Tag Archives: Medicare Part D Drugs

Revised House 21st Century Cures Bill Released Ahead of House Vote

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

MedPAC Report to Congress on Medicare and the Health Care Delivery System

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

OIG Releases FY 2015 Work Plan Mid-Year Update

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 Guidance on Beneficiary MA Drug Plan Disenrollments by Long Term Care Facilities

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

House Energy and Commerce Committee Unanimously Approves 21st Century Cures Bill

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

OIG Examines Medicaid/Part D Drug Rebate Policy

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 Releases 2016 Medicare Advantage/Part D Drug Plan Rates and Policies

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

MedPAC Meeting on Medicare Policy (April 2-3, 2015)

 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

GAO Calls for Expanded HHS Efforts to Reduce Antipsychotic Drug Use in Community Settings

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

Ways and Means Committee to Markup Medicare Fraud, Competitive Bidding, and other Medicare Policy Bills

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

Final Medicare Advantage/Part D Rule for Contract Year (CY) 2016

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

GAO Catalogues CMS Medicare Part D Program Integrity Practices

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

OIG Faults Medicare Payment for HIV Drugs after Beneficiaries’ Death

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 Delaying Enforcement of Medicare Part D Drug Prescriber Enrollment Requirements

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

OIG: Compendia Publishers Comply with Transparency Rules for Evaluating Anticancer Drugs, Identifying Potential Conflicts

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 Releases Medicare Advantage/Drug Plan Quality Data, Enforcement Statistics

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

Reed Smith Client Alert: Analysis of HHS OIG Proposed Rule to Amend the Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing Regulations

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

MedPAC Meeting on Medicare Policy Issues (Oct. 9-10)

MedPAC is meeting on October 9 and 10, 2014 to discuss a variety of Medicare policy issues, including: international comparison of rates paid to hospitals; sharing risk in Medicare Part D; potentially inappropriate opioid use in Medicare Part D; the next generation of Medicare beneficiaries; private-sector initiatives to manage post-acute care; and validating relative value … Continue Reading

CMS Seeks Input on Potential Delivery Innovations in Medicare Part D, Medicare Advantage, & Other Programs

CMS is seeking input on initiatives to test care delivery innovations in the Medicare Part D program, Medicare and Medicaid managed care plans, and other government programs. CMS notes that while “[h]ealth plans increasingly have responded to market developments and fiscal pressures with innovations in care delivery, plan design, beneficiary and provider incentives, and network … Continue Reading

OIG Releases Proposed Revisions to Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing

The OIG has just released a major proposed rule to amend the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) rule to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the anti-kickback statute.  In particular, with regard to the AKS, the OIG proposes: a technical … Continue Reading

HHS OIG Paints with Broad Brush in Criticizing Drug Manufacturer Coupon Programs

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
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