RACs Correct $2.4 Billion in Medicare Claims in FY 2012

CMS has released data on Recovery Audit Contractor (RAC) operations fiscal year 2012. Key findings included the following:

  • In FY 2012, Medicare fee-for-service (FFS) RACs collectively identified and corrected 1,272,297 claims for improper payments, which resulted in $2.4 billion in improper payments being corrected ($2.3 billion in overpayments/$109.4 million in underpayments). Subtracting fees, costs, and first level appeals, the Medicare FFS Recovery Audit Program returned over $1.9 billion to the Medicare trust funds.
  • The Part D RAC’s initial review focused on identifying improper payments for prescriptions written by excluded prescribers or filled by excluded pharmacies beginning with contract year 2007. Recoupment of approximately $2 million in overpayments began in the first quarter of FY 2013 for those plans identified in the Part D RAC's initial audit review. The Part D RAC is continuing its review of excluded providers and pharmacies for contract years 2008 and 2009. In addition, CMS posted a notice on April 4, 2013, seeking potential contractors to perform Part C RAC activities.
  • As of September 30, 2012, 36 states had implemented Medicaid RAC programs, and other states are in various stages of preparation. For FY 2012, the states have recovered a total federal and state share combined amount of $95.64 million. CMS expects recoveries to increase as more states have fully operational State Medicaid RAC programs.

As previously reported, CMS has “paused” its RAC audits in preparation for the procurement of new RAC contracts and to “allow CMS to continue to refine and improve the Medicare Recovery Audit Program.”

CMS Announces System to Collect Hospice Care Data Beginning July 1, 2014

On April 8, 2014, CMS published a notice announcing that it is establishing a new “system of records” to collect data to support the Hospice Quality Reporting Program. The new “Hospice Item Set” (HIS) is a standardized mechanism for abstracting data from a patient’s medical record to confirm that the appropriate assessments were made and concerns were addressed for the following domains of care: (1) Pain; (2) Respiratory Status; (3) Medications; (4) Patient Preferences; and (5) Beliefs & Values. The notice is effective on May 8, 2014, and comments will be accepted until that date. Beginning July 1, 2014, hospices will be required to submit two HIS records for each patient admitted to their organization: an HIS-Admission record and an HIS-Discharge record. 

FDA Proposal Amends Medical Device Classification Rules

This post was written by Jennifer Pike.

On March 25, 2014, the Food and Drug Administration (FDA) published a proposal to amend its regulations governing the classification and reclassification of medical devices. In addition to conforming the regulations to recent changes made by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), the proposed rule makes changes unrelated to FDASIA. Among other changes to 21 CFR Part 860, FDA proposes to:

  • Amend several definitions at 21 CFR § 860.3, including the definitions of Class I, Class II and Class III to reflect the key principle underlying device classification that a reasonable assurance of safety and effectiveness is necessary for all three classes, but that the level of regulation necessary to provide such assurance is specific to the level of risk.
  • Amend the definition of Class III to clarify which devices fall in this category.
  • Establish special controls for Class II devices by replacing the term “performance standards” in 21 CFR § 860.7.
  • Amend 21 CFR § 860.84 to remove from the classification process the requirement to answer the classification questionnaire and provide information using the supplemental data sheet.
  • Revise the procedure at 21 CFR § 860.130 to reflect the FDASIA requirement that devices reclassified under 513(e) of the Food, Drug and Cosmetic Act be reclassified using an administrative order procedure.
  • Revise the process under 21 CFR § 860.133 for the filing of a premarket approval for Class III preamendment devices to conform to FDASIA.

Comments to the proposed rule may be submitted in writing, or at www.regulations.gov, on or before June 23, 2014.

Obama Administration Continues to Update ACA Insurance Exchange and Health Plan Regulations

The Administration has issued numerous regulations recently that make additional changes to operational policies, payment provisions, and other standards applicable to health plans and Health Insurance Exchanges (also called Marketplaces) under the Affordable Care Act (ACA). Highlights include the following:

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CMS Rule Increases FY 2014 Medicare Payments for Low-Volume Hospitals

On March 18, 2014, CMS published an interim final rule with comment period that implements changes to the payment adjustment for low-volume hospitals and to the Medicare-dependent hospital (MDH) program for fiscal year 2014 in accordance with the Pathway for SGR Reform Act of 2013. The rule, which applies to discharges on October 1, 2013 through March 31, 2014, is estimated to increase Medicare inpatient prospective payment systems (IPPS) payments to these hospitals by an additional 0.24%, or $227 million.  Comments on the rule will be accepted until May 13, 2014.

CMS Rule Requires Qualified Health Plans to Accept Certain Third-Party Premium Payments

Today CMS published an interim final rule with comment period that requires qualified health plan (QHP) issuers to accept premium and cost-sharing payments made on behalf of enrollees by the Ryan White HIV/AIDS Program, Indian tribes and organizations, and other federal and state government programs that provide premium and cost sharing support. This rulemaking was prompted by CMS concerns that some QHP issuers continue to reject Ryan White cost-sharing payments despite previous CMS guidance, which is resulting in beneficiary access problems. This standard applies to all individual market QHPs, including Stand Alone Dental Plans (SADP), regardless of whether they are offered through a federal or state Exchange or outside of the Exchanges. On the other hand, CMS specifies in the preamble that the rule would not prevent QHPs and SADPs from rejecting premium and cost sharing payments made by other third parties, including hospitals, other healthcare providers, and other commercial entities. CMS continues to encourage QHPs and SADPs to reject such payments, given CMS’s concern that they “could skew the insurance risk pool and create an unlevel competitive field in the insurance market.” The interim final rule is effective on March 14, 2014; comments will be accepted on the rule until May 13, 2014.

ONC Proposes Updated Electronic Health Record (EHR) Certification Criteria for 2015

The Office of the National Coordinator for Health Information Technology (ONC) is seeking comments on revisions to health information technology certification regulations for 2015. CMS is updating these criteria more frequently to provide more incremental regulatory changes, give stakeholders earlier information and greater opportunity for input, and respond more quickly to newer industry standards to enhance interoperability. ONC observes that its previous two to three-year regulatory cycle was “sub-optimal” because it “created cycles of significant peaks and valleys from a health IT development standpoint; resulted in missed opportunities to improve interoperability and programmatic alignment because of mismatched regulatory and standards balloting cycle timelines; and adversely affected EHR technology developers’ ability to strategically plan their development and product rollout processes due to uncertain regulatory timelines.” The proposed rule provides that the 2015 Edition EHR certification criteria would be voluntary; providers would not need to adopt this edition, and no EHR technology developer who has certified its EHR technology to the 2014 Edition would need to recertify to the 2015 Edition for users to participate in the Medicare and Medicaid EHR Incentive Programs. The proposed rule also includes revisions to the ONC HIT Certification Program intended to improve regulatory clarity, simplify certification of EHR Modules not used for achieving meaningful use; and discontinue the use of the “Complete EHR” certification concept. ONC will accept comments on proposed rule until April 28, 2014.

Preliminary FY 2014 DSH Allotments Announced

CMS has published a notice announcing the preliminary federal share disproportionate share hospital (DSH) allotments for fiscal year (FY) 2014, along with the preliminary federal share FY 2014 limits on aggregate DSH payments that states may make to institutions for mental diseases (IMD) and other mental health facilities. The CMS notice also includes additional information regarding the calculation of the FY 2014 DSH allotments and FY 2014 IMD DSH limits.

CMS Takes First Steps to Cut Medicare DMEPOS Fees Based on Competitive Bidding Prices

On February 26, 2014, CMS published an advance notice of proposed rulemaking (ANPRM) seeking public comments on two potential changes to Medicare reimbursement for durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS) that could impact payment to DMEPOS suppliers nationwide regardless of whether they participate in competitive bidding. At this point, CMS is providing more questions than answers on the future of Medicare DMEPOS reimbursement policy, as discussed below.

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Obama Administration Issues ACA Health Coverage Waiting Period Regulations

On February 24, 2014, the Departments of HHS, Labor, and Treasury published final regulations that generally bar employer-sponsored group health plans and group health insurance issuers from imposing a health coverage waiting period of more than 90 days after an employee is otherwise eligible for coverage. Other conditions for eligibility are generally permissible, such as being in an eligible job classification, achieving job-related licensure requirements specified in the plan's terms, or satisfying a reasonable and bona fide employment-based orientation period. Note that the rules do not require coverage be offered to any particular individual or class of individuals, nor do they require any waiting period to be imposed). The 90-day waiting period limitation provisions apply to group health plans and group health insurance issuers for plan years beginning on or after January 1, 2015.  A companion proposed rule would limit to one month the length of a bona fide employment-based orientation period for purposes of the waiting period rules. Comments on the proposed regulations will be accepted until April 25, 2014.

There are HOW many calories in that? FDA Seeks Comments on Proposal to Update Nutrition Facts Food Label

As mentioned on our Life Sciences Legal Update blog, the Food and Drug Administration (FDA) announced today it has proposed significant updates to the Nutrition Facts label for foods intended to expand and highlight the information consumers need to make well-informed food choices.  FDA also is proposing changes to how serving sizes themselves are calculated. FDA will be accepting comments on the proposed regulations for 90 days.  To read the entire post, click here.

FDA to Overhaul an OTC System That "Isn't Working"

This post was written by Kevin M. Madagan and Jillian W. Riley

The Food and Drug Administration (FDA) has just announced that it will hold a public hearing March 25 and 26, 2014 to obtain input on the Agency’s current process for reviewing over-the-counter (OTC) drugs. This is a significant advancement in FDA’s long-standing plan to overhaul the OTC drug system. According to the announcement, the Agency’s OTC drug review “needs a critical examination at this juncture to examine whether and how to modernize its processes and regulatory framework.”

Teeing up the importance of the public hearing, Dr. Janet Woodcock, the Director of FDA’s Center for Drug Evaluation and Research (CDER), informed the Wall Street Journal that the Agency was “looking for creative ideas about how to improve the process.”1 According to Dr. Woodcock, “The current system isn’t working well for the public or for us.”  Additional details are available after the jump.

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Coming to a TV Near You? FDA Seeks Public Input on Limiting Risks Presented in Direct-to-Consumer Television Ads

This post was written by Jennifer Pike.

In a notice published in the Federal Register on February 18, 2014, the Food and Drug Administration (FDA) asked for feedback on a proposed research study related to prescription drug television advertisements. The study, Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television (TV) Advertisements (Ads), would investigate the impact of limiting the risks presented in DTC prescription drug TV ads to those that are serious and actionable. The ads would also include a disclosure statement to alert consumers that there are other product risks not included in the ad.

Current FDA regulations (21 CFR § 202.1) require that TV and radio ads present a product’s major risks in audio, or audio and visual parts of the ads (“major statements”). FDA is concerned that these major statements are too long, resulting in reduced consumer comprehension, minimization of important risk information, and potentially, therapeutic noncompliance due to fear of side effects. At the same time, and in conflict with the above, FDA is concerned that DTC TV ads do not include adequate risk information. FDA believes that providing limited risk information in ads will promote improved consumer perception and understanding of serious and actionable drug risks.  Comments to the study should be submitted in writing, or electronically at www.regulations.gov, by April 21, 2014.

CMS Extends and Expands Moratoria on Enrollment of Home Health Agency, Ambulance Suppliers in Designated Areas

Citing significant potential for fraud and abuse, CMS has announced that it is temporarily suspending new home health agency (HHA) and ground ambulance enrollment in Medicare, Medicaid, and the Children’s Health Insurance Program in several geographic areas, and it is extending the current enrollment moratoria for these provider types in separate areas. Specifically, effective January 30, 2014, CMS is establishing a 6-month moratorium on HHA enrollment in the following metropolitan areas: Fort Lauderdale, Detroit, Dallas and Houston. CMS also is temporarily suspending enrollment of new ground ambulance suppliers in the Greater Philadelphia area. In addition, CMS is extending for six-months a current enrollment moratoria (announced in July 2013) impacting HHAs in Chicago and Miami and ground ambulance suppliers in Houston. Note that CMS may lift the moratoria earlier or extend them for another six months through issuance of a Federal Register notice.

While existing providers and suppliers can continue to deliver and bill for services in moratoria areas, no new applications for the designated provider types will be approved, unless the provider’s enrollment application has already been approved, but not yet entered into PECOS or the State Provider/Supplier Enrollment System at the time the moratorium is imposed. According to CMS, the initial moratoria that began in July 2013 resulted in the denial of the enrollment applications of 231 HHAs and 7 ambulance companies in the geographic areas affected by the moratoria. A CMS notice explains the rationale for the imposition and extension of the moratoria.

CMS Seeks New Participants for Bundled Payments for Care Improvement Initiative

On February 14, 2014, CMS published a notice announcing an open period for additional organizations to be considered for participation in Models 2, 3, and 4 of the Bundled Payments for Care Improvement initiative. The three models are described as follows:

  • Model 2--Retrospective bundled payment models for hospitals, physicians, and post-acute providers for an episode of care consisting of an inpatient hospital stay followed by post-acute care.
  • Model 3--Retrospective bundled payment models for post-acute care where the episode does not include the acute inpatient hospital stay.
  • Model 4--Prospectively administered bundled payment models for the acute inpatient hospital stay and related readmissions.

Interested parties must submit the requisite forms by April 18, 2014. 

IRS Issues ACA Employer "Shared Responsibility" Guidance; Delays Compliance Deadlines for Certain Employers

This post was written by Allison Warden Sizemore and Debra McCurdy.

On February 12, 2014, the Internal Revenue Service (IRS) published final regulations modifying the timeline under which certain employers will be required to make “shared responsibility” payments if they do not provide qualified health insurance for their full-time employees and dependents pursuant to the Affordable Care Act (ACA). Specifically, under a new “transition relief” policy, the IRS is delaying the shared responsibility payment obligation for employers with 50 to 99 full-time equivalent employees from 2015 until 2016, although such employers will have to submit reports regarding their employees’ coverage in 2015. In order to qualify for transition relief, employers must certify that they have not laid-off workers to drop below the 100 employee threshold and must not eliminate or materially reduce their coverage offerings. The regulations also provide that employers subject to the employer responsibility provisions in 2015 (i.e., employers with 100 or more full-time equivalent employees) must offer coverage to at least 70% of full-time employees to avoid a penalty, rather than 95% (the 95% threshold will take effect in 2016). The regulations also clarify whether certain types of employees or employees in certain occupations are considered full-time (such as volunteer firefighters and emergency responders, educational employees, and seasonal workers) and clarify other open questions from the prior proposed regulations.

Final HIPAA Rule Gives Patients Right to Access Test Results Directly from Labs

On February 6, 2014, the Department of Health & Human Services (HHS) published a final rule making changes to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations to provide individuals with a greater ability to directly access their laboratory test reports. The rule is summarized in a post on our Life Sciences Legal Update blog.

CMS Invites Proposals for Frontier Community Health Integration Demonstration

CMS has published a notice inviting applications for a new Frontier Community Health Integration Project Demonstration, which will test new models of integrated health care delivery in sparsely-populated rural counties with the goal of improving health outcomes and reducing Medicare expenditures. The demonstration is limited to critical access hospitals in Alaska, Montana, Nevada, North Dakota, and Wyoming.  Applications are due by May 5, 2014.

CMS Finalizes Rule to Strengthen Home- and Community-Based Services (HCBS) Options

On January 16, 2014, CMS published a final rule that implements expanded federal support for HCBS offered as an optional benefit through state Medicaid programs, as authorized by the Affordable Care Act (ACA) and the Deficit Reduction Act. Specifically, the rule establishes eligibility requirements for Medicaid HCBS provided under sections 1915(c), 1915(i), and 1915(k) of the Social Security Act. In a fact sheet accompanying the rule, CMS emphasized the important stakeholder input it received during the rulemaking process, which resulted in CMS “moving away from defining home and community-based settings by ‘what they are not,’ and toward defining them by the nature and quality of individuals’ experiences” (although certain institutional facilities, including nursing facilities, institutions for mental diseases, intermediate care facilities for individuals with intellectual disabilities, and hospitals generally are not considered to meet the definition of a home and community-based setting).

Under the rule, CMS intends to promote access to the most integrated settings that provide alternatives to services provided in institutions, using an “outcome-oriented definition” of HCBS settings instead of one based on location, geography, or physical characteristics. Under the rule, home and community-based settings must: be integrated in and support full access to the greater community; be selected by the individual from among setting options; ensure individual rights of privacy, dignity and respect, and freedom from coercion and restraint; optimize autonomy and independence in making life choices; and facilitate choice regarding services and who provides them. Note that the rule includes additional requirements for provider-owned or controlled home and community-based residential settings, including that the individual has a lease or other legally enforceable agreement, and standards related to the individual’s privacy, control over schedule and visitors, and physical accessibility of the setting.

In addition to defining home and community-based settings, the final rule addresses many other aspects of Medicaid HCBS programs, including requirements that services under section 1915(c) and 1915(i) be established through a person-centered planning process that addresses health and long-term services and support needs in a manner that reflects individual preferences and goals. It also implements new flexibility for states to target services to specific populations and to combine multiple target populations in one waiver, while streamlining waiver administration.

The rule is effective March 17, 2014, but CMS is providing transition periods both for states adopting new programs, and for those states with currently-approved waivers and state plans that may need to develop a plan to bring their program into compliance. The text of the rule is available at , and additional materials are posted at http://www.medicaid.gov/HCBS. CMS also stresses that there will be continued opportunities for stakeholder input as it works with states to implement this final rule.

HHS Publishes FY 2015 FMAP Amounts

HHS has published a notice announcing the Federal Medical Assistance Percentages (FMAP), Enhanced Federal Medical Assistance Percentages (eFMAP), and disaster-recovery FMAP adjustments for fiscal year (FY) 2015. The new amounts will be used in the calculation of federal matching for state Medicaid and Children's Health Insurance Program (CHIP) expenditures and other HHS programs, beginning October 1, 2014.

Older Entries

January 29, 2014 — Reed Smith Client Alert: CMS/OIG Extend Protections for Electronic Health Record Donations

January 20, 2014 — FDA Seeks Comments on Drug Company Social Media Guidance

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

January 7, 2014 — CMS Proposes Emergency Preparedness Requirements for Medicare/Medicaid Providers

January 7, 2014 — CMS, FDA Extend Pilot Program for Parallel Review of Medical Products

January 7, 2014 — OIG Seeks Anti-Kickback Safe Harbor, Fraud-Alert Topic Proposals

January 7, 2014 — HHS Proposes HIPAA Amendments Addressing Gun Background Checks

January 7, 2014 — CMS Proposes 2015 Funding Methodology for ACA Basic Health Program

January 7, 2014 — CMS Issues Formally Updates 2014 Health Exchange Enrollment Deadlines

January 7, 2014 — FDA Releases Final Guidance on Qualification Process for Drug Development Tools

January 6, 2014 — HHS Proposed Rule on Health Plan Certification of Compliance Requirements

January 6, 2014 — CMS Seeks Comments on MSP CMP Policies, Appeals Process

December 27, 2013 — Final Rules Issued Extending Protections of Electronic Health Record Donations

December 10, 2013 — CMS Issues Final Medicare OPPS, ASC Policies for 2014

December 10, 2013 — CMS Updates Medicare Physician Fee Schedule, Other Part B Policies for CY 2014

December 10, 2013 — CMS Finalizes 2014 ESRD PPS Rates; Phases in ESRD Drug Utilization Cut

December 10, 2013 — CMS Proposed Rule on ACA Benefit and Payment Parameters for 2015

December 10, 2013 — CMS Boosts Provider Enrollment Fee for 2014

December 3, 2013 — CMS Adopts Changes to Medicare Payment, Coverage Rules for DMEPOS

November 25, 2013 — Medicare Home Health PPS Rates Cut 1.05% Under Final 2014 Rule

November 25, 2013 — CMS Seeks Input on Quality Ratings for ACA Exchange Plans

November 14, 2013 — CMS Invites Nominees for Members of Advisory Panel on Hospital Outpatient Payment

November 14, 2013 — HHS Corrects March 2013 ACA Benefit, Payment Parameter Rules

November 13, 2013 — Obama Administration Publishes Final Mental Health/Substance Abuse Parity Rule

October 30, 2013 — CMS Finalizes ACA Exchange Program Integrity & Financial Oversight Standards

October 30, 2013 — CMS Releases Medicare Deductible, Coinsurance Amounts for 2014

October 30, 2013 — Nominees Invited for PCORI Physician Representative

October 30, 2013 — CMS Warns of Delay in Final CY 2014 Medicare Rules

October 29, 2013 — CMS Finalizes Medicare Conditions of Participation for Community Mental Health Centers

October 10, 2013 — HHS Proposes ACA Basic Health Program Regulations

October 10, 2013 — CMS Final Rule Refines FY 2014 DSH Payment Calculations

October 10, 2013 — CMS Proposes Rules for Medicare FQHC PPS, CLIA Amendments

October 9, 2013 — CMS Announces 2014 Amounts in Controversy Threshold Amounts for Medicare Appeals

October 9, 2013 — CMS Corrects FY 2014 Medicare Payment Rules

September 17, 2013 — HHS Seeks Comments on Draft National Action Plan for Adverse Drug Event Prevention

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

September 17, 2013 — CMS Finalizes ACA Exchange/Qualified Health Plan Financial Integrity and Oversight Standards

September 17, 2013 — IRS Finalizes ACA Individual "Shared Responsibility" Payment Requirements

September 16, 2013 — CMS Releases ACA Medicaid DSH Funding Final Rule

September 16, 2013 — HHS Invites Suggestions for Streamlining Regulations

September 16, 2013 — OIG Report Examines Critical Access Hospital Qualifications

September 16, 2013 — HHS Draft Strategic Plan Outlines Department Goals

September 16, 2013 — OIG Focuses on Improper Medicare Diabetes Test Strip Payments

September 16, 2013 — OIG Reports Point States to Potential Medicaid DMEPOS Savings

September 16, 2013 — OIG Seeks Improvements to RAC Program, Enhanced CMS Efforts to Stop Improper Medicare Payments

September 16, 2013 — OIG Urges CMS Action on Medicaid Drug Pricing Changes in Preparation of ACA Enrollment Expansion

September 11, 2013 — CMS Issues Technical Corrections to CY 2014 Proposed OPPS/ASC Rule

September 3, 2013 — Recent Updates to the Hospital Readmissions Reduction Program

August 28, 2013 — CMS Finalizes FY 2014 Medicare IPPS, LTCH Rates

August 28, 2013 — CMS Issues Final FY 2014 Medicare Inpatient Rehabilitation Facility (IRF) Rule

August 27, 2013 — HHS Seeks Comments on ACA Provision Preventing Discrimination in Certain Health Programs, Activities

August 27, 2013 — CMS Publishes Final FY 2014 Medicare SNF PPS Rates, Policies

August 27, 2013 — CMS Finalizes Hospice Policies, Rates for FY 2014

August 27, 2013 — CMS Issues Final FY 2014 Inpatient Psychiatric Facility PPS Rates

August 27, 2013 — CMS Suspends Medicaid NARP Drug Data Collection

August 27, 2013 — Medicare Billing For Cancelled Elective Surgeries

August 27, 2013 — OIG Questions Hospital Use of Observational Stays

August 27, 2013 — OIG Examines Clinical Trial Data and Safety Monitoring Boards

August 27, 2013 — Medicaid Disproportionate Share Hospital Allotments

August 19, 2013 — Hard Drives on Used Photocopiers Result in HIPAA Violations and $1.2M Settlement to the OCR

August 15, 2013 — China Life Sciences Regulatory Crackdown Spreads to Medical Device Sector

August 12, 2013 — CMS Revises Medicare National Coverage Determination Process, Eases Path to Discontinue Outdated Coverage Policies

August 2, 2013 — FDA Proposes New Rule to Exercise its Administrative Detention Authority for Drugs

July 29, 2013 — CMS Issues Proposed OPPS, ASC Policies for 2014, Including Expanded OPPS Packaging Proposal

July 29, 2013 — CMS Announces First Temporary Moratoria on HHA, Ambulance Supplier Enrollment in High-Risk Areas under ACA Authority

July 29, 2013 — CMS Proposes Updates to Medicare Physician Fee Schedule, Other Part B Policies for CY 2014

July 29, 2013 — CMS Proposed Rule Calls for 9.4% Cut in CY 2014 ESRD PPS Rates

July 29, 2013 — CMS Finalizes ACA Health Insurance Exchange "Navigator" Standards

July 29, 2013 — CMS Issues Final Medicaid Eligibility/Enrollment Rule under the ACA

July 29, 2013 — Obama Administration Finalizes Revised ACA Contraceptive Coverage Requirements

July 29, 2013 — HRSA Finalizes Policy on Exclusion of Orphan Drugs Under 340B Program

July 29, 2013 — HHS Spring 2013 Semiannual Regulatory Agenda Released

July 5, 2013 — CMS Proposes Updates to DMEPOS Payment, Coverage Rules

July 5, 2013 — Medicare Home Health PPS Rates to Drop under Proposed CY 2014 Rule

July 3, 2013 — Obama Administration Announces Delay in Employer ACA "Shared Responsibility" Payments, Reporting Requirements until 2015

June 27, 2013 — CMS Finalizes Medicare/Medicaid Requirements for Long Term Care Facilities Providing Hospice Services

June 27, 2013 — IPPS/LTCH Rule Correction Notice

June 27, 2013 — HHS Releases Final ACA Exchange Rule on "Shared Responsibility" Payments

June 27, 2013 — CMS Proposes ACA Exchange/Qualified Health Plan Financial Integrity and Oversight Standards

June 26, 2013 — HHS Seeks Comments on IRB Assessment of Risks in Standard of Care Interventions Research; Aug. 28 Meeting Scheduled

June 20, 2013 — FDA Amends Orphan Drug Regulations

June 11, 2013 — CMS Sets Provider Payment Rates Under the ACA Pre-Existing Condition Insurance Plan Program

June 11, 2013 — CMS Publishes Final ACA Small Business Health Option Program (SHOP) Rule

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

June 11, 2013 — CMS Seeks Additional Applicants for Bundled Payments for Care Improvement Program

June 11, 2013 — State DSH Allotments Methodology

June 11, 2013 — OIG Final Rule on Data Mining by State Medicaid Fraud Control Units

June 11, 2013 — DOL Releases Insurance Exchange Notice Guidance and Model Notices

June 11, 2013 — OIG Issues Semiannual Report for First Half of FY 2013

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

June 11, 2013 — OIG Identifies Vulnerabilities with Part B Claims with "G" Modifiers

June 11, 2013 — OIG Recommends Changes to Medicare Dialysis Payments to Reflect Lower Drug Utilization

June 11, 2013 — Obama Administration Issues Final ACA Wellness Program Rules

June 5, 2013 — Bioethics Panel Seeks Comments on Ethical/Legal Issues Involving "Incidental Findings" in Research and Testing

May 14, 2013 — CMS Proposes Medicare IPPS and LTCH PPS Rates/Policies for FY 2014

May 14, 2013 — CMS Issues FY 2014 Medicare SNF PPS Proposed Rule

May 13, 2013 — CMS Proposes Hospice Payment Policies for FY 2014

May 13, 2013 — CMS Proposes Updated FY 2014 Medicare Payments and Other Policies for IRFs

May 13, 2013 — IRS Proposes Regulations to Implement Certain ACA Insurance Premium Tax Credit, Medical Loss Ratio Provisions

May 13, 2013 — CMS Notice Prepares for Termination of Early Retiree Reinsurance Program