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HHS releases regulations to overhaul the Stark Law to entice value-based payment arrangements

The Trump administration has proposed new exemptions and safe harbors to the Stark Law and anti-kickback statute to spur more physicians and healthcare facilities into value-based care arrangements.

The reforms, a proposed rule from the Centers for Medicare & Medicaid Services and another proposal from Health and Human Services’ Office of Inspector General, aim to update the 1989 Stark Law that bans physicians from referring patients to facilities they have a financial stake in. The proposed regulations would create a permanent exception to the law to shield legitimate value-based deals from penalties.

“Unfortunately the looming threat of liability under the Stark Law has discouraged many providers from entering into value-based arrangements in the first place,” Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma said in a call with reporters Tuesday.

Verma said that currently, CMS does provide waivers for value-based care arrangements, but they are only for Medicare-based payment models such as accountable care organizations.

“The proposal would allow for these similar types of exceptions for these other models that are Medicare or in the private sector,” she said.

CMS’ proposed rule would require healthcare entities to provide a written document to the government that “spells out the arrangements between them and indicate what patient population they are going to target and what outcomes they are going to measure in terms of what value they are going to produce here,” said Deputy HHS Secretary Eric Hargan on a call with reporters.

Those outcomes will be monitored to ensure the value-based arrangement doesn’t violate the law.

Some examples of value-based care arrangements include if a hospital discharges a patient after a diabetes emergency and assigns a nurse educator and equipment to help the patient keep their diabetes under control.

“All of those things could be viewed as an inducement” under the current law, HHS Secretary Alex Azar said.

The proposed rule would also provide flexibility for sharing information. For example, if a cardiologist has data analytics they currently under Stark can’t give that information to the primary care practice for free, Verma said. The primary care doctor has to pay a price because it refers patients to the cardiologist.

“Our proposed rule would address that problem,” she said.

Another new proposed exception to Stark would protect the donation of cybersecurity software from a hospital to a doctor’s office.

“A hospital that wants to protect electronic health records and other data may be worried about providing cybersecurity software to physicians for free or reduced due to the Stark Law,” Verma said. “Our proposed rule would allow for such a common-sense arrangement while ensuring physicians won’t be obligated to make referrals.”

HHS expects to also propose clarifications to terms in the Stark Law to help hospitals with compliance, but HHS officials did not divulge what terms would be affected.

The agency is also soliciting comments on what role price transparency will play in the regulations. CMS wants to know if it should require cost-of-care information when a physician or hospital issues a referral, a fact sheet on the new regulations said.

The proposed rule would also provide additional guidance on how to determine if compensation from one physician to another runs afoul of Stark.

OIG’s proposed rule has changes to safe harbors to ensure that the new exceptions and changes to Stark also don’t violate the federal anti-kickback law.

Article: https://www.fiercehealthcare.com/payer/hhs-will-release-regulations-to-overhaul-stark-law-to-entice-value-based-payment-arrangements?elq_cid=2420582&x_id=

 

Pennsylvania Expands Home Visiting Support to First-Time Mothers and Children with Special Needs

Harrisburg, PA – The Wolf Administration announced today that, under the guidance of the Department of Human Services (DHS), it is expanding home visiting supports to first-time mothers and mothers of children with special needs covered by Medicaid. The expansion, made possible in collaboration with physical health Medicaid managed care organizations (MCOs), will guarantee at least two home visits to new parents and families with children with additional risk factors across Pennsylvania, expanding access to evidence-based models that promote and support healthy child and family development.

“There is no more important focus of my administration than giving all children and families a strong start,” Gov. Wolf said. “By expanding access to evidence-based home visiting programs, we will put more kids, parents and families on a path to a healthy, happy future.”

Since 2015, investments totaling nearly $16.5 million in state funds have helped increase the number of children and families who can receive home visiting supports in communities around Pennsylvania. Guaranteeing a minimum of two home visits to all first-time mothers and mothers of children with special needs through Medicaid continues this work.

“Being a parent can be a challenge for anyone,” said Secretary Miller. “Because children don’t come with an instruction manual home visiting programs create support systems for families to learn to better understand children’s needs, monitor milestones, and identify other opportunities for support that can continue to facilitate healthy long-term growth. A home visitor can be a major resource for parents to bond with their child(ren) and create bridges to success in early childhood and primary education.”

The home visiting expansion is effective January 1, 2020 through the MCOs’ 2020 agreement. Under the new agreements, MCOs will be required to establish an evidenced-based, standardized maternal, infant and early childhood home visitation program for all first-time parents and parents of infants with additional risk factors. All parents and children identified through this effort will receive at least two home visits at no cost, and depending on need, may be referred to other established home visiting programs to continue these services. DHS expects that these programs will be in place with eligible new parents receiving home visiting services  by July 1, 2020.

Evidence-based home visiting family support programs have a family-centered focus and strength-based approach that works with both the child and parent. A home visitor can help parents gain the skills and connect to resources necessary to improve their family’s health, safety, economic security, and success in early childhood education. Studies of various nurse-family partnership programs have shown positive impacts for the mother and baby during pregnancy and after birth, such as a decrease in domestic violence and smoking during pregnancy, a significant decrease in pre-term births, and a majority of babies being born at a healthy weight.

Home visiting can also improve parents’ child development knowledge and skills, help develop social support systems, and improve access to education, health, and community services. Examples of services include:

  • Regularly scheduled home visits with trained family development specialists;
  • Monthly parent meetings; and
  • Routine screenings to identify post-partum depression and detect potential problems with vision, hearing, growth, and learning age-based milestones.

Gov. Wolf is committed to helping the youngest Pennsylvanians. In September, his Ready to Start Task Force released its report, including two priorities tied directly to home visiting: to “increase availability of high-quality childcare and home-visiting service slots” and  to “promote education, engagement, and support of parents and families as children’s first teachers.”

“This significantly expanded access to home visiting truly helps to fulfill our mission for increasing the ways to help our youngest residents get a strong, focused beginning,” Gov. Wolf said.

Read the Ready to Start Task Force report here.

For more information on home visiting programs, visit dhs.pa.gov.

Health and Human Services Proposes Stark Law and Anti-Kickback Statute Reforms to Support Value-Based and Coordinated Care

Today, the Department of Health and Human Services (HHS) announced proposed changes to modernize and clarify the regulations that interpret the Physician Self-Referral Law (the “Stark Law”) and the Federal Anti-Kickback Statute.

The proposed rules provide greater certainty for healthcare providers participating in value-based arrangements and providing coordinated care for patients. The proposals would ease the compliance burden for healthcare providers across the industry, while maintaining strong safeguards to protect patients and programs from fraud and abuse.

The proposed rules are part of HHS’s Regulatory Sprint to Coordinated Care, which seeks to promote value-based care by examining federal regulations that impede efforts among providers to better coordinate care for patients.

“President Trump has promised American patients a healthcare system with affordable, personalized care, a system that puts you in control, provides peace of mind, and treats you like a human being, not a number. But too often, government regulations have stood in the way of delivering that kind of care,” said HHS Secretary Alex Azar. “Regulatory reform has been a key piece of President Trump’s agenda not just for faster innovation and economic growth, but also better, higher-value healthcare. Our proposed rules would be an unprecedented opportunity for providers to work together to deliver the kind of high-value, coordinated care that patients deserve.”

The Stark Law’s new value-based exceptions, under the proposed rule issued by the Centers for Medicare & Medicaid Services (CMS), acknowledge that incentives are different in a healthcare system that pays for value, rather than the volume, of services provided. They include proper safeguards that ensure the Stark Law will continue to provide meaningful protection against overutilization and other harms, while giving physicians and other healthcare providers added flexibility to improve the quality of care for their patients.

The proposed changes to the regulations related to the Federal Anti-Kickback Statute and the Civil Monetary Penalties Law issued by the Office of Inspector General (OIG) would, if finalized, address the longstanding concern these laws unnecessarily limit the ways in which healthcare providers can coordinate care for patients. The changes would offer flexibility for beneficial innovation and improved coordinated care through, for example, outcome-based payment arrangements that reward improvements in patient health. The changes would also make it easier for physicians and other healthcare providers to ensure they are complying with the law by offering specific safe harbors for these arrangements.

Read the HHS Press Release

Read OIG’s proposed rule
Read CMS’s proposed rule
More on the changes to the Stark Law
More on the changes to the Federal Anti-Kickback Statute

Centers for Disease Control and Prevention: Children at Risk During Flu Season

According to the CDC, children younger than 5 years of age –especially those younger than 2 years old– are at high risk of serious flu-related complications.  In his remarks launching the HHS Annual Flu Vaccination Campaign, HHS Secretary Azar said, “Illness occurs very quickly: 65 percent of reported flu deaths in children happen within seven days after symptom onset, 38 percent of deaths occur before being admitted to the hospital.” Adding “of those children 6 months and older who died from the flu between 2010 and 2016, only 22 percent were fully vaccinated against flu.”  Learn more on how to protect children during flu season here.

Health Resources and Services Administration Releases 2018 National Survey of Children’s Health Data Release

The Health Resources and Services Administration (HRSA) has released the 2017 National Survey of Children’s Health data from nearly 21,000 households across the U.S. This voluntary survey, funded and directed by HRSA’s Maternal and Child Health Bureau, provides annual national- and state-level estimates of key measures of child health and well-being. Anyone can access the data free of charge.

“The HRSA National Survey of Children’s Health is an innovative, unique tool providing information on the health status and health service needs of children throughout our nation,” said HRSA Administrator George Sigounas, MS, Ph.D. “These data empower people at the state and federal levels to develop policies and programs informed by recent, quality data.”

The 2016 and 2017 data can be combined to provide a nationally-representative sample of over 70,000 children. Key findings include:

  • In 2016-2017, 13.8 million children (or 18.8 percent of children) ages 0-17 years in the United States were reported to have a special health care need.
  • Among children ages 3-17 who were reported as needing mental health services in the past 12 months, 80 percent received these services in 2016-2017.
  • In 2016-2017, 76 percent of infants up to one year old were placed to sleep on their backs most of the time. The American Academy of Pediatrics recommends infants always be placed to sleep on their backs.

“The HRSA National Survey of Children’s Health gives the most current state-by-state snapshot of data on some of the most consequential health issues affecting children today,” said Laura Kavanagh, Acting Associate Administrator of HRSA’s Maternal and Child Health Bureau. “What we learn from the Survey enables HRSA and its partners to strengthen and support families.”

Since it began in 2003, the HRSA National Survey of Children’s Health has informed HRSA’s Maternal and Child Health Services Title V Block Grant national performance and outcome measures, as well as HHS’s Healthy People objectives. HRSA works with the U.S. Census Bureau to conduct the survey, oversee sampling, and produce a final data set for public use. For more information about the HRSA National Survey of Children’s Health, visit https://mchb.hrsa.gov/data/national-surveys.

Sam’s Club Piloting Health Care Packages in Pennsylvania

Pittsburgh’s NPR news station reports that starting in early October, Sam’s Club members in Pennsylvania as well as Michigan and North Carolina will be able to buy one of four bundles of healthcare services ranging in annual fees from $50 for individuals to $240 for a family of up to six members. Each bundle offers savings on dental services with a network of providers through the health insurer Humana as well as unlimited telehealth for $1 per visit through a Seattle-based company called 98point6.The bundles also offer discounted vision exams and optical products, and free prescriptions on certain generic medications. The number of free generics range from 5 to 20 of the most popular medications, depending on what the member chooses. Customers will be introduced to a new form of care from 98point6 where patients can be diagnosed and treated without talking to or seeing the doctor. Patients who click on the 98point6 app first tell their symptoms to a chatbot or automated assistant that uses artificial intelligence. The information then get passed along to a doctor for diagnosis and treatment. Video and phone conversations will also be available when needed.  Read more.

October is Health Literacy Month

The Pennsylvania Insurance Department partnered with the Pennsylvania Association of Community Health Centers and other organizations to produce a total of 10 health insurance literacy videos that help consumers understand why and when to buy insurance, as well as how to select a plan and read an explanation of benefits (EOB).  See  below for links to the resources that are available.

Pennsylvania Governor’s Administration Distributes Nearly 7,000 Free Naloxone Kits

Pennsylvania Governor Wolf’s administration announced it handed out 6,774 kits of free naloxone as part of September opioid overdose prevention events. The kits were made available at 95 locations across the state. Secretary of Health Dr. Rachel Levine said more than 4,400 people died from a drug overdose in Pennsylvania in 2018. Issued by Levine in 2018 and most recently updated in July, a standing order prescription is available to any Pennsylvanian to get naloxone at a pharmacy for anyone who may need it. According to the PA Department of Health, more than 25,000 people have been revived with naloxone by police officers and EMS providers in the commonwealth since Nov. 2014. The FY 2019-20 state budget included a $1.5 million increase in funding for first responders, who have access to free naloxone and are permitted to administer it as part of their treatment of someone who has overdosed.

Opportunity Zones in Appalachia

Qualified Opportunity Zones are economically-distressed communities where new investments, under certain conditions, may be eligible for preferential tax treatment. This can help bring new investments into previously under-capitalized areas. Localities qualify as Opportunity Zones if they have been nominated for that designation by the state, and that nomination has been certified by the Secretary of the U.S. Treasury via his delegation of authority to the Internal Revenue Service. As Appalachia is home to 737 Opportunity Zones, or 8.5 percent of the country’s total, ARC is actively working with communities to leverage Opportunity Zone designations, and ARC’s Federal Co-Chair serves on President Trump’s White House Opportunity and Revitalization Council to better coordinate Federal resources to these areas.

Two of Appalachia’s designated Opportunity Zones are along the Oostanaula River in Rome, Georgia. In these neighborhoods, the City of Rome is performing needed water infrastructure upgrades using ARC support.  This will help the Rome Downtown Development Authority, the Rome-Floyd Chamber of Commerce, and surrounding property and business owners make the area shovel-ready for major development, attract capital, and create jobs.

In Kentucky, there are Opportunity Zones tracts in every one of the state’s 54 Appalachian counties. The Kentucky Cabinet for Economic Development (KCED) has stood up kyoz.org,  a dedicated dashboard for potential Opportunity Zone investors. With ARC assistance, KCED will expand this resource to engage marketing, site and project development, project financing, and other professionals to work closely with local leaders to identify and cultivate additional Opportunity Zone investment prospects to help communities better leverage Opportunity Zone investment incentives.