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FLASCO ASCO Update
- 1. ASCO Policy Update: 2017 Outlook Friday, March 31, 2017 Bruce Johnson, MD, FASCO
- 3. ASCO PRIORITIES: 2017-18 GOAL 1: Pursue access to high quality, affordable care for every patient with cancer Examples: Drug Price, Medicaid/Medicare parity GOAL 2: Advance policies and delivery system reform that supports oncology providers in their delivery of high quality, high value cancer care Examples: MACRA, Payment Reform GOAL 3: Advocate for policies that support a robust federally funded cancer research, prevention, drug development and clinical trials system Examples: Right to Try, Clinical Trials Coverage, NIH Funding
- 4. Top 3 Practice Pressures, ASCO Oncology Practice Trends Survey (2015-2016) 4 0% 10% 20% 30% 40% 50% 60% Staffing Issues Payer Pressures Electronic Health Records Drug Pricing Increasing Practice/Facility Expenses 2015 (n=177) 2016 (n=123)
- 6. Your New Healthcare Team President Donald Trump Tom Price Secretary of HHS Seema Verma CMS Administrator Francis Collins Director of NIH Scott Gottlieb FDA Commissioner Nominee
- 7. Right off the bat…. • January 20: ACA Roll Back – Agencies to use all discretion to remove financial burdens on states, individuals, families, providers and insurers • January 30: Regulatory Relief – Includes requirement involving cost analyses that could fundamentally alter the process and content of regulations
- 8. American Health Care Act (AHCA) • Repeals Prevention Fund • 1-year freeze Planned Parenthood $ • Repeal of Medicaid expansion (grandfathers current enrollees) • Tighter Medicaid eligibility criteria • Safety net $, non-expansion states • 30% surcharge lapsed coverage • Higher premiums for older Americans • Per capita allotment for Medicaid • Repeals “essential health benefits” • Changes HSA contributions • Tax credits low and middle-income Some Highlights:
- 9. What the AHCA Kept from the ACA • Pre-existing conditions • Lifetime caps • Coverage on family policy to age 26
- 10. What the AHCA Changes • Repeals Individual Mandate – Reduces penalty to zero …BUT, Must Maintain Continuous Coverage – Break in Coverage? • 63 Days can still purchase insurance w/out regard to preexisting conditions. Beyond that premiums would be 30% higher for 12 months. • Tax Credits – ACA: Tied to Income – AHCA: Tied to Age; but insurers can charge more as you get older • Help for High Income Earners – Repeal of Certain Taxes – Health Savings Account Deposits – Restores Some Flexible Savings Account Benefits
- 11. The Future of Medicaid • ACA established a new “expansion” population providing coverage to childless adults. AHCA would roll back expansion • State governments controlled by both parties are invested in protecting coverage for this population • Per Capita Caps/Block Grants may cause significant numbers to lose coverage Parity with Medicare requirements (e.g., clinical trials coverage)
- 12. CBO Score on AHCA • 24 million uninsured by 2026 • Reduce Deficit by $151 billion
- 13. ASCO’s Position: Ensure Access to Insurance Coverage • Coverage for those with pre-existing conditions • Coverage for all cancer patients regardless of income and health • No lifetime coverage caps • Guaranteed renewability • Coverage of cancer screenings 13
- 14. What’s Next? Three Phases of Reform Legislation for everything else Administrative Actions Budget Reconciliation (American Healthcare Act)
- 16. As we know them… • Budget • Drug Pricing • Right to Try • MACRA Implementation • Medicare Reform? • Others?
- 17. “Skinny” President’s Budget • HHS: Cut $15.1B – 17.9% • 21st Century CURES: Funds for program integrity and implementation. • FDA: Doubles user fees to $2B; administrative changes to speed drug approvals. • NIH: Cut $5.8B – 18.3%; structural/administrative changes to reduce cost. • AHRQ: Consolidated with other programs Source: Washington Post, March 16, 2017
- 18. Drug Pricing • President, bipartisan promising action – Medicare negotiation for drug price? – Re-importation of drugs? – Performance based pricing? – No more Part B demo… • Hold physicians accountable for utilization…not market entry pricing Oncology must not be used to claim the high cost of drugs has been addressed.
- 19. What’s Next? “I am working on a new system where there will be competition in the Drug Industry. Pricing for the American people will come way down!” “Phase 2 or 3” of repeal and replace Medicare negotiation…importation…faster generics?
- 20. Right to Try 33 States have passed legislation allowing Concerns About Bills • Removing FDA review of safety and efficacy • No provision for IRB, associated patient protections • No systematic data collection on safety and efficacy, which could help all patients What ASCO is Doing • Working with trial sponsors and FDA to relax the eligibility criteria for clinical trials to enable more patients to participate • Launched TAPUR and CancerLinQ to learn from individual patients, help build evidence base for delivery of high-quality cancer care. • Developing Position Statement
- 21. Trickett Wendler Right to Try Act of 2017 Senator Ron Johnson (R) Wisconsin
- 22. Oversight of MACRA Implementation • Monitor implementation of MACRA to ensure the intent of the law is followed; including: – Test multiple innovative alternative payment models – Ensure providers MIPS scores are not negatively impacted by the cost of drugs 22
- 23. MACRA: Influencing Implementation Ensuring a smooth transition • Numerous training webinars • State presentations • Train the trainer • Testimony to Congress • Comments to CMS • Agency and Hill meetings On October 14 CMS released its Final Rule, which allows practices to ‘pick their pace,’ accepts a number of ASCO recommendations
- 25. Payment Reform and Practice Transformation are Key • Center for Medicare & Medicaid Innovation’s (CMMI) Oncology Care Model • ASCO will Submit to Physician Technical Advisory Committee by August
- 26. Action Increasingly at the State Level High Priority • Opioids Therapy • Safe Handling of Hazardous Drugs • Clinical Pathways • Oral Chemotherapy Parity Also Tracking Tobacco (“Tobacco 21,” Smoke free workplace) Medicaid (Clinical trials coverage) HPV Vaccination Prescription Drug Costs Biosimilars Brown Bagging Prior Authorization Specialty Tiers Step Therapy/Fail First
- 27. Prescription Opioids • Bipartisan, high priority in states • 400+ bills in 46 states • Assisting State Affiliates • Balancing support for action with appropriate treatment • Top concerns • Limits on opioid prescriptions (dosage or days) • Prescription Drug Monitoring Program (PDMP) prescriber query requirements
- 28. Safe Handling of Hazardous Drugs • Ongoing support for State Affiliates • Tracking state action • Status in flux • USP <797>: to be posted for 2nd public comment period • USP <800>:July 1, 2018 official implementation date, states can adopt at any time • NIOSH Alert: updated version to be released
- 29. Clinical Pathways • Model legislation and assistance for states • Improving pathways development • Addressing practice burden • 2017 state bills • CT HB5960 • CA AB1107
- 30. Oral Chemotherapy Parity • Laws in 42 states and DC • ASCO supports 2017 bills • AR HB1592: Passed! • MI to be introduced • NC H206/S152 • TN HB1059/SB922 • Participate in cancer treatment fairness coalitions
- 31. Tobacco 21 Legislation in Florida • FL legislation raising the legal age of tobacco purchase to 21 introduced recently • HB1093/SB1138 in early stages • Bipartisan support in House and Senate • FLASCO and ASCO sent joint letters of support • FL one of seven states with similar bills that ASCO supports
- 32. • ASCO.org State Advocacy page – State legislative calendar – ASCO’s state policy priorities – Infographics and state cancer fact sheets • State ACT Network – Focus solely on state legislative action – Includes CQ clickable map by state • Policy Toolkits – On opioids, pathways, oral parity and the safe handling of hazardous drugs – Toolkits may include policy statements and briefs, model legislation and FAQ’s State Advocacy Resources
Editor's Notes
- Uncertain times, a lot of anxiety. ASCO’s strategy for now is to avoid partisan politics, keeping focus on policies that support delivery of high value care for every patient with cancer.
- Uncertain times, a lot of anxiety. ASCO’s strategy for now is to avoid partisan politics, keeping focus on policies that support delivery of high value care for every patient with cancer.
- Since the Board just approved the new priorities, it makes sense to talk about them first. Each year, the Government Relations Committee works with all of the committees at ASCO, including the State Affiliates, to recommend to the Board policy priorities for the coming year. These are the 2017-18 priority areas. Goal 1 focuses on patients and access to affordable care and examples of work to be done there includes drug price and Medicare/Medicaid parity. Goal 2 focuses on the delivery system and that emphasis right now is payment reform and MACRA. Goal 3 focuses on clinical research, examples of that are the Right to Try laws, clinical trials coverage and NIH funding.
- Our goals are driven by what we hear from you, our members. This is one example of what we’re hearing from practices regarding the pressures that you’re facing is reflected here. This is from our recent State of Cancer Care report and you’ll see pressures that are not surprising, and are reflected in some of the initiatives that I am going to talk about today.
- There is a lot differing opinions about what is going on this year – with this administration and this Congress – than in previous administrations. The tone, tenor and pace of things is much different. ASCO is non-partisan and our members have varied views about whether the actions taken by the administration/Congress are positive or negative. Some, who voted for Trump believe that this is exactly what they elected him for. Others believe that is it disruptive and dangerous. One thing that is clear regardless of your political opinion is that it is different. And why that matters for the issues we care about is that things that have typically been “safe” may not be safe anymore and it means that things that have traditionally been under threat may not be anymore. And most of all, it means we don’t know what’s coming…and it means that our typical ways of doing things may not work.
- President Trump: Healthcare does not seem to be his thing. He’ll likely defer healthcare administrative actions to the team he’s put in place. Tom Price. ASCO knows him well. MD, Orthopedic Surgeon, leader of the House Doctors Caucus. Opposed Part B demo, Advocate of MACRA, interested in reducing admin burdens, already brought doctors in to meet with him, including ASCO. Has some controversial views about privatizing Medicare – that are in conflict with Trump’s views – but generally cares a lot about making your lives easier and leaving the practice of medicine to the doctors. Frances Collins – Holdover from Obama administration. Generally well respected. No changes expected for NIH but will have a difficult time with potential budget issues Scott Gottlieb – Much better than other potentials who would have advocated that the FDA only look at safety, not efficacy, of drugs. MD, Venture investor and former FDA official. Not set out to destroy the agency, but has written extensively about how the pendulum may have swung too far in the direction of safety and efficacy and less in the support of innovation. His confirmation hearing is likely to be in the next few weeks and he’s likely to be confirmed. Seema Verma – New Medicare Administrator. Less known about her. She is not a doctor, but has her masters in public health. Has run a consulting firm for most of her career and worked with Gov Pence in Indiana on Medicaid reform. One of her first actions as administrator was to send a letter to states urging them to charge Medicaid Recipients for ER visits, encourage them to get jobs, etc
- The Administration is clearly moving quickly to demonstrate its commitment to making good on campaign promises. On Inauguration Day, the president signed an Executive Order requiring agencies to “exercise all authority and discretion available to them to waive, defer, grant exemptions from, or delay the implementation of any provision or requirement of the Act that would impose a fiscal burden on any State or a cost, fee, tax, penalty, or regulatory burden on individuals, families, healthcare providers, health insurers, patients, recipients of healthcare services, purchasers of health insurance, or makers of medical devices, products, or medications.” It is not clear how this will play out…nor how it will stack up against his Jan 30 executive order requiring two regulations to be eliminated for every one published. The details of that order are slim and the criteria for how they will analyze the rules and decide on which get jettisoned are still to be determined by OMB.
- The AHCA has obviously been the subject of a lot of drama on Capitol Hill. Obviously you all know that the bill was pulled after much back and forth and the Republicans were unable to get the votes to pass it. We are still talking about it because the principles are important and the Republicans will likely still try to advance these principles one way or another. This is the Republican effort to repeal Obamacare, of the Affordable Care Act. You can see on this slide some of the key components of that bill. We will get more into detail on these issues in upcoming slides, but essentially, it repeals the individual mandate – the requirement that all Americans have insurance – changes some of the requirements for insurance plans. Shifts the funding for Medicaid and alters the tax regime under Obamacare.
- Keeps prohibition on discrimination based on pre-existing conditions, limitation on lifetime caps and allows kids up to age 26 to stay on their parents insurance. This was part of what the President promised in his campaign and what some members of the Freedom Caucus – 40 members of conservative lawmakers -- were trying to get them to drop. Had they dropped these, ASCO would’ve opposed. Hard to find a picture of Trump and Obama shaking hands!
- These are the basics of what was in the AHCA.
- A number of Republican-led states chose to pursue Medicaid expansion, which has resulted in providing coverage for many citizens. These governors are worried about changes that might cause these individuals to lose that coverage and have opposed the AHCA. Although the general sentiment of Republicans is to return control to the states, the Medicaid question creates tension with these competing priorities. The current bill would allot a per capita amount for Medicaid recipients and allow those in the form of a block grant, allowing states more discretion. It also repeals the EHB for Medicaid. Per Capita Cap: States receive capped amount per enrollee. If enrollees increase so does money to states. Block grants: States receive base amount. If enrollees increase, additional money needs to come from the state. Not guaranteed coverage under either and less money will generally mean less coverage and tightening eligibility. States get more flexibility but less money from federal government .
- The score didn’t help the AHCA. People disagree about whether the CBO gets things right, but the talking point of having 24 million more people uninsured in 2026 doesn’t help, even if you’re saving the country money.
- ASCO’s membership if very mixed on ACA and the AHCA. ASCO did not support or oppose the ACA, but weighed in on issues we felt clearly affected cancer patients, and we took the same approach to the AHCA and will apply these principles to any proposals moving forward. You’ll see our principles outlined here – some of this is included in the bill and we’ve weighed in with Congress on areas where we believe there is more work to be done.
- This was the grand vision for the process. The first step – the one that failed – was to pass what they could through reconciliation, which is a budget tool that allows the bill to pass with just a simple majority. This was important mostly for the Senate (or so we thought) because they’d have the votes to pass it without any Democrats. The second phase is through administrative actions. That is at the agency discretion and could still happen even thought the bill failed. An example of this could include lack of enforcement of the individual mandate or reducing the penalties for not having insurance to the point that they are meaningless. Another thing they could do is change the Essential health benefits requirements to significantly reduce coverage. The third phase under their plan was to do everything that they could not do through reconciliation or administrativelly They would need 60 votes in the Senate for this – so a good chunk of Democrats would have to agree with the policy changes. The theory was that they could bring some Democrats once phase one and two were complete. They are clearly reassessing this now.
- So there is other things the administration and Congress want to get done.
- These are Administration policy priorities as we know them today….they could shift…and because the administration is unpredictable it is hard to know what will be in the “other” category.
- This is the president’s budget proposal for FY 2018. He has proposed additional cuts for the remainder of FY2017. This is a non-binding recommendation to Congress by the President and word on the Hill is that it is DOA. But here’s why it matters – it sets a new tone for the budget and appropriations talks. Typically, things like NIH have been protected by bipartisan support, but now all the sudden a 2 or 3% cut will not look that bad when faced with almost 20% cut. ASCO will continue to advocate for an increase. With a separate funding stream for the Beau Biden moonshot activities, but this is now what we’re facing.
- The escalating price of drugs is a bipartisan issue, with both sides communicating the same message: something has to be done. Proposals have ranged from Medicare negotiating drug prices to performance based pricing. There have been many attempts to control price by targeting provider reimbursement; the Part B demonstration proposed by CMMI recently is one example. ASCO’s position is that: Manipulating Part B drug reimbursement without overall payment reform will not achieve the desired effect—and it has the potential to erode access to care, harm practices already struggling. It also assumes a wide array of choice among differently priced drugs for treatment of most cancers….which is not the case. This demo is off the table….for now. But there are still folks in Congress who think it should have happened. ASCO’s position is that physicians should be held accountable for what they control: utilization. (Choosing Wisely, guidelines, performance measurement, pathways, etc.). Physicians do not control market launch price. Things like the Part B demo, targeting oncologists should not be implemented so everyone can check the box on “fixing” drug price.
- But here’s what the President has said so we don’t know what is coming. Once Scott Gottlieb is confirmed, they’ll likely get to work on a plan.
- Right to Try legislation has gained momentum, especially in the current environment. There are now 33 states that have such laws on the books. VP and Pres have both signaled support for these laws. These provisions permit terminally ill patients to use drugs that have passed Phase I trials but are not yet FDA approved for use in that particular cancer. Advocates of these laws say they are needed to get around the long FDA review process and that patients should have the right to pursue options when they have no others. These laws do not require manufacturers to provide the drug. ASCO’s concerns as stated above. We are focused on streamlining the clinical trials process/system and supporting big data that can provide rapid insight.
- There is also a federal bill being considered. This bill would enact similar to the state laws at the federal level and allow patients to have access to drugs after phase I trials, however it does not mandate that the manufacturer provide the drug and it does protect the manufacturer from liability. Likely to move on a user fee reauthorization bill this year. ASCO developing statement encouraging enhancement of expanded access provisions over RTT laws Just FYI, Trickett Wendler was a young mother of three who had ALS and talked to the Senator about trying to access experimental drugs. She has since passed away, but her story touched the Senator and he has become a lead advocate for right to try.
- Another thing facing the administration right now is the implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Our job is to make sure it is implemented in a way that works for oncologists and is consistent with the intent of the law. ASCO is focusing on two areas (1) that more than one APM is available for oncologists and (2) that oncologists are not unfairly penalized because of their use of the high cost of drugs
- A huge amount of energy has gone into the The Medicare Access and CHIP Reauthorization Act of 2015 —monitoring and shaping implementing rules and working to prepare/support members for this new environment. The final rule released in October slowed the aggressive timeline, allowing practices to pick their pace for 2017. However….2017 is still the baseline measurement year and all practices should be participating in the Quality Payment Program.
- A recent survey signaled that more than a third of health systems are unprepared for MACRA and have no plans for how they will participate. Don’t you be one of them. …..if there are specific questions, be in touch with our new Clinical Affairs Department (Dr. Steve Grubbs), who leads an entire team focused on practice support.
- ASCO has embarked on a new phase in its work as a Society to help practices achieve the now-commonly used term, “practice transformation.” One path to relief from the reporting requirements under the new Quality Payment Program is to be an active participant in advanced payment models. There is only one oncology model right now, the Center for Medicare & Medicaid Innovation’s (CMMI’s) Oncology Care Model. ASCO is in the process of upgrading its Patient Centered Oncology Payment model for submission this August to one of CMMI’s physician advisory panels. The goal is to have PCOP as another alternative.
- As noted previously, a growing amount of policy action is happening at the state level. The list is long, but here are 4 areas where ASCO is particularly active.
- As the opioids epidemic continues, states are considering a wide range of policies to address the problems. ASCO’s opioids policy statement balances support for state efforts to respond to the opioid epidemic, with making sure well-intentioned polices do not have the unintended consequence of limiting access to appropriate pain management for patients with cancer. We are most concerned with proposals to limit opioid prescriptions by dose or days, and to require prescription drug monitoring program checks for opioid prescriptions for cancer-related pain. ASCO is assisting the state societies as their states take up opioids legislation and regulations.
- There continues to be activity in the states related to the safe handling of chemotherapy. ASCO is working with states where laws/regulations have surfaced to be sure the language does not impair access to care, especially when there is not sufficient evidence to merit these actions. Several sets of standards are in flux: The U.S. Pharmacopeial Convention (USP) 797 is a publication issued by the United States Pharmacopeia and aims to improve the safety of the compounding environment and the products produced in that environment, USP 797 is mandated by some state boards of pharmacy and recommended by others. USP 797 is under revisions now. The final USP General Chapter 800, “Hazardous Drugs – Handling in Healthcare Settings,” was released in 2016 and has an official implementation date of July 1, 2018 to allow entities time to implement the standard. USP 800 is focused on worker protections. ASCO is analyzing USP 800 in detail and more information on the impact for practicing oncologists is forthcoming. The National Institute for Occupational Safety and Health (NIOSH) is part of the Centers for Disease Control and Prevention (CDC) and is responsible for conducting research and making recommendations for the prevention of work-related injury and illness. The NIOSH Alert is a document entitled “Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings” that was published in 2004. NIOSH officials are currently updating the Alert.
- We have heard reports that some practices are subject to 8 or 10 different pathway programs for the same cancers. Some have assigned different colors to patients charts to reflect the specific pathway program. Many of the pathway programs are not transparent about the underpinning of recommended pathway treatments. This is administratively burdensome and potentially interfering with appropriate care. ASCO has published criteria for high quality pathway programs. A couple of states have launched legislative initiatives to improve the transparency and implementation of the pathways programs practices are required to use. ASCO has crafted a model pathways bill as a resource for the State Affiliates. The model bill outlines a process and criteria based on recommendations in ASCO’s pathways statement (e. g transparent process, evidence-based, developed by oncologists). We also provide assistance to states by reviewing legislation and providing input to make sure language is consistent with ASCO criteria.
- Campaigns continue in 2017 with oral parity or cancer treatment fairness legislation. Arkansas passed HB 1592 on March 14. TN HB1059 passed out of subcommittee and votes are planned next week in a full House committee and Senate committee. ASCO has supported campaigns working with State Affiliates by participating in coalitions, submitting support letters, providing testimony, sending Alert Congress Now messages, as well as social media messages.
- Bills popping up throughout country regarding increasing the legal age of tobacco purchase Florida is one of seven similar bills that ASCO supports ASCO submitted letter of support with FLASCO to House and Senate cosponsors. Tobacco 21 alert is currently live on the ASCO State ACT Network which allows constituents to email their State House Members.
- ASCO has created several new state advocacy resources to help the State Affiliates: A new state advocacy page on ASCO.org with links to legislative action alert center, legislative calendars, cancer state fact sheets and state advocacy policy priorities ASCO’s State ACT Network showcases a Congressional Quarterly (CQ) tracking map where ASCO members can click by state to see legislation in their state on key issues. It also offers the ability to send messages to state and local representatives and senators on priority bills, such as the oral chemotherapy parity bills. ASCO also offers policy toolkits on priority issues which can help State Societies build model language, answer Member’s questions and review ASCO’s policy statements. Additionally, ASCO is starting to hold state advocacy-focused webinars on key issues to foster discussion between the State Affiliate Council and share ASCO policy and advocacy resources. A state opioids policy webinar was held last month.