Tag Archives: Affordable Care Act

Data Analyses Indicate HCV Treatment for All Saves Money; Part 2

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

Last week, HEAL Blog discussed some of the thinking behind a “Treatment for All” paradigm for dealing with America’s burgeoning Hepatitis C (HCV) problem. The argument put forth in the study released in the American Journal of Managed Care (AJMC; Younossi et al, 2017) suggests that adopting a policy of treating every HCV-infected client on government-funded healthcare rosters will ultimately lead to long-term cost savings by reducing the incidence of multiple co-morbidities, such as cirrhosis, hepatocellular carcinoma, and the number of liver transplants. This is a position that advocates (including HEAL Blog) have been arguing for years – since the release of Sovaldi (Gilead) and Olysio (Janssen) in 2013. The pharmaceutical companies who manufacture Direct Acting Agents (DAAs) to treat HCV have been arguing this position, as well.

Read Part 1, “Data Analyses Indicate HCV Treatment for All Saves Money

All of these parties are coming up against the stark reality of the budgetary process. Rather than being calculated based on long-term expenditures, they are calculated using estimated yearly expenditures using the amount of money given to them by the Federal and state governments – resources that are limited, and unlikely to increase without significant increases in tax revenues generated by tax hikes (business, corporate, and personal) or some unexpected increase in profits that comes out of nowhere. Medicaid directors and drug purchasing officials have repeatedly made the claim that treating everyone on their rosters infected with HCV will outstrip their pharmacy budgets several times over. Tom Burns, head of drug purchase for the Oregon Health Authority in 2014, said in an interview that “…Oregon can afford to wait” to see how other HCV drugs develop, and that “…the vast majority [of the 5,600 clients infected with HCV] could wait while we figure out a policy that doesn’t bankrupt this state” (Millman, 2014).

Image of a stethoscope wrapped around a $20 bill , laying next to an open medication bottle

Affordable Healthcare

This line of thinking has been echoed by virtually every state’s Medicaid program. The Centers for Medicare and Medicaid Services (CMS), however, didn’t buy that line, and in 2015 issued an official guidance that reminded Medicaid programs that they are required by law to cover these drugs under section 1927(b) of the Social Security Act (CMS, 2015). Furthermore, states facing litigation related to treating HCV patients have found little sympathy from the Judicial Branch. In May 2016, Federal U.S. District Court Judge John C. Coughenour ordered Washington state’s Medicaid provider to cover HCV drugs for all patients by granting a preliminary injunction that forced the state Health Care Authority (HCA) to halt a 2015 policy that restricted access to the drugs based on a fibrosis score (Aleccia, 2016). This injunction was in response to a class action lawsuit against Apple Health, Washington’s Medicaid program, on behalf of two clients and 28,000 other enrollees. Another Federal U.S. District Judge, Robert Mariani, ordered the Pennsylvania Department of Corrections (DOC) to provide HCV treatment to well-known inmate, Mumia Abu-Jamal (Moran, 2017). While his ruling applied only to Abu-Jamal, the judge went on record, stating that the DOC’s interim protocol for treating HCV “…presents deliberate indifference to the known risks which follow from untreated chronic Hepatitis C.”

The report in the AJCM found that if Medicaid in the U.S. continues its use of restrictions to treatment, the estimated total cost of treating the HCV cohort will come to $9.7 billion, with the majority of costs (50.4%) attributable to downstream costs of care (i.e. – hospitalization costs, outpatient costs, and non-Harvoni pharmacy costs). Conversely, treating all Medicaid patients with Chronic HCV using Harvoni led to a 39.4% savings – $3.8 billion – over the model time horizon and decreased the relative proportion of total costs attributable to downstream costs of care to 18.3% (Younossi).

While most of the cost savings were related to downstream medical cost offsets, even the pharmacy costs attributed to Harvoni treatment over non-Harvoni treatment decreased 2%, from $4.84 billion to $4.75 billion. This is due in part to the 9,618 patients in the cohort potentially eligible for an 8-week regimen of Harvoni to achieve a Sustained Virologic Response (SVR), rather than the traditional 12-week regimen. Treating all Medicaid patients with Harvoni led to a 19.8% savings per SVR, given that earlier treatment of HCV resulted in better health and cost outcomes (Younossi).

Though this analysis is a fantastic tool, another harsh reality is the [potential] repeal and replacement of the Affordable Care Act (ACA). It was announced, last week, that the Fiscal Year 2018 budget resolution has been put on hold, pending the repeal of the ACA (Shutt, 2017). This means that any type of Federal budgeting process for Medicaid (as well as the Centers for Disease Control, and other domestic spending programs) has stalled for the foreseeable future, leaving virtually everyone involved in those organizations in the lurch, waiting for their fates to be handed down to them. Most HIV and HCV advocates, however, are heartened by Tom Cole (R-OK) saying, “We thought it was wrong when Democrats said for every increased dollar on defense, you had to increase domestic. It’s just as wrong to say for every increase on defense you have to cut domestic.” He finished that statement, however, by saying that he believes those increases should be offset on “…the entitlement side of the ledger.” That statement is considerably LESS heartening.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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The 2016 Election, and What This May Mean for Healthcare

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

The passage of the Affordable Care Act (ACA), also known as Obamacare, included a provision that gave states the option to expand Medicaid coverage in order to cover citizens whose incomes were above the Federal Poverty Level (FPL), but whose incomes still present a significant barrier to purchasing health insurance. Of the 50 United States and the District of Columbia, 32 states (including DC) have opted to expand their Medicaid programs. Nineteen states have opted not to expand access.

Expanding access to Medicaid is an essential piece of the ACA, as it was designed to help increase the number of people with access to affordable healthcare. Because the ACA envisioned low-income people receiving coverage through Medicaid, it does not provide financial assistance to people below poverty for other coverage options. As a result, in states that do not expand Medicaid, many adults fall into a ”coverage gap” of having incomes above Medicaid eligibility limits, but below the lower limit for Marketplace premium tax credits (Garfield & Damico, 2016). Since the expansion of Medicaid under the ACA, 73,137,154 Americans were enrolled in Medicaid/CHIP as of August 2016 (Henry J. Kaiser Family Foundation, 2016).

There are an estimated 2.6 million Americans who currently fall into that coverage gap, and of the states that did not expand Medicaid, four states represent 64% of those people (TX – 26%, FL – 18%, GA – 12%, NC – 8%). When looking at the geographic distribution of those 2.6 million Americans, 91% are in the American South (Garfield & Damico, 2016). Demographically, 46% are White non-Hispanics, 18% are Hispanic, and 31% are Black, and over half are middle-aged (age 35-54) or near elderly (55 to 64). Additionally, the majority of people in the coverage gap are in poor working families.

Donald J. Trump

Photo Source: NBC News

President-elect, Donald J. Trump, as well as the incoming Republican-led Congress and Senate, have openly stated that their first priority, at the beginning of the next legislative session, is the repeal of the ACA. There are very few comprehensive plans being proffered to replace the ACA, and healthcare professionals, providers, payers, patients, and advocates, alike, are currently unsure about the future of the expansion, and whether or not that aspect of the ACA will be retained in the forthcoming repeal.

It bodes poorly for those existing people infected with viral hepatitis, especially Hepatitis C (HCV), who stand to lose coverage if the Medicaid expansion does not survive the repeal, even with the existence of drug manufacturer and private Patient Assistance Programs (PAPs). In order for those PAPs to be accessed, however, people must first know about them; without the aid of social workers, healthcare aides, and advocates, people living with HCV are unlikely to find out about these PAPs, unless this information is provided to them by a doctor or nurse.

An additional concern exists for those recipients of the Ryan White Program. Over the past eight years, HIV/AIDS advocates and policy wonks have been in a near-constant debate about whether to reopen the Ryan White Care Act for reauthorization to address some of the ways in which the current law has not necessarily aged well, in terms of keeping up with newer treatments, costs, and funding paradigms. The concern over the past five years has been that the Republican-controlled Congress would “gut” the bill, cutting out many of the provisions upon which organizations and patients have come to rely. With repealing the ACA having played such a large role in this year’s election, concerns about reopening the act are likely to deepen, rather than abate. It is important to note that many states include HCV therapies under their AIDS Drug Assistance Program’s drug formularies.

The HEAL Blog  will pay close attention to both programs, as well as other HIV and HCV-related issues throughout 2017.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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When the Standard of Care Isn’t Standard Procedure

By: Marcus J. Hopkins, Blogger

This past week, I has the privilege of attending the ADAP Advocacy Association’s AIDS Drugs Assistance Program (ADAP) Regional Summit in Birmingham, AL. This was the sixth such meeting since 2011, with the previous year’s meeting having been held last year in Atlanta, GA. These summits are designed to discuss issues involving state-administered ADAPs that face specific regions, and three times now, this meeting has focused on the South.

This Southern focus is no accident: of the top ten states with the highest incidence of new HIV infections in 2014, Southern states fill five of those spots — including Florida, Georgia, Louisiana, North Carolina, and Texas (Kaiser Family Foundation, 2015). In addition, these states face significant barriers – endemic poverty, geographic barriers to care, inadequate Federal and state funding for assistance programs, and endemic distrust of authority and medical professionals – that largely prevent them from providing low- or no-cost HIV treatment and medications for low-income patients.

Map of the United States, with the southern states highlighted in red

Photo Source: Dialect Blog

In addition to leading the nation in regional HIV infections, the South also leads the nation in opioid prescribing. Of the top ten states for opioid prescriptions per 100 people, nine of those spots are occupied by Southern states (Centers for Disease Control, 2014). Alabama, host of this year’s Regional ADAP Summit, currently boasts the highest rate – 142.9 opioid prescriptions per 100 people. States with higher opioid prescribing rates inevitably have more Injection Drug Users (IDUs), which bodes poorly for the burgeoning rate of new HCV infections in these states. In 2015, the CDC released a report linking the increase in new HCV infections to IDUs under the age of 30 (CDC, 2015). The prescribing data, IDU rates, and HCV infection rates combine to create a bleak omen for the South’s burgeoning co-infection crisis.

ADAPs were created to serve the healthcare needs of people living with HIV for whom primary insurance coverage was essentially impossible to find. Combine a lack of access to adequate coverage with the high cost of HIV Direct Acting Agents (DAAs), and lower-income people living with HIV faced (and continue to face) seemingly insurmountable costs of care.

ADAPs are Federally-funded through a grant process; once those funds are allocated to each state (using a formula to determine the amount of ADAP funds each state is awarded), each state is then responsible for operating their own ADAP on the state-level, resulting in a sad-but-true adage: “When you’ve seen one ADAP, you’ve seen one ADAP.” This state-level administration of the program creates a massively uneven landscape, with no one state offering the same services or formulary coverage – what’s true in Tennessee may not be true in Alabama, or Georgia, or North Carolina.

Southern ADAPs almost all fail to provide coverage for the current standard of care for HCV (Infectious Diseases Society of America, 2016), which includes only newer Direct Acting Agents (DAAs) – Sovaldi, Harvoni, Olysio, Viekira Pak, Daklinza, Technivie, and Zepatier – for treatment, as opposed to the poorly tolerate ribavirin- and Pegylated interferon-based treatment regimens. Of the seventeen states that make up the American South, only three offer coverage for one or more HCV DAAs (AR, VA, & TN), while five states – all of which have very high HCV infection rates – offer no coverage, whatsoever (FL, GA, KY, LA, & TX). The remaining states provide coverage only for last decade’s poorly tolerated treatment regimens.

These older regimens often have very high failure rates for curing HCV – achieving a Sustained Virologic Response (SVR) – largely because they are so poorly tolerated that many patients simply cannot complete the regimen before they abandon treatment. In addition to being more easily tolerate, the newer DAAs have much higher success rates in achiever SVRs. This means that patients are more likely to successfully complete their treatments in a single go, rather than repeatedly failing using older regimens. With so few Southern ADAPs providing coverage for these DAAs, clients are much more likely to remain co-infected and continue to drain precious financial resources through repeated unsuccessful treatments.

There are, however, significant costs associated with these DAAs. Each of these drugs boast some of the highest Wholesale Acquisition Costs (WACs) in the pharmaceutical industry. Zepatier, the newest DAA on the market, currently sports the lowest WAC of the pack at the comparatively low price of only $54,000 for twelve weeks of treatment. Even with negotiated pricing and rebate deals between ADAPs and drug manufacturers that may lower those costs by up to 80% off the WAC, many ADAPs, Southern or otherwise, find themselves unable to afford the cost of coverage, leaving ADAP recipients to fend for themselves in an attempt to pay for treatment.

Under the Affordable Care Act (ACA), states were asked to voluntarily expand their Medicaid programs, which would have allowed Ryan White Part B ADAP programs to shift a significant number of their clients off of their rosters and onto their states’ Medicaid programs. However, this voluntary expansion plan ended up working out exactly as expected: the states that most needed the Medicaid expansion to address their healthcare needs ended up being the states that opted not to expand their programs. Of the seventeen Southern states, only seven states have expanded their programs, only three of which (AR, KY, & LA) fall in the area commonly referred to as the “Deep South.”

In these non-expansion states, ADAPs and their clients continue to face barriers related to coverage of the HCV DAA drugs. Of the nineteen states whose legislatures (or governors, via executive order) have opted not to expand Medicaid, only five (ME, OK, SD, TN, & VA) off expanded DAA coverage, while seven (FL, GA, KY, LA, NE, TX, & UT) offer no coverage, whatsoever. The remaining seven states (AL, MS, MO, NC, SC, WI, & WY) provide the outdated, ribavirin- and Pegylated Interferon-based treatments.

Further complicating issues of coverage is that many ADAPs (including Alabama’s and Louisiana’s) have decided to pay for their clients to enroll in private insurance plans through the ACA, rather than pay directly for their care. This can be considerably problematic, because it essentially ties drug coverage to whatever plans are available and their respective formulary coverage. These formularies vary from payer to payer, and in many Southern states, options can be limited to only a handful of insurance providers; in some states, those options are essentially monopolies.

What makes these insurance formularies problematic for ADAP clients is that many plans categorically shunt many of the HIV and HCV DAA and combination therapy drugs into higher tiers that require patients to pay exponentially higher co-pays to fill prescriptions; and, again, each state’s respective ADAP determines whether or not those co-pays are paid for by ADAP funds or left up to the patient.

Anecdotally, my personal Highmark West Virginia Blue Cross/Blue Shield provider currently has an HIV formulary that does not reflect the current standard of care for HIV, covering only a single single-pill regimen (Atripla), which is no longer being actively prescribed. When I contacted Highmark to inform them that their formulary is outdated and needs to come into compliance with ACA non-discrimination requirements, I was told that I was welcome to seek coverage with another insurer. As of April 15th, 2016, I filed a complaint with the Department of Health and Human Services Office of Civil Rights to begin an investigation into the provider.

While ADAPs go a long way toward helping lower-income HIV patients afford the cost of care and treatment, co-infected clients still face significant hurdles when trying to address their HCV-related care. This situation is slowly being ameliorated, as more state ADAPs add DAAs to their respective formularies. That said, there are still myriad obstacles to overcome in order to ensure that all lower-income HIV and HIV/HCV co-infected patients receive the care they need in order to live a happy, healthy, and productive life.

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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Co-Paying the Piper

By: Marcus J. Hopkins, Blogger

One of the biggest changes for many lower income patients under the Affordable Care Act (ACA) has been the transition to paying co-pays for their medical care. For patients living with HIV, this has been exceptionally difficult in states whose Ryan White Part B programs – the AIDS Drugs Assistance Programs (ADAPs) – have opted to pay for their clients’ insurance premiums, rather than simply directly paying for services as they’re administered. What this means for patients is that, where they once never had to worry about doctors’ visits or paying for medications, depending on their state of residence, they may not be responsible for paying co-pays for services.

To the average American with a stable, if thinly stretched, income, this may not seem like a big deal; but, to those of us living with HIV/AIDS on fixed or fluctuating incomes, this distinction may create an additional barrier to care that may not have existed, prior to now. It can be difficult to explain to people how, when one’s income is already low, paying $20-$30 for a visit to the doctor requires foregoing other basic necessities such as food or a utility bill put off until later; paying $100 for your HIV medications every month can mean that you no longer have enough to afford rent.

People who live without a chronic disease often fail to see the hardships presented with treating that disease. Outside of simply the cost of treatment, there are additional social and emotional issues at play. Having to rely on government assistance for any reason is frequently derided in our nation as a weakness; a moral failing that renders the recipient incapable of taking care of themselves. As such, there is often a guttural sense of shame and humiliation that accompanies having to rely on these assistance programs. It is this component that is so often left out of the conversation.

More than just the psychosocial aspect of seeking assistance, the reality is that, when a patient discovered their HIV-positive status, they are often unaware of the options that exist, in the way of coverage. Now that people with pre-existing conditions can no longer be barred from insurance coverage, many simply assume that private insurance is the only option available to them. In states where Medicaid services have not been expanded to include coverage for people living with HIV, many patients are unaware of the existence of the Ryan White or ADAP programs that are in place to provide assistance for lower income patients who cannot afford the cost of treatment.

Even with these programs in place, their assistance does not meet the Federal requirement for insurance coverage, and clients whose incomes are higher than the maximum allowed for exemption from the penalty for not having private insurance are often left to foot that bill, as well. This is one of several reasons why many ADAP programs are switching their coverage over to paying for private insurance, rather than a direct payment model.

For lower-income patients still having trouble paying for treatment, even with insurance, Patient Assistance Programs (PAPs) exist that can help to partially or totally defray the costs. These programs are, however, largely unknown to people outside of the “know,” as it were – if you don’t “know” about them, you don’t know about them, and oftentimes, you only find out about them through random word of mouth. Sadly, many ADAP programs’ employees are unaware of these programs, and aren’t able to provide adequate information about either their existence or the requirements for applying.

One such program – the Patient Access Network (PAN) Foundation – has long served this purpose for people who are underinsured living with HIV. The maximum award level is $7,500 per year. Patients may apply for a second grant during their eligibility period subject to availability of funding.

Unfortunately, funds available through this program have been depleted. As of March 14th, 2016, patients seeking assistance for HIV are being encouraged to go to the Patient Advocate Foundation (PAF) for assistance. Individuals who have been recently approved for grants through the PAN Foundation will not be affected. When needing additional assistance or to re-enroll, individuals are encouraged to check back with PAN to determine if the fund has been re-opened and/or to seek additional support through PAF.

LOGO: Patient Advocate Foundation

While the funds at PAN for HIV assistance have been exhausted for 2016, there are still funds available for patients who are mono- or co-infected with HCV at both PAN and PAF; one only needs to apply separately for assistance with that specific condition, as funds for HIV drugs do not carry over to HCV without an additional application.

Additionally, it should be made clear that these programs are not designed for the uninsured; rather, they are designed for the underinsured – those who carry some form of insurance, but for whom co-pays are unaffordable. It is also crucial to understand that these programs cover only the costs associated with drug co-pays; office visits and other non-pharmaceutical costs are not covered, and are left up to the individual and/or the Ryan White funds allocated to their clients.

For more information about PAF, and how it differs from the National Patient Advocate Foundation, please visit www.patientadvocate.org.

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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The ACA Took My Security Away

By Marcus J. Hopkins, Blogger

I’ve gone on record several times that I’m no fan of the Affordable Care Act (ACA). Several provisions of the act have rubbed me the wrong way since its passage, most of all the requirement that everyone purchase health insurance – a product that can be offered at any price, with no caps on the premium. This year, I finally purchased coverage under the marketplace, after two years of having qualified for Medicaid in the state of West Virginia, and I find that my frustrations are further justified.

I have been a client of WV’s AIDS Drugs Assistance Program for three years, now, and have, for the most part, been satisfied with the services they provide. When I found out that they would cover the price of health insurance premiums, I made the leap, and following their advice, signed up for the plan that seemed to best serve my needs.

President Obama signing the Affordable Care Act

President Obama signing the Affordable Care Act.

I did my research, spending hours looking at the three different plans they would pay for, checking the formularies (which were identical) to ensure that my HIV medication – Stribild – would be covered by the prescription plan. I tried to ensure that my monthly premium would remain low enough to be affordable, so I would pose the least amount of burden on the program, to reserve money for others who require more assistance than I.

Imagine my surprise, then, when I checked to see how much my prescriptions would be, and couldn’t find a price for my medication on their website. After calling Highmark West Virginia’s customer service line, I was told that my drug was “covered,” per se, but that I would be paying $100/month out of pocket for it. The customer service representative (CSR) suggested an alternative therapy – Atripla – which is no longer being actively prescribed, because it’s a ten-year-old drug, and there are better options.

Infuriated that I had gotten so much wrong about my coverage, I called my local ADAP representative to see what I should do, only to find out that there wasn’t really much. They will pay for the cost of medications, but it requires approval from the ADAP director, with whom I’ve had little luck getting in contact for the past year. Also, I was now responsible for paying the co-pays for visits and any associated bills for labs.

These are the kinds of problems that ADAP and Ryan White were designed to solve for people. I have, in the past, touted the wisdom of ADAP paying for primary insurance premiums for its clients as a way to defray some of the costs associated with treatment, but now I see the folly – each visit will cost me $30, because my doctor is a specialist; each month, I’ll be shelling out over $100 for medication; God only knows how much labs are going to cost.

For the first time since I qualified for Ryan White, I find myself panicked, because these were problems that I’d never had to face since I gained access to the program. The insecurity and financial worry – how will I afford my treatment; will I be able to still pay my bills just for life, much less for meds – Ryan White was supposed to be there to help me face those concerns.

Finally, after over a week of waiting for a response from either my local representative or my ADAP director, I decided to advocate for myself, and ended up turning to the Patient Access Network (PAN) Foundation – a Patient Assistance Program (PAP) designed to help people afford the cost of medications. I filled out an application online in fewer than ten minutes, and was approved immediately. Sure, there were extra steps involved in added a secondary insurance to my local pharmacy, but it all worked out for me, and now, I won’t have to worry about the cost of medications.

Now…whether or not I’ll have to cover the $30 visit fee for each visit has yet to be seen. I am grateful to the PAN Foundation for stepping up to help out where my ADAP program has failed. I cannot recommend their service enough, and encourage all people who are facing similar concerns to check them out at the link below this paragraph.

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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