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President Trump Signs Executive Orders that Enable Access to Affordable Meds

On Friday, July 24, 2020, President Trump signed four Executive Orders concerning prescription drug pricing which collectively direct the Secretary of the Department of Health and Human Services (HHS) to take the following actions:

1. Increase Patient Access to Insulin and Injectable Epinephrine

The first Executive Order, “Access to Affordable Life-saving Medications,” directs HHS to condition future federal grants available to Federally Qualified Health Centers (“FQHCs”) under the Public Health Service Act on the FQHCs having established practices which make insulin and injectable epinephrine available for discounted prices to patients who:

  1. Have a high cost sharing requirement for these drugs;
  2. Have a high, unsatisfied deductible; or
  3. Have no health care insurance.

The intent of the Executive Order is to enable Americans who may otherwise struggle to afford these necessary medications access to them at a much lower price — comparable to what FQHCs pay through the 340B Drug Pricing Program. In other words, FQHCs would be required to pass their 304B savings onto medically underserved patients.

2. Facilitate the Importation of Certain Prescription Drugs

The President’s Executive Order, “Increasing Drug Importation to Lower Prices for American Patients,” aims at expanding access to low-cost imported drugs by directing HHS to:
(1) facilitate waivers relative to the prohibition of importation of prescription drugs,
(2) authorize reimportation as “required emergency medical care,” and (3) finalize a rule to allow importation of prescription drugs from Canada.

The Executive Order builds on the Safe Importation Action Plan issued by HHS and the Food and Drug Administration (FDA) last year, which provided two pathways to providing safe, lower cost drugs to American consumers. Under the new Executive Order, individual waivers to import drugs are permitted as long as the importation does not pose a risk to public safety.

3. Remove the Anti-Kickback Safe Harbor Protection for Prescription Rebates

President Trump’s third Executive Order, “Lowering Prices for Patients by Eliminating Kickbacks to Middlemen,” directs HHS to finalize its rule: “Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees,” commonly referred to as the “Rebate Rule.”

As it stands, prices that patients pay at the point-of-sale are oftentimes significantly higher than the prices that insurance companies, or the “middlemen” hired by insurance companies, actually pay for the drugs. This leads to those middlemen receiving large “rebate” checks which are, in essence, kickbacks for the heightened prices paid by Medicare patients.

In finalizing the Rebate Rule, HHS would:

  1. exclude from the safe harbor protections of the Anti-Kickback Statute certain reductions in price that are not applied at the point-of-sale or other remuneration that drug manufacturers provide to health plan sponsors, pharmacies, or PBMs in operating the Medicare Part D program; and
  2. establish new safe harbors that would permit health plan sponsors, pharmacies, and PBMs to apply discounts at the patient’s point-of-sale in order to lower the patient’s out-of-pocket costs, and that would permit the use of certain bona fide PBM service fees.

If finalized, the Rebate Rule would have the effect of collectively saving Medicare patients billions of dollars on prescription drugs.

4. Implement the “Most Favored Nation” Order to Lower Medicare Part B Drug Cost

In issuing the above Executive Orders, President Trump also announced another initiative — the “Most Favored Nation” order — which builds on his International Pricing Index (IPI) model to ensure lower cost Medicare Part B drugs that would set United States pricing at rates comparable to countries similarly situated economically.

Under the IPI model, the United States federal government would pay certain vendors directly for Medicare Part B drugs and certain physicians and hospitals administration fees for distribution.

To date, the IPI model has not been put into effect; however, President Trump indicated his intent to implement the Executive Order in late-August 2020.

The collective effect of the four Executive Orders issued by President Trump last week serves to make access to affordable medications for Americans, particularly vulnerable populations, a public health priority.

As a practical matter, however, the power of the Executive Order is limited — making the functional impact of the new directives dependent on how quickly HHS moves through the formal rule-making process.

As a result, the time frame in which the healthcare industry can expect to see systematic changes from the President’s Orders remains uncertain. In the meantime, healthcare entities should keep a watchful eye for new guidance from HHS.

Please contact BMD Health Law Attorney Jeana Singleton (jmsingleton@bmdllc.com) for questions regarding the new Executive Orders and their practical effect, or for any other healthcare questions.

Ohio Supreme Court Clarifies Medical Statute of Limitations

The Ohio Supreme Court issued a decision in late December that clarifies and finalizes the Ohio law regarding the period of time in which patients can assert claims for medical malpractice. The Court was examining the interplay between three different statutes being the statute of limitations, the statute of repose, and the savings statute.

Ohio Hospitals and Healthcare Clinics: It’s Time to Revisit Your Billing and Collection Practices

According to a recent Cuyahoga County case, certain healthcare entities may not be protected from liability when engaging in unfair or deceptive billing acts. This decision is consistent with the growing trend across the country to encourage price transparency and eliminate unfair surprise billing practices by health care organizations. Now is the time for hospitals and other health care organizations to revisit their billing and collection policies and procedures to confirm that they are legally defensible and consistent with best practices.

HIPAA Business Associate Agreements: Why These Contracts Matter

No one loves drafting, reading or negotiating HIPAA Business Associate Agreements (BAAs). Yet many of us need to do so, and some of us do so daily. They are often boring, dense and technical, but BAAs are important from both a legal and a business perspective, and they deserve our attention. Failure to enter a BAA when one is required can constitute a HIPAA violation that results in substantial liability, as demonstrated by certain recent Department of Health & Human Services (HHS) settlements.1 A business associate who makes a disclosure that is not authorized by the applicable BAA or required by law can be subject to civil and, in some cases, criminal penalties. Further, parties are often presented with BAAs that contain onerous one-sided indemnification and other provisions that can be devasting to an organization in the event of a HIPAA breach. The significance of a BAA is often not fully understood by the parties until something goes wrong (e.g., a HIPAA security incident or breach, an Office of Civil Rights (OCR) audit or a fracture in the relationship between the parties) and, at that point, there is limited opportunity to mitigate legal and business risk. Ideally, attention should be given at the commencement of the business associate relationship, when the parties are able, to thoughtfully addressing regulatory requirements, planning and preparing for potential adverse events and appropriately allocating risk among the parties. As with most healthcare regulatory compliance initiatives, a proactive approach with respect to BAAs is preferable. This article provides a broad overview of certain BAA requirements and some practical negotiating tips for the parties involved.

“I’m Out Of Here!” Now What?

We all know that the healthcare industry is experiencing a wave of integration. This trend has been evident for many years. Fewer physicians are willing to assume the legal, financial and other business risks associated with owning their own practices. More and more physicians, including anesthesiologists, are becoming employed by large physician groups, health systems and national providers. This shift necessarily involves not only entry into new employment arrangements but also the termination of existing relationships. And those terminations are often governed by written employment agreements, state and federal healthcare laws and employer benefit plans and other policies and procedures. Before pursuing their next opportunity, physicians should pause for a moment and first attend to the arrangement that they are leaving. Departing physicians need to understand their legal rights and obligations when leaving their current employment relationships in order to avoid unintended consequences and detrimental missteps along the way. Here are a few words of practical advice for physicians contemplating an exit from their current employment arrangements.

Investment Training for the Second and Third Generations

Consider this scenario. Mom and Dad started the business from the ground up. Over the decades it has expanded into a money-making machine. They are able to sell the business and it results in a multimillion-dollar payday for their labors. The excess money has allowed Mom and Dad to invest with various financial advising firms, several fund management groups, and directly with new startups and joint ventures. Their experience has made them savvy investors, with a detailed understanding of how much to invest, when, and where. They cannot justify formation of a full family office with dedicated investors to manage the funds, but Mom and Dad have set up a trust fund for the children to allow these investments to continue to grow over the years. Eventually, Mom and Dad pass. Their children enjoy the fruits of their labors, and, by the time the grandchildren are adults, Mom and Dad's savvy investments are gone.