Health Care Reform Memo: June 13, 2011
Deloitte Center for Health Solutions publication
The health care reform memos are issued on a weekly basis, highlighting news from the previous week's activities in the administration and implications for the C-suite and various stakeholder groups.
From Paul Keckley, Executive Director, Deloitte Center for Health Solutions
Costs are the product of volume and price. It’s basic economics. It’s a simple formula—volume times price equals cost. In health care, however, nothing is simple. And in the debate about health reform, even simple concepts are neglected.
Volume is driven by the prevalence of diseases and injuries, consumer preferences for treatments, and the practice patterns of physicians who authorize tests, procedures, and prescriptions. It’s complex. In the Affordable Care Act (ACA), the Patient-Centered Outcome Research Institute (PCORI) is tasked to build the comparative effectiveness toolkit so consumers can compare the effectiveness of treatment options and understand their appropriateness based on strength of evidence. And the meaningful use of electronic medical records (EMR), via the Health Information Technology for Economic and Clinical Health (HITECH) Act, and changes to the Physician Quality Reporting Initiative (PQRI) assure that hospital and physician practice patterns will be public record so that volume is traceable. If PCORI recommendations are followed by Congress, incorporated by employers and plans, or paid attention by consumers, unnecessary care and volume might be less. Inappropriate variation might be reduced. But it’s tricky. The evidence is rarely black or white. Medicine remains the blend of art and science, and though powerful analytic tools let us more accurately predict outcomes and chart effective plans of care, more is unknown than known. And on the basis of evidence, in some categories of care, like preventive health and behavioral medicine, under-use might increase volume rather than drive decreases. So volume is addressed, though the journey to appropriate volume will be slow and surely a hot topic.
Prices for health care goods and services are likewise complex. For the same unit of service—an hour of nursing care, an aspirin, a day in the emergency room, an implantable device, a basic health plan—prices vary depending who is paying the bill. They are different due to the pricing models used by hospitals, plans, and manufacturers to recoup losses, investments in research and development (R&D), operating costs, and margin requirements for sustainability and growth. In hospitals and doctors’ offices, it’s even more complicated: prices reflect cost shifting to commercially insured customers to make up for underpayments from Medicaid and Medicare and bad debt from services provided to those without insurance. The health care industry is labor intense and capital intense. Pricing is not as simple as posting a list of ten items. ACA does little to make it simpler to understand prices. The new excise taxes on the health insurance, pharmaceutical, and medical device industries likely will be passed through, to a substantial degree, to purchasers in higher prices. New regulations facing the health insurance industry—waivers of co-payments for preventive health, premium controls, medical loss ratio (MLR) constraints, risk ratio ceiling of three to one, cuts in Medicare Advantage reimbursement by Medicare, and additional reporting requirements—will add four to five percent to premium prices in addition to underlying medical costs. And regulations facing hospitals and physicians—additional safety, quality, and patient experience reporting, implementation of health information technologies, clinical integration, and risk-sharing with payers—are certain to increase prices as costs are passed through.
Efforts to make it simpler to understand and manage appropriate volume and makes prices more transparent and comprehensive are included in ACA, though the jury is still out on how effective they’ll be. The Independent Payment Advisory Board (IPAB, Section 3403) will have the power to restrain spending if aggregate costs exceed one percent above the gross domestic product (GDP). Per Section 1003, states will review and authorize rate increases for insurance companies. PCORI (Section 6301) will determine what treatments work best and make that information available to Congress, and administrative simplification will make administration and paperwork in the industry easier to comprehend and simple (Section 1104).
The concepts of volume and price are simple. But in health care, even the simplest concepts escape rational discussion. So as we enter the era of health reform 2.0 featuring attention to ACA implementation, changes, funding, and timelines, these are three suggestions to move this discussion of volume and price forward:
- Providing objective, unbiased, easy to access and understand information about volume (including appropriateness) and prices for health care goods and services should be the centerpiece for health reform 2.0.
- The approach should be “tools, not rules”. The underlying calculus should be transparent. The purpose should be equipping consumers, providers and all stakeholders with valid and reliable information upon which business decisions may be made rather than gamesmanship.
- The convergence of volume (clinical) and price (financial) information should lead to a national discussion about value in the U.S. health system; costs are an element, but its value proposition more relevant.
Health costs are the product of volume and price. The health care industry can ill afford to default to its complexity as an excuse not to make both more understandable and useful.
Paul Keckley, Ph.D., Executive Director, Deloitte Center for Health Solutions
ACO rule update
The comment period for the Medicare Shared Savings Program, also known as the accountable care organization (ACO) program (ACA Section 3022), ended Monday. Among notable comments:
- Provider organizations (American Hospital Association [AHA], American Medical Association [AMA]) challenged the costs of implementing and operating an ACO.
- Health plans (America’s Health Insurance Plans [AHIP]) suggested the antitrust safety zone limit too lax and recommended lowering the threshold from 30 percent to 20 percent.
- Device makers (AdvaMed) encouraged the addition of independent clinical oversight of ACOs to avoid skimping on appropriate technologies and interventions and additional accounting procedures that accurately include medical devices.
- The Medicare Payment Advisory Commission (MedPAC) encouraged Centers for Medicare & Medicaid Services (CMS) to allow more time for ACOs to phase in the two-sided risk model, prospective assignment of beneficiaries, fewer clinical process quality measures, and larger bonuses in both ACO models.
- AARP recommended adding a special category for assigned enrollees—an “at-risk” group for beneficiaries in medically underserved or low socioeconomic status areas and public reporting of cost of care and enrollee satisfaction.
- The American Medical Group Association (AMGA), representing 390 large medical groups, encouraged a fix for the sustainable growth rate (SGR) payment formula for physicians be included in final ACO regulations.
Since the rule was proposed March 31, CMS has offered three changes to encourage participation:
- Pioneer ACO: May 17, CMS announced the Pioneer ACO Model as a way for providers with risk management experience to participate starting this fall. It differs from the Section 3022 ACO in the following areas:
ACO (Section 3022) Pioneer ACO Length of agreement Three years; begins January 2012 Three years; begins as early as Fall 2011 with possible extension for five years Minimum number of Medicare enrollees 5,000 15,000 (5,000 if in rural area) Enrollee assignment Retrospective Retrospective/prospective (based on three years claims data) Payments model One sided model assumes no risk in Years 1-2, and assume risk in Year 3;
Two-sided model assumes risk in all three years
“Core Payment Arrangement” for first two years with risk for losses and savings upside, then shifting to a capitation model (per member, per month) to allow for more flexibility in managing population health Commercial plan participation Does not address Encourages ACO to add commercial contracts by Year 2 Quality measurement 65 measures; scored to achieve optimal savings Same. CMS will report Pioneer ACO quality results on its website Antitrust “safety zones” 30 percent “safe” based on primary care market; at 50 percent, regulatory approval required 30 percent “safe” based on primary care market; at 50 percent, regulatory approval required Governance Consumer representation required Consumer representation required or meaningful collaboration with at least one “community stakeholder”
- Advance payment for ACO start-up costs: in its May 17 letter, CMS indicated it was reconsidering ways whereby ACOs might get advance payments from future earned Medicare savings to fund start-up costs for ACO staff and infrastructure. CMS requested comments on this alternative funding model by June 17, 2011. Note: CMS estimates start-up costs at $1.7 million; most industry trade groups have estimated the costs much higher.
- Accelerated development learning sessions: sessions focus on core competencies for ACOs—quality management, risk management, care coordination, data collection, reporting, etc. Four sessions will be offered in 2011; attendance is not mandatory for potential applicants.
ACA constitutional challenges update: Atlanta circuit court
Wednesday, the 11th Circuit Court of Appeals in Atlanta heard oral arguments in the 26-state lawsuit led by Florida (Florida v the U.S. Department of Health and Human Services [HHS]) and the National Federation of Independent Business (NFIB) challenging the constitutionality of the individual mandate. The case is on appeal from a January 31, 2010 ruling by U.S. District Court Judge Roger Vinson that the individual mandate exceeds Congress’s authority under the Commerce Clause and that the entire law was not sustainable without the individual mandate.
Note: if the 11th Circuit Court of Appeals upholds Judge Vinson’s ruling, the U.S. Department of Justice may request an en banc hearing where all of the judges from the entire 11th Circuit would hear the case, before it moves to the U.S. Supreme Court. If the en banc hearing is granted, the U.S. Supreme Court may not rule on the individual mandate and the law in its entirety until after the 2012 election.
House subcommittee focuses on IPAB repeal
Tuesday, the House Energy and Commerce health subcommittee will hold a hearing on the repeal of IPAB. GOP House members have enlisted seven House Democrats to sign onto a bill to repeal IPAB; the Senate's version of the repeal bill has 28 co-sponsors but no Democrats have signed on.
IRS extends deadline for BCBS health plans to implement MLR provision
Friday, the Internal Revenue Service (IRS) announced a one-year delay in the enforcement of the 85 percent MLR requirement for eligibility for the special deduction and unearned premium treatment accorded to certain Blue Cross Blue Shield plans and certain similar organizations. The IRS Notice 2011-51 said organizations will now have until the “first taxable year beginning after Dec. 31, 2010” to meet its reporting requirements for the law.
Revisions to CLASS Act sought by House GOP
Tuesday, Representatives Charles Boustany (R-LA) and Phil Gingrey (R-GA) sent a letter to HHS Secretary Kathleen Sebelius requesting clarity about its receptivity to changes in the Community Living Assistance Services and Supports (CLASS) program, the ACA long-term care insurance program. (Section 8002). In a June 3 letter, HHS indicated it was considering revisions such as increasing enrollee employment and earnings requirements, indexing premiums to increase in parallel with the overall costs of benefits and minimizing re-enrollment loopholes. In March, Boustany, Gingrey, and Representative Dan Lipinski (D-IL) introduced legislation to repeal the CLASS program, and 15 other members of Congress have signed onto the bill. In the Senate, John Thune (R-SD) sponsored companion legislation that has 32 co-sponsors, all Republicans.
Note: $230 billion is spent each year on long-term care (10.6 percent of all health expenditures). Of that amount, 48.5 percent is covered by Medicaid programs financed jointly by the federal (57 to 75 percent) and state (25 to 43 percent) governments. To be eligible for Medicaid support to finance a nursing home stay, a person must demonstrate financial need; individuals who are unable to pay out of pocket typically spend down their assets to meet that eligibility requirement. Medicare, on the other hand, currently covers only short-term nursing home stays following acute episodes of illness.
In 2007, Senator Edward M. Kennedy (D-MA) introduced the original CLASS Act to augment long-term care services beginning in 2009. The Senate and House of Representatives each included the CLASS Act in their proposed health reform legislation as a voluntary program that provides benefits of up to $50 per day for those unable to perform at least two daily functions or suffering from cognitive impairment that is expected to last more than 90 days. In ACA, it is funded through voluntary monthly payroll deductions from workers over the age of 18; premiums are based on age and enrollment year and can be increased if necessary to sustain the program. Active workers are automatically enrolled, but may opt out. As conceived, the CLASS Act did not replace traditional private long-term care insurance or Medicaid, but offers supplemental coverage. The cash benefit to individuals may be used for non-medical expense. Medicaid recipients residing in nursing homes could keep five percent of their cash benefit, and individuals receiving benefits under home and community-based waivers could keep 50 percent of their cash benefit.
To be eligible for benefits, the program calls for a five-year vesting period during which premiums would be paid into the program before any benefits are paid out.
The GOP has two concerns: does the CLASS Act create a new “entitlement” program that further obligates the federal government to payments, and is the formula for the CLASS program self-sustainable or will it lead to higher deficits.
Tax on home care devices focus of advocacy effort
Last week, 18 patient advocacy groups petitioned the U.S. Department of the Treasury to exempt wheelchairs, oxygen supplies, and other durable medical equipment used in the home from the 2.3 percent sales tax on certain medical devices set to start 2013 (ACA Section 9009). The law exempts eyeglasses, contact lenses, hearing aids, and “any other medical device determined by the Secretary to be of a type which is generally purchased by the general public at retail for individual use.”
FDA report: budget cuts threaten biosimilar pathway development, generic review approval processes, and food safety
Last week, the U.S. Food and Drug Administration (FDA) notified lawmakers that the proposed 11.5 percent cut ($285 million) in its fiscal year (FY) 2012 operating budget would threaten biosimilars pathway development, limit illegal drug importation surveillance efforts, slow approvals of generic drugs, and stall efficiency improvements in the agency’s approval processes for devices and generic drugs. Per the FDA advisory, the cuts might also force limits on implementation of food safety oversight activity planned and increased surveillance of food-borne illness.
Note: in 2010, FDA received $2.4 billion of its total operating budget of $3.3 billion from the federal government. Some of its operating costs are funded through industry fees which are expected to increase as the scope of its responsibilities increase.
HHS funds ACA demonstration projects for Federally Qualified Health Centers
Monday, HHS announced a new ACA initiative – “The Federally Qualified Health Center Advanced Primary Care Practice (FQHC APCP) demonstration project” providing $42 million in payments over three years to up to 500 FQHCs that serve 195,000 Medicare enrollees. The demonstration will be operated by CMS and the Health Resources Services Administration (HRSA) and will test whether physicians and other health professionals working in teams improve care. FQHCs that have provided medical services to at least 200 Medicare enrollees in the past 12 months may apply to participate. Applications are due August 12, 2011; the demonstration will run from September 1, 2011 through August 31, 2014.
HHS announces $40 million in ACA funding for state chronic disease programs
Tuesday, HHS announced $40 million in ACA funding (per Section 4002) for the “Prevention and Public Health Fund Coordinated Chronic Disease Prevention and Health Promotion Program”. The program targets the top five chronic disease-related causes of death and disability: heart disease, cancer, stroke, diabetes, and arthritis. The Centers for Disease Control and Prevention (CDC) expects to award funds for three-year coordinated statewide chronic disease programs to all U.S. states and territories, with an estimated $40 million available for the first 12-month budget period. Applications are due by July 22, 2011.
Note: Chronic diseases account for seven out of ten deaths in the U.S. and about three-fourths of the more than $2.5 trillion in annual health care spending.
AMGA asks OMB to use lower ACO savings estimates in its budgeting process
Thursday, AMGA sent a letter to the Office of Management and Budget (OMB) asking officials to use the lower savings estimate ($170 million) for the Medicare Shared Savings (Section 3022) program instead of the higher threshold ($510 million) in its budget forecast. In doing so, CMS might have more latitude to add incentives/bonuses to providers based on unbudgeted savings.
Democratic lawmakers form Health Care Innovation Task Force
Nine Democratic Congressional members formed the Health Care Innovation Task Force co-chaired by Representatives Allyson Schwartz (D-PA) and Kathy Castor (D-FL). The task force will focus on technological, scientific, and medical innovation, insurance market reforms, and promoting quality and patient-centered care. The task force sent comments to CMS on the proposed ACO rule suggesting that CMS should ease the burden of initial capital investments that organizations would need to establish ACOs, develop targeted and reasonable quality measures, and allow academic medical centers to participate in ACOs.
Senate Democrats urge Administration to reject GOP Medicaid proposal
In a letter to the White House, 36 Senate Democrats urged President Obama and his Administration to reject Republican proposals to cap federal Medicaid funding or impose block granting: “Since 1965, the federal government has helped states pay for the basic health care and long-term services low-income Americans need…A cap on federal funding or block grant would undermine this federal commitment. We are unwilling to allow the federal government to walk away from Medicaid’s 68 million beneficiaries, the providers that serve them and the urban and rural communities in which they live.” Four other Democratic senators sent similar letters to the White House.
Bipartisan effort to protect NIH funding
A bipartisan group of Senate and House lawmakers sent a letter to the chairs and ranking members of key appropriations subcommittees to support funding for the National Institutes of Health (NIH). The House letter was signed by Representatives David Reichert (R-WA), Jim Gerlach (R-PA), and 11 other members; the Senate letter was signed by Senators Robert Casey (D-PA) and Richard Burr (R-NC).
AHRQ analysis: employee health care costs are increasing
A June Agency for Healthcare Research and Quality (AHRQ) report analyzed employer-sponsored insurance cost trends from 2001-2009. Key findings include:
- Over the eight years, premiums for single coverage increased by 61.6 percent from $2,889 to $4,669 while employee contributions increased by 92.2 percent from $498 to $957
- Average annual share for employees with employee-plus-one coverage increased by 121 percent from $1,070 to $2,363, while the premium cost to the employer for the same plan increased by 65.7 percent from $5,463 to $9,053
- Family coverage premiums increased 73.5 percent over the eight years ($7,509 to $13,027), compared to a 99.5 percent increase ($1,741 to $3,474) in employee contributions
- Both premiums and employee contributions for all coverage types increased much more rapidly than overall consumer prices. The annual Consumer Price Index for All Urban Consumers was up 21.1 percent from 2001 to 2009
The Medical Device Manufacturers Association encourages investment in R&D
Wednesday through Friday, the Medical Device Manufacturers Association (MDMA) held its 17th annual meeting focusing on how the U.S. can sustain global leadership in medical technology innovation and how the industry can play role in creating legislation and regulations. Featured speakers included Senators Scott Brown (R-MA), Orrin Hatch (R-UT), and Amy Klobuchar (D-MN); Representative Erik Paulsen (R-MN); FDA commissioner Margaret Hamburg, M.D.; and FDA Center for Devices and Radiological Health Director Jeffrey Shuren, M.D.
AdvaMed outlines recommendations to sustain leadership in the medical technology industry
The Advanced Medical Technology Association (AdvaMed) released six policy proposals to sustain U.S. leadership in the medical technology industry. Below are the recommendations:
- Innovation in the life sciences must be a government priority: an office of medical innovation policy should be created in the White House to provide oversight of government policies supporting medical innovation. The office could develop an innovation index to compare the U.S. to its major competitors. Agencies would develop an “innovation impact” statement to assess when promulgating government regulations.
- The FDA review process must be reformed: FDA should streamline its review process to significantly speed up review of 510(k) and promotional marketing association products and assure timely initiation of clinical trials. FDA should develop guidance documents on requirements for product submission and monitor the review process. FDA should adopt a risk-based review pathway for diagnostic tests. FDA should ensure staff is properly trained and converge its regulations with the principles established by the Global Harmonization Task Force.
- Payment policy must support medical innovation: new payments systems (e.g. ACOs, bundling, and value-based purchasing) should not penalize providers for offering consumers access to new treatments that are not yet the standard of care. CMS should reform the coding process to avoid payment delays (some up to two years) for new treatments. CMS should reform payment for new diagnostic tests to support high-value diagnostics and personalized medicine.
- A vigorous trade policy must support export growth and provide a level playing field for U.S.-based manufacturing: the President’s National Export Initiative (NEI) should make bilateral and regional free trade agreements with developed and developing markets a priority. The Administration should continue vigorous opposition to non-tariff barriers to trade. Under the NEI, U.S. government agencies–including the United States Trade Representative (USTR), U.S. Small Business Administration, and Department of Commerce–should assist small and medium sized businesses to compete in export markets.
- Strategic tax policies to level the playing field must be implemented: the R&D tax credit should be permanent and increased to align or surpass credits provided by U.S. major competitors. R&D manufacturers in the U.S. should be eligible for a lower corporate tax rate. The medical device excise tax should be repealed.
- The American R&D infrastructure must be sustained and improved: research programs including those that support start-up companies developing breakthrough treatments and those at academic institutions should be improved and expanded. The federal government should provide grant funding to states and localities to establish or expand bioscience R&D clusters. Institutional Review Board activities should be streamlined.
U.S. Supreme Court to hear case to determine if hospitals can sue states over Medicaid payment rates
This fall, the U.S. Supreme Court will hear a case to determine whether providers and Medicaid recipients can sue states if they think the state is violating federal law. A decision is expected in spring of 2012. The case stems from a 2008 lawsuit in California where hospitals sued California after the state planned to reduce Medicaid payments rates by ten percent. The U.S. 9th Circuit Court of Appeals ruled against the state.
Insurance exchanges: update
June 4, the Connecticut House voted to establish the state’s health insurance exchange. The bill awaits Governor Dan Malloy’s (D) signature.
Thursday, both Georgia Governor Nathan Deal (R) and Alabama Governor Robert Bentley (R) issued executive orders to set up an exchange study commission. Each had exchange legislation die during this legislative session. The Alabama Senate also approved a proposal to allow residents to vote in November 2012 on a constitutional amendment to let the state opt out of ACA requirements. The state House approved the vote in April.
Also Thursday, New York Senator James L. Seward (R) introduced legislation to create the state’s insurance exchange and in Montana legislators announced their intent to apply for ACA funds to establish a health insurance co-op.
OIG audits identify $61 million in improper Medicaid claims in NC, WA
Tuesday, HHS Office of Inspector General (OIG) released two audits identifying $61 million in improper payments made for Medicaid undocumented personal care services (such as bathing, dressing, meal preparation) undocumented in North Carolina and Washington state. The OIG said the states should refund the improper payments. Previous state audits in New York City (June 3, 2009) identified $275 million in improper claims between January 2004 and December 2006, and in New York State (October 8, 2010) identified $100 million in improper claims.
“Doctors are notorious death-deniers, often more reluctant than their patients to admit that it is pointless to pursue treatment that is medically futile. They either fail to mention hospice care or suggest it far too late — usually within a week of death, when hospice personnel have little time to get to know the patient and family and to provide the kind of care that can make for a graceful exit from this world. Studies have shown that patients with a short life expectancy who choose hospice over continued treatment and last-ditch assists like ventilators and feeding tubes live not only better but, surprisingly, longer on average. Researchers also have found that surviving family members are less likely to experience prolonged depression and grief when their loved ones are spared grotesque medical interventions and receive only comfort care at the end of their lives.”
– “Law on End-of-Life Care Rankles Doctors,” New York Times June 6, 2011 on New York State’s new Palliative Care Information Act passed last summer and in effect in February 2011
“Now, I like lawyers. That’s good enough. But how about having somebody that has real experience in the area at which they’re writing the regulation rather than a lawyer write a regulation…Well, that’s just idiotic. It’s asinine. And yet that’s [referring the ACO rule March 31] the regulation that came out on one of the few positive things that came out of the Affordable Care Act.”
– June 9 speech on Senate Floor by Senator Tom Coburn (R-OK) arguing that the specifics of the ACO rule are inadequate and argued for repeal of the ACO in ACA
“If trade barriers remain or increase, U.S. efforts to improve domestic competitiveness and expand exports would be undermined. Companies will relocate outside the U.S. to manufacture behind the barriers and foreign companies will thrive at the expense of U.S. competitors. Other countries are pursuing bilateral and regional trade agreements that will put U.S. manufacturers at a competitive disadvantage.”
– “A Competitiveness Policy for the Medical Technology Industry: Six Policy Proposals to Sustain American Leadership,” AdvaMed June 6, 2011
“It would be a mistake to assess the success of the shared savings program by counting how many ACOs participate in the initial agreement period. A program that builds gradually and is carefully designed to meet the goals of high quality care and slower spending growth is likely to succeed and contribute to the long-term sustainability of the Medicare program..”
– MedPAC letter to CMS on the pending ACO rule June 6, 2011
- As of May 13, 2011, HHS has granted 1,372 annual limit waivers and MLR adjustments to Maine, New Hampshire, and Nevada. MLR waivers for Delaware, Florida, Georgia, Guam, Indiana, Iowa, Kansas, Kentucky, Louisiana, and North Dakota are pending. (Source: HHS)
- One in five elderly patients discharged from the hospital is readmitted within a month. (Source: Health Affairs)
- Women who retired last year will need an average of $93,000 in savings to pay for health care expenses in retirement. Men will need $65,000. (Source: Employee Benefit Research Institute [EBRI])
- The federal budget deficit is $929 billion for the first eight months of fiscal year 2011—$6 billion less than the shortfall recorded over the same period last year. (Source: Congressional Budget Office [CBO])
- Increasing access of vaccines to 90 percent of children in 72 of the world’s most impoverished countries could prevent the deaths of 6.4 million children, while saving $151 billion in treatment costs and lost productivity and producing $231 billion in economic benefits. (Source: Health Affairs)
- Prescription drug user fees paid by drug and biotechnology companies when submitting new products for review will increase $100 million over their current level, from $2.9 billion under the last reauthorization of the Prescription Drug User Fee Act (the next reauthorization is set for 2012) to $3 billion. (Source: Politico)
- Thirty percent of employers will “definitely” or “probably” stop offering health insurance after 2014. (Source: McKinsey & Company)
National health reform: What now?
National health reform is here. The health reform bills (HR3590 and HR4872) are now law and will trigger sweeping changes and disruptions – some rather quickly and some over many years. The industry is asking, “What now?” At Deloitte, we continue to explore and debate the key questions facing the industry, and we look forward to helping our clients find and implement the right answers for their organizations. To learn more, visit www.deloitte.com/us/healthreform/whatnow today.
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