Archive for 'April 2018'

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

    April 27, 2018 11:14 AM by billupsj

    Tues April, 17, 2018

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

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

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

    Hillary Stemple, Arent Fox, Washington, DC

    Feature Friday April 27, 2018

    April 27, 2018 10:36 AM by carsons


    Welcome to Feature Friday!

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

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

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

    Now, on to our Feature Friday questions!

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

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

    Q: Why health law?

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

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

    Hal: I’m an introvert at heart!

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

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

    Q: How do you define success?  

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

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

    Hal: A therapist.

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

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


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

    LabCorp and Mount Sinai Enter Agreement to Enhance Laboratory Operations

    April 26, 2018 2:40 PM by billupsj

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

    HHS Releases Mental Health and Substance Use Disorder Parity Action Plan

    April 26, 2018 12:15 PM by billupsj

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

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

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

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

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


    HHS Takes New Steps to Implement Value-Based Agenda

    April 26, 2018 12:12 PM by billupsj

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

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

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

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

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


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

    April 26, 2018 12:10 PM by billupsj

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

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

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

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


    AHRQ National Guideline Clearinghouse Will Lose Funding after July 16th

    April 26, 2018 12:02 PM by billupsj

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

    Court of Federal Claims Grants Class Action Status in CSR Case

    April 26, 2018 12:01 PM by billupsj

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

    FDA Employs Innovative Methods to Prevent Illegal Products from Entering US

    April 26, 2018 11:58 AM by billupsj

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

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

    April 26, 2018 11:57 AM by billupsj

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

    FDA Pushes Creation of Cybersecurity Team

    April 26, 2018 11:49 AM by billupsj

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


    CMS Proposes Changes to Meaningful Use Program

    April 26, 2018 11:48 AM by billupsj

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


    Fresenius Medical Care To Sell Sound Inpatient Physician Holdings

    April 26, 2018 11:46 AM by billupsj

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

    Nomination Slate for Officers and Council Members for FY 2019

    April 23, 2018 3:13 PM by carsons

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

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

    • Hal Katz, Husch Blackwell LLP Austin, TX


    SECRETARY (1-year term)




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


    Automatic Ascension:

    CHAIR (1-year term beginning August 2018)


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


    BUDGET OFFICER (3-year term beginning August 2018)


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


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

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

    April 23, 2018 10:45 AM by carsons

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

    Medicare Part E for All Proposed But Passage Remains Uncertain

    April 20, 2018 11:32 AM by billupsj

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

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

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

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

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

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

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

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

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


    Healthcare Litigation & Risk Management Tweet Chat April 25

    April 20, 2018 9:56 AM by billupsj

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

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

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

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

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

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

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

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


    Pennsylvania Adds Treatment for Opioid Withdrawal to State Medical Marijuana Program

    April 19, 2018 3:49 PM by billupsj

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

    Senate HELP Committee Continues Work on Opioid Epidemic

    April 19, 2018 3:47 PM by billupsj

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

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

    April 19, 2018 3:45 PM by billupsj

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

    Coalition asks HHS to Take Action Against ESRD Steering

    April 19, 2018 3:44 PM by billupsj

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

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

    April 19, 2018 3:42 PM by billupsj

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

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

    April 19, 2018 3:39 PM by billupsj

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

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

    April 19, 2018 3:37 PM by billupsj

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

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

    April 19, 2018 3:36 PM by billupsj

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

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

    OIG Releases Report on Medicare Telehealth Program

    April 19, 2018 3:32 PM by billupsj

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

    Movement on New Federal Bills, Addiction and the Workforce

    April 12, 2018 12:53 PM by billupsj

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

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



    Feds Seek to Join Opioid Suit

    April 12, 2018 12:48 PM by billupsj

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



    Surgeon General Issues Advisory on Naloxone

    April 12, 2018 12:47 PM by billupsj

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

    Hospital Workers' Unions Pushing Proposals to Decrease Dialysis Clinic Reimbursements

    April 12, 2018 12:45 PM by billupsj

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


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

    April 12, 2018 12:43 PM by billupsj

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

    CVS Blames Pharma Rising Drug Prices

    April 12, 2018 12:41 PM by billupsj

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


    California Sues Sutter Health Alleging Anticompetitive Contracts

    April 12, 2018 12:40 PM by billupsj

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


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

    April 12, 2018 12:38 PM by billupsj

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

    CMS Publishes 2019 Payment Notice and Related Guidance for Health Insurers

    April 12, 2018 12:36 PM by billupsj

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

    Outcome Health Agrees to Settle Class Action Lawsuit Over Text Messages

    April 12, 2018 12:34 PM by billupsj

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


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

    April 12, 2018 12:32 PM by billupsj

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


    Massachusetts Eye and Ear Joins Partners Healthcare

    April 12, 2018 12:31 PM by billupsj

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

    St. David's HealthCare Acquires The Austin Diagnostic Clinic

    April 12, 2018 12:29 PM by billupsj

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

    BCBS Adopts New Opioid Prescribing Standards

    April 5, 2018 3:11 PM by billupsj

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

    Iowa Law Expands Mental Health Services

    April 5, 2018 3:09 PM by billupsj

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


    Final Exchange Enrollment Data Shows Slight Decline

    April 5, 2018 3:04 PM by billupsj

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


    Companies Form Alliance to Improve Data Sharing

    April 5, 2018 3:03 PM by billupsj

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


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

    April 5, 2018 3:01 PM by billupsj

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

    Virginia Ambulance Provider Settles False Claims Act Allegations

    April 5, 2018 2:59 PM by billupsj

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

    ONC Releases Guide to Educate Individuals on Accessing Health Records

    April 5, 2018 2:56 PM by billupsj

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


    OCR Cyber Security Newsletter: Importance of Contingency Planning

    April 5, 2018 2:54 PM by billupsj

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


    Ascension and Providence St. Joseph Cease Merger Discussions

    April 5, 2018 2:52 PM by billupsj

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

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

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


    Community Health Systems To Sell Three Hospitals

    April 5, 2018 2:51 PM by billupsj

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