On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to modernize and clarify the regulations that interpret the Medicare physician self-referral law (often called the “Stark Law”), which has not been significantly updated since it was enacted in 1989. As CMS tries to reconstruct the healthcare field, it is imperative for compliance programs to prepare for the changes in regulations to come. The following discussion provides a brief overview of the proposed changes but is not an exhaustive list of all rulemakings related to the physician self-referral law.
On September 5, 2019, the Centers for Medicare and Medicaid Services (“CMS”) released its final rule with comments on Program Integrity Enhancements to the Provider Enrollment Process (“ The Program Integrity Enhancements”). The final rule gives CMS the power to revoke Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) enrollments of providers or suppliers who have an “affiliation” with previously sanctioned entities, even if those providers and suppliers aren’t directly violating any existing rules themselves. CMS says that this new authority will help to “stop fraud before it happens.”
In March 2019, Rush University Medical Center (“Rush University”) sent out breach notification letters to approximately 45,000 patients. The letter advises patients that a privacy incident occurred that may have involved the patients’ personal information. The privacy incident was caused by an employee of a third-party financial services vendor. The employee released a file that contained patient information to an unauthorized person. According to the breach notification letter, law enforcement and regulatory officials were involved in the investigation of the privacy incident. Rush University sent the breach notification letter in compliance with the Health Insurance Portability and Accountability Act’s privacy and security rules.
The Common Rule, the Federal policy protecting human subjects of biomedical and behavioral research, was published in 1991. The process to update the policy has taken place over the last several years, leading to the final rule revisions which were effective as of July 19, 2018. After January 20, 2019, institutions are now permitted to implement the entirety of the revised Common Rule. Any institution receiving funds, supervision, or review from any of the twenty Federal Departments and Agencies that have codified the Common Rule must implement this revised rule in their compliance programs.
On January 31, 2019, the Trump administration proposed yet another regulation in efforts to control rising prescription costs for Americans. If the regulation becomes final, drug manufacturers and Pharmacy Benefit Managers (“PBM”) will no longer be able to harbor from Anti-Kickback violations when negotiating discounts with Medicare and Medicaid managed care programs. The Administrations, continuing the tone of transparency, will instead provide Medicare Part D beneficiaries with the ability to receive discounted prices at the pharmacy counter. The administration hopes this will allow patients to not endure high out-of-pocket costs by purchasing medications at a more affordable price necessary to sustain their health.
A pair of injunctions in the Northern District of California on January 13, and the Eastern District of Pennsylvania on January 14, halted the implementation of amendments to a religious exemption to the so-called contraception “mandate” of the Affordable Care Act, also known as Obamacare. The “mandate” requires most employers to include contraception coverage in the insurance plans they offer to employees. While Obama administrative agencies contemplated religious exemptions early on, contentious litigation and political transition expanded the scope of the exemption until these latest developments.
In August, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) made an additional focus in its Work Plan for the oversight of nursing facility staffing levels. These changes were made in the light of backlash from a July 2018 news article which reported that nearly 1,400 nursing homes had fewer qualified staff on duty than they were required or failed altogether to provide reliable staffing information to the Centers for Medicare and Medicaid Services (“CMS”).
Access to quality, comprehensive health care services seems to always be at the forefront of our health care industry. One’s ability to gain access measured in terms of utilization, is dependent upon financial affordability, and physical accessibility. While a seemingly small issue under the overarching ‘access to health care’ topic, talks about access to medication and its affordability in particular for the vulnerable and underinsured patients must also be addressed. A number of health organizations have sued HHS for delaying the implementation of rules that would force drug companies to be transparent about their pricing and punish them for overcharging participating hospitals in the federal program that discounts outpatient medication. Due to HHS’ delays, hospitals cannot challenge drug manufacturers for overpricing outpatient medication thus they cannot access refunds of discounts that are due to them under statute.
After years in an opioid crisis, the United States now faces an opioid epidemic that has left the government and public desperate for relief and a workable solution. A group of senators hopes to be part of the solution with the introduction of a bipartisan bill that aims to better enable the DEA to establish opioid quotas. Despite already-present struggles to effectively manage its quota system and policies, the DEA would be given significantly more responsibility under this bill. Drug manufacturers, directly responsible for following DEA, FDA, and OIG regulations to hopefully resolve the epidemic, will need to grow their compliance efforts and create responsive solutions to remain both profitable and compliant.
For the first time since 2013, on Saturday, January 20th, 2018, the U.S. government ran out of money when Congress failed to pass a spending bill to fund the federal government. Much of the federal government’s operations have ground to a halt due to the lack of funding. Because Congress is seemingly at an impasse over immigration policy, the shutdown may last several days, if not weeks. In light of Loyola’s upcoming symposium exploring what happens when regulation is not enforced, it is interesting to consider how, in a similar vein, the shutdown affects compliance.