HHS Office of Medicare Hearings and Appeals (OMHA) Hosting Second Medicare Appellant Forum (Oct. 29)

On October 29, 2014, the OMHA is hosting its second OMHA Medicare Appellant Forum. The meeting will update OMHA appellants on the status of OMHA operations and discuss OMHA and CMS initiatives designed to mitigate the Medicare appeals backlog at the OMHA-level of the administrative appeals process. The deadline for in-person registration is October 28, and registration for remote/webinar attendance ends October 24.

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.

CMS Call on 2013 Physician Quality and Resource Use Reports (Oct. 23)

On October 23, 2014, CMS is hosting a call on 2013 Quality and Resource Use Reports (QRURs) for physician group practices and physician solo practitioners. The 2013 QRURs contain quality and cost performance data that will be used in determining the applicable Value-Based Payment Modifier for 2015. 

Hospital Outpatient Payment Advisory Panel Meeting (March 9-10, 2015)

The Advisory Panel on Hospital Outpatient Payment will be holding its first semi-annual meeting for 2015 on March 9-10, 2015. The purpose of the Panel is to advise CMS on (1) the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and (2) hospital outpatient therapeutic services supervision issues. Registration will be open January 19 through February 20, 2015. CMS will accept comments and presentations for the agenda until February 6, 2015.

OIG and CMS Extend Fraud/Abuse Waivers for Medicare Shared Savings Program/ACOs; Invite Feedback on Waiver Policy

Today the OIG and CMS published a joint notice continuing the effectiveness of fraud and abuse law waivers granted in 2011 in connection with the Medicare Shared Savings Program, which is intended to encourage physicians, hospitals, and certain other types of providers and suppliers to form accountable care organizations (ACOs). 

By way of background, in a November 2, 2011 joint OIG-CMS interim final rule with comment period, the agencies established waivers of the application of the federal physician self-referral law, the federal anti-kickback statute, and certain civil monetary penalties law provisions to specified arrangements involving ACOs participating in the Shared Savings Program (the Waiver IFC).  In 2011 Reed Smith prepared an in-depth analysis of the Medicare Shared Savings Program, including an analysis of the Waiver IFC.  Because of a general 3-year deadline for publishing Medicare final rules after the publication of a proposed or interim final rule, the agencies are extending the timeline for publication of a final rule concerning Shared Savings Program waivers to avoid “creating legal uncertainty for ACOs participating in the Shared Savings Program and potentially disrupting ongoing business plans or operations of some ACOs.”  The notice also states that CMS is developing a proposed rule to make certain modifications to the Shared Savings Program regulations; in order to ensure that the final waiver regulations align with the Shared Savings Program rules, the agencies believe “the prudent course of action at this time is to extend the effectiveness of the Waiver IFC.”  Thus the Waiver IFC will remain in effect through November 2, 2015, unless a final waiver rule becomes effective on an earlier date.

 

In the notice, the agencies also suggest that they would benefit from additional stakeholder input to inform their understanding of:

  1. how and to what  extent ACOs are using the waivers;
  2. whether the existing waivers serve the needs of ACOs and the Medicare program;
  3. whether the  waivers adequately protect the Medicare program and beneficiaries from the types of harms associated with referral payments or payments to reduce or limit services; and
  4. whether there are new or changed  considerations that should inform the development of additional notice  and comment rulemaking.

No deadline is specified for providing feedback on these considerations. 

CMS Releases Preliminary Determinations for New 2015 Clinical Laboratory Fee Schedule Codes

CMS has posted its preliminary payment determinations for new 2015 clinical laboratory fee schedule codes. The document lists CMS’s recommendation regarding the basis of payment for codes -- either crosswalk or gap-fill. Note that CMS is recommending to delay pricing various individual drug testing screening codes given “the potential for overpayment when billing for each individual drug test rather than a single code that pays the same regardless of the number of drugs that are being tested for.” Additional information about the comment and reconsideration process is available on the CMS website.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Regulatory Developments. The OIG has published a major proposed rule to amend the safe harbors to the Anti-Kickback Statute and the Civil Monetary Penalty rule. CMS regulations and notices have addressed home health conditions of participation, amount in controversy thresholds for Medicare appeals, and corrections to the final FY 2015 Medicare IPPS/LTCH rule. The ONC has issued a final rule on electronic health record certification criteria, and the DEA published a final rule on secure disposal of controlled substances.
  • Other HHS Developments. CMS has announced changes to the Nursing Home Five Star Quality Rating System; launched the “Open Payments” public database; requested input on delivery innovations in Medicare Part D, Medicare Advantage, and other programs; released new Medicare Recovery Auditors statistics; and posted updated Medicare Part B drug pricing files. HHS has released guidance on the HIPAA Privacy Rule and same-sex marriage. Draft FDA guidance documents address laboratory developed test regulatory oversight and medical device cybersecurity).
  • OIG & GAO Developments.  The OIG has issued a Special Advisory Bulletin on Pharmaceutical Manufacturer Copayment Coupons, along with a report on this topic. Other recent OIG reports have focused on state standards for access to care in Medicaid managed care, CMS enforcement of rural health clinic location criteria, and Part B drug dispensing and supplying fees. The OIG also has highlighted state Medicaid policies that inflate federal costs.  The GAO has called for improvements to Healthcare.gov information security and privacy controls.
  • Legislative Developments. President Obama has signed into law the Improving Medicare Post-Acute Care Transformation Act; Reed Smith has prepared a client alert summarizing the new law.  President Obama also signed bills addressing muscular dystrophy research, emergency medical care for children, and autism research and intervention.
  • Health Industry Events. CMS is hosting calls on hospital appeals settlements and transitioning to ICD-10. HHS is holding a workshop on “Integrating Plans for Long-Term Services and Supports and Health Care Delivery through Health Information Technology.” MedPAC is meeting to discuss various Medicare policy issues.
  • @ReedSmithHealth is on Twitter. For the latest health policy news, follow us at @ReedSmithHealth.

Proposed Revisions to Home Health Conditions of Participation

On October 9, 2014, CMS is publishing a proposed rule that would extensively revise the conditions of participation (CoPs) that home health agencies (HHAs) must meet to participate in the Medicare and Medicaid programs. The rule is intended to provide HHAs with enhanced flexibility while focusing provider efforts on the services delivered to the patient, the quality of care furnished by the HHA, and quality assessment and performance improvement efforts. According to CMS, the proposed CoPs “reflect a fundamental change in our regulatory approach -- a change that to a large extent establishes a shared commitment between CMS and HHA providers to achieve improvements in the quality of care furnished to HHA patients.” CMS expects its patient-centered, outcome-oriented approach to enhance the working relationship between state survey agencies and HHAs, and provide a basis for improved performance that will help ensure that quality care is provided to all patients.

More specifically, CMS proposes to establish the following four CoPs (in addition to retaining current requirements related to comprehensive assessment of patients):

  • “Patient rights” would emphasize the HHA's responsibility to respect and promote the rights of each home health patient.
  • “Care planning, coordination of services, and quality of care” would incorporate the interdisciplinary team approach to provide home health services focusing on the care planning, coordination of services, and quality of care processes.
  • “Quality assessment and performance improvement” (QAPI) would require each HHA to conduct ongoing quality assessment, incorporate data-driven goals, and maintain an evidence-based performance improvement program of its own design to affect continuing improvement in the quality of patient care.
  • “Infection prevention and control” would require HHAs to follow accepted standards of practice to prevent and control the transmission of infectious diseases and to educate staff, patients, and family members or other caregivers on these accepted standards.

CMS proposes to remove many process details from the current CoPs where they do not achieve the goal of ensuring desired outcomes. CMS is not proposing to incorporate by reference any specific clinical practice guidelines or professional standards of practice; HHAs would be responsible for identifying their own performance problems through their QAPI programs, addressing them, and continuously striving to improve the quality of care, patient outcomes and satisfaction, and efficiency/economy. The proposed CoPs also are designed to enable surveyors to look at outcomes of care and “how effectively the provider was pursuing a continuous quality improvement agenda.”  CMS will accept comments for 60 days after publication (December 8, 2014).

CMS to Revise Five Star Quality Rating System for Nursing Homes

CMS has announced that it will make a series of improvements to the Nursing Home Five Star Quality Rating System, including additional quality measures, new data verification processes, and a revised quality scoring methodology. Among other things:

  • CMS will add a new quality measure on antipsychotic medication use starting January 2015, and include claims-based data on re-hospitalization and community discharge rates in the future.
  • CMS and states will implement focused survey inspections for a sample of nursing homes to verify staffing and quality measure information, effective January 2015.
  • CMS will implement a quarterly electronic reporting system that is auditable back to payrolls to verify staffing information and allow for the calculation of staffing-related quality measures.
  • CMS will strengthen requirements to ensure that states maintain a user-friendly website and complete timely, accurate nursing home inspections for inclusion in the rating system.
  • CMS will revise the methodology used to calculate each facility’s quality measure rating in 2015.

President Obama Signs Post-Acute Care Transformation Act and Other Health Policy Bills

On October 6, 2014, President Obama signed into law H.R. 4994, the Improving Medicare Post-Acute Care Transformation Act of 2014 (the “IMPACT Act”). The IMPACT Act’s provisions will affect a broad range of post-acute care (PAC) providers: home health agencies (HHAs), skilled nursing facilities (SNFs), inpatient rehabilitation facilities (IRFs), and long-term acute care hospitals (LTCHs). Various facets of daily operations of these PAC providers will change as a result of the Act and ensuing regulations: what information PAC providers must collect and report, the information the public will receive about PAC providers, and the method of determining future Medicare payments to PAC providers, among others. The IMPACT Act also increases survey frequency for Medicare-certified hospice programs. A Reed Smith client alert summarizing the Impact Act is available here.

Separately, President Obama also signed into law a number of other health policy bills approved by Congress, including the following:

  • H.R. 594, Paul D. Wellstone Muscular Dystrophy Community Assistance, Research and Education Amendments of 2014, which revises and expands research, surveillance, and education activities relating to muscular dystrophy at the National Institutes of Health and the Centers for Disease Control and Prevention, and expands the federal agencies comprising the Muscular Dystrophy Coordinating Committee;
  • S. 2154, Emergency Medical Services for Children Reauthorization Act of 2014, which reauthorizes appropriations through fiscal year 2019 for a program to provide highquality emergency medical care to children; and
  • H.R. 4631, Autism Collaboration, Accountability, Research, Education, and Support (CARES) Act of 2014, which reauthorizes Combating Autism Act funding for autism research, screening, intervention, and education activities, as well as an HHS coordinating committee.

CMS Launches "Open Payments" Public Database; Usability Concerns Remain

Despite a series of technical problems and data disparities leading up to the launch, CMS met its schedule to release the first round of “Open Payments” data on September 30, 2014. Note that initial use of the database of financial payments made by drug and device manufacturers and group purchasing organization to physicians and teaching hospitals has been hampered by large file sizes, multiple databases, and confusing instructions. CMS has stated that it plans to launch a more user-friendly search tool later this month.

The first wave of data details 4.4 million payments valued at nearly $3.5 billion attributable to 546,000 individual physicians and almost 1,360 teaching hospitals during the last five months of 2013 (future annual updates will include 12 months of data). Because CMS identified payment records that appeared to have inconsistent physician information (e.g. a National Provider Identifier for one doctor and a license number for another) that could not be matched, CMS has temporarily “suppressed” the personally-identifiable information for those records. In fact, CMS estimates that about 40% of the records published initially are de-identified, and additional disputed data was not published, which could skew initial attempts to draw conclusions about payment patterns. CMS cautions that financial ties between manufacturers and providers “do not necessarily signal wrongdoing” or conflicts of interest, given that some relationships may lead to the development of beneficial new technologies and therapies. CMS encourages patients to discuss these financial relationships with their health care providers.

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."

GAO Calls for Improvements to Healthcare.gov Information Security and Privacy Controls

The Government Accountability Office (GAO) has assessed the effectiveness of CMS controls intended to protect the security and privacy of the information and information technology (IT) systems used to support Healthcare.gov. The GAO determined that while CMS has taken steps to protect Healthcare.gov security and privacy, “weaknesses remain both in the processes used for managing information security and privacy as well as the technical implementation of IT security controls.” The GAO warns that until such weaknesses are fully addressed, risks remain with regard to unauthorized access, disclosure, or modification of the information collected and maintained by Healthcare.gov and related systems, along with potential disruption of services. The GAO made a series of recommendations to implement security and privacy management controls related to Healthcare.gov. For details, see the full report, “Healthcare.gov: Actions Needed to Address Weaknesses in Information Security and Privacy Controls.”

FDA Releases Two Draft Guidance Documents on Proposed Laboratory Developed Test (LDT) Regulatory Oversight

This post was written by Jennifer Pike and Vicki Morris.

On September 30, 2014, the Food and Drug Administration (FDA) announced the availability of two draft guidances intended to implement a new regulatory oversight framework for LDTs, which are defined by the FDA as "a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory" and which are intended for clinical use. Release of the documents follows on the heels of FDA’s notification to Congress in late July of its intent to issue draft guidance in this area. The first draft guidance, "Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)" (Framework Guidance), describes a risk-based framework for addressing the regulatory oversight of LDTs. The Framework Guidance also describes FDA’s priorities for enforcing pre- and post-market requirements for LDTs, and the process by which FDA intends to phase in enforcement of FDA regulatory requirements for LDTs over time. The second draft guidance, "FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)" (Notification and Reporting Guidance), describes the process for clinical laboratories to notify FDA of the LDTs they manufacture as well as the Medical Device Reporting (MDR) requirements for clinical laboratories that manufacture LDTs. Both draft guidances reflect the FDA’s effort to take steps to encourage the advancement of personalized medicine by helping to ensure the reliability of certain diagnostic tests. The guidances are neither final nor in effect at this time.  

The following is an overview of the specific issues addressed in the draft guidances:

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HHS Guidance HIPAA Privacy Rule and Same-sex Marriage

The HHS Office of Civil Rights (OCR) has released guidance on “HIPAA and Same-sex Marriage: Understanding Spouse, Family Member, and Marriage in the Privacy Rule.” The guidance stems from a Supreme Court decision in United States v. Windsor striking down Section 3 of the Defense of Marriage Act (DOMA), which had provided that federal law would recognize only opposite-sex marriages. In light of the ruling, HHS explains that legally married same-sex spouses are family members for the purposes of applying various provisions of the Privacy Rule, including standards for sharing an individual’s protected health information with a family member and the prohibition on using or disclosing genetic information of a family member for underwriting purposes. OCR intends to issue additional clarifications to address same-sex spouses as personal representatives under the Privacy Rule.

OIG Faults CMS Enforcement of Rural Health Clinic Location Criteria

The OIG continues to fault CMS for failing to issue final regulations – authorized by the Balanced Budget Act of 1997 (BBA) – to enforce the location requirements for rural health clinics (RHCs). By way of background, facilities can be designated as RHCs and qualify for enhanced Medicare and Medicaid reimbursement if they are: (1) located in rural areas and (2) located in areas that have a shortage of health care providers. The BBA allows CMS to terminate of RHCs that no longer met the location requirements as long as they are not determined to be "essential provider" RHCs, but CMS has not issued regulations to allow RHCs to apply as essential provider RHCs. The OIG determined that about 12% of RHCs no longer met the location requirements in 2013 (a 56% increase since 2003, when the OIG last examined this issue). The Medicare program and its beneficiaries paid approximately $132 million to these RHCs in 2012. The OIG points out that these providers they should continue to qualify as RHCs only if they are determined to be essential providers. In order to ensure that CMS can enforce the BBA provisions relating to RHCs, the OIG recommends that CMS issue regulations to enable RHCs determined to be essential providers to remain certified as RHCs. CMS thanked OIG for “their efforts on this issue,” but declined to commit to issuing regulations.

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.

HHS Workshop: Integrating Plans for Long-Term Services and Supports & Health Care Delivery through Health IT (Oct. 16)

On October 16, 2014, the Administration for Community Living (ACL) and the HHS Office of the National Coordinator on Health Information Technology (ONC) are holding a public workshop entitled “Putting the Person at the Center: Integrating Plans for Long-Term Services and Supports and Health Care Delivery through Health Information Technology.” The workshop will focus on the use of health information technology to enable a person-centered approach for planning and delivering long-term services and supports and health care, including how to improve communication and collaboration among community-based organizations and health care partners. The agenda includes care planning, technology and integration; key opportunities and challenges; and delivery and payment reform policy levers. The registration deadline for the event is October 10, 2014.

CMS Corrects Final FY 2015 Medicare IPPS/LTCH Rule

CMS has published corrections to its August 22, 2014 final update to the Medicare Hospital Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital Prospective Payment System for FY 2015. Among other things, CMS made technical errors in its calculation of the operating and capital IPPS budget neutrality factors, outlier threshold, operating standardized amounts, capital federal rates, and impacts. CMS also made errors in determining the FY 2015 readmissions payment adjustment factors; CMS has revised the estimated savings under the Hospital Readmissions Reduction Program to $428 million, from $424 million in the final rule.

OIG Examines Varying State Standards for Access to Care in Medicaid Managed Care

The OIG has issued a report evaluating state standards for access to care for Medicaid managed care program enrollees, an issue which the OIG notes has taken on heightened importance as enrollment in such programs grows. Based on a review of the 33 states with comprehensive, "full risk" Medicaid managed care, the OIG concluded that state standards for access to care vary widely. For example, state standards for primary care providers range from one primary care provider for every 100 enrollees to one provider for every 2,500 enrollees. The OIG also pointed out varying state strategies to assess compliance with access standards, and noted that most states did not identify any violations of such standards over a five-year period. The OIG recommend that CMS: (1) strengthen its oversight of state standards, including ensuring that states develop standards for key provider types; (2) strengthen its oversight of states' methods to assess access standard compliance; (3) improve states' efforts to identify and address violations of access standards; and (4) provide technical assistance to states. CMS concurred with the recommendations.

CMS Releases CY 2015 Amount in Controversy Thresholds for Medicare Appeals

CMS has published a notice announcing the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. Specifically, the calendar year 2015 AIC threshold amounts are $150 for ALJ hearings and $1,460 for judicial review. These amounts are effective for requests for ALJ hearings and judicial review filed on or after January 1, 2015.

RACs Identified $3.75 Billion in Improper FFS Medicare Payments in FY 2013

According to a new CMS report, fee-for-service (FFS) Medicare Recovery Auditors identified and corrected 1,532,249 claims for improper payments in FY 2013, representing $3.75 billion in improper payments. Of this amount, $3.65 billion was attributable to overpayments, compared to 102.4 million of the improper claims were underpayments that were repaid to providers and suppliers. According to CMS, after taking into consideration all fees, costs, and first level appeals (but not expenses related to third and fourth levels of appeal), the Medicare FFS Recovery Audit Program returned over $3.0 billion to the Medicare Trust Funds. With regard to provider type, inpatient hospital claims represented almost all overpayments (94%).

ONC Final Rule on EHR Certification Criteria

The Office of the National Coordinator for Health Information Technology (ONC) published a final rule on September 11, 2014 that is intended to introduce regulatory flexibilities with regard to certification to the 2014 Edition Electronic Health Records (EHR) Certification Criteria. The rule also codifies certain revisions to the ONC Health Information Technology (HIT) Certification Program for certification to the 2014 Edition and future editions, and it makes administrative updates to associated regulations. ONC specifies that EHR technology developers do not have to update and recertify their products to the revised 2014 Edition Release (also referred to as the “2014 Edition Release 2”), nor do eligible providers have to upgrade to EHR technology certified to the 2014 Edition Release 2, although ONC encourages such stakeholders “to consider whether the 2014 Edition Release 2 offers any opportunities that they might want to pursue.”

FDA Releases "Purple Book," Including Biosimilar Products

The FDA’s new “Purple Book” lists biological products licensed by FDA under the Public Health Service Act (the PHS Act). The publication includes information on whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act, and whether the FDA has determined a biological product to be biosimilar to or interchangeable with a reference biological product.

OIG Highlights State Medicaid Policies that Inflate Federal Costs

The OIG has created a “Spotlight” page on its internet site focusing on “Medicaid: State Policies that Result in Inflated Federal Costs.” The page compiles OIG reports that highlighted “State policies that distort the cost-sharing arrangement, causing the Federal Government to pay more than its share of Medicaid expenditures.” According to the OIG, such mechanisms do not increase benefits to beneficiaries, but they increase states' funds at the expense of the federal government. The OIG discusses steps that have been taken to close loopholes in this area, but it notes that more work remains. The OIG continues to recommend that CMS seek legislation to strengthen its ability to curb wasteful federal spending stemming from states claiming reimbursement for excessive payments.

CMS Call: Transitioning to ICD-10 (Nov. 5)

CMS is hosting a call on November 5, 2014 to discuss implementation issues associated with the transition to ICD-10 on October 1, 2015. The call will cover the following topics: final rule and national implementation; Medicare Fee-For-Service testing; the Medicare Severity Diagnosis Related Grouper (MS-DRG) Conversion Project; partial code freeze and annual code updates; plans for national coverage determinations and local coverage determinations; home health conversions; and claims that span the implementation date.

CMS Call: Hospital Appeals Settlement Update (Oct. 9)

CMS is hosting a call on October 9, 2014 to provide additional information on its proposed administrative agreement for acute care hospitals and critical access hospitals to resolve certain appeals of patient status denials. All administrative agreement requests are due to CMS on October 31, 2014.

CMS Call on Hospital Compare/HCAHPS Star Ratings (Oct. 8)

On October 8, 2014, CMS is hosting a call to discuss its plans to begin publicly reporting Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Star Ratings on the Hospital Compare website. CMS intends to begin the HCAHPS Star Ratings reporting in April 2015.

DEA Issues Final Rule on Safe, Secure Disposal of Controlled Substances

The Drug Enforcement Administration (DEA) has published a final rule to implement the Secure and Responsible Drug Disposal Act of 2010, which was intended to mitigate prescription drug abuse by providing safe and secure mechanisms for “ultimate users” to dispose of unused or unwanted pharmaceutical controlled substances. The regulations allow authorized manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies to voluntarily administer mail-back programs and maintain collection receptacles. In addition, this rule expands the authority of authorized hospitals/clinics and retail pharmacies to voluntarily maintain collection receptacles at long-term care facilities. According to the DEA, it has expanded the entities that may be authorized collectors in response to public concerns regarding ultimate users’ ability to have convenient disposal options. The rule also establishes standards related to each element of the disposal process, including the transfer, delivery, collection, destruction, return, and recall of pharmaceutical controlled substances. Also in response to comments, the DEA has relaxed some of the proposed security requirements related to storage and destruction of controlled substances. The rule is effective October 9, 2014. 

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.