Health Industry Washington Watch

Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry

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Latest from Health Industry Washington Watch

Health Industry Washington Watch

House Clears Prescription Drug Price Transparency, Health Workforce Legislation

By Debra A. McCurdy

November 4, 2019

The House of Representatives has approved — without objection — a series of bills intended to promote prescription drug pricing transparency and invest in the health care workforce. With regard to drug pricing transparency, the House approved HR 2115, the Public Disclosure of Drug Discounts Act, as amended to include HR 3415, the Real-Time Beneficiary Drug Cost Bill. The legislation would require the Secretary of Health and Human Services to make public certain…

Health Industry Washington Watch

Three House Panels Approve HR 3, the Lower Drug Costs Now Act

By Debra A. McCurdy

November 4, 2019

Three House committees have approved drug pricing legislation that is a high priority of the House Democratic leadership. Specifically, HR 3, the Lower Drug Costs Now Act of 2019, has been approved by the Energy and Commerce Committee, the Ways and Means Committee, and the Education and Labor Committee. While the details of the committee-approved bills vary, they generally would require manufacturers of certain prescription drugs to negotiate prices with the…

Health Industry Washington Watch

CMS Updates Medicare DMEPOS Policies, Including Overhaul of Pricing Framework for New HCPCS Codes

By Debra A. McCurdy

November 1, 2019

The Centers for Medicare & Medicaid Services (CMS) has adopted — with limited changes — its controversial plan to rewrite Medicare pricing rules for new items of durable medical equipment (DME), prosthetics, orthotics and supplies (DMEPOS) as part of its annual DMEPOS policy update for calendar year (CY) 2020. The rule also makes minor changes to DMEPOS competitive bidding program (CBP) rules, streamlines certain requirements for ordering DMEPOS items, and makes other related policy changes. The rule…

Health Industry Washington Watch

OIG, CMS Propose Changes to Stark, Anti-Kickback Rules to Promote Value-Based Arrangements: Reed Smith Analysis

By Debra A. McCurdy

October 28, 2019

As previously reported, the Department of Health and Human Services has published highly anticipated proposed changes to align the regulations under the Physician Self-Referral Law, the federal Anti-Kickback Statute, and the Civil Monetary Penalties Law with value-based health care arrangements. Reed Smith is providing a series of client alerts and teleseminars that analyze key aspects of the proposals and significant areas for comment (the comment period runs through December 31, 2019). Part One, presented…

Health Industry Washington Watch

HHS to Rescind Standard Unique Health Plan Identifier and Other Entity Identifier

By Debra A. McCurdy

October 28, 2019

The Department of Health and Human Services (HHS) has adopted its proposal to rescind the standard unique health plan identifier (HPID) and the “other entity identifier” (OEID), along with related implementation specifications and requirements for their use. HHS adopted the HPID and OEID in a September 5, 2012 final rule in order to improve the utility of the HIPAA transactions, but subsequently delayed enforcement due to implementation concerns raised by health plan and other…

Health Industry Washington Watch

Wrap-Up of October Congressional Health Policy Hearings

By Debra A. McCurdy

October 28, 2019

October Congressional hearings have focused on the following health policy topics: A House Ways and Means Committee hearing addressed “Investing in the U.S. Health System by Lowering Drug Prices, Reducing Out-of-Pocket Costs, and Improving Medicare Benefits.” A House Energy and Commerce Committee hearing, “Sabotage: The Trump Administration’s Attack on Health Care,” featured testimony from CMS Administrator Seema Verma. The Senate Aging Committee examined national, state, and local fall prevention efforts. The Senate Finance Committee held…

Health Industry Washington Watch

Expansive New CMS Enrollment and Participation Rules Set to Go Live November 4, Although Comments Still Being Accepted

By Debra A. McCurdy

October 25, 2019

The Centers for Medicare & Medicaid Services (CMS) has published a final rule with comment period establishing sweeping disclosure and monitoring obligations for providers and suppliers enrolled or enrolling in federal health programs, and expanding CMS’s authority to deny or revoke enrollment status. In particular, the rule establishes an expansive new “affiliations” disclosure requirement that allows CMS to identify individuals and organizations that, according to CMS, pose an undue risk of fraud, waste or abuse…

Health Industry Washington Watch

President Trump Signs Executive Order on “Protecting and Improving Medicare for Our Nation’s Seniors”

By Debra A. McCurdy

October 22, 2019

President Donald Trump has signed an executive order that commits the Department of Health and Human Services (HHS) to taking a series of regulatory and subregulatory actions intended to enhance the fiscal sustainability of the Medicare program, reduce regulatory burdens on providers, and increase beneficiary choice. The planned initiatives, which would require further policy development and potentially statutory changes, generally are in line with market-based themes the Administration has emphasized previously. The President also used…

Health Industry Washington Watch

CMS Posts Preliminary 2020 Medicare Clinical Lab Payment Determinations

By Debra A. McCurdy

October 15, 2019

Preliminary 2020 Medicare clinical laboratory fee schedule (CLFS) payment determinations for new and reconsidered clinical lab test codes are now available for review. For each code, the Centers for Medicare & Medicaid Services (CMS) announces whether it intends to use crosswalking or gapfilling to establish the payment rate, along with the agency’s rationale for its decision. CMS will accept public comments on these preliminary determinations through October 27, 2019, and final determinations will be…

Health Industry Washington Watch

CMS Schedules Town Hall Meeting to Consider FY 2021 IPPS New Technology Add-On Payment Applications

By Debra A. McCurdy

October 15, 2019

Fiscal year (FY) 2021 applications for Medicare inpatient prospective payment system (IPPS) new technology add-on payments will be discussed at a December 16, 2019 Centers for Medicare & Medicaid Services (CMS) town hall meeting. Depending on the number of applications, a second day of meetings may be held on December 17. The meetings provide an opportunity for interested parties to present data and recommendations regarding whether pending applications meet the CMS substantial clinical improvement criterion,…

Health Industry Washington Watch

Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry

Blog Authors

House Clears Prescription Drug Price Transparency, Health Workforce Legislation

Three House Panels Approve HR 3, the Lower Drug Costs Now Act

CMS Updates Medicare DMEPOS Policies, Including Overhaul of Pricing Framework for New HCPCS Codes

OIG, CMS Propose Changes to Stark, Anti-Kickback Rules to Promote Value-Based Arrangements: Reed Smith Analysis

HHS to Rescind Standard Unique Health Plan Identifier and Other Entity Identifier

Wrap-Up of October Congressional Health Policy Hearings

Expansive New CMS Enrollment and Participation Rules Set to Go Live November 4, Although Comments Still Being Accepted

President Trump Signs Executive Order on “Protecting and Improving Medicare for Our Nation’s Seniors”

CMS Posts Preliminary 2020 Medicare Clinical Lab Payment Determinations

CMS Schedules Town Hall Meeting to Consider FY 2021 IPPS New Technology Add-On Payment Applications

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