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Friday, July 6, 2018

Amazon Business’s medical supply chain ambitions

Amazon Business, the B2B purchasing arm of the e-commerce behemoth, is looking to disrupt the healthcare supply chain amid accelerating hospital operating expenses, flattening admissions and an increasing need to cut costs.

Under pressure to pare down unnecessary spending, supply chain professionals are increasingly rethinking traditional distribution and supplier models to gain a competitive advantage.

Some have turned to Amazon, whose shadow looms ever larger in the healthcare space. Much has been discussed concerning the Amazon-BerkshireHathaway-JPMorgan employee health cost endeavor (along with Amazon’s recent acquisition of PillPack) but one can’t ignore Amazon’s subtle foray into the supply chain sector.

Amazon Business provides a marketplace for medical supplies in a format very similar to its popular Amazon Prime service. The B2B purchasing venture has generated more than a billion dollars in sales its first year alone and introduced three business verticals last year — education, government and healthcare. Already, hundreds of thousands of medical products are available on Amazon Business, from hand sanitizer to biopsy forceps.

“The shopping experience feels the same, but in the background we’ve configured that organization’s procurement practices and policies,” Chris Holt, global healthcare leader at Amazon, told Healthcare Dive in an interview. “So, if they want to service particular suppliers in a given category or focus on diversity suppliers, women-owned businesses, quality-certified suppliers, they can search for things based on their own company-specific credentials, and that drives the algorithms that feed our search results.”

In the interview, Holt discussed Amazon’s marketplace model, workflow approvals aimed at streamlining ordering and its “tail spend” strategy. Here are the highlights.

1) Amazon is using its tried-and-true disruption model built around a marketplace

Amazon’s disruption of sectors from publishing to food is well known. In healthcare, Holt said there is a “needed shift” from an old, inefficient supply chain model that runs on physical contracts with distributors and manufacturers to Amazon’s “marketplace” model.

“If you look at most healthcare providers, they have a central procurement team that tries to control the purchasing of all the employees,” Holt said. In theory, this should get them better pricing because every department is purchasing off the same product contracts. But in reality, Holt said, that drives “tremendous inefficiency, because the end user that needs the product has to go through a lot of procedural steps” — steps that tend to be driven on antiquated technology.

Since the marketplace is transparent, new suppliers are available to hospital procurement teams using Amazon Business. Amazon contends that their ability to shop across numerous suppliers will deliver big savings. One example is Summit Pacific Medical Center in rural Washington, which Amazon said it helped cut labor expenses by 80% and lowered spend related to delays in lead time and shipping upcharges.

Along with being able to accommodate IDN- and GPO-negotiated pricing and payment via invoice, the marketplace touts price transparency — an important step as hospitals shoulder increasing expense and labor costs.

This comparison-shopping ethos contrasts to older models based on fixed contracts that can obfuscate prices and where middleman fees add ancillary costs.

“Online channel[s are] going to be the primary marketplace[s] for even the most premium of medical devices in the future,” Holt said.

2) Workflow and licensing approval are baked into the purchasing process

When an employee buys a product requiring approval — maybe it’s over a certain dollar amount or in a restricted category of devices — Amazon’s website can process it automatically, sending the purchase request straight to the correct approver.

So, Holt said, a lot of “manual processes that break down get replaced by these digital, automated processes.”

Amazon Business claims a number of their healthcare customers have seen their labor costs cut by more than half — and it’s not just big hospitals they are going after.

A professional licensing platform allows physicians to post their license with Amazon. After Amazon verifies their credentials with the state board of pharmacy, that physician may purchase restricted and regulated medical products on the marketplace, as opposed to needing new approval each time.

“It’s a big part of what we’re trying to do,” said Holt, “to enable [physicians] to buy what they use everyday — not just things you might initially think of Amazon for, like office products or IT products, but also all the medical products that they consume.”

3) Data pushes reporting capabilities for disparate purchasing groups

In a 2018 Global Healthcare Exchange survey, approximately 60% of supply chain leaders indicated that data and analytics were the highest priority areas for improvement in the next year.

Similarly, healthcare providers are looking to dynamic technology to add rigor and automation to their business processes. Amazon is counting on the fact that many workers are already familiar with the Amazon experience to give them a head start.

“When an employee sits down at work, and they see Amazon, they already know exactly what to do — they don’t even need to be trained,” Holt said. This recognizability negates the need for employee training in the system.

According to Holt, the system’s analytics capabilities allow different employees to view and manipulate their purchasing data on a macro level, allowing them to do such things as prepare customized spending reports grouped into customer-specific batches.

“Maybe you’ll have the hospital maintenance department in one group, and then the care providers like nurses and doctors in another group, and then the supply chain purchasing department in another group,” Holt said. “To all of those different employees, we provide analytics on what each different group is doing, what kind of spend categories they’re buying in, how that’s trending over time [and] insights into the price and cost-effectiveness of what they’re buying.”

Amazon Business touts the system’s benefits for manufacturers too. With real-time visibility on which of their products sold on the marketplace today and in what quantity, manufacturers know how much they need to make tomorrow in order to replenish their stock.

Also in Amazon’s crosshairs are outdated technological processes, like static itemmasters, where you have to lock in what you’re allowed to buy.

“The procurement tools often feed back into an ERP (enterprise resource plan) or financial system that has a very standardized general ledger that does really well when it’s a repeat order, but isn’t very good at anything new,” Holt said. “We’ve been building technology to integrate backwards into all of these systems, even to enable EDI (electronic data interchange) transactions,” allowing Amazon’s system to fully interact with the healthcare system’s.

4) Amazon is gunning for suppliers’ margins

Amazon Business is aiming to take on the roughly 20% of spread out and potentially mismanaged spending that accounts for 80% of a healthcare system’s suppliers.

“That’s all the volume where you don’t spend a lot with a particular supplier; [It] could be things that aren’t high-volume purchases for your organization, and it’s generally very poorly managed,” Holt said. “It’s not worth the time and effort to negotiate contracts with those suppliers, to negotiate specific pricing or terms, or delivery capabilities.”

“As a result, you have this long tail of suppliers that are poorly managed, you don’t know if the prices are good or not, it’s not cost effective for your procurement team to engage with those suppliers,” he continued.

Amazon is strategizing to acquire this 20% of tail spend, allowing procurers “instant selection from hundreds of thousands of suppliers where you don’t need to negotiate pricing or a contract with them.”

“We hear from our customers that just being able to clean that up and being able to simplify that and then have analytics and insight on how that’s doing is a hugely strategic procurement initiative,” Holt said.

Challenges and next steps

To be sure, Amazon is far from taking over the market.

The CEO of New York-Presbyterian told Healthcare Dive in late May that Amazon was unable to achieve better pricing for part of NYP’s supply chain.

Some hospitals have also been reluctant to buy supplies, citing lack of options and control over purchases and shipping. In a sector where prompt arrival and continuity of product is crucial, hospitals may stick to a known — albeit outdated — entity.

Yet costs due to administration, marketing, shipping and storage account for an estimated 20-30% of healthcare supply costs — a huge opportunity for increased competition in a market that’s forecasted to reach $2.3 billion by 2022.

UPS, FedEx, and DHL have made significant investments in their healthcare supply chains. In 2015, UPS reported that healthcare was one of its fastest-growing streams of revenue. Additionally, the healthcare supply chain space is already crowded with big companies such as Cardinal Health, McKesson and AmerisourceBergen.

Yet ultimately, Holt said Amazon is betting it can help the healthcare supply chain evolve from its current pricey “push” model to a more constructive “pull” model: one that relies on demand instead of supply.

A recent Reaction Data survey found 62% of healthcare executives are hoping Amazon can shake up the industry’s supply chain, and Amazon is counting on this shifting healthcare bedrock to give it an edge as it grows.

“I think healthcare leaders are desperate for new models and are eager to try new things,” Holt said. “That intake process of expanding our customers, being obsessed with them, and listening to them and learning from them is really the key to all of this.”

https://bit.ly/2lXEc9F

Hospital hiring spiked 71% in June

June was a busy month for hospital hiring. The sector made 10,600 new hires last month, a 71% spike from its sluggish May job growth.

The U.S. healthcare sector overall added 25,200 jobs in June, lower than the 28,900 jobs it added in May, according to the U.S. Bureau of Labor Statistics’ newest jobs report released Friday. Healthcare has added 309,000 jobs in the last 12 months.

The unemployment rate ticked up to 4% last month, even after dropping slightly in May. The BLS provided the caveat that the unemployment rate had been 4.3% a year earlier, when there were 7 million unemployed Americans, up from the current 6.6 million.

June’s hospital hiring bucked a monthslong trend of slowed job growth. The sector dipped to 6,200 new hires in May, down from 8,000 in April and nearly 10,000 in March.

Healthcare’s ambulatory sector once again made the most new hires last month. The sector added 13,500 jobs, a 25% dip from 18,000 in May. Within the ambulatory sector, offices of other health practitioners saw the highest growth, adding 3,900 new jobs. Physician’s offices made 3,200 new hires in June, a 26% dip from the previous month’s hiring.

Nursing care and residential mental health facilities continue their dramatic fluctuations between job growth and losses. The former lost 1,500 jobs last month after adding 2,600 in May and shedding even more than that in April. Residential mental health made 2,100 new hires last month after shedding 400 in May and gaining 1,500 in April.

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Vegetarian Diet Improves HbA1c, Reduces CV Risk in Diabetes

Vegan and vegetarian diets help lower HbA_1c and cholesterol levels and improve other cardiometabolic risk factors in middle-aged, overweight people controlling their type 2 diabetes with medications, say authors of a literature review published online in Clinical Nutrition.

Effie Viguiliouka, MSc, with the Clinical Nutrition and Risk Factor Modification Center at St. Michael’s Hospital in Toronto, Ontario, and colleagues, analyzed findings from nine randomized controlled trials involving 664 participants who were taking oral glucose-lowering drugs, insulin, lipid-lowering agents, and/or anti-hypertensive agents.

They found that vegetarian diets compared with nonvegetarian diets improved the primary outcome of HbA_1cby 0.29%.

While the HbA_1c reduction may seem moderate, Cara Schrager, MPH, RD, CDE, of the Joslin Diabetes Center in Boston, Massachusetts, pointed out that the improvement is the same as the therapeutic threshold the US Food and Drug Administration uses when considering new medications for diabetes.

Schrager told Medscape Medical News that this level of reduction suggests that patients could consider moving toward a plant-based diet with primarily vegetables, fruits, whole grains, and legumes, perhaps even before they move to diabetes medications.

Vegetarian Diet Also Helped Reduce BMI

Other results included reductions in fasting glucose of 0.56 mmol/L; LDL-cholesterol (0.12 mmol/L); non-HDL-cholesterol (0.13 mmol/L); body weight (2.15 kg or 4 lbs, 12 oz); body mass index (BMI) (0.74 kg/m²), and waist circumference (2.86 cm) with the vegetarian compared with nonvegetarian diets.

No significant differences were seen in blood pressure, fasting insulin, HDL-cholesterol, or triglycerides.

Only diets that excluded meat and fish (from vegan [no animal products] to vegetarian diets that included eggs and dairy products) were considered vegetarian in the meta-analysis.

The authors stress that the link between diabetes and heart disease is strong and well-established.

“Sixty to seventy percent of people who have type 2 diabetes die of heart disease,” study coauthor Hana Kahleova, MD, PhD, director of clinical research at the Physicians Committee for Responsible Medicine said in a press release.

“This study shows that the same simple prescription — eating a plant-based diet — can reduce our risk for heart problems and improve type 2 diabetes at the same time.”

The researchers acknowledge, however, that the findings had a low-to-moderate confidence level and they encourage further study.

Findings Build on Body of Evidence: No Downside to a Plant-Based Diet

Katherine Zeratsky, a registered dietitian nutritionist (RDN) at the Mayo Clinic in Rochester, Minnesota, told Medscape Medical News that this new review adds to a body of evidence that indicates eating less red meat and more vegetables can benefit people with type 2 diabetes.

Many of the noted reductions in this study fit with what others have shown, she said.

“We know that weight in and of itself is a strong risk factor for diabetes — so it makes sense that a plant-based diet will have a large impact on health overall,” she said, while countering that she wished the evidence “was stronger.”

But as with all nutrition research, she said, “It’s very difficult to say with absolute certainty that if you do this, this will happen.”

However for most patients, she added, there isn’t a downside to trying a plant-based diet.

It Doesn‘t Have to Be All or Nothing: How to Move Away From Meat

Still, fewer than 10% of people in North America and Europe have adopted vegetarian diets, according to national survey data cited by the authors.

Zeratsky emphasized that moving away from meats and toward vegetables, fruits, and whole grains doesn’t have to be an all-or-nothing effort.

A good start is cutting meat consumption at a meal from 8 oz to 6 oz and filling the plate with more fruits and vegetables to curb hunger, she said.

Schrager suggested adding “meatless Mondays” or trying the diet one day a week at first.

“It is a shock to the system if you suddenly stop eating a certain group of foods,” she said.

Some foods, such as lasagna or chili, have comparable meatless versions, she noted, and beans can add bulk. Adding protein sources such as tofu and tempeh can also give dishes a meaty texture.

Drug Labels to Get FDA Revamp

Prescribers can soon expect to see prescription drug labels with clearer descriptions of the conditions and patient populations for which an FDA-approved drug is indicated, under draft guidance for industry that the FDA released Friday.

Although the agency didn’t indicate specific problems with existing labels that may have prompted the new guidance, some of the examples of preferred language give clues. For instance, “if a study evaluating a drug in adults enrolled patients of a certain age range … the indication should be worded to reflect the broader age group (i.e., ‘in adults’) rather than the exact ages studied,” the guidance stated, as long as there is no reason to believe the drug is unsafe in adults outside that range.

Overall, the agency’s goal with the new guidance is to give prescribers more precise yet also more understandable information on which conditions a drug is approved to treat, and which patients are appropriate to receive it.

In addition to suggesting the information labels should include, the guidance also indicates what they should omit — mainly, information so obvious that it merely clutters the label. As one example, the document said, “if an indication is clearly worded as being approved for use in combination with another drug, there is no need for a limitation of use stating that the subject drug should be used only in combination and not as monotherapy.”

Likewise, labels need not “address the absence of data in populations in which the drug was not studied” when it’s clear the drug isn’t indicated for those populations. For example, the label for an anti-rejection drug indicated for heart transplant patients doesn’t have to state that there is no data on its use in lung transplant patients.

“We believe this guidance will help healthcare providers identify appropriate treatment options for their patients,” said Jacqueline Corrigan-Curay, MD, MD, director of the Office of Medical Policy in FDA’s Center for Drug Evaluation and Research, in announcing the draft guidance.

The agency will accept comments on the draft guidance for 60 days, after which it will issue a final version. FDA guidance documents are non-binding but manufacturers typically pay close attention to them.

https://bit.ly/2tZ5hxG

Medicare Loosens Rules on Continuous Glucose Monitors

Clinicians will now have an easier time finding out how some of their Medicare patients with diabetes are doing, thanks to a change in Medicare’s coverage policy for continuous glucose monitors (CGMs) that use smartphone apps to transmit data.

In January 2017, the Centers for Medicare & Medicaid Services (CMS) announced that certain continuous glucose monitors would be covered by Medicare. In its announcement, the agency noted that “Medicare does not cover CGMs approved by the FDA for use as adjunctive devices to complement, not replace, information obtained from [fingerstick] blood glucose monitors. In our view, such devices are not used for making diabetes treatment decisions, such as changing one’s diet or insulin dosage … and therefore, have not been covered under Medicare.”

However, CMS added, “the FDA recently approved expanding the indications of one CGM product to include replacement of blood glucose monitors for diabetes treatment decisions.” It was that product — the Dexcom G5 CGM — that CMS approved coverage for. (Abbott’s FreeStyle Libre CGM is now also covered.) But the coverage came with a caveat: the device would only be covered if patients didn’t use the smartphone app to transmit information about their glucose readings.

According to a March 23, 2017 article from Medicare contractor CGS explaining the new coverage policy, “Coverage of the CGM system supply allowance is limited to those therapeutic CGM systems where the beneficiary ONLY uses a [CGM data] receiver classified as DME [durable medical equipment] to display glucose data. If a beneficiary uses a non-DME device (smartphone, tablet, etc.) as the display device, either separately or in combination with a receiver classified as DME, the [CGM supplies are] non-covered by Medicare.”

“That effectively eliminated the opportunity to use a smartphone together with, or on different days than, the receiver,” explained James Scott, president and CEO of Applied Policy, a consulting firm in Alexandria, Va.

The new policy, announced last month by CMS but not yet finalized, eliminates that caveat. “CMS heard from numerous stakeholders who shared their concerns that Medicare’s CGM coverage policy limited their use of CGMs in conjunction with their smartphones, preventing them from sharing data with family members, physicians, and caregivers,” the agency said. “After a thorough review of the law and our regulations, CMS is announcing that Medicare’s published coverage policy for CGMs will be modified to support the use of CGMs in conjunction with a smartphone, including the important data-sharing function they provide for patients and their families.”

“This is good news for everybody and it’s the right thing to do,” said Scott, whose clients include Dexcom and who lobbied to get the policy changed. “Most of all, it’s a victory for people with diabetes who are now able to access the full functionality of a CGM system, particularly alerts and alarms that can share unusually high or low readings with a loved one. For example, if [people with diabetes] have a high or low blood sugar while they’re asleep, the app can alert their partner who can wake them up” in time to take action.

The change will also make it easier for patients to share the information with doctors “to the extent that doctors want that information,” he continued. “For the right patients and their doctor who wants to closely watch [their readings] for a period of time … this is a big benefit.”

“This really should have happened when they [first] announced they would cover CGMs,” said Joanne Rinker, RD, CDE, director of practice and content development at the American Association of Diabetes Educators, in Chicago. “This helps the elderly who have caretakers, so they can keep up with what’s happening throughout the day.”

It also helps clinicians because “you could have a person with diabetes call their diabetes educator and say, ‘Can you look at my CGM for the last 2 days? Everything is acting crazy,’ and we can talk it through over the phone,” she said. “It gives that opportunity to be able to help in real time.”

The change will affect Medicare claims for CGMs submitted on or after June 7, 2018, according to an update from contractor CGS. CMS said it would issue a revised policy article “in the near future.”

https://bit.ly/2MVDOUK

Could HPV Vaccine Treat Skin Cancer?

A novel treatment for squamous cell carcinoma (SCC) using HPV vaccine could some day prove useful in patients who are poor surgical candidates, have multiple lesions, or who defer surgery, researchers reported.

A single case report of an elderly woman with multiple, inoperable cutaneous basaloid SCC, showed that systemic and direct intratumoral injection of 9-valent HPV vaccine resulted in complete regression of all cutaneous malignant tumors, according to Anna J. Nichols, MD, PhD, of the University of Miami Miller School of Medicine in Miami, and colleagues.

All tumors resolved 11 months after the first injection of vaccine, they reported in JAMA Dermatology.

No systemic adverse effects were reported, they added, and at the patient’s last follow-up visit 24 months after the first intratumoral dose of the HPV vaccine, there was no clinical evidence of SCC recurrence.

“The marked regression of numerous SCCs after initiation of the intratumoral injections eliminated the need for additional treatment,” the authors wrote. “Tumors not directly injected with the vaccine also regressed, possibly by local dispersion of the vaccine or its effects on immune-mediated mechanisms. These findings suggest that the 9-valent HPV vaccine can provide a therapeutic option for inoperable cutaneous SCCs, in addition to its approved use to prevent anogenital HPV infection.”

The mechanisms for the vaccine’s therapeutic efficacy in cutaneous malignant tumors are not yet clear, they acknowledged. Similarly, it is not known whether systemic use of the vaccine played a therapeutic role.

“The potent therapeutic benefit may reflect a combination of immunologic, antiviral, and antitumor effects of 9-valent HPV vaccine,” they suggested.

Nichols’ group pointed out that in patients with SCC and basal cell carcinoma (BCC), surgery remains the standard of care. For patients who are poor surgical candidates, or who have multiple lesions, or who defer surgery, alternate treatment options are limited.

The investigators noted that the 9-valent HPV vaccine is currently used to treat including recalcitrant cutaneous warts and oral papillomas. In a previous study, they showed that vaccination against HPV in immunocompetent patients could prevent the development of SCC and BCC.

“This, combined with the fact that other types of vaccines delivered directly into tumors elicit immune responses capable of eradicating tumor cells, led to our using a combination of systemic and intratumoral HPV vaccine for this patient,” Nichols told MedPage Today.

Nichols confirmed that her group did not test for the presence of HPV DNA in the patient’s tumors. “There is evidence that HPV proteins may modify the cellular response to UV exposure, possibly augmenting UV-induced DNA damage,” she added.

Looking ahead, this therapeutic approach may have broader applications in the treatment of SCC skin cancer, Nichols said. “Our multidisciplinary team is preparing to expand on this report by conducting a small proof-of-concept clinical trial in the near future.”

Adam Friedman, MD, of George Washington School of Medicine and Health Sciences in Washington, called the case report “interesting,” but said he did not see this approach being widely adopted or undergoing clinical testing.

“My impression from this case is that the efficacy is a result of immunostimulation induced by the HPV vaccine, rather then a direct immune response to HPV,” Friedman, who was not involved in the case report, told MedPage Today.

The report also did not discuss cost, “as insurance will surely not cover this treatment,” noted Friedman, who is a fellow of the American Academy of Dermatology. It also didn’t discuss “the potential adverse effects associated with the immune activation,” he said.

“It is important to realize that HPV may be involved in some squamous cell carcinoma, but basal cell carcinoma is four to five times more common,” pointed out Whitney A. High, MD, of the University of Colorado School of Medicine in Boulder.

“In basal cell carcinoma, HPV seems to be much much less involved that it is in squamous cell carcinoma,” noted High, who was not involved with the case report.

High also said she found the case report interesting. “I am quite glad the authors shared the experience, for it may trigger additional critical work in the area, which might, potentially, lead to additional management strategies.”

However, she emphasized that “far more study would be necessary before we routinely relied upon this as a treatment regimen.”

In the case report, a female patient in her 90s was treated at a university-based outpatient dermatology clinic from March 17, 2016, through Feb. 27, 2017. She was then followed until May 21, 2018.

The patient was initially treated with two doses of intramuscular HPV vaccine given 6 weeks apart. Three weeks after the second intramuscular dose, three of the largest tumors were treated intratumorally with 9-valent HPV vaccine (0.5 mL) diluted with sterile saline (2.5 mL).

Over the next 8 months, three similar doses of the HPV vaccine were administered intratumorally, resulting in complete resolution of the tumors.

Although the patient received no further treatment, histopathologic analysis of a single, small, pink, scaly papule on her right leg, where the tumors had been, revealed mild cellular atypia of basal keratinocytes with hyperkeratosis.

Nichols disclosed no relevant relationships with industry. Some co-authors disclosed a patent pending for this application of HPV vaccine.

Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco

LAST UPDATED 07.06.2018

Primary Source

JAMA Dermatology

Source Reference: Nichols AJ, et al “Combined systemic and intratumoral administration of human papillomavirus vaccine to treat multiple cutaneous basaloid squamous cell carcinomas” JAMA Dermatol 2018; DOI: 10.1001/jamadermatol.2018.1748.

https://bit.ly/2J4T8w0

Biogen makes Feuerstein hesitate

On Friday’s PreMarket Prep trading show, STAT News senior writer Adam Feuerstein weighed in on the results from Biogen Inc BIIB 19.37% and Eisai’s Alzheimer’s therapy candidate BAN2401.

While BAN2401 failed to show a significant difference from a placebo in a 12-month Phase 2 study, the companies said an 18-month study yielded a significant effect in patients treated with the highest doses of the drug. This caused Biogen’s share price to rise nearly 20 percent.

Adam F’s Take

Feuerstein, a renowned biotech reporter, warned investors not to get overly excited. The details released concerning the study are surface-level; Feuerstein called the report “a sliver of positive news” that leaves “lots of unresolved questions.” Still, he welcomes any glint of hope in Alzheimer’s treatment, which he described as having a historical “100-percent failure rate.”

He said BAN2401 is like Biogen’s “back-up drug.” Another Alzheimer’s candidate from Biogen, aducanumab, is undergoing Phase 3 clinical trials.

Feuerstein said something like this Biogen news “could get people more interested” in larger-cap biotech stocks, but warned of cautiousness in general moving forward.

You can listen to Adam’s full interview on the Benzinga YouTube page by following this link. Adam’s appearance begins at the 9:05 mark.

Looking Ahead

While the July 5 report didn’t provide in-depth data, which Feuerstein noted wasn’t unusual, investors should be on the lookout for Alzheimer’s conferences in the coming months where Biogen will likely present a more complete trial report. The Alzheimer’s Association International Conference begins on July 22 and the American Neurological Association’s annual meeting begins Oct. 21.

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