Stage 3 EHR Incentive Program, Health IT Certification Rules at OMB

HHS has sent to the White House Office of Management and Budget (OMB) for final regulatory clearance a proposed rule on Stage 3 meaningful use criteria for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. The Stage 3 rule will focus on advanced use of EHR technology to promote improved outcomes for patients, and it propose changes to the reporting period, timelines, and structure of the program, including providing a single definition of meaningful use. Likewise, HHS is seeking review of proposed rule that would, among other things, establish a new 2015 Edition Base EHR definition and modify the ONC Health Information Technology (IT) Certification Program to make it more broadly applicable to other types of health IT health care settings and programs. The rules are not available yet, but could be approved for publication in the Federal Register at any time.

Electronic Distribution of Prescribing Information for Prescription Drugs & Biologicals

The FDA published a proposed rule on December 18, 2014 that would require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the prescription drug or biological product packaging. FDA also is proposing that prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed, except as provided by this regulation. According to the FDA, its proposal is intended to facilitate the distribution of updated prescribing information as new information becomes available or prescribing information changes are made, and to ensure that “the most current prescribing information for distributed prescription drugs will be available and readily accessible to health care professionals at the time of clinical decisionmaking and dispensing.” Comments on the proposed rule will be accepted until March 18, 2015.

CMS Publishes Medicare QIO Criteria

CMS has published notices setting forth the criteria it will use to evaluate the effectiveness and efficiency of Quality Innovation Network (QIN) and Beneficiary and Family Centered Care (BFCC) Quality Improvement Organizations (QIOs) that entered into contracts with CMS in 2014.

IRS Issues Additional ACA Requirements for Tax-Exempt Hospitals

On December 31, 2014, the IRS published final regulations providing guidance on the community health needs assessment and financial assistance policy requirements for charitable hospitals under the ACA. The regulations address the entities that must meet these requirements, related reporting obligations, and the consequences for failing to satisfy these ACA requirements. The regulations apply to taxable years beginning one year after December 29, 2014.

FDA One Step Closer to New Direct-To-Consumer Television Ad Requirements

This post was written by Jennifer Pike.

Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television advertisements. In a notice published in the Federal Register on January 13, 2015, FDA announced its intention to continue to move forward with the proposed study. Specifically, the notice announced that the Agency had submitted a proposed collection of information to the Office of Management and Budget (OMB) for review and approval. The notice describes the general framework for the study, entitled “Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television (TV) Advertisements (Ads),” and it provides FDA’s response to the 55 comments it received regarding its February 2014 notice.

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.

OMB is accepting comments on the collection of information until February 12, 2015.

Administration Issues Proposed Rules on ACA Summary of Benefits and Coverage, Excepted Benefits/Wraparound Coverage

On December 30, 2014, the Internal Revenue Service (IRS), the Employee Benefits Security Administration (EBSA), and the Centers for Medicare & Medicaid Services (CMS) published a proposed rule that would revise Affordable Care Act (ACA) summary of benefits and coverage (SBC) and uniform glossary requirements for group health plans and health insurance coverage. The changes, which would modify a February 14, 2012 rulemaking, are intended to help plans and individuals better understand their health coverage options and compare plans. For instance, the proposed rule would add another coverage example to the SBC to illustrate costs for consumers, streamline the SBC, and revise the uniform glossary that helps consumers understand insurance terms. If finalized, the new requirements would be implemented for plan years beginning on or after September 1, 2015. Comments on the proposed changes are due by March 2, 2015.  The Departments also issued revised draft SBC template, instructions, and supplemental materials.

Separately, the agencies published a proposed rule on December 23, 2014 that would amend the definition of excepted benefits to allow group health plan sponsors, in limited circumstances, to offer wraparound coverage to individuals who are purchasing individual health insurance in the private market, including through the ACA Health Insurance Marketplace. The rule proposes the following pilot programs for wraparound coverage: a pilot allowing wraparound benefits only for Multi-State Plans in the Marketplace, and a pilot allowing wraparound benefits for part-time workers or retirees who enroll in an individual market plan. There are several significant conditions and limitations to this type of coverage. This type of wraparound coverage could be offered as excepted benefits to coverage that is first offered no later than December 31, 2017 and that ends on the later of: (1) the date that is three years after the date wraparound coverage is first offered; or (2) the date on which the last collective bargaining agreement relating to the plan terminates after the date wraparound coverage is first offered.  Comments will be accepted until January 22, 2015.

Annual OIG Solicitation of Anti-Kickback Safe Harbor, Fraud-Alert Topic Proposals

Today the HHS Officeof Inspector General (OIG) published its annual solicitation of recommendations for new or modified safe harbor provisions under the federal anti-kickback statute, as well as potential topics for new OIG Special Fraud Alerts. Comments will be accepted until March 2, 2015. 

In a separate report, the OIG discusses three safe harbor proposals received in response to its 2013 solicitation:

  • A new safe harbor protecting free continuing medical education programs offered by hospitals to physicians – The OIG is not adopting this suggestion, stating that the concept of free programs could vary greatly and should be addressed on a case-by-case basis, such as under the advisory opinion process.
  • A new safe harbor that would permit health care providers and suppliers in certain circumstances to compensate individuals in clinical trials and to provide services related to the clinical trials at no cost, including the waiver of cost-sharing obligations – The OIG is considering the adoption of a safe harbor that would protect the waiver of cost-sharing obligations and possibly other incentives to participants in clinical trials sponsored by certain federal government entities.
  • A new safe harbor protecting clinically integrated networks’ entry into contracts with commercial third party payors for value-based payments, including pay-for-performance bonuses and shared savings awards for high quality and cost-effective health care – The OIG believes the issues raised in the proposal require further study.

Happy New Year! FDA Helps Industry Ring in New Year with Generous DSCSA Compliance Policy

This post was written by Kevin M. Madagan.

Time to pop the bubbly a little early! FDA announced today that the Drug Supply Chain Security Act (DSCSA) deadline of January 1, 2015 for product tracing (i.e., the new federal pedigree standards) will not be enforced until May 1, 2015. This means manufacturers, wholesale distributors, and repackagers have an additional four months to work with trading partners to determine how best to comply with the DSCSA pedigree standards.  Although we are not surprised by this development, it is still cause to celebrate, given the potential adverse impact of enforcing the requirements before industry is prepared for compliance.

The new DSCSA Compliance Policy – DSCSA Implementation: Product Tracing Requirements – Compliance Policy Guidance for Industry – announces that FDA “recognizes” that some manufacturers, wholesale distributors, and repackagers “may need additional time to work with trading partners” to ensure that all of the product tracing information required under the DSCSA is provided to and captured by the recipient trading partner. It also acknowledges the very real concern that enforcing the January 1, 2015 deadline could disrupt the supply chain and impact patients’ access to needed prescription drugs. 

The DSCSA Compliance Policy is clear: FDA “does not intend to take action against trading partners (manufacturers, wholesale distributors, and repackagers) who do not, prior to May 1, 2015, provide or capture the transaction information, transaction history, and transaction statement required by section 582 of the FD&C Act (product tracing information) associated with each transaction of certain human, finished prescription drugs, as defined in section 581 of the FD&C Act (21 U.S.C. 360eee).” The policy is limited only to the DSCSA requirements that trading partners provide and capture product tracing information; it does not extend to other DSCSA requirements, such as verification related to suspect and illegitimate product (including quarantine, investigation, notification and recordkeeping) and requirements related to engaging in transactions only with authorized trading partners.

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.

Older Entries

December 2, 2014 — FDA Public Meeting on Regulatory Oversight of Laboratory Developed Tests (Jan 8-9)

December 1, 2014 — CMS Extends Comment Period on Home Health COP Proposed Rule

November 20, 2014 — CMS Publishes Final 2015 Medicare Physician Fee Schedule Rule for 2015

November 20, 2014 — CMS Finalizes CY 2015 Medicare OPPS/ASC Rates & Policies

November 20, 2014 — CMS Adopts Major Changes to Medicare DMEPOS Payment/Coverage Policy Inside/Outside of Competitive Bidding Areas

November 20, 2014 — CMS Finalizes 0.3% Cut in Medicare Home Health PPS Rates for CY 2015

November 20, 2014 — CMS Publishes Final 2015 ESRD PPS Rule

November 19, 2014 — CMS Adopts Changes to Open Payments/Physician Payment Sunshine Act Regulations

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