Centers for Medicare & Medicaid Services

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On July 18, 2019, the Centers for Medicare & Medicaid Services (CMS) published a Final Rule establishing requirements for arbitration agreements between long-term care (LTC) facilities and their residents. The Final Rule represents a revamping by CMS of a prior rule that had been published in October 2016 that prohibited pre-dispute binding arbitration agreements. CMS undertook to revise the 2016 rule after the U.S. District Court for the Northern District of Mississippi enjoined enforcement of the prohibition on pre-dispute binding arbitration agreements.
Continue Reading CMS Issues Final Rule Restricting Arbitration Agreements with Long Term Care Facilities

On November 30, 2018, the Solicitor General of the United States filed a long-awaited amicus brief in response to the U.S. Supreme Court’s request for the government’s view of the False Claims Act (FCA) case U.S. ex rel. Campie v. Gilead Sciences, Inc. (see here for previous analysis of the Ninth Circuit decision in the case, and here for discussion of the Supreme Court’s request).

In its brief, the Solicitor General states that the conclusion of the Ninth Circuit – that “the fact of continued government payments did not by itself require dismissal of [the relator’s FCA] claims at the pleading stage” – was “correct and consistent with decisions issued by other circuits in comparable circumstances” and as a result no further review is warranted. The Solicitor General’s brief appears to advocate for a more narrow reading of the Ninth Circuit decision than many commenters have undertaken, explaining that “the relevance of a governmental payment decision turns on whether the government had ‘actual knowledge’ of violations at the time of payment” but in this case it is disputed what the government knew about alleged violations and when it learned about such violations.
Continue Reading In Amicus Brief, Government Discourages Supreme Court Review of Pro-Relator Ninth Circuit FCA Decision, but Pledges to Seek Dismissal of Case Upon Remand

On August 17, 2018, the Centers for Medicare & Medicaid Services (CMS) published its Hospital Inpatient Prospective Payment Systems final rule for Fiscal Year 2019 (Final Rule). The Final Rule contains a number of important updates to Medicare Part A that take effect October 1, 2018.

Among other provisions  in the Final Rule, CMS finalized its proposed update of the regulations that govern hospital admissions under Medicare Part A (42 C.F.R. § 412.3). Specifically, the Final Rule revises language in 42 C.F.R. § 412.3(a) to remove the current requirement that an inpatient admission order “must be present in the medical record and be supported by the physician admission and progress notes, in order for the hospital to be paid for hospital inpatient services under Medicare Part A.” As a result, starting October 1, 2018, CMS will “no longer require a written inpatient admission order to be present in the medical record as a specific condition of Medicare Part A payment.”
Continue Reading CMS Revises Hospital Inpatient Admission Order Documentation Requirements

The Centers for Medicare & Medicaid Services (CMS) recently published a Proposed Rule, primarily intended to modify certain Medicare payment policies.  The Proposed Rule contains several provisions that address the growing use of telehealth. CMS noted that it had received many suggestions regarding the expansion of access to telehealth as well as appropriate pay for the same, in response to its call for comments in the CY 2018 Medicare physician fee schedule (PFS) proposed rule.
Continue Reading Medicare Proposes Revised Telehealth Services and Payments

In a Draft Call Letter issued February 1, 2018, the Centers for Medicare & Medicaid Services (CMS) announced that it is considering a number of new strategies to address opioid overutilization within the Medicare Part D program.  CMS is particularly concerned with chronic overuse among beneficiaries taking high levels of prescription opioids (e.g., beneficiaries prescribed opioids with a 90 morphine milligram equivalent (MME) dose or higher per day), beneficiaries with multiple prescribers, and “opioid naïve” patients (i.e., patients newly prescribed opioids).

CMS’s strategies include consideration of a 7-day supply limit for initial fills of prescription opioids for the treatment of acute pain, potentially paired with a daily dose maximum (e.g., a limit of 50 MME).  According to CMS, this type of restriction may reduce the number of leftover opioid pills available to an opioid naïve patient, which in turn can reduce the risk that the patient develops an “affinity” for opioids that can lead to misuse and diversion.  CMS also proposes that Medicare Part D sponsors implement formulary-level opioid safety edits at the point-of-sale (POS) at pharmacies of 90 MME, which could only be overridden by a sponsor, and which may be paired with a 7-day supply allowance for initial opioid prescriptions for the treatment of acute pain.


Continue Reading CMS Considers 7-Day Limit on Initial Opioid Prescriptions under Part D

On January 29, 2017, the Centers for Medicare and Medicaid Services (CMS) announced a temporary moratorium on enrolling Part B non-emergency ambulance providers/suppliers and home health agencies, subunits and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania and New Jersey.  CMS is taking this measure “to prevent and combat fraud, waste and abuse.”  The moratorium…

The Centers for Medicare & Medicaid Services (CMS) issued a rare advisory opinion (CMS-AO-2017-1) under the Stark Law (Section 1877 of the Social Security Act, codified at 42 U.S.C. § 1395) earlier this fall, addressing a proposed arrangement under which a web-based diagnostic testing portal sought to provide referring physicians with free alerts related to test results.
Continue Reading CMS Approves Laboratory Alerts to Physicians in Rare Stark Law Advisory Opinion

The Centers for Medicare & Medicaid Services (CMS) announced a Proposed Rule scheduled to be published in the Federal Register on June 8, 2017, revising its prior restrictions on binding arbitration provisions between long term care facilities and their residents set forth in a Final Rule published in October 2017.  Comments are due sixty days after publication of the Proposed Rule. In the Final Rule published last year, CMS had prohibited pre-dispute binding arbitration agreements and imposed requirements on facilities that asked residents to sign arbitration agreements.  The U.S. District Court for the District of Missouri had issued a preliminary injunction  against CMS prior to the Final Rule taking effect.  After the court ruling, CMS issued a memorandum to states and Medicare contractors notifying them that the Final Rule would not be enforced until the injunction was lifted.

The Proposed Rule also comes on the heels of a closely-watched case we reported on earlier relating to nursing home arbitration agreements, Kindred Nursing Centers Ltd v. Clark, et al. In that case, the U.S. Supreme Court held that the Federal Arbitration Act preempted a rule applied by a state court that had refused to enforce binding arbitration agreements between a nursing home and individuals who held general powers of attorney on behalf of residents.Continue Reading CMS Reverses Direction in Proposed Rule on Long Term Care Facility Arbitration Agreements

The Centers for Medicare & Medicaid Services (CMS) is proposing to delay the effective date for the revised Conditions of Participation (CoPs) for Home Health Agencies (HHAs).  The original effective date was July 13, 2017.  The proposed delay would extend the effective date for an additional six months, until January 13, 2018.  In a previously published post, we discussed the HHA CoPs.
Continue Reading CMS Proposes Delay of Home Health Agency Conditions of Participation

On March 28, the Centers for Medicare & Medicaid Services (CMS) revised the procedures and posted new forms for its Voluntary Self-Referral Disclosure Protocol (SRDP).  The SRDP is a mechanism established pursuant to the Affordable Care Act for health care providers and suppliers to facilitate settlement of violations of the physician self-referral law (Stark Law).

Under the Stark Law, physicians (or their immediate family members) who have a financial relationship with an entity are prohibited from making referrals to that entity for certain designated health services (DHS) that are payable by Medicare, unless an exception applies.  In addition, the entity is prohibited from presenting (or causing to be presented) claims to Medicare, or another individual, entity or third-party payer, for the services referred in violation of the Stark Law.  Violations of the Stark Law can result in monetary penalties of $10,957 to $21,916 per claim submitted. 
Continue Reading CMS Revises Process for Reporting Stark Law Violations and Posts New SRDP Forms