Search This Blog

Monday, December 2, 2019

FDA OKs Amneal’s generic Revatio and Amicar; shares up 2% after hours

The FDA approves Amneal Pharmaceuticals’ (NYSE:AMRX) generic versions of Pfizer’s (NYSE:PFE) Revatio (sildenafil citrate) Oral Suspension 10 mg/mL and Clover Pharms’ Amicar (aminocaproic acid) Tablets USP, 500 mg. Commercialization will begin immediately.
Per IQVIA, the U.S. market for the former is ~$180M and ~$23M for the latter.
Shares up 2% after hours.

UnitedHealth sees ~9% increase in 2020 earnings

Ahead of tomorrow’s Investor Conference in New York City, UnitedHealth Group (NYSE:UNHannounces preliminary 2019 results and 2020 outlook.
2019: Revenues: ~$242B; EPS: ~$14.25 from $14.15 – 14.25; non-GAAP EPS: ~$15.00 from $14.90 – 15.00.
2020: Revenues: $260B – 262B; EPS: $15.45 – 15.75; non-GAAP EPS: $16.25 – 16.55 (+9% from midpoint); cash flow ops: $19.0B – 19.5B.

What Prescription Does This Startup Have For Healthcare Real Estate?

In the medical real estate space, HealCo is a tech startup on a mission.
Launched in 2019, the company conducts a marketplace for medical and wellness office timesharing, management and compliance. HealCo brings together the spectrum of parties involved in the lease agreement process — from the healthcare provider to the medical office building owner and the hospital system operator — via the company’s technology platform.
With the healthcare consumer in mind, HealCo’s work is about connecting the provider with the right space for the right amount of time, and for fair market value. Their tech platform’s early-stage features simplify the search and the securing of space for healthcare practitioners, so that they can focus the vast majority of their time delivering high-quality, cost-effective outpatient care.
“Timeshares involve sharing a space with other providers to ensure optimal use,” said HealCo founder and CEO Kirat Kharode. “As a result, timeshares often lead to an ecosystem of complementary providers operating under one roof. It’s a medical office co-working system of sorts.”
Kharode spent almost two decades as a health system executive. He witnessed the thorny challenges, avoidable inefficiencies and opportunities to improve patients’ experiences. He knew the future of the healthcare real estate sector needed to stretch to accommodate the changes coming from the health and insurance industries.
Incorporated as an S-corp last January, and with seed funding secured, the Jersey City-based startup is growing its customer base. HealCo has more than 1,000 doctors and providers using its platform to find medical space to share. They’ve assisted property owners in timesharing over one million square feet across 42 of the continental 48 states.
HealCo’s mission is to facilitate the entrance of healthcare providers into real estate and communities where they are needed the most, especially as they are ramping up their practice, without binding them in long-term leases and brick-and-mortar investment decisions.
“A major learning from our proprietary data has been how closely our customer base of physicians reflects the same geographic areas as the highest Medicare Advantage concentrations across the country,” observed Kharode. “This patient population tends to be the greatest consumer of healthcare services in the United States. Decreasing their cost of care is extremely relevant to the country’s fiscal wellbeing.”
Right out of the gates, it has been an exhilarating year one. They’ve already rebranded from Healtor to HealCo, to better reflect their focus on the entire medical community. This month, they’ve relaunched their website to reflect the shift.
For capacity and trusted advice, HealCo has assembled an advisory board, with initial representation from the professions of commercial real estate, healthcare law and healthcare insurance, from the likes of CBREHall RenderMarshLincoln Harris CSGLDM Commercial and Meridian.
Next year’s prognosis: more hustle. HealCo shows no sign of slowing down, and they’re getting experimental.
“In early 2020, we’re opening new HealCo-managed office spaces, beginning with two offices in New Jersey,” announced Kharode. “These sites allow us to get closer to understanding the needs of our customers.”
“These locations are different from conventional medical office timeshares, operated by hospitals for example, because we partner with the providers in helping them succeed by hosting community networking events for patients – focusing on social determinants of health – and networking events to meet other physicians in the area.”
Kharode and his team are limbering up to stretch themselves, too.
“We are planning to expand our enterprise offerings to health systems and large medical office building groups. We currently have started exploratory partnerships with four regional, multi-hospital systems in New Jersey, California, Florida and North Carolina.”

Are Dangerous Microbes Hiding In Your Makeup? New Study Says Yes

A new study has revealed that the majority of opened, in-use makeup products, such as lip gloss, mascara and blending sponges are contaminated with potentially dangerous bacteria such as E.coli and Staphylococci.
The research published today in the Journal of Applied Microbiology by researchers at Aston University in the U.K., found that 9 out of 10 products tested contained bacteria capable of causing illnesses such as skin infections and even blood poisoning if used near the eyes, mouth or cut or grazed skin.
The risk is especially high in people who are immunocompromised and more susceptible to contract these infections from bacteria which might normally be otherwise kept in check by the immune system. However, the presence of potentially dangerous bacteria in this makeup does not necessarily mean people will get sick and substantial research is currently lacking correlating this.
The research looked at a variety of makeup products, comprising 467 individual items, including ‘blending sponges,’ contoured sponges used to apply makeup such as skin foundation to the face. These sponges were found to have the highest levels of potentially harmful microbes, likely due to often being left damp after use, creating a breeding ground for harmful bacteria.
The study found that two-thirds of users had dropped their sponges on the floor at some point, but that 93% of them had never been cleaned by their owners, further contributing to the likelihood that harmful microbes would be present.
“Consumers’ poor hygiene practices when it comes to using make-up, especially beauty blenders, is very worrying when you consider that we found bacteria such as E.coli – which is linked with fecal contamination – breeding on the products we tested,” said Dr Amreen Bashir, lead author of the study from Aston University’s School of Life and Health Sciences.
The requirements to put expiry dates on makeup vary widely around the world. In the European Union, most cosmetic products are required to have a “date of minimum durability” i.e. “best used before the end of” or a “period after opening” to show how long the product should be kept or used. However, in the U.S., there are no laws or regulations that require cosmetics to have specific shelf lives or have expiration dates on their labels, according to the FDA.
“More needs to be done to help educate consumers and the make-up industry as a whole about the need to wash beauty blenders [blending sponges] regularly and dry them thoroughly, as well as the risks of using make-up beyond its expiry date,” said Bashir.

Ardelyx conference call tomorrow on late-stage tenapanor data

Ardelyx (NASDAQ:ARDX) will host a conference call tomorrow, December 3, at 8:00 am ET to discuss results from the Phase 3 PHREEDOM study evaluating tenapanor in chronic kidney disease patients on dialysis.
In September, the company announced that the trial met the primary and all key secondary endpoints.
Shares up 1% after hours.

3 different communities, many reasons why Medicare payments are higher

How much the Medicare program pays hospitals for their services varies widely, driven by a host of factors.
Academic medical centers receive much higher payments because they provide graduate medical education. Safety-net hospitals receive higher payments for treating indigent patients. Patients’ acuity, the area wage index, outlier payments and patient migration patterns also play a role.
Modern Healthcare identified three Census Bureau statistical areas of interest based on Medicare data that indicate they receive some of the highest payments in the Eastern U.S.: Baltimore, Burlington, Vt., and Charlottesville, Va. They’re decidedly different communities treating very different patient populations with different socio-economic factors to consider, underscoring the reasons for their higher-than-usual Medicare rates.
Baltimore’s place on the list is likely explained by the fact that Maryland hospitals operate under a unique, global budgeting system in which the rates they receive from all payers are established by a state commission. Unlike in other states, Medicare payments to Maryland hospitals are more on par with those of commercial insurers.
Burlington and Charlottesville are similar to each other in that large academic medical centers dominate their inpatient care and draw patients from expansive rural areas that surround the cities. Medicare pays teaching hospitals more to cover expenses related to staffing residents and interns.
“The academic impact on rates from a Medicare perspective is pretty significant and likely one of the drivers pushing Vermont and Charlottesville to the top of the list,” said Jeff Leiback, a director with Navigant.
Baltimore-Columbia-
Towson, Md.

REIMBURSEMENT PER MEDICARE DAY: $3,266
POPULATION: 2.8 million
MEDIAN AGE: 38.5
MEDIAN HOUSEHOLD INCOME: $80,469
BELOW POVERTY LINE: 10.1% 
Sources: U.S. Census Bureau, 2018 core-based statistical area data; Modern Healthcare Metrics
It shouldn’t come as a surprise that any city in Maryland shows up as an outlier when it comes to Medicare payments to hospitals. Hospitals there have operated outside the typical payment paradigm for decades.
Maryland hospitals participate in an aggressive global budgeting system in which their total revenue is fixed, a model that’s been shown to lower volumes and mortality rates, said Bob Atlas, CEO of the Maryland Hospital Association.
In exchange for shouldering the risk of fixed revenue, Medicare and Medicaid reimburse Maryland hospitals at higher rates than in other states. As of this year, those programs pay just 7.7% less than commercial payers—a much smaller differential than in other states, Atlas said.
“That’s the bargain that’s been struck: Hospitals can get more per-unit revenue from Medicare and Medicaid in return for taking on substantial risk,” Atlas said. “We’re seen as a model for the nation.”
Like in other states, the rates Medicare pays are adjusted based on a number of factors, perhaps the biggest one being extra money for training interns and residents. Baltimore has two prominent academic medical centers: Johns Hopkins Health System and the University of Maryland Medical System.
Johns Hopkins has a large teaching program with upward of 800 interns and residents, and the cost of that is embedded into its Medicare base rates, said Ed Beranek, Johns Hopkins’ vice president of revenue management and reimbursement.
“So essentially all payers or all patients coming to our hospital have a portion built into their charges that helps pay for the teaching of those interns and residents,” he said.
In states other than Maryland, Medicare is the only entity that reimburses for graduate medical education. In Maryland, commercial payers and Medicaid contribute their fair share of that cost, Beranek said.
The University of Maryland’s and Johns Hopkins’ hospitals also tend to draw higher-acuity patients with more complex conditions, which also drives up the cost.
The University of Maryland Medical Center has a shock-trauma subhospital that treats people with serious injuries, Atlas said, and also has a helipad on its roof.
“So you get the idea of the level of capability that’s present there,” Atlas said.
Roughly 20% of Johns Hopkins’ patients come from outside of Maryland, Beranek said. That includes domestic and international patients, who often come specifically for specialty programs in pediatrics or organ transplantation, he said.
“They drive a very high case mix index and bring a high level of cost with them,” Beranek said.
Baltimore’s high socio-economic risk factors are another driver of hospitals’ higher per-patient Medicare revenue. About one-third of Baltimore households earn less than $25,000, according to a 2017 community health assessment performed by the city of Baltimore. The report also noted a high concentration of vacant buildings in certain areas, as well as lead paint exposure—conditions that have been connected to poor health outcomes. About one-quarter of the city’s residents lived in food deserts in 2015, the report found.
Tradition of price-setting
Maryland’s all-payer rate-setting system for hospitals has been in place in various forms for about 40 years, and the program has grown increasingly ambitious. A state commission sets the prices that commercial health insurers and government programs pay hospitals for services. Beginning in 2019, hospitals entered a new agreement where they will take on partial risk for the total cost of care for all Medicare fee-for-service beneficiaries statewide.
In other states, hospitals often raise their rates on commercial payers and self-pay patients to make up for lower government reimbursement. That doesn’t happen in Maryland, Beranek said.
Maryland’s system makes it so that independent hospitals can thrive, too. In Boston, Partners HealthCare gets higher rates from commercial payers than community hospitals because of its strong market power, said Dr. John Chessare, CEO of the Greater Baltimore Medical Center. In Maryland, by comparison, market share doesn’t matter as much because hospitals don’t negotiate prices with payers.
“In other states, if you’re a single hospital or a safety-net provider, you don’t have any clout with the payers,” Chessare said. “In Maryland, Greater Baltimore Medical Center is a single-hospital true system of care through the eyes of the patient. We don’t have to negotiate rates. The rate commission tells Blue Cross and Cigna and Aetna what to pay us.”
He added that the rate-setting system also contributes to Maryland hospitals’ generally strong financial positions and balance sheets. Indeed, most of the few dozen hospitals in the Baltimore area have posted strong operating results in recent years.
Modern Healthcare Metrics data show both Anne Arundel Medical Center in Annapolis and MedStar Harbor Hospital in Baltimore reported about 8% operating margins in 2018. Nationally, not-for-profit hospitals’ median operating margins were 1.7% in 2018, according to Moody’s Investors Service. Another MedStar hospital, Good Samaritan Hospital in Baltimore, posted a 6.2% operating margin in 2018.
But Atlas and others say it’s also working well for patients. Readmissions in the state dropped nearly 22% from 2013 to 2017, compared with 5.7% nationwide in that time, according to the hospital association. The percentage of Maryland Medicare beneficiaries who died within 30 days of admission dropped 12.2% from 2013 to 2017, compared with a drop of 6.4% nationwide, the report found.
Maryland had the nation’s second-lowest healthcare spending in the country in 2017, according to a Health Care Cost Institute analysis based on 40 million insurance claims. “What might look like high Medicare costs per discharge ought to be considered in light of the fact that we have much lower hospital costs for private payers and the people they insure,” Atlas said.
Charlottesville, Va., metro area
REIMBURSEMENT PER MEDICARE DAY: $3,512
POPULATION: 232,000
MEDIAN AGE: 38.4 
MEDIAN HOUSEHOLD INCOME: $71,052
BELOW POVERTY LINE: 13.9%
Sources: U.S. Census Bureau, 2018 core-based statistical area data; Modern Healthcare Metrics
Albemarle County, Va., which includes Charlottesville, is a bustling, growing region of about 109,000 people. But neighboring Nelson County has just 15,000 residents. Buckingham County to the south has a mere 17,000 residents, and Greene County to the north has about 20,000.
“You can quickly, within a few minutes, drive out and are in sparsely populated areas,” said Dr. Denise Bonds, health director for the Thomas Jefferson Health District, a unit of the Virginia Health Department that serves five counties, including Albemarle.
The Charlottesville area’s position as a population center in the middle of a rural region is one reason its Medicare payment rates are higher than in other areas.
The census area includes just two hospitals, both in Charlottesville: the University of Virginia Medical Center, a prominent academic medical center with $1.6 billion in revenue in 2018, and Sentara Martha Jefferson Hospital, a relatively small hospital with about $314 million in revenue in 2018. Sentara Martha Jefferson accounts for one-quarter of the area’s total Medicare inpatient days, and just 14% of the total revenue, Sentara Healthcare spokeswoman Kelsea Smith wrote in an email.
UVA’s higher Medicare payments are in part because it’s the only safety-net hospital in a large area, said Doug Lischke, chief financial officer for UVA Health. Its payer mix is more than 60% government programs. “We accept all regardless of ability to pay,” he said. “So, as you can imagine, we receive a lot of transfers from hospitals that don’t accept all.”
UVA also draws a number of more complex, high-acuity patients from western and southwestern Virginia and beyond who come for specialized care, another factor that drives up costs. The hospital is a Level 1 trauma center and has extensive organ transplant and stem cell transplant programs.
“We see the sickest of the sick,” Lischke said.
And, of course, UVA is a teaching hospital with more than 800 residents and fellows. Medicare pays higher rates to support graduate medical education.
In recent years, Charlottesville has become a popular retirement destination. From 2013 to 2017, the number of people between the ages of 70 and 79 grew by 46% within the Thomas Jefferson Health District, faster than any other age group. By comparison, the number of 20- to 29-year-olds grew by just 4.5% in that time.
Elderly patients tend to be more complex cases. UVA is working to adapt to caring for an aging population by upping its focus on hips and knees, as well as cancer care, he said. It’s a delicate balance between focusing on providing those services and ensuring UVA is still meeting the unique pediatric needs of its children’s hospital, Lischke said.
The growing Medicare population also poses a challenge for UVA because Medicare payments don’t cover the cost of delivering care, which forces UVA to make it up elsewhere, Lischke said.
“It strains our operating margins, which then puts a strain on investing in our research and our education back into programs to grow the community care that we’re trying to provide,” he said.
Like other areas, Charlottesville is also dealing with a number of social factors that are negatively affecting people’s health. The urban area keeps growing and affordable housing is becoming increasingly strained, Bonds said. There’s also a severe shortage of mental health providers who treat low-income patients, especially in the rural areas, she said.
Access to transportation is another big issue.
“The issues this community is grappling with are more the social determinants of health,” Bonds said.
Burlington-South Burlington, Vt.
REIMBURSEMENT PER MEDICARE DAY: $2,440
POPULATION: 221,000
MEDIAN AGE: 37.7
MEDIAN HOUSEHOLD INCOME: $71,452
BELOW POVERTY LINE: 12%
Sources: U.S. Census Bureau, 2018 core-based statistical area data; Modern Healthcare Metrics
Burlington, Vt., is effectively a one-hospital town.
The University of Vermont Medical Center is a massive, 450-bed operation that drew $1.4 billion in revenue in 2018 and posted a healthy 4% operating margin.
The census area that includes Burlington has one other hospital, Northwestern Medical Center, a small facility that collected $111 million in operating revenue in 2018. It’s located in St. Albans, about 30 miles north of Burlington. Jonathan Billings, the hospital’s vice president of community relations, said Burlington is served almost exclusively by UVM.
“Our folks are up here in the Northwest corner, in the rural area, and we wouldn’t go that far south into Burlington,” he said.
UVM’s status as a teaching hospital is the biggest factor driving up its Medicare payments, said Lynne Winter, the hospital’s manager of reimbursement. The additional money helps compensate for the time spent teaching residents and for additional tests residents might run because they’re learning, she said.
“We need to teach our future doctors,” she said, “so it’s an aspect of the cost structure that people have recognized as being a community good.”
UVM also gets a lot of patient referrals from outside the area, which in turn drives up the hospital’s case mix, Winter said. The hospital runs transplant and dialysis programs, which drives up the acuity of the patients it sees.
Winter said the hospital also receives Medicare disproportionate-share hospital payments for treating low-income residents. Those patients often delay care until conditions become more severe, she said.
“You have people that fall through the cracks and don’t get insurance and have been delaying getting care,” Winter said.
UVM is also seeing its patient population get relatively older. From fiscal 2016 to fiscal 2018, the number of patients age 65 and older grew nearly 8% to about 61,000, according to a UVM presentation from August. At the same time, patients ages 19 to 25 dropped 5.3% to about 21,000. The proportion of patients covered under Medicare grew 5.7% in that time, while commercially insured patients remained flat.
The health system also noted that the age and complexity of its patients are growing. Other pressing issues include low unemployment and increasing wage inflation, increasing pharmaceutical costs, commercial rate increases that don’t cover the cost of inflation and a lack of mental health services.
Mental health was the No. 1 priority area identified in UVM’s 2019 community health needs assessment. Community members interviewed for the study cited funding gaps, availability of services and provider burnout as the biggest barriers to mental health delivery in the area.

States prepare Rx importation plans after Trump assurances

State officials are moving forward with prescription drug importation programs on President Donald Trump’s repeated assurances that he wants to allow states to import drugs from Canada, though HHS has not approved any such program. Vermont on Tuesday will become the second state to submit an importation plan to HHS behind Florida.
Facilitating drug imports is one of Trump’s favorite healthcare talking points and he reiterated his support for approving state plans on Friday. Republican Florida Gov. Ron DeSantis and Trump talked about drug imports on a phone call the day before.
HHS Secretary Alex Azar “and I will soon release a plan to let Florida and other States import prescription drugs that are MUCH CHEAPER than what we have now! Hard-working Americans don’t deserve to pay such high prices for the drugs they need. We are fighting DAILY to make sure this HAPPENS…” Trump tweeted.
Colorado, Florida, Maine and Vermont have passed laws creating Canadian importation programs.
Vermont’s plan differs in a few key ways from Florida’s. Vermont’s plan would apply to consumers in the commercial market instead of just those served by public payers. Plans would be required to pass any cost savings to consumers by lowering premiums, deductibles and co-pays for prescription drugs.
But Trump talks the most about approving Florida’s plan, which the state submitted to HHS in August. Joe Grogan, chief of the White House Domestic Policy Council , on Nov. 8 singled out Florida and Colorado by name as partners on importation programs. HHS has legal authority to approve the programs if the department certifies the move would not pose additional safety risks and would significantly reduce costs for American consumers.
Florida is important for the presidential electoral map and Sen. Cory Gardner (R-Colo.) is one of the GOP’s most vulnerable Senate incumbents up for re-election in 2020.
Despite not having approval from HHS, DeSantis on Nov. 18 asked state lawmakers to allocate $20 million to the state’s nonexistent importation program. DeSantis told reporters that pharmaceutical lobbying was responsible for the delay.
“I wish I could say that this will happen tomorrow, but I just know how Washington works and I know specifically when you get into something that is dealing with probably the most powerful industry in Washington—certainly one of the top two or three—it just is never easy,” DeSantis said, CBS Miami reported.
The Trump administration’s drug importation plan has two pathways: One would allow states to import drugs from Canada, and another would allow drugmakers to import their own products and sell them under different drug codes.
Several groups with ties to the pharmaceutical industry have met or are scheduled to meet with officials from the White House Office of Management and Budget on pending Food and Drug Administration guidance that would implement the latter pathway.
Pharmaceutical Research and Manufacturers of America, the brand-drug industry lobby, met with White House budget officials Nov. 4.
“We requested the meeting to discuss issues pertaining to the guidance under review implementing pathway 2 of HHS’s Safe Importation Action Plan. I’m not going to get into the specifics of the meeting or those in attendance,” PhRMA spokesperson Nicole Longo said.
The Pharmaceutical Distribution Security Alliance, a group that represents industry stakeholders, including drugmakers, distributors and pharmacies, is set to meet with OMB about the guidance on Tuesday. The Partnership for Safe Medicines, a not-for-profit with deep ties to PhRMA, is scheduled to meet with OMB officials Jan. 7.
However, OMB has not held any publicly disclosed meetings on a proposed rule that is expected to outline the approval process for importing drugs from Canada. The regulatory agenda released last week indicated the administration expects to release the proposed rule on drug imports in January.
A source familiar with the policy said that the administration may not have to wait for rules to be finalized to begin approving state import programs. The rulemaking process could take years and would likely extend until after the 2020 election.
Maine initiated a formal plan for its importation program on Nov. 15 and HHS Commissioner Jeanne Lambrew said Maine does not want to wait for federal rulemaking to develop a plan and submit it for approval, the Bangor Daily News reported.
Colorado officials plan to deliver the state’s importation proposal by Jan. 15.
Other states are also looking to create their own importation programs in the next legislative session.
Lawmakers in the Michigan state House and Senate have introduced bills that would create a Canadian-drug importation program for the state’s 2020 legislative session. Democrats in New Hampshire included importation in a legislative package several state senators filed on drug pricing, and Connecticut state lawmakers from both parties have expressed interest in reviving importation legislation that stalled in 2019.
Dan Feltes, the New Hampshire Senate majority leader and a Democratic gubernatorial candidate in 2020, introduced a bill that would allow the state to import Canadian drugs that is based on Vermont’s legislation. Feltes said he is hopeful for federal prospects on drug importation whether Trump wins or a Democratic challenger prevails. All of the leading Democratic presidential candidates have expressed support for drug importation and it has been a priority for Trump, though Feltes said he generally does not place much confidence in the president’s statements.
“I’m hopeful this may be one of his commitments (Trump) would follow through on, or that a new president actually moves forward on that,” Feltes said.
Trish Riley, executive director of the National Academy of State Health Policy, said many additional states are interested in importation, but are waiting to see how the four current test cases play out. The academy is helping states develop drug importation proposals and tracking drug-pricing legislation across the country.
“They don’t know what to expect. Everybody is waiting to see what happens,” Riley said.