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Entries filed under 'Health Law Section'

    VA Releases Nursing Home Ratings

    June 21, 2018 4:01 PM by billupsj

    Recently, the VA released an 18-month rating and review of 133 of its community living centers. The report is divided into four sections: overall stars, survey stars, staffing stars, and quality stars. Of the quality ratings, 58 of the 134 facilities scored a rating of 1, or the lowest score possible. According to the VA, its centers compare and rank closely with private sector nursing homes, with 34.1 percent of one-star facilities. The ratings report says 60 of the facilities improved their scores from 2nd Quarter FY17 to 2nd Quarter FY18.


    DOL Publishes Association Health Plan Final Rule

    June 21, 2018 3:59 PM by billupsj

    On June 19, the DOL released a final rule that expands access to association health plans.  The Trump administration has touted the change in regulations as a way to broaden access to coverage and reduce costs of coverage. The proposed rule was published in January and received significant criticism from consumer advocates and certain payor and provider groups. The final rule changes the definition of “employer” under ERISA to allow more groups to form association health plans and bypass, in part, certain ACA requirements related to coverage. Current anti-discrimination prohibitions related to underwriting and eligibility would apply. While prior restrictions on “industry” relationship are eliminated (allowing unrelated workers to form/join associations), the associations will be limited geographically.  Associations limited to a single industry can offer national coverage. Additional changes from current regulations include the ability of self-employed workers to join associations and the associations do not need to be formed for a purpose beyond insurance. There are concerns that regulation at the state level will again be difficult as ERISA may preempt many such attempts.

    Personal Injury Law Firm Agrees to Implement Compliance Program and Reimburse US

    June 21, 2018 3:57 PM by billupsj

    Philadelphia personal injury law firm, Rosenbaum & Associates, and its principal attorney, Jeffrey Rosenbaum, agreed to settle allegations of improper practices regarding obligations to repay Medicare for amounts collected in personal injury lawsuits that have been previously paid by Medicare.  The Medicare Secondary Payer provisions authorize Medicare to make payments for medical items or services under certain conditions.  If an injured person receives a settlement or judgment, Medicare regulations require entities that received settlement proceeds to repay Medicare.  If the injured person fails to do so, the government is entitled to recover conditional payments from the injured party’s attorneys. Terms of the settlement included a payment of $28,000 by the law firm and an ongoing obligation to implement a compliance program.

    Conservative Coalition of Groups Release Outline of Plan to Repeal and Replace ACA

    June 21, 2018 3:54 PM by billupsj

    On June 19, the Health Policy Consensus Group, a coalition of conservative groups including the Heritage Foundation, the Galen Institute and the Hoover Institution, released an outline of a new proposal to repeal and replace the ACA.  The plan is similar to the Graham-Cassidy bill that Congress failed to enact last year.  If implemented, the proposal would: (i) eliminate federal subsidies and state Medicaid expansion and convert federal funding into block grants for states to administer to provide financial assistance to individuals to purchase coverage; and (ii) abolish certain ACA mandates including essential health benefits that requires plans to cover certain services including mental health and prescription drugs, single risk pools, minimum loss ratio requirements for insurer profits, and the 3-to-1 age ratio that limits how much elderly enrollees pay compared to younger enrollees.   Unlike the Graham-Cassidy legislation, the proposal does not convert Medicaid funding to per-capita payments.


    Federal Circuit Rules in the ACA Risk Corridor Cases

    June 21, 2018 3:51 PM by billupsj

    On June 14, 2018, a three judge panel of the U.S. Court of Appeals for the Federal Circuit ruled against insurance companies in two Court of Federal Claims cases by a two to one margin in ACA “risk corridor” litigation.  The cases are styled Moda Health Plan v. United States and Land of Lincoln Health Insurance Co. v. United States, Moda is the principal decision of the two.

    As background for the litigation, the ACA created three programs – risk adjustment, reinsurance and risk corridors – that were intended to stabilize its new health insurance marketplaces. The risk corridor program was intended to subsidize unprofitable qualified health plans (“QHP”) with money contributed by profitable QHPs in the first three years of the marketplaces’ existence -- 2014, 2015, and 2016. Unfortunately, financial losses in the ACA marketplaces vastly overshadowed financial gains in those years. Based on Congressional action taken in appropriations laws for fiscal years 2015, 2016, and 2017, HHS declined to fund the net risk corridor losses incurred by ACA marketplace insurers, totaling approximately $12.3 billion.

    In response, health insurers filed over two dozen cases against the federal government in the U.S Court of Federal Claims.  The outcomes at the U.S. Court of Federal Claims level were mixed in favor of both the insurers and the federal government.  The Moda and Land of Lincoln cases are more favorable to the US, and in all likelihood, the next stop for these issues and disputes will be the U.S. Supreme Court.


    90 Physicians Leave Atrium Health and Form Tryon Medical Partners

    June 21, 2018 3:48 PM by billupsj

    Approximately 90 physicians recently left Atrium Health’s Mecklenburg Medical Group (Charlotte, NC) to form Tryon Medical Partners, formerly known as Mecklenburg Multispecialty Group.  After extended litigation, Atrium Health agreed to release the group of physicians from their employment agreements, including the non-compete provisions.  The physicians will continue to be employed at Mecklenburg Medical Group through August 2018 before becoming the new independent Tryon Medical Partners.

    Mayo Clinic Explores Blockchain Usage in Healthcare

    June 21, 2018 3:37 PM by billupsj

    Mayo Clinic and Medicalchain have signed a joint working agreement to explore the utilization and benefits of blockchain technology in healthcare.  One avenue of exploration is the usage of blockchain -based electronic health records. According to a statement from Medicalchain, “Blockchain technology is a revolutionary innovation that first gained traction within financial services for its ability to speed up transactions, reduce costs, and provide a shared immutable ledger. The same principles are widely applicable to healthcare and show promise in addressing some of the systemic problems our systems face today, such as data security, fragmentation, high costs, and lack of patient centricity.”

    CVS Offers Prescription Delivery Nationwide

    June 21, 2018 3:35 PM by billupsj

    CVS Pharmacy, with over 9,800 locations, is now offering pharmacy and front store delivery.  Medication can be ordered for next-day or two-day delivery via the CVS Pharmacy app or by phone with certain markets (New York City, Boston, Miami, Philadelphia, San Francisco, Washington, DC) offering same-day prescription delivery.  The delivery service charge is $4.99 ($8.99 for same-day).

    Feature Friday- Bill Horton- 06.22.18

    June 21, 2018 1:43 PM by blakleyr

    Untitled Document

    Welcome to Feature Friday

    Happy Friday to all! We are so pumped to announce that our Feature Friday participant this month is none other than Former Section Chair, Bill Horton.

    Bill Horton is a partner with Jones Walker LLP, where he serves as Co-Leader of the firm’s Healthcare Industry Team and head of its Birmingham, Alabama office. His primary focus is on the representation of healthcare providers and other business enterprises in the areas of mergers, acquisitions and joint ventures, securities and corporate finance law, regulatory compliance and corporate governance matters. He represents healthcare providers and businesses in a wide variety of business transactions and regulatory matters.  He also has significant experience in government and internal investigations.

    A nationally recognized speaker and author on healthcare, corporate and securities law and professional responsibility topics, Bill has served for several years in leadership positions with both the ABA Health Law Section, where he served as the Section’s 2015-2016 Chair and currently serves as one of its representatives to the ABA House of Delegates, and the American Health Lawyers Association, where he served from 2011-2014 as Chair of the Business Law and Governance Practice Group currently serves as a member of the AHLA Dispute Resolution Council.

    Bill has been a contributing author to numerous books and journals and frequently comments on healthcare industry topics for national and regional publications.  He is listed in Chambers USA 2018, in The Best Lawyers in America® and in Mid-South Super Lawyers®.  In addition to his practice, Bill serves as an adjunct professor at the University of Alabama School of Law and as a Clinical Associate Professor at the School of Optometry of the University of Alabama at Birmingham and is the founding President of the National Board of Health Lawyers, a specialty certification organization.

    (On the top, Bill is pictured in his everyday eyewear. On the bottom, Bill is pictured with his beautiful family.)

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

    Bill: I enjoy the feeling when you’ve accomplished something for a client and you know you’ve made someone better off than they would have been without you.

    Q: Why health law?

    Bill: In all honesty, I semi-stumbled into it through a combination of interest and what my first law firm needed.  But I’ve stuck with it because it’s fascinating and important, and because it gives me the chance to work with some great clients who are helping people every day.  I really can’t imagine a practice I’d enjoy more.

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

    Bill: If you write numbers in words-and-figures, like “ten (10)”, it gives you two chances to put the wrong number in.  Don’t do that; most people can read numbers just fine.

    Q: What is one surprising fact about you?

    Bill: I rode the last rollercoaster I’m ever going to ride in 1976.

    Q: If you could give your 16-year-old self some advice, what would you say?

    Bill: “Just go ahead and ask her out; the worst she can say is ‘no’.” – which is, of course, exactly what I was afraid would happen.

    Q: How do you define success?

    Bill: If my family, my clients and American Express are all happy with me at the same time, I feel pretty successful.

    Q: What are three things on your bucket list?

    Bill: 1.) Attending the Festival of Nine Lessons and Carols at King's College, Cambridge 2.) Hearing McCoy Tyner in concert
    3.) Getting the number of books that I own but haven’t read down to 100.  Okay, 200.

    Q: Would you rather be able to speak every language in the world or talk to animals?

    Bill: Given that I already talk with my cats on a daily basis, I’d have to go with the languages.

    Q: How does the Health Law Section impact you?

    Bill: We don’t really have enough space to cover that.  The Section gives me resources that help my clients, it gives me the opportunity to develop referral relationships, it gives me the chance to do things that I hope benefit the profession, and it has given me some of the best friends I’ve ever had.

    Q: Tell us about one of your proudest moments.

    Bill: Several years ago, I was representing a young doctor in a licensure appeal before our state medical board.  It was a very messy situation, with a doctor who had done one thing, not patient-related, that was, by his own admission, really stupid. I felt strongly that he needed another chance, and I wrote a long, impassioned letter brief to the board making every argument I could think of as to why they should give him that chance.  I asked my wife to proofread it for me.  She read the letter, and when she handed it back to me she just said, “Doctor _____ is lucky you’re his lawyer.”  Those simple words coming from that particular source meant as much to me as any recognition I’ve ever gotten…

    Q: Tell us about an embarrassing moment in your life.

    Bill: There have been many, but probably the most distinctive one was the time I fell out of the choir loft in the middle of a church service.  It’s a long story.

    Q: What do you like about being part of the Health Law Section?

    Bill: Again, there are so many ways I could answer that question that covering them all would take all day.  If I had to pick one thing, though, I would say it is the camaraderie and support, both professional and personal. Obviously, it’s great to have a group of lawyers around the country I can call on for advice or to share referrals, but it’s even better to have been able to make so many genuine friends through the Section. There’s almost never a day when I’m not in touch with someone I met through Section activities, and I am most profoundly grateful for that.


    Thank you to Bill for graciously participating in this week's Feature Friday. We appreciate everything you do for the Section and the Health Law field. Get to know your HLS leaders and fellow members. Check us out every Friday to see who we will feature next! #MakingFridayFunAgain #FeatureFriday

    Feature Friday -C. Joyce Hall- 06.15.18

    June 14, 2018 1:27 PM by blakleyr

    Welcome to Feature Friday!

    Happy Friday to all! This week we are excited to introduce you to Immediate Past Section Chair, C. Joyce Hall. Joyce is currently the Vice Chair of ABA Relations and the Marketing Committee.

    Ms. Hall is a member of the regional law firm of Watkins & Eager PLLC headquartered in Jackson, Mississippi and practices in the health care, general business, and commercial/public finance areas. Ms. Hall is a leader in the firm’s healthcare practice group and serves as Vice-Chair of the firm’s management committee. Ms. Hall is admitted to both the Mississippi Bar and the Louisiana Bar Associations and continues to be licensed in both states. She graduated from Mississippi College (B.S., with special distinction, 1984) and Mississippi College, School of Law (J.D., with special distinction, 1987). While in law school, she served as the Managing Editor of the Mississippi College Law Review. Early in her career, she was named by the Mississippi Bar Association as the “Outstanding Young Lawyer in Mississippi”, 1993-1994.  She is a past Chair of the Business Law Section of the Mississippi Bar. Ms. Hall is active in the American Bar Association, Health Law Section and is currently serving as Immediate Past Chair of the Section. Ms. Hall has authored and co-authored several articles in the Health Law field, including health law forms for the AMA. She has spoken at numerous health care conferences on the topics of compliance plans, fraud and abuse, physician contracting issues, health care reform, physician self-referral issues, HIPAA, ACO’s and Enterprise Risk Management. She has been recognized in The Best Lawyers in America® (2013 - 2018, Commercial Finance Law, Health Care Law, and Public Finance Law) and in Chambers USA (2015-2017, Corporate/Commercial: Banking & Finance). She was included in the Mississippi Business Journal’s Mississippi's 50 Leading Business Women (2009) and Leadership in Law Award, Top Ten Recipient (2015). She enjoys travelling and spending time with her family: husband- Daniel - and children - Dan (San Francisco), Drew (New York City) and Alyssa (Colorado).

    (Aloha! The Hall Clan is pictured here in Hawaii. They certainly are a good looking bunch!)


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

    Joyce: Every day is different. I love the variety of my work and the folks I get to meet along the way.

    Q: Why health law?

    Joyce: The health of our nation’s people is vital to the health of our country – both physical and mental health. We have a unique role to play as lawyers when we help our clients navigate the complexities of the laws affecting the way they deliver services – whether our clients are providers, payors, teachers/professors/academic medical centers, enforcers, or consumers. Health law is not stagnate and it’s recession proof.

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

    Joyce: Always do the right thing – even when it’s hard, even when it’s not popular.

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

    Joyce: (1) lots of drinking water; (2) sunscreen (from my dermatologist!); (3) a gas powered generator (filled with gas) so when my cell phone died I could power back up at least for a little while!

    Q: How do you define success?

    Joyce: Fulfilling my calling/job to the best of my ability and leaving things better than I found it.

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

    Joyce: (1) take the train to Chicago and go to a Cubs game; (2) go back to Hawaii (after the volcano calms down); (3) tour the Holy Land

    Q: What is one of your most embarrassing moments? 

    Joyce: Oh wow. One doesn’t usually like to re-live these moments. The embarrassing moments that come to mind all involve falling at inappropriate moments! I had a business lunch at a restaurant in Jackson. The parking lot badly needed an overlay. Fully clad in a business suit (skirt not pants), I hit the ground tripping on a broken place in the parking lot. The first thing I did was make sure I didn’t break anything, then I hopped in my car as quickly as possible to assess the damage. Aside from bloody knees and a bruised ego, I was ok.

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

    Joyce: Snickers candy bars because I love them AND it shows (insert gritting teeth emoji).

    Q: If you could pick up one skill very quickly, what would it be?

    Joyce: To play the piano by ear (my piano teachers from years past are cringing right now).

    Q: Would you rather be able to speak every single language or be able to communicate with animals? Why?

    Joyce: I would rather be able to speak every language. I love to travel, so this trait would come in extremely handy!

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

    Joyce: A teacher. In fact, I should probably add that to my bucket list!

    Q: What is your favorite thing about the Health Law Section?

    Joyce: My favorite “thing” about the Section is definitely the people – the HLS Staff, the leaders and the members. It is the most collegial professional group I have ever joined. Some of my favorite memories over the years have happened at HLS meetings. My professional life has been blessed and enhanced because of the relationships formed through the Section.


    We would like to extend a huge thank you to the lovely C. Joyce Hall for graciously participating in the Health Law Section's Feature Friday. Get to know your fellow HLS leaders and members. Check out Feature Friday every week on our HLS blog. We are #MakingFridayFunAgain! #FridaysAreForTheLawyers

    Changes to ACA Continue

    June 14, 2018 12:15 PM by billupsj

    The Trump Administration continues to make changes in ACA, including efforts to end protections for those with preexisting condition coverage.  The elimination of such protections could potentially be devastating for people with substance use and mental health conditions.

    Need for Increase in Number of Mental Health Facilities

    June 14, 2018 12:13 PM by billupsj

    Concerns about the need to improve quality and access to good addiction care has created discussions regarding the need to develop new mental health facilities. Increasing insurance parity, developing continuums of care and sensible commitment standards were also considered necessary next steps. 

    NIH Launches New Program for Addiction and Pain Research

    June 14, 2018 12:11 PM by billupsj

    The National Institutes of Health (NIH) released its research plan called Helping to End Addiction Long-term (HEAL), a long-term plan funded with $500 million added to its base appropriation, starting in FY 2018. The NIH will invest these resources to support science that advances national priorities for addiction and pain research.  HEAL includes a planned new public-private partnership to develop innovative therapies.  The NIH will also collaborate with industry and governmental agencies, as well as the Foundation for the NIH, to collect and evaluate treatment programs developed by academic and industry entities with the goal of coordinating and accelerating the creation of effective treatments for pain and addiction. 

    Increase in Homicide Charges Filed in Overdose Deaths

    June 14, 2018 12:08 PM by billupsj

    There has been a growing trend to prosecute and bring homicide charges against individuals, including friends, family and fellow users, who provide drugs to people who die by overdose. The phenomenon results from local communities seeking to address overdoses.

    OIG Advisory Opinion Supports Provision of Free Telemedicine Equipment

    June 14, 2018 12:07 PM by billupsj

    In a recent OIG Advisory Opinion, the OIG supported the provision of free telemedicine equipment to a referral source.   The opinion involved HIV prevention efforts at a Federally Qualified Health Center “look-alike” entity. 

    HHS Requests Comments on Healthcare Innovation and Investment Workgroup

    June 14, 2018 12:04 PM by billupsj

    A Request for Information (RFI) published in the June 7 Federal Register seeks comments on the structure of a workgroup to increase innovation and investment in the healthcare industry.  The Immediate Office of the Secretary of HHS seeks comments on how to structure the workgroup in order to "spur investment, increase competition, accelerate innovation and allow capital investment in the healthcare sector to have a more significant impact on the health and wellbeing of Americans." The forum would create a mechanism for agency leadership to collaborate with: healthcare innovation-focused companies; healthcare startup incubators and accelerators; healthcare investment professionals; healthcare-focused private equity firms; healthcare-focused venture capital firms; and lenders to healthcare investors and innovators.

    HHS seeks comments on areas of inquiry and focus for the workgroup; the structure of the workgroup including the subsectors of the healthcare economy that should participate; and opportunities for dialogue between the agency and innovators and investors in healthcare for the purposes of a durable and sustainable approach for increasing innovation and investment in healthcare.  This is the third request for information focused on healthcare innovation issued by the Trump Administration. In September 2017 the CMS Innovation Center (CMMI) published an RFI requesting comments on the new direction for the center and received over 1,000 comments in response.  In April, CMMI published an RFI on Direct Provider Contracting Models that would permit CMS to contract with Medicare providers and suppliers.  Comments were due by May 25, 2018.

    Comments to the RFI must be submitted to HHS by July 9, 2018 through regulations.gov or by mailing comments to: Immediate Office of the Secretary, Office of the Deputy Secretary, U.S. Department of Health and Human Services, Attention: RFI Regarding Healthcare Sector Innovation and Investment Workgroup, 200 Independence Avenue SW, Washington, DC 20201.


    VA MISSION Act Aims to Expand VA System

    June 14, 2018 12:02 PM by billupsj

    President Trump recently signed into law the VA MISSION Act of 2018. The bill aims to expand the VA system by offering veterans more options to healthcare. Notably, the bill establishes a Community Care Program, which requires VA to schedule medical appointments in a timely manner, including coverage for veterans who utilize care outside of a region where they reside. Additionally, the program requires access to community care – or non-VA care – if VA does not offer the care or services the veteran needs. 

    Signature HealthCARE Resolves FCA Allegations With DOJ

    June 14, 2018 12:00 PM by billupsj

    Signature HealthCARE, LLC (Signature), which owns and operates approximately 115 skilled nursing facilities, has agreed to resolve allegations that it violated the False Claims Act.  Signature was accused of knowingly submitting false claims to Medicare for rehabilitation therapy services that were not reasonable, necessary and skilled.  The settlement also resolves allegations regarding the forgery of pre-admission certifications of patient need for skilled nursing, which are required under the Medicaid program.  Under the settlement agreements, Signature has agreed to pay more than $30 million, a portion of which will be shared with the State of Tennessee. 

    Former Pain Management Doctor Imprisoned and Fined for Health Care Fraud

    June 14, 2018 11:56 AM by billupsj

    Rassan M. Tarabein, a former neurologist and pain treatment specialist, was sentenced to 60 months imprisonment in a health care fraud case.  Tarabein was ordered to pay restitution totaling $15,010,682 to six different health care benefit programs, including Medicare and the Alabama Medicaid Agency.  He was also ordered to undergo one year of supervised release after his imprisonment and to pay a $200 mandatory special assessment.

    Addiction Treatment Center Owner Charged with Fraud and Unlawfully Distributing Buprenorphine

    June 14, 2018 11:54 AM by billupsj

    Jennifer Hess of Washington, Pennsylvania, the owner of Redirections Treatment Advocates, LLC, an opioid addiction treatment practice with offices in Pennsylvania and West Virginia, has been indicted on charges of unlawfully dispensing controlled substances and health care fraud.  The indictment is the eleventh in a series of charges filed in the region by the Opioid Fraud and Abuse Detection Unit and its efforts, target and prosecute opioid-related health care fraud.

    U.S. Weighs in on ACA Constitutionality Case

    June 14, 2018 11:51 AM by billupsj

    Earlier this year, a group of twenty state attorneys general filed a lawsuit against the federal government alleging that the congressional decision to zero out the ACA's individual mandate penalty, effective next year, rendered the ACA unconstitutional. A group of states, led by California, intervened as defendants to support the law. Last week, the federal government filed its response to the plaintiff’s application for preliminary injunction.  Relying upon the federal government’s position in NFIB v Sebelius, the Justice Department argued that the zeroing out the individual mandate renders the individual mandate and the interrelated guaranteed issue and community rating provisions unconstitutional. The remaining part of the law, including the employer mandate and the Medicaid expansion provisions, are severable and unaffected by the zeroing out of the individual mandate. The Justice Department also argued that the appropriate remedy is a declaratory judgment, not a preliminary injunction.

    Virtua Health to Acquire Lourdes Health System

    June 14, 2018 11:47 AM by billupsj

    Virtua Health, a New Jersey non-for-profit health system, has signed a definitive agreement with Maxis Health System, an entity of Trinity Health, to acquire Lourdes Health System.  The acquisition includes: Our Lady of Lourdes Medical Center, Camden; Lourdes Medical Center of Burlington County, Lourdes Medical Associates; and Lourdes Cardiology Services.

    Virtua Health provides health care through is 500+ provider medical group, three hospitals, eight urgent care centers, and multiple ambulatory surgery centers and other facilities.  Virtua Health also participates in Virtua Physician Partners, a clinically integrated network of 1,000 providers.


    WellCare Agrees to Acquire Meridian for $2.5 Billion

    June 14, 2018 11:45 AM by billupsj

    WellCare Health Plans, Inc. has entered into an agreement to acquire Meridian Health Plan of Michigan, Inc., Meridian Health Plan of Illinois, Inc., and MeridianRx in a $2.5 billion cash transaction.  The transaction is expected to close by the end of 2018, subject to regulatory approval. Through the deal, WellCare expects to have the largest Medicaid membership market share in Michigan and Illinois.

    Meridian Health Plan of Michigan and Meridian Health Plan of Illinois have approximately 508,000 and 565,000 Medicaid members, respectively, with both also having Medicare Advantage Plans.  MeridianRx is a pharmacy benefit manager serving all Meridian customers as well as others.


    Opioids and Well-Being Examined by Fed

    June 7, 2018 10:57 AM by billupsj

    According to the Federal Reserve Board’s Report on the Economic Well-Being of American Households the opioid epidemic is taking an economic toll on American households. It was the first time the Fed has included questions about opioid addiction in its annual survey, which began in 2013.  The report also found that one out of five Americans say they personally know someone who has been addicted to opioids or prescription painkillers.


    Effective State Alcohol Policies

    June 7, 2018 10:55 AM by billupsj

    Researchers reported in the Journal of the American Medical Association (JAMA) that strengthening state alcohol policies by 10% can reduce the odds of alcohol-related motor vehicle deaths by the same amount.  They examined more than 500,000 crash deaths and then used a scale of 29 possible alcohol policies a state can have, weighted by effectiveness. Alcohol taxes are among the most effective policies in reducing crash deaths, the researchers found.


    Congress Explores Addiction Treatment Industry

    June 7, 2018 10:54 AM by billupsj

    There is growing attention in the media, in state capitols and in Washington, DC to the quality of treatment and business practices of some addiction treatment providers. The House Energy and Commerce committee announced that it is examining addiction treatment call aggregators and sent pointed letters to eight entities requesting detailed information regarding their business practices.


    Opioid Package To Be Considered Week of June 11 in US House

    June 7, 2018 10:52 AM by billupsj

    The US House is slated to hold what some refer to as “Opioid Week” beginning on June 11 when more than 60 opioid-related bills will be considered by the full House. In the Senate, many addiction-related bills are on the table, but floor action has yet to be scheduled.  CARA 2.0, a follow-up to the Comprehensive Addiction and Recovery Act, has been opposed by the AMA due to the bill's proposed opioid prescription limits, education mandates, and requirement that doctors check databases before prescribing certain drugs.


    CMS May Bring Back Pre-Claim Review Demonstration for Home Health Claims

    June 7, 2018 10:44 AM by billupsj

    CMS issued a notice on May 31, 2018, seeking public input on a proposal to bring back a pre-claim review demonstration for home health health claims. CMS is proposing that initially the demonstration will be implemented in Illinois, Ohio, North Carolina, Florida, and Texas with the option to expand to other states in the Palmetto/JM jurisdiction. Providers in the demonstration states will have the option to participate in either 100% pre-claim review or 100% postpayment review. If a provider does not elect either option, the provider will receive a 25% payment reduction on all claims submitted for home health services and may be eligible for review by the Recovery Audit Contractor.


    Pentagon Reports Cancer-Causing Agents on Certain Military Installments

    June 7, 2018 10:43 AM by billupsj

    The Pentagon recently released a report to the House Armed Services Committee regarding DoD testing of military, public, and private drinking water systems. The results confirm excess levels of Polyfluoroalkyl Substances (PFOS) above EPA acceptable levels on over four hundred US military bases.  In the 1970's, DoD began using the man-made chemicals in fire-fighting foam. PFOS may be associated with cancers and developmental delays in fetuses and children.  In 2017, DoD began installing water filters in these installments and supplying bottled water as an alternative to wells.


    Nurse Practitioners Arrested And Indicted For Unlawful Distribution Of Prescription Opioids And Health Care Fraud

    June 7, 2018 10:40 AM by billupsj

    On Friday, June 1, three Southern Nevada residents, including two nurse practitioners, were arrested and charged in a 29-count indictment for unlawful distribution of prescription opioids and Medicare/Medicaid fraud. The indictment alleges that the defendants engaged in a conspiracy to distribute prescription opioids and to commit health care fraud through a variety of actions including but not limited to improper usage of a prescription pad belonging to a physician, distribution of Hydrocodone and Oxycodone in exchange for cash without a legitimate medical purpose, and receipt of cash kickbacks from an unnamed pharmacy for patient referrals.

    Allegiance Health Management to Pay More Than $1.7 Million to Resolve FCA Allegations

    June 7, 2018 10:39 AM by billupsj

    Allegiance Health Management, Inc., (Allegiance), a Louisiana post-acute healthcare management company and four Allegiance hospitals have agreed to pay more than $1.7 million to resolve FCA allegations.  Claims against Allegiance were originally brought by a whistleblower involving a variety of practices relating to the provision of outpatient psychotherapy and counseling services.

    Virginia to Expand Medicaid in January 2019

    June 7, 2018 10:37 AM by billupsj

    Virginia is expected to become the 33rd state (plus the District of Columbia) to expand Medicaid under the ACA following the passage of a budget by the Virginia legislature.  The expansion will take effect on January 1, 2019, and it is expected to provide coverage to approximately 400,000 individuals.  Prior attempts to expand Medicaid in Virginia by former Governor Terry McAuliffe were stifled by an unsupportive legislature. The legislation expanding Medicaid passed with some Republican support, which was conditioned on the inclusion of an 1115 demonstration request containing a work or community engagement eligibility requirement.  The requirement will be gradually escalated, requiring at least 20 hours of work or community engagement a month beginning 3 months after enrollment and 80 hours after 12 months of enrollment. Under the ACA, the federal government will cover 90% of the cost of the expansion population, with the state responsible for the remaining 10% of funding.  Virginia will implement a tax on hospitals in order to pay for the state share of expansion funding.


    IRS Announces Two Healthcare Related Items

    June 7, 2018 10:36 AM by billupsj

    On May 11, 2018, the IRS announced the calendar 2019 inflation adjusted minimums and maximums for IRC § 223 high deductible health plans (“HDHP”) and health savings accounts (“HSA”).  Compared to 2018, the HSA contribution limits will increase by $50 to $3,500 for self only coverage and $100 to $7,000 for family coverage. The HDHP minimum deductibles are unchanged from 2018 -- $1,350 for self only coverage and $2,700 for family coverage. The HDHP out of pocket maximums will increase by $100 to $6,750 for self only coverage and by $200 to $13,500 for family coverage.

    On May 21, 2018, the IRS announced the inflation adjusted percentage that applicable large employers will use to determine whether the minimum essential coverage offered to employees is affordable as required by the ACA for plan years beginning after December 31, 2018. The specified percentage is 9.86%, up from the current 9.56%.


    OCR Proposes to Share HIPAA Data Breach Settlements With Victims

    June 7, 2018 10:35 AM by billupsj

    HHS plans to issue an advance notice of proposed rulemaking regarding potentially sharing HIPAA breach settlements with victims. The notice states that new proposed rules will be issued in November 2018 to solicit public opinion on creating a process for sharing a percentage of any penalty or settlement with those harmed by an offense punishable under HIPAA. Section 13410(c)(3) of the HITECH Act requires HHS to establish a methodology to distribute such monetary collections to those harmed.

    Exeter Health Resources, Massachusetts General, and Wentworth-Douglass Plan Regional Network

    June 7, 2018 10:32 AM by billupsj

    Exeter Health Resources, Massachusetts General Hospital, and Wentworth-Douglass Hospital signed a letter of intent to develop a regional health network to deliver care in the Seacoast Region.  The plan, approved by the entities respective boards, includes development of a non-profit corporation to serves as the parent of Exeter and Wentworth-Douglas as a subsidiary of Massachusetts General.  The due diligence and regulatory review process is expected to take 15 to 18 months to complete.

    Advocate Children's Hospital and NorthShore University Health System To Partner on Pediatric Care

    June 7, 2018 10:31 AM by billupsj

    Advocate Children’s Hospital and NorthShore University Health System announced a partnership seeking to expand pediatric care in Illinois by creating a comprehensive system of pediatric care in the Chicagoland area.  The partnership expects to consist of over 600 pediatricians, pediatric subspecialists, and maternal fetal medicine physicians along with hospital and ambulatory programs and services.  The delivery system has a planned launch of July 2018.

    Feature Friday June 8, 2018

    June 6, 2018 1:12 PM by blakleyr


    Welcome to Feature Friday

    Happy Friday to all! Thank you for finding your way to Feature Friday! Each week we have the pleasure of helping you get to know one of your fellow HLS members. Today, we have the honor of introducing you to Anjali B. Dooley. Anjali is a Vice Chair of the eHealth, Privacy and Security Interest Group, a Vice Chair of the Leadership Meeting Planning Committee, and a Vice Chair of the Web & Technology Committee.  

    Now, without further ado, we would like to present, Anjali!

    (Anjali is pictured on the beach. ***Editor's note- I wish I was on the beach.)

    Anjali is an attorney (admitted to the Bar in the states of Missouri, Kansas, and Illinois), entrepreneur, and business leader with extensive experience in healthcare, emerging technology, and business law. In her private law practice, her focus was on the representation of start-up businesses in financing and business development matters and on healthcare regulatory compliance. Previously, she has served as both a Special Prosecutor and Public Defender. Anjali is a leader within the American Bar Association Health Law Section, serving as Vice-Chair of the Section’s Web & Technology Committee and its eHealth, Privacy, and Security Interest Group. Her longstanding interest in rural health has led her to serve on various policy committees for the National Association of Rural Health Clinics. She also serves as an Adjunct Professor at Saint Louis University, John Cook School of Business. She is a legal analyst/expert for local and national news outlets, magazines, and bar associations. Anjali received her law degree from the University of Missouri-Kansas City School of Law, her MBA from the DePaul University-Charles H. Kellstadt Graduate School of Business and her BA in Economics from the University of Illinois at Champaign-Urbana IL. She remarks: “I am so excited to be joining the Forefront Team where I can put to work my years of experience in healthcare and my expertise in both healthcare and business law to help build a really great company.”


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

    Anjali: The ability to logically solve problems for physicians and other providers and assist them in making healthcare more efficient.

    Q: Why health law?

    Anjali: Both my parents are physicians, so honestly that’s all I know.  I also didn’t go to medical school (I mean that would take too long and I got a D in physics in college, so wasn’t happening), and really now I get to tell my parents what to do. Just kidding mom & dad.

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

    Anjali: A trial judge that practiced infront of said, “Don’t lose sight of the forest for the trees, meaning be concise in your briefs and I won’t read 60 pages of law. I need to know the facts in a logical manner.” I have always thought about what he said, and I try to be concise and not use legalese in writing.

    Q: How do you define success?

    Anjali: Being healthy and surrounded by a few people who love you.

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

    Anjali: Um… Unlimited supply of Watermelon (yes that is one thing); A good book, and possibly a boat to get off the island.

    Q: Who is the most inspirational person to you?

    Anjali: (I have two) and those are my kids. They teach me love and patience.

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

    Anjali: Um, I saw the Black Panther, so Wakanda!

    Q: What do you like about being part of the Health Law Section?

    Anjali: The friendships I have developed both personally and professionally. 



    We would love to thank Anjali for participating in this week’s Feature Friday! Thank you for all you do for the Section and the Health Law Field.
    Make sure to come back every Friday to check out our new Features. Happy Friday, everyone! #FeatureFriday #MakingFridayFunAgain

    Feature Friday June 1, 2018

    May 31, 2018 5:09 PM by blakleyr


    Welcome to Feature Friday

    Today for Feature Friday, we are beyond pleased to present the man of many degrees and former Section Council Chair, Mr. Paul R. DeMuro, CHC, FHFMA, FACMPE, CPA, MBA, MBI, JD, PhD.

    Paul R. DeMuro is Of Counsel in the Fort Lauderdale office of Broad and Cassel LLP and a voluntary Associate Professor of Public Health Sciences at the University of Miami Miller School of Medicine.  Previously a partner at several prominent law firms, including Latham & Watkins, Paul's passion is the cost-effective delivery of quality health care using data analytics. 

    Paul is a member of the American Institute of Certified Public Accountants, the American Medical Informatics Association, the Medical Group Management Association (where he is both Certified and a Fellow of the American College of Medical Practice Executives), the Healthcare Financial Management Association (where he is a Fellow and a former member of the National Board and its Executive Committee and Past President of the Northern California Chapter), the Healthcare Compliance Association (where he is Certified in Healthcare Compliance), the American College of Healthcare Executives, and the American Health Lawyers Association (where he is both a Fellow and a former Vice Chair of the ACO Task Force), the American Bar Association (where he is a Fellow of the American Bar Foundation, and former Chair of both the Health Law Section and the Joint Committee on Employee Benefits).

    He holds a bachelor's degree, summa cum laude, in Economics from the University of Maryland, is a Certified Public Accountant, with an MBA (Finance) from the Haas School of Business of the University of California, Berkeley.  He holds a Juris Doctorate from Washington University in St. Louis, and a Master and PhD in Biomedical Informatics from the Oregon Health & Science University School of Medicine, where he was a National Library of Medicine post-doctoral fellow, and studied the healthcare systems of many countries.

    He has authored or co-authored over 175 publications and has delivered over 400 presentations throughout the world.

    Now, ladies and gentleman, please put your hands together for Paul!

    (Paul says, "These girls are now 25 (living in NYC, working as a Management Consultant in Data Analytics), 22 (living in Chicago, working as an Investment Banker), and 20 (a computer science major at Harvey Mudd College and a Legal Studies major at Claremont McKenna College in So. Cal., interning this summer for both a health information technology company and a congressional candidate.)" Clearly the apple doesn't fall far from the tree in this family. **Editor cues song, "All I Do is Win.")


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

    Paul: The Attorney Client Privilege

    Q: Why health law? 

    Paul: I started in corporate, transferred to litigation, and what I liked most about each was health law

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

    Paul: Never stop learning and striving to be a better person.

    Q: How do you define success? 

    Paul: If my three daughters are happy, successful, and productive members of society.

    Q: What did you like most about being a Section Chair?

    Paul: Being able to make a difference in diversity. I was able to add a Vice-Chair to the interest groups which did not have a culturally diverse Vice-Chair and have them appoint one.  I also was able to reject those programs which did not have, in my opinion, enough women or culturally diverse individuals on them.

    Q: What is your favorite quote? 

    Paul: Enjoy every day.  It may be your last.

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

    Paul: a deep water well with unlimited fresh water; a solar generator; and access to satellite internet

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

    Paul: I would uninvent the cigarette.  It has caused countless harm around the world.  We would all be better off without it. Less people would be ill and our healthcare costs would be lower.

    Q: If you could pick up a new skill in an instant, what would it be?

    Paul: Be proficient in Python coding

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

    Paul: Develop an educational program that ensures that people can critically analyze data to help fill the over one million jobs requiring this skill, thus lifting up many members in society; become certified as an airline transport pilot (ATP); become a resident of the Grand Cayman

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

    Paul: An actor

    Q: What was your first job? 

    Paul: Clerk typist at a GEICO insurance agency. (I do not think GEICO even has insurance agencies today.)

    Q: You recently went to Cuba. What was that like for you? What were some main takeaways?

    Paul: My impression of Cuba is that someone broke a clock, but time also stopped.  I was told that Cuba had developed a good preventive care system with little money.  I was aghast at what little healthcare Cubans really have access to, e.g., no screening for colorectal cancer unless one is symptomatic, no screening for breast cancer until a woman is 55, no shock trauma units, and a paucity of high tech equipment.  There is very little access to the internet for clinicians, let alone the population. (I could only use the internet in the hotel lobby when it was working.)  Although Cubans have the right to health protection and care, it is only what little care that is available that they have access to.  On the positive side, the physicians who are paid very little seem, to know their patient population and take an interest in health.  There are significantly more physicians than attorneys. My favorite moment was when a member of the delegation who advised me at the start that she was a socialist, later told me at the end of the trip that she had changed her mind about socialism.

    Q: What is one of your most embarrassing moments?

    Paul: One of my most embarrassing moments was as a new associate at the Ober Grimes & Shriver firm in Baltimore, which became Ober | Kaler, which is now part of Baker Donelson.  We had a cocktail reception before starting.  For some reasons, the drinks were in plastic glasses.  I was so nervous that I clutched mine too hard and it cracked, spilling my drink all over. Thankfully, this was not a summer associate position, as I might not have received an offer.

    Q: Why do you attend PLI and what do you like about it?

    Paul: I am attending my first PLI next week and am very much looking forward to it.  It seems to bring together physicians and attorneys, consultants and advisors in a collaborative atmosphere and addresses cutting edge issues.

    Q: What is your favorite thing about the ABA Health Law Section? 

    Paul: The people


    The Section would like to thank Paul for graciously participating in Feature Friday. We very much appreciate your support for the Health Law Section and your betterment of the health law field.

    Get to know your HLS leaders and fellow members. Check out Feature Friday every week to learn about someone new! #MakingFridayFunAgain

    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!

    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.