On October 9, 2019, the Department of Health and Human Services (“HHS”) Centers for Medicare and Medicaid Services (“CMS”) and Office of Inspector General (“OIG”) released proposed rules in conjunction with HHS’ “Regulatory Sprint to Coordinated Care.” The Regulatory Sprint to Coordinated Care “aims to remove potential regulatory barriers to care coordination and value-based care created by four key Federal health care laws and associated regulations: (1) the physician self-referral law [(“Stark Law”)]; (2) the anti-kickback statute [(“AKS”)]; the Health Insurance Portability and Accountability Act of 1996 [(“HIPAA”)]; and (4) the rules… related to opioid and substance use disorder treatment.”
Continue Reading CMS and OIG Propose Regulatory Changes Impacting the Scope of the Stark Law and the Federal Health Care Program Anti-Kickback Statute

In its recently updated Work Plan, the Office of the Inspector General (“OIG”) at the Department of Health & Human Services (HHS) announced that it will conduct an audit focusing on how selected state Medicaid agencies and Medicaid managed care organizations (“MCOs”) leverage telehealth to provide behavioral healthcare.
Continue Reading OIG to Audit Provision of Behavioral Health Services Through Tele-Health Under Medicaid Managed Care

A 2016 Final Rule from CMS created a new regulatory requirement for long-term care facilities, 42 C.F.R. § 483.85, that mandates such facilities have in operation, by November 28, 2019, a compliance and ethics program that is “reasonably designed to be effective in preventing and detecting criminal, civil, and administrative violations under the [Social Security] Act and in promoting quality of care.” The following eight components of a compliance and ethics program are required for all long-term care facilities’ operating organizations:
Continue Reading Long-Term Care Providers and Corporate Compliance Programs: The Impending November 28, 2019 Deadline is Fast Approaching

There are big changes happening in military healthcare procurement. Some are unsurprising given the October 1, 2019 deadline for the reorganization of all military hospitals and clinics under the management of the Department of Defense (DOD), Defense Health Agency (DHA). But some may be unexpected, reaching all the way to Department of Veterans Affairs (VA) procurement, though the extent to which the VA will ultimately be affected is unclear. In the past few weeks, at least three major announcements were made regarding military healthcare: (1) DHA and the Defense Logistics Agency (DLA) signed a memorandum of agreement (MOA) regarding their respective rolls in DOD healthcare, (2) DLA gave the VA access to its medical/surgical prime vendor formulary indefinitely, and (3) the VA cancelled its long-anticipated prime vendor solicitation under the Medical/Surgical Prime Vendor (MSPV) 2.0 program. Is this all a coincidence? Probably not.
Continue Reading What’s the VA Got to Do With It? Military Medical Procurement Changes Reach the VA

On July 16, 2019, the Congressional Budget Office (“CBO”) released a Cost Estimate for Senate Bill S. 1895, the “Lower Health Care Costs Act.” The bipartisan bill, introduced June 19, 2019, intends to end surprise medical bills, reduce the prices of prescription drugs, improve transparency in health care costs, and increase public health awareness and access to health information.
Continue Reading CBO Report Shows Senate’s Bipartisan Bill on Surprise Billing, Drug Prices, Transparency, and More Would Result in Deficit Decrease

On May 3, 2019, the Centers for Medicare & Medicaid Services (“CMS”) published a comprehensive proposed rule (“Proposed Rule”) to revise the Medicare payment structure for inpatient prospective payment systems (“IPPS”) hospitals. According to the preamble of the Proposed Rule, the purpose of the Proposed Rule is to bump up Medicare’s reimbursements to rural hospitals, some of which receive the lowest rates in the country.

Unfortunately for urban hospitals, any proposed changes in the Medicare reimbursement system must be budget-neutral; therefore, any increase in rural hospital reimbursement must be matched with an equal and offsetting decrease in urban hospital reimbursement.[1] As reported in the Kaiser Health News on June 3, 2019, the Kaiser Family Foundation likens this to a Robin Hood-like effect – robbing from the rich to give to the poor. Like in Sherwood Forest, there are winners and losers in the world of Medicare reimbursement.
Continue Reading CMS Proposes Changes to Medicare Wage Index that Would Increase Reimbursement Rates to Rural Hospitals at the Expense of Urban Hospitals

On June 24, 2019, President Trump signed an executive order that purports to create a more transparent health care market for both patients and providers. The order attempts to decrease the prevalence of opaque pricing, while increasing the amount of health care data available to health care users and stakeholders alike.

The executive order lays out a series of deadlines by which regulations, proposals and recommendations must be completed that intend to generate: (i) more informed patient choices, (ii) enhanced health care analytics, and (iii) greater financial options for individual payment.
Continue Reading More Data. More Choices. Better Care? New Executive Order Relies on Market Principles to Improve American Healthcare

On June 6, 2018, President Trump signed the “John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and Strengthening Integrated Networks Act” a.k.a. the VA MISSION Act of 2018 (“VAMA”) into law, a $52 billion reform bill aimed at improving access to, and the quality of, medical services provided to veterans by the Department of Veterans Affairs (the “VA”). We explored the pros and cons associated with VAMA in a June 12, 2018 blog article that we have linked here.
Continue Reading The VA Mission Act: Expanding Access to the VA Telemedicine System

On April 10, 2019, the Department of Justice filed notices[1] appealing two District Court rulings that struck down Medicaid work requirements in both Kentucky[2] and Arkansas[3] to the U.S. Court of Appeals for the District of Columbia Circuit. The rulings, issued on March 27, 2019, by Judge James E. Boasberg of the Federal District Court for the District of Columbia, held that the U.S. Department of Health and Human Services (“HHS”) acted arbitrarily and capriciously in violation of the Administrative Procedure Act (“APA”) when it approved the Arkansas Works Amendments and Kentucky HEALTH programs. Arkansas and Kentucky halted the programs, pending resolution of the appeals.
Continue Reading Arkansas and Kentucky Halt Medicaid Work Requirements

If you overheard Medicaid providers breathe audible sighs of relief on April Fool’s Day, it may be because on April 1, 2019, the Health Resources & Services Administration of the Department of Health and Human Services (“HRSA”) finally updated the Office of Pharmacy Affairs 340B Information System website (the “340B Website”) to allow 340B Drug Pricing Program (the “340B Program”) providers – including 340B Program-eligible hospitals and other eligible healthcare providers– to use the 340B Website to verify the accuracy of the ceiling prices that they are being charged by manufacturers of 340B Program-covered drugs.
Continue Reading Years in the Making: The Health Resources & Services Administration Launches a Website to Increase Pricing Transparency in the 340B Program