Last Build Date: Wed, 18 Jan 2017 21:03:32 +0000
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 likely lose out, and in a large way. Without benefit standards, interstate sales offe[...]
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 does so without any individual mandate. Medicare prevents adverse selection by pena[...]
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, insurers would increase premiums by 20 to 25 percent and about 10 percent of the populat[...]
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. After unsuccessful health reform efforts in the Clinton Administration, Congress did [...]
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 tied to different payers, each with unique requirements around quality measures, for[...]
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 the merits, that it is likely to suffer irreparable harm without relief, that the[...]
Fri, 13 Jan 2017 14:41:40 +0000In December, Health Affairs published a thematic issue on oral health, a first for the journal. With the timing of that issue and the presidential inauguration upon us, it is the perfect time to discuss Obamacare, Trumpcare, and your mouth. The Mouth Separated from the Body The dental-medical divide—the systemic separation of nearly all aspects of medical and dental care—began a century ago, and health care policy has historically reinforced it. In terms of coverage, dental care for adults is not an essential health benefit under the Affordable Care Act (ACA). Dental care for adults is an optional benefit in Medicaid, and Medicare does not cover routine dental care. In contrast, dental care for children is a mandated benefit in Medicaid and CHIP and an essential health benefit under the ACA. Most notably, however, dental care for all age groups is financed and delivered separately from medical care through dental-only insurance plans and dentist offices that are largely siloed from the rest of the health care system. Given the approach to oral health in state and federal health care policy, it ought to be no surprise that children, especially low-income children, are seeing steady improvements in oral health, access to dental care, and dental care use, while adults are seeing increasing rates of unmet dental care needs and rising emergency room visits for oral conditions. It is also unsurprising that financial barriers to dental care are more severe than for any other health care service and dental care is less readily available compared to medical care within federally qualified health centers and accountable care organizations. The Affordable Care Act and Dental Care Though the ACA reinforced the status quo approach of maintaining separate medical and dental care financing and delivery systems, there have been some interesting lessons learned worth highlighting. The inclusion of children’s dental care as an essential health benefit under the ACA has had major implementation challenges. This is largely due to the fact that dental insurance plans are offered alongside medical plans and there is no mandatory purchase. As a result, dental insurance coverage for children has not expanded much under the ACA. Navigating the dental coverage options in the health insurance marketplace can be very difficult for consumers. Information on key components of dental insurance plans is lacking in the vast majority of states. Consumers are highly confused because basic information on dental coverage is missing or incorrect. This makes it impossible for consumers to make well-informed choices. Embedding dental coverage within medical insurance benefits consumers. For example, about one out of three medical plans on Healthcare.gov includes child dental coverage. The incremental premium associated with embedding children’s dental coverage within medical plans is much lower than dental insurance premiums, and key aspects of coverage (e.g. first-dollar coverage for preventive services and coinsurance rates) are similar between embedded and dental-only plans. In a new paper in Pediatrics, we show that total financial outlays for dental care for child beneficiaries are lower, on average, under medical plans that include dental coverage compared to dental-only plans. Medicaid expansion has improved access to dental care for low-income adults, allowing over 5 million adults to gain dental coverage. This has led to a decline in cost barriers to dental care for low-income adults and a modest increase in dental care utilization. Expanded dependent coverage has also improved access to dental care for young adults. Although dental care was not subject to the expanded dependent coverage provision of the ACA, dental insurance coverage for young adults expanded anyway through a “spillover” effect. This reduced financial barriers to dental car[...]
Fri, 13 Jan 2017 14:17:52 +0000Enthusiasm can be a double-edged sword, as Christopher Langston notes in his recent critique of Project ECHO. He describes the model’s success as a case of enthusiasm overtaking evidence. It’s true that the spread of ECHO has outpaced the publication of the research exploring it. The enthusiasm of specialists and primary care providers engaged in this model of collaborative practice and mentorship has spurred tremendous momentum for ECHO all over the world. In fewer than 14 years, Project ECHO, which I developed with my colleagues at the University of New Mexico Health Sciences Center as a way to help people with hepatitis C get treatment, has spread to address more than 50 complex medical conditions. More than 100 academic organizations lead ECHO projects in 30-plus states and 21 countries, connecting with thousands of community clinics. And more than 200 other ECHO projects are in the pipeline. The Research Meanwhile, 46 published peer-reviewed papers from 18 academic centers in five countries describe a range of benefits and positive impacts from ECHO. But more research is needed to continue to build our understanding of the model and its impacts and ensure its continual improvement. At the ECHO Institute, we are committed to a full and rigorous exploration of the ECHO model, which is why outcome monitoring is a critical pillar in our work. It’s the only way we will achieve our goal of improving the lives of underserved populations around the world. The body of work included in the research review referenced by Mr. Langston demonstrates positive effects of ECHO on provider knowledge, self-efficacy, and professional satisfaction across multiple conditions. The period covered by that review ended more than a year ago. Since then, several important studies have been published. These include a study from Beth Israel Deaconess in Boston showing that its ECHO-AGE program significantly reduced the use of physical restraints and antipsychotic medications among nursing home residents. Another study, on ECHO’s substance abuse treatment program, won recognition from the journal Substance Abuse as the best paper of 2016. A forthcoming research paper, undertaken as part of a grant award from the Center for Medicare and Medicaid Innovation, will demonstrate improved access and reduced costs, hospital admissions, and emergency room visits from a project focused on care for the most complex Medicaid patients. The manuscript is in preparation. Additional research is underway, in diabetes, autism, and opioid addiction treatment. Several ECHO partners and state government agencies are conducting cost analyses of their ECHO programs including looking at return on investment. Finally, we are excited that the recently enacted ECHO Act, which directs the Department of Health and Human Services to examine the model’s impact across a range of conditions, will add to our collective understanding. What ECHO Is… And Is Not It is critical here to clarify what ECHO is — and what it isn’t. ECHO is not a continuing medical education program that relies on seminars and lectures. Nor is it a quality improvement program. At its core, Project ECHO is a model for sharing knowledge to expand the capacity of the existing health care workforce so that many more people are able to get high-quality care for their conditions, in or near the communities where they live. Four characteristics distinguish ECHO from other models: the commitment of primary care providers to become experts in an area of community need; their active involvement in presenting patient cases from their own practices; the development of a community of practice and learning; and the establishment of meaningful, ongoing connections with specialists who serve as mentors for primary care providers. ECHO is about true partnership. We often describe ECHO as a [...]
Thu, 12 Jan 2017 20:00:00 +0000The Republican House and Senate have begun the process of repealing the Affordable Care Act (ACA) through the budget reconciliation process. Enacting a budget reconciliation bill is likely to take weeks, however, and at this point it seems likely that such a bill will delay repeal of some of the most important provisions of the ACA for much longer. In a meeting with Republican lawmakers on January 4, 2017, Vice-President-elect Mike Pence stated that the Trump administration may move much more quickly against the ACA through executive action. He told reporters that the Trump administration would begin on the first day of the administration an orderly transition process to unwind the ACA: “We’re working now on a series of executive orders that will enable that orderly transition to take place even as Congress appropriately debates alternatives to and replacements for ObamaCare.” The President and the executive departments and agencies clearly do have a great deal of power. They can exercise their authority through issuing executive orders, rules, and guidance. The executive branch of government operates programs, decides whether and how to defend or settle litigation, and exercises discretion in enforcing the law. But within our constitutional system the president and executive departments and agencies must comply with the laws and operate according to the processes laid down by law. What can the executive do to unwind a law without congressional action and within the law? The ACA Was Implemented Primarily Through Regulation And Guidance, Not Executive Orders Vice-President-elect Pence referred explicitly to “executive orders.” There is a long tradition of American presidents issuing executive orders, although they are not specifically authorized by the Constitution or a statute. Executive orders are generally directed at government agencies and only indirectly affect individuals. When issued pursuant to a statute or the Constitution they are legally binding. An executive order cannot, however, repeal or amend a statute and is not authoritative if it is contrary to law. President Obama issued only one executive order under the ACA, which prohibited the use of the ACA’s premium tax credits and cost-sharing reduction payments or community health center funding to pay for abortions except in cases of rape, incest, or life endangerment. President-elect Trump could perhaps direct the agencies that implement and enforce the ACA to minimize regulatory or reporting burdens, but he could not legally repeal the ACA or any of its requirements through executive order. The ACA has been implemented primarily through regulations promulgated by the Departments of Health and Human Services, Treasury, Labor, and other agencies over the past six years. Regulations are promulgated under the Administrative Procedures Act, which sets out clearly the rulemaking procedures. Ordinarily an agency must publish a proposed rule for public comment, consider the comments it receives, and publish a final rule, responding to the comments. Agencies must publish specific analyses with a rule considering, for example, the paperwork burdens the rule imposes and its effect on federalism and small businesses. Significant regulations must be reviewed by the Office of Management and Budget at both the proposed and final stage. Agencies are permitted to promulgate rules without first receiving public comment, but only when “good cause” is shown, which for important rules would normally mean an emergency exists requiring immediate action. New administrations have authority to pull regulations that are not yet published as final and to delay for a short period of time regulations that are final but not yet effective. Once a regulation is effective, however, it can only be amended or revoked through a new[...]