In a previous blog, we reviewed pending and approved 1115 waivers in 11 states. These reviews provide an overview of 1115 waiver applications, including a focus on work requirements, lock-outs, changes in coverage structures, repealing the Medicaid IMD exclusion, and other behavioral health initiatives.  As we continue to monitor these applications, we’ve created a new site to track 115 waivers and will be continuing to update this site with additional state waiver requests and approvals.

On April 30, 2018, Ohio became the latest state to submit an 1115 waiver to include work requirements for certain Medicaid beneficiaries. The waiver application requires individuals in the Group VIII category – those with income level of 0-138% of the federal poverty level (FPL) – to meet the Work and Community Engagement requirement to maintain their Medicaid eligibility. These requirements will closely mirror existing SNAP and Able-Bodied Adults without Dependents (ABAWD) requirements. There are at least fifteen exemptions to the work requirements outlined in the 1115 waiver request.

If the individual is not exempt, they will need to work or participate in a community engagement activity for a minimum of 20 hours per week, or 80 hours averaged monthly. These activities include education and training activities, job search or readiness programs, or the Work Experience Program, which supports beneficiaries in meeting work activity requirements through private or government entities.

Lastly, Ohio is requesting a federal match for supportive services such as transportation to help eligible beneficiaries in meeting the work and community engagement goals. If there is no federal match, the State would consider granting beneficiaries a good cause exemption. To date, Ohio is the only state with a submitted 1115 waiver including work requirements that is pursuing federal match for supportive services to help beneficiaries meet the work requirement.

A complete summary of the Ohio 1115 waiver application is found here.

You can view our complete waiver summary and links to state-by-state summaries by clicking here.

Recently the U.S. Department of Justice (DOJ) issued a statement that it had intervened in a False Claims Act (FCA) case against Insys Therapeutics, Inc. and consolidated five separate qui tam cases into one case, U.S. ex rel Guzman v. Insys Therapeutics, Inc., filed in the U.S. District Court for the Central District of California. The complaint revealed that multiple states—California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Michigan, Minnesota, Montana, Nevada, Massachusetts, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas, Virginia, and Washington—as well as the District of Columbia, have also joined the case.

Continue Reading DOJ Continues Aggressive Enforcement Action Against Opioid Manufacturers

On Wednesday May 9th, I was floored when the Administration released the Spring 2018 Unified Agenda of Regulatory and Deregulatory Actions, which contained this nugget: by December 2018, HRSA will publish its 340B Omnibus Guidance. Readers of our blog know that, as we predicted, this so-called Mega-Guidance was withdrawn in January 2017 without ever seeing the light of day. Within a day, the Unified Agenda was reposted with references to the so-called 340B Mega-Guidance removed, and HRSA acknowledged that its inclusion in the Unified Agenda was an error. The 340B Guidance remains shelved.  Continue Reading Last Week in 340B: the Revival [not] of the 340B Mega-Guidance, Another Senate Hearing, and the Trump Blueprint to Lower Drug Prices

This week, the House is set to vote on Right to Try legislation which has gained the support of FDA Commissioner Scott Gottlieb. In the Senate, the HELP Committee will review the Pandemic and All-Hazards Preparedness and Advancing Innovation Act, or PAHPA, along with rural health care issues, which the Senate Finance Committee also happens to be looking at this week. On the Administration’s side, several agencies took steps forward consistent with the President’s agenda on drug pricing. How this plays out over the next several months will be relevant to all stakeholders in this space. We cover this and more in this week’s preview, which can be found here.

Earlier this week, our colleague Don Davis addressed the increasing amount of disability discrimination litigation against health care entities on the Employment Matters Blog. In the blog post, Don provides an overview of the Americans with Disabilities Act (“ADA), describes employment disability discrimination litigation and enforcement trends in the health care industry, and highlights the recent spike in accessibility-related litigation (including issues related to both facility accessibility and website accessibility).

The full post is available here.

In less than 10 days, the European Union will begin enforcing its General Data Protection Regulation (GDPR) which will apply to any company that collects, processes, or uses EU-origin personal data, regardless of where the company is located. Though many of our readers are focused on HIPAA, some engage engage in activities that may trigger the GDPR, or they may have future aspirations to expand their business into the EU. Fortunately for our readers, our colleague Cynthia Larose has been relentlessly covering the GDPR at Privacy & Security Matters, and recently published a refresher list of webinars on GDPR issues related to contracts, human resources data, data transfer and more.

This week, the House Energy & Commerce Committee will hold its second round markup of opioid-related legislation. While they remain on pace for passage by Memorial Day, the timing will be determined by how smooth the markup this week goes. Additionally, Ways & Means is also considering a markup of four large packages of opioid legislation. Anything the House passes will have to go to the Senate. In other words, the June work period seems more likely for significant action in this space.

Additionally, the Administration is moving ahead with its drug pricing initiative. While the initial reaction was skepticism, the Administration would not have put the initiative in writing if they didn’t mean it. As the key players continue discussing the various proposals, understanding where the Administration has the authority to act and how it could impact what you do is key to staying ahead of any proposals that gain traction. We cover this and more in this week’s health care preview, which you can find here.

On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration’s plan to lower drug prices and reduce out-of-pocket costs.

The speech made pointed attacks on “the middlemen” and drug lobbyists. President Trump even called out Secretary Azar’s past role as a drug company executive when calling out drug companies’ role in high drug prices. Continue Reading President Trump Delivers Much Anticipated Drug Pricing Speech

Businesses engaged in human drug compounding, both traditional pharmacies and the more recently created outsourcing facilities, have been on quite a rollercoaster ride since congressional enactment of the Drug Quality and Security Act (DQSA) approximately four-and-a-half years ago. Federal and State inspectional mandates have changed, FDA guidance documents (and a few regulations) have been churned out, and some entities have been the target of aggressive enforcement actions and even criminal prosecutions by the FDA/Department of Justice. Suffice it to say, this blog post cannot capture everything that compounders have been grappling with or how their compliance policies have been evolving. So today, we are sharing one important and positive bit of news for health systems and other entities that may be considering whether and how to set up an outsourcing facility under Section 503B of the Food, Drug, and Cosmetic Act (as amended by the DQSA). Continue Reading FDA Alters Course on Definition of Compounding “Facility” in Final Guidance

Back in late 2015, we blogged about the interesting twist in the $125 million Warner Chilcott settlement that a Massachusetts physician had been criminally charged with violating the Health Insurance Portability and Accountability Act (HIPAA).   See HERE for that previous post.

That physician has now been convicted of the HIPAA violation, as well as an unrelated charge of obstructing a federal health care investigation.  The US Attorney’s Office in Boston made the announcement late last month.

The Warner Chilcott settlement involved illegal drug promotion.  Specifically, sales reps were accused of flagging patient medical records with product brochures and filling out the provider’s prior authorization forms in advance for specific patients.  All of this required impermissible access to patient records.  The physician’s criminal liability stems from providing these sales reps with access to her patients’ records.  In some cases, the reps were even allowed to take the records home with them!

We are often reminded through settlements with the HHS Office for Civil Rights that HIPAA violations are taken seriously and can include hefty fines and corrective action plans (see HERE, HERE and HERE for just a few examples).  This case serves as fair warning that intentional misuse of protected patient information can lead to jail time.  When this physician is sentenced, she could be looking at up to a year in prison, a $50,000 fine, and a year of supervised release.  If you picture a sales rep combing through your personal health issues in his or her living room to determine whether you might be a sales target, it shouldn’t be so surprising that this conduct can rise to the level of criminal liability.