In particular, they have complained that renal dialysis facilities are paying, either directly or through charities to which they contribute, the premiums of very high-cost end-stage renal disease (ESRD) patients to allow them to enroll in marketplace plans. The motivation for this practice, it is claimed, is that facilities are paid far more by commercial payers than by Medicare or Medicaid, both of which cover treatment for ESRD. The enrollment of high-cost dialysis patients who would eligible for public coverage, however, significantly increases the cost of those plans to insurers, and ultimately to enrollees. In August, CMS issued a request for information attempting to learn more about third party payment practices and their effects. On December 13, CMS issued an interim final rule, in its capacity as a regulator of Medicare ESRD facilities, requiring annual disclosures by ESRD facilities both to patients and to insurers of certain information specified in the rule. The interim final rule was promulgated without any prior opportunity for notice and comment on a proposed rule. Under the interim final rule, facilities must give their patients a disclosure describing how a patient’s access to and cost of ESRD care and other care would be affected by individual market versus Medicare and Medicaid/CHIP coverage, and how each option would affect anticipated pre- and post-transplantation costs. This would include disclosure of potential gaps in coverage or penalties if enrollment in Medicare is delayed. Facilities must also describe their premium assistance programs, including limits on that assistance and potential termination if patients switch facilities. Facilities must, finally, disclose to patients information about “reimbursements for services that the facility receives as a result of subsidizing such enrollment.” The regulation further requires facilities to disclose to individual market insurers the fact that the facilities are paying premiums, either directly or through charities, and receive assurances from the insurers that the insurer will accept payments throughout the plan year. The facility may not pay the premiums unless such assurances are received. Since insurers actively oppose third party payments, and since CMS has earlier said that it discourages such payments, the predictable effect of the rule would be to end most third party payments for ESRD treatment. The rule was to have gone into effect on January 13, 2017, but Judge Mazzant’s order blocks implementation of the rule for now. His opinion noted a long history of charitable organizations, such as the American Kidney Fund, assisting ESRD patients with insurance premiums; he also noted that patients have long received donations from dialysis providers; in 1997 the HHS Office of Inspector General issued guidelines regulating these donations. A party seeking injunctive relief, including temporary restraining orders, must show that it is likely to succeed on[...]