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FDA chief leads redefinition of digital-health-product regulation


— Graphic by Paul Sonnier

The Food and Drug Administration is redefining how it regulates digital health products.

The agency’s new commissioner, Scott Gottlieb, M.D., says its new Digital Health Innovation Plan will “include a novel, post-market approach” to digital devices and that the FDA will present new guidance for digital health product design to provide more clarity for manufacturers.

Dr. Gottlieb asserts that that program will help eliminate regulatory ambiguity while promoting innovation and free  regulators to focus  on more pressing  healthcare matters.

Digital health industry leaders were happy about Dr. Gottlieb’s remarks.

“All in all, I feel like I’ve died and gone to heaven,” Bradley Merrill Thompson, a medical-device lawyer with Epstein Becker Green and the Clinical Decision Support Coalition’s general counsel, told FierceHealthcare.

Health IT Now Executive Director Joel White said he is “deeply encouraged” by the  Dr. Gottlieb’s approach, adding that regulations need to keep pace the “rapid development cycles of health IT.”

“This is all about a modern FDA that better serves the needs of patients,” he said.

Dr. Gottlieb likes a “third party certification program” in which lower-risk devices could be marketed without FDA approval, while  approval of higher- risk devices could be streamlined and speeded based on a company’s history.

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Panel: Expand preventive services with no cost-sharing for women


For Kaiser Health News

The list of preventive services that women can receive without paying anything out of pocket under the health law could grow if proposed recommendations by a group of mostly medical providers are adopted by federal officials later this year.

The draft recommendations, which are open for public comment until Sept. 30, update the eight recommended preventive services for women. That list was developed by the Institute of Medicine — now called the National Academies of Sciences, Engineering, and Medicine — to build on existing recommendations and fill in gaps that weren’t addressed in the health law. Under the IOM list, which took effect in 2012, most health plans are required to cover well-woman visits, screening and/or counseling for sexually transmitted infections, domestic violence and gestational diabetes as well as breastfeeding support and supplies.IOK

In addition, most health plans must cover, without cost-sharing, all methods of contraception that have been approved by the Food and Drug Administration. That controversial requirement led to numerous lawsuits by religious institutions and employers that object to providing such coverage, including several cases that reached the Supreme Court.

When it developed the initial list, the IOM advised that the guidelines be reviewed and updated at least every five years in order to stay current with scientific evidence. This year, the review panel also weighed in on breast cancer screening, coverage of follow-up testing or procedures as part of the preventive services and male methods of birth control.

The proposed new recommendation would allow women at average risk for breast cancer to begin screening as early as age 40 and receive a mammogram every one or two years. That is a more liberal standard than the guidelines that insurers rely on for free screening from the U.S. Preventive Services Task Force, which recommends women generally be screened every other year starting at age 50.

“We have really confused the heck out of women,” said Dr. Hal Lawrence, executive vice president and chief executive officer of the American Congress of Obstetricians and Gynecologists. “Do I start at age 40, do I start at 50, do I do it every year or do I do it every other year? We wanted to get some uniformity.”

ACOG was awarded a 5-year grant to manage the review process, working in conjunction with a steering committee of nearly two dozen provider groups from different women’s health disciplines.

In addition to the breast cancer screening itself, the ACOG working group proposes that if imaging tests, biopsies or other interventions are required to evaluate the mammogram findings that those be considered an integral part of the screening, which would mean they would be provided without charge to women.

Such follow-up care emerged as a theme from the panel: If additional testing or procedures are necessary following a preventive service, it should be covered as part of the service. The recommendations also clarify that some of the preventive services may require more than one visit and provide other specifics on coverage requirements.

“It’s critically important for plans and people to recognize that the well-woman visit [required under the current guidelines] could happen in multiple places and require multiple visits,” said Mara Gandal-Powers, senior counsel at the National Women’s Law Center, which participated in the ACOG working group. “If you’re a woman who needs a Pap test and a colonoscopy, you’re probably not getting them from the same providers and you’re hopefully not getting them at the same time.”

The recommendations’ specificity is important: The original IOM guidelines left implementation details vague, leading to scuffles between patient advocates and insurers over precisely what was covered, and that ambiguity required ongoing guidance from the federal government. For example, if a plan covers oral contraceptives without cost sharing, could it charge for other hormonal methods such as the contraceptive patch? Answer: No.

“It’s helpful to get the real-world piece,” said Dania Palanker, assistant research professor at Georgetown University’s Center on Health Insurance Reforms. “For insurers, what do we mean when we say you have to cover a service?”

A spokesperson for America’s Health Insurance Plans said that the trade group will likely submit comments on the proposed recommendations and declined to comment before then.

The working group recommended expanding the scope of what’s covered without cost sharing in some important ways. The contraceptive coverage requirement, for example, would cover over-the-counter methods of birth control without a prescription and allow women to receive a full-year supply of contraceptives all at once, which has been shown to improve adherence.

The ACOG group also proposes covering contraception methods used by men, including condoms and vasectomy.

“The best contraceptive method for a woman at a particular time may be her partner,” said Adam Sonfield, a senior policy manager at the Guttmacher Institute, a reproductive health research and policy organization.

The working group will submit its final recommendations to the Health Resources and Services Administration, part of the Department of Health and Human Services, by Dec. 1, and HRSA will make the final decision on adoption of the recommendations. If adopted before the end of the year, they would go into effect for most plans at the beginning of 2018.


6 ‘solutions’ to U.S. healthcare problems


Private-sector healthcare leaders have identified six “common-sense solutions” to improve the U.S. healthcare system  that  they say would get support from both major political parties even in an election year. They are, as summarized by FierceHealthcare:

  • “Set a ‘firm date’ — Dec. 31, 2018 — to achieve health-information interoperability everywhere in the U.S., with the private sector leading the way to help healthcare organizations share data.”
  • “Implement reforms to improve the Food and Drug Administration, including easing administrative burdens imposed on the agency and taking steps to more quickly deliver innovative treatments and technologies to patients.”
  • “Implement ‘best practices’for Medicare, insurers and healthcare providers to improve all aspects of care for chronically ill patients. Specifically, the report outlines a set of comprehensive care planning principles using diabetes patients as an example.”
  • “Reform outdated physician self-referral and anti-kickback statutes, and expand Medicare payment waiver policies in order to encourage care coordination while preventing fraud and abuse.”
  • “Standardize … privacy laws on the state and federal levels, and improve access to patient data for research. For example, the report notes that “one particularly burdensome barrier to nationwide health information exchange is the many diverse state laws across the country regulating health information alongside HIPAA.”
  • “Improve the Centers for Medicare & Medicaid Services’ Enhanced Medication Therapy Management (MTM) Model, including allowing participating plans to help develop the quality indicators that comprise the uniform set of MTM data elements, and employing a public comment process that allows a full range of stakeholders to provide input into the final measure set.”


‘Cures Act’ more life-saving than dangerous?


“The 21st Century Cures Act” is in  Congress. Scores of patient groups, professional organizations and healthcare industry officials like it.

The bill’s congressional backers say that the legislation, HR 6, would “accelerate the discovery, development and delivery of life-saving and life-improving therapies.” Proponents argue that the bill ought to become law because major advances in genetics now get to patients too slowly.

But foes say  the bill would loosen Food and Drug Administration rules at the expense of patient safety.

Some hospital officials says the measure would eliminate  regulatory bottlenecks delaying access to better drugs — good news for institutions struggling to improve patient outcomes and prevent readmissions.  But others say that the legislation  would pour unsafe drugs, including new antibiotics, onto the market and cause many serious health effects — bad news for hospitals.


Phil Galewitz: New hope for heart patients, and hospital revenues


By PHIL GALEWITZ, for Kaiser Health News


CLEARWATER, Fla. – Inch by inch, two doctors working side by side in an operating room guide a long narrow tube through a patient’s femoral artery, from his groin into his beating heart. They often look intently, not down at the 81-year-old patient, but up at a 60-inch monitor above him that’s streaming pictures of his heart made from X-rays and sound waves.

The big moment comes 40 minutes into the procedure at Morton Plant Hospital here. Joshua Rovin, M.D.,  unfurls from the catheter a metal stent containing a new aortic valve that is made partly out of a pig’s heart and expands to the width of a quarter outside the catheter. The monitor shows it fits well over the old one. Blood flow is normal again.  “This is pretty glorious,” Rovin said.

The surgeon has performed one of the fastest-growing procedures in U.S. heart care known as a transcatheter aortic valve replacement, or TAVR. The operation was approved in the U.S. in late 2011 to help patients too ill or frail for traditional “open-heart” valve surgery. The procedure has rapidly gained doctors’ acceptance, particularly for patients in their 80s and 90s.

For hospitals like Morton Plant, the new valve technology comes at a fortuitous time – just as they confront rapidly falling demand for one of their most lucrative heart procedures, coronary artery bypass surgery. That has been used for more than 40 years to restore blood flow around blocked arteries, but less invasive treatments such as angioplasty have gained favor.

The opposing trends – fewer bypasses, more valve surgeries – demonstrate the hospital industry’s record of finding new ways to fill beds and increase revenue even as advances in health and technology shrink demand for inpatient care.  “Hospitals are like investment bankers, they are always looking for the next big deal and in this regard the next big deal is valve surgery,” said Gerard Anderson, director of the Johns Hopkins University Center for Hospital Finance and Management.

Valve surgery has risen more than 50% since 2012; the annual totals bolstered partly by more TAVR procedures, according to estimates from Frost & Sullivan, a consulting firm. About 16,000 TAVRs were done last year and hospitals are on pace to perform at least 20,000 in 2015, according to a national TAVR registry kept by two major medical groups.

But as with other new medical technology, TAVR draws concerns about possible overuse or adoption by hospitals lacking proficiency, which could harm patients and increase health care costs.

Verdi DiSesa, M.D., chief operating officer at Temple University Health System, said he worries too many hospitals are racing to perform TAVR before science has determined its best use.

TAVR should be limited to “regional centers of excellence” to ensure quality, DiSesa said. But in thePhiladelphia area alone, 10 hospitals, including Temple, offer TAVR in the Philadelphia area alone. Nearly 400 hospitals offer TAVR nationwide.

Hospital officials and device makers see a huge potential market.

About 1.5 million people in the U.S. have aortic stenosis, the narrowing of the aortic heart valve, which obstructs blood flow from the heart to the rest of the body. About 500,000 have severe aortic stenosis, which restricts daily activities such as walking and climbing stairs. Without a new valve, half of those die within two years,according to the Food and Drug Administration.

Yet, a third of patients with severe stenosis are too sick or frail for traditional valve surgery, which involves opening the chest and stopping the heart temporarily, a weeklong hospital stay and months of recovery. In contrast, TAVR requires only tiny incisions, patients can be discharged in two days and recovery usually takes two weeks. Early studies show TAVR’s two-year mortality rate is 32 percent compared to 50 percent for standard treatment combining drugs with a procedure using a balloon-tipped catheter to open the diseased valve.

Bob Howard, a retired intelligence officer at the Defense Department, is enthusiastic about his TAVR. He was the patient on the table the day Kaiser Health News observed his surgery at Morton Plant in August. Two days later, he returned to his Palm Harbor home north of Clearwater.

TAVR has brought new patients to hospitals like Morton Plant that are performing far fewer bypass surgeries than a decade ago.  Cardiac bypass began in the 1960s and ranked among the most expensive high-volume procedures at major medical centers for decades. But after peaking around 2000, demand fell as studies showed many patients fared better with less-invasive angioplasty and stents that prop open narrowing arteries. Increased use of cholesterol-lowering medications also reduced demand.

Nationally, cardiac bypass operations declined more than a third from about 350,000 cases in 2003 to 219,000 in 2010, according to the latest available data from theAmerican Heart Association. The slide has continued, shows data from the Society of Thoracic Surgeons.

From 2010 through 2014, Morton Plant’s coronary bypass cases fell 41 percent to 221. But its valve procedures rose 50 percent to 307. About 40 percent of those were TAVR.

On average, Medicare’s reimbursement rate for TAVR and a coronary bypass are in the same range. Morton Plant’s average reimbursement for TAVR is $38,000, the hospital said. Medicare pays Morton Plant about $30,000 for a coronary bypass. The doctors’ fees are billed separately.

“Our focus is on what does the community need … and how do we position ourselves to offer the leading edge treatments,” said Hoce.

The TAVR program has helped Morton Plant maintain a double-digit operating profit margin the past three years. Morton Plant made an $83 million operating profit last year on $489 million in revenue, a 17 percent margin, according to its latest audited financial statement. That was nearly triple the industry average.

Rovin said the keys to TAVR success are choosing the right patients and intense teamwork among doctors, nurses and technicians in the operating room.

Afterward, Rovin said, patients can often return to playing golf or tennis.

“When patients come back, they and their families are over the moon … This is a patient population that was underserved and I can’t tell you the amount of hugs, kisses and tears and outright joy from patients that feel they get their life back,” he said.

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