Cardinal releases research exploring issues impacting today’s oncology practices
According to new research from Cardinal Health Specialty Solutions, oncologists are growing more confident in their ability to meet the requirements of the Medicare Access & CHIP Reauthorization Act (MACRA). The findings were released in the fourth edition of Oncology Insights, a research-based report series summarizing the views of more than 160 US oncologists about the key trends in today’s oncology practices. The report compares current views about MACRA to responses collected in early 2017, shortly after MACRA went into effect. The number of participating oncologists who said they have some level of confidence in their practices’ ability to meet MACRA requirements while achieving financial success increased from 53% to 77%. Compared to 2017, more oncologists report having the resources and staff needed to manage MACRA (24% compared to 10%). However, nearly one in four participating physicians (24%) still do not have a strategy in place.
FDA to overhaul 510(k) medical-device approvals
The FDA announced it plans to overhaul the 510(k) clearance process for medical devices. The FDA wants to nudge companies to base new products on devices that are no older than 10 years old. The agency is considering publicizing devices and manufacturers whose products are based on even older technology, according to CNBC. Congress established the 510(k) pathway in 1976 to allow manufacturers to pursue an expedited approval process if they could prove new products were substantially equivalent to those that were grandfathered in at the time. That means some new products entering the market are comparing themselves to technology that’s decades old. The FDA wants to retire those predicates (older base products), which sometimes aren’t even on the market anymore, and make it easier for companies to establish new ones. Last year, the FDA cleared 3,173 devices through the 510(k) system, or 82% of the total devices cleared or approved. Nearly 20% of products cleared through the 510(k) pathway are based on a predicate device that’s more than 10 years old. The FDA plans to finalize its guidance on establishing an alternative accelerated pathway early next year.
Hill-Rom announces new executive appointments
Hill-Rom Holdings Inc (Chicago, IL) announced several senior leadership appointments, effective December 3, 2018. Barbara W. Bodem was named SVP and CFO of Hill-Rom. Bodem joins Hill-Rom from Mallinckrodt, where she was SVP, Finance. She succeeds Steven J. Strobel, who will retire as CFO. Andreas G. Frank, currently SVP, Corporate Development and Strategy, and chief transformation officer, was appointed SVP and president of the company’s Front Line Care business, which includes Welch Allyn, Vision Care, and Respiratory Care. Frank replaces Alton Shader. Mary Kay Ladone, currently VP, Investor Relations, was appointed SVP, Corporate Development, Strategy, and Investor Relations. In this role, Ladone will be responsible for mergers and acquisitions, business development and strategy in addition to her role leading the company’s Investor Relations function.
Partners HealthCare mandates flu shots for all employees
Partners HealthCare (Boston, MA) is requiring all 74,000 employees to receive flu shots for the first time, according to The Boston Globe. Under the mandatory flu shot policy, employees who don’t get vaccinated or provide a valid reason for skipping the flu shot could lose their jobs. The policy applies to all hospital-based workers, as well as thousands of employees who work at Partners’ corporate office in Somerville, Massachusetts. The policy took effect this fall. So far, 99 percent of employees have received a flu shot or an exemption for religious or medical reasons. Partners modeled the systemwide policy on a mandatory vaccination policy Brigham and Women’s (Boston, MA) implemented in 2017. The Massachusetts Nurses Association sued the hospital in an attempt to block the policy but was unsuccessful.
USDA to invest $501M in rural healthcare
The U.S. Department of Agriculture is putting $501 million into 60 rural healthcare projects nationwide via the USDA’s Community Facilities direct loan program. With the projects, the agency aims to expand access to healthcare for approximately 2 million people in 34 states.
PTS Diagnostics announces new wellness brand
PTS Diagnostics (Indianapolis, IN) announced the upcoming global launch of PreVantage, an all-encompassing family of solutions and partnerships aimed at addressing the growing demand for the achievement of positive population health outcomes. The configurable solutions of the PreVantage brand are offered under singular umbrella brand and can be customized based upon unique customer needs, the company said. PreVantage is being unveiled in the US and select countries in early 2019. According to the company, the brand “will continue to grow nationally as healthcare shifts from a fee-for-service model to merit-based incentivization. The brand will also mature globally as PTS Diagnostics assists with meeting unique healthcare needs abroad.”
HHS to launch new mandatory bundled payment models
HHS Secretary Alex Azar said the agency will roll out mandatory bundled payment demonstrations. The announcement is a reversal of a decision by HHS in 2017 where it canceled and scaled back major mandatory bundled payment models under the leadership of then-Secretary Tom Price, MD. In a speech at the Patient-Centered Primary Care Collaborative Conference on November 8, Azar discussed some of the current voluntary models, including BPCI Advanced (Bundled Payments for Care Improvement Advanced). However, he said mandatory models are coming.
HHS to implement 340B drug pricing rule in January
HHS on January 1, 2019 will implement the long-delayed final rule for enforcing 340B drug ceiling price transparency. The rule directs pharmaceutical manufacturers participating in the 340B drug pricing program to disclose the maximum per unit ceiling price that can be charged to 340B hospitals. Enforcement will be maintained through a closed website available to 340B participating hospitals and providers. Federal regulators will post drug pricing information on the site. The rule includes monetary penalties for drug companies that overcharge.
Cigna, Express Scripts delay merger deadline to mid-2019
Cigna and Express Scripts do not expect their deal to close by a December 8 deadline and have extended the deadline six months. The merger’s review process is being held up in three states: California, New York, and New Jersey. The companies’ new merger-termination date is June 8, 2019. Despite the deadline extension, Cigna and Express Scripts do expect their $67 billion deal to close in 2018, according to an SEC filing.
MedTech/MedCare appointee announcements
- Scottie Adams – ASC Specialist in Georgia. Adams graduated from Georgia Gwinnett College with a Bachelor’s in Business Administration and a concentration in Management Information Systems. His market focus will be on all ASC products.
- Jordan Brown – Acute Care in the Pacific Northwest. Jordan Brown is MTMC’s new Northwest acute care territory sales manager. Brown comes with 10 years of LTC Pharmacy experience and 15 years of sales experience.
- Penny Dermody – Acute Care in New England. Dermody brings 16 years of medical sales and distribution experience in Massachusetts and Rhode Island. She has sold in alternate care and acute care markets.
- Donna Lynch, Strategic Account Director, will be retiring at the end of 2018. After a long career in healthcare sales, 13 of which were partnered with MTMC, Lynch has decided to retire in her new location, Tucson, Arizona.
- Kayla Witsoe, ambulatory care rep in Northern California, will be joining the Strategic Account Team. Kayla Witsoe started in the medical industry eight years ago as a sales representative for MTMC in the Northern California territory.