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Activists Urge St. Joseph-Providence Combo Scrutiny

Some advocacy groups are urging regulators not to waive a merger review of Irvine-based St. Joseph Health and Renton, Wash.-based Providence Health and Services’ proposed mega-affiliation.

St. Joseph Health and Providence are working on creating Providence St. Joseph Health, a new parent organization based in Renton with a system office in Irvine. Both have emphasized that there’s no transfer of assets.

St. Joseph Health operates 16 hospitals as part of a $5.2 billion nonprofit healthcare organization serving communities in California, Texas and New Mexico. The system includes St. Joseph Hospital-Orange, St. Jude Medical Center in Fullerton, and Mission Hospital, which has facilities in Mission Viejo and Laguna Beach.

This month, 13 organizations wrote to the office of Ellen Rosenblum, Oregon’s attorney general, to ask her to turn down a request for a waiver from the standard process for reviewing transactions such as St. Joseph and Providence.

Eight of the almost 50 hospitals involved in the combination are in Oregon and owned by Providence.

“Even absent the transfer of assets, significant changes in healthcare delivery are likely to occur,” the groups’ letter said. “… It behooves the Attorney General to undertake the full review process to ensure that this transaction preserves existing healthcare services and benefits the public interest.”

The groups later said in the letter that a public hearing should be conducted and not waived.

Their concern centers on what is known as the Ethical and Religious Directives, a set of rules that Catholic hospital operators such as St. Joseph Health and Providence abide by. Such directives forbid reproductive health services and also restrict end-of-life care options.

Requesting a waiver is not uncommon, “particularly where there will be no changes in the medical services that the Oregon hospitals provide,” according to Providence spokeswoman Colleen Wadden.

She also noted that there would be no material changes to governing documents, no asset transfers or changes to rights and privileges of medical service providers.

“To require the time and expense of a full review would not be a good use of charitable or government resources,” Wadden said, adding that Providence is “confident” that Rosenblum’s office will grant the waiver based on recent precedent.

California Attorney General Kamala Harris’ office has already rejected a similar waiver request, according to the advocacy groups.

St. Joseph and Providence have said they hope to complete the review and approval process this year. The systems first confirmed negotiations toward an affiliation last July.

Edwards Gets FDA OK

Irvine-based Edwards Lifesciences Corp. received Food and Drug Administration approval this month for an expanded indication study for its Edwards Sapien 3 replacement heart valve.

It plans to enroll in the study elderly patients with severe, symptomatic aortic stenosis who’ve been determined by a heart team to be at low risk of dying if they were to undergo open-heart surgery to replace their valves.

Sapien 3 was approved last year for treating high-risk patients with severe symptomatic aortic stenosis, which is a narrowing of the body’s main artery.

The device maker said in a news release that the patients must be at least 65, exhibit symptoms of severe aortic stenosis, and have a surgical risk score of less than 4% as determined by a risk calculator established by the Society of Thoracic Surgeons.

It plans to enroll about 1,300 patients at up to 50 sites beginning in the second quarter. The company added that the trial will include a 400-patient “sub-study” that will use advanced medical imaging to evaluate leaflet motion in tissue heart valves.

The new Sapien 3 trial, if successful, “will allow heart teams to choose a treatment approach that is best suited to every patient’s individual need,” said Larry Wood, Edwards’ corporate vice president, transcatheter heart valves.

Alignment Contracts

Orange-based Alignment Healthcare LLC said it’s working with Tampa, Fla.-based HCA West Florida, which provides services to Medicare beneficiaries in Manatee, Pinellas and Sarasota counties.

Alignment works with hospitals, health plans and primary care doctors’ groups to streamline medical care for chronically ill seniors who receive Medicare.

The companies said Medicare patients in the three counties would have access to Alignment’s services at seven HCA West Florida hospitals in the area.

Alignment is also opening six care centers in Florida intended to provide what it calls “concierge-level care” to beneficiaries. Its care centers offer personalized, comprehensive disease management programs for patients with diabetes, chronic obstructive pulmonary disease and congestive heart failure. The centers also offer wound care, preoperative and post-hospitalization care.

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