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Following closely after the clarifying independent dispute resolution process Final Rule, the four executive branch entities tasked with implementing the provisions of the No Surprises Act, the Office of Personnel Management, the Centers for Medicare & Medicaid Services (CMS), Employee Benefits Security Administration and the Internal Revenue Service have issued a request for information to help the agencies craft the next stage of regulations for the surprise billing law.

The request is the latest effort by agencies to seek stakeholder input on the contours of the regulations implementing the No Surprises Act, this time with a focus on the requirements in the law for providers to issue a good faith estimate (GFE) to plans for services that their covered patients will submit for reimbursement and for insurers to issue an advanced explanation of benefits (AEOB) to their plan participants based on estimated charges relayed to them by providers.

Specifically, the entities are looking for information and recommendations on the process of transferring data from providers and facilities to plans, issuers and carriers to facilitate the GFE and AEOB processes, as well as the economic impacts of implementing these requirements. The notice was added to the Federal Register on Friday, Sept. 16 and comments are due to the agencies by November 15.…

Continue Reading Agencies Look for Input on No Surprises Act Good Faith Estimate Rules

In a March 11 advisory opinion the Department of Health and Human Services’ Office of Inspector General (“OIG”) permitted a medical device manufacturer to pay Medicare-reimbursable costs for subjects enrolled in a clinical trial sponsored by the manufacturer and involving the manufacturer’s therapy.

The OIG indicated it would not impose administrative sanctions, despite the fact…

On February 4, 2022, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a favorable advisory opinion on a proposal by a nonprofit children’s hospital to enter into an arrangement with two individual donors, who intend on making a testamentary gift to the hospital that would be used to reduce and subsidize costs incurred by patients.

The OIG indicated it would not impose administrative sanctions, despite the fact that the proposed arrangement would not fall squarely within any safe harbor under the federal Anti-Kickback Statute (“AKS”) or exception to the definition of “remuneration” for purposes of the beneficiary inducement prohibition (“Beneficiary Inducement CMP”).

Arrangement created restricted endowment fund

Under the proposed arrangement, the hospital would be the beneficiary to a restricted endowment fund established through a testamentary gift from two donors. The fund would be used to subsidize bills for families with children who have an established care relationship with the hospital’s physicians and who receive services provided by the hospital’s programs.…

Continue Reading OIG approves arrangement involving a testamentary gift to a nonprofit hospital to reduce costs for pediatric patients

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

…

CMS is putting health care providers on notice that it considers it “inappropriate” for providers to offer premium or cost-sharing assistance to Medicare or Medicaid beneficiaries in order to “steer” the patient to an individual market plan “for a provider’s financial gain.”  In a request for information to be published on August 23, 2016, CMS cites anecdotal reports that some health care providers have determined that private plan rates are sufficiently high compared to Medicare or Medicaid reimbursement to allow a provider to pay a Medicare- or Medicaid-eligible patient’s private insurance premiums and still benefit financially.
Continue Reading CMS Flags Potential Provider “Steering” of Medicare/Medicaid Beneficiaries to Favorable ACA Marketplace Plans to Obtain Higher Rates

CMS has released the Medicare Part A inpatient hospital deductible and hospital and extended care services coinsurance amounts for 2015. Specifically, the 2015 Part A deductible for hospital inpatient admissions for the first 60 days of care will be $1,260, followed by $315 per day for days 61-90 and $630 per day for stays beyond …

The OIG has issued a report on Medicare beneficiary copayment costs for outpatient services provided at critical access hospitals (CAH). Beneficiaries who receive services at CAHs pay Medicare coinsurance amounts based on CAH charges, in contrast to patients at acute care hospitals who are responsible for coinsurance amounts based on outpatient prospective payment system (OPPS)…

On September 19, 2014, the Office of Inspector General (OIG) of the Department of Health & Human Services issued a Special Advisory Bulletin (SAB) in which it identified several potential regulatory risks to federal health care programs as the result of coupon programs used by drug manufacturers to reduce or eliminate patient copayments for brand-name drugs. In the SAB, the OIG explains that coupon program sponsors and pharmacies will risk the receipt of penalties if they do not take steps to actively prevent federal health care program beneficiaries from using the coupons. According to the OIG, these coupon programs qualify as examples of remuneration offered to consumers to encourage the purchase and use of specific items, and therefore implicate the federal Anti-Kickback Statute. In addition, a claim that includes items or services resulting from such a kickback violation would constitute a false or fraudulent claim under the False Claims Act.
Continue Reading HHS OIG Paints with Broad Brush in Criticizing Drug Manufacturer Coupon Programs

Today CMS published an interim final rule with comment period that requires qualified health plan (QHP) issuers to accept premium and cost-sharing payments made on behalf of enrollees by the Ryan White HIV/AIDS Program, Indian tribes and organizations, and other federal and state government programs that provide premium and cost sharing support. This rulemaking was prompted…

CMS published notices on October 30, 2013 announcing the 2014 Medicare inpatient hospital deductible and hospital and extended care services coinsurance amounts. The 2014 Part A deductible for hospital inpatient admissions for the first 60 days of care will be $1,216, followed by $304 per day for days 61-90 and $608 per day for…