The Obama Administration’s proposed fiscal year (FY) 2017 budget, released on February 9, 2016, includes a number of legislative proposals that would revise Medicare and Medicaid policies to achieve budget savings and make other program reforms. The largest pool of Medicare savings would result from various Medicare prescription drug proposals, including the following (all savings … Continue Reading
The OIG has issued a policy statement clarifying the conditions under which hospitals may discount or waive Medicare beneficiary copayment amounts for self-administered drugs (SADs) received in outpatient settings without running afoul of OIG fraud authorities. In particular, the OIG addressed questions that have arisen from a 2003 CMS statement that a hospital’s decision not … Continue Reading
The House Energy and Commerce Subcommittee on Health has scheduled an October 21, 2015 hearing to examine the Medicare Part D Medication Therapy Management Program. In addition the Health Subcommittee is holding an October 23 hearing entitled “”Reviewing the Accuracy of Medicaid and Exchange Eligibility Determinations.”… Continue Reading
The latest CMS “innovation model” will test whether providing Medicare Part D prescription drug plan (PDP) sponsors with financial incentives and flexibility with regard to medication therapy management (MTM) program requirements can improve quality and reduce costs by “right-sizing” investment in MTM services. Specifically, CMS will allow stand-alone PDP sponsors in 11 states to apply … Continue Reading
Later this week, the House of Representatives is expected to consider the H.R. 6, the 21st Century Cures Act. Ahead of the House vote, the House Rules Committee released a revised version of the bill with new funding offsets and other policy changes. Notably changes in the newest version include: A provision excluding authorized generics … Continue Reading
The Medicare Payment Advisory Commission (MedPAC) has released its June 2015 Report to the Congress on Medicare and the Health Care Delivery System. The report includes a series of recommendations on Medicare hospital short-stay policy, in response in part to hospital concerns about related Medicare Recovery Audit Contractor (RAC) Program audits and appeals and the … Continue Reading
The HHS OIG has updated its FY 2015 Work Plan to reflect new and/or completed items since release of its Work Plan in October 2014. Of note, the OIG has announced its plans to conduct several new Medicare reviews addressing: intensity-modulated radiation therapy; hospital preparedness and response to high-risk infectious diseases; access to DME in competitive … Continue Reading
CMS has released guidance for long term care (LTC) facilities, including nursing facilities and skilled nursing facilities, on beneficiary disenrollments. According to the guidance, “CMS continues to see an unacceptable practice of LTC facilities disenrolling beneficiaries from Medicare Advantage prescription drug plans (MAPDs) and enrolling them into stand-alone drug plans (PDPs) without the beneficiary’s or … Continue Reading
Today the House Energy and Commerce Committee approved H.R. 6, the “21st Century Cures Act,” by a bipartisan, unanimous 51-0 vote. This major legislation is intended to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability … Continue Reading
The OIG has issued a report, Medicaid Rebates for Brand-Name Drugs Exceeded Part D Rebates by a Substantial Margin,” comparing statutory Medicaid rebate amounts for brand name drugs with rebates Part D plan sponsors negotiate with drug manufacturers for such drugs. Based on 2012 data, the OIG determined that total rebates under Medicaid were substantially higher … Continue Reading
CMS published an interim final rule with comment period (IFC) on May 6, 2015 that modifies a previously-adopted regulatory requirement regarding qualifications to prescribe Part D drugs. By way of background, under a final rule published May 23, 2014, Part D sponsors must deny a pharmacy claim for a Part D drug if the physician … Continue Reading
CMS has released the 2016 Medicare Advantage (MA) and Part D Rate Announcement and Call Letter. According to a CMS fact sheet, the final policies increase Medicare Advantage rates by 1.25% (compared to an earlier forecast of a 0.95% reduction), although considering coding trends the agency expects revenues to increase by 3.25%. In addition, CMS … Continue Reading
On April 2-3, 2015, the Medicare Payment Advisory Commission (MedPAC) is meeting to discuss various Medicare policy issues, including: hospital short stay policy; polypharmacy/multiple drug use (focusing on Part D opioid use); Medicare Part D risk sharing; measuring low-value care; using episode bundles to improve care efficiency (including potential refinements to the Medicare spending per … Continue Reading
The Government Accountability Office (GAO) has issued a report examining the extent to which antipsychotic drugs are prescribed for older adults with dementia in nursing homes and other settings. The GAO found that, according to Medicare Part D data, about one-third of older adults with dementia who spent more than 100 days in a nursing … Continue Reading
On February 26, 2015, the House Ways and Means Committee is scheduled to vote on the following bills: H.R. 1021, “Protecting the Integrity of Medicare Act of 2015” – a sweeping bill to promote Medicare program integrity and efficiency. Among many other things, the bill would: eliminate civil money penalties for inducements to physicians to … Continue Reading
CMS has published a final rule revising Medicare Advantage (MA) and Part D prescription drug benefit regulations for CY 2016. Among other things, the final rule: Implements a statutory provision requiring MA and Part D contracts to provide the right to “timely”’ inspection and audit and allowing CMS to require MA organizations or Part D … Continue Reading
A recent GAO report, “Medicare Program Integrity: CMS Pursues Many Practices to Address Prescription Drug Fraud, Waste, and Abuse,” lists current and planned CMS prevention, detection, and monitoring policies intended to promote program integrity in the Medicare Part D prescription drug program. The report does not include new recommendations.… Continue Reading
Based on a review of Prescription Drug Event (PDE) records for human immunodeficiency virus (HIV) drugs and other beneficiary records, the OIG determined that Medicare Part D paid for HIV drugs for over 150 deceased beneficiaries in 2012, most of which were dispensed by retail pharmacies. The OIG identified shortcomings in CMS claims edits that … Continue Reading
CMS has announced that it is delaying a provision of its 2015 Medicare Advantage/Medicare Part D final rule, published on May 23, 2014, that requires physicians and other eligible professionals who prescribe Part D drugs to be enrolled in Medicare (or have a valid opt-out affidavit on file) for their prescriptions to be covered under … Continue Reading
Under current law, Medicare Parts B and D cover anticancer drugs for indications not approved by the FDA only if the drugs are supported by one or more of four authorized compendia. Publishers of these compendia must comply with statutory requirements to maintain transparent processes for evaluating anticancer drug therapies and identifying potential conflicts of … Continue Reading
CMS has posted the 2015 Medicare Star Ratings for Medicare Advantage (MA) and Medicare Part D prescription drug plans (PDPs). According to a CMS fact sheet, there are increases in the number of Medicare beneficiaries in high-performing MA plans and PDPs for 2015, while CMS notes “dramatic improvement” among plans that had received the low … Continue Reading
The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a major proposed rule that would amend the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty rules to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the AKS. Reed Smith has prepared a Client Alert analyzing the proposed rule, highlighting areas where the OIG is seeking public comment. Overall, the OIG appears to recognize that new health care delivery mechanisms demand a more flexible approach to fraud and abuse enforcement than has been the case in the past, as discussed in our analysis.… Continue Reading
In a recent report, the OIG concluded that Medicare would have saved millions of dollars in 2011 if Medicare Part B prescription drug dispensing and supplying fees had been aligned with the rates paid by Medicare Part D plans or state Medicaid programs. Specifically, if Part B dispensing and supplying fees had been the same … Continue Reading
