Archive for '2018'

    NIH halts $100 million moderate drinking study

    May 24, 2018 11:34 AM by billupsj

    The NIH halted a $100 million, 10-year study of moderate drinking largely funded in large part by the alcoholic-beverage industry. The decision to halt the study was made after news reports about the National Institute on Alcohol Abuse and Alcoholism’s involvement in soliciting the industry funding.  NIH Director Francis Collins has reportedly ordered two reviews of the study. The first will ‘determine if any process or conduct irregularities occurred with grants associated with the Moderate Alcohol and Cardiovascular Health (MACH) Trial,’ and the second will examine the scientific merit of the study.

    House To Consider 57 Opioid and Addiction Bills in June

    May 24, 2018 11:32 AM by billupsj

    The House Energy and Commerce committee is expected to bring 57 bills related to opioids and addiction to the House in June, where one week has been dedicated to deliberations on the proposals from the committee.  Among the bills is H.R. 5795, the Overdose Prevention and Patient Safety Act, that would change existing law to permit substance use disorder treatment records, currently governed under 42 CFR Part 2, to be shared in accordance with HIPAA for the specific purposes of treatment, payment and healthcare operations.

    Fentanyl and the Illegal Drug Market

    May 24, 2018 11:31 AM by billupsj

    Because fentanyl is an opioid analogue that can be created in a laboratory, unlike other illegal drugs that are plant-based, it has the potential to dramatically alter global drug policy.  While the impact of synthetic opioids has yet to be fully understood, it affects the basic nature of drug trafficking because it doesn’t require land to produce, agricultural workers to plant and harvest, or processing and transportation systems. “Producers can set up small labs within consuming countries and thus avoid the smuggling altogether,” along with advantages based on fentanyl’s potency.


    CMS Clarifies that "Gag Clauses" are Improper to Medicare Part D Plans

    May 24, 2018 11:26 AM by billupsj

    On May 17, 2018, CMS issued a memo to Medicare Part D sponsors indicating that “gag clauses” applicable to pharmacies are unacceptable. Some health plans and pharmacy benefit managers impose “gag clauses” on pharmacies, which prevent pharmacies from communicating to patients that prescription drugs may be less expensive if the patient pays for the drug out of pocket, rather than using insurance.  In these situations, the patient’s co-pay exceeds the amount the patient would pay if the patient paid cash for the drug. CMS’ memo stated that such “gag clauses” are unacceptable and contrary to CMS’ efforts to promote drug price transparency and lower drug prices.

    Link Found Between Military Trauma and Fibromyalgia

    May 24, 2018 11:24 AM by billupsj

    At the Annual Meeting of the American Psychiatric Association, a study was reported that suggests a link between military trauma and the risk of developing chronic pain. The American Psychiatric Association stated that service members who experience trauma, including sexual trauma, are at an increased risk of developing chronic medical conditions, including posttraumatic stress disorder (PTSD). 

    Five Clinical Lab Salesmen Sentenced For Bribing Physicians In $100 Million Scheme

    May 24, 2018 11:22 AM by billupsj

    Five former salepersons were sentenced for bribes paid to physicians for referrals to Biodiagnostic Laboratory Services LLC (BLS), of Parsippany, New Jersey.  The long running and elaborate scheme involved the salespersons, the BLS president and part owner, David Nicoll and his brother, Scott Nicoll, and physicians.  53 convictions, 38 against doctors, have resulted from the investigation in which doctors were bribed with cash to induce their referrals of blood specimens to BLS. The five salespersons admitted that sham consulting companies created and controlled by the salespersons were used to cover the fact that BLS was the true source of the bribes.

    Owner of Home Health Agency in Michigan Pleads Guilty for Role in Medicare Kickback Scheme

    May 24, 2018 11:21 AM by billupsj

    Atheir Amarrah, a resident of  West Bloomfield Michigan, and the owner of a Michigan home health agency, Prompt Care Home Health Services, Inc., pled guilty to charges against him due to his role in a Medicare fraud scheme.  Mr. Amarrah, 43, admitted to his role in paying and receiving kickbacks with sentencing is scheduled for Sept. 25.

    CMS Rejects Ohio's Waiver Request On Individual Mandate

    May 24, 2018 11:19 AM by billupsj

    On May 17,  CMS denied Ohio’s request for a State Innovation Waiver under section 1332 of the (ACA).  Previously, Ohio had submitted an application for the waiver of §5000A of the ACA, which requires applicable individuals to maintain minimum essential coverage or make a shared responsibility payment.  The Tax Cuts and Jobs Act changed the individual mandate penalty to $0, but it did not eliminate the requirement to maintain minimum essential coverage. CMS denied Ohio’s application because it was incomplete and failed to “include a description of any program implementing a waiver plan for providing coverage that meets section 1332 requirements.”  Section 1332 of the ACA permits the Secretaries of HHS and Treasury to approve a state’s waiver of certain requirements in the individual and small group insurance markets so long as it would: provide coverage as comprehensive and affordable as under the ACA; cover at least a comparable number of residents as under the ACA; and not increase the federal deficit.  CMS has approved 1332 waivers in Alaska, Oregon, Hawaii, and Minnesota. Wisconsin has submitted an application for a 1332 waiver and comments may be submitted to CMS through June 8, 2018.


    Feature Friday May 24, 2018

    May 24, 2018 11:14 AM by blakleyr

    Welcome to Feature Friday

    Happy Friday to all! As you know, #FeatureFriday is a way for the Health Law Section to Showcase some of our awesome Leaders and Members. We know that lawyers have busy and stressful jobs, so we wanted to inject a little fun into your work week!

    Today I am stoked to announce that royal wedding loving and Aunt Lydia hating, Denise E. Hanna is our Feature Friday.

    Denise E. Hanna, Co-Chair of Locke Lord LLP’s Health Care Practice Group and Managing Partner of the Firm’s Washington, D.C. office, concentrates her legal practice on representing health insurance companies, managed care organizations and their intermediaries on a range of regulatory and transactional matters. Denise’s legal experience includes lead roles in mergers and acquisitions for both strategic and financial buyers and sellers, joint ventures and other strategic transactions, internal restructures, change of control regulatory proceedings, managed care and provider contracting and commercial transactions.

    Among other honors, Denise has been named to The Best Lawyers in America for Health Care Law (2016-2017) and recognized by, Chambers USA for Health Care (2017-2018).

    Denise is a frequent speaker and writer on health reform and health law topics. Denise currently serves on the ABA Health Law Section’s Governing Council and Co-Chairs its Health Reform Task Force.

    Denise is a member of her Firm's Board of Directors and the former Chair of the Firm’s Diversity Committee.

    And now, Ladies and Gents, Denise E. Hanna...

    (Denise is pictured looking royal wedding ready! **Editor's Note- Try saying "royal wedding ready" fast 5 times)

    Q: What do you like most about being a lawyer?

    Denise: I enjoy that there continue to be knotty problems to solve, and novel deals to structure and document, for our health industry clients that continue to try to find better ways to deliver and pay for health care. I have the most fun when clients present new relationships that they’d like to form and I have to provide a legal structure to a mere set of ideas and aspirations and craft the documentation not from the latest form, but from my years of experience as a health care regulatory and deal lawyer.  It’s like building your dream house when you’re the architect, prime contractor and, then, the one who closes the sale.

    Q: Why health law?

    Denise: Dumb luck! Or, Providence!  Coming out of law school, my focus was on being a deal lawyer.  My second law firm just happened to be a health care boutique which needed another deal lawyer.  Although I naively resisted calling myself a health care lawyer for about 15 years, I really protested way too much. I so appreciate that my practice allows me to work with clients engaged in the most vital and personal decisions we, as individuals . . . as humans must face.  As their lawyer, I get to help clients develop better (i.e., more effective and efficient) ways to care for us when we’re sick and to keep us healthy.

    Q: What is one piece of advice that was given to you and has stuck with you?

    Denise: As a first-year lawyer, I recall asking a young partner, who already was a “star” in Los Angeles as a name partner in her own entertainment law firm: Just how does one get clients?  I had no idea what to do, and my family had no business connections.  The partner told me simply to just do good work for your clients.  Then, your reputation will spread and new clients will follow.  Well, for a long, long time I thought her advice was hooey.  However, once I was in the right law firm environment and, perhaps, the right frame of mind, the truth of those simple words – do a good job – have come true. 

    Q: How do you define success?

    Denise: What I realize now, at least for myself, is that success is elusive, whether it is achieving professional or personal goals.  Once you think you have it, it slips through your fingers as you recalibrate and refocus on new goals not yet achieved.  So, I try not to focus as much on goal fulfillment as happiness fulfillment.  Now, when I think about success, it’s just waking up happy and being excited about the day, and having the opportunity to engage with others and contribute to their personal well-being or professional endeavors in a positive way.  If we’re smiling or laughing and having a good time, I feel happy and successful – whether I’m at work or at play. 

    Q: Tell us three things that are on your bucket list.

    Denise: I’m not really a bucket list person.  Everyone is on my list.  That is, every good thing.  That is, as long as it doesn’t involve camping in the outdoors or encountering wild animals or bugs or any other primal sacrifice, like showers.

    Q: What fictional world or place would you like to visit?

    Denise: That’s a really hard one, since I’m so completely wrapped up into dystopian dramas, right now.  Well, I tell you that I probably shouldn’t venture to the Handmaid’s Tale dystopia because I’d make sure that Aunt Lydia knew that there is a special place in h*ll for women who torture other women. (Editor’s Note*** Denise would be a part of Mayday for sure! Under his eye…. ***eye roll***)

    Still, if it were only a visit, my friends would guess that I would want to drop in on the Walking Dead’s dystopia to hang out for a little while with all my friends in the “group” – that is, those who are still alive.  Who wouldn’t want to hang out with Rick and Daryl and Maggie and Carol. They are so, so Bad A$$.  Then, once I reminded myself that all the Four Seasons were dilapidated and there were no good restaurants left, I’d be out of there real quick. 

    Q: What is one thing people probably don’t know about you?

    Denise: Some people think I have tattoos . . . but alas, I don’t.

    Q: If you could uninvent one thing, considering the implications of uninventing it, what would it be and why?

    Denise: I would uninvent the “calorie” leaving me and everyone else free to eat their favorite foods without guilt or weight gain. Now, technically, I understand that if we had zero calories, we’d wither away to nothing, so I think I’d re-invent the ½ calorie to replace the full calorie.

    Q: What is one thing that people should know about the ABA Health Law section but they probably don’t?

    Denise: The HLS leadership is committed to serving the Section and in engaging in a thoughtful exchange of ideas about the complex and ever-evolving areas within health law.  HLS leadership appreciate how important these topics are to our society, both with respect to the businesses operated in the health industry and to consumers.  This is inspiring to me when many organizations seem to be more about self-promotion than the promotion of ideas.  Okay, granted, that may be more than one thing.  THE END.


    Long Live Denise!

    We would like to thank Denise for taking the time to participate in Feature Friday. The Health Law Section wants to thank all of our members for working hard to make our section awesome. Stay tuned for next week’s Feature Friday. Get to know your fellow HLS Leaders and Members. As Dani Borel said, we are #MakingFridayFunAgain. Have a great day!

    Seeking Program Proposals for Upcoming Conferences

    May 23, 2018 10:54 AM by blakleyr


    The ABA Health Law Section is seeking program proposals for the upcoming Washington Health Law Summit and Conference on Emerging Issues in Healthcare Law. As a benefit of your Health Law Section membership, you are being provided exclusive access to this request for proposals! Note that Section member proposals receive priority over other submissions.

    The deadline to complete the program proposal form is no later than Monday, June 18, 2018 to be considered. The Health Law Section continually strives to increase the participation of women, diverse ethnicities, disabled and LGBTQ speakers in Section activities, as well as to promote diversity in geographic location and practice settings. Please consider these criteria when proposing prospective speakers.

    Feel free to contact Danielle Daly (Danielle.Daly@americanbar.org) if you have any concerns.

    We value your participation, and look forward to your proposals!

    Feature Friday May 18, 2018

    May 18, 2018 9:34 AM by blakleyr

    Welcome to Feature Friday!

    Happy Friday to everyone! We would like to take a second and warmly welcome you to #FeatureFriday. Today we are happy to announce that our feature is none other than Vice Chair of the Distance Learning Committee and Young Lawyer Division Liason to Membership, Danielle L. Borel.

    Danielle is an associate at Breazeale, Sachse, & Wilson LLP in the Baton Rouge office, practicing in the areas of commercial litigation and healthcare litigation. Her principal areas of practice include litigation involving: healthcare provider licensing and payment disputes; trademark disputes; unfair trade practices and unfair competition; contract disputes; and general business and commercial issues. Ms. Borel litigates matters before the state and federal courts and before administrative courts. She has been involved in appeals before Louisiana administrative courts, Louisiana state courts, Louisiana federal courts, and the United States Court of Appeals for the Fifth Circuit. Ms. Borel has experience in representing pharmaceutical companies in opioid litigation brought by municipalities and counties.

    Ms. Borel received her Juris Doctor from Louisiana State University Paul M. Hebert Law Center, magna cum laude, in 2014 and was a member of The Order of Coif. She served as the Articles Editor for the Louisiana Law Review, and was a member of the Trial Advocacy and Moot Court boards. She received her Bachelor of Science from Louisiana State University, with honors, in 2011.

    (Dani is pictured looking pretty in pink!)

    Q: What do you like most about being a lawyer?

    Dani: I see the issues I deal with as logic problems, and I find them fun!

    Q: Why health law?

    Dani: Healthcare lawyers are masters of a very complicated, federally regulated area. Litigators are masters of persuasion, speaking, and handling adverse situations. I loved the idea of being a healthcare litigator because I saw it as the best of both worlds. I have the challenge of an intellectual subject matter and the fun of going to court. 

    Q: What is one piece of advice that was given to you and has stuck with you?

    Dani: Just keep swimming. When things seem overwhelming, the best way to conquer them is to take them one at a time.

    Q: What is one thing that people probably don’t know about you?   

    Dani: I make a mean blackberry pie.

    Q: How do you define success?

    Dani: I define success as being a well-rounded person. A successful person has a career they enjoy, is involved in their community, and has close friends and family. That is what I strive for.

    Q: What is one of the first things you bought with your own money?

    Dani: Own money? I was independent long before I was a working lawyer, but when I became a working lawyer, I purchased a very impractical car. It’s beautiful!

    Q: If you could uninvent one thing, considering the implications of uninventing it, what would it be and why?

    Dani: Electronic book readers. I like actual paper books and still buy at least one a month. Reading a book on an electronic reader diminishes the experience in my opinion.

    Q: Tell us three things that are on your bucket list.

    Dani: White water rafting, attending the D.C. Mardi Gras Ball, and attending the Kentucky Derby. 

    Q: What is your favorite thing to do in your free time?

    Dani: Be active. I’ve recently picked up golf, so most of my free time is spent on a golf course, riding bikes, or attending sporting events. 

    Q: What did you want to be when you were little?

    Dani: A “prostitute.” I meant prosecutor. Needless to say, I wasn’t allowed to watch Law & Order again after that class report.

    Q: What do you like about the ABA Health Law Section and what is one thing you wish people knew about it?        

    Dani: I like how welcoming the Health Law Section is and how friendly the members are.  I wish people knew that there are multiple ways to be involved.


    Huge thanks to Dani for taking the time to participate in Feature Friday this week. THANKS, Dani! Get to know your ABA Health Law Section Leaders and fellow members. Keep your eyes open for next week's Feature Friday!

    Co-Defendant’s "Indispensable Status" Keeps Baltimore's Opioid Lawsuit Out of Federal Court

    May 17, 2018 3:15 PM by billupsj

    Defendants in the City of Baltimore’s lawsuit alleging conspiracy to overprescribe opioids failed in their attempt to remove the state court action to federal court.  One local healthcare provider foiled complete diversity and could not be severed from the case, as the court deemed them an indispensable party.  

    OIG Congressional Testimony on the 340B Drug Pricing Program

    May 17, 2018 3:05 PM by billupsj

    On May 15, 2018, Ann Maxwell, the OIG’s Assistant Inspector General for Evaluation and Inspections, testified before the Senate Committee on Health, Education, Labor, and Pensions, discussing ways to protect the integrity of the 340B Drug Pricing Program.  Ms. Maxwell noted that there are two vulnerabilities with the 340B Program that impede its effective operation and oversight: “(1) a lack of transparency that prevents ensuring that 340B providers are not overpaying pharmaceutical manufacturers and that State Medicaid programs are not overpaying 340B providers; and (2) a lack of clarity regarding program rules that creates uncertainty, resulting in inconsistent program implementation and limited accountability.”  In order to address these vulnerabilities, Ms. Maxwell testified that the OIG recommends increasing transparency to support payment accuracy (HRSA should share ceiling prices with 340B providers and State Medicaid agencies through CMS, and require State Medicaid agencies to use claim-level methods to identify 340B claims), and clarifying rules to ensure that the 340B Program operates as intended (clarify the definition of an eligible patient and whether 340B providers must offer discounted 340B prices to uninsured patients).  Ms. Maxwell testified that since both HRSA and CMS have stated that they do not have sufficient authority to carry out these recommendations, the OIG encourages Congress to act. 

    Hospital Operator Agrees to Pay $14.25 Million to Settle FCA Allegations

    May 17, 2018 3:02 PM by billupsj

    Mercy Health of Cincinnati Ohio, has agreed to pay $14.25 million to settle allegations of improper relationships with referring physicians in violation of the FCA.  Mercy Health is a nonprofit organization that operates healthcare facilities in Ohio and Kentucky.  Mercy Health self-reported certain arrangements with six employed physicians that exceeded the fair market value of their services.

    South Texas Doctor Charged in $240 Million Health Care Fraud and Money Laundering Scheme

    May 17, 2018 3:00 PM by billupsj

    A McAllen, Texas, physician was charged in an indictment in connection with a $240 million health care fraud and international money laundering scheme.  The indictment alleges that beginning in 2000, Dr. Jose Zamora-Quezada and his co-conspirators engaged in numerous improper activities, including falsely diagnosing patients, with various degenerative diseases, including rheumatoid arthritis, administering or prescribing unnecessary medications, and conducting fraudulent, repetitive, and excessive medical procedures to increase revenue and fund his lavish and opulent lifestyle.  

    UC Davis Health and Adventist Health Lodi Memorial Partner on Pediatric Care

    May 17, 2018 2:59 PM by billupsj

    UC Davis Health and Adventist Health Lodi Memorial (Lodi) have entered into a professional services agreement to expand pediatric neonatal care services at Lodi.  UC Davis physicians and nurses will provide care through a Level II Neonatal Intensive Care Unit as well offer expanded inpatient and outpatient pediatric services at Lodi.

    Emory Partners with Australian Hospital for Unique teleICU Arrangements

    May 17, 2018 2:54 PM by billupsj

    Emory has also agreed to partner with Royal Perth Hospital in Australia and Philips, a health technology company, for intensive care coverage.  Because of the 12-hour time difference, Emory practitioners will be able to work at Royal Perth Hospital during daytime hours while will providing remote teleICU coverage for the night shifts at Emory.  The Emory providers will utilize remote Phillip’s electronic intensive care unit technology to provide backup support to the care teams on-site in the Atlanta locations.  

    Emory Healthcare Closer to Completing Partnership with DeKalb Medical

    May 17, 2018 2:52 PM by billupsj

    The FTC approved a proposed partnership between Emory Healthcare and DeKalb Medical, and the proposed transaction will now proceed to be reviewed by the Georgia Attorney General.  If approved, the transaction is anticipated to close within 100 days with DeKalb joining the Emory Healthcare System. DeKalb consists of 3 hospitals and 50 physician group offices with a medical staff of over 800+ doctors.

    Feature Friday May 11, 2018

    May 11, 2018 2:18 PM by carsons

    Welcome to Feature Friday

    Happy Friday to all! Today we have a special treat for Feature Friday. Our ABA Health Law Section Council Chair, Hilary Young has been roped into our super fun Friday feature.

    And now, ladies and gentlemen, Hilary Young!

    Hilary Young is a partner with Joy & Young LLP. Her practice focuses on Texas and federal regulatory, licensing, certification, and operations matters. Ms. Young is the current Chair of the ABA Health Law Section. In addition, she served on the State Bar of Texas Health Law Council and the Texas Board of Legal Specialization Examination Committee. Ms. Young is board certified in Health Law by the Texas Board of Legal Specialization. She earned her J.D. from the University of Texas School of Law, an M.A. in Latin from the University of Oklahoma, and an A.B. in Latin and History, Cum Laude, from Duke University.  Before entering private practice, Ms. Young served as a law clerk for the late Jerre S. Williams, Senior Judge for the United States Court of Appeals for the Fifth Circuit.

    (Crikey! Now, that's a croc! Check out our fearless Section Chair conquering her pathological childhood fear of death by alligator by posing with a friend during a swamp tour in New Orleans at EMI in 2017.)

    Q: What do you like most about being a lawyer?  

    Hilary: I like having and using the perspective and analytical skills that I acquired in law school and through practice.  And I like working with my clients and colleagues to solve problems, comply with rules, and resolve disputes.


    Q: Why health law?  

    Hilary: Health law is a great fit for me substantively and procedurally.  First, I grew up interested in medicine.  My father was a doctor whose internal medicine and hematology training took him into oncology before it was a widely recognized specialty.  I loved discussing his work with him.  I worked in his office and later in the emergency department of a community hospital during high school.  But my preference for Latin, history, and theatre studies over chemistry led me to teaching rather than medical school.  After working for ten years I went to law school.  The skills I enjoy include a combination of research, writing, teaching, counseling, collaborating with others, problem-solving, and seeking win-win solutions.  A litigation practice was not for me, and health law was.  There are many different ways to practice health law.  For me, the fun is in advising health care providers, typically those working in hospitals, on how to operate in compliance with the rules and on how to demonstrate compliance to regulators.  We often work with the same client contacts and the same regulators, and it is gratifying to have positive working relationships with both groups.


    Q: What is one piece of advice that was given to you and has stuck with you?  

    Hilary: Answer the client’s question—and don’t just analyze the law and tell a client “no” if there is a way the client can legally achieve their goals.


    Q: If you could uninvent one thing, considering the implications of uninventing it, what would it be? 

    Hilary: Today it would be the atomic bomb.  While the bomb arguably brought WW2 to an abrupt close, and nuclear energy offers some environmental upside in generating power, this technology poses an unacceptable threat to the world if it is under the control of unstable and mercurial leaders.


    Q: How do you define success? 

    Hilary: Doing satisfying work, having a wonderful group of friends and family, being able to contribute and help others, having enough resources to not worry about how to cover my bills and have some extra to put out into the world, and laughing every day.


    Q: If you were stuck on a desert island and could have 3 things with you, what would those 3 things be?

     Hilary: A knife, a magnifying glass, and a blanket.


    Q: Tell us three things that are on your bucket list.  

    Hilary: Go to Hawaii, go to Australia and New Zealand, and spend an extended period of time in Paris.


    Q: Who is one person, dead or alive, that you would like to have dinner with? Why?  

    Hilary: Amal Clooney.  I would love to hear her story, what drew her to her practice and her commitment to human rights, and how she forged that path.


    Q: Why are ABA Health Law Section important to you?  

    Hilary: The professional community.  I love the Section and being involved with it.  Initially, the Section provided me with helpful information and tools to support my practice.  But then I attended my first Emerging Issues Conference in 2002, and over the next few years the Section became an important community for me.  I now have significant mentors, close friends, and wonderful colleagues around the country.  If I have a thorny issue, all I have to do is “phone a friend” from the Section to get guidance and support.  I have been able to get involved through various leadership positions.  And I love going to our in-person meetings and conferences and seeing everyone.


    Q: What have you liked most about being the Section Chair? 

    Hilary: There are several things that come to mind.  I love working closely with Simeon Carson, the Section Director, and also with the staff and officers to deal with issues and keep the Section humming along.  I love the in-person Council meetings, where magic can happen—people come up with ideas that spark more ideas from others, and a new pathway suddenly opens up.  And I love being a part of the SOC Executive Committee and OneABA Working Group, giving the Section a voice in the bigger organization, and I hope communicating the Section’s long-standing commitment to being innovative and inclusive in serving our members and supporting the goals of the ABA.


    I think we can all agree that Hilary is a rock star. The Health Law Section would like to thank Hilary for participating in Feature Friday and for her continued service to the ABA and the law profession.


    CMS Issues Update on Medicare "Low Volume" Payments to Qualifying Hospitals

    May 10, 2018 11:56 AM by billupsj

    On April 24, 20918, CMS announced an update on the implementation of section 50204 of the Bipartisan Budget Act of 2018, which extends temporary changes to the Medicare low-volume payment adjustment through federal fiscal year (FY) 2018 for qualifying hospitals.  For FY 2018, low-volume hospitals will continue to be defined as those that are more than 15 road miles from another comparable hospital and that have up to 1,600 Medicare discharges. For fiscal years 2019 through 2022, the add-on payment will be calculated using a continuous linear sliding scale ranging from 500 total discharges to 3,800 total discharges. The update serves to provide some assurance to small rural hospitals across the nation that benefit from the payment that must be renewed regularly by Congress.

    Opioid Abuse Leads to Patient Endangerment

    May 10, 2018 11:54 AM by billupsj

    A nurse at a hospital in Washington state was arrested for infecting patients with hepatitis C while diverting pain medications from IV preparations. Cora Weberg, 31, is facing second-degree assault charges involving the intentional infection of two patients with the disease as well as the misappropriation of drugs from the Puyallup Good Samaritan Hospital.  The nurse discovered she was infected with Hepatitis C in March 2018.

    CMS Provides Clarity on Supplemental Benefits and Uniformity Requirements

    May 10, 2018 11:36 AM by billupsj

    On April 27, CMS released additional guidance on Medicare Advantage policy changes for the 2019 plan year.  The guidance addresses the expansion of supplemental benefits and the reinterpretation of the uniformity requirement.  The agency will not permit plans to be structured in a discriminatory manner but will permit plans to condition cost-sharing reductions or provide access to targeted supplemental benefits based on certain requirements.  CMS stated their expectation that the expanded definition of supplemental benefits will be used by plans to “make adjustments to their annual supplemental benefit offerings based on the expected needs of their plan population.”  These policy changes will provide plans with increased flexibility to design plans in innovative ways. 

    Five Physicians from Drug Addiction Treatment Practice Charged with Unlawful Distribution and Health Care Fraud

    May 10, 2018 11:34 AM by billupsj

    Five physicians engaged as contractors by Redirections Treatment Advocates, LLC, an opioid addiction treatment practice in Pennsylvania and West Virginia, have been indicted on charges of illegally dispensing controlled substances and Medicare and Medicaid fraud.   According to the indictment, the defendants created and distributed unlawful prescriptions for Subutux and Suboxone, forms of buprenorphine, a drug used to treat individuals with addiction.  The defendants were charged with health care fraud for allegedly causing fraudulent claims to be submitted to the federal health benefits programs for payments to cover the costs of the unlawfully prescribed buprenorphine.  The investigation was part of an effort by the Department of Justice to use data to target and prosecute individuals who commit opioid-related health care fraud including physicians who "ignore their oath to do no harm."


    Physicians To Pay $700,000 to Settle FCA Allegations Regarding Improper Relationship with Drug Testing Laboratory

    May 10, 2018 11:33 AM by billupsj

    On Monday, May 7, Robert Fetchero, D.O., of Jeannette, Pennsylvania, Sridhar Pinnamaneni, M.D., of Windermere, Florida, and Thelma Green-Mack, M.D., of Zionsville, Indiana, separately agreed to settle allegations that they each received improper payments for referrals from Universal Oral Fluid Laboratories, a Greensburg, Pennsylvania, drug testing lab.  By agreeing to accept these payments, the three physicians caused false claims to be submitted to Medicare for drug testing services. According to the DOJ, the physicians referred Medicare patients to the laboratory for drug testing services while engaged in a financial relationship with the lab. 

    CMS Approves New Hampshire Section 1115 Demonstration; Rejects Lifetime Limits in Kansas

    May 10, 2018 11:31 AM by billupsj

    On May 7, CMS approved New Hampshire’s section 1115 demonstration project requiring work or community engagement as an eligibility requirement.  On the same day, the agency partially denied a waiver request from Kansas by rejecting its request  to impose lifetime limits on Medicaid benefits. CMS believes the New Hampshire waiver will “promote health and wellness through increased upward mobility.”  New Hampshire’s demonstration project will eliminate retroactive coverage and require beneficiaries who gained coverage under Medicaid expansion to participate in 100 hours per month of work or community engagement activities.   The agency previously approved similar waivers for Kentucky, Arkansas, and Indiana, and CMS issued a State Medicaid Director letter on January 11, 2018, that encourages states to submit demonstrations that test work and community engagement requirements.  In rejecting the portion of the Kansas section 1115 waiver that would have imposed a lifetime limit, Administrator Verma stated that “community engagement programs should be designed to support a pathway out of poverty for individuals and promote overall health and well-being.”  The decision to reject a lifetime limit provides the Trump administration’s first views on the limits of section 1115 demonstration authority.   


    Elliott Management Offers to Acquire athenahealth

    May 10, 2018 11:29 AM by billupsj

    Elliott Management Corporation (Elliott), a private investment firm and presently the owner of 9% of the outstanding common stock of athenahealth, Inc., released a letter detailing its unsolicited offer to acquire all of athenahealth.  Elliott asserted that athenahealth, as a public company, is “not working” and citing the company’s great potential, proposed to acquire the company for $160 per share in cash.  The offer provides athenahealth a total market value of approximately $6.9 billion and represents a 27% premium to the stock price. The Board of athenahealth responded with an announcement that it will review the offer from Elliott. 

    Baptist Health to Purchase Hardin Memorial Hospital

    May 10, 2018 11:27 AM by billupsj

    Baptist Health, the largest not-for-profit health system in Kentucky, and Hardin Memorial Hospital (HMH) have agreed to a $361 million asset purchase agreement, subject to approval by HMH’s board.   HMH, a 300-bed facility currently owned by Hardin County, Kentucky and managed by Baptist Health for the past 20 years, will be renamed Baptist Health Hardin.  Pending regulatory approval, the sale is expected to finalize in December of this year.

    May 10th HIPAA Tweet Chat Questions

    May 9, 2018 11:43 AM by carsons

    Join Us for our #HLSChat on May 10th at 12:00PM EST


    Below you will find a list of questions to be covered during our #HLSChat.

    How does HIPAA align with and support digital health solutions? 

    How does information blocking manifest and what can be done to stop it? 

    How can HIPAA enhance and promote use of digital communication tools?

    What surprising activity for use/disclosure of health information is permitted? 

    What can be done to prepare for effective communication during emergencies?

    Bonus: What law or regulation would you like to see enacted or removed to help digital health? 


    Don't forget to join us at 12:00pm EST. Happy tweeting! 

    Feature Friday May 4, 2018

    May 3, 2018 5:02 PM by clarkp

    Welcome to Feature Friday

    The ABA Health Law Section would like to take this time to introduce you to another one of our awesome members. This week we would like you to meet the Co-Chair of the Distance Learning Committee and the Vice-Chair of both the EMI Planning Committee and the Marketing Committee, Matt Fisher.

    Matt is a Partner and Chair of the Health Law Group at Mirick O’Connell and he attended Suffolk University Law School. 

    And now for the Feature Friday questions!

    (Matt is pictured on the left, not to be confused with the gentleman on the right.)

    Q: What do you like most about being a lawyer?  

    Matt: I like constantly learning about new business ideas and developments from working with clients. There is no stop to the learning opportunities, including in areas that I would not necessarily have found for myself.

    Q: Why health law?

    Matt: I like health law because it is an essential part of society and has the opportunity to help many people. If I can make a project or idea come to fruition for a provider or someone helping the industry, then there can be a much larger and widespread impact than in many other areas. As with the general idea of learning, I also get to see many innovative concepts and help to find a place for them within the regulatory environment.

    Q: What is one piece of advice that was given to you and has stuck with you?

    Matt: If you do not enjoy what you are doing, then try something else. This was a lesson my parents taught and encouraged and one that I have followed. When you find something that you enjoy and are passionate about, then it becomes a lot easier.

    Q: How do you define success?

    Matt: I define success as being happy and content with what you are doing. That does not mean being content to stay still, but having goals in mind and working toward them. There is never a destination so much as an ongoing journey.

    Q: If you were stuck on a desert island and could have 3 things with you, what would those 3 things be?

    Matt: If I were stuck on a desert island I would want an e-reader with unlimited books and unlimited battery power, an unending supply of New England IPAs (preferably from Tree House), and my wife.

    Q: Tell us three things that are on your bucket list.

    Matt: People know some of these, but 3 things would be to visit Australia, to visit a brewery in every US state, and to see my kids have happy lives.

    Q: What fictional world or place would you like to visit?

    Matt: I want to visit the Cosmere and preferably as someone like Hoid. (**Editor’s Note- for those of you who are not familiar with Cosmere, google it. I did and now I wouldn’t mind going there either.)

    Q: What is your favorite part about PLI?

    Matt: This will be my first time attending PLI. Like all Health Law Section events though, I am looking forward to connecting with old friends and making new ones.


    Big shoutout to Matt for being super awesome and participating in our second Feature Friday.

    Join us for the Physicians Legal Issues Conference (PLI) on June 7-9 in Chicago. To find out more information, please visit: http://ow.ly/QOV530jcHcb

    Get to know your ABA HLS Leaders. Look out for next week's #FeatureFriday and see who we will feature next!

    More States Considering Medical Marijuana As An Opioid Alternative

    May 3, 2018 12:24 PM by billupsj

    The Illinois Senate voted on April 26 to allow doctors to prescribe medical marijuana as an alternative to opioids and those suffering from opioid addiction would be eligible to apply for a medical marijuana program card. Colorado has proposed a new bill that would allow doctors to write a medical-marijuana recommendation for any condition, for which a physician could prescribe an opiate for pain. The Colorado bill is currently pending in the state Senate.

    U.S. House Energy and Commerce Health Subcommittee Hearing May 8

    May 3, 2018 12:22 PM by billupsj

    On May 8, the House Energy and Commerce Subcommittee on Health will hold a hearing to discuss the Overdose Prevention and Patient Safety Act, which proposes to amend 42 CFR Part 2 that governs confidentiality of substance use records. This Act is intended to align 42 CFR Part 2 with HIPAA.  A number of healthcare organizations, including the AHA, have formed a coalition and have advocated for alignment to ensure that providers have access to their patient's entire medical history. The Substance Abuse and Mental Health Services Administration recently released a final rule which takes some steps to modernize Part 2, but, according to the AHA, it does not go far enough.  The Act includes changes clarifying definitions for "treatment," "payment," "healthcare operations," and "protected health information" and also strengthens the protection of patient confidentiality in criminal proceedings.

    CMS Announces Expanded Access to Medicare Advantage Data

    May 3, 2018 12:19 PM by billupsj

    CMS will make Medicare Advantage encounter data available to researchers for the first time, beginning with the 2015 benefit year.  This data has become increasingly important as more than one-third of beneficiaries are now enrolled in Medicare Advantage plans.  CMS will provide annual updates and intends to also release data from Medicaid and the Children’s Health Insurance Program in the future.  CMS Administrator Verma stated that “[d]ata has the potential to help produce better, more targeted treatments for patients, improving their quality of life while at the same time reducing costs.”

    Nevada Physicians Agree To Pay $1.5 Million To Settle FCA Allegations

    May 3, 2018 12:05 PM by billupsj

    Cardiovascular and Thoracic Surgeons of Nevada, Inc. (CTS) and its principal physician, Dr. Bashir Chowdhry, have reached a settlement with the US to resolve False Claim Allegations.  CTS will pay $1.5 million to resolve allegations that CTS improperly billed federal healthcare programs for surgical services not actually provided, and for higher cost services than those actually provided to its patients.

    CMS Focuses on Patient-Centered Care and Reducing Paperwork Burden in Proposed Payment Rules

    May 3, 2018 12:03 PM by billupsj

    CMS has proposed payment system changes that enhance patient-centered care while reducing the administrative burden on providers. In particular, CMS is proposing a modernized system for SNF payment that aims to incentivize providers to treat the needs of the whole patient by tying payment to patients’ needs rather than to the volume of services provided. CMS also proposed a new payment system rule for IRFs that recognizes telecommunications advances by permitting rehabilitation physicians to perform certain meetings without being physically present. CMS proposed updates to the Hospice Wage Index and Payment Rate Update and the IPF Prospective Payment System, as well.

    Maine Sued for Failure to Expand Medicaid

    May 3, 2018 12:00 PM by billupsj

    Advocacy groups and residents of Maine have filed a lawsuit against Maine’s Department of Health and Human Services (DHHS) for failing to expand Medicaid.  Under the terms of the Medicaid Expansion Act, passed by Maine voters in November, 2017, the state was required to submit a state plan amendment to CMS by April 3, 2018.  Governor LePage has said he will not expand Medicaid unless the legislature provides adequate funding. Despite the Governor’s earlier vetoes of Medicaid expansion legislation, Maine law does not permit a Governor to veto a law passed by citizens’ initiative.  The lawsuit asks the Court to require DHHS to submit the state plan amendment within three days and implement Medicaid expansion by July 2, 2018.

    Ohio submits 1115 Demonstration Proposal

    May 3, 2018 11:59 AM by billupsj

    On April 30, Ohio submitted a Section 1115 demonstration proposal to CMS that would require adults in the Medicaid expansion population to work at least 20 hours a week or be engaged in other community engagement activities.  New enrollees would need to meet the work requirement and current enrollees would need to meet the requirement during their annual eligibility renewal. Ohio estimates that 95% of current enrollees will be exempt or meet the requirements, if approved.  Approximately 36,000 enrollees may need to find work or community engagement activities to remain enrolled in Medicaid coverage. Ohio anticipates that 18,000 enrollees will lose coverage. CMS has previously approved Section 1115 waivers containing work requirements from Kentucky, Indiana, and Arkansas.  The Kentucky waiver is being challenged in the U.S. District Court for the District of Columbia.  Oral arguments have been set for June 13, 2018.

    Can Republican-Lead States Succeed In Enjoining The Affordable Care Act?

    May 3, 2018 11:47 AM by billupsj

    Beginning January 1, 2019, the Tax Cuts and Jobs Act of 2017 reduces to zero dollars the tax penalty imposed by ACA on many individuals who fail to maintain minimum essential coverage (i.e., the individual mandate), thus gutting a critical pillar of ACA and potentially creating a new path to invalidate all of ACA’s health insurance market reforms and Medicaid expansion.  As a result of the new law, multiple state attorneys general joined in filing a federal lawsuit to invalidate the ACA, contending that the individual mandate should fail on constitutional grounds because it will no longer serve as a mechanism to raise tax revenues. On April 26, these same attorneys general filed a motion seeking to preliminarily enjoin HHS and IRS from enforcing ACA’s health insurance market reforms (e.g., guaranteed issue coverage and community-rating) that are inextricably bound to the individual mandate in advance of the sunset of the mandate’s tax penalty.

    Interestingly, plaintiffs rely on the U.S. Supreme Court’s decision in National Federation of Independent Business v. Sebelius as providing the grounds for now rendering the mandate unconstitutional. Plaintiffs contend that compelling individuals to purchase health insurance, without the benefit of tax revenues, exceeds Congressional power under the Commerce Clause – a conclusion reached in a dissenting opinion signed on by five Justices.  Thus, the United States should not continue to enforce the individual mandate and, by implication, the remainder of ACA, because Congress, in its legislative findings and as codified in the ACA, determined the mandate to be essential to, and intertwined with, ACA’s health insurance reforms.

    The plaintiffs intimate that states can better design and regulate their unique health insurance markets and that widespread and immediate relief (e.g., alleviate consumer spending on high-cost ACA coverage, save States the expense of propping up failing ACA coverage and eliminate increased federal spending on premium subsidies) would follow a preliminary injunction of ACA.   It is difficult to speculate on how the court will respond to plaintiffs’ claims that immediate relief is warranted when the individual mandate tax penalty is not repealed until year-end. Additionally, plaintiffs have failed to address what will happen to Americans covered by ACA exchange plans, who actually want or need to maintain coverage, if the federal government is compelled to immediately stop subsidizing such coverage.

    Federal Agencies Issue Clarification on GOT Rules

    May 3, 2018 11:45 AM by billupsj

    In 2010, an interim final rule was issued implementing the ACA’s patient protection provisions that are applicable to non-grandfathered group and individual plans. One of the protections included in the law requires affected health plans to cover out-of-network charges without prior authorization and at in-network cost sharing.  Further, benefits must be based on the greater of (1) the payment negotiated with in-network providers, (2) the payment made to out-of-network providers, or (3) the Medicare payment rate. This approach is colloquially known as the “Greater of Three” or GOT.

    In May 2016, the American College of Emergency Physicians (“ACEP”) filed a lawsuit asserting that the GOT final rule should be invalidated under the Administrative Procedure Act.  ACEP alleged that the GOT rule (1) did not ensure a reasonable payment, (2) concerns relating to the purported deficiencies in the second prong of the GOT e.g. lack of transparency and manipulation, were not addressed, and (3) the request for the creation or designation of an out-of-network claims pricing database for use when calculating the second GOT prong was ignored.  On April 30, 2018, in response to the court’s requirement that they respond to ACEP allegations, the Departments of Treasury and Labor, as well as HHS, issued a clarification of the final GOT regulations.  The agencies noted that (1) patients have a right under the ACA and ERISA to obtain transparent information supporting the calculation of their benefits, (2) explained that the proposed database would be problematic, and (3) pointed out that it is a greater of the three prong results. “Thus, [the agencies] * * * maintain that the existing GOT regulation provides a statutorily supportable, and also a more practical, and cost-effective approach for group health plans and health insurance issuers to determine the required minimum payment amounts.” Consequently, no change was made to the GOT rule. The case now returns to federal court for its evaluation of this decision.

    IRS Reverses Change to Limit on Contributions to HSA

    May 3, 2018 11:42 AM by billupsj

    Earlier this year, the IRS reduced the 2018 maximum amount that an individual with family coverage was permitted to contribute to a health savings account HSA from $6,900 to $6,850.  The change was a result of the Tax Cuts and Jobs Act enacted late last year, which required the IRS to recalculate certain provisions that are adjusted for inflation.   

    Last week, the IRS issued Rev. Proc. 2018-27, reversing the reduction and reinstating the original limit of $6,900 for those with family coverage.


    University of Kansas Health System and Great Bend Regional Hospital Signed Letter of Intent

    May 3, 2018 11:37 AM by billupsj

    The University of Kansas Health System and Great Bend Regional Hospital signed a letter of intent for the University of Kansas Health System to acquire Great Bend Regional Hospital and its affiliated clinics.  The transaction is expected to close summer of 2018. The University of Kansas Health System currently includes the University of Kansas Hospital, HaysMed, Pawnee Valley, and the University of Kansas Health System St. Francis Campus.


    Humana Launches Hospital Incentive Program

    May 3, 2018 11:36 AM by billupsj

    Humana announced the launch of a national, value-based care Hospital Incentive Program (HIP) to be offered to general acute hospitals.  The HIP’s objectives are to deliver more integrated care and reduce duplicative services, readmissions, and complication rates, and the HIP will offer compensation based on improvement/performance in three areas: patient experience; patient safety; and patient outcomes.  Quality improvement and performance will be tracked by measures including infection rates, care coordination, and palliative care and will incorporate programs developed by the Joint Commission.

    The Final 60-Day Overpayment Rule: Overview, Recent Developments, and What It Means for You and Your Clients

    April 27, 2018 11:14 AM by billupsj

    Tues April, 17, 2018

    To view slides, click here
    To view recording, click here

    In this webinar, Hillary provided a brief overview of the 60-day Overpayment Rule and its intersection with the False Claims Act, followed by an in-depth discussion of recent updates and relevant cases and settlements in order to address those questions with which practitioners may still struggle

    Calvin Marshall, Chambliss, Bahner & Stophel PC, Chattanooga, TN 

    Hillary Stemple, Arent Fox, Washington, DC

    Feature Friday April 27, 2018

    April 27, 2018 10:36 AM by carsons


    Welcome to Feature Friday!

    The ABA Health Law Section would like for everyone to get to know their leaders a little better. So, we will be highlighting our leaders through Feature Friday (#FeatureFriday).

    For our first ever Feature Friday, we would like to introduce you to Council Vice-Chair candidate for FY 2019, Hal Katz. Of course, many of you already know him, but Hal was gracious enough to answer our Feature Friday questions. 

    But first, let’s get the formalities out of the way. Hal is a Partner at Husch Blackwell LLC in Austin, Texas and is a member of the firm’s Healthcare, Life Sciences and Pharmaceuticals Strategic Business Unit.  He is Board Certified in Health Care Law by the Texas Board of Legal Specialization, and focuses on corporate, transactional and regulatory matters for traditional providers and innovative businesses in the healthcare space.  Hal received his Doctor of Jurisprudence from the University of Houston Law Center and his Bachelor of Arts from the University of Texas in Austin. 

    Now, on to our Feature Friday questions!

    Q: What do you like most about being a lawyer?

    Hal: Having the ability to use the law to help people.

    Q: Why health law?

    Hal: Truth: I stumbled into it.  I was clerking in the litigation section, but the firm only had a health law position open.  In spite of being at a law school that had one of the best health law programs in the country, health law was completely unknown to me.

    Q: What is one thing that people probably don’t know about you?

    Hal: I’m an introvert at heart!

    Q: What is one piece of advice that was given to you and has stuck with you?

    Hal: Success is 85% attitude, 15% aptitude.

    Q: How do you define success?  

    Hal: Leaving the world a better place than how I found it.

    Q: If you weren’t a lawyer, what would you be?

    Hal: A therapist.

    Q: Tell us three things that are on your bucket list.

    Hal: Fly fishing in Alaska, African Safari, and Traveling Asia (Thailand, India and Vietnam).


    Big thanks to Hal for agreeing to be our first feature.
    Get to know your ABA HLS Leaders. Look out for next week's #FeatureFriday and see who we will feature next!

    LabCorp and Mount Sinai Enter Agreement to Enhance Laboratory Operations

    April 26, 2018 2:40 PM by billupsj

    LabCorp, a global life sciences company, and Mount Sinai Health announced a contract to enhance laboratory operations at Mount Sinai’s seven acute care hospitals.  LabCorp is now the primary reference laboratory for Mount Sinai and will help improve the quality of laboratory services through standardization and greater efficiency.  This agreement is in addition to several previous arrangements between LabCorp and Mount Sinai, including LabCorp’s acquisition of Mount Sinai’s clinical outreach laboratories in 2017. 

    HHS Releases Mental Health and Substance Use Disorder Parity Action Plan

    April 26, 2018 12:15 PM by billupsj

    The 21st Century Cures Act directed HHS to develop an Action Plan related to the ongoing implementation of the Mental Health Parity and Addiction Equity Act (MHPAEA). The Action Plan provides a brief background on parity; description of the public stakeholder listening session that was held on July 27, 2017; and outlines recent and planned actions to continue parity enforcement.

    Recent and planned actions of the Plan are organized into five categories: reporting and enforcement; disclosure requirements and increased transparency; consumer and compliance tools; state technical assistance, and research. Some highlights of planned actions include:

    • the Substance Abuse and Mental Health Services Administration is in the process of developing a toolkit targeted at state insurance regulators and behavioral health authority staff, human resources professionals and insurance executives to educate these groups on what parity is and how to comply with federal parity laws and regulations;

    • HHS plans to continue to update the Parity Portal for consumer in evaluating whether they have experience a parity violation;

    • Department of Labor will continue to release data and summaries of parity enforcement activities.


    HHS Takes New Steps to Implement Value-Based Agenda

    April 26, 2018 12:12 PM by billupsj

    On April 24, HHS announced new steps in implementing HHS Secretary Alex Azar's value driven healthcare agenda as part of the CMS Fiscal Year 2019 Inpatient Prospective Payment System (IPPS) proposed rule released on the same date.

    On April 23, CMS disclosed public suggestions to reshape the CMS Medicare Innovation Center, which the Affordable Care Act funded with $10 billion.  “The [public] responses focused on a number of areas that are critical to enhancing quality of care for beneficiaries and decreasing unnecessary cost, such as increased physician accountability for patient outcomes, improved patient choice and transparency, realigned incentives for the benefit of the patient, and a focus on chronically ill patients. In addition to the themes that emerged around the [Request for Information] RFI’s guiding principles and eight model focus areas, the comments received in response to the RFI also reflected broad support for reducing burdensome requirements and unnecessary regulations.”

    Additionally, CMS addressed the proposed policy changes in a fact sheet and the fiscal impact is addressed as follows:

    The proposed increase in operating payment rates for general acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program and are meaningful electronic health record (EHR) users is approximately 1.75 percent. This reflects the projected hospital market basket update of 2.8 percent reduced by a 0.8 percentage point productivity adjustment. This also reflects a proposed +0.5 percentage point adjustment required by legislation, and the -0.75 percentage point adjustment to the update required by the Affordable Care Act.

    CMS projects that the rate increase, together with other proposed changes to IPPS payment policies, will increase IPPS operating payments by approximately 2.1 percent, and that proposed changes in uncompensated care payments, capital payments, and the changes to the low-volume hospital payments will increase IPPS payments by an additional 1.3 percent for a total increase in IPPS payments of 3.4 percent.


    CMS Requests Comments for Proposed Rule Changes to IPPS and LTCH PPS

    April 26, 2018 12:10 PM by billupsj

    CMS has proposed changes to its Medicare Inpatient Prospective Payment and Long-Term Acute Care Hospital Prospective Payment Systems.  These proposed changes seek to advance its priority to reduce the administrative burden on hospitals while increasing price transparency and interoperability.  According to CMS, the proposed rule eliminates 25 total measurements across 5 quality-reporting and pay-for-performance programs, reducing more than 2 million burden hours, and resulting in cost saving of approximately $75 million.

    Under the rule, CMS will require hospitals to post a list of their standard charges online, and it renames the “Meaningful Use” program to “Promoting Interoperability.” It will also update the LTCH PPS standard Federal payment rate by 1.15 percent and eliminate the 25-percent threshold policy.  The proposed changes further include a 1.75 percent increase in operating payment rates under the IPPS for general acute care hospitals that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program and are meaningful electronic health record (EHR) users.

    Finally, the rule changes seek to ease documentation requirements for payment under Medicare Part A by no longer requiring certification statements detailing “where” in the medical record the required information can be found, removing the requirement for a written inpatient admission order to be present in the medical record and other actions.

    Deadline to submit comments on the proposed rule is June 25, 2018.


    AHRQ National Guideline Clearinghouse Will Lose Funding after July 16th

    April 26, 2018 12:02 PM by billupsj

    AHRQ National Guideline Clearinghouse (NGC) will no longer have funding after July 16th. and as a result, its website will no longer be available.  The NGC is a publicly available database of evidence-based clinical practice guidelines and related documents. It provides internet users with free online access to updated and new guidelines. NGC was originally created by AHRQ in partnership with the American Medical Association (AMA) and the American Association of Health Plans (now America's Health Insurance Plans [AHIP]).

    Court of Federal Claims Grants Class Action Status in CSR Case

    April 26, 2018 12:01 PM by billupsj

    Judge Margaret Sweeney, of the Court of Federal Claims, has granted Common Ground Healthcare Cooperative’s motion to certify a class in their lawsuit against the United States for cost-sharing reduction payments (“CSR”).  Common Ground is seeking to recover, for itself and other members of the class, CSR payments since October 2017. On October 12, 2017, the Trump administration announced they would no longer make CSR payments to issuers.  Issuers of qualified health plans are required to provide CSR to eligible insureds under section 1402 of the Affordable Care Act.  While acknowledging the issue has not been fully briefed, Judge Sweeney noted that the government did not identify a statutory provision that would support an argument that increased premium tax credit payments offset insurer losses following the cessation of CSR payments.  The government must provide a list of potential class members no later than May 18, 2018. The certified class consists of all persons or entities that offered QHPs during the 2017 or 2018 benefit year that provided CSR payments for eligible insureds.

    FDA Employs Innovative Methods to Prevent Illegal Products from Entering US

    April 26, 2018 11:58 AM by billupsj

    US International Mail Facilities (IMFs) receive 275 million packages a year. One of the FDA’s important public health functions is to closely monitor the FDA-regulated products arriving at the IMFs every day to prevent unsafe, counterfeit, and unapproved products from entering the country. One tool that FDA has deployed is advanced screening technologies that can allow FDA inspectors to screen packages containing suspected drug products more efficiently and reliably.

    Miami Man Sentenced to 8 Years in Prison for Role in Fraud Scheme

    April 26, 2018 11:57 AM by billupsj

    For his part in a health care fraud scheme, Vladimir Prado, a 52 year old Miami, Florida resident, was sentenced to 97 months in prison on April 20, 2018.  The scheme involved a now-defunct home health clinic and two sham physical rehabilitation clinics located in South Florida.  In addition to prison time, Prado is required to serve three years of supervised release following his release from prison, and to pay restitution of more than $4 million.  Prado’s clinic has submitted claims admitted to be false of more than $5 million. 

    FDA Pushes Creation of Cybersecurity Team

    April 26, 2018 11:49 AM by billupsj

    FDA released the “Medical Device Safety Action Plan," outlining five focus areas of the agency on medical device security.  One proposal by the FDA to enhance public safety of medical devices is to develop a team of experts that could investigate cybersecurity incidents involving medical devices. This would be a public-private partnership that would complement existing device vulnerability coordination and response mechanisms and serve as a resource for device makers and FDA. Its functions would include assessing vulnerabilities, evaluating patient safety risks, adjudicating disputes, assessing proposed mitigations, serving in a consultative role to organizations navigating the coordinated disclosure process, and serving as a “go-team” that could be deployed in the field to investigate a suspected or confirmed device compromise at a manufacturer’s or FDA’s request.


    CMS Proposes Changes to Meaningful Use Program

    April 26, 2018 11:48 AM by billupsj

    On April 24, 2018, CMS released the proposed inpatient prospective payment system (IPPS) and Long Term Acute Care Hospital (LTCH) rule for FY 2019 and proposed changes in the implementation of electronic health records (EHRs) systems.  CMS is renaming the Meaningful Use program to "Promoting Interoperability Program," emphasizing the purpose of the program to exchange health information between providers and patients. The IPPS-LTCH rule reiterates the requirement that providers use the 2015 Edition of Certified EHR Technology (CEHRT) in 2019.  CMS announced that it is changing the EHR incentive program to make the program more flexible and less burdensome; emphasize measures that require the exchange of health information; and incentivize providers to make it easier for patients to obtain their medical records electronically. CMS is requesting feedback through a Request for Information on how to revise the Medicare Conditions of Participation to promote interoperability and increase health data exchange between hospitals. CMS is also proposing that EHR reporting periods in 2019 and 2020 for new and returning participants would be a minimum of any continuous 90-day period within each of the calendar years 2019 and 2020.  The reporting period for the new program would be one, self‑selected calendar quarter of CY 2019 data, reporting on at least four self-selected clinical quality measures (CQMs) from the set of 16. Beginning with the 2020 reporting period, CMS is proposing to remove eight of the 16 CQMs.


    Fresenius Medical Care To Sell Sound Inpatient Physician Holdings

    April 26, 2018 11:46 AM by billupsj

    Fresenius Medical Care, the world’s largest provider of dialysis products and services, signed a definitive agreement to sell its controlling interest in Sound Inpatient Physician Holdings (Sound) to an investment group led by Summit Partners for $2.15 billion.  Closing of the transaction is expected in late 2018. Sound is a physician services organization offering a broad spectrum of services including emergency medicine, critical care, hospital medicine, and transitional care, with revenues of over $1 billion in 2017.

    Nomination Slate for Officers and Council Members for FY 2019

    April 23, 2018 3:13 PM by carsons

    The ABA Health Law Section Nominating Committee is pleased to announce the slate of candidates for Officers and Council members for FY 2019:

    VICE-CHAIR (1-year term with automatic ascension to Chair-Elect and Chair)

    • Hal Katz, Husch Blackwell LLP Austin, TX


    SECRETARY (1-year term)




    COUNCIL MEMBERS-AT-LARGE (3-year terms ending 2020)


    Automatic Ascension:

    CHAIR (1-year term beginning August 2018)


    CHAIR-ELECT (1-year term beginning August 2018)


    BUDGET OFFICER (3-year term beginning August 2018)


    IMMEDIATE PAST CHAIR (1-year term beginning August 2018)


    Per Article VI, Section 1 of the Health Law Section Bylaws, notice is hereby given to the members of the Health Law Section. The election of such Officers and Council will occur at the Section Business Meeting during the ABA Annual Meeting in Chicago in August.

    W. Thomas Smith Receives the Champion of Diversity and Inclusion Award

    April 23, 2018 10:45 AM by carsons

    The Health Law Section is pleased to announce W. Thomas Smith as the recipient of this year’s Champion of Diversity and Inclusion Award. The award honors an ABA Health Law Section member who has made exceptional efforts to promote diversity and inclu­sion within the Section and/or the legal profession. Mr. Smith is a Dean of Pharmacy at the Manchester University College of Pharmacy in Fort Wayne, Indiana. The award was presented to him on February 21, 2018 at the Section’s Emerging Issues Conference in Scottsdale by Diversity Committee Chair Tiffany Santos. Adrienne Dresevic and Clinton Mikel of the Health Law Partners in Farmington Hills, Michigan, nominated Mr. Smith for the award.

    Medicare Part E for All Proposed But Passage Remains Uncertain

    April 20, 2018 11:32 AM by billupsj

    Since the Fall of 2017, the Trump Administration has used its executive and regulatory authority to roll back coverage requirements for ACA health plans and expand access to association health plans that would be offered outside of ACA's exchanges to small businesses and self-employed individuals.  In response to the Administration’s efforts to diminish the ACA, which include repealing the individual mandate penalty in the Tax Cuts and Jobs Act, Congressional Democrats, on April 18, 2018, released the Choose Medicare Act, a legislative proposal that would permit, but not require, non-Medicare age individuals and businesses to opt into health insurance coverage offered under a new Medicare Part E program financed by premium payments just as private insurance is today.  The Choose Medicare Act would not replace ACA exchange plans.  Instead, new Medicare Part E plans would be offered on the ACA exchanges alongside other private exchange plan options.

    The Choose Medicare Act is intended to build on ACA’s protections, key features are:

    •  Make available new Medicare Part E plans to individuals of all ages in all fifty states;

    •  Opens Medicare to allow all employers to purchase health coverage for employees without replacing employment-based health insurance;

    • Provide employees an option to choose Medicare Part E over their employer offered coverage;

    • Mandate coverage of essential health benefits plus all items and services covered by Medicare;

    • Increases the generosity of premium tax credits and extends eligibility of these credits to middle-income earners; and

    • Allow Medicare to negotiate prices for prescription drugs (a proposal that enjoys bipartisan support as well as support from the Trump Administration).

    The Choose Medicare Act is the fifth Democratic proposal to support the ACA as some concerns remain regarding the long-term viability of the ACA’s exchange plans without legislation or Trump Administration initiatives to stabilize the exchange marketplace.  Despite the Choose Medicare Act’s focus on freedom of choice over the mandate-laden ACA – an approach which might garner some bipartisan support – the general consensus is this latest legislative proposal has little chance of passage by the current Congress and enactment into law.


    Healthcare Litigation & Risk Management Tweet Chat April 25

    April 20, 2018 9:56 AM by billupsj

    Join the Section for a Tweet Chat on the Pros and Cons of Litigation, Arbitration and Mediation

    Have you always wondered if arbitration and/or mediation would benefit your practice? Join the Health Law Section for a tweet chat, moderated by the Healthcare Litigation & Risk Management Interest Group, which will occur simultaneously with an open membership call and BrownBag Conversation, "Litigation v. Arbitration v. Mediation: Which is Better, When?" at 12 p.m. CT on April 25. Our informal raconteurs -- David Ellenbogen, David Cook and Tony DiLeo -- have a lot of experience with all three. While the call is taking place, join the conversation on Twitter! The hashtag for the tweet chat will be #HLSChat. The Section's Twitter account is @abahealthlaw. The Interest Group's Twitter Account is @HLSHLRM.

    Share your ideas, thoughts and insights on the following topics:

    - Has the cost of protracted litigation facilitated the rise of mediation and arbitration? Is money the only factor? #HLSChat

    - What are the differences between arbitration and mediation? #HLSChat

    - Are there certain circumstances when mediation should be used instead of arbitration, and vice versa? #HLSChat

    - Are there still matters where litigation is the preferred route to resolution, rather than mediation/arbitration? #HLSChat

    - As practitioners, is it incumbent on us to use mediation/arbitration more frequently, to ease the stress on our courts? #HLSChat


    Pennsylvania Adds Treatment for Opioid Withdrawal to State Medical Marijuana Program

    April 19, 2018 3:49 PM by billupsj

    Following New Jersey’s lead, Pennsylvania has approved adding the treatment of opioid withdrawal to be added to the list of approved uses for the state's medical marijuana program. By adding opioid withdrawal to this list, Pennsylvania's Secretary of Health is hopeful there will be increased clinical research in both marijuana and opioids at state health systems.

    Senate HELP Committee Continues Work on Opioid Epidemic

    April 19, 2018 3:47 PM by billupsj

    The Senate HELP Committee introduced the Opioid Crisis Response Act of 2018 (“OCRA”), which includes 40 wide ranging proposals aimed at curbing the opioid epidemic. The OCRA puts a focus on leveraging certain technology tools, such as EHR, telemedicine and prescription drug monitoring programs, in tracking and flagging suspicious controlled substances prescriptions. The bill also calls for increased educational efforts and training programs, including those for first responders to improve treatment of cases involving fentanyl overdoses.

    CMS Issues Final Rule for CY 2019 with Policy and Technical Changes to CARA

    April 19, 2018 3:45 PM by billupsj

    On April 16, 2018, CMS issued a final rule, which is effective as of June 15, 2018, to implement certain provisions of the Comprehensive Addiction and Recovery Act of 2016 (CARA). CARA enacted to address the opioid epidemic, has empowered CMS to create a framework for the establishment of new drug management procedures. To implement CARA, CMS has included a provision that creates a lock-in status for certain at-risk beneficiaries, protecting the safety of these beneficiaries by limiting coverage to specific pharmacies. While an estimated $19 million reduction in 2019 and $20 million reduction in 2023 in Trust Fund expenditures is expected, the cost of this provision to the industry is estimated at $2.8 million per year. CMS also provided provisions to cut costs allowing beneficiaries to opt in to electronic copies of disclosures, saving the industry $54.7 million annually in printing and mailing costs if at least 67% of the current beneficiaries opt-in. The final rule also involves a change in preclusion list requirements for prescribers in Part D and individual entities in Medicare Advantage (MA), Cost Plans, and PACE. Under this rule, prescribers of Part D drugs and providers of MA services and items will no longer be required to enroll in Medicare for coverage. Instead, either a Part D plan sponsor or its pharmacy benefit manager (PBM) will be required to reject the drug if the prescriber is on the preclusion list. Initially the revision will save providers $34.4 million but will cost sponsors or their PBMs $9.3 million. However, in the years following 2019, providers will save nothing and sponsors or their PBMs will incur negligible costs. Finally, physicians will enjoy a $204.6 million annual savings with updated stop-loss insurance requirements that will allow higher deductibles. 

    Coalition asks HHS to Take Action Against ESRD Steering

    April 19, 2018 3:44 PM by billupsj

    A group, comprised of insurance companies, businesses, unions, and consumer groups, sent a letter to HHS asking the agency to take actions against the American Kidney Foundation (AKF).  This informal coalition believes AKF is steering Medicaid and Medicare patients with end stage renal disease (ESRD) to commercial insurance coverage.  The letter alleges that the AKF is providing premium assistance for individuals with ESRD to purchase commercial insurance with the purpose of obtaining higher reimbursements for dialysis centers.  The group cites to a J.P. Morgan analysis finding “that 6,400 Qualified Health Plans purchased through the AKF HIPP program drove an estimated $1.7 billion in adverse selection.“ The AKF responded by noting that charitable assistance allows individuals with kidney failure a choice between private or public coverage.

    Drug Company 'Shenanigans' to Block Generics Come Under Federal Scrutiny

    April 19, 2018 3:42 PM by billupsj

    Trump Administration officials are looking to target branded companies who are not sharing samples of their drugs so that generic versions can be potentially created. FDA Commissioner Gottlieb said that drugmakers must “end these shenanigans”. The FTC is also investigating these practices.

    Former Employee of Southern California Ambulance Company Sentenced to Prison for Involvement in Medicare Fraud Scheme

    April 19, 2018 3:39 PM by billupsj

    Aharon Aron Krkasharyan, former employee of a Southern California ambulance company, pleaded guilty to one count of conspiracy to commit healthcare fraud. Krkasharyan’s actions resulted in more than $1.1 million in fraudulent claims to Medicare and he was sentenced by U.S. District Judge George H. Wu to 36 months in prison. Krkasharyan was also required to pay $484,556 in restitution to Medicare, with other co-conspirators yet to be sentenced.

    DOJ Report: FY 2017 Healthcare Fraud Enforcement Activities Result in $2.6B Recovery

    April 19, 2018 3:37 PM by billupsj

    DOJ and HHS resulted in a recovery of $2.6 billion in taxpayer dollars during FY 2017. Included amongst the most prevalent fraudulent practices uncovered through these efforts in FY 2017 are false claims related to ambulance transportation services, misrepresentations of capabilities by EHR providers, and false claims related to physical and occupational therapy services.

    GAIG and PH&P IG Membership Meeting – Includes a Featured Presentation by Sarah Somers on Medicaid and Work Requirements: The Kentucky Waiver

    April 19, 2018 3:36 PM by billupsj

    The HLS’ Government Attorneys Interest Group (GAIG) and the Public Health and Policy Interest Group (PH&P IG) are hosting a complimentary membership call on Wednesday, April 25, 2018, from 3:00-4:00pm EDT.  To participate, please dial in to 866 646 6488, code: 360 951 4833. This call will provide an opportunity for HLS members to learn more about the GAIG and PH&P IG, as well as the networking and engagement opportunities, educational programs, and other resources offered by these groups.

    In addition to learning more about the GAIG and PH&P IG, those on the call will have the opportunity to hear substantive remarks from Sarah Somers, JD, MPH, managing attorney with the Network for Public Health Law’s Southeastern Region Office/ National Health Law Program.  Ms. Somers’ presentation, entitled Medicaid and Work Requirements: The Kentucky Waiver, will discuss the Section 1115 waiver approved by CMS that will enable Kentucky to require many Medicaid beneficiaries to work in order to receive coverage.  The Section 1115 waiver also imposes premiums on very low income people and introduces other eligibility requirements that previous Administrations had refused to implement.  Advocates quickly sued, arguing that the approval of the Section 1115 waiver violates federal law.  Sarah will provide an overview of the legal and policy background on Section 1115 waivers, discuss the Kentucky waiver, and highlight key details about the lawsuit challenging the waiver.

    OIG Releases Report on Medicare Telehealth Program

    April 19, 2018 3:32 PM by billupsj

    OIG recently released a report finding that almost one third of telemedicine claims sampled did not meet Medicare requirements. OIG found that 31 of the 100 claims examined failed to meet Medicare requirements.  The predominant failure involved beneficiaries receiving, services at non-rural originating sites. OIG estimated that Medicare could have saved $3.7 million in the audit period had the rules been enforced. The OIG audit made the following recommendations to CMS: (1) conduct periodic post-payment reviews, (2) work with contractors to implement all telehealth claim edits, and (3) offer education and training sessions to practitioners on Medicare telehealth requirements.

    Movement on New Federal Bills, Addiction and the Workforce

    April 12, 2018 12:53 PM by billupsj

    The US House and Senate continue to work on bills to address the opioid epidemic and addiction. The House Energy and Commerce Committee concluded a series of hearings addressing the epidemic. The Senate’s H.E.L.P. Committee released a discussion draft of a substantial, multipronged bill called the Opioid Crisis Response Act of 2018 (“OCRA”) and held a hearing on the OCRA on April 11th.  The bill is intended to (i) spur the development of a non-addictive painkiller, (ii) give the FDA authority to require drug manufacturers to package certain opioids for a set duration, (iii) require manufacturers to give patients simple and safe ways to dispose of unused opioids, (iv) improve the detection and seizure of illegal drugs like fentanyl, and (v) improve data sharing so doctors and pharmacies know if patients have a history of substance misuse and states can better track prescriptions. The follow-up to the Comprehensive Addiction and Recovery Act is also on the table.

    The American Action Forum found in a recent study that nearly 1 million people were not working because of opioid addiction in 2015. The number of Americans not in the workforce because they were dependent on opioids grew each year between 1999 and 2015. The cost to the U.S. economy was $702 billion, or just under $44 billion each year.



    Feds Seek to Join Opioid Suit

    April 12, 2018 12:48 PM by billupsj

    The US Dept. of Justice filed a motion requesting to join settlement talks in federal court involving hundreds of lawsuits against manufacturers and distributors of opioid painkillers. The plaintiffs (more than 400 US cities and counties) are requesting repayment for the substantial expenses imposed on them by the opioid epidemic. The historic, multijurisdictional proceeding has brought together hundreds of lawsuits from cities, counties, Native American tribes and unions in a single, massive case presided over by Judge Dan Aaron Polster of the Northern District of Ohio.



    Surgeon General Issues Advisory on Naloxone

    April 12, 2018 12:47 PM by billupsj

    Surgeon General Jerome Adams has issued a rare advisory for Americans to get trained in administering the overdose reversal drug naloxone.  He urges people to talk to their doctors or pharmacists about obtaining naloxone, learn the signs of opioid overdose, and become trained in how to administer naloxone, if needed.

    Hospital Workers' Unions Pushing Proposals to Decrease Dialysis Clinic Reimbursements

    April 12, 2018 12:45 PM by billupsj

    A major hospital workers’ union in California is pushing a ballot initiative to cut off dialysis clinics’ commercial insurance reimbursement at 115% of care costs  which would result in cuts to their current rates. Proponents claim that the initiative may pressure clinics to improve care by increasing staffing and raising their standards in order to bump the cost of care which would result in a higher reimbursement cap. Critics claim the proposal may cause losses for dialysis clinics, hospitals, and state and federal resources. In addition to California, unions in Ohio and Arizona have similar efforts underway.


    Pharmacy Owner and Pharmacist Sentenced to 13 years in Prison for Medication Cream Kickback Scheme Against TRICARE

    April 12, 2018 12:43 PM by billupsj

    Larry Howard, a pharmacist and the owner of Fertility Pharmacy, was sentenced to serve 160 months in prison and ordered to pay $4.3 million in restitution for his role in a kickback scheme. Federal prosecutors say Howard, along with co-defendants Nicole Bramwell and Raymond Stone, entered into an arrangement to funnel patients to doctors pre-selected by Howard. The doctors would prescribe expensive pain medications and scar creams that cost up to $17,000 per bottle.  The medications were billed to TRICARE, and TRICARE, in turn, paid the pharmacy.

    CVS Blames Pharma Rising Drug Prices

    April 12, 2018 12:41 PM by billupsj

    A CVS Health Corp. report, as well as a similar study from Express Scripts Holding Co. earlier this year, highlight the ongoing battle between pharmacy benefit managers and pharmaceutical manufacturers. While drugmakers cast blame on PBMs for lack of transparency and not passing on rebate savings to patients, PBMs point to high list prices as the driving factor.


    California Sues Sutter Health Alleging Anticompetitive Contracts

    April 12, 2018 12:40 PM by billupsj

    On March 29, 2018, California Attorney General Xavier Becerra filed a civil antitrust action against Sutter Health, one of California’s largest healthcare providers. The state alleges that Sutter imposes a series of anticompetitive terms in its contracts, including price secrecy terms that prevent disclosure of Sutter’s negotiated rates, all-or-nothing provisions that require health plans to include all Sutter hospitals in their networks, and anti-incentive terms that prevent plans from offering cost or quality-based incentives to direct patients to non-Sutter hospitals. If the state prevails, the case could significantly alter contracts between healthcare groups, health plans and providers in California. This case is also one to watch amid a growing tide of industry consolidation nationwide.


    Fifth Circuit Opens Door to Injunctive Relief for Providers Awaiting ALJ Hearing on Alleged Overpayment

    April 12, 2018 12:38 PM by billupsj

    On March 27, 2018, the United States Court of Appeals for the Fifth Circuit issued a decision that potentially opens the door for Medicare providers to seek injunctions against the recoupment of alleged overpayments while awaiting a hearing before an Administrative Law Judge (ALJ).  In Family Rehabilitation, Incorporated v. Azar, No. 17-11337 (5th Cir., Mar. 27, 2018), a home health services provider received an audit notice from a Zone Program Integrity Contractor (ZPIC) alleging that it had received an overpayment of more than $7.8 million.  The provider challenged the audit, but the ZPIC’s findings were upheld through the first two stages of the administrative appeals process. At that point, the Medicare program began recouping the alleged overpayment, despite the fact that the provider had requested a hearing before an ALJ.  The provider sued to enjoin the recoupment until the administrative appeal had concluded, arguing that, given the significant backlog of administrative appeals at the ALJ stage (resulting in a three- to five-year stretch before the matter would be heard--a timeline “effectively conceded” by the government), the provider would be forced to shut down due to the recoupment.  The district court held that it lacked subject-matter jurisdiction because the provider had not exhausted administrative remedies, but the Fifth Circuit reversed and remanded the case, finding that the provider met the requirements under a “collateral-claim exception” to the general rule requiring exhaustion of the administrative appeals process. While it remains to be seen what ultimately comes of the case, the Fifth Circuit’s decision potentially provides an avenue for interim relief when the Medicare program begins recoupment in a matter that is subject of an administrative appeal.

    CMS Publishes 2019 Payment Notice and Related Guidance for Health Insurers

    April 12, 2018 12:36 PM by billupsj

    On April 9, 2018, CMS issued a highly anticipated final rule containing policies affecting health insurers in the individual and small group markets.  The Notice of Benefit and Payment Parameters for 2019 final rule (Payment Notice) was released along with several important guidance documents that create additional hardship exemptions; extend the transitional policy through 2019; and provide technical policies for insurers offering plans through an Exchange.  The finalized policies transfer additional regulatory responsibilities to states and align with the Trump administration’s goal of increasing state flexibility.  The Payment Notice finalizes significant changes to essential health benefits requirements beginning with the 2020 plan year. States will have expanded options when selecting their essential health benefits benchmark plan, including the ability to select a set of benefits as its benchmark plan.  CMS also finalized policies that defer to state determinations regarding network adequacy and essential community providers; allow states to request adjustments to medical loss ratio standards; permit Small Business Health Options Program (SHOP) Exchanges to eliminate online enrollment; removes the requirement that an Exchange have at least two Navigator entities; and eliminates the meaningful difference requirement for qualified health plans.  CMS has decided to no longer provide standardized options, which for the 2017 and 2018 plan years have received preferential display on healthcare.gov. The Payment Notice also finalized a proposal to allow states to request a reduction to the risk adjustment transfers in their state starting with the 2020 plan year.

    Outcome Health Agrees to Settle Class Action Lawsuit Over Text Messages

    April 12, 2018 12:34 PM by billupsj

    Outcome Health has agreed to pay $2.9 million to settle a class-action lawsuit alleging that Outcome Health (known at the time as ContextMedia) violated the Telephone Consumer Protection Act (TCPA) by continuing to send automated text messages to users despite repeated requests by users to opt out of receiving any further text messages. The lead plaintiff in this case opted in to receiving automated text messages from Outcome Health containing nutrition tips. After receiving some text messages, the plaintiff decided she no longer wanted to receive these messages. She claimed the company continued to send her text messages despite her numerous attempts to opt out. Under the TCPA, consumers are permitted to revoke prior express consent to receive text messages and the opt-out can be done in writing, such as through a responsive text message. Outcome Health had submitted a petition to the Federal Communications Commission requesting clarification on whether an unknowable technical error that caused the improper processing of unsubscribe requests to text messages would be protection from liability under the TCPA. As part of the settlement, Outcome Health agreed to take all reasonable efforts within its power to withdraw this petition.


    New Jersey AG General Reaches Settlement with Virtua Medical Group for HIPAA Violations

    April 12, 2018 12:32 PM by billupsj

    Virtua Medical Group has agreed to pay $417,816 to settle allegations with the New Jersey AGA's office that Virtua failed to implement adequate security measures as required under HIPAA. Virtua had engaged a third party vendor to transcribe dictations of medical notes, letters and reports by doctors. The third party vendor updated software on a password-protected File Transfer Protocol website (FTP Site) where the transcribed documents were kept. During the update, the vendor unintentionally misconfigured the web server, allowing the FTP site to be accessed without a password. After this mistake, anyone who searched Google using search terms that happened to be contained within the dictation information could easily access this information. As part of the settlement, Virtua will implement a corrective action plan and hire a third-party to conduct a thorough security risk analysis. This settlement sends a strong message to providers regarding their duty to carefully vet all third party vendors.


    Massachusetts Eye and Ear Joins Partners Healthcare

    April 12, 2018 12:31 PM by billupsj

    After the transaction closed on April 1, Massachusetts Eye and Ear joined the Partners HealthCare system. Massachusetts Eye and Ear, a specialty teaching hospital, is the oldest ENT hospital in the United States and provides patient care at 19 locations in Boston, MA and Providence, RI.  Founded by Brigham and Women’s Hospital and Massachusetts General Hospital, Partners HealthCare is an integrated health system comprised of two academic medical centers, community and specialty hospitals, community health centers, a physician network, a managed care organization, home health and long-term care services, and other health-related entities. 

    St. David's HealthCare Acquires The Austin Diagnostic Clinic

    April 12, 2018 12:29 PM by billupsj

    On April 6, St. David’s HealthCare announced it acquired The Austin Diagnostic Clinic (ADC).  St. David’s Healthcare plans to integrate ADC, a primary and specialty care physician group with over 150 physicians and providers, into its system.  St. David’s HealthCare includes 119 sites across Texas and seven hospitals and is a partnership between HCA and two non-profit organizations, St. David’s Foundation and Georgetown Health Foundation.  ADC’s physicians and providers practice in over 20 medical specialties and nine locations throughout Texas.

    BCBS Adopts New Opioid Prescribing Standards

    April 5, 2018 3:11 PM by billupsj

    The Blue Cross and Blue Shield Association (BCBS) has adopted new opioid prescribing standards that mirror the guidelines set by the Centers for Disease Control and Prevention. According the new BCBS standard, opioids should not be the first or second treatment options to manage pain. Increasingly, insurers, pharmacies and distributors have been issuing new opioid prescription guidelines and restricting the number and size of opioid prescriptions given to patients. But there is still a fear among physicians that reducing the opioid supply could cut off access to patients who are in actual need of these drugs.

    Iowa Law Expands Mental Health Services

    April 5, 2018 3:09 PM by billupsj

    The Governor of Iowa recently signed two pieces of legislation aimed at treating children and adults facing mental health challenges. The governor signed into law House File 2456 dealing with comprehensive mental-health upgrades and Senate File 2113 to set up required training for Iowa's educators to recognize and address the signs of a young person facing a mental-health crisis. Among the features of the House File 2456 is the establishment of six new access centers that will offer short-term assistance to Iowans in crisis situations.  The centers will offer a lower-cost option to psychiatric hospital units which are often already at capacity. The new law also removes the state's cap on subacute beds and expands treatment teams that monitor and assist Iowans with chronic mental illness. Under Senate File 2113, one hour of training in suicide awareness and prevention would be required annually for Iowa school employees working with students.


    Final Exchange Enrollment Data Shows Slight Decline

    April 5, 2018 3:04 PM by billupsj

    On April 3, CMS released a report detailing Exchange enrollment for the 2018 open enrollment period.  Approximately 11.8 million individuals enrolled in coverage through Exchanges during the 2018 open enrollment period, a small decline from the 12.2 million enrollments during the 2017 open enrollment period.  According to CMS, 27% of enrollees were new and the majority of individuals enrolled in silver plans, which provide cost-sharing reductions for eligible insureds. The average premium before the application of advance payment of the premium tax credit was $621, up from $476 during the 2017 open enrollment period.  After application of advance payment of the premium tax credit the average premium was $89 a month. A press release indicated CMS spent just over $1 per Healthcare.gov enrollee and that consumer satisfaction averaged 90%.


    Companies Form Alliance to Improve Data Sharing

    April 5, 2018 3:03 PM by billupsj

    Humana, UnitedHealthcare, Optum, Quest Diagnostics, and MultiPlan have joined forces to explore the use of blockchain technology to improve the sharing of healthcare data.  The alliance believes blockchain technology can be used to improve data quality and reduce administrative costs, including ensuring the accuracy of provider directories.  It is estimated that the healthcare industry currently spends over $2 billion annually in pursuit of the information necessary to keep provider directories up to date.  The pilot program would share provider information between members of the alliance and is expected to launch later this spring.  A survey of payers last fall found that 70% plan to integrate blockchain technology into their systems by 2019.


    FDA Issues New Draft Guidance for Alzheimer's Trials that Could Open Up Approvals

    April 5, 2018 3:01 PM by billupsj

    Alzheimer’s has long eluded drug researchers, as few effective treatments have been brought to market in the past decades.  New FDA draft guidance, issued in February 2018, seeks to change that status quo and bring more options to people suffering from the debilitating neurological conditions.  The changes have been largely welcomed by Alzheimer’s research organizations, including the president of an Alzheimer’s consultancy organization who called the changes “refreshing”.

    Virginia Ambulance Provider Settles False Claims Act Allegations

    April 5, 2018 2:59 PM by billupsj

    A Virginia-based ambulance services provider agreed to settle False Claims Act allegations for $9 million.  Medical Transport, LLC, is alleged to have submitted false claims to Medicare, Medicaid, and TRICARE for non-medically necessary transports that should have been billed to other payors. As a part of the settlement, the provider entered into a five-year Corporate Integrity Agreement with the OIG.

    ONC Releases Guide to Educate Individuals on Accessing Health Records

    April 5, 2018 2:56 PM by billupsj

    ONC released a new online resource for individuals, patients, and caregivers in an effort to improve patients' access to their electronic health information. In 2017, half of all Americans reported they were offered access to online medical record by a provider or insurer, which is up from 42% in 2014. Educating the public on the right to access their health information is an area of focus for the ONC.  Individuals’ ability to access and use their health information electronically is a measure of interoperability and a cornerstone of ONC’s efforts to increase patient engagement, improve health outcomes, and advance person-centered healthcare.


    OCR Cyber Security Newsletter: Importance of Contingency Planning

    April 5, 2018 2:54 PM by billupsj

    In the latest edition of OCR's Cyber Security Newsletter, OCR emphasized the importance of contingency planning in the event of a cyberattack. A contingency plan allows an organization to return to its daily operations as quickly as possible after an unforeseen event (i.e., cyberattacks, fires, floods). In the event data is compromised due to a cyberattack, restoring the data from backups may be the only option to recover the data and restore normal business operations. There are two main objectives to a contingency plan: (1) containing the damage the incident has caused; and (2) continuing operations of the organization. It's important to remember that the HIPAA Security Rule requires that HIPAA covered entities and business associates establish and implement a contingency plan.


    Ascension and Providence St. Joseph Cease Merger Discussions

    April 5, 2018 2:52 PM by billupsj

    On March 28th, it was reported that Ascension and Providence St. Joseph Health ended their restructuring discussions that would have created the nation’s largest hospital system.  The deal would have created a single entity that owned 191 hospitals in 27 states, with a projected annual revenue of $44.8 billion.  The parties did not completely quash the possibility of reopening the negotiations, according to insiders.

    Ascension, the country’s largest non-profit hospital system, currently operates 153 hospitals in 22 states and the District of Columbia.  Providence St. Joseph, also a non-profit system, operates 51 hospitals in 7 states, including Alaska, California, Montana, New Mexico and Oregon, states in which Ascension does not currently have a healthcare presence.

    The merger discussions ended in part due to the diverging strategies of the two systems.  Providence’s current focus involves broadening investments in new healthcare fields, including digital, retail, and ambulatory care spaces.  Meanwhile, Ascension is in the midst of a new strategic plan to increase growth and improve labor productivity. Ascension’s plan was enacted as a response to the dual pressure of insurers seeking to reduce reimbursement and a new healthcare paradigm where patients seek alternative healthcare to avoid hospital costs.


    Community Health Systems To Sell Three Hospitals

    April 5, 2018 2:51 PM by billupsj

    Community Health Systems, a hospital company based in Franklin, TN with 127 affiliated hospitals, executed a definitive agreement to sell three hospitals and their related assets to West Tennessee Healthcare. The hospitals include: Tennova Healthcare-Dyersburg Regional (225 beds); Tennova Healthcare-Regional Jackson (150 beds); and Tennova Healthcare-Volunteer Martin (100 beds).  West Tennessee Healthcare is a not-for-profit organization headquartered in Jackson, Tennessee, with four hospitals, two medical centers, and other healthcare operations primarily serving the population of western Tennessee.  The transaction is expected to close in the second quarter of 2018.

    Dept. of Justice/Opioid Response

    March 29, 2018 10:15 AM by billupsj

    Attorney General Jeff Sessions announced that the U.S. Drug Enforcement Administration is sending 250 task force officers, and dozens of analysts, to places in the nation “where the opioid crisis is at its worst.”  Additionally, Sessions has assigned a dozen federal prosecutors to “opioid hot-spots” to focus on investigating opioid-related health care fraud.  Further, the DOJ has released its Guidance Regarding Use of Capital Punishment in Drug-related Prosecutions.

    $3 Billion in New Federal Funding Signed Into Law

    March 29, 2018 10:14 AM by billupsj

    The FY 2018 spending bill, signed into law by President Trump, includes over $3 billion in new opioid and addiction funding. An additional $3 billion was included as part of the two-year budget agreement.  The bill includes $1 billion in new funding for grants to states and tribes, as well as $350 million extra to help the CDC with overdose surveillance and prevention efforts at the national, state and local levels. The bill also includes funding for law enforcement, research, and treatment and recovery support services for rural Americans, veterans, American Indians and Alaska natives.  The new funding is on top of $500 million already appropriated for FY 2018 in the 21st Century Cures Act.


    FDA Releases 2018 Compounding Policy Priorities Plan

    March 29, 2018 10:08 AM by billupsj

    The FDA Compounding Priorities Plan (“Plan”), as the name suggests, provides an overview of the FDA’s key priorities regarding compounded drugs. Most of the outlined priorities are well underway while several draft and final guidances were announced in connection with the Plan.  Other parts of the Plan will be rolled out over the course of the coming year with full implementation expected to be completed in 2018.

    DOJ Announces $33.2 Million FCA Settlement with Medical Device Manufacturer Alere

    March 29, 2018 10:04 AM by billupsj

    On March 23, 2018, the DOJ announced a $33.2 million FCA settlement with Massachusetts-based medical device manufacturer Alere Inc. and its subsidiary Alere San Diego.  The settlement resolved allegations that Alere sold materially unreliable point-of-care diagnostic testing devices to hospitals, causing the submission of false claims to Medicare, Medicaid, and other federal healthcare programs.  The civil lawsuit was initially filed by a former employee of Alere who blew the whistle on Alere’s Triage® devices, which were supposed to aide in the diagnosis of acute coronary syndromes, heart failure, drug overdose, and other serious conditions. Despite receiving customer complaints that the devices were providing incorrect results, Alere allegedly failed to take action. FDA inspections eventually prompted a nationwide product recall in 2012.  The whistleblower received about $5.6 million from the settlement.

    OIG Report Finds Outpatient PT Claims Did Not Comply With Medicare Requirements

    March 29, 2018 10:01 AM by billupsj

    On March 23, 2018, the OIG released a report finding that in its study of 300 outpatient physical therapy claims, 184 (61%) did not comply with Medicare medical necessity, coding or documentation requirements.   Based on these audit results, the OIG concluded that Medicare overpaid providers $367 million from July 1, 2013, through December 31, 2013 and that these overpayments occurred, because CMS did not have effective controls in place for preventing improper payments for outpatient physical therapy services.  In the claims that were found to be not medically necessary, the OIG concluded that the services were billed even though the services were not reasonable, the services were not effective, the services did not require the skills of a therapist, and/or that there was no expectation of significant improvement. The coding errors identified by the OIG included claims where timed units did not match treatment notes, modifiers were missing, and/or incorrect codes were used. Finally, documentation errors included deficiencies in the plans of care, treatment notes, and recertifications.  CMS responded and disagreed with some of the OIG findings.

    India's Proposed Law Seeks to Strengthen Health Data Protections

    March 29, 2018 9:59 AM by billupsj

    The Indian government is requesting public commentary on proposed legislation seeking to strengthen healthcare data privacy protections. As the draft currently reads, it prioritizes patients’ privacy and autonomy over their personal information. Patients reserve the right to refuse or cancel previous consent for the collection of their data.

    The Digital Information in Healthcare Security Act (Act) permits health data to be collected, generated, stored, and transmitted by an authorized entity in certain cases. However, when an individual or entity “intentionally, dishonestly, fraudulently or negligently” shares unencrypted digital health information, without obtaining proper consent from the patients whose information was disclosed, the individual or entity is considered to have committed a “serious digital health data breach” and will be subject to imprisonment, for a period of three years to five years, or receive a fine of five lakh of rupees minimum.

    Under the proposed law, a data breach charge may not be contested in a court of law except when the complaint is made by the “Central Government, State Government, the National Electronic Health Authority of India, State Electronic Health Authority, or a person affected.” In addition to establishing the National Electronic Health Authority, State Electronic Health Authority and Health Information Exchanges, this legislation intends to protect sensitive health-related information, which includes but is not limited to sexual orientation and use of narcotic or psychotropic substances, or abortion history. Those who want to add their voices in support or against the Health Ministry’s proposal have until April 21, 2018 to submit commentary.

    US healthcare providers, with business ties with India, should pay close attention. For instance, the draft legislation defines entities, which could be held liable, as any “association of persons or a body of individuals, whether incorporated or not, in India or outside India” or “any body corporate incorporated by or under the laws of a country outside India.”

    HCA Enters Into LOI with Mission Health

    March 29, 2018 9:56 AM by billupsj

    The board of directors of Mission Health signed a letter of intent to enter into exclusive discussions to join HCA Healthcare, one of the nation’s leading healthcare providers with 179 locally managed hospitals and nearly 1,800 outpatient facilities.  Mission Health, operating six hospitals and a Level II trauma center, is North Carolina’s sixth largest health system. The potential acquisition would allow HCA to expand operations into North Carolina.

    Ascension Agrees to Letter of Intent with Hartford HealthCare

    March 29, 2018 9:55 AM by billupsj

    On March 27, 2018, Ascension and St. Vincent’s Medical Center (located in Bridgeport, CT) agreed to a non-binding letter of intent with Hartford HealthCare for Hartford to acquire St. Vincent’s and join Hartford’s network, which includes acute-care hospitals, an extensive behavioral health network, a large multispecialty physician group, a regional home care system, a physical therapy and rehabilitation network, and an accountable care organization.  St. Vincent’s has over 3,200 employees, a 473-bed community hospital, a 76-bed inpatient psychiatric facility, and a large multispecialty physician group.

    Doctors Charged in Bribery and Kickback Scheme

    March 22, 2018 3:14 PM by billupsj

    A federal indictment charges five New York doctors with participating in a bribery and kickback scheme that sought to increase the sales of Subsys, a spray form of fentanyl manufactured by Insys.  The doctors allegedly received more than $100,000 annually in return for prescribing millions of dollars worth of Subsys.  Insys Therapeutics is accused of funneling the illicit payments to the doctors through a sham “speakers bureau.”  All of the physicians have pleaded not guilty.  Insys and its executives are also the subject of criminal charges.

    Trump Announces Initiative to Stop Opioid Abuse

    March 22, 2018 3:13 PM by billupsj

    New research finds that federal government estimates of opioid overdose deaths have been undercounting by 20 percent to 35 percent.  As the death toll increases, President Trump announced his plan for addressing the epidemic, following up on his October 2017 declaration of addiction as a national health crisis.  He proposed his “Initiative to Stop Opioid Abuse and Reduce Drug Supply and Demand” featuring an emphasis that is tough on crime and includes additional funding for treatment and recovery support services.  His calls for the death penalty for drug dealers has drawn a lot of attention, including from Baltimore City Health Commissioner Dr. Leana Wenn, who stated, “much of his announcement … is deeply troubling.” She is concerned about the focus on punishment, the lack of sustained funding, and failure to propose the use of evidence-based practices.

    One proposal is for a nationwide anti-drug ad campaign.  A 2009 American Journal of Public Health study found that ads sponsored by the Office of National Drug Control Policy led to no benefits – and potentially increased the risk of later marijuana use.  The ads portrayed kids on drugs as “potheads,” or “human puppets.” A 2006 Government Accountability Office report also found similar ads to be ineffective.