On June 25, the Supreme Court issued their decision in the highly watched King v. Burwell case, ruling that the more than 6 million people currently purchasing insurance through a federal exchange can continue to access subsidies. At issue was the legality of federal subsidies for those in states that opted not to create a state health insurance exchange. Without these subsidies, the Court felt that the insurance markets would have essentially collapsed in the 34 states with federally run marketplaces, with the majority of those accessing subsidies unable to afford coverage when faced with full premium costs and, as a result, costs rising exponentially for those remaining in the market. Specifically, the court said: “[t]he combination of no tax credits and an ineffective coverage requirement could well push a State’s individual insurance market into a death spiral.”
A different decision in King would have likely created much disruption in the marketplace for both patients and providers. According to Kaiser Family Foundation, more than 6 million Americans might have lost subsidies, and faced an average premium increase of 287%. RAND estimated the number of insured Americans would have declined by 9.6 million. The healthy insured may have elected to discontinue coverage, leaving high-cost patients to constitute the majority of the insurance pool. Cancer patients might have been faced with paying unsubsidized and substantially increased premiums, which for some may have been unattainable.
Overturning subsidies would have also placed providers in the precarious position of caring for patients that became uninsured. The financial and ethical implications of treating newly uninsured patients are great. While providers may have chosen not to terminate patients undergoing a course of treatment regardless of a change in insurance status out of ethical obligation, the financial result would have been challenging, particularly for those community-based practices that lacked programs for low-income patients. For hospital-based providers, the financial implications would also have been great, undermining provisions in the Affordable Care Act that reduced Disproportionate Share Hospital (DSH) Medicare payments in exchange for a substantially reduced uninsured population. In short, without current federal subsidies in place, the mechanisms for providing and funding care for millions of Americans would have needed to be revisited. With a lack of agreement in Congress on the best approach to renewed healthcare reform, providers would have faced a great deal of uncertainty.
With a 6-3 decision, Justice Roberts’ Court concluded that “Congress passed the Affordable Care Act to improve health insurance markets, not destroy them. If at all possible, we must interpret the Act in a way that is consistent with the former, and avoids the latter.”
Post updated 6/26/2015
A proposed rule regarding 340B pricing enforcement was published in the Federal Register on June 17. The proposed rule responds to a mandate in the Affordable Care Act, which required the Health Resources and Services Administration (HRSA) to provide for imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge 340B-covered entities. The rule also provides a methodology for ceiling price calculation.
While not addressing more controversial aspects of the 340B program, such as patient definition, hospital eligibility criteria, and contract pharmacy arrangements, the rule does provide some important clarifications. Codification of the ceiling price calculation would provide 340B-covered entities with needed clarity in ensuring appropriate pricing. The rule would also impose a civil monetary penalty of up to $5,000 per instance of knowing and intentional overcharge of a covered entity, regardless of whether the order is placed with a manufacturer, wholesaler, authorized distributor or agent.
ACCC continues to closely watch for developments related to 340B, including expected release this summer of HRSA’s “mega-guidance,” anticipated to clarify several issues for which the agency does not believe it has rulemaking authority. HRSA has also indicated that it intends to release another rule on the administrative dispute resolution process in the near future. Stay tuned.
By Maureen Leddy, JD, Policy Coordinator, ACCC
Recently, ACCC submitted comments on the U.S. Pharmacopeia (USP) draft Chapter <800>, proposed standards for handling hazardous drugs in healthcare settings. The comments are in response to USP’s latest draft of Chapter <800>.
As you likely recall, USP released a first draft of Chapter <800> in March 2014. In response to comments by ACCC and other stakeholder groups, USP issued a revised Chapter <800> draft in December 2014.
In responding to the initial draft, ACCC and other stakeholder groups expressed concern about the difficulties providers would face implementing the proposed Chapter <800> standards, in large part due to the financial investment they would require. Many, including ACCC, anticipated that if USP Chapter <800> was adopted as first drafted, some cancer facilities would no longer be able to offer compounding services to patients or might even close altogether.
ACCC is pleased that USP’s revised Chapter <800> draft provides more flexibility, but concerns remain. We continue to request additional pathways to comply with the new USP standards and to ask for more clarity on specific requirements. ACCC supports USP’s ultimate goal of ensuring healthcare worker safety; however, we believe that in several instances there are more cost-efficient protective measures that would provide more certain safety enhancements.
USP is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP standards, such as Chapter <800>, are generally adopted by states and enforced by state Boards of Pharmacy or other regulatory entities. USP has indicated that the earliest likely effective date for Chapter <800> is August 2016; however, the many structural and procedural changes in the current draft would make compliance by that date a stretch for oncology programs.
The ACCC policy team is watching closely for a further revised or final draft of Chapter <800>; we will keep you posted.
By Leah Ralph, Manager, Provider Economics & Public Policy, ACCC
Once again attention is focusing on the 340B Drug Pricing Program. With policymakers – and a variety of stakeholders – increasingly clamoring for more clarity and with some calling for more restrictions, HRSA has struggled with its authority to issue regulations on certain topics, including patient definition, hospital eligibility criteria, and contract pharmacy arrangements.
Last week, it looked like policymakers might address the issue legislatively, attempting to insert last-minute language into the House Energy and Commerce Committee-led effort, 21st Century Cures legislation, that would “overhaul” the program and include many of the issues HRSA has attempted to address in regulations and guidance. However, the Committee ran out of time to find consensus on the comprehensive 340B reform plan, and the language ultimately did not make it into HR 6, the bill that passed out of committee last week.
In keeping with the growing momentum, last week MedPAC also released a report on the 340B Program at the request of Congress. The report provides an overview of the program and evaluates the trend in program growth and spending since its inception. This report could be used to set the stage for future reforms.
Perhaps most important, following HRSA’s withdrawal of its “mega-rule” last fall due to a court ruling against the agency’s treatment of orphan drugs under the program, HRSA recently submitted “mega-guidance” to OMB for review. While language is not yet public, we expect the guidance to cover topics where HRSA does not believe it has the rule-making authority, including patient definition, hospital eligibility, contract pharmacy, and audits. While OMB typically has up to 90 days to review submissions, the agency is not required to take the whole period, and we may see guidance published as early as June.
ACCC continues to follow the 340B dialogue closely, and looks forward to seeing clear, comprehensive rules and definitions to ensure compliance and the long-term viability of the program. For more, see the ACCC position statement.
By Maureen Leddy, JD, Policy Coordinator, ACCC
On May 21, the House Energy and Commerce Committee advanced its 21st Century Cures legislation, HR 6, by a unanimous vote of 51-0. The Committee has publicly pledged that HR 6 will be taken up on the House floor sometime in June, with the goal of final passage in the House by the end of the year. The Cures legislation represents a tremendous step toward advancing research in the field of oncology and healthcare, as well as improving the process for bringing new technologies into oncology programs nationwide. ACCC supports these efforts and continues to watch carefully. Read on for background and an analysis of key provisions in the current draft.
21st Century Cures: The Road to Passage
A year ago the House Energy and Commerce Committee, led by Chairman Upton (R-MI) and Representative DeGette (D-CO), issued a call to action on the 21st Century Cures initiative. The focus was to be the discovery, development, and delivery of life-saving drugs and devices to patients. Through a series of hearings and meetings with stakeholders and government officials, the Committee developed draft legislation, originally circulated in January 2015. The most recent draft incorporates the input of multiple stakeholders and represents a collaborative effort toward developing a better pathway to bring new therapies to patients.
Importantly, the prospects in the Senate, at least for 2015, remain uncertain. The Senate Health, Education, Labor and Pensions Committee (HELP) has been conducting a similar effort toward producing draft legislation focused on new drug and device development. The HELP Committee released a white paper in January 2015 that focused on barriers to development and delivery of new drugs and devices to patients, and examined potential solutions within FDA and NIH. On April 28, the Committee held a hearing, “Continuing America’s Leadership: The Future of Medical Innovation for Patients,” its third hearing on development and delivery of new treatments. While we are encouraged by these efforts, Chairman Lamar Alexander (R-TN) has indicated that the Senate may not develop its own legislative draft language until early 2016.
HR 6: Where Was Consensus Reached?
Despite uncertainty around the Senate’s parallel effort, HR 6 represents an extraordinary collaborative effort toward improving the pathway for disease treatment development. Exactly what did they agree to that will impact ACCC members and their patients?
- NIH Funding
ACCC was pleased to see provisions included that would significantly advance NIH biomedical research. Provisions supporting high-risk breakthrough research and facilitating clinical trial and health data sharing would spur the development and use of new cancer treatment technologies. The establishment of a 21st Century Cures Council, consisting of representatives from NIH, FDA, CMS, industry, insurers, patients, providers, as well as academic researchers, would allow for continued collaboration by this wide range of stakeholders. This council is tasked with setting a strategic agenda for cures development, identifying gaps in innovation and proposing recommendations, and identifying opportunities for collaboration in the U.S. and abroad.
- Drug Development Tools and Precision Medicine
HR 6 follows President Obama’s January announcement of the research-focused Precision Medicine Initiative, clarifying terms and the development of precision drugs and biologics, and requiring guidance documents. The bill defines “biomarker” and requires establishment of a framework for development of biomarkers, including a taxonomy for biomarker classification. The FDA would be required to define “precision drug or biological product” as well as issue guidance on development of biomarkers to inform prescribing decisions. The legislation would also establish a pathway for accelerated drug approval through use of surrogate endpoints.
The field of oncology is witnessing a tremendous growth in the number of molecular biomarkers, as well as diagnostic tests. These improvements in classification of biomarkers as well as clear guidance on prescribing are key to the adoption of these new technologies in cancer care programs.
- Clinical Trials
The option to participate in clinical trials is critical to cancer patients that do not respond to standard treatments. HR 6 would advance federal clinical trial participation, requiring NIH to standardize patient inclusion and exclusion information. It would also require the creation of a scientific research sharing system for federally funded trials. 21st Century Cures would also promote clinical trials by eliminating regulatory duplication through harmonization of HHS and FDA Human Subject Regulations. The legislation modernizes provisions and streamlines the review process to account for trials conducted at multiple sites.
ACCC is pleased that consensus was reached on these and other key provisions regarding research and development of innovative cures. We will continue to monitor this legislation as it reaches the House floor, and watch the Senate for parallel legislation. Stay tuned.
As the clock ticks down to the May 7 deadline for CMMI Oncology Care Model (OCM) provider Letters of Intent (LOIs), some ACCC members may still be on the fence about submitting an LOI. CMS introduced the Oncology Care Model—the agency’s first specialty-specific alternative payment model—back in February. Those physician practices selected for OCM participation will begin receiving reimbursement for chemotherapy treatment episodes of care under the Oncology Care Model in spring 2016.
Since the introduction of the OCM, ACCC members have raised numerous questions as they weigh whether to apply for participation. In general, these questions have focused on three main issues: performance benchmarking methodology, payer collaboration, and the financial feasibility of achieving the practice transformation requirements. CMS has responded to some of these concerns, but we hope the agency will continue to provide clarity as the LOI submission period closes and our members prepare final applications for the June 18 deadline. Read on for a summary of CMS’s responses on these three key issues.
Performance Benchmarking Methodology
The initial Request for Applications (RFA) from CMS generated questions about the benchmarking methodology used to calculate a provider’s baseline or target price for specific episodes of care. Providers raised concerns about outliers with extremely high costs of care. CMS has responded that it will use Winsorization, resetting the outlying episode to a specific percentile within the provider’s total average care costs. Providers also raised concerns about how an already lean practice may benefit from OCM participation, where the benchmark for performance is based on the specific practice’s past performance. CMS has responded that the baseline period will likely be a three-year period beginning in 2012. The agency believes that this will help account for any very recent practice improvements. CMS has also indicated that the baseline for the entire five-year model will remain that same three-year period, ensuring practices that quickly adopt performance targets are not penalized in later years.
In CMS’s applicant scoring methodology, participation with other payers (i.e., in addition to Medicare) will represent 30 points out of 100, a signal that the agency highly values the expansion of the OCM beyond Medicare. CMS has announced that 48 payers have submitted LOIs, and providers have raised concerns about whether to apply if no payer will be participating in their region. CMS has indicated that while it is an advantage for provider practices to partner with other payers, it is possible for a practice to be selected to participate in the OCM with only Medicare. There have also been indications that once the list of providers submitting LOIs is made public, there may be opportunity for payers to expand their participation regions.
ACCC members have also raised concerns about whether the $160 per beneficiary per month fee is sufficient to achieve all of the practice transformations called for in the OCM. CMS has noted that other payers are expected to provide enhanced payments, which can also be used for the infrastructure changes called for in the OCM. For patients that do not fall within the OCM, practices may also continue to bill for chronic care management and transitional care management. CMS believes that this will provide sufficient revenue to support the required infrastructure changes. However, ACCC welcomes further feedback from members.
As we enter the post-SGR era, ACCC will be working to keep members informed on alternative payment model initiatives. We are pleased to hear that several members will apply to participate in the CMMI Oncology Care Model, and will continue to provide updates on this and other relevant alternative payment models as details become available.
By Maureen Leddy, Policy Coordinator, ACCC
On April 14, 2015, after years of uncertainty and 17 short-term “doc fix” patches to prevent severe annual cuts to physician payments, Congress approved H.R. 2, Medicare Access and CHIP Reauthorization Act (MACRA). This bipartisan, bicameral compromise finally puts an end to the sustainable growth rate (SGR) formula. MACRA provides physicians with the predictability in payments needed to continue to provide high-quality cancer care, while transitioning over a 10-year period to a new dual Medicare reimbursement system.
What’s in Store?
Under MACRA physicians must eventually participate in a Merit-Based Incentive Payment System (MIPS) or an Alternative Payment Model System. Through June 2015, MACRA calls for Medicare physician reimbursement at the rate set by last year’s “doc fix” patch. Then, for five years, through 2019, annual 0.5% increases to payment rates are established.
In 2020, a second five-year phase begins during which reimbursement rates remain flat. During this second phase, providers will need to transition to the Merit-Based or Alternative Payment Model Systems. Ultimately MACRA encourages providers to participate in Alternative Payment Model Systems through higher incentive payments; beginning in 2026, physicians will receive automatic payment updates of 0.75% if participating in an APM, and 0.25% if participating in MIPS, with an opportunity to receive additional bonus payments based on performance. Payments under the MIPS will be subject to positive or negative adjustments based on the following performance criteria:
- quality of care
- resource use
- clinical practice improvement activities
- use of electronic health records (EHR) technology.
During the second five-year phase through 2024, providers participating in an Alternative Payment Model will be eligible for annual lump-sum bonuses equaling 5% of the prior year’s payments upon achieving specified targets in transitioning from fee-for-service payments. Providers participating in MIPS will be eligible during this second five-year period for additional positive adjustments in rates for exceptional performance.
Payment Model Technical Advisory Committee
MACRA encourages the development of Alternative Payment Models applicable to specialties and small practices, as well as models that align private and state-based payers. The legislation calls for creation of a Payment Model Technical Advisory Committee that will recommend additional Alternative Payment Models to CMS. CMMI’s recently launched Oncology Care Model (OCM) already provides one venue for many cancer providers to participate in an Alternative Payment Model. Visit ACCC’s Oncology Care Model Resource Center for answers to providers’ questions on eligibility, reimbursement, and key considerations for participation in this new payment model, plus links to application forms and CMMI OCM materials.
Going forward, ACCC will be vigilantly monitoring the Payment Model Technical Advisory Committee recommendations for other Alternative Payment Models that may be relevant to oncology practices.
ACCC looks forward to working with our members to effectively implement the bill and transition towards a new future for physician reimbursement.
On Wednesday, April 22, ACCC is hosting a members-only conference call with presenter Dan Todd, former Senior Health Counsel, Senate Finance Committee, and a primary author of MACRA, that will provide an in-depth look at what MACRA means for oncology providers and the future of physician reimbursement. ACCC members can access call-in information here.
As ACCC members know, last week brought unprecedented momentum on an issue physicians and Congress have been struggling with for over a decade: repealing the sustainable growth rate (SGR). Just days before the current SGR “patch” expired, the House of Representatives overwhelmingly passed H.R. 2, the Medicare Access and CHIP Reauthorization Act, legislation that would permanently replace the SGR formula with stable Medicare payment updates and encourage physicians to increasingly participate in alternative payment models. The bill builds on last year’s bipartisan, bicameral compromise that ultimately hit roadblocks when legislators struggled to find a way to pay for it.
The Senate was expected to take up the House bill, but on March 27, the chamber recessed for two weeks, leaving a very small window to consider the bill when they return on April 13.
Senate Majority Leader Mitch McConnell has said the bill should move “very quickly” when the chamber comes back into session, and there is “every reason” to believe the bill will pass.
Meanwhile, the current “patch” expired March 31, and CMS has indicated that it will hold claims for two weeks, or 10 business days, through April 14.
We’re in the homestretch; we’re closer to a permanent fix to the SGR than we have ever been before. But are we there yet? Not quite. Now is the time to contact your Senators, and urge them to support passage of H.R. 2, to ensure that physicians have the predictable, appropriate payments they need to continue to provide high-quality cancer care.
Stay tuned. And make your voice heard. Contact your Senators today.
On Thursday, March 26, the U.S. House of Representatives passed H.R. 2, legislation to permanently repeal and replace Medicare’s sustainable growth rate (SGR) formula for physician reimbursement. Read a summary of the legislation here.
Unfortunately, the Senate announced late Thursday evening that they will not consider the SGR repeal bill until they return from recess on April 13, 2015. CMS has indicated it will hold claims for two weeks, through April 14.
ACCC urges members to contact your Senators in the next two weeks and ask them to support a permanent repeal of the SGR.
On March 26, by a vote of 392-37 the U.S. House of Representatives overwhelmingly passed H.R. 2, the Medicare Access and CHIP Reauthorization Act of 2015, legislation to permanently repeal and replace Medicare’s sustainable growth rate (SGR) formula for physician reimbursement. Read a summary of the legislation here.
Rep. Michael C. Burgess, MD, (R-Texas), the bill’s primary sponsor, said in a statement, “This is the work of a collaborative body. . . .It is time to end the SGR. Let us never speak of this issue again.”
On March 25, the White House expressed support for the bill.
The Senate is expected to vote on the bill March 27, before Congress recesses for two weeks.
ACCC urges members to contact your Senators and ask them to support a permanent repeal of the SGR. As an expert in cancer care, they need to hear from you!