Health Care

On July 30, 2019, the Centers for Medicare & Medicaid Services (CMS) announced more proposed changes to the Open Payments Program, otherwise known as the Sunshine Act. The proposed changes include new requirements that are expected to impose burdens on pharmaceutical and medical device manufacturers.

On July 31, 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published a proposal, called the Safe Importation Action Plan, to allow certain entities to import drugs from foreign entities. While this development was not a surprise given President Trump’s campaign promises to lower drug prices by, among other things, removing barriers to drug product importation, it represents a stark departure from prior agency positions that the importation of drugs could not be adequately verified as safe and would not lead to significant cost reductions.

In June 2019, the Delaware Supreme Court issued a decision reaffirming a risk of director liability where there is no board-level reporting process for essential compliance matters.  The facts of the case arise from a 2015 listeria outbreak at Blue Bell manufacturing which resulted in the death of three people. The Delaware case reaffirmed the position that directors may be subject to liability if the director “(1) completely fail[ed] to implement any reporting or information system or controls, or (2) having implemented such a system or controls, consciously fail[ed] to monitor or oversee its operations thus disabling themselves from being informed of risks or problems requiring their attention.”  

Earlier this month, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued its 2019 “Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: Top Unimplemented Recommendations.” The OIG releases a version of this report each year outlining its top 25 unimplemented recommendations to reduce fraud, waste, and abuse (“FWA”) among HHS programs. This blog post focuses on those recommendations specific to Medicare Part C and Part D for 2019.

$100 million in Federal funds may soon become available to help healthcare providers cover the costs of broadband and connected care services. Earlier this month, the Federal Communications Commission (FCC) voted on a proposal, on which it will seek public comment, for a new “Connected Care Pilot Program,” and the comment period on that proposal has now begun. The proposed program would direct money to telehealth initiatives, especially for medically underserved populations like low-income families and veterans. The money would come from the Universal Service Fund (USF), which is an existing fund of fees paid by telecommunications service providers currently used for a variety of purposes.

Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR), Chairman and Ranking Member (respectively) of the Senate Finance Committee, have fired the latest shot in Congress’s ongoing battle against high drug prices. Last week, the Senators introduced their much-anticipated proposal to lower drug prices: a chairman’s mark called the Prescription Drug Pricing Reduction Act (PDPRA) of 2019.

This week, the Senate is expected to vote on a budget deal that would also suspend the debt limit for two years. This clears a major hurdle come September when both chambers of Congress will be in session with a laundry list of policies and programs to address, including appropriations. We cover this and more in this week's preview, which you can find by clicking here. 

On July 29, 2019, the Food and Drug Administration (FDA) published a notice to the Federal Register (84 Fed. Reg. 36609). The notice invites comments on information collected in connection with FDA research by obtaining information from pharmacists and other management at outsourcing facilities as well as related compounding businesses. The collected information will support a comprehensive analysis of the outsourcing facility sector with hopes to inform future FDA work in this area.

Earlier this month, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) released two reports regarding its concerns and recommendations related to quality of care at hospice facilities. These reports follow a portfolio report that the OIG released last summer regarding significant vulnerabilities in the Medicare hospice benefit. In these reports, the OIG outlines several quality of care issues and recommends several ways that CMS should strengthen safeguards, all of which may further increase enforcement in an already heavily scrutinized area.

There are reports that HHS plans to issue a proposed rule next month, which would again amend 42 CFR Part 2 (“Part 2”) and modify how the medical records of patients with substance abuse disorders are currently shared between providers. Part 2 amendments, especially amendments to align Part 2 with the Health Insurance Portability and Accountability Act (“HIPAA”), would be welcome news to the many stakeholders in the industry who have repeatedly voiced their concerns regarding the regulatory hurdles that surround the disclosure of drug and alcohol treatment records.

Regular readers of this blog know that we’re closely following the FDA’s proposed regulatory framework for software as a medical device (SaMD), known as precertification—Pre-Cert for short. Generally, Pre-Cert involves a premarket evaluation of a software developer’s culture of quality and organizational excellence and continual, real-time postmarket analyses to assure software meets the statutory standard of reasonable assurance of safety and effectiveness.

On July 11, 2019, the Centers for Medicare and Medicaid Services (CMS) issued its Home Health Prospective Payment System proposed rule for 2020. The proposed rule implements a previously finalized reimbursement methodology for Home Health Agencies (HHAs) called the Patient-Driven Groupings Model (PDGM). The proposal reflects CMS’s continued efforts to shift towards value-based payment models in the Medicare program.

This week, the House is set to vote on repeal of the Cadillac tax, which is a forty-percent tax on high-cost health plans established by the Affordable Care Act. While its prospects for passage in the Senate are not entirely clear, passage out of the House clears an important hurdle. In other news, we are continuing to monitor the evolving drug pricing debate which is still expected to ramp up in the coming weeks with action from the Administration and Senate.

In an unexpected turn of events, the Trump administration has apparently reversed course and has withdrawn the proposed rule that would have amended the discount safe harbor under the Anti-Kickback Statute to eliminate protections for certain drug rebates paid by pharmaceutical manufacturers. “Based on careful analysis and thorough consideration, the president has decided to withdraw the rebate rule. The Trump administration is encouraged by continuing bipartisan conversations about legislation to reduce outrageous drug costs imposed on the American people, and President Trump will consider using any and all tools to ensure that prescription drug costs will continue to decline," White House Deputy Press Secretary Judd Deere said in a statement.

On June 26, 2019, the Office of Civil Rights (OCR) within the U.S. Department of Health and Human Services (HHS) released Frequently Asked Questions (FAQs) on how HIPAA allows health plans to share protected health information (PHI). The FAQs pose two questions: (1) whether HIPAA permits one health plan to share PHI about individuals in common with a second health plan for care coordination purposes; and (2) whether HIPAA permits health plans to use and disclose PHI to inform individuals about other health plans that it offers, without the individuals’ authorization, if the health plan received the PHI for a different purpose. The former answer is an affirmative “yes,” and the latter is a qualified answer of “yes, in certain circumstances.”

The Third Circuit Court of Appeals recently dismissed a relator’s False Claims Act (“FCA”) case under the pre-Affordable Care Act (“ACA”) version of the public disclosure bar. The court decided in U.S. ex rel. Denis v. Medco that to escape the FCA’s public disclosure bar by qualifying as an “original source” under the pre-ACA version of the FCA, a relator must have first-hand, non-derivative knowledge of conduct giving rise to the FCA claim.

On June 13, 2019, the Department of Health and Human Services (HHS), the Department of Labor (DOL), the Department of the Treasury (Treasury Department) and the Internal Revenue Service (IRS) (collectively, the “Departments”) issued a coordinated set of final regulations (“final rules”). Entitled, “Health Reimbursement Arrangements and Other Account-Based Group Health Plans,” the final rules expand employers’ ability to offer health reimbursement arrangements (HRAs) to their employees to be used in conjunction with individual market coverage and recognize a new type of excepted benefit HRA that allows employees to pay for HIPAA excepted benefits and short-term coverage. This post summarizes the final rules.

In follow-up to our previous post, the pharmaceutical industry gained a win on July 8th when a federal judge struck down the Trump administration’s rule that would have required drugmakers to include list prices for drugs in TV ads.

This week, the Affordable Care Act (ACA) is back in the news with oral arguments set to begin before the U.S. Court of Appeals for the Fifth Circuit. The court will decide whether to uphold a federal district court's ruling that struck down the ACA. This case has the potential to reshape the political landscape in 2020 if it reaches the Supreme Court. On Capitol Hill, policymakers are working hard to bring forth a drug pricing package before the August recess. They will also have to balance the Administration's efforts, which is expected to issue an executive order this month on lowering drug costs. We cover this and more in this week's preview. 

Last week, President Trump signed an “Executive Order on Improving Price and Quality Transparency in American Healthcare to Put Patients First.” The order, which “seeks to enhance the ability of patients to choose the healthcare that is best for them,” includes a number of provisions requiring the Departments of Health and Human Services, Labor, Treasury and others to pass regulations to increase transparency for patients. The following is a summary of the executive order and a brief overview of what providers and others in the healthcare industry can anticipate going forward.