As reintroduced in the U.S. House of Representatives by Rep. Frank Pallone, Jr. (D-NJ-6) on April 22, 2021 after originally being introduced on September 19, 2019, H.R. 3, also known as known as the Elijah E. Cummings Lower Drug Costs Now Act, proposes to grant the U.S. Department of Health and Human Services (“HHS”) the authority to negotiate directly with pharmaceutical companies in order to lower drug prices in Medicare Part B and Medicare Part D (the “Proposal”).  The Proposal would require that 125 brand-name drugs that cost Medicare the most to be subject to negotiation by Medicare, with a cap on the price for each drug set at 120% of the average price paid in six other countries.  The Proposal is part of a $3.5 trillion budget proposal that, as of this writing, faces an uncertain future in Congress.  While not a novel idea, the Proposal is controversial and faces strong opposition from pharmaceutical companies in particular.

Continue Reading Elijah E. Cummings Lower Drug Costs Now Act: The Long and Winding Road to Drug Pricing Reform

A major California-based health care system, Sutter Health, and several of its medical practice foundation affiliates have agreed to pay a total of $90 million to settle allegations that they violated the False Claims Act (“FCA”) by knowingly submitting inaccurate information about the health status of beneficiaries enrolled in Sutter Health’s contracted Medicare Advantage (“MA”) Plans.[1]  The Sutter Health settlement is the largest FCA settlement ever paid by a health care provider for alleged MA fraud.

Continue Reading Sutter Health Settles Medicare Fraud Case For $90 Million: The Largest Settlement For Medicare Advantage Fraud

On August 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) issued its hospital inpatient prospective payment system (“IPPS”) final rule (“Final Rule”) for fiscal year 2022. In addition to a number of other changes, the Final Rule repeals the price transparency requirement for hospitals, discussed in our September 2, 2020 blog post, obligating hospitals to report certain contract terms with Medicare Advantage (“MA”) plans for cost reporting periods ending on or after January 1, 2021.

Continue Reading CMS Backs Off Price Transparency for Providers and Plans

On August 10, 2021, the Senate passed H.R. 3684, a roughly $1 trillion infrastructure bill (the “Infrastructure Bill”) that authorizes funds for federal-aid highways, transit, broadband access and other infrastructure purposes.  Notably, the Infrastructure Bill is paid for in part through changes to several healthcare policies, including delaying a Medicare Part D rebate rule for an additional three years and reducing Medicare payment amounts to providers.  The Infrastructure Bill’s changes to healthcare policies provide a mixed impact to health care industry stakeholders, with both expected benefits and burdens to providers, payers, and drug manufacturers.

Continue Reading The Infrastructure Investment and Jobs Act: Potential Impact on Healthcare Policy and Spending

On July 30, 2021, the Special Inspector General for Pandemic Recovery (“SIGPR”), Brian D. Miller, submitted his quarterly report to Congress.  SIGPR was created as an independent watchdog of the Department of the Treasury under the CARES Act.  It is tasked with investigating fraud and abuse of federal stimulus funds in response to COVID-19, and works in collaboration with law enforcement and U.S. Attorney’s Offices throughout the country.  These investigative efforts have resulted in civil and criminal enforcement actions against recipients of federal funding throughout the country, and such enforcement action investigations are sure to continue.  The quarterly report showed that the federal government has been active in investigating fraud and abuse related to stimulus funds, and its call for additional funding signals an increase in future enforcement against recipients of federal stimulus funds.

Continue Reading The Special Inspector General for Pandemic Recovery Calls For Increased Funding and Expanded Jurisdiction In Its Quarterly Report To Congress

On August 13, 2021, the D.C. Circuit Court of Appeals reversed a district court opinion vacating CMS’ Overpayment Rule, 42 C.F.R. 422.326, for Medicare Advantage organizations (“MAOs”).  UnitedHealthcare Insurance Co. et al. v. Becerra et al., case number 18-5326.  As a result of this decision, CMS can once again rely on the Overpayment Rule to impose voluntary refund obligations for MAOs.  MAOs – already subject to significant government enforcement related to their risk adjustment coding practices – should carefully consider the implications of this decision for their coding and auditing practices.

Continue Reading D.C. Circuit Gives New Life to CMS Overpayment Rule

On July 13, 2021, the Centers for Medicare & Medicaid Services (“CMS”) unveiled a proposal to temporarily extend Medicare coverage for particular telehealth services granted during the COVID-19 public health emergency (the “Pandemic”), in order to evaluate which services should be covered permanently. Through the 2022 Physician Fee Schedule (“PFS”), CMS is allowing certain services to remain on the telehealth list until the end of December 31, 2023.

Continue Reading CMS’ Proposal to Expand Telehealth Coverage

On June 23, 2021, Delaware Governor John Carney signed House Bill 160, the Telehealth Access Preservation and Modernization Act of 2021 (the “Bill” or “HB160”) which continues and enhances Delaware residents’ access to telehealth services and, through the adoption of the Interstate Medical Licensure Compact (the “Compact”), ensures that telehealth services can be provided through qualified medical practitioners in a streamlined and efficient pathway to licensure that, according to the Bill’s supporters, meets the health care delivery system needs of the 21st century.

Continue Reading The “State” of Telehealth: Delaware Expands Access to Telehealth

In July 2020, we discussed a ruling by the D.C. Court of Appeals upholding the Department of Health and Human Services’ (HHS) site-neutral payment rules. On Monday, June 28, 2021, the Supreme Court declined, without comment, to hear an appeal from the American Hospital Association (AHA) and other provider groups asking it to reverse this ruling.

Continue Reading Site-Neutral Payments Stand: SCOTUS Declines to Hear AHA Appeal, Preserving Lower Payments to Off-Campus Provider-Based Departments

In its June 2021 physician supply and demand report, “The Complexities of Physician Supply and Demand: Projections From 2019 to 2034” (the “Report”), the Association of American Medical Colleges (“AAMC”) highlights the ongoing concern of physician shortages in the United States.  According to the Report, the U.S. faces a potential physician shortage of between 37,800 to 124,000 doctors by 2034. While an improvement from AAMC’s June 2020 report, the COVID-19 pandemic highlighted the consequences of failing to address this problem, as medical schools and teaching hospitals were forced to graduate medical students early, and hospitals scrambled to call up retired physicians and to pay steep travel and relocation rates, all to address the public health emergency. Continue Reading Congressional Action in the Face of Mounting Concerns Regarding Current and Future Physician Shortages