CMS Proposes Changes to Medicare Shared Savings Program/ACO Payment Regulations

On December 8, 2014, CMS published a proposed rule that would revise the regulations governing 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) to provide cost-effective, coordinated care to Medicare beneficiaries. The Shared Savings Program now includes more than 330 ACOs in 47 states and serves more than 4.9 million Medicare fee for service (FFS) beneficiaries.

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CMS Proposes Updating Certain Medicare/Medicaid Policies to Recognize Same-Sex Marriages

On December 12, 2014, CMS published a proposed rule to revise selected conditions of participation (CoPs) for providers, conditions for coverage (CfCs) for suppliers, and requirements for long-term care (LTC) facilities to conform with the Supreme Court decision in United States v. Windsor, and ensure that same-sex spouses in legally-valid marriages are recognized and afforded equal rights in Medicare and Medicaid participating facilities. The proposed rule addresses nine specific provisions located in the CoPs and CfCs for ambulatory surgical centers, hospices, hospitals, LTC facilities, and community and mental health centers that CMS believes could be interpreted to support the denial of federal rights and privileges to a same-sex spouse if the state of residence does not recognize same-sex marriages. CMS states that its “goal is to provide equal treatment to spouses, regardless of their sex, whenever the marriage was valid in the jurisdiction in which it was entered into, without regard to whether the marriage is also recognized in the state of residence or the jurisdiction in which the health care provider or supplier is located, and where the Medicare program explicitly or impliedly provides for specific treatment of spouses.”   Comments on the proposed rule will be accepted until February 10, 2015.

CMS Proposes 2016 ACA Marketplace Plan Benefit & Payment Parameters

CMS has issued a proposed rule that would establish ACA Marketplace health plan payment parameters and essential benefit standards for 2016. Specifically, the wide-ranging proposed rule addresses, among other things: the risk adjustment, reinsurance, and risk corridors programs; cost sharing parameters; user fees for federally-facilitated exchanges; standards for qualified health plans, including network adequacy and quality improvement; the Small Business Health Options Program; guaranteed availability and renewability, rate review; the medical loss ratio program; and minimum essential health benefits (including new policies and procedures for enrollee requests for prescription drugs not included on a plan’s formulary).  CMS will accept comments on the proposed rule until December 22, 2014.

HHS Posts Fall 2014 Regulatory Agenda

The Administration has posted its fall regulatory agenda listing major pending or planned regulatory actions and anticipated timing of rulemaking. The agenda lists numerous pending HHS proposed and final rules in a range of policy areas, including Medicare payment updates, revisions to provider conditions of participation, and changes to fraud and abuse authorities, among many others. Note that the anticipated release dates set forth in the agenda are subject to change.

FY 2016 Federal Financial Participation Matching Amounts Released

HHS has published the FY 2016 Federal Medical Assistance Percentages (FMAP), Enhanced FMAP, and disaster-recovery FMAP adjustments. These percentages, which will apply from October 1, 2015 through September 30, 2016, apply in determining the federal matching for state expenditures for Medicaid and certain other medical and other social services.

CMS Finalizes Rule to Strengthen Medicare Provider Enrollment Regulations and Permit Revocations for Patterns/Practices of Improper Claims Submissions; Defers Expanded Awards for Medicare Fraud Tipsters

This post was authored by Elizabeth Carder-Thompson and Debra McCurdy.

On December 5, 2014, the Centers for Medicare & Medicaid Services (CMS) published a final rule that expands the circumstances under which it may deny or revoke the Medicare enrollment of entities and individuals on program integrity grounds, effective February 3, 2015.  

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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.

CMS Announces 2015 Provider Enrollment Application Fee Amount

Today CMS published a notice announcing that the CY 2015 provider enrollment application fee is $553, up from $542 in 2014. This application fee is required for institutional providers that are initially enrolling or revalidating enrollment in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP) or adding a new Medicare practice location on or after January 1, 2015 and on or before December 31, 2015. Note that CMS uses a broad definition of institutional entities subject to the application fee; it applies to “[a]ny provider or supplier that submits a paper Medicare enrollment application using the CMS-855A, CMS-855B (not including physician and non-physician practitioner organizations), CMS-855S, or associated Internet-based PECOS enrollment application,” along with additional categories of Medicaid-only and CHIP-only institutional providers. 

Presidential Bioethics Commission Seeks Comments on Ethical Implications of Public Health Response to Ebola Outbreak & Other Emergencies

On December 8, 2014, HHS is publishing a notice announcing that the Presidential Commission for the Study of Bioethical Issues is requesting public comment on ethical considerations related to public health emergency response, focusing on the current Ebola virus disease (EVD) epidemic. In particular, the Commission is examining:

  • U.S. public policies that restrict association or movement (e.g., quarantine), which have been proposed and/or employed for health care workers and military personnel returning from countries affected by EVD in western Africa;
  • The ethics of placebo-controlled trials in the context of public health emergencies, and the EVD epidemic specifically, where the tested drug might be effective against the disease in question; and
  • The ethical considerations relevant to collecting and storing biospecimens during a public health emergency such as the EVD epidemic, and sharing these specimens and associated data internationally for future research.

Comments will be accepted for 60 days after publication.

CMS Adopts Changes to Medicaid DSH Rules

On December 3, 2014, CMS published a final rule that defines “uninsured” for purposes of calculating the Medicaid hospital-specific disproportionate share hospital (DSH) payment limit. Under the Social Security Act, DSH payments to a hospital cannot exceed the uncompensated costs of furnishing hospital services by the hospital to individuals who are Medicaid-eligible or “have no health insurance (or other source of third party coverage) for the services furnished during the year.” The final rule provides this test will be applied on a service-specific basis; that is, the calculation of uncompensated care for purposes of the hospital-specific DSH limit will include the cost of each service furnished to an individual by that hospital for which the individual had no health insurance or other source of third party coverage. Although the final rule’s definition of uninsured may affect the calculation of the hospital-specific DSH limit, the rule does not modify the DSH allotment amounts and will have no effect on a state’s ability to claim federal financial participation (FFP) for DSH payments made up to the published DSH allotment amounts. The final rule also provides additional clarification to states and hospitals regarding costs eligible for inclusion in the calculation of the hospital-specific DSH limit. The rule is effective on December 31, 2014.

CMS Publishes Corrections to Home Health PPS, DMEPOS Surety Bond Rules

On December 2, 2014, CMS published a correction to its November 6, 2014 final 2015 Medicare home health prospective payment system (PPS) rule to correct a technical error related to the applicability date for a therapy reassessment provision.  Separately, on November 24, 2014, CMS published a notice making technical amendments to durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier surety bond requirements under 42 CFR 424.57. According to the preamble, the notice corrects non-substantive regulatory paragraph designations, an omission, and a technical correction to previously published regulatory text, and makes terminology and cross-references changes.

CMS to Conduct Hyperbaric Oxygen Prior Authorization Pilot Program

CMS intends to conduct a three-year Medicare prior authorization model for non-emergent hyperbaric oxygen therapy services in Illinois, Michigan, and New Jersey, where CMS contends there have been high rates of improper payments for these services. Under this model, CMS will require that all relevant clinical or medical documentation requirements are met before services are rendered to beneficiaries and before claims are submitted for payment; no new clinical documentation requirements will be created. The model is scheduled to begin on March 1, 2015.  CMS also recently announced a similar prior authorization model for repetitive scheduled nonemergent ambulance transports.

FDA Public Meeting on Regulatory Oversight of Laboratory Developed Tests (Jan 8-9)

The FDA has scheduled a public workshop on the “Framework for Regulatory Oversight of Laboratory Developed Tests'' on January 8 – 9, 2015. The purpose of the workshop is to discuss FDA's proposal for a risk-based framework for addressing the regulatory oversight of “laboratory developed tests,” a subset of vitro diagnostic devices intended for clinical use and designed, manufactured and used within a single laboratory. Among other things, the FDA will address LDT labeling considerations; clinical validity and intended use; enforcement discretion; adverse event reporting; quality system regulation; and procedural issues. The workshop registration deadline is December 12, 2014. FDA will accept comments related to the public workshop until February 2, 2015.

CMS Extends Comment Period on Home Health COP Proposed Rule

Today CMS published a notice extending the comment period on its October 9, 2014 proposed rule that would revise the conditions of participation (CoPs) that home health agencies must meet to participate in the Medicare and Medicaid programs. Specifically, the comment period is extended for 30 days, from December 8, 2014 until January 7, 2015.

CMS Publishes Final 2015 Medicare Physician Fee Schedule Rule for 2015

On November 12, 2014, CMS published its final rule to update the Medicare physician fee schedule (MPFS) for CY 2015. Highlights of the sweeping rule include the following:

  • The Protecting Access to Medicare Act (PAMA) of 2014 provides for a 0% update to the conversion factor (CF) for MPFS services furnished between January 1, 2015 and March 31, 2015, with the CF adjusted afterwards according to the statutory Sustainable Growth Rate (SGR) formula. In the final rule, CMS determined that based on the zero percent update under PAMA and adjustments necessary to maintain budget neutrality, the CF for the first quarter of 2015 will be $35.8013 (compared to $35.8228 in 2014). CMS also announced that the CF for April 1, 2015 through December 31, 2015 will be $28.2239 – a 21.2% reduction -- unless Congress establishes an alternative CF or otherwise modifies the SGR formula. While there is an expectation that Congress eventually will override this payment cut, the form any such action might take is speculative at this point.
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CMS Finalizes CY 2015 Medicare OPPS/ASC Rates & Policies

On November 10, 2014, CMS published its final rule to update the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System rates and policies for calendar year (CY) 2015. The following are highlights of this major rulemaking:

  • The final OPPS fee schedule increase factor is 2.2%. This update reflects a hospital market basket increase of 2.9%, which is offset by two Affordable Care Act (ACA) provisions: a 0.2% reduction and a -0.5% “multi-factor productivity” (MFP) adjustment. The update for individual procedures can vary, and hospitals that do not meet Hospital Outpatient Quality Reporting (OQR) Program requirements are subject to a 2.0% reduction. CMS projects a 2.3% increase in total OPPS payments (about $900 million) for 2015, considering all policies in the rule.
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CMS Adopts Major Changes to Medicare DMEPOS Payment/Coverage Policy Inside/Outside of Competitive Bidding Areas

This post was written by Elizabeth Carder-Thompson, Carol C. Loepere, and Debra A. McCurdy.

On November 6, 2014, CMS published a final rule that makes significant and highly technical changes to Medicare payment policies for durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS).  Notably, the rule finalizes a new methodology for adjusting Medicare DMEPOS fee schedule payment amounts across the country using information from the Medicare DMEPOS Competitive Bidding Program (CBP). CMS estimates that this methodology will cut Medicare DMEPOS reimbursement by more than $4.4 billion over fiscal years 2016 through 2020. The rule also finalizes a mechanism to test the use of bundled monthly payment amounts for certain DME under competitive bidding; modifies CBP change of ownership (CHOW) and termination of contract rules; and codifies Medicare hearing aid coverage policy. Note that CMS did not adopt its proposal to clarify practitioner qualifications for providing custom fitting services for orthotics. The following is a summary of the final rule, with particular emphasis on revisions to CMS’s July 11, 2014 proposed rule.

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CMS Finalizes 0.3% Cut in Medicare Home Health PPS Rates for CY 2015

On November 6, 2014, CMS published a final rule to update the Medicare home health prospective payment system (HH PPS) for CY 2015. CMS estimates that the final rule will cut Medicare payments to home health agencies (HHAs) by 0.30%, or $60 million, in 2015. Specifically, while the rule provides a 2.1% home health payment update percentage ($390 million increase), that update is more than offset by a reduction of 2.4% ($450 million) attributable to a rebasing adjustment (the second year of a four-year phase-in). Under the final rule, the national standardized 60-day episode payment for CY 2015 is $2,961.38.

The final rule also adopts a number of policy proposals. Notably, CMS is simplifying the home health face-to-face encounter documentation requirements, including eliminating the narrative as part of the certification of eligibility and providing more flexibility in procedures for obtaining documentation supporting patient eligibility. The final rule specifies that associated physician claims for certification/re-certification of eligibility will not be covered when a patient does not meet home health eligibility criteria. CMS also discusses comments it received on a potential HHA Value-Based Purchasing (VBP) model, under which CMS would test whether payment incentives would lead to higher quality of care for beneficiaries. CMS is considering testing such a model beginning in 2016; additional details will be provided in future rulemaking. The final rule also, among other things: recalibrates HH PPS case-mix weights; simplifies therapy reassessment timeframes; establishes a minimum OASIS assessment submission threshold; revises the speech-language pathology personnel conditions of participation; and places limitations on the reviewability of civil monetary penalties imposed for HHA noncompliance with federal participation requirements.

CMS Publishes Final 2015 ESRD PPS Rule

CMS published its final rule to update the Medicare end-stage renal disease (ESRD) PPS for CY 2015 on November 6, 2014. For CY 2015, the final ESRD PPS base rate is $239.43, which reflects a 0.0 percent update mandated by section 217(b)(2) of PAMA, and the application of a wage index budget-neutrality adjustment factor to the CY 2014 ESRD PPS base rate of $239.02. Nevertheless, CMS estimates that the rule will increase payments to ESRD facilities by approximately $30 million in 2015 due to updates to the outlier threshold amounts. The final rule also, among other things: rebases the ESRD bundled market basket using 2012 data; revises the market basket measures; updates the labor-related share value with a two-year transition; clarifies the eligibility criteria for the low volume payment adjustment; and implements a PAMA provision providing that payment for ESRD-related oral-only drugs will not be made under the ESRD PPS prior to January 1, 2024. CMS also adopted updates to the ESRD Quality Incentive Program (QIP) for payment years 2017 and 2018, including changes to the measure sets and establishment of a new scoring methodology beginning in 2018. Finally, the rule makes significant changes to Medicare reimbursement policy for DME, prosthetics, orthotics, and supplies (DMEPOS), as discussed in a separate post.

CMS Adopts Changes to Open Payments/Physician Payment Sunshine Act Regulations

This post was written by Elizabeth Carder-Thompson, Katie C. Pawlitz, Nancy E. Bonifant and Debra A. McCurdy.

As part of the final 2015 Medicare physician fee schedule rule, CMS is adopting – with certain refinements – its proposed changes to the regulations implementing the Physician Payment Sunshine Act. By way of background, the Sunshine Act requires pharmaceutical and medical device manufacturers and group purchasing organizations to submit to CMS certain information on payments and transfers of value to physicians and teaching hospitals, as well as physician ownership information. This data is being made publicly available on the CMS “Open Payments” website, http://go.cms.gov/openpayments.

Specifically, In the final rule, published on November 13, 2014, CMS adopted the following provisions pertaining to the Sunshine Act regulations:

  • CMS deleted the reporting exclusion for payments made to speakers at accredited continuing medical education events. Importantly, CMS points out that such payments may still be excluded from reporting, since “payments or other transfers of value, including payments made to physician covered recipients for purposes of attending or speaking at continuing education events, which do not meet the definition of an indirect payment, as defined at §403.902, are not reportable.” Under §403.902, indirect payments refer to payments or other transfers of value made by an applicable manufacturer to a covered recipient through a third party, where the applicable manufacturer requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient(s).
  • The Final Rule requires the reporting of the marketed name and therapeutic area or product category of the related covered drug, device, biological, or medical supply, unless the payment or other transfer of value is not related to a particular covered or non-covered drug, device, biological or medical supply. Previously, for devices or medical supplies manufacturers had the option of reporting the therapeutic area or product category instead of the marketed name. In the Final Rule, CMS also removed language allowing manufacturers the option to report “up to five” related covered products. It is not clear from the Final Rule whether such an option will still be available in practice, or if manufacturers will only be able to report a single, related covered product. Reporting marketed names for non-covered drugs, devices, biologicals, or medical supplies will continue to be optional. CMS also acknowledges that a payment or other transfer of value associated with a research payment regarding a device or medical supply may not have a marketed name. Therefore, CMS is specifying that manufacturers will continue to have an option to report either a device or medical supply marketed name, therapeutic area or product category when reporting research payments.
  • CMS is requiring applicable manufacturers to report stocks, stock options, or any other ownership interest as distinct categories.
  • CMS is deleting the definition of “covered device” as duplicative of the definition of “covered drug, device, biological or medical supply.”

CMS is implementing data collection requirements for these provisions beginning January 1, 2016, for reporting to CMS in 2017.

Older Entries

November 19, 2014 — CMS Announces 3-State Medicare Prior Authorization Model for Repetitive Nonemergent Ambulance Transport

November 19, 2014 — NIH Releases Proposed Rule on FDAAA Requirements for ClinicalTrials.Gov Registration and Results Submission

November 18, 2014 — HRSA Withdraws Pending 340B Rule, Plans New 2015 Rulemaking

November 5, 2014 — HHS OMHA Soliciting Suggestions for Reducing Medicare Appeals Backlog

October 29, 2014 — OIG Extends Comment Deadline on Permissive Exclusion Criteria

October 28, 2014 — Final CY 2015 Medicare Payment Rules in the Pipeline

October 28, 2014 — CMS Seeking Nominations for New Advisory Panel on Clinical Diagnostic Lab Tests

October 28, 2014 — CMS Proposes 2016 Funding Methodology for ACA Basic Health Program

October 28, 2014 — CMS Announces Medicare Deductible, Coinsurance Amounts for 2015

October 28, 2014 — Draft HHS Guidance on Disclosing Risks in Standards of Care Research

October 28, 2014 — ONC Invites Applications for "Market R&D Pilot Challenge"

October 21, 2014 — Reed Smith Client Alert: Analysis of HHS OIG Proposed Rule to Amend the Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing Regulations

October 17, 2014 — OIG and CMS Extend Fraud/Abuse Waivers for Medicare Shared Savings Program/ACOs; Invite Feedback on Waiver Policy

October 8, 2014 — Proposed Revisions to Home Health Conditions of Participation

October 6, 2014 — CMS Corrects Final FY 2015 Medicare IPPS/LTCH Rule

October 6, 2014 — CMS Releases CY 2015 Amount in Controversy Thresholds for Medicare Appeals

October 6, 2014 — ONC Final Rule on EHR Certification Criteria

October 3, 2014 — DEA Issues Final Rule on Safe, Secure Disposal of Controlled Substances

October 2, 2014 — OIG Releases Proposed Revisions to Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing

September 24, 2014 — HHS OIG Paints with Broad Brush in Criticizing Drug Manufacturer Coupon Programs

September 8, 2014 — OMB Clears OIG Proposed Rule on Anti-Kickback Safe Harbors, CMPs for Beneficiary Inducements & Gainsharing

September 8, 2014 — CMS Final Rule Revises EHR Meaningful Use Timeline

September 4, 2014 — CMS Finalizes ACA Marketplace Eligibility Redetermination/Renewal Process for 2015

September 4, 2014 — HHS Revises ACA Contraception Coverage Requirements

August 26, 2014 — FDA Seeks Comments to Updated Guidance on Informed Consent in Clinical Trials

August 20, 2014 — CMS Finalizes Medicare Hospice Payment Policies for FY 2015

August 19, 2014 — CMS Issues FY 2015 Medicare SNF PPS Final Rule

August 18, 2014 — CMS Finalizes Medicare IPPS/LTCH PPS Update for FY 2015

August 18, 2014 — CMS Publishes Final FY 2015 Update to Medicare IRF PPS

August 16, 2014 — IRS issues ACA Branded Prescription Drug Fee Regulations

August 12, 2014 — CMS Issues Final Medicare Inpatient Psychiatric Facility PPS Rule for FY 2015

August 12, 2014 — HHS Officially Sets October 1, 2015 Date for ICD-10 Implementation

August 12, 2014 — CMS Again Extends Moratoria on Enrollment of HHAs, Ambulance Suppliers in Designated Areas

July 25, 2014 — CMS Issues Proposed CY 2015 Medicare OPPS/ASC Rule

July 25, 2014 — CMS Publishes Proposed MPFS Rule for 2015

July 25, 2014 — CMS Proposes ESRD PPS Update for CY 2015

July 25, 2014 — Proposed ACA Eligibility Redetermination/Renewal Process for 2015

July 23, 2014 — OIG Seeks Input on Potential Revisions to its Permissive Exclusion Criteria

July 23, 2014 — Proposed ACA Eligibility Redetermination/Renewal Process for 2015

July 7, 2014 — CMS Proposes Major Changes to Medicare DMEPOS Payment/Coverage Policy Inside/Outside of Competitive Bidding Areas

July 3, 2014 — CMS Proposes Changes to Sunshine Act "Open Payments" Regulations in 2015 Medicare Physician Fee Schedule Rule

July 1, 2014 — CMS Proposes 0.3% Cut in Medicare Home Health PPS Rates for CY 2015

June 27, 2014 — CMS Planning Changes to Medicare Shared Savings Program/Accountable Care Organization (ACO) Rules

June 24, 2014 — Medicare Payment Adjustments for Low-Volume Hospitals and Medicare-Dependent Hospitals

June 24, 2014 — HHS Issues Spring 2014 Semiannual Regulatory Agenda

June 24, 2014 — Obama Administration Finalizes Employment Orientation Limit Applicable to ACA Health Coverage Waiting Period

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

June 2, 2014 — CMS Finalizes ACA Exchange, Insurance Market Standards for 2015 and Beyond

May 30, 2014 — CMS Formally Proposes Modified Electronic Health Record (EHR) Meaningful Use Timeline

May 22, 2014 — CMS Proposes Medicare Prior Authorization Process for DMEPOS Subject to "Unnecessary Utilization"

May 20, 2014 — OIG Proposed Rule Would Expand Civil Monetary Penalty Authority

May 16, 2014 — HHS OIG Proposes Expansion of Exclusion Authorities

May 16, 2014 — Another OIG Fraud Rule in the Pipeline: Anti-kickback Safe Harbors, CMPs for Beneficiary Inducements, Gainsharing

May 15, 2014 — CMS Adopts Final Rule to Reduce Provider Regulatory Burdens

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

May 15, 2014 — CMS Proposes FY 2015 Update to Inpatient Psychiatric Facility PPS

May 15, 2014 — CMS Adopts PPS for Federally Qualified Health Centers (FQHCs), Amends CLIA Rules

May 15, 2014 — IRS Issues Final Rules on Affordable Insurance Exchange Reporting Requirements

May 14, 2014 — CMS Proposes FY 2015 Update to Medicare IRF PPS

May 14, 2014 — OIG Proposes Rules to Expand Exclusion, CMP Authorities

May 13, 2014 — CMS Invites Comments on Sunshine Act "Open Payments" Dispute Resolution/Corrections Process

May 13, 2014 — CMS Issues FY 2015 Medicare SNF PPS Proposed Rule

May 8, 2014 — Hundreds of Drugs and Biologics Face Labeling Changes under New FDA Plan

May 8, 2014 — CMS Streamlines Medicare Requirements for Imaging Services Performed in ASCs and Hospital Radiopharmaceutical Preparation

May 1, 2014 — CMS Releases Proposed Medicare Inpatient PPS/LTCH Update for FY 2015

April 28, 2014 — Proposed FY 2015 Medicare Payment Rules in the Pipeline

April 28, 2014 — CMS Proposes Updated Life Safety Code for Health Care Facilities

April 25, 2014 — Busy Week for FDA's Center for Devices and Radiological Health

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

April 8, 2014 — CMS Announces System to Collect Hospice Care Data Beginning July 1, 2014

April 2, 2014 — FDA Proposal Amends Medical Device Classification Rules

March 24, 2014 — Obama Administration Continues to Update ACA Insurance Exchange and Health Plan Regulations

March 20, 2014 — CMS Rule Increases FY 2014 Medicare Payments for Low-Volume Hospitals

March 19, 2014 — CMS Rule Requires Qualified Health Plans to Accept Certain Third-Party Premium Payments

March 4, 2014 — ONC Proposes Updated Electronic Health Record (EHR) Certification Criteria for 2015

March 4, 2014 — Preliminary FY 2014 DSH Allotments Announced

March 3, 2014 — CMS Takes First Steps to Cut Medicare DMEPOS Fees Based on Competitive Bidding Prices

March 3, 2014 — Obama Administration Issues ACA Health Coverage Waiting Period Regulations

February 27, 2014 — There are HOW many calories in that? FDA Seeks Comments on Proposal to Update Nutrition Facts Food Label

February 24, 2014 — FDA to Overhaul an OTC System That "Isn't Working"

February 24, 2014 — Coming to a TV Near You? FDA Seeks Public Input on Limiting Risks Presented in Direct-to-Consumer Television Ads

February 18, 2014 — CMS Extends and Expands Moratoria on Enrollment of Home Health Agency, Ambulance Suppliers in Designated Areas

February 17, 2014 — CMS Seeks New Participants for Bundled Payments for Care Improvement Initiative

February 17, 2014 — IRS Issues ACA Employer "Shared Responsibility" Guidance; Delays Compliance Deadlines for Certain Employers

February 17, 2014 — Final HIPAA Rule Gives Patients Right to Access Test Results Directly from Labs

February 11, 2014 — CMS Invites Proposals for Frontier Community Health Integration Demonstration

January 30, 2014 — CMS Finalizes Rule to Strengthen Home- and Community-Based Services (HCBS) Options

January 30, 2014 — HHS Publishes FY 2015 FMAP Amounts

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