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Monday, October 14, 2019

Premier joins forces with Amphastar on 7 drugs in short supply

  • Premier, the country’s largest group purchasing organization, has announced a partnership with Amphastar Pharmaceuticals to offer seven drugs in short supply to providers.
  • The agreement is part of Premier’s ProvideGx program and will focus mostly on pre-filled syringes for emergency use, according to a Tuesday statement. Premier didn’t release financial details, but said the deal won’t materially affect its fiscal year 2020 results.
  • Amphastar said it’s bringing on new manufacturing capacity by the end of the year that will help it meet the demand for drugs experiencing supply shortages. The agreement with ProvideGx, which works with a network of about 4,000 hospitals and health systems, covers phytonadione injection and pre-filled syringes of calcium chloride, epinephrine, sodium bicarbonate, atropine sulfate, dextrose and lidocaine.
The Premier-Amphastar agreement is another example of how healthcare companies are searching for new ways to address drug shortages. About 113 medicines are either not readily available at U.S. hospitals or at risk of becoming in short supply, Premier said.
Also this week, Premier said ProvideGx, working with Exela Pharma Sciences, has put an end to a multiyear national shortage of cysteine hydrochloride injection, which is used for patients who need parenteral nutrition.
“We hope to replicate this success for many other drugs currently in shortage,” Premier President Michael Alkire said in the company’s statement. More than 4,000 U.S. hospitals and health systems aggregate under Premier to leverage their volume to negotiate lower prices with manufacturers and other vendors.
Exela is also working with Civica Rx, a group of health systems that joined together to make generic drugs in a bid to address shortages and rising costs. Under that agreement, Exela will supply member hospitals with sodium bicarbonate.
The ProvideGx program has provided reliable supplies of scarce drugs, including metoprolol, sodium bicarbonate, and hydromorphone, according to Premier. The program plans to introduce further drugs from a list of more than 60 targets in coming months, Premier said.
Several of the medicines for pre-filled syringes have been in short supply for years and not available at all in some parts of the country, Alkire said.
https://www.healthcaredive.com/news/premier-joins-forces-with-amphastar-on-7-drugs-in-short-supply/564811/

Few alternatives to cancer-causing chemical used for sterilization

A recent push from the Food and Drug Administration to find alternatives to ethylene oxide, a gas used to sterilize about 50% of the nation’s medical devices, is challenged by the lack of substitutes and the industry’s huge reliance on the gas.
The FDA has asked the industry to bring forward new processes that can effectively sterilize medical devices amid renewed concerns that ethylene oxide is harmful to workers and surrounding communities, after an Illinois sterilization facility run by Sterigenics closed.
The Illinois Environmental Protection Agency forced the plant to stop operations in February when it was prohibited from using ethylene oxide after high emissions of the gas were found. While effective at cleaning medical devices, it’s considered a human carcinogen and has been tied to some instances of cancer.
Sterigenics declined to comment.
The FDA said the proposed methods must be able to do all that ethylene oxide can do. Therefore the agency asked for submissions of sterilizing agents compatible with lots of different packing materials and fabrics as well as able to sterilize large volumes of devices.
Ethylene oxide is a low-temperature gas so it’s able to sterilize wound dressings and gowns as well as plastics and complex devices like pacemakers without causing damage to the products. It can also sterilize in bulk.
The deadline to submit alternatives to the FDA closes Oct. 15 and a review period runs until Nov. 16.
In light of FDA’s scrutiny, devicemakers are exploring alternatives to ethylene oxide, said Greg Crist, spokesman for AdvaMed, which represents the medical technology industry. Manufacturers recognize that the gas is harmful to people, but it’s difficult to find another method that is as effective. For instance, hydrogen peroxide is commonly mentioned as an alternative because it’s a very good germ killer. The problem is it hasn’t been used before to sterilize large fleets of devices, said Chris Lavanchy, engineering director of the health services group at the ECRI Institute, a not-for-profit focused on the safety of medical technologies and practices. Crist also said hydrogen peroxide can’t penetrate some materials.
The hospital industry supports finding alternatives to ethylene oxide but emphasizes how much it relies on the gas right now. The closure of the Sterigenics plant in Illinois briefly led to shortages in breathing tubes.
“We can’t just stop using it,” said Nancy Foster, vice president of quality and patient safety at the American Hospital Association. Until sufficient alternatives are available, Foster said devicemakers must do all they can to ensure they’re using the gas safely.
Devicemakers are examining how to reduce the amount of ethylene oxide currently in use, Crist said. There may be opportunities to lower emissions by using materials that are less difficult to penetrate. Right now, ethylene oxide sterilizes devices in cardboard, which requires a lot of the gas, he said.
The FDA is also interested in ways to slash emissions. Along with its inquiry for alternatives to the gas, it’s also seeking methods “to reduce emissions to as close to zero as possible from the ethylene oxide sterilization process.”
https://www.modernhealthcare.com/medical-devices/few-alternatives-cancer-causing-chemical-used-sterilization

Dialysis companies to feel squeeze from Calif. reimbursement bill

California’s governor dealt a blow to dialysis companies over the weekend when he signed into law a bill that limits the reimbursement they receive for kidney disease patients who get insurance premium assistance from third-party organizations.
Gov. Gavin Newsom signed the bill, known as Assembly Bill 290, in the face of intense opposition from dialysis companies DaVita and Fresenius Medical Care, which together control most of California’s dialysis clinics. A similar measure was vetoed by then-Gov. Jerry Brown last year. The companies have argued the legislation would increase patients’ out-of-pocket medical costs and hinder their access to care.
“This bill will directly affect nearly 4,000 low-income, primarily minority, California dialysis patients who rely on charitable support to pay for their healthcare costs,” DaVita Kidney Care commented on Monday. “Based on statements made by the American Kidney Fund regarding their inability to continue operations in the state were AB 290 to become state law, we anticipate thousands of California dialysis patients face financial harm.”
Fresenius suggested the legislation would also increase hospital utilization.
“This charitable support helps ensure vulnerable patients don’t have to choose paying for their healthcare over housing and food. We are also concerned that this law will result in patients only being able to access their life-saving care at hospitals due to lack of insurance coverage, and we will support these patients’ transitions to whatever extent possible,” the company said in a statement on Monday.
While in their public statements the companies focused on how the new law would affect patients, the companies are also likely worried about their bottom lines. Early this year DaVita’s then-CEO, Kent Thiry, said that the law could reduce operating income by $24 million to $40 million. DaVita’s 2018 revenue totaled $11.4 billion, while its operating income was $1.5 billion.
Meanwhile, Fresenius Medical Care, whose parent company is based in Germany, reported 2018 revenue of 16.5 billion euros and operating income of 3 billion euros.
Rice Powell, CEO of Fresenius Medical Care, told Modern Healthcare in August that the company would “work our way through it” should the bill succeed. He argued it doesn’t make sense that the state should be able to determine how much the company makes.
“That doesn’t necessarily work with the way that capitalism in the United States works,” he said.
AB 290, which was introduced by Calif. Assemblyman Jim Wood, a Democrat, is meant to stop dialysis companies from collecting what Wood called excessive profits. It caps payments to dialysis companies at Medicare rates or a rate determined by a dispute resolution process when patients’ insurance premiums are paid by not-for-profit organizations, such as the American Kidney Fund. The American Kidney Fund, which receives most of its donations from DaVita and Fresenius, helps pay for health coverage for low-income dialysis patients.
Wood and other supporters of AB 290 have argued this system of premium assistance allows the dialysis companies to collect higher reimbursement by directing patients to private insurance, which pays more than Medicare or Medicaid.
“We can’t allow corporations to boost their profits at the expense of patients and increasing healthcare costs and I will continue to uncover these abusive practices in order to contain healthcare costs and bring healthcare to all Californians,” Wood said in a statement Sunday.
The American Kidney Fund on Sunday said it will be forced to stop providing financial assistance to about 3,700 low-income patients in California when the law goes into effect. Certain provisions of the law will take effect in 2020 while the reimbursement changes go into effect in 2022.
https://www.modernhealthcare.com/politics-policy/dialysis-companies-feel-squeeze-calif-reimbursement-bill

Proposed accounting rule could shift millions into hospitals’ current debt

A proposed accounting rule would flip certain debt from non-current to current, and some hospital leaders say the change—affecting tens of millions of dollars in some cases—could throw their debt ratios out of whack.
The Financial Accounting Standards Board says the proposed standard, Topic 470, is meant to simplify debt classification on balance sheets, and comes after stakeholders complained the current method is unnecessarily complex. In essence, the rule would replace current guidance with uniform principles for determining debt classification, according to a FASB explainer.
Under the proposal, a letter of credit could no longer be used to classify a type of bond called a variable rate debt obligation as current. Today, VRDOs can be treated as long-term obligations so long as they’re remarketed, or have long-term LOCs.
“People look at your company different when you all of a sudden have an extra $75 million in short-term liability,” said Jared Grant, senior director of financial reporting for St. Luke’s Health System in Boise, Idaho.
About $75 million of the $900 million in debt offerings St. Luke’s reissued last year were VRDOs backed by LOCs, Grant said. That debt is classified as non-current on the health system’s balance sheet. Grant has not calculated what the change would do to St. Luke’s debt ratio, but he thinks it would be significant. He’s worried it could even have a negative effect on St. Luke’s bond ratings.
“It’s a large chunk,” he said. “If that went to current treatment all of a sudden, that would be a large shift.”
VRDOs backed by LOCs make sense for some health systems because they allow them to obtain financing at attractive rates, said Norman Mosrie, a partner with DHG Healthcare and chair of the Healthcare Financial Management Association’s principles and practices board.
Some of the VRDOs on today’s balance sheets are legacy deals. The method lost popularity in recent years as borrowers turned to fixed rate bonds to lock in low interest rates, he said. Back in 2014, the VRDO market was worth $222 billion, according to the Municipal Securities Rulemaking Board.
“This has been an important financing mechanism for health systems over the years,” Mosrie said.
Mosrie expressed concern over whether bondholders would accommodate potential negative impacts to bond covenants under the proposed rule, or whether credit rating agencies would move to downgrade based on the large amount of debt classified as current.
Rating agency representatives, however, said they would not hold it against a company’s rating. At S&P Global Ratings, analysts’ practice is already to classify VRDOs as long-term debt even if they’re listed as current on balance sheets, said Kenneth Gacka, a senior director and analytical manager in S&P’s not-for-profit healthcare division.
“I don’t think it will affect anything in terms of the presentation of our ratios, because we already make that adjustment whenever it is present,” he said.
Similarly, Kevin Holloran, a senior director with Fitch Ratings, wrote in an email that his agency would also consider that a long-term obligation. That said, a casual reader could potentially be misled, he said.
Mosrie hopes the FASB, a not-for-profit organization that sets standards companies must abide by if they follow generally accepted accounting principles, continues to allow long-term LOCs linked to debt financing transactions be classified as non-current. The FASB is accepting comments on the rule until Oct. 28. This proposal is an updated version of an earlier proposed rule released in 2017. The new version is based on substantial feedback.
FASB spokeswoman Christine Klimek wrote in an email that consistent with the goal of simplifying guidance, the board proposed precluding consideration of unused, long-term financing arrangements to provide financial statement users with more consistent and transparent information about the contractual maturities of debt arrangements.
If the rule ultimately does take effect, Rick Kes, a partner and healthcare industry senior analyst with RSM, said he thinks health systems with this type of debt will renegotiate it and change the terms.
“I think most health systems that can do it would rather not have current debt on their balance sheet if they can avoid it,” he said.
That’s what Doug Coffman, chief financial officer of West Virginia United Health System, said would likely be his course of action. Otherwise, his 10-hospital health system with more than $2 billion in annual revenue would see its debt ratio drop from about 2.5%, well above its peer group, to about 2%, right in the middle of the pack. Almost $80 million of WVU Medicine’s $1.3 billion in outstanding debt obligations is VRDOs, Coffman said.
Coffman thinks the potential effects of the change extend beyond health systems, and could hit the banks that issue LOCs and bond underwriters if the VRDO market becomes less attractive.
“I’m not sure that FASB fully grasped that possible impact as they drafted this, but maybe they did,” he said.
WVU Medicine chose VRDOs for two reasons: interest rate diversification and some of the system’s fixed rate swap agreements require that it have some variable rate debt, Coffman said.
When St. Luke’s was going over its financing options, investment bankers presented VRDOs backed by LOCs as one of multiple long-term debt vehicles, Grant said. The health system chose it as one of the five vehicles it used, in part to diversify and because the price was competitive.
If the proposed rule takes effect, Grant said St. Luke’s will consider getting out of VRDOs.
“I think eventually it would poison this vehicle a little bit from health systems on wanting to ever really even touch it if this was the guidance,” he said.
https://www.modernhealthcare.com/providers/proposed-accounting-rule-could-shift-millions-hospitals-current-debt

Senseonics up on expanded coverage of Eversense continuous glucose monitor

Senseonics Holdings (NYSEMKT:SENS) announces that Health Care Service Corporation (HCSC) – Blue Cross Blue Shield is now providing coverage for the Eversense Continuous Glucose Monitoring (CGM) System effective tomorrow, October 15.
HCSC, an independent licensee of the Blue Cross and Blue Shield Association, is the fourth largest health insurer in the U.S., operating as Blue Cross and Blue Shield plans in Illinois, Montana, New Mexico, Oklahoma and Texas serving more than 16M covered lives.
Shares up 10% after hours.
https://seekingalpha.com/news/3505630-senseonics-10-percent-hours-expanded-coverage-eversense-cgm

Reata’s omaveloxolone successful in mid-stage ataxia study

Reata Pharmaceuticals (NASDAQ:RETA) announces positive results from the registrational portion of its Phase 2 clinical trial, MOXIe, evaluating omaveloxolone in patients with a rare inherited neurodegenerative disorder called Friedreich’s ataxia (FA).
The study met the primary endpoint of the change in the modified FA Rating Scale (mFARS) at week 48 versus placebo. The treatment effect was time-dependent with the most significant improvement observed after 48 weeks.
Management will host a conference call tomorrow, October 15, at 8:00 am ET to discuss the results.
Nrf2 is a transcription factor that promotes normal mitochondrial function. Omaveloxolone is a Nrf2 activator that restores mitochondrial production of an enzyme called ATP (adenosine triphosphate) that plays an essential role in energy production. It also increases the production of antioxidants which reduces oxidative stress and inflammatory signaling, the underlying causes of a range of diseases.
Shares, currently halted, will resume trading at 4:30 pm ET.
Update: Shares up 33% after hours.
https://seekingalpha.com/news/3505622-reatas-omaveloxolone-successful-mid-stage-fa-study

FDA OKs Akorn’s betamethasone lotion

The FDA approves Akorn’s (NASDAQ:AKRX) betamethasone dipropionate lotion USP (augmented), 0.05%, a topical corticosteroid for the treatment of inflammatory skin conditions.
Per IQVIA, the U.S. market is ~$10M.
Shares up 6% after hours.
https://seekingalpha.com/news/3505625-fda-oks-akorns-betamethasone-lotion