The Department of Health and Human Services’ Office of Inspector General (OIG) will be lifting its long-standing refusal to accept requests for advisory opinions if the request describes a course of action that is “the same or substantially the same” as a course of action that is either under investigation by OIG, or is the … Continue Reading
In November 2020, four months after the Trump Administration issued a series of Executive Orders reiterating its policy goals on reducing the costs to consumers for prescription drugs and directing the Department of Health and Human Services, Office of Inspector General (“HHS-OIG”) to implement those policy objectives, HHS-OIG issued a Final Rule to amend certain … Continue Reading
In recent years, the U.S. Department of Justice (“DOJ”) has increasingly leveraged data analytics to combat fraud. Principal Deputy Chief of DOJ’s Fraud Section, Joe Beemsterboer, described the department’s data-mining capabilities as the “foundation of how [DOJ] investigate[s] and analyze[s] cases,” and explained that digital forensics equips the department with “powerful” tools for identifying “trends,” … Continue Reading
It is no secret that the coronavirus pandemic has driven our daily lives digital—work, education, social gatherings, and, of course, health care. Congress and CMS responded to the public health emergency by waiving limitations on reimbursement for telehealth services rendered to Medicare patients. These waivers introduced new flexibility and vastly expanded Medicare patients’ access to … Continue Reading
Following the distribution of billions of relief aid to healthcare providers and amidst the guidance issued around reopening of nursing homes throughout the country, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) unveiled a COVID-19 Response Strategic Plan on May 26, 2020 after updating its Workplan a few days earlier. … Continue Reading
The Trump Administration’s proposed fiscal year (FY) 2021 budget calls for significant cuts to federal health spending, including a 10% decrease in Department of Health and Human Services (HHS) discretionary spending in FY 2021 and a $1.6 trillion net reduction in health entitlements over the next decade. House Budget Committee leaders have blasted the HHS … Continue Reading
The Departments of Health and Human Services (HHS) has just published its “annual” inflation update to civil monetary penalty amounts (CMP) in its regulations – even though those penalties were just increased for inflation in November 2019. Under the latest update, CMPs are increased by a 1.01764 “multiplier” (that is, a 1.764% increase), applicable to … Continue Reading
According to its latest Semiannual Report to Congress, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) expects fiscal year (FY) 2019 investigative recoveries from criminal and civil actions to top $5 billion – up from $2.9 billion in FY 2018. Additionally, the OIG expects to recover $819 million as … Continue Reading
Reed Smith is hosting its 6th Annual Washington Health Care Conference on December 4, 2019 at The Almas Center in Washington, D.C., and is pleased to welcome another impressive line-up of speakers this year. Our keynote speaker is Dr. John Whyte, Chief Medical Officer of WebMD, who will be discussing “Artificial Intelligence in Health Care: … Continue Reading
Maximum civil monetary penalty (CMP) amounts that may be imposed by the Department of Health and Human Services (HHS) and its agencies have increased once again under the latest HHS inflation adjustment notice. Specifically, in conformance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (“the Act”), HHS is applying a 1.02522 … Continue Reading
The Centers for Medicare & Medicaid Services (CMS) has published a final rule with comment period establishing sweeping disclosure and monitoring obligations for providers and suppliers enrolled or enrolling in federal health programs, and expanding CMS’s authority to deny or revoke enrollment status. In particular, the rule establishes an expansive new “affiliations” disclosure requirement that … Continue Reading
President Donald Trump has signed an executive order that commits the Department of Health and Human Services (HHS) to taking a series of regulatory and subregulatory actions intended to enhance the fiscal sustainability of the Medicare program, reduce regulatory burdens on providers, and increase beneficiary choice. The planned initiatives, which would require further policy development … Continue Reading
Seeking to “eliminate any confusion,” the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has formally withdrawn proposed civil money penalty (CMP) and anti-kickback (AKS) safe harbor regulations that it no longer intends to finalize. Specifically, the OIG is withdrawing: A 1994 proposed rule that would have codified the … Continue Reading
Federal health care fraud judgments and settlements totaled $2.3 billion in fiscal year (FY) 2018 – down from $2.6 billion in recoveries in FY 2017 and $3.3 billion in FY 2016 — according to latest Health Care Fraud and Abuse Control (HCFAC) Program Annual Report. During FY 2018, the Department of Justice (DOJ) opened 1,139 new … Continue Reading
The Trump Administration’s proposed fiscal year (FY) 2020 budget includes extensive health policy provisions – as evidenced by the 162-page Department of Health and Human Services (HHS) “Budget in Brief.” This summary focuses on the major Medicare and Medicaid proposals most directly impacting providers and suppliers; note that we discuss the Administration’s proposed prescription drug … Continue Reading
The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) have finalized changes to State Medicaid Fraud Control Unit (MFCU) regulations to reflect statutory changes and policies adopted since the MFCU rules were first issued in 1978. Among other things, the regulations incorporate statutory policies that: authorize a federal matching … Continue Reading
The Office of Inspector General (OIG) of the Department of Health and Human Services has issued its Semiannual Report to Congress, which summarizes key program integrity efforts in fiscal year (FY) 2018. Notably, during FY 2018, OIG achieved: Expected investigative recoveries of $2.91 billion (compared to $4.13 billion in FY 2017) Criminal actions against 764 … Continue Reading
The Department of Health and Human Services (HHS) has just announced annual inflation-related increases to civil monetary penalties (CMPs) in its regulations, including those promulgated by the Office of Inspector General, the Centers for Medicare & Medicaid Services, and the Food and Drug Administration. Specifically, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements … Continue Reading
Congressional panels continue to focus on federal health care policy topics, including cost, quality, and program integrity issues. Recent hearings have included the following: The Senate Health, Education, Labor and Pensions (HELP) Committee held hearings entitled “Reducing Health Care Costs: Examining How Transparency Can Lower Spending and Empower Patients”; “Prioritizing Cures: Science and Stewardship at … Continue Reading
The Centers for Medicare & Medicaid Services (CMS) has determined that it should extend for an additional six months its current moratoria on the Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) enrollment of new home health agencies (HHAs) and Part B nonemergency ground ambulance suppliers in selected states. Under the latest notice, the moratoria … Continue Reading
The House Energy and Commerce Committee has scheduled three hearings this week on health topics: A July 24 hearing on advertising and marketing practices within the substance use treatment industry; A July 25 hearing on FDA and NIH implementation of the 21st Century Cures Act; and A July 26 hearing on the Medicare Merit-based Incentive … Continue Reading
On July 18, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) submitted to the Office of Management and Budget (OMB) for regulatory review a proposed rule entitled “Removal Of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor … Continue Reading
Citing an interest in improving its processes and eliminating unnecessary requirements, CMS is hosting July 13, 2018 “Provider Compliance Focus Group” meeting regarding Medicare fee-for-service compliance topics, including medical review, targeted probe and educate, and Recovery Audit Contractors. CMS states that it wants “to ensure claims are paid appropriately and preserve the Medicare Trust Fund … Continue Reading
Congressional committees have held numerous hearings and markups in recent weeks on health policy topics, including several hearings focused on health care costs. Highlights include the following: … Continue Reading
