Goodies Abound In 21st Century Cures Act

A sprawling health bill that passed the Senate Wednesday and is expected to become law before the end of the year is a grab bag for industries that spent plenty of money lobbying to make sure it happened that way.

Here are some of the winners and losers in the 21st Century Cures Act:

WINNERS

Pharmaceutical and Medical Device Companies. The bill will likely save drug and device companies billions of dollars bringing products to market by giving the Food and Drug Administration new authority and tools to demand fewer studies from those companies and speed up approvals.

The changes represent a massive lobbying effort by 58 pharmaceutical companies, 24 device companies and 26 “biotech products and research” companies, according to a Kaiser Health News analysis of lobbying data compiled by the Center for Responsive Politics. The groups reported more than $192 million in lobbying expenses on the Cures Act and other legislative priorities, the analysis shows.

Medical schools, hospitals and physicians. The bill provides $4.8 billion over 10 years in additional funding to National Institutes of Health, the federal government’s main biomedical research organization. (The funds are not guaranteed, however, and will be subject to annual appropriations.)

The money could help researchers at universities and medical centers get hundreds of millions more dollars in research grants, most of it toward research on cancer, neurobiology and genetic medicine.

The bill attracted lobbying activity from more than 60 schools, 36 hospitals and several dozen groups representing physician organizations. They reported spending more than $120 million in disclosures that included Cures Act lobbying.

Mental health and substance abuse advocates. The bill provides $1 billion in state grants over two years to address opioid abuse and addiction. While most of that money goes to treatment facilities, some will fund research.

The bill also boosts funding for mental health research and treatment, with hundreds of millions of dollars authorized for dozens of existing and new programs.

Mental health, psychology and psychiatry groups spent $1.8 million on lobbying disclosures that included the Cures bill as an issue.

Patient groups. Specialty disease and patient advocacy groups supported the legislation and lobbied vigorously. Many of these groups get a portion of their funding from drug and device companies. The bill includes more patient input in the drug development and approval process, and the bill is a boost to the clout of such groups.

More than two dozen patient groups lobbied the bill, and reported spending $6.4 million in disclosures that named the bill as one of their issues.

Health information technology and software companies. The bill pushes federal agencies and health providers nationwide to use electronic health records systems and to collect data to enhance research and treatment. Although it doesn’t specifically fund the effort, IT and data management companies could gain millions of dollars in new business.

More than a dozen computer, software and telecom companies reported Cures Act lobbying. The groups’ total lobbying spending was $35 million on Cures as well as other legislation.

LOSERS

Preventive medicine. The bill cuts $3.5 billion — about 30 percent — from the Prevention and Public Health Fund established under Obamacare to promote prevention of Alzheimer’s disease, hospital acquired infections, chronic illnesses and other ailments.

Consumer and patient safety groups. Groups like Public Citizen and the National Center for Health Research either fought the law outright or sought substantial changes. Although they won on some points, these groups still say Cures opens the door for unsafe drug and device approvals and doesn’t address rising drug costs.

Hair growth patients. The bill says federal Medicaid will no longer help pay for drugs that help patients restore hair. The National Alopecia Areata Foundation spent $40,000 on lobbying disclosures this cycle that included Cures.

The FDA. The bill gives the FDA an additional $500 million through 2026 and more hiring power, but critics say it isn’t enough to cover the additional workload under the bill. The agency also got something it opposed: renewal of a controversial voucher program that awards companies that approve drugs for rare pediatric diseases.

Kaiser Health News is an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente. http://www.kaiserhealthnews.com

Ascension Rebrands Michigan Facilities to Reflect Collaboration

As it works to integrate its national health system, Ascension facilities in Michigan and Wisconsin will be first to adopt the unified name of Ascension. The hospitals and other sites of care that are part of the current systems of Ascension Michigan – Borgess in the Kalamazoo region; Crittenton in suburban Detroit; Genesys serving the Flint/Grand Blanc area; St. John Providence in metro Detroit; St. Joseph in Tawas City; and St. Mary’s with services in Saginaw and Standish – will adopt the Ascension identity. Similarly, the hospitals and other care sites of the current systems of Ascension Wisconsin – Ministry Health Care, Columbia St. Mary’s and Wheaton Franciscan Healthcare, serving residents across the state – will now use the Ascension name.

The moves are intended to make it clearer and easier for patients to access care and to navigate their health through the Ascension system.

“We have an obligation to provide high-quality, affordable care, and quality outcomes, with an enhanced experience for our patients and our providers,” said Anthony R. Tersigni, EdD, President and Chief Executive Officer of Ascension. Adopting a unified Mission statement and creating a clear and consistent identity reflect our collaborative national system and move us in this direction.”

Collaboration among Ascension’s hospitals across the country has enabled them to participate in the Veterans Choice Program, more than 3,000 military veterans who were waiting for care through the U.S. Department of Veterans Affairs have been able to access Ascension hospitals, clinics and doctors across the country, according to Ascension.

“Having a unified identity that connects the care we provide in our communities will help patients and their caregivers coordinate and navigate their care, supporting our efforts to deliver high-quality, affordable care for everyone with special attention to those most in need,” said Nick Ragone, Chief Marketing and Communications Officer for Ascension.

By organizing the system’s areas of expertise within two divisions – Healthcare and Solutions – Ascension intends to enhance internal collaboration, better support its physicians and other caregivers, and provide affordable, high-quality care for its patients across much of the nation.

Ascension’s new Healthcare Division includes the organization’s hospitals and related sites of care, as well as community clinics, Ascension Senior Living, the home care and hospice partnership Ascension At Home, Ascension Clinical Holdings, and the nation’s second largest doctor-led physician practice, Ascension Medical Group.

Ascension’s newly organized Solutions Division brings together a number of existing subsidiary organizations that support the delivery of coordinated, high-quality healthcare services. These Ascension subsidiaries provide a variety of solutions including clinical care management, information services, contracting through Ascension’s provider-sponsored group purchasing and business transformation organization, biomedical engineering, venture capital investing, and an SEC-approved investment management company. A number of these solutions already offer services to other healthcare providers.

“For the past several years, Ascension has been on a journey to create what we call ‘One Ascension,” said Robert J. Henkel, Executive Vice President, Ascension, and President and Chief Executive Officer, Ascension Healthcare. “As we work together to sharpen our focus on clinical quality and safety, we also are expanding beyond traditional hospital-based approaches, collaborating with community partners to build clinically integrated systems of care to eliminate health disparities and improve the health of communities.”

Health Policy Reports Out Bill To License Advance Practice Nurses

The House Health Policy Committee Sept. 20 reported a bill to license and regulate nurses with a masters, post-masters or doctoral degree in a nursing specialty, called advance practice registered nurses (APRNs).

APRNs may be nurse-midwives, nurse practitioners or clinical nurse specialists. Currently, the Michigan Board of Nursing may grant specialty certification to a registered professional nurse who has training beyond the requirements of initial licensure.

The bill, HB 5400, would add a list of protected terms, restricted to be used only by individuals authorized to use them: “certified nurse midwife,” “CNM,” “advanced practice registered nurse,” “APRN,” “NP” “certified nurse practitioner,” “CNP,” “clinical nurse specialist,” “CNS,” “clinical nurse specialist-certified,” and “CNS-C.”

These nurses would have the ability to prescribe drugs and controlled substances, dispense complimentary starter doses of controlled substances and would allow APRNs to make house calls or go on rounds whose timing and frequency is unrestricted by a physician.

Bill sponsor Rep. Ken YONKER (R-Caledonia) has been working on this bill since his first term and this year worked with a variety of health care stakeholders to forge the draft reported last week. “It’s a very simple bill, but it’s been a very complex bill,” Yonker said.

The intent of the bill, Yonker said is to improve patient access to health care providers, in time when there is a shortage of providers in some parts of the state.

According to the House Fiscal Agency, the bill would create a new fee for APRNs ($75 for application processing and a $60 annual license fee) and increase licensing fees for all

Committee Reports Out Bill To License Advance Practice Nurses

Ascension Rebrands Michigan Facilities to Reflect Collaboration

Congressional Dems Drawing Battle Lines Over Flint Relief Funding

Legalized Pot Shops Bills Signed Into Law

U-M Health System, Meijer Pharmacies Partner On Hypertension Care

CMS Set To Reduce Flexibility On ICD-10 Oct. 1

Mental Health Group Awards WSU $3.2 Million For Research

Biotech Industry Could Be ‘The Next $1 Trillion Industry’

registered nurses. The application processing fee for prospective registered professional nurses, licensed practical nurses, and trained attendants would be increased from $24 to $75 and the annual license fee would be increased from $30 to $60.

Registered nurse and former 80th District candidate Abigail NOBEL opposed the bill on the basis that she believe it does nothing but doubles a tax while adding little value in the way of Department of Licensing and Regulatory Affairs (LARA) oversight.

“If anything, license fees should be reduced to encourage more nurses to practice in Michigan,” said Nobel in a press release. “Everyone’s budget is tight. Government agencies like LARA should be looking for ways to cut spending, as Michigan taxpayers have been forced to do.”

This story presented as part of a partnership between Healthcare Michigan and MIRS, a Lansing-based news and information service.

Congressional Dems Drawing Battle Lines Over Flint Relief Funding

A number of Congressional Democrats—including every Democrat in the Michigan Congressional Delegation—announced they’re going to battle after emergency funding for Flint was removed from a government-funding bill.

The issue is swiftly becoming the pivotal matter on which a government shutdown may rest. If the impasse lingers, it will likely invite more national scrutiny to Flint’s water crisis, and with that, further squabbling over the allocation of blame.

Minority leadership in the U.S. Senate coalesced to block a vote on the bill that would keep the government funded for the next 10 weeks, due to the exclusion of funding for Flint as it still grapples with the water crisis. Republicans have accused the Democrats of political motivations underscoring the action.

The provision looks to provide $220 million in aid to the city and is fully funded.

Despite broad bipartisan support in the Senate, it has been stonewalled in the House, where leadership asserts the funding would be better placed in the Water Resources Development Act (WRDA).

When U.S. Rep. Dan KILDEE (D-Flint) reportedly attempted to introduce the funding to that legislation as an amendment in committee, it was rejected when Republicans split over whether it had proper jurisdiction there.

Party leadership has since become the point people for the showdown, but all of Michigan’s Congressional Democrats had their moment in the spotlight earlier today when they spoke at a press conference on the issue, vowing to vote against the funding bill until a solution is found.

U.S. Sen. Debbie STABENOW (D-Lansing) said at the conference she had her hopes lifted by the Senate’s 95-3 approval of the original package, only to be dashed in the House when the Republican leadership refused to include the same funding.

It seems the prioritization of Louisiana disaster relief over aid to Flint has inspired particular rancor.

“Today we’re going to have a vote and we’re going to send it back to the drawing board to get this right. If, in fact, the people of Flint have to wait again, then the people of Louisiana can join them in that wait until the end of the year,” Stabenow said. “We don’t want that; we’re not suggesting that. We’re suggesting that now is the time to have a sense of urgency about a set of disasters that were not created by any of the people involved, and we can do something together in a bipartisan way to actually get help to those who need it.”

Senate Republicans argue the funding could find a home in WRDA, but as The Hill notes, waiting until a later iteration of the bill could prove problematic for Democrats who are looking to claim credit for taking substantive action on Flint’s troubles before November.

Legalized Pot Shops Bills Signed Into Law

For the first time since voters said “yes” to medical marijuana in 2008, the state will be legalized freestanding shops where the product can be sold, under legislation Gov. Rick SNYDER signed into law Sept. 21.

A five-tier regulatory structure will now co-exist with the current distribution model, in which a caregiver can grow plants for him or herself and five others.

The bills, HB 4209, HB 4210 and HB 4827, create a license structure for the growing, testing, processing and transporting of medical marijuana, as well as legalize medical marijuana in non-smokable forms.

Those with any of the five state licenses, however, will not be allowed to a license for any of the other four tiers. A grower can’t sell the marijuana to a customer, just as a transporter can’t test or process the product.

“This new law will help Michiganders of all ages and with varying medical conditions access safe products to relieve their suffering,” Snyder said in a statement. “We can finally implement a solid framework that gives patients a safe source from which to purchase and utilize medical marijuana.”

The bills, sponsored by Rep. Mike CALLTON (R-Nashville), Rep. Lisa LYONS (R-Alto) and Rep. Klint KESTO (R-Commerce Twp.), also allow “medibles,” oils, chocolates and other products that contain the active ingredients for marijuana for those who don’t want to or can’t smoke it.

The most common example of a beneficiary of this product is a child who suffers chronic epileptic seizures.

“We’ve spent over five long years advocating for safe access to all forms of medical cannabis and are overwhelmed with gratitude today,” said Robin Schneider, the legislative policy director and patient advocate for the National Patients Rights Association. “We’ve overcome so much adversity, found middle ground with law enforcement and finally settled on common sense reforms.”

Willie ROCHON, vice president and spokesperson for the Michigan Cannabis Development Association, called the bills’ signage a “watershed moment in the years-long endeavor to create a framework to license and regulate the medical marijuana industry in the state and expand access to non-smokable forms of medical marijuana for patients.”

This story presented as part of a partnership between Healthcare Michigan and MIRS, a Lansing-based news and information service.

U-M Health System, Meijer Pharmacies Partner On Hypertension Care

The University of Michigan Health System has established a new partnership with Meijer pharmacies to provide hypertension management services for adult patients.

U-M patients will be able to visit participating Meijer pharmacy locations to receive a blood pressure check and assessment. If the patient’s blood pressure is elevated, the clinically trained Meijer pharmacist will communicate directly with the patient’s U-M Health System provider. The patient will also receive appropriate follow-up and education about disease, clinical goals, medications and lifestyle.

In addition, documentation of the patient’s visit to their Meijer pharmacy will be recorded in their electronic medical record so the patient can easily discuss the reading and assessment with their U-M Health System provider at their next medical visit.

“This partnership is allowing us to provide our patients with clinical pharmacist services in the community,” says Hae Mi Choe, director and associate dean of pharmacy innovations and partnerships at U-M. “Our patients will have more access to an effective and safe hypertension treatment and monitoring program right in their neighborhood.”

The partnership is available at two participating Meijer locations in Ann Arbor: Meijer at 3825 Carpenter Road and Meijer at 3145 Ann Arbor-Saline Road.

Nearly 90 percent of Americans live within five miles of a pharmacy and a community pharmacist is one of the most accessible health care professionals in the U.S., according to the National Association of Chain Drug Stores.

“Improving blood pressure control is one of the U-M Health System’s goals,” Choe says. “We’re hoping this partnership will allow patients another convenient access point to high-quality care and improved management of their condition.”

Each participating Meijer location has purchased an automatic blood pressure monitor to provide more accurate readings to patients. The device takes six consecutive blood pressure readings and provides an average of the readings. The devices were purchased based on a recommendation from the U-M Health System Hypertension Quality Improvement Committee. U-M cardiology and chronic kidney disease clinics currently use these machines to ensure accurate blood pressure readings for patients.

U-M Health System patients with elevated blood pressure will be identified at clinic visits and given the option to visit the Meijer pharmacy for their follow-up care. There will also be outreach to patients with elevated blood pressure who live in close proximity to the participating Meijer locations inviting them to visit their local Meijer pharmacy, or return to their physician’s office, for their follow-up care.

“This affiliation presents us with a unique opportunity to collaborate with Meijer pharmacists and enhance our system of care for our patients to better meet their needs,” says David Spahlinger, M.D., executive vice dean for clinical affairs and president of U-M Health System.

The new services will be rolled out one clinic at a time throughout the Health System, beginning with clinics that see a large population of patients that reside close to the participating Meijer locations.

“We are excited to partner with the highly regarded University of Michigan Health System,” says Karen Mankowski, vice president of pharmacy operations at Meijer. “This partnership shows the importance of the collaboration between community pharmacists and health care providers. We look forward to offering our clinical services to the residents of Ann Arbor and the surrounding areas through this opportunity.”

CMS Set To Reduce Flexibility On ICD-10 Oct. 1

ICD-10, which contains more than 70,000 diagnostic codes, replaced the ICD-9 code set, which relied on just 11,000 codes.

The grace period had only applied to claims submitted to Medicare and Medicaid, and while many commercial insurers offered similar flexibility, the majority did not, according to a report in Healthcare IT News.
The lead-up to the ICD-10 had many healthcare providers worried that the exponential increase in diagnostic codes would lead to more errors in medical claims, and ultimately denials, due to the new specificity required. But the years of lead-up to the launch due to a handful Congressional delays gave healthcare providers more time to prepare. The years of training, and the extra time to staff-up coding departments paid off. Most studies show the rate of denials had gone practically unchanged since the roll-out.

Though the grace period will end on Oct. 1, CMS said providers will still be allowed to use unspecified codes when they are warranted.

“While you should report specific diagnosis codes when they are supported by the available medical record documentation and clinical knowledge of the patient’s health condition, in some instances signs/symptoms or unspecified codes are the best choice to accurately reflect the health care encounter. You should code each healthcare encounter to the level of certainty known for that encounter.”

Mental Health Group Awards WSU $3.2 Million For Research

Researchers in the Wayne State University School of Medicine’s Department of Psychiatry and Behavioral Neurosciences will use a new five-year, $3.2 million grant from the National Institute of Mental Health to explore the underlying mechanisms of impaired learning and memory in schizophrenia from the perspective of brain plasticity, function and network dynamics.

The NIMH defines schizophrenia as a chronic and disabling mental disorder that affects how a person thinks, feels and behaves, including loss of reality due to hallucinations, delusions, unusual or dysfunctional ways of thinking, and agitated body movements. People with the condition also have difficulty beginning or sustaining activities, focusing or paying attention, or remembering information immediately after learning it. About 1 percent of the United States population, or 2.2 million people, have schizophrenia, but the neurobiology of the illness remains poorly understood.

Principal Investigator and Associate Professor Jeffrey Stanley, PhD, and Co-Principal Investigator and Professor Vaibhav Diwadkar, PhD, lead the study “Advancing innovative brain imaging to detect altered glutamate modulation and network dynamics in schizophrenia,” which was funded on its first submission. The study is the first to combine functional MRI, or fMRI and complex analyses of brain imaging data with innovative measurement of the brain’s functional neurochemistry using functional magnetic resonance spectroscopy, or fMRS.

“While fMRI data are somewhat ‘distant’ from fundamental neurobiological processes because the signal relies on blood flow that is correlated with – but distinct from – neurophysiological and neuro-chemical events, in developing fMRS we are able to measure and quantify changes in hippocampal glutamate in the brain. We have an imaging technique that may provide more direct information about functional changes in the brain,” Dr. Stanley said.

Biotech Industry Could Be ‘The Next $1 Trillion Industry’

If technology and data was the last $1 trillion industry, data-driven advancement in biotechnology will be the next and West Michigan is positioned to take advantage, said former Hillary CLINTON innovation aide Alex ROSS.

Ross was a keynote speaker at the Grand Rapids Economic Club luncheon and drew on his experience as former senior innovation aide to Clinton while she was Secretary of State. Ross said the data collected mapping the human genome over the last 15 years will likely be used next to conduct “liquid biopsies”—an early cancer detection test–and pharmaceutical therapies tailored to a patient’s specific genetic needs.

“In five years, 95 percent of the hands in this room will go up,” Ross said about liquid biopsies. Right now the procedure is too cost-prohibitive, but that cost is likely to plummet Ross said. Today, the procedure costs $3,000, but 13 months ago it cost $14,000 Ross said.

The way the pharmaceuticals will also change. Ross said he believes that doctors will begin to “develop therapies and treatments not generically designed to treat an illness, but designed around an individuals genetics.”

Ross said the barriers to new bio-science therapies is “principally regulatory” as it takes “billions in FDA

[Food and Drug Administrations] drug trials” to get a new drug to market. Ross encouraged business leaders to begin developing a research agenda at the state and local level to signal to investors that Michigan is friendly territory.

Ross also said Michigan business leaders should be on the lookout for new opportunities in autonomous vehicle technology–dovetailing nicely with Michigan’s advanced manufacturing industry-and advancements in agriculture.

Aetna Pulls Back From Obamacare

The nation’s No. 3 insurer said this week it will reduce the number of states in which it sells policies on government exchanges from 15 to three or four.

Aetna, Inc, decided to pull out of the 11 states amid sizable losses on it’s individual policy business. The states remaining are Delaware, Iowa, Nebraska and Virginia.

“Following a thorough business review and in light of a second-quarter pretax loss of $200 million and total pretax losses of more than $430 million since January 2014 in our individual products, we have decided to reduce our individual public exchange presence in 2017, which will limit our financial exposure moving forward,”said Aetna Chairman and CEO Mark Bertolini Aug. 15. “More than 40 payers of various sizes have similarly chosen to stop selling plans in one or more rating areas in the individual public exchanges over the 2015 and 2016 plan years, collectively exiting hundreds of rating areas in more than 30 states. As a strong supporter of public exchanges as a means to meet the needs of the uninsured, we regret having to make this decision.”

Aetna’s action follows on the heels of similar moves by major insurers UnitedHealth Group and Humana, which have also cited financial losses on the government exchange business.

Aetna is attempting to buy Humana and is the target of a Justice Department anti-trust lawsuit, fueling speculation that Aetna’s move is also swipe at the federal government.

The risk adjustment mix, the number of healthy versus sick people who sign up for exchange plans is unbalanced, several insurers contend. Major insurers are unlikely to come back, unlness changes and more healthy people sign up and pay premiums to offset payouts for the sick, according to several analyses.

Aetna’s pullback also poses a unique problem for the Obama administration as Arizona will be left without an exchange plan option for its residents.

In addition to Arizona, Aetna is pulling out of Florida, Georgia, Illinois, Kentucky, Missouri, North Carolina, Ohio, Pennsylvania, South Carolina and Texas.