HRSA Issues Interpretive Rule on 340B Orphan Drug Exclusion

On July 21, 2014, the Health Resources and Services Administration (HRSA) released an “interpretive rule” reiterating that 340B-covered entities affected by the orphan drug exclusion may purchase orphan drugs at 340B prices when those orphan drugs are used for indications other than the rare disease or condition for which the drug received an orphan designation. HRSA’s previous regulations implementing this policy were vacated by a May 23, 2014 U.S. District Court ruling because of a lack of statutory authority to engage in such rulemaking.

Under the interpretive rule, HRSA reiterates that section 340B(e) of the Public Health Service Act (PHSA) excludes drugs with an orphan designation only when those drugs are transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the drug was designated as an orphan drug under section 526 of the Federal Food, Drug, and Cosmetic Act (FFDCA). The agency holds that Section 340B(e) does not exclude drugs used for conditions or diseases other than for which the drug was designated under section 526 of the FFDCA. According to HRSA, “interpreting the statutory language to exclude all indications for a drug that has an orphan drug designation would be contrary to the Congressional intent of section 340B(e) to balance the interests of orphan drug development and the expansion of the 340B Program to new entities.” To facilitate identification of drugs with an orphan designation for 340B Program purposes, HRSA will publish and update on a quarterly basis a listing of orphan drug designations, providing the name of the drug and the designated indication. If a covered entity lacks the ability to track drug use by indication, it would be unable to purchase drugs with orphan designations through the 340B Program.

The interpretive rule is effective July 21, 2014. Note that the Pharmaceutical Research and Manufacturers of America (PhRMA), which filed the original lawsuit on the 340B orphan drug regulation, has filed a motion asserting that “HHS’s actions are in direct circumvention” of the prior court ruling, and challenging HRSA’s authority to implement this policy through an interpretive rule.

HHS Provides Update on ACA Insurance Costs and Choices, Announces Management Changes

HHS has released a report on premiums, tax credits, and health plan choices on the ACA federal Marketplace for plans operating in 2014.  In addition, CMS has launched an initiative, dubbed “From Coverage to Care," designed to answer questions consumers may have about their new health coverage under the ACA and to help individuals make the most of their new benefits. The Administration also has announced a number of management changes at CMS designed to strengthen implementation of the ACA going forward, including a Principal Deputy Administrator to oversee ACA Marketplace and other agency operations, a Marketplace Chief Executive Officer, and a Marketplace Chief Technology Officer.

HRSA Stands by its Interpretation of the 340B Orphan Drug Exclusion Despite District Court Ruling

In a recent website update, the Health Resources and Services Administration (HRSA) reaffirmed its current interpretation of the 340B discount drug program orphan drug exemption – despite a May 23, 2014 U.S. District Court ruling that vacated HRSA’s orphan drug regulation because of lack of the statutory authority to engage in such rulemaking. According to HRSA, the Court did not invalidate HRSA’s interpretation of the statute, under which HRSA allows 340B-covered entities affected by the orphan drug exclusion to purchase orphan drugs at 340B prices when those orphan drugs are used for indications other than the rare disease or condition for which the drug received an orphan designation.

HHS Secretary Nominee Burwell Confirmed by Senate

The Senate has confirmed Sylvia Mathews Burwell to be Secretary of Health and Human Services on a bipartisan vote of 78 to 17.  Secretary Burwell was sworn in on June 9, 2014.

CMS to Implement Ordering/Referring Denial Edits for HHA Certifying Physicians, Effective July 1, 2014

CMS plans to apply “Phase 2” ordering and referring denial edits to certifying physicians of Part A home health agency (HHA) services effective July 1, 2014. These edits, which currently apply only to the attending physician of an HHA, will ensure that the physician that certifies the patient’s eligibility to receive services under the Medicare home health benefit has a valid individual National Provider Identifier (NPI) and are of a specialty type eligible to order and refer the HHA items and services on the claim. The edits will deny the claim when this information is missing or invalid.

CMS Announces Reforms to Quality Improvement Organization Program

On May 9, 2014, CMS announced it is implementing the first phase of its reforms to the Quality Improvement Organization (QIO) Program in an effort to “gain efficiencies, to eliminate any perceived conflicts of interest, and to better address the needs of Medicare beneficiaries.” Under this first phase, CMS has named two Beneficiary and Family-Centered Care (BFCC) QIO contractors -- Livanta LLC and KePRO -- to support case review and monitoring activities on behalf of patients, separate from traditional QIO quality improvement activities. Under the second phase, which is expected to be announced in July, CMS will award contracts to organizations that will focus on data-driven quality initiatives intended to improve patient safety, reduce harm, and improve clinical care and transparency.

CMS Extends "Hardship Exemptions" Policy for Health Insurance Purchasers

CMS has provided additional guidance on its evolving hardship exemptions policy for individuals who had difficulty signing up for a qualified health plan (QHP) through an Affordable Insurance Exchange by the March 31, 2014 deadline. As previously reported, in March CMS announced it had established a “special enrollment period” for individuals who were “in line” but could not complete the enrollment process by March 31 deadline; such individuals were permitted to claim a hardship exemption from the shared responsibility payment for the months prior to the effective date of their coverage. According to a subsequent May 2, 2014 guidance document, CMS believes that “some consumers may not have realized that the relief provided by the guidance above was limited solely to those individuals purchasing QHPs through the Marketplace.” CMS therefore is extending a comparable hardship exemption for all months prior to the effective date of coverage for individuals who obtained minimum essential coverage effective on or before May 1, 2014 outside of the Marketplace, whether the individual is in a state with a federally-facilitated Marketplace or a state-based Marketplace. The May 2 guidance also discusses special enrollment periods for individuals eligible for COBRA, individuals whose individual market plans are renewing outside of open enrollment, and AmeriCorps/VISTA/National Civilian Community Corps members.

Stolen Unencrypted Laptops Results in HIPAA Settlements for Two Health Companies

Two more health care companies have settled potential violations of the HIPAA Privacy and Security Rules arising from the theft of unencrypted laptops by paying a total of almost $2 million and agreeing to continued oversight by the HHS Office for Civil Rights (OCR). In both instances, the breaches were self-reported and the settlements resulted from OCR’s subsequent investigations. For details, see the report on our Life Sciences Legal Update blog.

HRSA Releases 340B Audit Results

On May 9, 2014, the Health Resources and Services Administration (HRSA) released the results of its FY 2012 audits of covered entity compliance with 340B drug discount program rules. Based on a review of 51 covered entities encompassing more than 410 outpatient facilities/sub-grantees and more than 860 contract pharmacy locations, HRSA identified “several recurring critical areas of non-compliance for hospitals and non-hospitals.” For non-hospitals, HRSA flagged the following major non-compliance areas: the covered entity’s inability to maintain accurate database information; billing contrary to the Medicaid Exclusion File (which may have resulted in duplicate discounts); and dispensing drugs to ineligible individuals (diversion) at the covered entity and contract pharmacies. For hospitals, the major area of non-compliance cited by HRSA was obtaining covered outpatient drugs through a Group Purchasing Organization (GPO) in violation of statutory restrictions. HRSA also identified best practices to minimize the risks of non-compliance by covered entities, including: development and documentation of comprehensive 340B Program policies and procedures; development of concrete methodologies for routine self-auditing; routine processes for internal corrective action; verification that contract pharmacy arrangements comply with the 340B requirements and are properly listed in the HRSA Office of Pharmacy Affairs database; and strong partnerships with state Medicaid agencies to meet state-specific requirements and prevent duplicate discounts.

Sebelius Stepping Down from HHS; Burwell Nominated

On April 11, 2014, President Obama formally nominated Sylvia Mathews Burwell to replace Kathleen Sebelius as Secretary of Health and Human Services (HHS). Burwell currently is the Director of the Office of Management and Budget (OMB). Previously, she served as President of the Walmart Foundation, President of the Global Development Program at the Bill & Melinda Gates Foundation, and in several roles during the Clinton Administration, including Deputy Director of OMB, Deputy Chief of Staff to the President, Chief of Staff to the Secretary of the Treasury, and Staff Director of the National Economic Council.

HHS Releases HIPAA Security Risk Assessment Tool

HHS has developed a Security Risk Assessment (SRA) tool to help providers comply with a Health Insurance Portability and Accountability Act (HIPAA) requirement that covered entities conduct a risk assessment to ensure compliance with HIPAA’s administrative, physical, and technical safeguards and to determine where electronic protected health information could be at risk. The SRA tool is intended to help entities regulated under HIPAA better understand potential vulnerabilities and identify safeguards that they could institute.

Obama Administration Proposes FY 2015 Budget with Medicare, Medicaid Savings Provisions

On March 4, 2014, the Obama Administration released its proposed federal budget for fiscal year (FY) 2015. Virtually all types of health care providers, health plans, and drug manufacturers would be impacted by the budget provisions if adopted as proposed – an unlikely scenario given the Republican House leadership’s reaction to the document. Nevertheless, the Medicare and Medicaid savings proposals (many of which are carry-overs from prior budgets) could resurface as spending offsets in the pending negotiations on Medicare physician fee schedule reform legislation or in future budget negotiations. Highlights of the Administration’s Medicare and Medicaid legislative proposals include the following (all savings estimates are for the 10-year period of FYs 2015-2024):

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FDA Provides Direction on "Dear Doctor" Letters

This post was written by Jillian W. Riley.

On January 16, 2014, the Food and Drug Administration (FDA) issued a final guidance document for industry providing specific recommendations on the content and format of Dear Health Care Provider (DHCP or “Dear Doctor”) letters. DHCP letters are an important means of communicating new information to the health care provider community about a product that is already on the market. The guidance provides insight into (1) when to send a DHCP letter, (2) what information should be included, (3) how to organize the letter, and (4) how to format the letter. The recent guidance finalizes a draft guidance FDA published in November of 2010. 

The guidance stresses the importance of collaborating with FDA when crafting DHCP letters to ensure that a DHCP letter is appropriate under the circumstances, that the target audience has been identified, and that the message is clearly conveyed. Additionally, the guidance provides template examples to aid industry in drafting a clear and effective DHCP letter.

Medicare Appeals Backlog Prompts Hold on New Provider Appeals

Citing a “rapid and overwhelming increase in claim appeals,” the HHS Office of Medicare Hearings and Appeals (OMHA) has temporarily suspended the assignment of most new provider requests for an Administrative Law Judge (ALJ) hearing. In a memorandum to high-volume appellants dated December 24, 2013, Chief ALJ Nancy Griswold announced that the suspension, which was effective July 15, 2013, is expected to last at least 2 years, during which the OMHA will work through a backlog of appeals involving almost 357,000 Medicare claims and entitlements already assigned to the 65 ALJs. Note that notwithstanding the suspension, OMHA will continue to assign and process requests filed directly by Medicare beneficiaries. As previously reported, the OMHA is hosting a Medicare Appellant Forum on February 12, 2014 to provide additional information to appellants and providers on efforts to make the appeals process work more efficiently.

FDA Releases Final Guidance on Qualification Process for Drug Development Tools

This post was written by Jennifer Pike.

The Food and Drug Administration (FDA) has announced the availability of a final guidance document which describes the qualification process for drug development tools (DDTs) intended for use, over time, in multiple drug development programs. DDTs are methods, materials, or measures that aid drug development. Examples of DDTs include biomarkers and patient reported outcome instruments.

The purpose of the guidance document is to describe the formal process that FDA will use in working with sponsors of DDTs to guide them as they refine the tools and rigorously evaluate them for use in the regulatory process. The guidance also provides a framework for interactions between FDA and sponsors to support work towards qualification of DDTs, as well as explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for FDA’s formal review of the data to ultimately qualify the DDT. For purposes of the guidance, the submitter of a DDT is the person, group, organization (including the federal government), or consortium that takes responsibility for and initiates a DDT qualification proposal using the procedures described in the guidance.

The creation of the DDT qualification process is one of multiple initiatives FDA has undertaken, as a result of its 2004 FDA’s Critical Path Initiative, to support the development of new DDTs. DDTs can help streamline the drug development process, improve the chances for clinical trial success, and yield more information about a treatment or disease. Comments to the guidance may be submitted at any time at www.regulations.gov.

HHS Allows Grandfathering of Certain Insurance Policies Cancelled under ACA Rules

President Obama announced on November 14, 2013 that HHS has adopted an administrative policy to allow insurers to continue to offer certain health insurance policies scheduled to be cancelled effective January 1, 2014 because of more stringent coverage requirements under the ACA. In short, under the“transitional” policy outlined in a letter to state insurance commissioners, health insurance issuers may choose to continue coverage that would otherwise be terminated or cancelled, and affected individuals and small businesses may choose to re-enroll in such coverage if the coverage was in effect on October 1, 2013 and the insurer meets certain conditions, including notification to the affected insureds regarding: (1) any changes in the options that are available to them; (2) which of the specified market reforms would not be reflected in any coverage that continues; (3) their potential right to enroll in a qualified health plan offered through a Health Insurance Marketplace and possibly qualify for financial assistance; (4) how to access such coverage through a Marketplace; and (5) their right to enroll in health insurance coverage outside of a Marketplace that complies with the specified market reforms.  State agencies responsible for enforcing the specific market reforms are “encouraged to adopt the same transitional policy.” The letter notes the risk corridor program should help ameliorate unanticipated changes in premium revenue for health insurers, although the Administration will consider additional regulatory changes to provide additional assistance. The policy applies to health insurance coverage that is renewed for a policy year starting between January 1, 2014, and October 1, 2014, but the Administration has left open the possibility of extending the transition policy. Despite this announcement, House Speaker John Boehner has indicated that the House will proceed with its scheduled vote tomorrow on H.R. 3350, the “Keep Your Health Plan Act.” 

Obama Administration Releases Initial Health Insurance Marketplace Enrollment Numbers

On November 13, 2013, HHS issued its first report on ACA Health Insurance Marketplace/Exchange enrollment statistics. According to the Administration, 106,185 individuals have selected health plans during the first 33 days of the open enrollment period (October 1 through November 2, 2013), although this figure also includes individuals who have not yet purchased a policy and who are technically not yet enrolled in a plan. Note that the majority of the individuals who have selected a plan – almost 75% -- have gone through a state-based marketplace, with fewer than 27,000 individuals selecting a plan through the federally-facilitated marketplace (where HHS is running the marketplace alone or in partnership with the state). State numbers vary significantly, with 35,364 individuals in California selecting a plan through the state-run marketplace (about a third of all insurance selections nationwide for the period), compared to only 42 North Dakota residents selecting a plan through the federal marketplace. An additional 396,261 individuals nationwide have been assessed to be eligible for Medicaid or CHIP, representing 26% of the total applicants for coverage through the marketplaces. HHS also reports high volumes of traffic on marketplace websites and call centers, with almost 25 million unique visitors on marketplace websites and more than 3.1 million calls to state and federal marketplace call centers.

CMS Announces Medicare DMEPOS Bidding Round 1 Recompete Contract Suppliers

CMS has announced the names of 282 suppliers that have been awarded 3-year contracts under the Medicare DME, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program “Round 1 Recompete.” As discussed in our previous reports, this phase of bidding applies to nine geographic areas where competitive bidding contracts have been in effect since 2011, but it includes a broader array of products than currently covered. The contract period for the Round 1 Recompete is January 1, 2014 through December 31, 2016.

By way of background, under DMEPOS competitive bidding, only suppliers that are winning bidders, meet licensing and other standards, and enter into a contract with CMS may furnish selected categories of DMEPOS to Medicare beneficiaries in competitive bidding areas (CBAs), with very limited exceptions. Contract suppliers are paid based on the median of the winning suppliers’ bids in the CBA, rather than the DMEPOS fee schedule amount. CMS reported earlier this year that Medicare reimbursement will be cut by an average of 37% compared to fee schedule amounts under the Round 1 Recompete contracts, which include the following six product categories: (1) Respiratory Equipment and Related Supplies and Accessories (includes oxygen, oxygen equipment, and supplies; continuous positive airway pressure devices and respiratory assist devices, and related supplies and accessories; and standard nebulizers); (2) Standard Mobility Equipment and Related Accessories (includes walkers, standard power and manual wheelchairs, scooters, and related accessories); (3) General Home Equipment and Related Supplies and Accessories (includes hospital beds and related accessories, group 1 and 2 support surfaces, transcutaneous electrical nerve stimulation devices (TENS), commode chairs, patient lifts, and seat lifts); (4) Enteral Nutrients, Equipment and Supplies; (5) Negative Pressure Wound Therapy Pumps and Related Supplies and Accessories; and (6) External Infusion Pumps and Supplies.

CMS reports that Round 1 Recompete contract suppliers have 620 locations to serve Medicare beneficiaries in the CBAs, and about 58% of these suppliers are “small suppliers” with gross revenues of $3.5 million or less. CMS will now accelerate educational efforts aimed at suppliers, referral agents, and beneficiaries in preparation for the new contracts.

CMS Guidance on Medicare Inpatient Hospital Admissions Two-Midnight Policy

CMS continues to release subregulatory guidance on the inpatient hospital admission/medical review criteria that were adopted in the final FY 2014 Medicare inpatient prospective payment system/long-term care hospital final rule. In short, under this new policy, if the ordering practitioner expects a beneficiary’s surgical procedure, diagnostic test, or other treatment to require a stay in the hospital lasting at least two midnights, and admits the beneficiary as an inpatient based on that expectation, it is generally appropriate that the hospital receive Medicare Part A payment. The order must also be documented in the medical record in accordance with the regulations, and a physician must certify the medical necessity of hospital inpatient services. CMS recently posted updated subregulatory instructions related to prepayment and post-payment review schedules and parameters, along with answers to frequently-asked implementation questions.

CMS Launches Virtual Research Data Center

On November 12, 2013, CMS announced the launch of its Virtual Research Data Center (VRDC), which is intended to provide researchers with more convenient, timely, and cost-effective access to secure CMS health care data without needing to request that the agency ship encrypted data files. According to CMS, traditional physical delivery of a large sample of Medicare Parts A, B, and D data can cost more than $100,000 for a single year of data, while a researcher’s use of the VRDC for a single project over the course of the year would cost approximately $40,000. CMS notes that individually-identifiable beneficiary information remains in the CMS data environment under the VRDC model, which helps safeguard against breaches or unauthorized uses of the data.

Older Entries

November 14, 2013 — Applications for 2015 HCPCS Codes Due Jan. 3, 2014

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

October 10, 2013 — ACA Health Insurance Marketplace Opens for Business to Mixed Reviews

October 10, 2013 — CMS Limits Compliance Reviews under New "2 Midnight" Inpatient Admissions Policy

October 10, 2013 — CMS Posts Revised Gapfill Payments for New Molecular Pathology Codes; Reconsideration Requests Due Oct. 30, 2013

October 9, 2013 — Government Shutdown Update: Medicare Claims Processing Continues, but Other Key Functions on Hold

October 9, 2013 — CMS Sets 1% Payment Update for Medicare Ambulance Rates in 2014

October 8, 2013 — HHS OCR Releases HIPAA Privacy Rule Guidance Documents

October 7, 2013 — Medicare Rates to Fall by Average of 37% under DMEPOS Competitive Bidding "Round 1 Recompete" Contracts

August 2, 2013 — New Draft Guidances from FDA Address Expedited Review, Safety Labeling and More

July 29, 2013 — OIG Self-Disclosure Protocol Submissions

June 28, 2013 — CMS Delays DME Face-to-Face Requirement until Oct. 1, 2013

June 11, 2013 — Medicare Trustees Forecast Longer Medicare Solvency

May 13, 2013 — HHS Releases Enhanced National Standards for Culturally and Linguistically Appropriate Services (CLAS) in Health Care, Highlights Compliance Efforts

May 13, 2013 — HHS Update on HIT Activities

April 15, 2013 — FDA Draft Guidance on Biosimilar Product Development Now Available

March 13, 2013 — CMS Issues First Guidance on Sequestration Impact on Medicare

March 13, 2013 — HHS Suspends Enrollment in Pre-Existing Condition Insurance Plan (PCIP)

March 13, 2013 — CMS Offers Tips and Timelines for ICD-10 Implementation

March 12, 2013 — 2013 Medicare Participation Enrollment Period for DMEPOS Suppliers Extended until April 15, 2013

March 12, 2013 — April 2013 Update to Medicare ASP Files

March 12, 2013 — FDA Issues New Guidance Documents

January 29, 2013 — CMS Issues Revised CMS-855S, 855O Medicare Enrollment Applications

January 29, 2013 — CMS Previews Medicaid Core Set of Health Home Quality Measures

January 29, 2013 — PCORI Seeking Nominations for Advisory Panels

January 29, 2013 — New FDA Draft Guidance Addresses Combination Product Postapproval Modification Submissions

January 14, 2013 — CMS Announces 90-Day Enforcement Discretion Period for HIPAA Eligibility & Claim Status Operating Rules

January 14, 2013 — ONC Seeks Comments on Health IT Patient Safety Action and Surveillance Plan

January 11, 2013 — CMS Releases Updated Draft Medicaid FUL Files

January 9, 2013 — OCR Announces First HIPAA Breach Settlement Involving Less than 500 Individuals

December 3, 2012 — OCR Issues Guidance on De-identifying Protected Health Information

November 12, 2012 — CMS Releases 2013 HCPCS Update

September 28, 2012 — Hospitals Return Fire After Administration Warns Hospitals Against Gaming Payments through Electronic Health Records

September 27, 2012 — CMS Invites Comments on Preliminary Supervision Level Decisions for Selected Hospital Outpatient Services

September 27, 2012 — CMS Releases October 2012 Update to Medicare Part B Drug ASP Files

September 27, 2012 — CMS Releases Medicare Beneficiary Ombudsman Report

September 27, 2012 — HHS Report Details Savings from ACA Insurance Premium Standards

September 5, 2012 — Preliminary 2013 Medicare Clinical Laboratory Fee Schedule Determinations

September 5, 2012 — FDA Guidance on FY 2013 Medical Device User Fee Small Business Qualification and Certification

September 5, 2012 — FDA Issues Guidance for Comment on Refuse to Accept Policy for 510(k)s

August 8, 2012 — Putting Contractors on Notice: The New Public-Private Partnership Joins DOJ, HHS, and Private Sector Partners to Combat Health Care Fraud

July 31, 2012 — Obama Administration Public-Private Partnership Targets Health Care Fraud Prevention

July 31, 2012 — HHS Announces Funding Opportunity for State Innovation Models Initiative

July 31, 2012 — FDA Issues Draft Guidance Regarding Acceptance & Filing Review for PMA Applications

July 31, 2012 — Updated Draft Medicaid Drug Payment FUL Files Released

July 19, 2012 — HIPAA Electronic Funds Transfer, Remittance Advance Standards

July 19, 2012 — CMS Nursing Home Action Plan

July 19, 2012 — CMS Guidance on Medicaid Integrated Care Models

July 19, 2012 — CMS Answers Questions on 3-Day Payment Window Impact on Physician Offices

June 27, 2012 — Health IT Pilot Targets Prescription Drug Abuse

June 27, 2012 — CMS Outlines Conditions for Provider Use of Repackaged Medications

June 27, 2012 — Insurers to Provide $1.1 Billion in Rebates Under ACA Medical Loss Ratio (MLR) Standard

June 18, 2012 — National Prevention Council Action Plan Released

June 8, 2012 — CMS Accepting Comments on Draft Methodology for Calculating National Average Drug Acquisition Cost (NADAC)

June 8, 2012 — CMS Updates Supervision Levels for Selected HOPPS Services

June 8, 2012 — HHS Resources on Patient Access to Health Data

May 31, 2012 — HHS Corrects ACA Affordable Insurance Exchanges Rule, Issues Guidance for States.

May 14, 2012 — HHS Risk Adjustment Bulletin

May 10, 2012 — New ONC Health IT Resources

April 23, 2012 — HHS Issues its Open Government Plan Version 2.0

April 23, 2012 — HHS Establishes Administration for Community Living

April 23, 2012 — HHS seeks Comments on Revised Healthcare-Associated Infections (HAI) Action Plan

March 14, 2012 — CMS Releases Redesigned Medicare Benefit Statements

March 14, 2012 — Medicare Claims Must Use Version 5010 Format By April 1, 2012

March 14, 2012 — CMS Launches Medicare Advantage (MA) Audit Initiative

March 14, 2012 — 340B Enforcement Activities.

February 28, 2012 — HHS Announces Intent to Delay ICD-10 Compliance Date

February 28, 2012 — CMS Seeks Comments on Approach to ACA Actuarial Value and Cost-Sharing Reductions

February 28, 2012 — CMS Selects Initial ACA Insurance CO-Ops

February 28, 2012 — Status Report on ACA Pre-Existing Condition Insurance Plan (PCIP) Program

February 28, 2012 — HHS Frequently Asked Questions (FAQs) on ACA Essential Health Benefits

February 28, 2012 — CMS Proposes Medical Loss Ratio (MLR) Consumer Notices

February 28, 2012 — CMS Upgrades to PECOS Enrollment System

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

February 28, 2012 — FY 2011 Health Care Fraud and Abuse Control Program Report

February 28, 2012 — CMS Updates Data on DMEPOS Competitive Bidding Program Health Outcomes

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

February 24, 2012 — CMS Posts Draft FUL Files for November 2011

February 13, 2012 — HHS Health IT Challenge Targets Post-Discharge Care

February 13, 2012 — FDA Issues Guidance on New Informed Consent Requirements

January 25, 2012 — CMS Finalizes Rules on Payments to Retiree Prescription Drug Plan Sponsors

January 25, 2012 — CMS Proposes Changes to Medicaid DSH Rules

January 25, 2012 — HHS Revises Rules Regarding Coverage of Contraceptive Services for Certain Religious Groups Offering Insurance

January 25, 2012 — CMS Establishes Procedures for Claims Against DMEPOS Surety Bonds

January 25, 2012 — CMS Releases Additional Draft ACA Medicaid Drug Pricing/FUL Files

January 25, 2012 — FDA Completes Work on Three Drug User Fee Programs

January 25, 2012 — FDA Guidance on Product Name Placement in Advertising and Promotional Labeling

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

January 25, 2012 — National Health Care Spending Slowing, CMS Finds

January 5, 2012 — CMS Seeks Comments on ACA "Essential Health Benefits Bulletin"

December 13, 2011 — HHS Announces New Deadlines for Meaningful Use Compliance/EHR Incentives

December 13, 2011 — Summary of Benefits and Coverage Requirement Effective Date Delayed

December 13, 2011 — CMS Announces FY 2011 RAC Recovery Amounts

December 13, 2011 — CMS Posts First quarter 2012 Part B Drug ASP Files

December 13, 2011 — CMS Addresses Denials of HHA Claims Related to Face-to-Face Documentation Issues

December 13, 2011 — CMS Seeks Early Input on Future Quality & Efficiency Measures

December 13, 2011 — CMS Posts 2012 ICD-10-CM Code Update

December 13, 2011 — FDA Draft Guidance on Artificial Pancreas Device Systems, Hepatitis B Screening of Blood/Blood Components

November 30, 2011 — New CMS Demonstration Programs Target Medicare Improper Payments

November 30, 2011 — CMS Launches $1 Billion "Health Care Innovation Challenge"