Health Reform WK-EDGE Top 10 stories for September 2020
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Tuesday, October 27, 2020

Top 10 stories for September 2020

By WK Editorial Staff

Catch up on the last month’s top stories.

Last month, Wolters Kluwer detailed strategies health facilities can use to minimize their effects on the environment, and CMS updated COVID-19 testing guidelines for nursing homes and other providers. The FDA also provided guidance related to the use of convalescent plasma in COVID-19 patients. Check out these and other stories you may have missed in September.

STRATEGIC PERSPECTIVES: Climate change adaptation and resilience: How health facilities can weather the storm

In the midst of a climate-related event such as an extreme storm or flooding, it is important that hospitals and other health facilities remain functional to provide critical services to the public. To maximize resilience and adaptation to climate events and disasters, health facilities—whose large carbon footprints contribute to the climate crisis (see Health facilities contribute to climate change, can be leaders in mitigation, April 3, 2020)—must analyze their risks and implement measures such as energy-efficient infrastructure. With wildfires and hurricanes of historic proportions seeming to be the norm, facilities that fail to take measures to ensure resilience risk not only financial effects due to revenue loss and major emergency repairs, but also possible permanent closure.

COVID-19—FINAL RULES: New rules regulate COVID testing, reporting for nursing homes, other providers

CMS will require nursing homes to test staff and offer testing to residents for the novel coronavirus disease 2019 (COVID-19). According to an interim final rule laboratories and nursing homes using point-of-care testing devices will be required to report diagnostic test results as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The interim final rule also require hospitals to provide COVID-19 cases and related data to HHS (Final rule, 85 FR 54820, September 2, 2020).

END-STAGE RENAL DISEASE—FINAL RULES: CMS rolls out new mandatory payment model for ESRD treatment

A new end-stage renal disease (ESRD) treatment choices (ETC) model is finalized as a mandatory payment model for those chosen to participate, with the goal of encouraging greater use of home dialysis and kidney transplants for patients with chronic kidney disease (CKD). CMS describes it as an innovative payment model that aims to test if the greater use of home dialysis and kidney transplantation for Medicare beneficiaries with ESRD will reduce Medicare expenditures, while at the same time, sustaining and improving the quality of care. In an advance release of a final rule, CMS estimates that the savings as a result of the new model will equal $23 million over five and a half years. Certain payments will by adjusted to ESRD facilities and nephrologists and other clinicians managing beneficiaries with ESRD (Managing Clinicians) that are selected to participate in the new ETC model.

ACUTE INPATIENT HOSPITALS—FINAL RULES: IPPS/LTCH PPS final rule supports antimicrobial innovation, interoperability

CMS expanded pathways for certain antimicrobial products and sought to increase quality efforts surrounding interoperability in the fiscal year (FY) 2021 inpatient prospective payment system (IPPS) and long-term care hospital prospective payment system (LTCH PPS) final rule. The rule also updated payment rates for both payment systems (Final rule, 85 FR 58432, September 18, 2020).

LABELING AND PACKAGING (FOOD, DRUGS & MEDICAL DEVICES)—PROPOSED RULE: Food labeling proposed rule would expand products eligible for generic labels

The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) has issued a notice of proposed rulemaking that will reduce label approval submissions to the agency by 33.8 percent and reduce label approval costs for industry by $468,864 annually. The proposal is estimated to result in annual savings to the agency of $235,690. The proposed rule will expand the existing "generically approved label program" that permits generic label approval for numerous meat, poultry, and egg products (Proposed Rule, 85 FR 56538, September 14, 2020).

PRESCRIPTION DRUGS—PROPOSED RULE: HHS seeks to implement executive order on access to affordable medications

HHS has issued a notice of proposed rulemaking (NPRM) and is seeking to have public comments submitted by October 28, 2020. The proposed rules are for the implementation of the "Executive Order on Access to Affordable Life-saving Medications," issued July 24, 2020. The Order requires that entities funded under section 330(e) of the Public Health Service Act (PHS Act or the Act), to establish practices to provide access to insulin and injectable epinephrine to low-income patients at the price the health center purchased these two drugs through the 340B Drug Pricing Program (Proposed rule, 85 FR 60748, September 28, 2020).

COVID-19—FDA GUIDANCE NOTICES: COVID-19 convalescent plasma may be used under an investigational new drug application

The FDA’s Center for Biologics Evaluation and Research has issued a guidance that supersedes the previous guidance issued in April 2020—and updated in May 2020—that addresses the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). The guidance is being implemented without prior public comment because the FDA has determined that prior public participation for the guidance is not feasible or appropriate, and although it is being implemented immediately, it remains subject to comment in accordance with the agency’s good guidance practices. The guidance authorizes use of COVID-19 convalescent plasma for investigational purposes, thereby expanding its use from treatment of hospitalized COVID-19 patients (Notice . 85 FR 59319, September, 2020).

MEDICAID—N.D. Ill.: Illinois obtains reversal of HHS decision to claw back $147 million in Medicaid overpayments

The Illinois Department of Healthcare and Family Services reasonably interpreted its Medicaid state plan to allow for a prospective method of computing hospital reimbursements, a Chicago federal district court has ruled. As a result, the IDHFS was entitled to summary judgment in an action brought to challenge an effort by the U.S. Department of Health and Human Services to disallow more than $147 million in federal reimbursements for Medicaid payments by Illinois to Illinois hospitals. While federal courts frequently defer to administrative decisions in such cases, the federal court reversed the decision in this case on a finding that the administrative board’s conclusion ordering the disallowance "conflicts with the plain text" (Illinois Department of Healthcare and Family Services v. Azar, September 25, 2020, Blakey, J.).

HEALTH CARE REFORM—D.D.C.: Fifth Amendment challenge of ACA individual mandate penalty fails

A district court dismissed a taxpayer’s allegations that the shared responsibility payments assessed against him under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) violated his Fifth Amendment rights. The district court noted that the payment has been found constitutional by the U.S. Supreme Court, and found that the complaint failed to adequately allege a violation of rights. Additionally, the taxpayer’s claims for refunds failed for lack of subject matter jurisdiction (Bucholz v. Mnuchin, September 10, 2020, Jackson, A.).

SUPREME COURT NEWS: Justice Ginsburg leaves rich legacy of legal thought on the ACA

On November 10, 2020, another Affordable Care Act (ACA) (P.L. 111-148) case will be heard before the U.S. Supreme Court, and, for the first time, an ACA case will be heard without Justice Ruth Bader Ginsburg. The case of California v. Texas will go forward without her, although her words from past cases on the topic may be reflected on by some as the court determines the future of the ACA. Notable cases are outlined below with quotes from Justice Ginsburg. Choosing a handful of quotes from what could be described as an intricately woven tapestry of sharp, intellectual thought could not fully demonstrate Justice Ginsburg’s dedication to legal analysis and her notorious talent and hard work. Links to decisions and oral arguments are provided for desired further reading.

MainStory: StrategicPerspectives AccessNews AgencyNews InpatientFacilityNews MedicaidNews MedicaidExpansionNews MedicarePartANews MedicarePartBNews MedicarePartCNews MedicarePartDNews ProviderPaymentNews ProgramIntegrityNews

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