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Tuesday, May 7, 2019

Tennessee 1st State to Embrace Block Grants for Medicaid Funding

Tennessee is moving toward becoming the first state to convert its Medicaid program to a block grant, opening up a new front in conservatives’ efforts to give states more flexibility over the health program while also raising concerns about potential cuts in coverage.
Republican Gov. Bill Lee is expected to sign legislation soon seeking Trump administration approval to turn federal funding for the state’s Medicaid program into a lump-sum grant. Currently, Tennessee, like other states, gets open-ended federal dollars because the government matches a percentage of state spending. A switch to block grants would essentially cap funding.
The move comes as the Trump administration has encouraged states to explore block grants as part of a White House effort to overhaul Medicaid. The federal-state program covers about 74 million low-income and disabled people, including almost 30 million children, and several Republican-controlled states have already adopted or are requesting federal approval for work requirements and other ways to rein in costs. Growth in Medicaid means the program is making up a larger share of state budgets.
“This would be a major change in the history of Medicaid,” said Michele Johnson, executive director at the Tennessee Justice Center, a public policy advocacy group, referring to block grants. “Republicans have wanted this for a long time.”
Supporters say block grants would free states from federal requirements that limit the ability to try novel ideas that may increase coverage and lower costs, as well as a way to better control Medicaid spending. Critics say the switch would challenge Medicaid’s guarantee of coverage for eligible low-income and disabled people, because funding amounts would generally be more fixed and wouldn’t keep pace with health-care inflation.
Both sides predict an escalation in the fight over Medicaid and how far the Trump administration can go in putting its conservative imprint on the program. Lawsuits are already underway over the administration’s approval of work requirements in Medicaid, and consumer groups predict litigation if block grants are approved.
“It’s extremely foolish for a state to sign up for this,” said Joan Alker, executive director of Georgetown University’s Center for Children and Families. “No amount of federal flexibility is worth the loss of federal dollars.”
Republican Tennessee state Sen. Paul Bailey, who sponsored the legislation, said guardrails in the block grant would make sure that funding keeps up with population growth, medical inflation, and pharmaceutical costs. Getting out from under federal restrictions on Medicaid would lead to more efficient management of the program, he said.
“The goal of this legislation is to make sure our current Medicaid population in Tennessee continues to receive coverage,” he said. “Our hope is we can create can an innovative system with cost savings that can cover more people.”
Nina Owcharenko Schaefer, a senior research fellow at the conservative Heritage Foundation, said decisions on Medicaid spending needed to be more local.
“Every state is different,” she said. “The statutory limits the federal government puts on is a burden. States want to tailor benefits to deliver better quality at lower cost.”
Tennessee now gets about $7.6 billion in federal funding to help pay for its program.
Health and Human Services Secretary Alex Azar has touted block grants as giving states more flexibility in designing their Medicaid programs, and the Trump administration has invited states to offer ideas to use waivers to change their Medicaid funding formulas. Democrats say the White House is trying to circumvent Congress after Republicans failed to change Medicaid to block grants during a 2017 attempt to repeal the Affordable Care Act.
While Alaska lawmakers said earlier this year they were working on a block-grant plan at the behest of Trump administration officials, Tennessee went first, approving legislation last week. The bill spurred objections from a coalition of patient groups such as the American Cancer Society, which said people could lose their health coverage.
The state’s move leaves a number of unanswered questions. While the administration has encouraged states to come up with proposals, there is no guarantee that Washington will approve specific plans. Tennessee would seek to change its funding for Medicaid by getting approval under a federal waiver, but some legal analysts said it was unclear if a block-grant request would be allowed under waiver requirements, which typically allow flexibility in the way states fund Medicaid as long as specific requirements are met.
“A benefit cut for the purpose of saving money isn’t legitimate,” said Joel McElvain, a lawyer at King & Spalding in Washington who is familiar with waivers.
The federal government spent about $375 billion on Medicaid in fiscal 2017, according to the nonpartisan Congressional Budget Office, and states spent $230 billion.
The administration’s actions have winnowed coverage. In Arkansas, an estimated 18,000 people have lost Medicaid coverage under newly imposed work requirements approved by the federal Centers for Medicare and Medicaid Services. The administration has also backed a plan in Utah that would cap Medicaid enrollment based on state-funding decisions. The approval was seen as the opening salvo in limiting coverage through other initiatives such as block grants.
Luz Belleza-Binns, 53, in Mount Juliet, Tenn, is worried. Ms. Belleza-Binns works for a juvenile court, and her two children have autism and get coverage through Medicaid. She says a move to a block grant could put their insurance at risk. “I don’t have to worry and I can provide them with medication and therapies they need,” said Ms. Belleza-Binns, who opposes the block-grant effort.

African Swine Fever Hurts U.S. Animal Health Business

Livestock health companies have seen a virulent hog disease take sizable bites of their business — and the worst may be yet to come.
African swine fever, a virus not harmful to humans but which means near-certain death for pigs, continues to ravage China’s hog supply. There is no vaccine for the virus, and companies that provide medicines, vaccines and diagnostic products to livestock producers are seeing sales slip as Chinese pig farmers opt to wait until the epidemic dissipates before restocking their operations.
Last month, Chinese officials warned that domestic pork prices could surge more than 70% this year after about a quarter of the nation’s hog population was culled or died from the disease.
However, some U.S. animal health companies think the numbers could continue to climb.
“People I see in China are talking about 50%,” said Jack Clifford Bendheim, chairman, president and CEO of Phibro Animal Health Corp, during an earnings call Tuesday. He said he believes China may lose as much as 350 million pigs this year, which is nearly as much as the total 2018 pigs of the European Union and the U.S. combined, according to USDA data.
In its earnings, Philbro reported an 8% drop in the adjusted Ebitda of its animal health division this quarter, partially attributed to how fast African swine fever kills infected pigs.
“The virus is so violent that often pigs don’t live past 10 days,” Mr. Bendheim told investors.
Zoetis felt a similar sting in its quarterly earnings, reporting last week a 10% drop in net income for the quarter due to African swine fever curbing the need for vaccines for other pig diseases in China. According to Zoetis CEO Juan Ramon Alaix, the company expects the virus to spread more quickly in the summer due to the warmer weather.
Elanco Animal Health is scheduled to report its first-quarter earnings on Thursday. In an earnings call in February, Elanco CEO Jeffrey Simmons said African swine fever had no impact on the company’s earnings in 2018, but officials were still keeping a close eye on the progress of the disease in China.
Executives expect the global pork market to react strongly to fill the gap left by China — with U.S. and E.U. producers expanding their operations.
“African swine fever has the potential to impact the global protein industry on a level that we have never experienced, and it is an event that will underscore the power of the Tyson business model,” said Tyson Foods CEO Noel White during the company’s earnings call Monday.
Mr. White told investors that Tyson would race to supply the deteriorating Chinese market. The company reported profits to all of its meat production but expects that disease-related profits won’t impact the company’s bottom line until the end of September.

Vericel price target raised to $32 from $23 at Oppenheimer

Oppenheimer analyst Kevin raised his price target on Vericel (VCEL) to $32 from $23 after the company reported Q1 results, raised its 2019 revenue guidance and announced a deal to license North American rights for NexoBrid from MediWound (WDWD). He keeps an Outperform rating on Vericel shares.

Beyond Meat continues post-IPO surge as Bernstein sees ‘more upside’ ahead

Beyond Meat opened at $46 per share in its initial public offering last Thursday
Shares of Beyond Meat (BYND) are on the rise after Bernstein analyst Alexia Howard started coverage of the stock with a Buy-equivalent rating. The analyst sees even more upside ahead, despite the shares’ outperformance since the company’s recent initial public offering.
BUY BEYOND MEAT: With the stock up more than 200% since its trading debut last week, Bernstein’s Howard still sees even more upside for Beyond Meat, albeit much smaller than its recent gains. The analyst started coverage of the stock with an Outperform rating and a $81 price target, noting that recent and planned expansion in production capacity look set to facilitate “rapid sales growth” in 2019 and beyond. Howard estimates that if the alternative meat category follows the same growth path as plant-based beverages, the total addressable market could reach about $40.5B in the U.S. over the next decade. While the company is facing competition from the likes of Impossible Foods, rising consumer demand should allow multiple brands to share the market, the analyst contended. Additionally, Howard argued that the African swine fever outbreak in China could drive up global meat prices, making plant-based burgers look more attractive.
On Thursday, Beyond Meat opened at $46 per share in its initial public offering after being priced at $25 per share. Other Wall Street analysts will be able to issue their opinions on the stock after research restrictions expire on May 28. Goldman Sachs, JPMorgan, Credit Suisse, Bank of America Merrill Lynch, Jefferies and William Blair are among banks that managed the company’s initial public offering.
WHAT’S NOTABLE: During its earnings conference call on Monday, Tyson Foods (TSN) said it expected some costs in its prepared food business to rise in the second half of this year, as beef and pork move higher on worries over the swine fever outbreak. Additionally, the company said it will launch its own meatless products starting this summer on a limited basis and a “much larger scale” in the fall. Tyson sold its stake in Beyond Meat, which produces plant-based meat substitutes, before the company went public.
PRICE ACTION: In afternoon trading, shares of Beyond Meat have jumped almost 13% to $84.50.

Novartis reports interim long-term follow-up data from Phase 1 START trial

AveXis, a Novartis company, announced interim long-term follow-up data from the Phase 1 START trial of the investigational product Zolgensma that showed durability of the gene therapy in patients with spinal muscular atrophy, or SMA, Type 1 nearly four years after treatment. These data were presented during the 2019 American Academy of Neurology Annual Meeting, the company noted. As of March 8, 2019, all patients maintained the motor function and milestones gained during the trial following treatment with Zolgensma. In addition, no patients had any additional requirements for ventilatory or nutritional support. Two of the four patients who required Bilevel Positive Airway Pressure support at the beginning of the long-term follow-up study no longer required it regularly. No new treatment-related adverse events have emerged during the follow-up period. Patients in START were treated with gene therapy alone during the 24-month study duration. In the long-term follow-up study, 7 of 10 patients remain on monotherapy alone. Initiation of combination therapy was at parental and physician discretion and was not due to loss of motor function, the company said.

How The Trump Administration Is Reforming Medicare

The Trump administration is making fundamental changes to the Medicare program. These reforms are every bit as radical as the changes we have seen in federal policy governing employer-provided coverage and the market for individual insurance. Furthermore, it seems likely that the changes initiated so far are only the beginning of a continuing shift in the role of government in health care.
The vision behind these reforms can be found in the Department of Health and Human Services’ Reforming America’s Healthcare System Through Choice and Competition. This 124-page document challenges a premise behind 50 years of thinking in health policy circles: that our most serious problems in health care arise because of flaws in the private sector. Most problems arise because of government failure, not market failure, the document declares, and it goes into great detail on how to correct the policy errors.
Trump policy toward health care appears to be based on the idea of promoting choice, competition, and the role of market prices. In Medicare, so far that means liberating telemedicine and accountable care organizations (ACOs), ending payment incentives that are driving doctors to become hospital employees, promoting hospital price transparency, reducing regulatory paperwork, and creating more transparency in the market for prescription drugs.
In this post, we will consider changes to the accountable care program, including efforts to make it more closely resemble the Medicare Advantage (MA) program.

ACOs Versus MA Plans

The idea behind ACOs and MA plans is similar. In both cases, the federal government is encouraging the private sector to find innovative ways to reduce costs and improve quality, generally through integrated, coordinated, managed care. If a plan successfully reduces costs and meets pre-established quality gates, it gets to keep some or all of the savings. Beyond that, the two models diverge.
In general, almost anything an ACO can do, an MA plan can do and do better. The reason? ACOs are structured differently, and they are shackled with all manner of limitations, rules, and restrictions that do not encumber a garden variety MA plan.
On the buyer side, enrollees in MA plans pay one premium to one plan, covering all Medicare Part A, B, and D benefits. The premium is usually no more than the Part B premium in ordinary Medicare. The enrollee typically gets such additional benefits as free transportation, expanded dental, eye care and hearing aid benefits, and maybe even a health club membership.
Seniors who are in an ACO plan, by contrast, are usually paying premiums to three plans (Part B, Part D, and Medigap) for traditional Medicare benefits. Even after that, there is no limit to their potential catastrophic expenses.
On the provider side, MA doctors are dealing with a relatively stable population that can be monitored, tracked, and serviced over a multiyear period. This is what makes integrated care possible. Enrollees know that they must generally stick to a network of providers as a condition of receiving the full set of benefits from their MA plan.
By contrast, seniors in ACO plans are not actually enrolled. They are assigned by the Centers for Medicare and Medicaid Services (CMS) to a primary care physician, and they usually don’t know they are assigned. Furthermore, ACO plans have been muzzled: Prior to this year, any communication to patients required CMS approval. Moreover, patients were not told that doctors with ACOs have financial incentives not totally dissimilar from an old-fashioned health maintenance organization (HMO).
Also, when ACO assignees go to an out-of-network provider, they (without their knowledge) might be assigned to another ACO. This type of churning, along with physician turnover, apparently happens so frequently, it’s amazing that ACOs have had any success at all. Until CMS changes its attribution methodology, this churning will continue.
Going forward, a new rule allows ACOs to communicate more freely with patients; it also requires ACOs to tell patients in writing that they are in an ACO and gives them some explanation of what that means. Even so, the MA market is better designed to meet four social goals: lower cost, higher quality, better information, and the ability to adjust to changes in market conditions.

Cost Incentives

CMS pays MA plans a global capitation rate each month, based upon beneficiary demographics, chronic conditions, and quality scores. Given a fixed payment, when an MA plan saves a dollar, it gets to keep the whole dollar. The plan reaps the entire benefit of its cost-reducing successes and bears the entire cost of its failures. If the MA market as a whole succeeds in lowering the social cost of care, Medicare can reduce its payment across the board to all plans (thus capturing the gain for the taxpayers) without changing these incentives.
By contrast, ACOs are not paid anything beyond Medicare’s standard fees unless they achieve cost savings in the range of 2 percent to 3 percent (depending on size) and an acceptable quality score. Even then, they are entitled to receive only a portion of the savings they generate. Some plans get to keep as little as 25 cents of every dollar they save, for example.
As plans become successful, Medicare raises the bar, changing the measurement of what constitutes a dollar saved, with a different standard for each plan. Thus, the more successful the ACO, the less it can expect to keep of each dollar saved, compared to other plans.
Also, ACOs do not receive their shared savings payment from CMS until at least September or October of the following year. This means that ACOs must use their own capital to fund any effort to institute integrated and coordinated care for up to almost two years before they receive a CMS payment.
For all these reasons, the incentives to reduce costs are much weaker for ACO plans than for MA plans. Notably, only a third of ACOs were paid anything by CMS in 2017.

Quality Incentives

MA plans are rewarded on a star system for meeting quality measures. Although the measurement of quality is imperfect—sometimes highly imperfect—the more stars, the more money the plan gets. Although Medicare may make the quality standard stricter over time, all plans are treated the same.
ACOs are also rewarded for meeting quality measures. The more successful the plan, the higher the percentage of monetary savings it gets to keep. However, since CMS continually raises the bar on what constitutes savings (plan by plan), ACOs that are more successful in reducing cost receive less of a quality reward than other plans with the same quality scores. And, as noted, there is a delay in payment. For these reasons, incentives for quality improvement are much weaker in the ACO system.

Information Incentives

All systems for rewarding cost-reducing, quality-improving changes work only so well as the ability to adjust plan populations for case severity. Without this ability, we have no idea what we are paying for.
The MA program is the only place in all of Medicare where doctors actually send medical records to CMS to make Medicare’s payments more accurate. This practice probably results in a higher average patient code than otherwise. But legitimate upcoding is not a problem as long as it is uniform across all doctors. Medicare can always lower the capitated fees it pays across the board.
Coding is a problem when it differs from doctor to doctor, as it undoubtably does in traditional Medicare and in the ACO program. The MA risk-adjustment process helps Medicare by making its information more accurate.

Specialty Incentives

In a previous Health Affairs Blog post, John Goodman and Thomas Saving noted that Medicare is trying to set hundreds of millions of physician fees every day. When it gets these prices wrong (as is inevitable), we get shortages and surpluses in the various specialties.
In Dallas, Texas, and other cities, for example, there are many internists who refuse to take new Medicare patients. Unlike ACO plans and traditional Medicare, where paying standard Medicare rates is mandatory, MA plans are free to pay higher rates to internists and other specialists to attract the services their patients need. MA plans can adjust to changes in market conditions; no other provider in Medicare can do that.

Political Origins Of ACOs

So why do ACOs even exist? The reason appears to be political. Although prominent Democrats had supported premium assistance for private Medicare plans in the past, by 2008, it was hard to find any Democrat who would support privatization in general, let alone privatization of Medicare. Also, Barack Obama ran for president that year criticizing MA plans. So, when Obamacare was created, the administration turned to stealth privatization. Seniors were led to believe Medicare was paying doctors fee-for-service as they always had, while (unbeknownst to seniors) the doctors who treated them gained financially if they reduced the volume of care.

Market Evolution

Attachment to ACOs exploded, almost overnight. At last count, there were 32.7 million patientsenrolled in ACOs. This includes 10.4 million Medicare beneficiaries, who mainly think they are participating in traditional Medicare. Yet, unlike MA plans, which generally have lower costs and higher-quality ratings than traditional Medicare, the ACO experiment has been largely disappointing. Without the tools routinely used by MA plans ACOs are neither saving money in the aggregate nor are they improving the quality of care.
That said, the top plans in both systems appear to be doctor-run. In fact, most MA insurers now contract with independent practice associations (IPAs) to run their plans. By contrast, the low-performing plans tend to be hospital-run.
Also, fee-for-service-payment is not the important factor. IntegraNet Health of Houston, Texas—where one of us (Wedekind) is CEO—collaborates on a risk-sharing basis with high-performing major MA plans in Texas (four-star MA plans including Aetna and Anthem) and operates Physicians ACO, which has been one of the best-performing ACOs on the basis of earned shared savings on a per-member-per-year basis five years in a row. IntegraNet doctors are paid fee-for-service, but they do not order medical tests willy-nilly because they know that if they lower costs and improve quality they will earn a financial bonus at the end of each period based upon their individual performance relative to process and clinical outcome metrics, including HEDIS measures.

Expected Changes

The original plan for ACOs was one of progression—from shared savings, to more savings for plans that take more risks, to full capitation. In other words, ACOs would look more and more like Medicare Advantage HMOs. For the Trump administration, we can’t seem to get there quickly enough. The administration is allowing Next Generation ACOs to have greater freedom to communicate with patients; reward patients for meeting compliance measures; offer additional benefits that patients must forgo if they go out-of-network; have broad freedom to use telemedicine; and in some cases, opt for full capitation.
The Trump administration is clearly pushing the envelope, in many cases acting to fill a void left by Congress. These changes will result in a very different health care system. It will be one that is shaped more by individual choice and market forces than by rules and regulations.

Allergan CEO: Urgently looking at all options to boost share price

Allergan Plc Chief Executive Brent Saunders said on Tuesday that he and the board of directors were looking with a sense of urgency at all options to revive the Botox maker’s falling share price, but a lack of specifics failed to boost investor sentiment.
Allergan shares fell more than 4 percent despite reporting better-than-expected first-quarter profit and raising its 2019 sales and earnings forecasts, more than twice the drop in the broader markets. They are trading nearly 60 percent below their 2015 high of about $340.
“We leave the first-quarter call with even less confidence that value in Allergan will be unlocked over the near term; catalysts are few, as are reasons to expect shares to move higher,” said RBC Capital Markets analyst Randall Stanicky.
Allergan shareholders last week voted down a non-binding proposal by activist investors that sought an immediate split of the CEO and chairman roles, but it was hardly a resounding victory for Saunders. Nearly 40 percent of shareholders backed the proposal.
Saunders said the board had talked to more than 50 shareholders recently and heard a common theme of frustration with the company’s falling stock price.
“I assure you that the board, management team and I recognize the urgency, and we will take decisive action to drive value-enhancing opportunities,” Saunders promised.
However, he did not outline any steps the board was considering, saying “everything is on the table.”

Excluding items, the company earned $3.79 per share, topping analysts’ average estimates by 24 cents, according to Refinitiv IBES data.
The company now expects 2019 adjusted profit to be greater than $16.55 per share, up from its prior expectation of greater than or equal to $16.36.
“The guidance they put out for full-year basically includes the beat in first quarter and doesn’t carry anything beyond that,” said Kevin Kedra, an analyst with Gabelli & Co, which owns Allergan’s shares.
Earnings were helped by a delay in generic competition for dry-eye drug Restasis. The company expects generic competition for Restasis later this month.
Botox sales, including cosmetic and prescription uses, rose 6.3 percent to $868.4 million, while Restasis sales fell 11.7 percent to $242 million, primarily due to lower net pricing.

U.S. sales of CoolSculpting, which removes fat non-surgically fell 27.8 percent to $62.9 million.
Revenue fell 2 percent to $3.59 billion in the quarter.
Allergan forecast 2019 sales between $15.13 billion and $15.43 billion, compared with its prior range of $15.00 billion to $15.30 billion.