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 of health technology, and other issues  It also would exclude journals, reprints, and other education-related items and payments from Physician Payment Sunshine Act reporting.

During markup, the panel approved an amendment offered by Chairman Upton making a number of policy revisions and offsets, including, among other things, provisions that:

  • Limit Medicaid durable medical equipment reimbursement rates to Medicare fee-for-service rates applicable in the state, effective January 1, 2020;
  • Make various changes to Medicare imaging reimbursement policy, including modification of Medicare physician fee schedule and outpatient prospective payment system payments to incentivize the transition from traditional x-ray imaging to digital radiography (with payment reductions for the use of non-digital technology) and a requirement that the Secretary conduct an empirical analysis before applying the multiple procedure payment reduction to the professional component of imaging services;
  • Implement OIG recommendation to delay certain Medicare Part D prescription drug plan prepayments;
  • Establish a Cures Innovation Fund equal to $110 million for each of fiscal years 2016 through 2020; and
  • Exempt certain FDA user fees from sequestration.

The bill now moves on to the full House.

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 than total rebates under Medicare Part D ($16.7 billion vs. $10.3 billion), even though Medicaid drug expenditures were much lower than Medicare Part D expenditures in 2012 ($35.7 billion vs. $66.5 billion). Rebates accounted for 47% of Medicaid expenditures in 2012, while rebates totaled 15% of Part D expenditures. The OIG also noted that more than half of Medicaid rebates owed by manufacturers for selected brand-name drugs were attributed to inflation-based add-on rebates. While recognizing the statutory limits on Part D rebate collection, the OIG recommends that “CMS and Congress to explore the costs and benefits of obtaining additional rebates under Part D,” potentially addressing beneficiaries eligible for both Medicare and Medicaid. “

CMS Updates Part D Prescribing Regulations

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 or eligible professional who wrote the prescription is neither enrolled in nor validly opted-out of Medicare. CMS previously announced that it was not enforcing the enrollment requirement until December 2015 to allow additional time for Part D prescribers to enroll in or opt-out of Medicare.

CMS has subsequently learned that certain pharmacists and other provider types who do not meet the statutory definitions of “physician” or “eligible professional” to enroll in Medicare may prescribe drugs under state law, but their prescriptions would be denied under the CMS rule because the prescriber is neither enrolled in nor opted-out of Medicare. In response, the May 6 IFC provides that pharmacy claims and beneficiary requests for reimbursement for Medicare Part D prescriptions, written by prescribers other than physicians and eligible professionals who are permitted by state or other applicable law to prescribe medications, will not be rejected at the point of sale or denied by the plan if all other requirements are met. In addition, to mitigate potential interruptions to beneficiaries’ access to medications, the IFC requires Part D sponsors to cover a provisional supply of drugs (3 months) and provide beneficiaries with individualized written notice before denying a Part D claim or beneficiary request for reimbursement on the basis of a prescriber’s Medicare enrollment status. The IFC applies the enrollment policy effective January 1, 2016. Comments will be accepted until July 6, 2015.

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 also, among other things, finalized proposed updates to the Part D risk adjustment model, required more public information on preferred cost sharing pharmacies, addressed plan requirements to maintain accurate provider directories, and discussed promoting valued-based payment models among health plans.

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 beneficiary measure); bundling oncology services; and synchronizing Medicare policy across payment models.

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 home in 2012 were prescribed an antipsychotic, compared to about 14% of Medicare Part D enrollees with dementia living outside of a nursing home were prescribed an antipsychotic that year. While several agencies within HHS have taken steps to address antipsychotic drug use in nursing homes as part of the National Alzheimer's Plan, these efforts have not applied to older adults in other settings, such as assisted living facilities or individuals' homes. The GAO therefore recommends that HHS update its National Alzheimer's Plan to expand outreach and educational efforts to reduce antipsychotic drug use among older adults with dementia residing outside of nursing homes; HHS concurred.  For details, see the full report, “Antipsychotic Drug Use: HHS Has Initiatives to Reduce Use among Older Adults in Nursing Homes, but Should Expand Efforts to Other Settings.” 

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 limit services that are not medically necessary; create a Part D drug management program for beneficiaries at risk of prescription drug abuse; require MACs to establish improper payment outreach and education programs for providers; expand the Senior Medicare Patrol program; require the HHS Secretary to issue guidance on the application of the “Common Rule” protecting individuals involved in research; and require the Secretary to issue a report on how to establish a permanent physician-hospital gainsharing program.
  • H.R. 284, “Medicare DMEPOS Competitive Bidding Improvement Act of 2015” -- which would require Medicare suppliers that bid under a durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program to submit binding bids or risk forfeiture of a surety bond.
  • H.R. 876, “NOTICE Act” – which would require hospitals to provide certain notifications to individuals classified as being under observation status rather than admitted as inpatients.
  • H.R. 887, “Electronic Health Fairness Act of 2015” -- which addresses the treatment of patient encounters in ambulatory surgical centers in determining meaningful electronic health record use.

** These bills were approved with amendments

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 prescription drug plan (PDP) sponsors to hire an independent auditor to validate correction of CMS audit findings.
  • Establishes U.S. citizenship and lawful presence as an eligibility requirement for enrollment in MA and Part D plans (effective June 1, 2015).
  • Makes several policy changes intended to promote efficient dispensing of drugs in long-term care (LTC) facilities, including prohibiting payment arrangements that penalize the adoption of more efficient LTC dispensing techniques by prorating dispensing fees based on days’ supply or quantity dispensed, and requiring that any difference in payment methodology among LTC pharmacies incentivizes more efficient dispensing techniques.
  • Requires MA Prescription Drug (MA-PD) plans to establish and maintain a process with network pharmacies to ensure timely and accurate point-of-sale transactions and coordinate Part A, Part B, and Part D drug benefits administered by the MA PD plan.
  • Requires a sponsor’s Pharmacy & Therapeutics committee to document its process for an objective party to determine whether disclosed financial interests are conflicts of interest and management of any recusals due to conflicts.

Other provisions of the rule address, among other things, business continuity for MA organizations and PDP sponsors; codification of recent quality improvement program policies; and notification requirements related to changes to Part D plans. CMS is not finalizing a number of proposals included in the January 2014 proposed rule, including provisions that would have: lifted the protected class designation on three drug classes; required Medicare Part D sponsors to include in preferred networks any pharmacy willing to accept the sponsor’s terms and conditions; reduced the number of Part D plans a sponsor may offer; and codified CMS interpretation of the Part D non-interference clause.

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.

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 reject PDE records for drugs with dates of service more than 32 days after death that allowed payment for drugs that do not meet Medicare Part D coverage requirements. The OIG recommends that CMS eliminate or, if necessary for administrative processing, shorten the window in which it accepts PDE records for drugs dispensed after a beneficiary's death; CMS concurred. The OIG also observes that while its report focuses on HIV drugs, the issues raised are relevant to all Part D drugs.

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 Medicare Part D. While the final rule stated that the effective date for this requirement would be June 1, 2015, CMS has announced that it is delaying enforcement of this provision until December 1, 2015. CMS notes that Part D drug prescribers must submit their Medicare enrollment applications or opt-out affidavits to their Medicare Administrative Contractors by June 1, 2015 to provide sufficient processing time and prevent prescription drug claims from being denied beginning December 1, 2015.

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 interest. In a recent report, the OIG concludes that each of the four authorized compendia publishers complied with these requirements, although the number and nature of disclosures of potential conflicts of interest varied across publishers.

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 performing icon in 2014. CMS also is interested in receiving information from the public regarding potential data differences in MA and Part D quality measurements for dual-eligible versus non-dual-eligible enrollees. Information is due November 3, 2014. Finally, CMS has released the MA and PDP annual audit and enforcement report for 2013. According to the report, CMS imposed 43 CMPs totaling almost $8.4 million on 39 different organizations and 5 cases of immediate suspension of enrollment and marketing activities for issues identified in 2012 and 2013. Most violations cited in enforcement actions related to inappropriate delays or denials of access to health services and medications for enrollees.

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.

The Client Alert is available here.

OIG Calls for Cuts in Part B Drug Dispensing and Supplying Fees

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 as average Part D rates in 2011, Part B would have saved $110.9 million, while use of average state Medicaid rates would have saved $106.3 million. The OIG recommended that CMS issue regulations to decrease Part B dispensing and supplying fees to rates similar to those of other payers, such as Part D and Medicaid. CMS did not concur with the OIG’s recommendation, and requested that the OIG study actual costs associated with dispensing these Part B drugs.  For additionl information, see the full report, “Medicare Part B Prescription Drug Dispensing and Supplying Fee Payment Rates Are Considerably Higher than the Rates Paid by Other Government Programs."

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 units in Medicare’s fee schedule for physicians and other health professionals.

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 design,” adoption of such innovations has been more limited in stand-alone Medicare Prescription Drug Plans (PDP), Medicare Advantage (MA) and Medicare Advantage Prescription Drug plans (MA-PD), Medicaid managed care plans, Medigap plans, and Retiree Supplemental health plans. CMS therefore is seeking responses to a request for information (RFI) on potential of models to test innovations in these plans related to: (1) plan design, (2) care delivery, (3) beneficiary and provider incentives; and/or (4) network design.

For instance, with respect to drug plans, CMS is considering a PDP model that will test the impact of “robust medication therapy management programs and cost sharing differentials that effectively target Part D beneficiaries and will better coordinate care, manage health care costs, and improve outcomes.” CMS is likewise exploring potential initiatives to collaborate with Medigap and Retiree Supplemental plans on models to manage the care of complex, high-cost beneficiaries. CMS also may explore innovations in MA and MA-PD health plan design for Medicare beneficiaries, including:

  • Value-based insurance design to incentivize beneficiaries with specific health conditions to use high-value health care services and/or providers;
  • Inclusion of remote access technologies beyond what is covered by original Medicare; and 
  • Integration of hospice care benefits concurrently with curative care in the basic benefit package.

CMS points out that testing such models will require collaboration with health plans, states, and other stakeholders. Comments will be accepted on the RFI until November 3, 2014. The RFI does not commit CMS to contracting or making a grant award in this area. 

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 correction to the existing safe harbor for referral services;
  • protection for certain cost-sharing waivers, including: pharmacy waivers of cost-sharing for financially needy Medicare Part D beneficiaries, and waivers of cost-sharing for emergency ambulance services furnished by state- or municipality-owned ambulance services;
  • protection for certain remuneration between Medicare Advantage organizations and federally qualified health centers;
  • protection for discounts by manufacturers on drugs furnished to beneficiaries under the Medicare Coverage Gap Discount Program; and
  • protection for free or discounted local transportation services that meet specified criteria.

The OIG also proposes to amend the definition of “remuneration” in the CMP regulations at 42 CFR 1003 by adding certain statutory exceptions for:

  • copayment reductions for certain hospital outpatient department services;
  • certain remuneration that poses a low risk of harm and promotes access to care;
  • coupons, rebates, or other retailer reward programs that meet specified requirements;
  • certain remuneration to financially needy individuals; and
  • copayment waivers for the first fill of generic drugs.

The OIG also proposes to codify the gainsharing CMP rule set forth in section 1128A(b) of the Social Security Act.  The official version will be published tomorrow; Reed Smith is preparing an analysis of this proposed rule.

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

This post was written by Robert Hill, Carol Loepere, and Joseph Metro

In its September 19, 2014 Special Advisory Bulletin (SAB), the Office of Inspector General (OIG) of the Department of Health & Human Services (HHS) noted the potential risks to federal health care programs presented by pharmaceutical manufacturers’ coupon programs designed to reduce or eliminate patient copayment requirements for brand-name drugs, and emphasized that coupon program sponsors and pharmacies are at risk of sanctions if they fail to take appropriate steps to carve out federal health care program beneficiaries from using the coupons. The OIG points out these coupon programs – which may take different forms, such as print coupons, electronic coupons, debit cards, and direct reimbursements – are remuneration offered to consumers to induce the purchase of specific items, and therefore implicate the criminal federal anti-kickback statute, 42 U.S.C § 1320a-7b(b). Where remuneration is knowingly and willfully paid with the intent to induce or reward referrals of items or services payable by a federal health care program, the anti-kickback statute is violated. The OIG goes on to observe that a claim that includes items or services resulting from a kickback violation would also constitute a false or fraudulent claim under the False Claims Act, 31 U.S.C. § 3729, and grounds for civil money penalties for beneficiary inducement if offer or acceptance of copayment coupons may induce a beneficiary to use a particular practitioner or pharmacy, 42 U.S.C § 1320a-7a(a)(5). While the SAB’s focus is on manufacturer coupon practices, in a footnote, the OIG states that pharmacies accepting coupons for Part D copayments may also be subject to these sanctions.

Notwithstanding the potential benefits of coupon programs to provide access to brand-name drugs and adherence to drug regimens, the OIG claims that such coupon programs may interfere with federal health care program cost-sharing requirements to promote prudent prescribing and purchasing choices by physicians and patients based on the “true costs” of drug and price competition in the market. As a result, the OIG writes, “[w]hile copayment coupons provide an immediate financial benefit to beneficiaries, they ultimately can harm both Federal health care programs and their beneficiaries.”

In the SAB, the OIG acknowledges that the pharmaceutical industry is aware of the potential anti-kickback concerns and generally has implemented a variety of controls to exclude federal health care program beneficiaries from these programs. The OIG’s concern seems to be that these controls don’t go far enough or don’t always work. In other words, the OIG sees the glass as “half empty.” The OIG does not seem to acknowledge that the glass may actually be half-full – i.e., the industry's attempt to have some controls (even if imperfect) evidences manufacturers’ intent to comply with the statute, making it difficult to show criminal liability.

In fact, the OIG’s report, “Manufacturer Safeguards May Not Prevent Copayment Coupon Use for Part D Drugs” (OEI-05-12-00540) http://go.usa.gov/pdYQ, issued concurrently with the SAB, describes in detail mechanisms used by various manufacturers, most notably through claims processing and “switches,” to prevent use of the coupons for drugs paid for by Medicare Part D. The report identifies the principal shortcomings identified with these mechanisms as stemming from the fact that CMS does not permit manufacturers to submit Part D enrollment verification requests (“E1 transactions”) to the Part D Transaction Facilitator because of privacy concerns, so that manufacturers must use various “proxies” to attempt to determine whether the individual using the coupon is enrolled in a Part D plan. The report finds that these proxies, which may include elements as inexact as beneficiary age, may not be accurate enough to guarantee exclusion of Part D claims. Consequently, the OIG appears to be asserting that manufacturers may have liability for having imperfect controls, even though the current claims-processing system does not make a perfect solution available to them. The report did not identify any specific Part D claims for which coupons had in fact been used contrary to coupon terms and conditions.

The OIG recommends that CMS cooperate with industry stakeholders to improve the reliability of pharmacy claims edits, and make coupons transparent. CMS concurred with the recommendation.

OIG Identifies Questionable Utilization of HIV Drugs under Medicare Part D

The OIG attributes $32 million in Medicare Part D spending on HIV drugs in 2012 to claims associated with “questionable utilization patterns.” Specifically, nearly 1,600 Part D beneficiaries with HIV drug claims had no indication of HIV in their Medicare histories, received an excessive dose or supply of HIV drugs, received HIV drugs from a high number of pharmacies or prescribers, or received contraindicated drugs. The OIG observes that while some of this utilization may be legitimate, these patterns warrant further scrutiny, since they could indicate that a beneficiary is receiving inappropriate drugs or diverting drugs, a pharmacy is billing for drugs that the beneficiary did not receive, or a beneficiary’s identification number was stolen. The OIG recommend that CMS: expand sponsors’ drug utilization review programs and use of beneficiary-specific controls; expand the Overutilization Monitoring System to additional drugs; restrict certain beneficiaries to a limited number of pharmacies or prescribers and limit their ability to switch plans; increase monitoring of beneficiaries’ utilization patterns; and follow up on questionable utilization patterns.

Older Entries

August 12, 2014 — GAO Highlights Differences in Federal Program Drug Prices

August 12, 2014 — Ways and Means Committee Seeks Comments on Medicare Program Integrity Bill

July 24, 2014 — Revised CMS Policy on Medicare Part D Drugs for Hospice Enrollees

June 25, 2014 — OIG Report Concludes Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles

June 2, 2014 — CMS Finalizes Updates to Medicare Advantage/Part D Policies for 2015

May 15, 2014 — CMS Proposes Medicare Hospice Payment Policies for FY 2015

April 9, 2014 — CMS Announces Final 2015 Medicare Advantage/Part D Drug Plan Rates and Policies

April 8, 2014 — HHS OIG Identifies "Top 25" Priorities

April 8, 2014 — RACs Correct $2.4 Billion in Medicare Claims in FY 2012

March 25, 2014 — CMS Finalizes 2014 Policy on Medicare Payment for Hospice Enrollees' Drug Expenses

March 4, 2014 — Congressional Health Policy Hearings

March 3, 2014 — CMS Proposes 2015 Payment, Policy Updates for Medicare Advantage and Drug Plans

January 8, 2014 — CMS Proposes Updates to Medicare Advantage/Part D Policies for 2015

January 6, 2014 — CMS Invites Comments on Medicare Payment for Hospice Enrollees' Drug Expenses

November 14, 2013 — OIG Examines Inappropriate Medicare Payments on Behalf of Deceased or Unlawfully-Present Beneficiaries

September 17, 2013 — OIG Call for Medicare Part B Drug Rebates Rejected by CMS

June 27, 2013 — OIG Focuses on Inappropriate Prescribing of Medicare Part D Drugs

June 11, 2013 — CMS Finalizes Medicare Advantage/Part D Plan Medical Loss Ratio Rules

June 11, 2013 — OIG Finds Medicare Plans Generally Cover Drugs Commonly Used by Dual Eligibles

June 11, 2013 — Health Policy Hearings

May 13, 2013 — CMS Sequestration Guidance for State Surveyors, Medicare Part C & D Plans

April 16, 2013 — CMS Finalizes Medicare Advantage, Part D Drug Plan Rates for 2014

April 10, 2013 — Obama Administration's Proposed FY 2014 Budget Includes $401 Billion in Health Program Savings

March 28, 2013 — MedPAC's March 2013 Report to Congress

March 12, 2013 — OIG Calls for Stronger Conflict-of-Interest Oversight for Medicare Part D P&T Committees

March 4, 2013 — Medicare and Sequestration - What Happens Now?

February 18, 2013 — CMS Proposes Medicare Advantage, Part D Drug Plan Medical Loss Ratio Rule and Advance 2014 Rate Information

January 30, 2013 — OIG Calls for Improvements to Medicare Parts C & D Benefit Integrity Activities

December 17, 2012 — OIG Releases 2012 Compendium of Unimplemented Recommendations

October 30, 2012 — GAO Finds Part D Coverage Gap Discount Program Did Not Spur Increased Drug Prices

October 16, 2012 — OIG Issues FY 2013 Work Plan

October 16, 2012 — CMS Releases Medicare Advantage/Part D Drug Plan Quality Data as Open Enrollment Period Begins

October 15, 2012 — OIG Assesses Inappropriate Medicare Part D Payments for Schedule II Drugs Billed as Refills

July 27, 2012 — MedPAC Issues 2012 Data Book

July 18, 2012 — OIG Examines Medicare Part D Drug Payments for Hospice Beneficiaries

June 18, 2012 — CMS Correction Notices (IPPS, LTCH-PPS, MA, PDP)

June 13, 2012 — OIG Concludes Part D Plans Include Drugs Used by Dual Eligibles

May 11, 2012 — OIG Examines Retail Pharmacy Billing for Part D Drugs

April 23, 2012 — CMS Finalizes Medicare Part D/Medicare Advantage (MA) Rules for 2013

April 23, 2012 — CMS Guidance on CY 2013 Part D Medication Therapy Management Programs

April 2, 2012 — MedPAC Issues March 2012 Medicare Recommendations

February 28, 2012 — OIG Examines MA Organizations' Identification of Potential Fraud & Abuse

February 25, 2012 — CMS Releases 2013 Medicare Advantage/Part D Combined Advance Notice and Draft Call Letter

February 14, 2012 — President Obama Proposes FY 2013 Budget

January 25, 2012 — CMS Seeks Comments on Part D Reporting Requirements, & Issues Other Part D Updates

January 4, 2012 — CMS Guidance to Part D Plans on Prescription Drug Abuse

January 4, 2012 — OIG Identifies Part D Oversight Gaps

December 13, 2011 — Congressional Budget Office Revised Part D Spending Patterns

December 13, 2011 — OIG Examines Part D Financial Record Audits

December 13, 2011 — MedPAC to Discuss Medicare Payment Policies (Dec. 15 & 16)

November 29, 2011 — OIG Examines How Part D Limits Drugs to Medically-Accepted Indications

November 14, 2011 — OIG Highlights Medicaid Rebate Program, Indian Health Services (IHS) Issues

November 11, 2011 — CMS Guidance on Medicare Part D Coverage Gap Discount Program, Cost-Sharing for Dual Eligibles

October 28, 2011 — Upcoming MedPAC Meeting (Nov. 3-4)

October 14, 2011 — CMS Proposes Changes To Medicare Part D/Medicare Advantage Rules

October 14, 2011 — CMS Seeks Ideas on Reducing Overutilization of Part D Drugs

October 14, 2011 — GAO Examines Part D "Doctor Shopping"

September 27, 2011 — Medicare Coverage Gap Discount Program: Low Dollar Invoice Amounts

September 19, 2011 — President Obama Outlines Proposal to Deficit Reduction Super-Committee; Medicare Provisions Loom Large

September 1, 2011 — CMS Finalizes MIPPA Medicare Advantage/Part D Drug Plan Rule

August 16, 2011 — OIG Compares Medicare Part D and Medicaid Drug Rebates

August 16, 2011 — Part D Plan Mid-Year Formulary Changes Reviewed by GAO

August 1, 2011 — OIG Report on Medicare Part D Plan Sponsors' Fraud Training

August 1, 2011 — GAO Report on Part D Drug Utilization for Low-Income Subsidy Beneficiaries

July 18, 2011 — CMS Solicits Comments on Medicare Coverage Gap Discount Program Issues

June 14, 2011 — CMS Updates Guidance on Medicare Coverage Gap Discount Program Appeals

May 31, 2011 — Part D Payments on Behalf of Deceased Enrollees.

April 29, 2011 — OIG Report on Part D Drugs for Dual-Eligible Beneficiaries

April 13, 2011 — CMS Finalizes Changes to Medicare Part D, Medicare Advantage Rules

April 13, 2011 — CMS Seeks Comments on Part D Coverage Gap Appeals; 2012 MA/Part D Call Letter Released

March 29, 2011 — Medicare Part D Guidance: Medication Therapy Management, Formulary Submissions

March 29, 2011 — Compendium of Unimplemented OIG Recommendations

March 29, 2011 — GAO and OIG Examine Medicare Part D Issues

March 29, 2011 — CBO Presents Budget Options, Including Potential Health Policy Savings

March 7, 2011 — OIG Identifies Top HHS Management Challenges, Including ACA Implementation

March 7, 2011 — OIG Faults Part D Rebate Reporting

February 18, 2011 — OIG Report on Invalid Prescriber IDs on Part D Schedule II Drug Claims

January 28, 2011 — New Medicare Part D Guidance Documents

January 13, 2011 — Medicare Advantage/Part D Plan Marketing Guidelines, Applications

December 29, 2010 — CMS Seeks Comments on Recovery Audit Contractors (RACs) for Medicare Parts C & D

November 29, 2010 — Medicare Part D Pharmacy Discounts

November 16, 2010 — CMS Proposes Changes to Medicare Part D, Medicare Advantage Rules

November 15, 2010 — Medicare Coverage Gap Discount Program - 2012 Benefit Year

November 15, 2010 — OIG Report on Part D Terminated Drugs

October 15, 2010 — Medicare Coverage Gap Discount Program - 2011 Labeler Code File

September 17, 2010 — Part D Drug Benefit Coverage Gap

August 31, 2010 — "Consistently Low Performer" Ratings for Part C/Part D Plans

August 31, 2010 — OIG Report on Less-Than-Effective Drugs in the Medicare Part D Program

August 13, 2010 — Final Medicare Part D Coverage Gap Discount Program Manufacturer Agreement

July 28, 2010 — Comment Opportunity on 2011 MA/Part D Bid Submissions

July 12, 2010 — CMS Rule on E-Prescribing and the Medicare Prescription Drug Program

July 10, 2010 — Invalid Part D Prescriber Identifiers

June 18, 2010 — CMS Updates on Part D Coverage Gap Rebates/Discount Program

June 17, 2010 — OIG Report on Medicare Part D Prescription Drug Event Reconciliation Process

June 8, 2010 — CMS Information on Generic Drugs in the Part D Coverage Gap

June 8, 2010 — CMS Corrects Part D/MA Rule

May 28, 2010 — Affordable Care Act Updates on Part D Coverage Gap Payments SNF Policy, Fraud Provisions, Beneficiary Improvements

May 24, 2010 — CMS Issues Revised Program Instructions and Draft Manufacturer Agreement for Medicare Part D Coverage Gap Discount Program; Releases Medicaid AMP Reporting Guidance

May 11, 2010 — Draft Program Instructions for Medicare Part D Coverage Gap Discount Program (Comments Due May 14)

April 16, 2010 — Medicare Part C/Part D Final Rule